ES2811323T3 - Sistemas para el guiado y la colocación de un dispositivo intravascular - Google Patents
Sistemas para el guiado y la colocación de un dispositivo intravascular Download PDFInfo
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- ES2811323T3 ES2811323T3 ES15746326T ES15746326T ES2811323T3 ES 2811323 T3 ES2811323 T3 ES 2811323T3 ES 15746326 T ES15746326 T ES 15746326T ES 15746326 T ES15746326 T ES 15746326T ES 2811323 T3 ES2811323 T3 ES 2811323T3
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- 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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Abstract
Sistema para guiar un dispositivo médico hasta una ubicación deseada dentro de la vasculatura de un paciente, que comprende: al menos un sensor de ECG intravascular para detectar una señal de ECG intravascular del paciente; un procesador configurado para recibir la señal de ECG intravascular, estando el procesador configurado además para: identificar una onda P de una forma de onda de la señal de ECG intravascular, variando la onda P según la proximidad del dispositivo médico a la ubicación deseada; determinar si la onda P identificada está elevada; determinar un valor de desviación de la onda P identificada cuando la onda P identificada está elevada; y notificar información relacionada con una ubicación del dispositivo médico dentro de la vasculatura del paciente al menos parcialmente según el valor de desviación determinado de la onda P elevada; y un dispositivo de salida configurado para notificar la información relacionada con la ubicación del dispositivo médico, en el que la determinación de si una onda P de una forma de onda de la señal de ECG intravascular está elevada se basa en una pluralidad de 25 umbrales predeterminados, variando la onda de P según la distancia del componente de sensor de ECG intravascular desde la parte de emisión de señales del corazón, estando los umbrales predeterminados relacionados con al menos lo siguiente: (a) una amplitud de la onda P de la señal de ECG intravascular dentro de un rango predeterminado; (b) una pendiente de la onda P de la señal de ECG intravascular dentro de un rango predeterminado; y (c) una componente de ruido de la señal de ECG intravascular dentro de un rango predeterminado.
Description
DESCRIPCIÓN
S is te m a s para el g u ia d o y la co lo ca c ió n de un d isp o s itivo in tra va scu la r
Breve sumario
R e su m id o con b reve da d , las re a liz a c io n e s de la p re se n te in ve n c ió n se re fie ren a un s is te m a de g u ia d o y co lo ca c ió n p ara a yu d a r a un m é d ico c lín ico en la c o lo ca c ió n de un c a té te r u o tro d isp o s itivo m é d ico d e n tro de la v a s c u la tu ra de un p ac ien te , y a m é to d o s re la c io n a d o s . El s is te m a de g u ia d o y co lo ca c ió n p erm ite c o lo ca r una pun ta d is ta l de un c a té te r d en tro de la va s c u la tu ra de l pac ien te en la p rox im id ad d e se a d a al co razón del pac ien te u sando se ñ a le s de E C G p ro d u c id a s p o r el co razón .
En un e je m p lo , se d ivu lg a un m é to d o para g u ia r un d isp o s itivo m é d ico h asta una u b ica c ió n d e se a d a d e n tro de la v a s c u la tu ra de un pac ien te . El m é to d o co m p re n d e d e te c ta r una se ñ a l de E C G in tra v a s c u la r de l p ac ie n te e id e n tif ica r una o nd a P de una fo rm a de onda de la señ a l de E C G in tra va scu la r, en el q ue la onda P v a ría seg ún la p rox im id ad del d isp o s itivo m é d ico a la u b icac ión d esea da .
El m é to do co m p re n d e a d e m á s d e te rm in a r si la o nda P ide n tificad a e stá e le vad a , d e te rm in a r un v a lo r de d esv ia c ió n de la onda P id e n tifica d a cu a n d o la o nda P ide n tificad a está e le vad a y n o tif ica r in fo rm a c ió n re lac io na da con una ub icac ión de l d isp o s itivo m é d ico d e n tro de la v a s c u la tu ra de l p ac ien te al m e n o s p a rc ia lm e n te según el v a lo r de d e sv ia c ió n d e te rm in a d o de la o nd a P e le vad a .
En una rea lizac ión , el d es tino p re te n d id o del ca té te r d en tro de l cue rpo del pac ien te es ta l q ue la pun ta d is ta l del ca té te r e stá d isp u e s ta en la p arte de 1/3 in fe rio r de la v e n a ca va s u p e r io r (“V C S ” ). El s is te m a de g u ia d o y co lo ca c ió n a na liza las se ñ a le s de E C G de l p a c ie n te p ara d e te rm in a r cu á n d o el c a té te r ha a lc a n za d o su d e s tin o p re te n d id o d e n tro de la va scu la tu ra , luego lo n o tifica al m é d ico c lín ico a tra vé s de una p a n ta lla de v isu a liza c ió n , p o r e je m p lo . P o r tan to , el s is te m a inc lu ye una m o da lida d de E C G para a yu d a r en la co lo ca c ió n de d isp o s itivo s m é d ico s d e n tro de l pac ien te . E s ta s y o tras c a ra c te rís tica s de las re a liza c io n e s de la p rese n te in ve n c ió n re su lta rá n m ás e v id e n te s a p a rtir de la s ig u ie n te d e sc rip c ió n y las re iv in d ica c io n e s a d ju n ta s , o p ue de n a p re n d e rse m e d ia n te la p rá c tica de las re a liza c io n e s de la inve n c ió n ta l co m o se e xp o n e m á s a d e la n te en el p re se n te d ocum e n to .
La inve n c ió n se d e fine m e d ia n te la re iv in d ica c ió n 1.
P ueden h a lla rse e je m p lo s de s is te m a s para lo ca liza r d isp o s itivo s in tra va scu la re s b a sá n d o se en va lo re s de d e sv ia c ió n de las o n d a s P de los E C G in tra va scu la re s en los d o cu m e n to s US 2012 /0059270 A1 y W O 2009 /100158 A1.
Breve descripción de los dibujos
U na d e sc rip c ió n m ás p a rtic u la r de la p rese n te d ivu lg a c ió n se re a liza rá con re fe re n c ia a re a liza c io n e s e sp e c ífica s de la m ism a q ue se ilus tra n en los d ib u jo s a d ju n to s . Se a p re c ia q u e e s to s d ib u jo s re p re se n ta n só lo re a liza c io n e s típ ica s de la inve nc ión y, p o r tan to , no d eben co n s id e ra rse lim ita tivo s de su a lcance . Se describ irán y e xp lica rá n re a liza c io n e s de e je m p lo de la in ve n c ió n con e sp e c ific id a d y d e ta lle a d ic io n a le s m e d ia n te el uso de los d ib u jo s a d ju n to s en los que: la fig u ra 1 es un d ia g ra m a de b lo q ue s q ue m u e s tra d ive rso s co m p o n e n te s de un s is te m a de g u ia do y co lo ca c ión según una re a liza c ió n ;
la fig u ra 2 m u e s tra el s is te m a de la fig u ra 1 en uso p ara g u ia r la in se rc ió n y c o lo ca c ió n de un c a té te r en el cu e rp o de un pac ien te ;
la fig u ra 3 m u es tra d ive rso s d e ta lle s de un co m p le jo de EC G ;
la fig u ra 4 m u es tra d ive rso s d e ta lle s de un tra za d o de ECG ;
la fig u ra 5 es un d ia g ra m a de b lo q ue s q ue m u e s tra d ive rso s a sp e c to s de un s is te m a de g u ia d o y co lo ca c ió n según una re a liza c ió n ;
la fig u ra 6 es un d ia g ra m a de b lo q u e s q ue m u e s tra d ive rsa s e ta p a s de un m é to d o p ara g u ia r un d isp o s itivo m é d ico según una re a liza c ió n ;
la fig u ra 7 m u e s tra d ive rso s d e ta lle s de un c o m p le jo de E C G in tra v a s c u la r ca p ta d o seg ún una re a liza c ió n ;
la fig u ra 8 m u es tra d ive rso s d e ta lle s de un c o m p le jo de E C G in tra v a s c u la r ca p ta d o seg ún una re a liza c ió n ;
la fig u ra 9 m u e s tra un á rbo l de d e c is io n e s para d e te rm in a r la sa lid a de v isu a liza c ió n a un s is te m a de g u ia d o y co lo ca c ió n según una re a liza c ió n ;
las fig u ra s 10A -10C m ues tran d ive rsa s ca p tu ra s de p an ta lla de una p an ta lla de v isu a liza c ió n de un s is te m a de g u ia do y co lo ca c ió n seg ún una re a liza c ió n ;
la fig u ra 11 es un d ia g ra m a de b lo q u e s q ue m u e s tra d ive rsa s e ta p a s de un m é to d o p ara g u ia r un d isp o s itivo m é d ico según una re a liza c ió n ;
la fig u ra 12 es una v is ta s im p lif ica d a de un co razón con p os ib le s z o n a s de n o tifica c ió n su p e rp u e s ta s , según una re a liza c ió n ; y
la fig u ra 13 m u es tra un á rbo l de d e c is io n e s para d e te rm in a r la sa lida de v isu a liza c ió n a un s is te m a de g u ia d o y co lo ca c ió n según una re a liza c ió n .
Descripción detallada de realizaciones seleccionadas
A h o ra se h ará re fe re n c ia a fig u ra s en las q ue se p ro p o rc io n a rá n a e s tru c tu ra s s im ila re s d e s ig n a c io n e s de re fe re n c ia s im ila res . Se e n tie n d e que los d ib u jos son re p re se n ta c io n e s e sq u e m á tica s y de d ia g ra m a de re a liza c io n e s a m o d o de e je m p lo de la p rese n te inve nc ión , y no son lim ita tivo s ni e s tán n e ce sa ria m e n te tra za d o s a esca la .
P ara m a yo r c la rida d , d eb e e n te n d e rse q ue el té rm in o “ p ro x im a l” se re fie re a un se n tid o re la tiva m e n te m ás ce rca n a a un m é d ico c lín ico que usa el d isp os itivo que va a d e sc rib irse en el p rese n te d o cu m e n to , m ie n tra s que el té rm in o “ d is ta l” se re fie re a un se n tid o re la tiva m e n te m ás a le ja d o del m é d ico c lín ico . P o r e je m p lo , el e x tre m o de un c a té te r co lo ca d o d e n tro de l cu e rp o de un p a c ie n te se co n s id e ra un e x tre m o d is ta l de l ca té te r, m ie n tra s q ue el e x tre m o del c a té te r que q u e d a fu e ra de l cu e rp o es un e x tre m o p ro x im a l de l ca té te r. A d e m á s , los té rm in o s “ q ue in c lu ye ” , “t ie n e ” y “ q ue t ie n e ” , ta l com o se usan en el p rese n te d ocum e n to , inc lu ida s las re iv ind ica c ion es , te n d rá n el m ism o s ign ifica do que el té rm in o “ q ue c o m p re n d e ” .
Las re a liza c io n e s de la p rese n te inve nc ión se re fie ren , en g en era l, a un s is te m a de g u ia d o y co lo ca c ión , ta m b ié n d e n o m in a d o en el p re se n te d o cu m e n to un “ s is te m a de c o lo ca c ió n ” o “ s is te m a ” , para a yu d a r a un m é d ico c lín ico en la co lo ca c ió n de un ca té te r u o tro d isp o s itivo m é d ico den tro de l cu e rp o de un pac ien te, ta l co m o d en tro de la vascu la tu ra . En una re a liza c ió n , el s is te m a de g u ia d o y co lo ca c ió n p erm ite c o lo ca r una pun ta d is ta l de un ca té te r d en tro de la v a s c u la tu ra de l p ac ie n te en la p ro x im id a d d e se a d a al co ra zó n u sa n d o se ñ a le s de E C G p ro d u c id a s p o r el co ra zó n del p ac ien te . En una re a liza c ió n , el d isp o s itivo m é d ico inc lu ye un c a té te r y el d e s tin o p re te n d id o del c a té te r d en tro del cu e rp o de l pac ien te es ta l que la pun ta d is ta l de l c a té te r esté d isp u e s ta en la parte de 1/3 in fe rio r de la ve n a cava s u p e r io r (“V C S ” ). El s is te m a de g u ia d o y co lo ca c ió n a na liza las se ñ a le s de E C G del p ac ie n te para d e te rm in a r cu á nd o el c a té te r ha a lca n za d o su d es tino p re te n d id o d en tro de la va scu la tu ra , luego lo n o tifica al m é d ico a tra vé s de una p a n ta lla de v isu a liza c ió n , p o r e je m p lo . P o r tan to , el s is te m a inc lu ye una m o da lida d de E C G para a yu d a r en la co lo ca c ió n de d isp o s itivo s m é d ico s d e n tro del pac ien te .
En una re a liza c ió n , la m o d a lid a d de g u ia d o de E C G del s is te m a de g u ia d o y c o lo ca c ió n m e n c io n a d a a n te r io rm e n te e stá a co m p a ñ a d a p o r una m o d a lid a d de u ltra so n id o s (“ U S ” ) para a yu d a r en la in se rc ió n in ic ia l de l d isp o s itivo m é d ico en el cu e rp o , y un se g u im ie n to b a sad o en e le m e n to s m a g n é tico s , o m o d a lid a d de s is te m a de lo ca liza c ió n de pun ta (“T L S ” , tip lo ca tio n sys te m ) para re a liz a r un se g u im ie n to de la p o s ic ió n y o rie n ta c ió n del d isp o s itivo m é d ico a m e d id a q ue a va n za h ac ia su d e s tin o p re te nd ido .
Se hace re fe re n c ia en p rim e r lu g a r a las fig u ra s 1 y 2 que re p re se n ta n d ive rso s co m p o n e n te s de un s is te m a de co lo ca c ió n (“s is te m a ” ), d e s ig n a d o en g en e ra l en 10, co n fig u ra d o según una re a liza c ió n de e je m p lo de la p rese n te inve nc ión . T a l com o se m uestra , el s is te m a 10 inc lu ye g e n e ra lm e n te una co n so la 20, una p an ta lla 30 de v isu a liza c ió n , una son da 40 y un s e n s o r 50, cad a uno de los cu a le s se d e sc rib e con m ás d e ta lle a con tin u a c ió n .
