ITTO20110394A1 - CATHETER EQUIPPED WITH ELECTROMAGNETIC POSITION SENSORS, AND LOCALIZATION SYSTEM FOR CATHETER AND WIRE GUIDES - Google Patents
CATHETER EQUIPPED WITH ELECTROMAGNETIC POSITION SENSORS, AND LOCALIZATION SYSTEM FOR CATHETER AND WIRE GUIDES Download PDFInfo
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- 208000002223 abdominal aortic aneurysm Diseases 0.000 description 2
- 210000003484 anatomy Anatomy 0.000 description 2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
- A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
- A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2051—Electromagnetic tracking systems
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Description
"Catetere munito di sensori elettromagnetici di posizione, e sistema di localizzazione per cateteri e fili guida" "Catheter equipped with electromagnetic position sensors, and localization system for catheters and guide wires"
DESCRIZIONE DESCRIPTION
La presente invenzione si riferisce ad un catetere comprendente The present invention relates to a catheter comprising
un corpo tubolare atto ad essere introdotto in una cavità corporea, detto corpo tubolare avendo una parte distale includente almeno una porzione curva o curvabile, e rispettivi segmenti di catetere ai capi di detta porzione curva o curvabile; e a tubular body adapted to be introduced into a body cavity, said tubular body having a distal part including at least one curved or curvable portion, and respective catheter segments at the ends of said curved or curvable portion; And
una pluralità di sensori elettromagnetici di posizione, ciascuno di questi essendo disposto su un rispettivo di detti segmenti di catetere, ed essendo predisposto per rendere disponibile, in risposta ad un campo magnetico generato esternamente, un segnale elettrico indicativo della posizione e dell’orientamento del rispettivo segmento di catetere. a plurality of electromagnetic position sensors, each of these being arranged on a respective of said catheter segments, and being arranged to make available, in response to an externally generated magnetic field, an electrical signal indicative of the position and orientation of the respective catheter segment.
La tecnica endovascolare à ̈ una branca miniinvasiva della chirurgia vascolare e non solo, in quanto negli anni à ̈ stata adottata da altre specialità , quali la radiologia interventistica, la cardiologia, la cardiochirurgia, la chirurgia toracica, chirurgia digestiva e neurochirurgia. The endovascular technique is a minimally invasive branch of vascular surgery and more, as over the years it has been adopted by other specialties, such as interventional radiology, cardiology, cardiac surgery, thoracic surgery, digestive surgery and neurosurgery.
La procedura endovascolare si basa sul cateterismo trans-arterioso o venoso attraverso il quale i dispositivi navigano su guide metalliche fino al sito del vaso da trattare. The endovascular procedure is based on trans-arterial or venous catheterization through which the devices navigate on metal guides to the site of the vessel to be treated.
L’accesso vascolare più utilizzato à ̈ quello retrogrado transfemorale (dall’arteria femorale comune), previa anestesia locoregionale con cateterizzazione secondo Seldinger. Se questo non fosse possibile, per l’occlusione dell’arteria femorale comune o iliaca, viene praticato un accesso brachiale o radiale. La guida viene inserita nell’ago, che poi verrà estratto, e viene inserito un introduttore standard ed eseguita un’arteriografia diagnostica, previo posizionamento di catetere tipo pig tail. L’angiografia evidenzia l’anatomia del vaso mediante l’iniezione di contrasto (un colorante radio-opaco) che viene proiettato live sul monitor dell’angiografo per mezzo di raggi X. The most used vascular access is the transfemoral retrograde one (from the common femoral artery), after locoregional anesthesia with catheterization according to Seldinger. If this is not possible, a brachial or radial approach is performed for occlusion of the common or iliac femoral artery. The guide is inserted into the needle, which will then be extracted, and a standard introducer is inserted and a diagnostic arteriography is performed, after placing a pig tail type catheter. Angiography highlights the anatomy of the vessel through the injection of contrast (a radio-opaque dye) which is projected live on the angiograph monitor by means of X-rays.