La fig u ra 2 m u es tra la re lac ió n g en e ra l de e stos co m p o n e n te s con re sp e c to a un p ac ien te 70 d u ra n te un p roce d im ie n to para co lo ca r un c a té te r 72 en la va s c u la tu ra del pac ien te a tra vé s de un s itio 73 de inse rc ión en la piel. La fig u ra 2 m u e s tra que el ca té te r 72 inc lu ye g e n e ra lm e n te una parte 74 p rox im a l q ue p e rm a n e ce e x te rio r al p ac ien te y una parte 76 d is ta l q ue re s ide d e n tro de la v a s c u la tu ra de l p a c ie n te d e sp u é s de q ue se c o m p le ta la co lo ca c ió n . En la p re se n te re a liza c ió n , el s is te m a 10 se e m p le a para co lo ca r en ú ltim a in s ta n c ia una pun ta 76 A d is ta l del c a té te r 72 en una p os ic ió n d e se a d a d en tro de la va s c u la tu ra del pac ien te . En una re a liza c ió n , la p os ic ió n d e se a d a para la pun ta 76 A d is ta l de l c a té te r es p róx im a al co razón del pac ien te , ta l co m o en la parte del te rc io (1 /3 ) in fe rio r de la ve n a cava s u p e r io r (“V C S ” ). P o r sup u e s to , el s is te m a 10 puede e m p le a rse p ara c o lo ca r la pun ta d is ta l del c a té te r en o tras u b icac ion e s. La parte 74 p rox im a l de l ca té te r inc lu ye a d e m á s un c o n e c to r 74 A que p rop o rc ion a co m u n ica c ió n de flu ido e n tre la una o m ás luce s de l c a té te r 72 y una o m á s pa tas 74B de e x te n s ió n que se e x tie nd en de m a n e ra p rox im a l d esde el con ec to r.
Un p ro c e sa d o r 22, q ue in c lu ye una m e m o ria no vo lá til ta l com o E E P R O M , p o r e je m p lo , se inc lu ye en la co n so la 20 p ara c o n tro la r la fu n c ió n de l s is te m a d u ra n te el fu n c io n a m ie n to de l s is te m a 10, a c tu a n d o a s í co m o un p ro c e sa d o r de con tro l. T a m b ié n se inc lu ye una c o n tro la d o r 24 d ig ita l/in te rfa z a n a ló g ica con la co n so la 20 y e stá en co m u n ica c ió n ta n to con el p ro c e sa d o r 22 com o con o tros c o m p o n e n te s de l s is te m a para re g u la r la in te rco n e x ió n e n tre la so n d a 40,
el s e n s o r 50 y o tros co m p o n e n te s de l s is tem a.
El s is te m a 10 inc lu ye a d e m á s p u e rto s 52 para la conex ión con el se n so r 50 y co m p o n e n te s 54 o p c io n a le s q ue inc luyen una im p re so ra , m e d io s de a lm a ce n a m ie n to , te c la d o , etc. Los p u e rtos en una re a liza c ió n son p ue rtos USB, a un qu e pueden u sa rse o tros tip o s de p ue rto o una co m b in a c ió n de tip o s de pue rto para esta y las o tras co n e x io n e s de in te rfa ce s d e sc rita s en el p rese n te d o cu m e n to . Se inc lu ye una con e x ió n 56 de a lim e n ta c ió n con la co n so la 20 para p e rm itir la con e x ió n o pe ra tiva a una fu e n te 58 de a lim e n ta c ió n exte rna . T a m b ié n puede e m p le a rse una ba te ría 60 in te rna , o b ien con o b ien sin una fuen te de a lim e n ta c ió n exte rna . El co n ju n to 59 de c ircu ito s de g estión de a lim en ta c ión se inc lu ye con el c o n tro la d o r 24 d ig ita l/ in te rfa z a n a ló g ica de la co n so la para re g u la r el uso y la d is trib u c ió n de la a lim e n ta c ió n .
La p a n ta lla 30 de v isu a liz a c ió n en la p rese n te re a liza c ió n e stá in te g ra d a en la co n so la 20 y se usa para v isu a liz a r in fo rm a c ió n al m é d ico c lín ico d u ra n te el p ro ce d im ie n to de co lo ca c ió n de l ca té te r. En o tra re a liza c ió n , la p an ta lla de v isu a liz a c ió n puede s e r in d e p e n d ie n te de la conso la . Ta l com o se o bserva rá , el co n te n id o re p re se n ta d o p o r la pan ta lla 30 de v isu a liz a c ió n ca m b ia según el m o do en el q ue se e n cu e n tra el s is te m a de co lo ca c ió n de ca té te r: US, t Ls o, en o tras re a liza c io ne s , co n firm a c ió n de pun ta de E C G . En una re a liza c ió n , p ue de n u sa rse una in te rfaz 32 de b o ton es de co n so la y los b o ton es inc lu ido s en la son da 40 para lla m a r in m e d ia ta m e n te un m o do d e se a d o a la pan ta lla 30 de v isu a liz a c ió n p o r el m é d ico c lín ico para a yu d a r en el p ro ce d im ie n to de co lo ca c ió n . En una re a liza c ió n , puede v isu a liz a rs e s im u ltá n e a m e n te la in fo rm a c ió n de m ú ltip le s m odos, ta le s co m o T L S y EC G . P o r tan to , la p a n ta lla 30 de v isu a liz a c ió n in d iv id u a l de la co n so la 20 de l s is te m a p uede e m p le a rse para el g u ia d o p o r u ltra so n id o s para a cc e d e r a la v a s c u la tu ra de un pac ien te , el g u ia d o m e d ia n te T L S d u ra n te el a va nce del ca té te r a tra vé s de la v a s c u la tu ra y (com o en re a liza c io n e s p o s te rio re s ) la co n firm a c ió n b asada en E C G de la co lo ca c ió n de la pun ta d is ta l del c a té te r con re spe cto a un nodo de l co razón del pac ien te . En una rea lizac ión , la pan ta lla 30 de v isu a liza c ió n es un d isp o s itivo LCD.
Se e m p le a la sonda 40 en re lac ió n con la p rim e ra m o d a lid a d m e n c io n a d a a n te rio rm e n te , es decir, v isu a liza c ió n basada en u ltra so n id o s (“ U S ”) de un vaso , ta l com o una ven a , en la p re p a ra c ió n para la inse rc ión de l c a té te r 72 en la va scu la tu ra . T a l v isu a liza c ió n p ro p o rc io n a un g u ia do p o r u ltra so n id o s en tie m p o real para in tro d u c ir el c a té te r en la va s c u la tu ra de l p a c ie n te y a yu da a re d u c ir las c o m p lica c io n e s a so c ia d a s n o rm a lm e n te con ta l in trod ucc ión , inc lu ida la p un c ió n a rte ria l ina d ve rtida , h em a to m a s, n eu m otó rax , etc.
C o m o ta l, en una re a liza c ió n , un m é d ico c lín ico e m p le a la p rim e ra m o d a lid a d de US para d e te rm in a r un s itio de in se rc ió n a d e cu a d o y e s ta b le ce r el a cce so va scu la r, ta l com o con una a gu ja y un in trod uc to r, luego con el ca té te r. E n to nce s, el m é d ico c lín ico puede c a m b ia r sin p rob lem as , m e d ia n te p u lsa c io n e s de botón en la b o to n e ra de la sonda , a la se g u n d a m o da lida d , TLS , sin te n e r que sa lir de l cam p o esté ril. El m o do de T L S puede usa rse e n to n ce s para a yu d a r en el a va n ce de l c a té te r 72 a tra vé s de la v a s c u la tu ra h ac ia un d e s tin o p re te nd ido .
La fig u ra 1 m u e s tra que la sonda 40 inc lu ye a d e m á s un c o n tro la d o r 42 de botón y m e m o ria para re g u la r el fu n c io n a m ie n to del botón y la sonda . El c o n tro la d o r 42 de botón y m e m o ria puede in c lu ir una m e m oria no vo lá til, ta l com o E E P R O M , en una re a liza c ió n . El c o n tro la d o r 42 de botón y m e m o ria e stá en co m u n ica c ió n o p e ra tiva con una in te rfaz 44 de son da de la co n so la 20, que in c lu ye un co m p o n e n te 44 A p ie zo e lé c trico de e n tra d a /sa lid a para in te ra cc io n a r con la m a triz p ie zo e lé c trica de so n d a s y un co m p o n e n te 44B de e n tra d a /sa lid a de botón y m e m o ria para in te ra cc io n a r con el c o n tro la d o r 42 de botón y m em oria .
C ab e d e s ta c a r que, a un qu e una ve n a se re p rese n ta n o rm a lm e n te en la p an ta lla 30 de v isu a liza c ió n d u ra n te el uso del s is te m a 10 en la m o d a lid a d de US, pueden o b te n e rse im á g e n e s de o tra s luces o partes co rp o ra le s en o tras re a liza c io n e s . C abe d e s ta ca r que el m o do de US p uede re p re se n ta rse s im u ltá n e a m e n te en la p an ta lla 30 de v isu a liz a c ió n con o tros m odos, ta le s co m o el m o do de T L S o el m o do de EC G , si se desea . A d e m á s de la p an ta lla 30 v isu a l de v isu a liza c ió n , el s is te m a 10 ta m b ié n puede e m p le a r in fo rm a c ió n aud itiva , ta l com o p itidos, to n o s , e tc., o se ñ a le s v ib ra to r ia s /b a s a d a s en m o v im ie n to para a yu d a r al m é d ico c lín ico d u ra n te la c o lo ca c ió n de l ca té te r. A de m á s, los b o ton es in c lu id o s en la so n d a 40 y la in te rfaz 32 de b o to n e s de co n so la pueden e s ta r c o n fig u ra d o s de va r ia s m a ne ra s , inc lu ido el uso de con tro le s de e n tra d a de u suario a d e m á s de botones, ta le s com o in te rru p to re s d es liza n te s , in te rru p to re s de pa lanca , pan e le s e le c tró n ico s o tá c tile s , etc. A d ic io n a lm e n te , las a c tiv id a d e s de US, T L S y E C G pueden p ro d u c irse s im u ltá n e a o e xc lu s iva m e n te d u ra n te el uso del s is te m a 10.
T a l com o a ca ba de d esc rib irse , se e m p le a la son da 40 de u ltra so n id o s de m a no com o parte de l s is te m a 10 de co lo ca c ió n de c a té te r in te g rad o para p e rm itir la v isu a liza c ió n por US de la v a s c u la tu ra p e rifé rica de un p ac ien te en p rep a rac ió n para la in trod ucc ión tra n scu tá n e a del ca té te r. S in e m ba rg o , en la p rese n te re a liza c ió n de e je m p lo , ta m b ié n se e m p le a la s o n d a p ara c o n tro la r la fu n c io n a lid a d de la parte de TLS , o s e g u n d a m o d a lid a d , de l s is te m a 10 cu a n d o se c o n d u ce el c a té te r hac ia su d e s tin o d e se a d o d en tro de la va s c u la tu ra ta l com o se d e sc rib e a co n tin u a c ió n . De nuevo , com o se usa la son da 40 d en tro de l cam p o esté ril de l pac ien te , esta ca ra c te rís tica p e rm ite que la fu n c io n a lid a d de T L S se co n tro le p o r co m p le to d esde d en tro del cam p o esté ril. P o r tan to , la son da 40 es un d isp o s itivo de dob le p rop ó sito , q ue p e rm ite un con tro l co n ve n ie n te de a m ba s fu n c io n a lid a d e s de US y T L S del s is te m a 10 d esde el cam p o e s té ril. En una re a liza c ió n , ta m b ié n puede e m p le a rse la son da para c o n tro la r p a rte o la to ta lid a d de la fu n c io n a lid a d re la c io n a d a con ECG , o la te rce ra m o da lida d , del s is te m a de co lo ca c ió n del c a té te r 10, ta l com o se d e sc rib e m ás a de lan te .
El s is te m a 10 de co lo ca c ión de ca té te r in c lu ye a d e m á s la se g u n d a m o da lida d m e n c io n a d a a n te rio rm e n te , es decir, T L S de c a té te r de base m a gn é tica , o s is te m a de lo ca liza c ió n de punta . El T LS p e rm ite al m é d ico c lín ico lo ca liza r y c o n firm a r rá p id a m e n te la p os ic ió n y /u o rie n ta c ió n de l c a té te r 72, ta l com o un c a té te r cen tra l de in se rc ió n p e rifé rica (“ C C IP ” ), un c a té te r v e n o s o cen tra l (“ C V C ” ) u o tro c a té te r o d isp o s itivo m é d ico a de cu ad o , d u ra n te la co lo ca c ió n in ic ia l en y el a va nce a tra vé s de la v a s c u la tu ra d e l p ac ien te 70. E sp e c ífica m e n te , la m o da lida d de T L S d e tec ta un cam p o m a g n é tico g e n e ra d o p o r un e stile te de lo ca liza c ió n de pun ta e qu ip a d o con e le m e n to s m a g n é tico s , que se carga p re v ia m e n te en una re a liza c ió n en una luz d e fin id a lo n g itu d in a lm e n te de l c a té te r 72, p e rm itie n d o a s í q ue el m é d ico c lín ico d e te rm in e la lo ca liza c ió n y o rie n ta c ió n g e n e ra le s de la pun ta de l c a té te r d en tro de l cu e rp o del pac ien te . En una re a liza c ió n , puede re a liza rse un se g u im ie n to de l con ju n to m a g n é tico u sando las e n se ñ a n za s de una o m ás de los s ig u ie n te s p a ten tes e s ta d o u n id e n se s : 5.775.322 ; 5.879.297 ; 6.129.668 ; 6.216.028 ; y 6.263.230. El T L S ta m b ié n v isu a liz a el se n tid o en q ue a pu n ta la pun ta de l ca té te r, lo que a yu da a d ic io n a lm e n te a la co lo ca c ió n p rec isa de l ca té te r. El T L S a yuda a d e m á s a q ue el m é d ico c lín ico d e te rm in e cu á n d o se ha p ro d u c id o un p o s ic io n a m ie n to inco rrec to de la pun ta de l ca té te r, ta l co m o en el caso en que la pun ta se ha d e sv ia d o de una v ía ve n o s a d e se a d a h ac ia o tra vena.
T a l com o se m e n c io n ó , el T L S usa un e s tile te para p e rm itir el se g u im ie n to de l e x tre m o d is ta l del c a té te r 72 d u ra n te su a va n ce a tra vé s de la va scu la tu ra . En una re a liza c ió n , el e s tile te inc lu ye un e x tre m o p ro x im a l y un e x tre m o d is ta l, con un m a ng o inc lu ido en el e x tre m o p rox im a l y un h ilo cen tra l que se e x tie nd e de m a n e ra d is ta l d esde el m ism o. Un co n ju n to m a g n é tico se d isp o n e de m a ne ra d is ta l con re spe cto al h ilo cen tra l. El con ju n to m a g n é tico inc lu ye uno o m ás e le m e n to s m a g n é tico s d isp u e s to s a d ya ce n te s e n tre s í ce rca de l e x tre m o d is ta l del e s tile te y e n ca p su la d o s p o r tu b o flex ib le . En la p re se n te re a liza c ió n , se inc lu ye una p lu ra lid a d de e le m e n to s m a gn é ticos , in c lu ye n d o ca d a e le m e n to un m a te ria l fe rro m a g n é tico só lido , de fo rm a c ilíndrica , a p ila do e x tre m o con e x tre m o con los d em á s e le m e n to s m a gn é ticos . U na pun ta a d h e s iva puede lle n a r la pun ta d is ta l de l tu b o flex ib le , de m a ne ra d is ta l con re spe cto a los e le m e n to s m a gn é ticos .
C ab e d e s ta c a r q ue en o tra s re a liza c io n e s , los e le m e n to s m a g n é tico s p ue de n v a r ia r de d ise ñ o no só lo en cu a n to a la fo rm a , s ino ta m b ié n en cu a n to a co m p o s ic ió n , núm ero , ta m a ñ o , tip o m a g n é tico y p os ic ió n en el se g m e n to d is ta l del e s tile te . P o r e je m p lo , en una re a liza c ió n , la p lu ra lida d de e le m e n to s m a g n é tico s fe rro m a g n é tico s se re e m p la za p o r un con ju n to e le c tro m a g n é tico , ta l com o una bob ina e le c trom ag né tica , que p rod u ce un cam p o m a gn é tico para la d e tecc ión p o r el sen sor. P uede h a lla rse o tro e je m p lo de un co n ju n to que p uede u sa rse en el p rese n te d ocum e n to , en la pa ten te e s ta d o u n id e n se n.° 5.099.845 , titu la d a “ M e d ica l In s tru m e n t L oca tio n M e a n s ” . S in e m ba rg o , aún pueden h a lla rse o tros e je m p lo s de e s tile te s que inc lu ye n e le m e n to s m a g n é tico s que pueden e m p le a rse con la m o da lida d de T L S en la p a ten te e s ta d o u n id e n se n.° 8.784.336 , titu la d a “ S ty le t A p p a ra tu s and M e th o d s o f M a n u fa c tu re ” . P o r tan to , estas y o tras v a r ia c io n e s e stán c o n te m p la d a s p o r re a liza c io n e s de la p rese n te inve n c ió n . D ebe a p re c ia rse en el p rese n te d o c u m e n to q ue el “ e s tile te ” ta l com o se u sa en el p re se n te d o c u m e n to p ue de in c lu ir uno cu a lq u ie ra de una v a rie d a d de d isp o s itivo s co n fig u ra d o s para la co lo ca c ión re tira b le den tro de una luz de l c a té te r p a ra a yu d a r a c o lo ca r un e x tre m o d is ta l del ca té te r en una ub icac ión d e se a d a d en tro de la va scu la tu ra del pac ien te . En una re a liza c ió n , el e s tile te inc luye un h ilo guía.
La fig u ra 2 m u e s tra la d isp o s ic ió n de un e s tile te 130 su s ta n c ia lm e n te d en tro de una luz en el c a té te r 72 de ta l m a ne ra q ue la parte p rox im a l del m ism o se e x tie n d e de m a n e ra p ro x im a l d esde la luz de l ca té te r, a tra vé s de l c o n e c to r 74 A y h ac ia fu e ra a tra vé s de una de las pa tas 74B de e x te n s ió n se le cc io n a d a s . A s í d isp u e s to d en tro de una luz del ca té te r, el e x tre m o 100B d is ta l del e s tile te 100 en la p rese n te re a liza c ió n es s u s ta n c ia lm e n te c o te rm in a l con el e x tre m o 76A d is ta l de l c a té te r de ta l m a n e ra que la d e te cc ió n p o r el T L S de l e x tre m o d is ta l del e s tile te ind ica de m a ne ra co rre sp o n d ie n te la u b ica c ió n de l e x tre m o d is ta l de l ca té te r. En o tra s re a liza c io n e s , son p os ib le s o tras re la c io n e s de p o s ic ió n e n tre los e x tre m o s d is ta le s de l e s tile te y el c a té te r o d isp o s itivo m édico .
El s e n s o r 50 de T L S lo e m p le a el s is te m a 10 d u ra n te la o pe ra c ió n de T L S para d e te c ta r el cam p o m a g n é tico p rod u c id o p o r los e le m e n to s m a g n é tico s de l e s tile te 130. Ta l com o se o b se rva en la fig u ra 2, el s e n s o r 50 de T L S se co lo ca en el tó ra x del p ac ien te d u ra n te la inse rc ión de l ca té te r. El s e n so r 50 de T L S se co lo ca en el tó ra x del pac ien te en una u b ica c ió n p re d e te rm in a d a , ta l com o m e d ia n te el uso de p un tos de re fe re n c ia e x te rn o s de l cu e rp o , para p e rm itir que se d e te c te el ca m p o m a g n é tico de los e le m e n to s m a g n é tico s de e s tile te , d isp u e s to s en el c a té te r 72 ta l com o se d e sc rib ió a n te rio rm e n te , d u ra n te el trá n s ito del c a té te r a tra vé s de la va s c u la tu ra del p ac ien te . De nuevo, co m o los e le m e n to s m a g n é tico s del c o n ju n to m a g n é tico de e s tile te son co te rm in a le s con el e x tre m o 76 A d is ta l de l c a té te r 72 en una re a liza c ió n (figu ra 2), la d e te cc ió n p o r el s e n s o r 50 de T L S del ca m p o m a g n é tico de los e le m e n to s m a gn é ticos p ro p o rc io n a in fo rm a c ió n al m é d ico c lín ico en cu a n to a la p os ic ió n y o rie n ta c ió n del e x tre m o d is ta l de l c a té te r d u ra n te su trá ns ito .
C on m a yo r d e ta lle , el s e n s o r 50 de T L S se co n e c ta o p e ra tiv a m e n te a la co n so la 20 del s is te m a 10 a tra vé s de uno o m á s de los p u e rto s 52, ta l co m o se m u e s tra en la fig u ra 1. C abe d e s ta c a r que ta m b ié n p ueden u sa rse sin lim ita c ió n o tros e sq u e m a s de con e x ió n entre el s e n s o r de T LS y la co n so la de l s is tem a. T a l com o a ca ba de describ irse , los e le m e n to s m a g n é tico s se e m p le a n en el e s tile te 130 p ara p e rm itir q ue la p o s ic ió n de l e x tre m o 76 A d is ta l de l c a té te r (fig u ra 2 ) p ueda o b se rva rse en re la c ió n con el s e n s o r 50 de T L S co lo ca d o en el tó ra x de l p ac ien te . La d e tecc ión m e d ia n te el s e n s o r 50 de T L S de los e le m e n to s m a g n é tico s del e s tile te se v isu a liz a g rá fica m e n te en la p an ta lla 30 de v isu a liz a c ió n de la con so la 20 d u ra n te el m o do de TLS . De e s ta m a ne ra , un m é d ico c lín ico que co lo ca el c a té te r es ca p a z de d e te rm in a r g e n e ra lm e n te la u b icac ión de l e x tre m o 76 A d is ta l del ca té te r den tro de la va scu la tu ra del p ac ien te en re lac ión con el s e n s o r 50 de T LS y d e te c ta r cu á n d o está p o s ic io n a d o in co rre c ta m e n te el ca té te r, ta l co m o q ue están
p ro d u c ié n d o se el a va n ce de l c a té te r a lo la rgo de una ve n a no d esea da .
T a l com o se co m e n tó a n te rio rm e n te , el s is te m a 10 inc lu ye una fu n c io n a lid a d a d ic io n a l en la p re se n te re a liza c ió n en la q ue la d e te rm in a c ió n de la p ro x im id a d de la pun ta 76 A d is ta l de l c a té te r con re lac ió n a un n odo s in o a u ric u la r (“ S A ” ) u o tro nodo e m iso r de im p u lso s e lé c trico s de l co razón de l pac ien te 70 puede d e te rm in a rse , p ro p o rc io n a n d o a sí una ca p a c id a d m e jo ra d a para c o lo ca r con p re c is ió n la pun ta d is ta l de l c a té te r en una u b icac ión d e se a d a p ró x im a al nodo. T a m b ié n d e n o m in a d a en el p rese n te d o cu m e n to “ E C G ” o “ c o n firm a c ió n de pun ta b asad a en E C G ” , e sta te rce ra m o da lida d del s is te m a 10 p e rm ite la d e te cc ió n de se ñ a le s de E C G p ro ce d e n te s de l nodo S A para co lo ca r la pun ta d is ta l de l c a té te r en una u b icac ión d e se a d a d en tro de la v a scu la tu ra de l pac ien te . C ab e d e s ta ca r q ue las m o d a lid a d e s de US, T L S y E C G se co m b in a n a la p erfe cc ió n en el p rese n te s is te m a 10, pero pueden e m p le a rse de fo rm a co n c e rta d a con o in d iv id u a lm e n te p ara a yu d a r en la co lo ca c ió n de l ca té te r. En una re a liza c ió n , se e n tie n d e que la m o da lida d de E C G ta l com o se d e sc rib e en el p rese n te d o cu m e n to puede in c lu irse en un s is te m a a u tó n o m o sin la inc lu s ió n de las m o d a lid a d e s de US y TLS . P o r tan to , los e n to rn o s en los que se d esc ribe n las re a liza c io n e s en el p rese n te d o cu m e n to se e n tien de n com o e n to rn o s de e je m p lo m e ra m e n te y no se con s id e ran lim ita tivo s de la p resen te d esc ripc ió n .
Ta l com o se describe , el e stile te 130 del ca té te r se d isp o n e p re v ia m e n te de m a nera re tira b le den tro de la luz del ca té te r 72 que se inse rta en el p a c ie n te 70 a tra vé s de l s itio 73 de inse rc ión . El e s tile te 130, a d e m á s de in c lu ir un con jun to m a g n é tico para la m o d a lid a d de T L S de base m a gn é tica , inc lu ye un c o m p o n e n te de d e te cc ió n , es dec ir, un co n ju n to in te rn o de s e n s o r de E C G in tra va scu la r, p róx im o a su e x tre m o d is ta l e inc lu ye una parte que es c o te rm in a l con el e x tre m o d is ta l de la p u n ta de l c a té te r para d e te c ta r p o r v ía in tra v a s c u la r las se ñ a le s de E C G p ro d u c id a s p o r el n odo SA, en la p rese n te re a lizac ión cu a n d o el c a té te r 72 y el estile te 130 a co m p a ñ a n te se d isp o n e n d en tro de la va s c u la tu ra del pac ien te . El co n ju n to de s e n so r de E C G in tra va scu la r ta m b ié n se d e n o m in a en el p rese n te d o cu m e n to co m p o n e n te de s e n s o r de E C G in te rn o o in travascu la r.
El e s tile te 130 in c lu ye una co rre a 134 q ue se e x tie n d e d e sd e su e x tre m o p ro x im a l q ue se co n e c ta o p e ra tiv a m e n te al s e n s o r 50 TLS , a un qu e se co n te m p la n o tros e sq u e m a s de con ex ió n al s is te m a 10. Ta l com o se d e sc rib irá con m ás d e ta lle , la co rre a del e s tile te 134 p e rm ite que las se ñ a le s de E C G d e te c ta d a s p o r el con ju n to de s e n s o r de EC G in c lu id o en una p arte d is ta l de l e s tile te 130 se tra n s m ita n h asta el s e n s o r 50 de T L S d u ra n te la co n firm a c ió n de la u b ica c ió n de la pun ta de l c a té te r co m o parte de la m o d a lid a d de c o n firm a c ió n de pun ta b a sad a en se ñ a le s de ECG.
Se unen e le c tro d o s 136 de E C G de re fe ren c ia e x te rn o s y de con ex ió n a t ie r ra al cu e rp o del p ac ien te 70 en la p rese n te re a liza c ió n y se unen o p e ra tiv a m e n te al s e n so r 50 de T L S para p ro p o rc io n a r una seña l de E C G de n ive l in ic ia l e xte rno al s is te m a 10 y p erm itir que el s is tem a filtre una a c tiv id a d e lé c trica de a lto n ive l no re lac io na da con la a ctiv ida d e léc trica de l nodo S A del co razón , lo que p erm ite la fu n c io n a lid a d de c o n firm a c ió n de pun ta b asada en EC G . T a l com o se m uestra , en la p rese n te rea lizac ión , se co loca un e lec trodo 136 e xte rno en la p ie l del pac ien te cerca de la parte s u p e rio r del h om b ro d e re ch o (co lo ca c ió n en “ b razo d e re c h o ”) m ie n tra s q ue se co lo ca o tro e le c tro d o e x te rn o ce rca de la parte in fe r io r izq u ie rd a del a bd om e n (co lo ca c ió n en la “ p ie rna izq u ie rd a ”). E s ta d isp o s ic ió n de e le c tro d o s p ro p o rc io n a una c o n fig u ra c ió n de d e riva c ió n II según el tr iá n g u lo del e le c tro ca rd io g ra m a de E in th ove n . La un ión o p e ra tiva de los e le c tro d o s 136 e x te rn o s con el s e n s o r 50 p e rm ite q ue las se ñ a le s de E C G d e te c ta d a s p o r los e le c tro d o s e x te rn o s se tra n s m ita n hasta la co n so la 20 d e l s is te m a 10 o hasta o tro d e s tin o a d e cu a d o . C o m o ta l, los e le c tro d o s 136 e x te rn o s s irven co m o e je m p lo de un co m p o n e n te de s e n so r de E C G e xte rno . O tros se n so re s e x te rn o s para d e te c ta r una señ a l de E C G de n ive l in ic ia l e x te rno al cu e rp o de l p ac ien te ta m b ié n pueden e m p le a rse en o tra s re a liza c io n e s . A d e m á s, ta m b ié n son p o s ib le s o tra s u b ica c io n e s de e le c trod o s.