Lo sviluppo delle tecniche endovascolari ha permesso il miglioramento dei risultati per quanto concerne morbilità e mortalità , allargando il numero di pazienti trattabili. Nonostante ciò la tecnica endovascolare non à ̈ priva di complicanze e seppur mini-invasiva, i rischi associati all’iniezione di mezzo di contrasto (che à ̈ un farmaco nefrotossico) [1] e l’uso di radiazioni ionizzanti (13.4 /-8.6 mSv per la riparazione endovascolare di aneurismi, EVAR [2]), rende questa metodica non ancora completa. The development of endovascular techniques has allowed the improvement of the results as regards morbidity and mortality, increasing the number of treatable patients. Despite this, the endovascular technique is not without complications and although minimally invasive, the risks associated with the injection of contrast medium (which is a nephrotoxic drug) [1] and the use of ionizing radiation (13.4 / -8.6 mSv for endovascular repair of aneurysms, EVAR [2]), makes this method not yet complete.
Sono inoltre numerose le difficoltà tecniche per il chirurgo. I fluoroscopi tradizionali infatti forniscono immagini bidimensionali proiettive che richiedono all'operatore un’innaturale ricostruzione mentale della struttura tridimensionale dei vasi. Tale processo mentale, per essere eseguito correttamente, necessita di una notevole esperienza da parte dell’operatore che, prima di operare autonomamente, deve aver svolto un lungo periodo di addestramento sotto la supervisione di un chirurgo esperto. La navigazione all'interno delle strutture vascolari, basata esclusivamente su serie di proiezioni 2D delle stesse, richiede un continuo riaggiustamento del punto di vista del fluoroscopio e l'acquisizione di nuove serie di immagini. Un erra to posizionamento del fluoroscopio può inoltre comportare problemi come l’oscuramento dei vasi di interesse a causa delle strutture sovrastanti o l’erronea percezione della lunghezza dei vasi. There are also numerous technical difficulties for the surgeon. Traditional fluoroscopes in fact provide two-dimensional projective images that require the operator an unnatural mental reconstruction of the three-dimensional structure of the vessels. This mental process, to be carried out correctly, requires considerable experience on the part of the operator who, before operating independently, must have undergone a long period of training under the supervision of an expert surgeon. The navigation inside the vascular structures, based exclusively on series of 2D projections of the same, requires a continuous readjustment of the fluoroscope point of view and the acquisition of new series of images. Incorrect positioning of the fluoroscope can also lead to problems such as the darkening of the vessels of interest due to the overlying structures or the erroneous perception of the length of the vessels.
I recenti sviluppi nell’ambito della computer graphics, della realtà virtuale e del processing delle immagini hanno prodotto i primi lavori nell’ambito dei sistemi di assistenza computerizzata per la chirurgia endovascolare [3-10] e soluzioni commerciali sono oggi a disposizione per il mapping cardiaco e per l’interventistica cardiaca [11-13]. Recent developments in the field of computer graphics, virtual reality and image processing have produced the first works in the field of computerized assistance systems for endovascular surgery [3-10] and commercial solutions are now available for cardiac mapping and cardiac interventional mapping [11-13].
Tra i lavori di letteratura, S. Pujol [3, 10] ha sviluppato un sistema per il trattamento dell’aneurisma aortico addominale (AAA) basato sulla localizzazione elettromagnetica dell’endoprotesi e sulla registrazione di modelli 3D dell’anatomia del paziente acquisiti in sede pre-operatoria con un procedura di scansione di tomografia computerizzata (TC). Among the works of literature, S. Pujol [3, 10] has developed a system for the treatment of abdominal aortic aneurysm (AAA) based on the electromagnetic localization of the endoprosthesis and on the recording of 3D models of the patient's anatomy acquired preoperatively with a computed tomography (CT) scan procedure.
Il sistema proposto da S. Pujol si basa sull’impiego di un unico sensore elettromagnetico alloggiato all’interno di un’endoprotesi opportunamente modificata. I primi test [3] di validazione del sistema sono stati svolti utilizzando un catetere vascolare (diametro 3F, lunghezza 260 cm) equipaggiato con un sensore elettromagnetico Aurora® a cinque gradi di libertà (diametro 0.8 mm, lunghezza 10 mm), prodotto da Northern Digital Inc. The system proposed by S. Pujol is based on the use of a single electromagnetic sensor housed inside a suitably modified endoprosthesis. The first validation tests [3] of the system were carried out using a vascular catheter (diameter 3F, length 260 cm) equipped with an Aurora® five degrees of freedom electromagnetic sensor (diameter 0.8 mm, length 10 mm), manufactured by Northern Digital Inc.
Sempre S. Pujol ha descritto in [5] l’impiego di un sistema di navigazione elettromagnetico per la neurointerventistica. Anche in questo caso, à ̈ stato realizzato un catetere sensorizzato con un solo sensore elettromagnetico Aurora®. S. Pujol also described in [5] the use of an electromagnetic navigation system for neurointervention. Also in this case, a sensorized catheter was created with a single Aurora® electromagnetic sensor.