Ju n to con la señ a l de E C G e x te rno re c ib id a d esde el co m p o n e n te de s e n s o r de E C G e x te rn o (es dec ir, los e le c tro d o s 136 de E C G e x te rn o s co lo ca d o s en la p ie l de l p ac ien te ), una señ a l de E C G in te rno , in tra v a s c u la r d e te c ta d a p o r el co m p o n e n te de s e n s o r de E C G in te rn o (es dec ir, el co n ju n to de s e n s o r de E C G de e s tile te de l e s tile te 130), la rec ibe el s e n s o r 50 de T L S s itu a d o en el tó ra x del pac ien te (fig u ra 10) u o tro co m p o n e n te d es ign ad o del s is te m a 10. El se n so r 50 de T L S y /o el p ro c e sa d o r 22 de la co n so la p ue de n p ro c e sa r los d a to s de se ñ a le s de E C G e x te rn o e in te rn o para p ro d u c ir uno o m ás tra za d o s e le c tro ca rd io g rá fico , inc lu ye nd o una serie de co m p le jo s de E C G d isc re tos , en la pan ta lla 30 de v isu a liza c ió n , ta l com o se d escrib irá . En el caso en el que el s e n s o r 50 de T L S p roce sa los d a tos de se ñ a le s de E C G e x te rn o e in te rno , se inc lu ye un p ro c e sa d o r en el m ism o para re a liz a r la fu n c io n a lid a d d esea da . Si la co n so la 20 p roce sa los da tos de se ñ a le s de EC G , el p ro c e sa d o r 22, el c o n tro la d o r 24 u o tro p ro c e sa d o r pueden u tiliza rse en la co n so la p ara p ro ce sa r los datos.
P o r tan to , a m e d id a q ue a va n za a tra vé s de la v a s c u la tu ra de l p ac ien te , el c a té te r 72 e q u ip a d o con el e s tile te 130 ta l com o se d e sc rib ió a n te r io rm e n te puede a va n z a r b a jo el s e n s o r 50 de TLS , q u e se s itú a en el tó ra x de l p a c ie n te ta l com o se m u e s tra en la fig u ra 10. E s to p erm ite que el s e n s o r 50 de T L S d e te c te la p os ic ión de l con ju n to m a g n é tico del e s tile te 130 (d e sc rito a d ic io n a lm e n te con a n te rio rida d ), q ue es co te rm in a l su s ta n c ia lm e n te con la pun ta 76 A d is ta l del c a té te r ta l co m o se e n cu e n tra u b ica d a d e n tro de la v a s c u la tu ra d e l p ac ien te . La d e te cc ió n m e d ia n te el s e n s o r 50 de T L S del co n ju n to m a g n é tico de l e s tile te se re p re se n ta en la p a n ta lla 30 de v isu a liz a c ió n d u ra n te el m o do de ECG .
D u ra n te el m o do de EC G , la p an ta lla 30 de v isu a liza c ió n puede re p re s e n ta r a d e m á s uno o m ás tra za d o s e le c tro c a rd io g rá fic o s de E C G p ro d u c id o s com o re su lta d o de la a c tiv id a d e lé c trica de l co razón de l p a c ie n te d e te c ta d a p o r los co m p o n e n te s de s e n s o r de E C G e x te rno e in te rn o d e sc rito s a n te rio rm e n te . C on m a yo r d e ta lle , los
co m p o n e n te s de s e n s o r e x te rn o s e in te rn os d e tec tan la a ctiv ida d e lé c trica de E C G del n odo SA, inc lu ida la onda P del tra za d o , y la re e n v ía n al s e n s o r 50 de T L S y la co n so la 20. La a c tiv id a d e lé c trica de E C G se p ro ce sa e n to n ce s para su re p re se n ta c ió n en la p a n ta lla 30 de v isu a liza c ió n , ta l com o se d e sc rib irá m ás a de lan te .
Un m é d ico q ue co lo ca el c a té te r p uede o b s e rva r e n to n ce s los d a tos del EC G , lo q ue a yuda a d e te rm in a r la co lo ca c ión ó p tim a de la pun ta 76 A d is ta l de l c a té te r 72, ta l co m o p o r e je m p lo p róx im a al nodo SA. En una re a liza c ió n , la con so la 20 inc lu ye los c o m p o n e n te s e le c tró n ico s , ta le s com o el p ro c e sa d o r 22 (fig u ra 1), n e ce sa rio s para re c ib ir y p ro c e sa r las se ñ a le s d e te c ta d a s p o r los c o m p o n e n te s de s e n s o r e x te rn o s e in te rn os . En o tra re a liza c ió n , el s e n s o r 50 de T L S p ue de in c lu ir los co m p o n e n te s e le c tró n ico s n e ce sa rio s q ue p ro ce sa n las se ñ a le s de ECG .
T a l co m o se c o m e n tó ya, la p a n ta lla 30 de v isu a liz a c ió n se usa p ara v is u a liz a r in fo rm a c ió n al m é d ico c lín ico d u ra n te el p ro c e d im ie n to de c o lo ca c ió n de l ca té te r. El co n te n id o de la p a n ta lla 30 de v isu a liz a c ió n cam b ia seg ún el m o do en que se encue n tre el s is tem a de co lo ca c ión de l ca té te r: US, T L S o ECG . El m éd ico c lín ico p uede lla m a r in m e d ia ta m e n te a cu a lq u ie ra de los tre s m o do s en la pan ta lla 30 de v isu a liz a c ió n y, en a lg u n o s casos, puede v isu a liz a rs e s im u ltá n e a m e n te in fo rm a c ión de m ú ltip le s m o do s, ta le s com o T L S y EC G . En una re a liza c ió n , com o antes , el m odo en el que se e ncue n tra el s is te m a p uede co n tro la rse m e d ia n te los b o ton es de con tro l inc lu ido s en la son da 40 de m ano, e lim in a n d o a s í la n e ce s id a d de q u e el m é d ico c lín ico sa lg a de l ca m p o e s té ril (ta l co m o to c a r la in te rfa z 32 de b o to n e s de la co n so la 20 ) p ara c a m b ia r de m odo . P o r tan to , en la p re se n te re a liza c ió n , se e m p le a la so n d a 40 para c o n tro la r ta m b ié n p a rte o la to ta lid a d de la fu n c io n a lid a d re la c io n a d a con el E C G del s is te m a 10. C ab e d e s ta c a r que ta m b ié n pueden u sa rse la in te rfa z 32 de b o to n e s u o tras c o n fig u ra c io n e s de e n tra d a para c o n tro la r la fu n c io n a lid a d de l s is te m a. T a m b ié n , a d e m á s de la p a n ta lla 30 v isu a l de v isu a liza c ió n , el s is te m a ta m b ié n p uede e m p le a r in fo rm a c ión a ud itiva , ta l co m o p itidos, ton os , e tc., p a ra a yu d a r al m é d ico c lín ico d u ra n te la co lo ca c ió n de l ca té te r.
C ab e d e s ta c a r q ue pueden h a lla rse m ás d e ta lle s re fe ren te s al s is te m a 10 en la p a ten te e s ta d o u n id e n se n.° 8.848.382 , e m itid a el 30 de s e p tie m b re de 2014 y titu la d a “A p p a ra tu s and D isp lay M e th od s R e la tin g to In tra va scu la r P la ce m e n t o f a C a th e te r” .
La fig u ra 3 re p re se n ta d ive rso s d e ta lle s de un co m p le jo 1176 de E C G de un tra za d o e le c tro ca rd io g rá fico de un p ac ien te , q ue inc lu ye una línea 1176 A isoe léc trica , una onda 1176P P, una o nd a 1176Q Q, una o nd a 1176R R y una o nd a 1176S S, y una o nd a 1176T T. La fig u ra 4 re p re se n ta o tro s d e ta lle s y re lac io ne s e n tre los co m p le jo s 1176 de E C G a d ya ce n te s , in c lu id o un in te rva lo 1180 RR entre co m p le jo s de E C G suce s ivos , que se e m p le an n o rm a lm e n te p ara d e te rm in a r la fre cu e n c ia c a rd ia ca de l p ac ien te . E s tas o n d a s e in te rva lo s los usa el s is te m a 10 en la p rese n te re a liza c ió n para d e te rm in a r la p rox im id ad del c a té te r 72 u o tro d isp o s itivo m é d ico al nodo S A u o tra u b icac ión d esea da d e n tro de la v a s c u la tu ra de l p ac ien te , ta l co m o se d e sc rib e en el p re se n te d ocum e n to .
La fig u ra 5 re p re se n ta una v is ió n g e n e ra l de l s is te m a 10 y un m é to d o 1200 para g u ia r el c a té te r h as ta una u b icac ión in tra v a s c u la r d esea da . Ta l com o se m u es tra , el m é to do 1200 e m p le a d a tos 1210 de E C G e x te rno a d q u irid o s de los e le c tro d o s 136 e x te rn o s (ta m b ié n d e n o m in a d o s en el p rese n te d o c u m e n to co m p o n e n te s de s e n s o r de E C G e xte rno ) co lo ca d o s e x te rn a m e n te en la p ie l de l p ac ie n te 70, ta l co m o se m u e s tra en la fig u ra 2, a u n q u e la u b icac ión p a rtic u la r de los e le c tro d o s puede va ria r. Ta l com o se m e nc ion ó , los e le c tro d o s 136 e x te rn o s en la p re se n te re a liza c ió n se co lo ca n en una d isp o s ic ió n de “ d e riva c ió n II” en b razo d e re ch o /p ie rn a izqu ie rda .
El m é to d o 1200 e m p le a a d e m á s d a to s 1212 de E C G in tra va scu la re s , in te rn os a d q u ir id o s de l co m p o n e n te de s e n s o r de E C G in te rn o d e sc rito a n te rio rm e n te , im p le m e n ta d o en la p re se n te re a liza c ió n co m o el co n ju n to de s e n s o r de E C G del e s tile te 130. Los d a tos 1210, 1212 de E C G e x te rn o e in tra v a s c u la r se re c ibe n y a co n d ic io n a n m e d ia n te co n ju n to s de c o m p o n e n te s de p ro ce sa m ie n to u b ica d o s en el s e n s o r 50 de T L S (fig u ra 2 ) en una re a liza c ió n , a u n q u e ta m b ié n pueden in c lu ir e sta fu n c io n a lid a d o tro s c o m p o n e n te s de l s is te m a , ta le s com o el p ro c e sa d o r 22 de la co n so la 20 del s is te m a.
B re ve m e n te y según una re a liza c ió n , se in trod uce n los d a tos 1210, 1212 de E C G e x te rno e in tra v a s c u la r en un a lg o ritm o 1216 de o nd a P para d e te rm in a r la p ro x im id a d in tra v a s c u la r de la pun ta d is ta l de l e s tile te al n odo S A u o tra u b ica c ió n d e se a d a d e n tro de l p ac ie n te 70 (fig u ra 2). El a lg o ritm o 1216 de o nd a P en una re a liza c ió n lo e je cu ta un p ro c e sa d o r inc lu ido en el s e n so r 50 de T L S o, en o tra re a liza c ió n , el p ro c e sa d o r 22 de la con so la 20, u o tro p ro c e sa d o r a de cu ad o .
La sa lid a p ro d u c id a p o r el a lg o ritm o 1216 de o nd a P inc lu ye d a tos re la c io n a d o s con el a n á lis is de la o nd a P de uno o m ás co m p le jo s de E C G de la señ a l de E C G in tra va scu la r y las d e s ig n a c io n e s de z o n a c o rre sp o n d ie n te s re la c io n a d a s con la p rox im id ad de la pun ta d is ta l del e s tile te 130 del ca té te r 72 al nodo S A del corazón . La sa lida se rec ibe (a tra vé s de la f le c h a 1216 A ) en u na a p lica c ió n de l s is te m a e je cu ta d a p o r el p ro c e s a d o r 22 de la co n s o la 20 de l s is te m a , que luego p uede e m itir (a tra vé s de la f le ch a 1218A ) in fo rm a c ió n g rá fica re la c io n a d a con la p os ic ió n de la pun ta d is ta l del e s tile te para su re p re se n ta c ió n en una pan ta lla 1220 de v isu a liz a c ió n del s is te m a, ta l com o la pan ta lla 30 de v isu a liz a c ió n de l s is te m a 10 (fig u ra s 1, 2). La o b se rva c ió n de la p an ta lla 30 de v isu a liz a c ió n p o r parte de l m é d ico c lín ico de la in fo rm a c ió n re la c io n a d a con la p os ic ió n in tra v a s c u la r de la pun ta d is ta l del estile te , que en la p rese n te re a liza c ió n es co te rm in a l con la pun ta d is ta l de l c a té te r 72, a yu da al m é d ico c lín ico a co lo ca r la pun ta d is ta l de l ca té te r en la u b icac ión d eseada .