Un catetere del tipo definito all’inizio, munito di una pluralità di sensori elettromagnetici di posizione, à ̈ descritto in EP 2 238 901. Tale catetere noto presenta una pluralità di sensori costituiti da singole bobine distribuite lungo la parte distale del catetere, e disposte concentricamente con l’asse longitudinale di questo. A catheter of the type defined at the beginning, equipped with a plurality of electromagnetic position sensors, is described in EP 2 238 901. This known catheter has a plurality of sensors constituted by single coils distributed along the distal part of the catheter, and arranged concentrically with the longitudinal axis of this.
Come à ̈ noto, l’applicazione di sensori può comportare degli inconvenienti legati alla creazione indesiderata di ostacoli all’interno del lume del catetere, all’aumento delle dimensioni trasversali dello strumento, e/o alla riduzione della sua flessibilità . As is well known, the application of sensors can lead to drawbacks linked to the undesired creation of obstacles inside the catheter lumen, to the increase in the transversal dimensions of the instrument, and / or to the reduction of its flexibility.
Uno scopo della presente invenzione à ̈ quello di fornire una nuova disposizione di sensori che semplifichi la sensoristica a bordo del catetere, in modo da ridurre al minimo ogni influenza negativa sullo strumento, e che permetta al contempo di poter ottenere i dati necessari per ricavare la posizione ed il decorso del catetere, e del suo filo guida, durante l’utilizzo. An object of the present invention is to provide a new arrangement of sensors which simplifies the sensors on board the catheter, in order to minimize any negative influence on the instrument, and which at the same time allows to obtain the data necessary to obtain the position and course of the catheter, and its guide wire, during use.
Tale scopo à ̈ raggiunto secondo l’invenzione da un catetere del tipo definito all’inizio, in cui ciascuno di detti sensori elettromagnetici di posizione presenta un corpo sostanzialmente aghiforme, avente asse longitudinale disposto parallelamente all’asse longitudinale del rispettivo segmento di catetere, ed à ̈ posizionato in corrispondenza della parete del rispettivo segmento di catetere, eccentricamente rispetto all’asse longitudinale di questo. This object is achieved according to the invention by a catheter of the type defined at the beginning, in which each of said electromagnetic position sensors has a substantially needle-like body, having a longitudinal axis arranged parallel to the longitudinal axis of the respective segment of catheter, and is positioned in correspondence with the wall of the respective segment of the catheter, eccentrically with respect to the longitudinal axis of this.
Forme di realizzazione preferite dell’invenzione sono definite nelle rivendicazioni dipendenti, che sono da intendersi come parte integrante della presente descrizione. Preferred embodiments of the invention are defined in the dependent claims, which are to be understood as an integral part of the present description.
Forma inoltre oggetto dell’invenzione un sistema di localizzazione per cateteri e fili guida, includente The invention also relates to a localization system for catheters and guide wires, including
mezzi generatori di un campo magnetico; means generating a magnetic field;
un catetere comprendente a catheter comprising
- un corpo tubolare atto ad essere introdotto in una cavità corporea, detto corpo tubolare avendo una parte distale includente almeno una porzione curva o curvabile, ed ai capi di detta porzione curva o curvabile rispettivi segmenti di catetere; e - a tubular body adapted to be introduced into a body cavity, said tubular body having a distal part including at least one curved or curvable portion, and at the ends of said curved or curvable portion respective catheter segments; And
- una pluralità di sensori elettromagnetici di posizione, ciascuno di questi essendo disposto su un rispettivo di detti segmenti di catetere, ed essendo predisposto per rendere disponibile, in risposta al campo magnetico generato, un segnale elettrico indicativo della posizione e dell’orientamento del rispettivo segmento di catetere; - a plurality of electromagnetic position sensors, each of these being arranged on a respective of said catheter segments, and being arranged to make available, in response to the generated magnetic field, an electrical signal indicative of the position and orientation of the respective catheter segment;
mezzi elaboratori, atti ad elaborare i segnali elettrici di detti sensori elettromagnetici di posizione per rendere disponibili dati relativi alla posizione ed all’orientamento di detta parte distale del corpo tubolare; processing means, adapted to process the electrical signals of said electromagnetic position sensors to make available data relating to the position and orientation of said distal part of the tubular body;
in cui ciascuno di detti sensori elettromagnetici di posizione presenta un corpo sostanzialmente aghiforme, avente asse longitudinale disposto parallelamente all’asse longitudinale del rispettivo segmento di catetere, ed à ̈ posizionato in corrispondenza della parete del rispettivo segmento di catetere, eccentricamente rispetto all’asse longitudinale di questo. in which each of said electromagnetic position sensors has a substantially needle-like body, having a longitudinal axis arranged parallel to the longitudinal axis of the respective catheter segment, and is positioned in correspondence with the wall of the respective catheter segment, eccentrically with respect to the longitudinal axis of this.
Ulteriori caratteristiche e vantaggi del catetere secondo l’invenzione diverranno più chiari con la seguente descrizione dettagliata di una forma di realizzazione del trovato, fatta con riferimento ai disegni allegati, forniti a titolo puramente illustrativo e non limitativo, in cui: Further characteristics and advantages of the catheter according to the invention will become clearer with the following detailed description of an embodiment of the invention, made with reference to the attached drawings, provided purely for illustrative and non-limiting purposes, in which:
- la figura 1 à ̈ una vista schematica in prospettiva di un catetere secondo l’invenzione; - figure 1 is a schematic perspective view of a catheter according to the invention;
- la figura 2 Ã ̈ una vista in sezione longitudinale del catetere di figura 1; - figure 2 is a longitudinal sectional view of the catheter of figure 1;
- la figura 3 rappresenta alcuni esemplari di catetere di foggia differente; - figure 3 represents some examples of catheter of different shape;
- la figura 4 rappresenta schematicamente una catetere secondo l’invenzione del tipo azionabile, in due differenti posizioni operative; e - figure 4 schematically represents a catheter according to the invention of the operable type, in two different operating positions; And
- la figura 5 à ̈ una vista schematica in prospettiva di un filo guida secondo l’invenzione. - figure 5 is a schematic perspective view of a guide wire according to the invention.
Con riferimento alle figure 1 e 2, con 1 à ̈ indicato complessivamente un catetere, o più precisamente una parte distale di esso. With reference to Figures 1 and 2, 1 indicates a catheter as a whole, or more precisely a distal part of it.
Il catetere 1 comprende un corpo tubolare 3 atto ad essere introdotto in una cavità corporea. Tale corpo tubolare 3, o meglio la parte distale di essa, include almeno una porzione curva o curvabile 5, e rispettivi segmenti di catetere 7, 9 ai capi della porzione curva o curvabile 5. The catheter 1 comprises a tubular body 3 adapted to be introduced into a body cavity. Said tubular body 3, or rather the distal part thereof, includes at least a curved or curvable portion 5, and respective segments of catheter 7, 9 at the ends of the curved or curvable portion 5.
Il catetere 1 comprende inoltre una pluralità di sensori elettromagnetici di posizione 17, 19. Ciascuno di tali sensori à ̈ disposto su un rispettivo segmento di catetere 7, 9, ed à ̈ predisposto per rendere disponibile, in risposta ad un campo magnetico generato esternamente, un segnale elettrico indicativo della posizione e dell’orientamento del rispettivo segmento di catetere. The catheter 1 further comprises a plurality of electromagnetic position sensors 17, 19. Each of these sensors is arranged on a respective segment of the catheter 7, 9, and is arranged to make available, in response to an externally generated magnetic field, an electrical signal indicative of the position and orientation of the respective catheter segment.
Un tale catetere à ̈ applicabile nell’ambito della chirurgia endovascolare, metodica “miniinvasiva†che consente la riparazione di vasi senza isolamento chirurgico dell’arteria interessata. Tale procedura chirurgica viene condotta per via endoluminale, utilizzando per l’accesso alle lesioni il lume stesso dell’arteria, raggiunto attraverso l’incannulamento di un’arteria periferica, accessibile in anestesia locale con una puntura transcutanea o con una mini-incisione (arteria femorale o ascellare), attraverso la quale vengono inseriti i fili guida, i cateteri e le protesi (endoprotesi) che vengono guidati sotto controllo fluoroscopico fino a raggiungere la lesione bersaglio. Such a catheter is applicable in the field of endovascular surgery, a â € œmini-invasiveâ € method that allows the repair of vessels without surgical isolation of the affected artery. This surgical procedure is carried out intraluminally, using the lumen of the artery itself for access to the lesions, reached through the cannulation of a peripheral artery, accessible under local anesthesia with a transcutaneous puncture or with a mini -incision (femoral or axillary artery), through which guide wires, catheters and prostheses (endoprostheses) are inserted and guided under fluoroscopic control until reaching the target lesion.