La fig u ra re p re se n ta a d e m á s d ive rso s d e ta lle s re fe ren te s al m é to d o 1200 (fig u ra 5) para g u ia r el c a té te r según la p rese n te re a liza c ió n . T a l com o se m u es tra , el m é to do 1200 inc lu ye un p roce so 1222 de E C G e x te rno que usa los d a tos 1210 de E C G e x te rn o y un p ro ce so 1224 de E C G in tra v a s c u la r que usa los d a to s 1212 de E C G in travascu la r, con d ive rsa s a cc io n e s in te rm e d ia s . De nuevo , en una re a liza c ió n , el m é to do 1200 se e je cu ta m e d ia n te un p ro ce sa d o r a d e cu a d o , ta l com o el p ro c e sa d o r 22 d isp u e s to en la co n so la 22 de l s is te m a o un p ro c e sa d o r d isp u e s to en el s e n so r 50 de TLS , u sa nd o d a to s de se ñ a le s de E C G e x te rno e in tra va scu la r d e te c ta d o s p or los co m p o n e n te s de l s is te m a, ta l co m o se d e sc rib ió a n te rio rm e n te .
La p arte s u p e r io r de la fig u ra 6 m u e s tra q ue los d a tos 1210 de se ñ a le s de E C G exte rno , in c lu id o s los co m p le jo s de E C G de una señ a l de E C G e x te rno d e te c ta d a p o r el co m p o n e n te de s e n s o r e x te rn o (es dec ir, los e le c tro d o s 136 e x te rn o s co lo ca d o s en la p ie l), los re c ibe el s e n s o r 50 de TLS . A s im ism o , los d a to s 1212 de se ñ a le s de E C G in tra va scu la r, in c lu id o s los co m p le jo s de E C G de una señ a l de E C G in tra v a s c u la r d e te c ta d a p or el co m p o n e n te de s e n s o r in tra v a s c u la r (es dec ir, el c o n ju n to de s e n s o r de E C G de e s tile te de l e s tile te 70), ta m b ié n los re c ibe el s e n so r 50 de TLS . E s to s d a tos se u tilizan en el m é to do 1200 ta l com o se d e sc rib e a con tin u a c ió n .
El p roce so 1222 de E C G exte rno , que u tiliza los d a tos 1210 de E C G exte rno , se rea liza en p rim e r lu g a r en la p rese n te re a liza c ió n . C abe d e s ta ca r que el p roce so 1222, ta l com o con los d e m á s p roce so s que van a d e sc rib irse en el p resen te d o cu m e n to , p uede re a liza rse m e d ia n te un p ro c e sa d o r a d e cu a d o inc lu ido en el s is te m a 10 o a so c ia d o o p e ra tiva m e n te al m ism o. T a l com o se m e n c io n ó ya, ta l p ro c e sa d o r p uede in c lu ir un p ro c e sa d o r de l s e n s o r 50 de TLS , el p ro c e sa d o r 22 de la co n so la de l s is te m a 10, etc.
El p roce so 1222 de E C G e x te rno in c lu ye la e ta pa 1230 en la que se ide n tifica un co m p le jo Q R S de un com p le jo de E C G a ctua l, ta l com o el c o m p le jo 1176 de E C G (fig u ra 3), en la señ a l de E C G de los d a tos 1210 de señ a l de E C G e xte rno . En particu la r, la e ta pa 1230 inc lu ye d e te rm in a r la u b icac ión o el pun to en el t ie m p o de a p a ric ió n de l co m p le jo Q R S en los da tos 1210 de se ñ a le s de E C G e xte rno , que ta m b ié n se d e n o m in a n en el p rese n te d o cu m e n to a p lica c ió n de se llo s de tie m p o del co m p le jo Q R S d en tro de los d a tos 1210 de se ñ a le s de E C G exte rno . P uede p ro d u c irse una a p lica c ió n de se llo s s im ila r para o tros a sp e c to s id e n tifica d o s d e l/d e los c o m p le jo (s ) de E C G de las e ta pa s pos te rio re s . En una re a liza c ió n , se e m p le a un filtro de re spu es ta fin ita al im p u lso (“ F IR ” , fin ite im p u lse re s p o n s e ) de o rden 16 para id e n tif ica r d os co m p le jo s Q R S (fo rm a s de o n d a ) su ce s ivo s en la e ta pa 1230. T a m b ié n pueden e m p le a rse o tros m odos para id e n tif ica r e s ta y o tra s c o m p o n e n te s de fo rm a de onda.
C ab e d e s ta c a r q ue los d a tos 1210 de se ñ a le s de E C G e xte rno y los d a tos 1212 de se ñ a le s de E C G in tra va scu la r son s ín c ro n o s en el tiem p o , de m o do que la a pa ric ión del co m p le jo Q R S u o tro a sp e c to de un co m p le jo de E C G d e tec tad o en los d a tos 1210 de señ a le s de E C G e x te rno co rre sp o n d e rá en el t ie m p o con el m ism o a sp ec to del co m p le jo de E C G d e te c ta d o en los d a tos de se ñ a l 1212 de E C G in tra va scu la r, en la p rese n te re a liza c ió n . P o r tan to , los a sp e c to s id e n tif ic a d o s de los c o m p le jo s de E C G en los d a to s 1210 de se ñ a le s de E C G e x te rn o p ue de n u sa rse p ara h a lla r los a sp e c to s co rre sp o n d ie n te s en los co m p le jo s de E C G en los d a tos 1212 de se ñ a le s de E C G in travascu la r.
En la e ta pa 1232, se d e te rm in a el in te rva lo de tie m p o para el in te rva lo R-R, ta l co m o el in te rva lo R -R 1180 m o s tra d o en la fig u ra 4, e n tre d os co m p le jo s de E C G su ce s ivo s en los d a tos 1210 de se ñ a le s de E C G e xte rno . E s to puede usa rse , e n tre o tra s cosas, para d e te rm in a r la fre cu e n c ia ca rd ia ca de l pac ien te .
En la e ta pa 1234, la o nd a T, ta l com o la o nda 1176T T de la fig u ra 3, se id e n tifica a p a rtir de l c o m p le jo de E C G a ctu a l de los d a to s 1210 de se ñ a le s de E C G e x te rno en a ná lis is . F in a lm e n te , en la e ta pa 1236, la o nd a P, ta l co m o la o nda 1176P P de la fig u ra 3, se ide n tifica a p a rtir de los co m p le jo s de E C G a c tu a le s de los d a tos 1210 de E C G exte rno . C on d ich a ide n tifica c ió n , el t ie m p o de in ic io (co m ien zo ), d e sp la za m ie n to (fin a liza c ió n ) y la am p litud m á x im a de la onda P id e n tifica d a se re a liza n en la e ta pa 1236 en el p rese n te re a liza c ió n .
C abe d e s ta c a r que se ha d e sa rro lla d o un a lg o ritm o p ara re a liz a r una re a liza c ió n de las e ta pa s 1230 a 1236 com o b ib lio te ca de o b je to s o b ib lio te ca de so ftw a re de M o ne bo T e ch n o lo g ie s , Inc., 1800 B arton C re e k B lvd., A u s tin , T X 78735. En una re a liza c ió n , p uede a cce d e rse a la b ib lio te ca de so ftw a re a tra vé s de una in te rfaz de p ro g ra m a de a p lica c ió n (“A P I” , a p p lica tio n p ro g ra m in te rfa c e ) com o fu n c ió n llam ab le . P uede a cce d e rse a la b ib lio te ca de so ftw a re m e d ia n te la a p licac ión 1218 de l s is te m a (fig u ra 5). T a m b ié n cab e d e s ta ca r que, en una re a liza c ió n , p ueden a n a liza rse m ú ltip le s co m p le jo s de E C G de los d a tos 1210 de señ a le s de E C G e xte rno al re a liz a r las e ta pa s d e sc rita s a n te r io rm e n te de l p roce so 1222 de E C G exte rno .
En la e ta pa 1240, se to m a la dec is ión de co n firm a r que la onda P se ha ide n tificad o en la e ta pa 1236. En caso negativo, el m é to d o 1200 a va n za a la e ta pa 1242, en la q ue los d a tos re fe ren te s a la u b icac ión de Q R S id e n tifica d a en la e ta pa 1230 se hacen p a sa r a un nue vo p ro ce d im ie n to en e ta pa 1244. De hecho , en la e ta pa 1244, la o nda P se ide n tifica de nuevo , pero se ide n tifica en los d a tos 1212 de se ñ a le s de E C G in travascu la r, u sa nd o la u b icac ión con se llo de tie m p o del co m p le jo Q R S id e n tifica d o de los d a tos 1210 de señ a le s de E C G e x te rno de la e ta pa 1230. De nuevo , cabe d e s ta c a r q ue d eb ido a que los d a tos 1210, 1212 de E C G e x te rn o e in tra v a s c u la r son m e d ic io n e s de la a ctiv ida d e lé c trica de l nodo S A del co razón de l pac ien te , e stán s in c ro n iza d o s en el tie m p o a p e s a r de d e te c ta rse a tra vé s de d ife re n te s a p a ra to s (es dec ir, los e le c tro d o s 136 e x te rn o s para los da tos de se ñ a le s de E C G exte rno , y el co n ju n to de s e n s o r de e s tile te del e s tile te 130 para los d a tos de se ñ a le s de E C G in tra va scu la r). P o r tan to , la id e n tifica c ió n del co m p le jo Q R S de un co m p le jo de E C G a p a rtir de los da tos 1210 de se ñ a le s de E C G e x te rno c o rre sp o n d e rá en
t ie m p o /u b ic a c ió n a un co m p le jo Q R S u o tra c o m p o n e n te de l co m p le jo de E C G co rre sp o n d ie n te en los d a to s 1212 de se ñ a le s de E C G in travascu la r.
En la e ta p a 1246, se d e te rm in a si la onda P in tra v a s c u la r (id e n tifica d a a p a rtir de los d a tos 1212 de se ñ a le s de E C G in tra va scu la r) se ha id e n tifica d o sa tis fa c to ria m e n te en la e ta pa 1244. Si la re sp u e s ta es “ n o ” , el p roce so e nv ía una señ a l de “ a u se n c ia de in fo rm e ” al s is te m a 10 en la e ta pa 1248. Si la re spu es ta en la e ta pa 1246 es “ s í” en cua n to a la id e n tifica c ió n s a tis fa c to ria de la o nda P in tra va scu la r, la u b icac ión con se llo de tie m p o de la o nda P in tra v a s c u la r se re e n v ía en la e ta pa 1250 al p roce so 1224 de E C G in travascu la r. A lte rn a tiva m e n te , si la re spu es ta en la e ta pa 1240 es “ s í” en cu a n to a la id e n tifica c ió n s a tis fa c to ria de la onda P e x te rna , se sa ltan las e ta p a s 1242, 1244 y 1246, ta l com o se o b se rva en la fig u ra 6, y la o nda P e x te rn a con m a rca de tie m p o ( id e n tifica d a a p a rtir de los d a tos 1210 de señ a le s de E C G e x te rn o ) se re e n v ía en la e ta pa 1250 al p roce so 1224 de E C G in travascu la r. En una re a liza c ió n , los d a to s de m a rca de tie m p o re fe ren te s a d ive rso s a sp e c to s de la o nd a P se re en v ía n , in c lu id o el t ie m p o de a pa ric ió n de la o nda P, el p ico de la o nd a P (o la a m p litu d m á x im a ) y el d e sp la za m ie n to de la o nd a P.
T ra s la re cep c ió n de la u b ic a c ió n de la o nda P (m e d ia n te la id e n tifica c ió n de la m ism a en los d a tos 1210 de se ñ a le s de E C G e x te rno en la e ta pa 1236 o en los d a tos 1212 de se ñ a le s de E C G in tra v a s c u la r en la e ta pa 1244) d esde la e ta pa 1250, el p roce so 1224 de E C G in tra va scu la r co m ie n za en la e ta pa 1260 re a liza n d o un a ná lis is de fre cu e n c ia de la o n d a P d e te c ta d a p or el s e n s o r de E C G in te rn o . En la p re se n te re a liza c ió n y ta l co m o lo e je c u ta el p ro c e sa d o r 22 (fig u ra 1) u o tro co m p o n e n te de p ro ce sa m ie n to a d e cu a d o , la e ta p a 1260 inc lu ye a n a liz a r la o nd a P en el d o m in io de la fre cu e n c ia para d e te rm in a r si sa tis fa ce o sup e ra un v a lo r u m bra l p re d e te rm in a d o . En una re a liza c ió n , la fre cu e n c ia de la o nd a P p ue de c o n s id e ra rse com o la p e n d ie n te inc lin a d a de la o nda P en el d o m in io de l tiem p o.
En la e ta pa 1264, ta m b ié n se re a liza un a n á lis is de a m p litud de la o nd a P en el d o m in io de l t ie m p o para d e te rm in a r si sa tis fa ce o su p e ra un v a lo r u m bra l p re d e te rm in a d o . En la p rese n te re a liza c ió n , se d e te rm in a que la o nd a P está en un m á x im o cu a n d o p re se n ta los s ig u ie n te s va lo re s um bra l: una a m p litu d de entre a p ro x im a d a m e n te 250 m ic ro vo ltio s y a p ro x im a d a m e n te 1500 m ic ro vo ltio s a 20 Hz o m ás; y un ra ng o de fre cu e n c ia (p e n d ie n te in c lin a d a ) en tre : s u p e r io r a a p ro x im a d a m e n te 10 m ic ro vo ltio s p o r m ilise g u n d o cu a n d o la a m p litu d de la o nda P es de a p ro x im a d a m e n te 250 m ic ro vo ltio s y s u p e rio r a 60 m ic ro vo ltio s por m ilise g u n d o cu a n d o la a m p litud de la o nda P es de a p ro x im a d a m e n te 1500 m ic ro vo ltio s . P o r sup ue s to , p ue de n u sa rse o tro s ra n g o s y v a lo re s en o tra s re a liza c io n e s según la a p lica c ió n , la s e n s ib ilid a d d esea da , la u b icac ión de l o b je tivo p re te nd ida , etc.