Più precisamente, il catetere secondo l’invenzione trova applicazione nella realizzazione di un sistema di assistenza intraoperatoria computerizzata per la chirurgia endovascolare ed in particolare di un navigatore basato sulla localizzazione elettromagnetica dello strumentario chirurgico. More precisely, the catheter according to the invention finds application in the realization of a computerized intraoperative assistance system for endovascular surgery and in particular of a navigator based on the electromagnetic localization of surgical instruments.
Il principio di localizzazione elettromagnetica si basa sull’impiego di bobine elettromagnetiche che, accoppiate ad un generatore di campo, forniscono informazioni riguardo alla loro posizione ed al loro orientamento nello spazio. The principle of electromagnetic localization is based on the use of electromagnetic coils which, coupled to a field generator, provide information about their position and orientation in space.
Ciascuno dei sensori elettromagnetici di posizione 17, 19 del catetere 1 à ̈ preferibilmente un sensore a cinque gradi di libertà , comprendente una singola bobina a solenoide. Tali sensori permettono di ricavare con precisione la loro posizione nello spazio (nello specifico la posizione del centro della bobina) e la direzione del loro asse longitudinale. Il loro orientamento à ̈ pertanto definito a meno della rotazione attorno a tale asse. Secondo una realizzazione alternativa, ciascuno dei sensori elettromagnetici di posizione del catetere potrebbe essere un sensore a sei gradi di libertà , comprendente due o più bobine accoppiate. Tali sensori forniscono tutte le informazioni necessarie ad individuare sia la loro posizione che il loro orientamento nello spazio: tre gradi di traslazione e tre gradi di rotazione. Each of the electromagnetic position sensors 17, 19 of the catheter 1 is preferably a five degrees of freedom sensor comprising a single solenoid coil. These sensors allow to accurately determine their position in space (specifically the position of the coil center) and the direction of their longitudinal axis. Their orientation is therefore defined except for rotation around this axis. According to an alternative embodiment, each of the catheter position electromagnetic sensors could be a six degrees of freedom sensor, comprising two or more coupled coils. These sensors provide all the information necessary to identify both their position and their orientation in space: three degrees of translation and three degrees of rotation.
Ciascuno dei sensori 17, 19 del catetere 1 presenta un corpo sostanzialmente aghiforme, ovvero di forma stretta ed allungata, ed ha asse longitudinale disposto parallelamente all’asse longitudinale del rispettivo segmento di catetere. Each of the sensors 17, 19 of the catheter 1 has a substantially needle-like body, that is, of a narrow and elongated shape, and has a longitudinal axis arranged parallel to the longitudinal axis of the respective catheter segment.
Un esempio di sensore elettromagnetico commerciale applicabile nella presente invenzione, à ̈ il sensore a cinque gradi di libertà NDI Aurora®, prodotto da Northern Digital Inc., avente dimensioni estremamente compatte (0,5 mm diametro x 8 mm lunghezza). Un sensore a sei gradi di libertà NDI Aurora® presenta dimensioni pari a 1,8 mm diametro x 9 mm lunghezza. An example of a commercial electromagnetic sensor applicable in the present invention is the NDI Aurora® five degrees of freedom sensor, produced by Northern Digital Inc., having extremely compact dimensions (0.5 mm diameter x 8 mm length). An Aurora® NDI six degrees of freedom sensor has dimensions of 1.8mm diameter x 9mm length.
La scelta delle bobine a cinque gradi di libertà permette pertanto di ridurre al minimo gli ingombri dei sensori. Tali sensori hanno dimensioni minori rispetto ai sensori a sei gradi di libertà e sono quindi preferibili per realizzare cateteri e fili guida sensorizzati mini-invasivi, rispettando i limiti dimensionali dello strumentario endovascolare standard. The choice of coils with five degrees of freedom therefore allows to reduce the overall dimensions of the sensors to a minimum. These sensors have smaller dimensions than the six degrees of freedom sensors and are therefore preferable for making minimally invasive sensorized catheters and guide wires, respecting the dimensional limits of standard endovascular instruments.
Ciascun sensore 17, 19 à ̈ posizionato in corrispondenza della parete del rispettivo segmento di catetere, eccentricamente rispetto all’asse longitudinale di questo. Il sensore può essere posizionato sulla superficie radialmente esterna di tale parete, come nell’esempio illustrato, oppure all’interno dello spessore della parete. Each sensor 17, 19 is positioned in correspondence with the wall of the respective catheter segment, eccentrically with respect to its longitudinal axis. The sensor can be positioned on the radially external surface of this wall, as in the example shown, or inside the thickness of the wall.
Di preferenza, i sensori elettromagnetici di posizione 17, 19 sono complessivamente disposti complanarmente gli uni rispetto agli altri. Preferably, the electromagnetic position sensors 17, 19 are generally arranged coplanar with each other.
La particolare disposizione dei sensori sopra descritta permette da una parte di ridurre al minimo l’ingombro, e dall’altra permette di rilevare la posizione e l’orientamento di “segmenti†diversi del catetere, in corrispondenza delle sedi di ciascun sensore. Ai fini della presente invenzione, con “segmento†si identifica genericamente ogni porzione di catetere avente una propria direzione della tangente all’asse longitudinale del catetere, che differisce o può essere fatta differire da quella di un’altra porzione del catetere. The particular arrangement of the sensors described above allows on the one hand to reduce the overall dimensions to a minimum, and on the other it allows to detect the position and orientation of different `` segments '' of the catheter, in correspondence with the seats of each sensor. For the purposes of the present invention, the term "segment" generically identifies each portion of the catheter having its own direction of the tangent to the longitudinal axis of the catheter, which differs or can be made to differ from that of another portion of the catheter.
L’impiego di almeno due sensori a cinque gradi di libertà à ̈ necessario per ottenere il sesto grado di libertà e quindi calibrare il catetere, e per ricostruire la curvatura ed il decorso della porzione curva 5 interposta fra due segmenti di catetere 7, 9. The use of at least two sensors with five degrees of freedom is necessary to obtain the sixth degree of freedom and therefore to calibrate the catheter, and to reconstruct the curvature and the course of the curved portion 5 interposed between two segments of the catheter 7, 9 .
La procedura di calibrazione permette di calcolare posizione ed orientamento del centro del lume del catetere in corrispondenza delle sedi di ciascun sensore, conoscendo la posizione dei sensori e l’orientamento del loro asse longitudinale (forniti dal sistema di localizzazione). The calibration procedure allows to calculate the position and orientation of the catheter lumen center at the locations of each sensor, knowing the position of the sensors and the orientation of their longitudinal axis (provided by the localization system).
Più in particolare, tale procedura permette di determinare le traslazioni che allineano gli assi delle bobine con l’asse del catetere in corrispondenza delle sedi di ciascun sensore. More specifically, this procedure makes it possible to determine the translations that align the axes of the coils with the axis of the catheter in correspondence with the seats of each sensor.
Le suddette traslazioni possono essere definite una volta individuati i versori ortogonali all’asse di ciascuna bobina e diretti verso il centro del lume del catetere (indicati con ed in figura 1). Questi ultimi possono essere identificati adoperando almeno una coppia di bobine, posizionate come mostrato in figura 2. I versori ed giacenti sul piano dei due sensori e perpendicolari rispettivamente a e (gli assi della prima e della seconda bobina), sono infatti ricavabili con semplici operazioni geometriche conoscendo la posizione e l’orientamento dell’asse delle due bobine. The aforementioned translations can be defined once the vector units orthogonal to the axis of each coil have been identified and directed towards the center of the catheter lumen (indicated with and in figure 1). The latter can be identified using at least one pair of coils, positioned as shown in figure 2. The vector units and lying on the plane of the two sensors and perpendicular to and respectively (the axes of the first and second coil), can in fact be obtained with simple geometric operations knowing the position and orientation of the axis of the two coils.
La curvatura della porzione curva 5 compresa tra i due sensori à ̈ infine stimabile attraverso tecniche di interpolazione, e di conseguenza à ̈ determinabile il decorso dell’intera porzione distale del catetere. Finally, the curvature of the curved portion 5 between the two sensors can be estimated through interpolation techniques, and consequently the course of the entire distal portion of the catheter can be determined.