En la e ta pa 1262, se re a liza un a ná lis is para d e te rm in a r si el ru ido en los d a tos 1212 de se ñ a le s de E C G in tra va scu la r su p e ra los n ive les a ce p ta b le s de ta l m a n e ra q ue es im p o s ib le una d e te rm in a c ió n fia b le de la o n d a P. C on d e ta lle , el p ro ce so 1224 en la e ta pa 1262 n o tifica un v a lo r re la c io n a d o con el n ive l de ru ido e n co n tra d o . En la p rese n te re a liza c ió n , los va lo re s u m bra l de ru ido inc lu ye n : el n ive l m á x im o de ru ido de a lta fre cu e n c ia (es dec ir, m a yo r de a p ro x im a d a m e n te 20 H z) p re se n te e n tre el d e s p la z a m ie n to o e l fin a l del co m p le jo Q R S de un co m p le jo de E C G y la a p a ric ió n o el in ic io de la o n d a P de l c o m p le jo de E C G su ce s ivo es m e n o r de a p ro x im a d a m e n te 35 m ic ro vo ltio s , con una razón del n ive l m á x im o de ru ido de a lta fre cu e n c ia con re spe cto a la a m p litu d m á x im a de la c o m p o n e n te de a lta fre cu e n c ia de la o nda P en el co m p le jo de E C G a ctua l es m e n o r de a p ro x im a d a m e n te el 50% . El p roce so 1224 puede e m p le a r o tros va lo re s de ru ido para d e te rm in a r n ive les u m bra l de ru ido ace p ta b le s .
En la e ta p a 1266, se d e te rm in a si se ha id e n tif ica d o una o nd a P e le va d a o m á x im a en el co m p le jo de E C G , ta l com o la o b se rva d a en 1176P en el c o m p le jo 1176 de E C G de la fig u ra 7. E sto se rea liza d e te rm in a n d o si se han sa tis fe ch o los va lo re s um bra l de fre cu e n c ia , am p litud y ru ido de la onda P co m e n ta d o s a n te rio rm e n te (d e te rm in a d o s en las e ta pa s 1260, 1264 y 1262, re sp e c tiva m e n te ). S i uno o m ás no se han sa tis fe cho , el p ro ce so re en v ía una se ñ a l de “ a usen c ia de in fo rm e ” al s is te m a 10 en la e ta pa 1248.
Si se ha sa tis fe ch o cada uno de los va lo re s um bra l a n te r io re s de las e ta pa s 1260, 1262 y 1264, la e ta pa 1266 n o tifica un “ s í” y se e je cu ta la e ta pa 1268, en la q ue se re a liza un a n á lis is de d esv ia c ió n de la o nda P. La fig u ra 8 m u es tra una p a rte de o nda P del co m p le jo 1176 de E C G que inc lu ye una p arte 1278 de d esv ia c ión , o co m p o n e n te de o nda P n e g a tiva que se su m e rg e p o r d e b a jo de la línea 1176 A iso e lé c trica an tes de e le va rse para fo rm a r la parte 1276 con in fle x ió n , la p a rte de la o nd a P que se e leva p o r e nc im a de la línea iso e lé c trica de la o nda P. La e ta pa 1268 a na liza la o nd a P p ara d e te rm in a r ta l d e sv ia c ió n . En la p re se n te re a liza c ió n , la e ta p a 1268 se re a liza d iv id ie n d o la a m p litu d de la p arte 1278 de d e sv ia c ió n de la o nd a P e n tre la p arte 1276 con in fle x ió n de la o nda P, lo q ue p ro d u ce un p orce n ta je de d e sv ia c ió n . El v a lo r de l p o rce n ta je de d e sv ia c ió n p e rm ite que el s is te m a 10 d e te rm in e la p ro x im id a d del s e n s o r de E C G in tra v a s c u la r ( im p le m e n ta d o com o el co n ju n to de s e n s o r de E C G de e s tile te de l e s tile te 130 en la pun ta d is ta l de l e s tile te ) y, p o r tan to , la p un ta d is ta l del ca té te r, al n odo SA.
En la p rese n te re a liza c ió n , un v a lo r de d e sv ia c ió n de a p ro x im a d a m e n te el 0 % ind ica que no hay su s ta n c ia lm e n te d esv ia c ión de la o nda P y que la pun ta d is ta l de l e s tile te está en o ce rca de una p arte 1354 de 1/3 in fe rio r de una V C S 1352 ce rca de un co ra zó n 1350 de la v a s c u la tu ra de l p ac ien te , a la q ue h ace re fe re n c ia el p ro ce so 1224 com o zo n a 1, m o s tra d a en la fig u ra 12. Un v a lo r de d e sv ia c ió n m a yo r de a p ro x im a d a m e n te el 0% pero m e n o r de o igua l a a p ro x im a d a m e n te el 10% ind ica q ue la o nda P está d esv ia d a m ín im a m e n te y que la pun ta d is ta l de l e stile te ha pasado pero e stá ce rca de la p arte 1354 de 1/3 in fe rio r de la V C S 1352, a la q ue hace re fe re n c ia el p ro ce so 1224 co m o zo n a 2. Un v a lo r de d e sv ia c ió n m a yo r de a p ro x im a d a m e n te el 10% ind ica q ue la o nda P e stá d e sv ia d a s ig n ifica tiva m e n te y q ue la pun ta d is ta l de l e stile te está m u y p o r d eb a jo de la p arte 1354 de 1/3 in fe rio r de la V C S 1352, a la q ue hace
re fe re n c ia el a lg o ritm o co m o z o n a 3. C ab e d e s ta c a r que la fig u ra 12 ilus tra q ue pueden d e fin irse y n o tifica rse zo n a s a d ic io n a le s p or el p ro ce so 1224 según su a ná lis is de las ca ra c te rís tica s de o nd a P d e tec tad as . De hecho, la fig u ra 12 m u es tra q ue p uede d e fin irse una v a rie d a d de zon as , ta l com o un rango q ue se e x tie n d e d esde -2 h as ta 4, q ue están e q u ie s p a c ia d a s a d ife re n te s d is ta nc ias de la p arte 1354 de 1/3 in fe rio r a 1352. P o r sup ue s to , ta m b ié n pueden d e fin irse o tras z o n a s y e sp a c ia d o s com o p arte de l m é to do 1200.
La zo n a a s ig n a d a p o r el p ro ce so 1224 se n o tifica a una a p lica c ió n 1218 de l s is te m a de l s is te m a 10 en la e ta pa 1270. En una re a liza c ió n , la a p lica c ió n 1218 de l s is te m a inc lu ye una a p lica c ió n de so ftw a re o firm w a re de con tro l e je cu ta d a p o r el p ro c e sa d o r 22 (fig u ra 1) u o tro co m p o n e n te a d e cu a d o de l s is te m a 10. C ab e d e s ta c a r q ue en una re a liza c ió n , el m ism o p roce sa d o r, ta l com o el p ro c e sa d o r 22 de la co n so la 20 de l s is te m a (fig u ra 1), p ue de e m p le a rse para e je cu ta r ta n to el m é to do 1200 com o la a p lica c ió n 1218 del s is tem a. Las tre s zo n a s d e sc rita s a n te rio rm e n te , que ind ican la p ro x im id a d de l e x tre m o d is ta l del c a té te r al co razón 1350 del p ac ien te (fig u ra 12), pueden n o tif ica rse en la e ta pa 1270 a la a p lica c ió n 1218 de l s is te m a. T a m b ié n pueden d e fin irse y n o tifica rse z o n a s a d ic io n a le s , en o tra re a liza c ió n . La a p lica c ió n 1218 del s is te m a p uede u sa r la n o tifica c ió n de ta le s z o n a s para tra n s m it ir in fo rm a c ión p e rtin e n te al usuario del s is te m a 10 para a yu d a r al usuario a c o lo ca r el c a té te r en una u b icac ión d e se a d a d en tro de la va scu la tu ra , ta l com o se d e sc rib e m ás a de lan te .
El m é to do 1200 d escrito a n te r io rm e n te se e je cu ta de m a ne ra ite ra tiva en la p rese n te re a liza c ió n para e va lu a r co m p le jo s de E C G su ce s ivo s del pac ien te d e te c ta d o s p o r el s is te m a 10. En o tras re a liza c io n e s , es p os ib le el fu n c io n a m ie n to no ite ra tivo . U na ve z que un n úm e ro su fic ie n te de in fo rm e s de zo n a (es dec ir, los in fo rm e s de la zo n a en la q ue se e n cu e n tra la pun ta d is ta l de l e s tile te con re sp e c to al co ra zó n del p a c ie n te ) según el a n á lis is de la o nd a P p o r el m é to do 1200 los re c ibe la a p lica c ió n 1218 del s is te m a de l s is te m a 10 (a tra vé s de las e ta p a s 1270 y /o 1248), la p a n ta lla 30 de v isu a liz a c ió n (fig u ra s 1, 2 ) puede a c tu a liza rse para in d ica r la zo n a n o tifica da , si la hay, y a yu d a r al m é d ico a d e te rm in a r cu á n d o la pun ta d is ta l de l c a té te r u o tro d isp o s itivo m é d ico a d e cu a d o ha a lca n za d o la u b icac ión in tra v a s c u la r d eseada .
A la luz de lo a n te rio r, las fig u ra s 10 A -10C m u es tra n d ive rso s e je m p lo s de la re p re se n ta c ió n de los in fo rm e s de zo n a p ro p o rc io n a d o s p o r el m é to d o 1200 de la fig u ra 6 a la a p lica c ió n 1218 de l s is te m a , en la p a n ta lla 30 de v isu a liz a c ió n de l s is te m a 10 (fig u ra s 1, 2). En p a rticu la r, las fig u ra s 10A -10C m u e s tra n d ive rsa s re p re se n ta c io n e s o ca p tu ra s 1320 de p a n ta lla de la p a n ta lla 30 de v isu a liz a c ió n d u ra n te el uso de l s is te m a 10 p ara g u ia r y c o lo ca r un c a té te r d e n tro de la v a s c u la tu ra de un p ac ien te . Ta l co m o se m u e s tra en la fig u ra 10A, e stá p rese n te un tra za d o 1322 de E C G exte rno , ta l co m o se d e te c ta p or el c o m p o n e n te de s e n s o r de se ñ a le s de E C G e xte rno , q ue en la p re se n te re a liza c ió n inc lu ye los e le c tro d o s 136 e x te rnos , ta l com o se d e sc rib ió a n te rio rm en te . T a m b ié n se re p re se n ta un tra za d o 1324 de E C G in tra va scu la r, ta l com o se d e te c ta p o r el c o m p o n e n te de s e n s o r de se ñ a le s de E C G in tra va scu la r, q ue en la p rese n te re a liza c ió n inc lu ye el co n ju n to de s e n s o r de E C G de e s tile te de l e s tile te 130.
T a m b ié n se m u es tra una im agen 1326 de sensor, q ue re p rese n ta el s e n so r 50 (fig u ra s 1, 2 ) y su d e tecc ión de la pun ta d is ta l del e s tile te . Se m u es tra un icono 1328 de p os ic ió n de e s tile te su p e rp u e s to en la im a g e n 1326 de se n so r para in d ic a r la p o s ic ió n de la pun ta d is ta l de l e s tile te a tra v é s de se g u im ie n to m a g n é tico en el m o do de TLS , se g u im ie n to de E C G en el m o do de E C G que aca ba de d esc rib irse , o una co m b in a c ió n de am bos. C abe d e s ta c a r que el icono 1328 en la fig u ra 10A inc lu ye una co n fig u ra c ió n de d iana, que ind ica que el s is te m a m ie n tra s e s ta ba en el m o do de se g u im ie n to de E C G aún no ha d e te c ta d o q ue la pun ta d is ta l de l e s tile te h aya lleg a do a la z o n a 1 p ró x im a a la parte 1354 de 1/3 in fe rio r de la V C S 1352 (fig u ra 12).
La fig u ra 10B m u e s tra la ca p tu ra 1320 de p an ta lla con la im agen 1326 de s e n s o r a u m e n ta d a de ta m a ñ o , q ue es una o pc ión se le cc io n a b le p o r el m é d ico c lín ico o re a liza d a a u to m á tica m e n te p o r el s is te m a 10, en una re a liza c ió n . C abe d e s ta c a r q ue el icono 1328 de p os ic ió n de e s tile te ha ca m b ia d o a un rom bo, que puede s e r de c o lo r ve rde , lo que ind ica q ue el s is te m a 10 ha d e te rm in a d o q ue la pun ta d is ta l de l e s tile te está u b ica d a d en tro de las z o n a s 1 ó 2 (fig u ra 12), ta l co m o se n o tificó al s is te m a p o r el p ro ce so 1224 (fig u ra 6).
En la fig u ra 10C y seg ún una re a liza c ió n , las partes de o nd a P de los co m p le jo s de E C G q ue se m u e s tra n en los tra za d o s 1322, 1324 de E C G e x te rno e in te rn o de la ca p tu ra 1320 de p an ta lla se resa ltan , ta l com o m e d ia n te un color, para co n ve n ie n c ia de l m é d ico c lín ico . La fig u ra 10C m u es tra que si la pun ta d is ta l del e s tile te se hace a v a n z a r m ás a llá de la parte 1354 de 1/3 in fe r io r de la V C S 1352, el p roce so 1224 de l m é to d o 1200 n o tifica ría una zo n a 3. Esto hace, a su vez , q ue el icono 1328 de p os ic ió n de e s tile te ca m b ie de un ro m b o ve rd e a un o c tó g o n o ro jo, lo q ue ind ica un m a yo r a va n ce del e s tile te 130 y el c a té te r 72 d e b e ría de ten e rse . P o r sup ue s to , el s is te m a puede e m p le a r o tros co lo re s , fo rm as , d ise ñ o s y co n fig u ra c io n e s para el icon o de p os ic ió n de e s tile te . De hecho , pueden h a lla rse o tros e je m p lo s de iconos de pos ic ión en la pub licac ión de so lic itud de p a te n te e s ta d o u n id e n se n.° 2014 /0188133 , p re se n ta d a el 7 de m a rzo de 2014 y titu la d a “ Icon R e p re se n ta tio n s fo r G u id a n ce o f an Ind w e lling M e d ica l D e v ice ” .
La fig u ra 9 m u e s tra un á rbo l 1280 de d e c is io n e s de n o tifica c ió n de z o n a s q ue e m p le a la a p lica c ió n 1218 de l s is te m a en la p rese n te re a lizac ión para d e te rm in a r cuá nd o se ju s tif ica el ca m b io /a c tu a liza c ió n de la pan ta lla 30 de v isu a liza c ió n p ara re fle ja r con p re c is ió n la p os ic ió n de la p un ta d is ta l de l e s tile te y, p o r tan to , la p un ta de l c a té te r d is ta l. D u ra n te la e je cuc ión del m é to do 1200 (fig u ra 6 ) m ie n tra s el e s tile te 130 y el ca té te r 72 se hacen a va n za r d en tro de la v a scu la tu ra de l pac ien te , la p a n ta lla 30 de v isu a liz a c ió n re p re se n ta rá el icono 1328 de p os ic ió n de e s tile te com o una d iana de c o lo r a m arillo , ta l com o la que se o b se rva en la fig u ra 10 en la im a ge n 1326 de sen sor, cua nd o el p roce so 1224 ha
n o tif ica d o a u se n c ia de zo n a a la a p licac ión 1218 del s is tem a. Esta s itu a c ió n co rre sp o n d e al b lo q ue 1282, m a rca d o co m o “Y l” para in d ica r el c o lo r de icono a m a rillo (Y = ye llo w ). C ab e d e s ta c a r que en la p re se n te re a liza c ió n , el m é to do 1200 n o tifica rá de m a n e ra ite ra tiva una zo n a (e ta p a 1270 en la fig u ra 6 ) o una a u se n c ia de zo n a de (e ta p a 1248) a la a p lica c ió n 1218 de l s is te m a d u ra n te la e je cu c ió n del m é to d o y el fu n c io n a m ie n to de l s is te m a 10.
C u a n d o el p roce so 1224 n o tifica una zo n a 1 ó 2 a la a p lica c ió n 1218 de l s is te m a (fig u ra 6), se p ro d u ce el a va nce d e sd e el b lo q u e 1281 Y1 h as ta el b lo q ue 1284, q ue e stá m a rca d o co m o “G 1 ” para in d ica r q ue se p ro d u ce un e sta do v e rd e in ic ia l (G = gree n ). C u a n d o el p ro ce so 1224 n o tifica de m a n e ra ite ra tiva una se g u n d a z o n a 1 ó 2 suce s iva , se re a liza un a va n ce d esde el b lo q ue 1284 G1 h a s ta el b lo q ue 1286, q ue se m a rca com o “G 2 ” p ara in d ic a r un e sta do ve rde . E s to c o rre sp o n d e al icono 1328 de p os ic ió n de e s tile te q ue se ca m b ia d e l icono de d ia n a a m a rilla de la fig u ra 10A a un icono de ro m b o ve rd e ta l com o se o b se rva en la fig u ra 10B.
Si el p roce so 1224 n o tifica una zo n a 3 o s u p e r io r a la a p lica c ió n 1218 del s is te m a, se p rod u ce el a va nce d esde el b lo q ue 1286 G 2 h asta el b lo q ue 1288, q ue e stá m a rca d o com o “ r1 ” para in d ic a r un e s ta do ro jo in ic ia l. S i el p roce so 1224 n o tifica de m a nera ite ra tiva una seg un da zo n a suce s iva 3 o m ayor, se a va nza d esde el b loque 1288 R1 al b loque 1290, q ue se m a rca com o “ R 2” para in d ic a r un e s ta d o ro jo (R = red). E s to c o rre sp o n d e al icono 1328 de p os ic ió n de e s tile te q ue se cam b ia de l ro m b o ve rd e de la fig u ra 10B al o c tó g o n o ro jo ta l co m o se o b se rva en la fig u ra 10C.
Si el p roce so 1224 n o tifica luego una zon a 1 ó 2 a la ap licac ión 1218 del s is tem a, se re a liza un a va n ce d esde el b loque 1290 R2 de v u e lta al b lo q ue 1284 G1 para p ro ce d e r ta l com o se d e sc rib ió a n te rio rm e n te . E s to , a s í co m o un a va n ce s im ila r has ta el b loque 1284 G1 d esde el b loque 1288 R1 o el b loque 1281 Y1, se ind ica con las fle ch a s 1294. De m a ne ra co rre sp o n d ie n te , el a va nce hac ia el b loque 1288 R1 d esde los b lo q ue s 1282, 1284 o 1286 se ind ica m e d ia n te fle ch a s 1296.
En c u a lq u ie ra de los b lo q u e s 1282, 1284, 1286, 1288 y 1290, la fa lta de c u a lq u ie r n o tifica c ió n d esde el p ro ce so 1224 d u ra n te un p e rio do de m e n o s de tre s se g u n d o s hace que la a p lica c ió n 1218 del s is te m a p e rm a n e zca en el m ism o b lo q ue d es ig n a d o . Esto se ind ica m e d ia n te las fle ch a s 1292 en buc le a d ya ce n te s a cada uno de los b lo q ue s 1282, 1284, 1286, 1288 y 1290.
En cu a lq u ie ra de los b lo q u e s 1282, 1284, 1286, 1288 y 1290, la fa lta de c u a lq u ie r n o tifica c ió n d esde el p ro ce so 1224 d u ra n te un p e rio d o igua l o s u p e r io r a tre s s e g u n d o s hace q ue la a p lica c ió n 1218 de l s is te m a re v ie rta al b lo q ue 1281 Y1, con el cam b io co rre sp o n d ie n te de l icon o 1328 de p os ic ión de estile te . Esto se ind ica m e d ia n te las fle ch a s 1302 d is co n tin u a s q ue co n d u ce n al b lo q ue 1281 Y1 d esde los b lo q u e s 1284, 1286, 1288 y 1290.
En el b lo q ue 1286 G 2 y el b lo q ue 1290 R2, la n o tifica c ió n c o n tin u a d a d esde el p ro ce so 1224 de la m ism a z o n a hacen que la a p lica c ió n 1218 de l s is te m a p e rm a n e zca en el m ism o b loque d es ign ad o . E sto se ind ica m e d ia n te las fle ch a s 1298 y 1300 en b uc le para el b lo q ue 1286 G 2 y el b lo q ue 1290 r2, re sp e c tiva m e n te .
La fig u ra 13 m u e s tra un á rbo l 1400 de d e c is io n e s de n o tifica c ió n de z o n a s que se e m p le a en una re a liza c ió n p o r la a p lica c ió n 1218 del s is te m a para d e te rm in a r cu á n d o se ju s tif ic a el c a m b io /a c tu a liza c ió n de la p a n ta lla 30 de v isu a liz a c ió n para re fle ja r con p rec is ión la pos ic ión de la pun ta d is ta l de l e stile te y, p o r tan to , la pun ta d is ta l del ca té te r, d u ra n te la inse rc ión y co lo ca c ió n de l ca té te r. En p a rticu la r, el m é to d o 1400 se e je cu ta en una re a liza c ió n p o r la a p lica c ió n 1218 del s is te m a para d e c id ir cóm o y cuá nd o a c tu a liza r la re p re se n ta c ió n en la p an ta lla 30 de v isu a liza c ió n , inc lu ido el icono 1328 de p os ic ión de e s tile te (vé a n se las fig u ra s 10A -10C ), b a sá n d o se en los in fo rm e s 1248, 1270 de zo n a de la sa lid a 1216 A de o nd a P de l p roce so 1224.
El m é to do 1400 com ie n za en la e ta pa 1402 co n su lta n d o los d a tos de in fo rm e de zo n a (ta m b ié n d e n o m in a d o “ co n ju n to de d a to s ” ) p ro p o rc io n a d o s a la a p lica c ió n 1218 de l s is te m a p o r el p ro ce so 1224 a tra vé s de la sa lid a 1216 A de o nda P. C a d a in fo rm e de zo n a en los d a tos de in fo rm e de zo n a inc lu ye una in d ica c ió n de a u se n c ia de zo n a o una de las tre s in d ica c io n e s de zon a : ba ja , a lta e idea l, ta l com o se d e sc rib e m ás a de la n te . En la e ta p a 1404 se d e te rm in a si el re cu e n to de co n su lta s , o el n ú m e ro de in fo rm e s de z o n a p ro p o rc io n a d o s a la a p lica c ió n 1218 del s is te m a, es igu a l a o m a yo r de 50. En ca so n eg a tivo , se e je cu ta la e ta pa 1406, q ue a ñ a d e o tra con su lta , o in fo rm e de zo n a , en la e ta pa 1402.
Si el re cu e n to de co n su lta s en la e ta pa 1404 p rod u ce 50 o m ás en can tida d , se e je cu ta la e ta pa 1408, en la que se e xa m in a el ú ltim o in fo rm e de zo n a p ara d e te rm in a r si n o tifica una zo n a (co rre sp o n d ie n te a una “zon a n o tif ica d a ” en la e ta p a 1270 en la fig u ra 6 ) o si n o tifica una “ a u se n c ia de z o n a ” (c o rre sp o n d ie n te a u na “ a u se n c ia de zo n a n o tif ica d a ” en la e ta pa 1248 en la figu ra 6). S i el ú ltim o in fo rm e de z o n a es una a u se n c ia de zon a , se e je cu ta la e ta pa 1410, en la q ue un c o n ta d o r de a u se n c ia de zon a se increm enta en uno y se cue n ta el n ú m e ro de a u se n c ia de z o n a s con se cu tiva s . Luego , en la e ta pa 1412, se d e te rm in a si el n ú m e ro de a u se n c ia de z o n a s c o n se cu tiva s co n ta d a s es igua l a o m a yo r de 20. En caso nega tivo , se e je cu ta la e ta pa 1406, q ue a ña de o tra con su lta , o in fo rm e de zon a , a la e ta pa 1402. Si el la re sp u e s ta en la e ta pa 1412 es “s í” , un c o n ta d o r de zo n a s se re in ic ia a ce ro en la e ta p a 1414, se d e c la ra un e s ta do a lto en la e ta pa 1432, en el q ue la a p licac ión 1218 del s is te m a re p re s e n ta rá una in d ica c ió n a pro p ia d a en la pan ta lla 30 de v isu a liz a c ió n (fig u ra 2), p o r e jem p lo , q ue ind ica al u su a rio que el c a té te r puede h a ce rse a v a n z a r m á s y aún no ha lle g a d o al d e s tin o d esea do , en este caso , la p a rte 1354 de 1/3 in fe rio r de la V C S 1352. En una re a liza c ió n , la re p re se n ta c ió n en la p an ta lla 30 de v isu a liz a c ió n inc lu ye el d ise ñ o de d ia n a a m a rilla del icono 1328 de p os ic ió n de
e s tile te ta l com o se o b se rva en la fig u ra 10A. U na ve z que se v isu a liza la re p re se n ta c ió n , el m é to do 1400 re v ie rte a la e ta pa 1406 y luego a la e ta pa 1402, en la que los da tos de in fo rm e de zo n a se con su ltan de nuevo. En una re a liza c ió n , se e lim in a n los d a tos de co n su lta a lm a ce n a d o s p re v ia m e n te y se a dq u ie re n nue vo s datos. El p roce so d escrito a n te r io rm e n te es ite ra tivo con re sp e c to a la n o tifica c ió n de a u se n c ia de zona.
C abe d e s ta c a r que en la p rese n te re a liza c ió n , el re cue n to de co n su lta s de 50 en la e ta pa 1404 co rre sp o n d e a a p ro x im a d a m e n te c inco se g u n d o s de d a tos ca p ta d o s p or el s is te m a 10 y el m é to do 1200 (fig u ra 6), es dec ir, la ve lo c id a d de tra n s m is ió n de d a to s de 500 h ertz ios re c ib id a p o r el s e n s o r 50 de T L S p ro ce sa d o s en b lo q ue s de 50, p ro d u c ie n d o 10 d e te rm in a c io n e s de z o n a p o r seg un do . La m e m o ria in te rm e d ia u sada para a lm a c e n a r los d a to s de la e ta pa 1402 fu n c io n a con una base de p rim e ro en entra r, p rim ero en sa lir (“ F IF O ” , firs t-in , firs t-o u t), e xp u lsa n d o el v a lo r m ás a n tig u o en la m e m o ria in te rm e d ia cu a n d o se rec ibe un n uevo va lo r.
Si, en la e ta p a 1408, el ú ltim o in fo rm e de zo n a n o tifica una zon a , se e je cu ta la e ta p a 1416, en la q ue el c o n ta d o r de a u se n c ia de zo n a se re in ic ia a ce ro y el con tro l a va n za a la e ta pa 1418. En la e ta pa 1418, los d a tos se a na liza n , c o m e n za n d o con los in fo rm e s de zo n a m ás rec ien tes , y en la e ta pa 1420 en cue s tió n , se d e te rm in a si están p rese n te s al m e n o s c inco in fo rm e s de zo n a en los d a tos de in fo rm e de zo n a co n su lta d o s de la e ta pa 1402 (no es n ecesa rio que los al m e no s c inco in fo rm e s de zo n a sean c o n se cu tivo s en los da tos). En caso nega tivo , el m é to do re v ie rte a la e ta pa 1406, en el q ue se a ña de o tra co n su lta a la e ta pa 1402 y el m é to do co n tin ú a d esde allí.