L’impiego di più di due sensori può essere utile nel caso di cateteri con forma complessa. In figura 3 sono rappresentati esemplari di cateteri di foggia differente. Il primo a sinistra à ̈ un catetere vertebrale; per ricostruire la sua curvatura sono sufficienti due sensori. I sei esemplari centrali rappresentano vari tipi di cateteri di Simmons, mentre gli ultimi due a destra rappresentano cateteri del tipo “Shepherd’s hook†. Per ricostruire la curvatura di questi sono necessari almeno tre sensori (uno per ciascun segmento di catetere fra una porzione curva e l’altra). The use of more than two sensors can be useful in the case of catheters with a complex shape. Figure 3 shows examples of catheters of different shapes. The first on the left is a vertebral catheter; two sensors are sufficient to reconstruct its curvature. The six central specimens represent various types of Simmons catheters, while the last two on the right represent â € œShepherdâ € ™ s hookâ € catheters. To reconstruct the curvature of these, at least three sensors are required (one for each segment of the catheter between a curved portion and the other).
In figura 4 à ̈ illustrata la parte distale di un catetere 1, del tipo azionabile mediante cavi per variare la curvatura della parte distale suddetta. In tale esempio di realizzazione i segmenti di catetere 7, 9 su cui sono disposti i sensori 17, 19 sono collegati da una parte curvabile 5, la cui curvatura à ̈ selettivamente modificabile (ad esempio nella configurazione indicata dalla linea a tratti) mediante azionamento di mezzi di comando manovrati da un operatore. Figure 4 illustrates the distal part of a catheter 1, of the type that can be operated by means of cables to vary the curvature of the aforesaid distal part. In this embodiment example, the catheter segments 7, 9 on which the sensors 17, 19 are arranged are connected by a bendable part 5, whose curvature can be selectively modified (for example in the configuration indicated by the dashed line) by actuating control means operated by an operator.
Fra i cateteri azionabili in commercio esistono soluzioni caratterizzate da un doppio lume interno. Vantaggiosamente, uno dei due lumi può essere impiegato per alloggiare i sensori elettromagnetici senza richiedere particolari modifiche progettuali al sistema di attuazione esistente né variazioni delle dimensioni del catetere. Among the operable catheters on the market there are solutions characterized by a double internal lumen. Advantageously, one of the two lumens can be used to house the electromagnetic sensors without requiring particular design modifications to the existing actuation system or variations in the dimensions of the catheter.
La presente invenzione si riferisce naturalmente anche a cateteri rettilinei e non attuati. Tali cateteri sono notoriamente flessibili, e quindi curvabili, per potersi adeguare all’andamento del lume corporeo nel quale sono destinati ad essere introdotti. The present invention naturally also refers to straight and unactuated catheters. These catheters are notoriously flexible, and therefore bendable, in order to adapt to the course of the body lumen into which they are intended to be introduced.
Con riferimento alla figura 5, con 21 Ã ̈ indicata complessivamente la parte distale di un esempio di filo guida per guidare il catetere 1. With reference to Figure 5, 21 indicates the distal part of an example of guide wire for guiding the catheter 1 as a whole.
I fili guida sono strumenti essenziali per l’esecuzione delle procedure endovascolari: rappresentano il supporto per l’inserimento e la manovra dei cateteri, permettono l’accesso e l’attraversamento delle lesioni e forniscono supporto per i cateteri per interventistica. The guide wires are essential tools for the execution of endovascular procedures: they represent the support for the insertion and maneuvering of catheters, they allow the access and the crossing of the lesions and they provide support for the interventional catheters.
I fili guida devono avere una punta flessibile ed atraumatica ed un corpo più rigido che garantisca la manovrabilità dello strumento (“pushability†del filo guida). The guide wires must have a flexible and atraumatic tip and a more rigid body that guarantees the maneuverability of the instrument (â € œpushabilityâ € of the guide wire).
Il filo guida 21 rappresentato in figura 5 presenta un corpo tubolare 23 di materiale flessibile, ad esempio Nitinol, all’interno del quale à ̈ disposta con un’anima tubolare di rinforzo 25, ad esempio di acciaio inox medicale. In corrispondenza della sua estremità distale il filo guida 21 à ̈ privo dell’anima tubolare 25, per alloggiare un sensore elettromagnetico di posizione 27. Il cavo elettrico di uscita 29 del sensore 27 à ̈ fatto passare attraverso l’anima tubolare 25 del filo guida per collegare il sensore a mezzi elaboratori esterni (non illustrati). The guide wire 21 shown in Figure 5 has a tubular body 23 of flexible material, for example Nitinol, inside which it is arranged with a tubular reinforcing core 25, for example of medical stainless steel. At its distal end, the guide wire 21 is devoid of the tubular core 25, to house an electromagnetic position sensor 27. The electrical output cable 29 of the sensor 27 is made to pass through the tubular core 25 of the guide wire for connecting the sensor to external processing means (not shown).
Il sensore 27 à ̈ disposto sulla punta del filo guida 21, ed à ̈ predisposto per rendere disponibile, in risposta ad un campo magnetico generato esternamente, un segnale elettrico indicativo della posizione e dell’orientamento della punta del filo guida. The sensor 27 is arranged on the tip of the guide wire 21, and is designed to make available, in response to an externally generated magnetic field, an electrical signal indicative of the position and orientation of the tip of the guide wire.
In particolare, il sensore elettromagnetico di posizione 27 del filo guida 21 presenta un corpo sostanzialmente aghiforme, ovvero di forma stretta ed allungata, ed ha asse longitudinale disposto allineato con l’asse longitudinale del filo guida. Preferibilmente, il sensore elettromagnetico di posizione 27 del filo guida 21 à ̈ un sensore a cinque gradi di libertà , comprendente una singola bobina a solenoide. In particular, the electromagnetic position sensor 27 of the guide wire 21 has a substantially needle-like body, that is, of a narrow and elongated shape, and has a longitudinal axis arranged aligned with the longitudinal axis of the guide wire. Preferably, the electromagnetic position sensor 27 of the guide wire 21 is a five degrees of freedom sensor comprising a single solenoid coil.
Il filo guida sensorizzato, utilizzato congiuntamente al catetere sensorizzato sopra descritto durante la navigazione computer assistita, permette di ottenere tutte le funzionalità necessarie all’esecuzione di complete procedure endovascolari (individuazione della porzione distale del catetere e della porzione distale del filo guida). The sensorized guide wire, used in conjunction with the sensorized catheter described above during computer assisted navigation, allows to obtain all the necessary functions for the execution of complete endovascular procedures (identification of the distal portion of the catheter and of the distal portion of the guide wire).
Le informazioni fornite da un unico sensore a cinque gradi di libertà , posizionato sull’asse del filo guida come in figura 5, sono sufficienti a descrivere la posizione e l’orientamento dell’estremità distale del filo guida. The information provided by a single sensor with five degrees of freedom, positioned on the axis of the guide wire as in figure 5, is sufficient to describe the position and orientation of the distal end of the guide wire.
Al fine di determinare il decorso dell’intero tratto distale del filo guida à ̈ sufficiente ricorrere alle informazioni sulla posizione e l’orientamento della punta del catetere sensorizzato (ricavate come descritto in precedenza). Il filo guida à ̈ infatti vincolato a passare attraverso la punta del catetere. In order to determine the course of the entire distal part of the guide wire, it is sufficient to use the information on the position and orientation of the tip of the sensorized catheter (obtained as previously described). The guide wire is in fact bound to pass through the tip of the catheter.
La soluzione sopra descritta permette di ridurre il numero di sensori e di conseguenza il numero di fili elettrici da alloggiare all’interno del filo guida: pertanto ottimizza l’ingombro della sensoristica rispettando i limiti dimensionali dello strumentario endovascolare standard. Secondariamente non si compromettono le caratteristiche meccaniche del filo guida irrigidendo troppo la sua struttura a causa dei molteplici sensori ed i relativi cavi da alloggiare al suo interno, ed infine si riducono i costi. The solution described above allows to reduce the number of sensors and consequently the number of electrical wires to be housed inside the guide wire: therefore it optimizes the dimensions of the sensors respecting the dimensional limits of standard endovascular instruments. Secondly, the mechanical characteristics of the guide wire are not compromised by stiffening its structure too much due to the multiple sensors and the relative cables to be housed inside it, and finally costs are reduced.
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Claims (13)
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| PCT/IB2012/052219 WO2012150567A1 (en) | 2011-05-05 | 2012-05-03 | A catheter with electromagnetic position sensors and a location system catheters and guide wires |
| EP12729203.5A EP2704631A1 (en) | 2011-05-05 | 2012-05-03 | A catheter with electromagnetic position sensors and a location system for catheters and guide wires |
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| IT000394A ITTO20110394A1 (en) | 2011-05-05 | 2011-05-05 | CATHETER EQUIPPED WITH ELECTROMAGNETIC POSITION SENSORS, AND LOCALIZATION SYSTEM FOR CATHETER AND WIRE GUIDES |
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Also Published As
| Publication number | Publication date |
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| WO2012150567A1 (en) | 2012-11-08 |
| EP2704631A1 (en) | 2014-03-12 |
| WO2012150567A8 (en) | 2013-07-25 |
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