S i la re sp u e s ta en la e ta p a 1420 es “ s í” , se e je cu ta la e ta p a 1422, en la q ue se a n a liza n los al m e n o s c inco in fo rm e s de zo n a y en la e ta pa 1424, se d e te rm in a si cua tro o m ás de los in fo rm e s de zo n a son in fo rm e s de zo n a “ b a ja ” , lo que ind ica q ue la p un ta d is ta l del e s tile te 130 ha p a sa d o la p a rte 1354 de 1/3 in fe rio r de la V C S 1352 (co m o en las zo n a s 3, 4 de la fig u ra 12). En ca so a firm a tivo , se d e c la ra un e s ta d o b a jo en la e ta p a 1426, en la que la a p lica c ió n 1218 del s is te m a re p re se n ta rá una ind icac ión a p ro p ia d a en la pan ta lla 30 de v isu a liza c ió n (fig u ra 2), p o r e jem p lo , q ue ind ica al u su a rio q ue el c a té te r se ha h echo a va n za r d e m a s ia d o . En una re a liza c ió n , la re p re se n ta c ió n en la p a n ta lla 30 de v isu a liz a c ió n inc lu ye el d ise ño de o c tó g o n o ro jo del icono 1328 de p os ic ión de e s tile te ta l com o se o b se rva en la figu ra 10C. U na ve z q ue se v isu a liz a la re p re se n ta c ió n , el m é to do 1400 re v ie rte a la e ta pa 1406 y luego a la e ta pa 1402, en la que los da tos de in fo rm e de zo n a se co n su lta n de nuevo . En una re a liza c ió n , se e lim in a n los d a tos de co n su lta a lm a ce n a d o s p re v ia m e n te y se a d q u ie re n n u e vo s datos.
Si la re sp u e s ta en la e ta p a 1424 es “ no ” , se e je cu ta la e ta p a 1428, en la q ue se a n a liza n los al m e n o s c inco in fo rm e s de zo n a y en la e ta pa 1430, se d e te rm in a si tre s o m ás de los in fo rm e s de z o n a son in fo rm e s de zon a “a lta ” , lo que ind ica que la pun ta d is ta l de l e s tile te 130 aún no ha lle g a d o p ró x im a a la parte 1354 de 1/3 in fe rio r de la V C S 1352 (co m o en las zo n a s -2, -1 ó 0 de la figu ra 12). En caso a firm a tivo , se d e c la ra un e s ta do a lto en la e ta pa 1432, en la q ue la a p lica c ió n 1218 del s is te m a re p re se n ta rá una ind icac ión a p ro p ia d a en la p an ta lla 30 de v isu a liza c ió n (fig u ra 2), p o r e je m p lo , q ue ind ica al u su a rio que el c a té te r puede h ace rse a v a n z a r m ás. En una re a liza c ió n , la re p re se n ta c ió n en la p a n ta lla 30 de v isu a liz a c ió n in c lu ye el d ise ñ o de d ia n a a m a rilla de l icono 1328 de p o s ic ió n de e s tile te ta l com o se o b se rva en la fig u ra 10A. U na ve z que se v isu a liz a la re p rese n tac ió n , el m é to d o 1400 re v ie rte a la e ta pa 1406 y luego a la e ta pa 1402, en la q ue los d a tos de in fo rm e de zo n a se con su lta n de nuevo . En una re a liza c ió n , se e lim inan los d a tos de co n su lta a lm a ce n a d o s p re v ia m e n te y se a dq u ie re n n ue vo s datos .
Si la re sp u e s ta en la e ta pa 1430 es “ no ” , se e je cu ta la e ta pa 1434, en la q ue se a na liza n los al m e no s c inco in fo rm e s de z o n a y en la e ta pa 1436, se d e te rm in a si cua tro o m á s de los in fo rm e s de z o n a son in fo rm e s de z o n a “ id e a le s ” , lo q ue ind ica q ue la pun ta d is ta l de l e s tile te 130 ha lleg a do p róx im a a la parte 1354 de 1/3 in fe rio r de la V C S 1352 (com o en las z o n a s 1 o 2 de la fig u ra 12). En ca so a firm a tivo , se d e c la ra un e s ta d o idea l en la e ta pa 1438, en la que la a p lica c ió n 1218 del s is te m a re p re se n ta rá una ind icac ión a p ro p ia d a en la p an ta lla 30 de v isu a liz a c ió n (fig u ra 2), p o r e je m p lo , q ue ind ica al u su a rio que el c a té te r ha lleg a do a su d es tino p re te n d id o según a la p rese n te re a liza c ió n . En una re a liza c ió n , la re p re se n ta c ió n en la p an ta lla 30 de v isu a liza c ió n inc lu ye el d ise ñ o de ro m b o ve rd e del icono 1328 de p os ic ió n de e s tile te ta l com o se o b se rva en la fig u ra 10B. U na v e z que se v isu a liz a la re p re se n ta c ió n , el m é to do 1400 re v ie rte a la e ta pa 1406 y luego a la e ta pa 1402, en la que los d a to s de in fo rm e de zo n a se con su lta n de nuevo. En una re a liza c ió n , se e lim in a n los d a tos de co n su lta a lm a ce n a d o s p re v ia m e n te y se a d q u ie re n n ue vo s datos.
Si la re sp u e s ta en la e ta pa 1436 es “ no ” , se e je cu ta la e ta pa 1440, en la q ue se a n a liza n los al m e n o s c inco in fo rm e s de z o n a a c tu a le s y se to m a una d e c is ió n en una o m ás de las tre s e ta p a s 1440, 1442 y 1444. En la e ta pa 1440, si la d e te rm in a c ió n de zon a a n te r io r en una ite rac ión in m e d ia ta m e n te p rev ia de l m é to do 1400 p rod u jo un e s ta do idea l y tre s de los c in co in fo rm e s de z o n a a c tu a le s son in fo rm e s de z o n a baja , lue g o se d e c la ra un e s ta d o ba jo en la e ta p a 1426, e ta pa q ue se e je cu ta ta l com o se d e sc rib ió ya a n te rio rm e n te .
Si la re sp u e s ta en la e ta p a 1440 es “ n o ” , se e je cu ta la e ta pa 1442, en la q ue si la d e te rm in a c ió n de z o n a a n te r io r en la ite ra c ió n in m e d ia ta m e n te p rev ia de l m é to do 1400 p rod u jo un e sta do idea l y d os o m á s de los c inco in fo rm e s de zo n a a c tu a le s son in fo rm e s de zo n a idea l, e n to n c e s se d e c la ra un e s ta d o idea l en la e ta pa 1438, e ta p a q ue se e je cu ta ta l com o se d e sc rib ió ya a n te rio rm e n te .
Si la re sp u e s ta en la e ta pa 1442 es “ n o ” , se e je cu ta la e ta pa 1444, en el q ue si la d e te rm in a c ió n de z o n a a n te r io r en la ite rac ión in m e d ia ta m e n te p rev ia del m é to do 1400 p rod u jo un e s ta do ba jo y dos o m ás de los c inco in fo rm e s de zo n a a c tu a le s son in fo rm e s de zon a baja, e n to n ce s se d ec la ra un e s ta do bajo en la e ta pa 1426, e ta pa que se e je cu ta ta l
com o se d e sc rib ió ya a n te rio rm e n te .
Si la re spu es ta en la e ta pa 1444 es “ no ” , se d ec la ra un e s ta do a lto en la e ta pa 1432, e ta pa q ue se e je cu ta ta l com o se d e sc rib ió a d ic io n a lm e n te con a n te rio rida d . U na ve z que se v isu a liz a la re p re se n ta c ió n seg ún las e ta p a s 1426, 1432 ó 1438, el m é to do 1400 re v ie rte a la e ta pa 1406 y luego a la e ta pa 1402, en el q ue los da tos de in fo rm e de zo n a se co n su lta n de nuevo. En una re a liza c ió n , se e lim in a n los d a tos de c o n su lta a lm a c e n a d o s p re v ia m e n te y se a dq u ie re n n u e vo s datos.
C abe d e s ta c a r que el m é to d o 1400 se e je cu ta de m a n e ra ite ra tiva d u ra n te el p ro ce d im ie n to de co lo ca c ió n de d isp o s itivo s m é d ico s u sando el s is te m a 10. T a m b ié n cabe d e s ta c a r q ue los n úm e ro s de u m bra l p a rticu la re s usados en la e va lu a c ió n de los in fo rm e s de zo n a p ueden v a r ia r con re spe cto a lo q ue se d e sc rib e en el p re se n te d ocum e n to , ta l co m o p ue de a p re c ia r un e xp e rto en la té cn ica . A d e m á s, pueden e m p le a rse m á s de tre s in fo rm e s de zon a , en una re a liza c ió n .
C abe d e s ta c a r que ta m b ié n pueden e m p le a rse o tros m o d o s para a c tu a liz a r la p an ta lla 30 de v isu a liz a c ió n seg ún la in fo rm a c ió n de zon a n o tifica d a p o r el m é to do 1200, inc lu id o s d ife re n te s icon os o s ím b o lo s o m o do s de sa lida , icon os de d ife re n te s co lo res, etc. M ás g e n e ra lm e n te , p ueden u sa rse o tros á rb o le s de d e c is io n e s de n o tifica c ió n para re g u la r la re p re se n ta c ió n de in fo rm a c ió n de zo n a de l m é to d o 1200 en la p an ta lla 30 de v isu a liz a c ió n u o tro m o do de sa lida p o r la a p licac ión 1218 de l s is tem a. En aún o tra re a liza c ió n , el m é to do 1200 p uede n o tif ica r p a rá m e tro s d is tin to s de las zon as .
C abe d e s ta c a r que las e ta pa s 1260 -1264 del p roce so 1224 pueden re a liza rse s im u ltá n e a m e n te o en un o rden d ife ren te al q ue se m u e s tra en la fig u ra 6. A d e m á s, el a lg o ritm o del m é to d o 1200 p ue de e v a lu a r o tro s p ará m e tros , inc lu ye n d o la fre cu e n c ia c a rd ia ca del p ac ien te , la f lu c tu a c ió n iso e lé c trica /d e n ive l in ic ia l y la ve rtica lid a d de l co m p le jo Q R S d e te c ta d o . P o r e je m p lo , p uede u sa rse un u m bra l de fre cu e n c ia ca rd ia ca de l pac ien te de e n tre a p ro x im a d a m e n te 50 y a p ro x im a d a m e n te 150 la tid o s p or m inuto com o p a rá m e tro para la e va lua c ió n m e d ia n te el m é to do 1200 para g a ra n tiza r la co lo ca c ió n in tra v a s c u la r a p ro p ia d a de l d isp o s itivo m é d ico . En o tro e je m p lo , puede u sa rse com o p a rá m e tro una f lu c tu a c ió n de n ive l in ic ia l a d m is ib le de /- a p ro x im a d a m e n te 300 m ic ro vo ltio s a 2 ,5 herc ios. En aún o tro e jem p lo , puede u sa rse com o p a rá m e tro una lon g itu d del co m p le jo Q R S de e n tre a p ro x im a d a m e n te 0 ,08 y a p ro x im a d a m e n te 0 ,10 se g u n d o s de d u ra c ión . P ueden e m p le a rse e s to s y o tros p a rá m e tro s a d e cu a d o s . En g en era l, se o b se rva que p ueden inc lu irse m ás o m e no s e ta pa s en el m é to do 1200 en o tras re a liza c io n e s para a yu d a r a re a liza r un se g u im ie n to de y c o lo ca r el c a té te r u o tro d isp o s itivo m é d ico a de cu ad o .
La fig u ra 11 m u es tra el m é to do 1200 según o tra rea lizac ión , en el que en lu g a r de los co m p o n e n te s de s e n so r de EC G ta n to e x te rn o com o in tra v a s c u la r u sa d o s para d e te rm in a r el m á x im o de la o nd a P, só lo se e m p le a el c o m p o n e n te de s e n s o r de E C G in tra va scu la r. C o m o ta l, no se d isp o n e n e le c tro d o s e x te rnos , ta le s com o los e le c tro d o s 136 e x te rn o s (fig u ra 2), en la p ie l de l p ac ien te . En cam b io , las e ta p a s 1230, 1232, 1234, 1236 y 1240 se e je cu ta n usa nd o una seña l de E C G de n ive l in ic ia l. La señ a l de E C G de n ive l in ic ia l se a d q u ie re u sa nd o se ñ a le s de E C G d e te c ta d a s p o r el c o n ju n to de s e n so r de e stile te del e stile te 130 (es decir, el co m p o n e n te de s e n so r de E C G in tra va scu la r). En particu la r, la señ a l de E C G de n ive l in ic ia l se a d q u ie re a p a rtir del co n ju n to de s e n s o r de E C G de e s tile te de l e s tile te 130 cu a nd o la pun ta d is ta l de l e s tile te se d isp o n e en la v a s c u la tu ra e n tre el s itio 73 de inse rc ión (fig u ra 2 ) y a lre d e d o r de la reg ión de l hom b ro de l b razo en el que se insertan el e stile te y el ca té te r 72 (es decir, el b razo d e re cho en el e je m p lo m o strado en la fig u ra 2). C abe d e s ta ca r que, en o tra rea lizac ión , el s itio de inse rc ión puede e s ta r en o tra e x tre m id ad del pac ien te , ta l com o la p ie rna , en cu yo ca so la se ñ a l de E C G de n ive l in ic ia l se a d q u ie re a p a rtir del c o n ju n to de s e n s o r de E C G de e s tile te cu a n d o la pun ta d is ta l del e s tile te se d isp o n e e n tre el s itio de inse rc ión y el pun to de un ión de la e x tre m id ad (p ie rn a ) con el to rso de l pac ien te .
La d e tecc ión de se ñ a le s de E C G cu a n d o el con ju n to de s e n s o r de e s tile te se s itú a ta l com o se d e sc rib ió in m e d ia ta m e n te an tes (con el s itio de inse rc ión d isp u e s to en el b razo del p a c ie n te ) se a p ro x im a a la d e tecc ión de se ñ a le s de E C G de un p a r de e le c tro d o s e x te rn o s co lo ca d o s en la p ie l en una co n fig u ra c ió n de “ d e riva c ió n II” basad o en el tr iá n g u lo de E in thoven . C om o tal, la señ a l de E C G a sí d e tec tad a p e rm a n e ce rá su s ta n c ia lm e n te e s tá tica y puede u sa rse com o señ a l de E C G de re fe re n c ia de n ive l in ic ia l fre n te a la señ a l de E C G in tra v a s c u la r d e te c ta d a p o r el co n ju n to de s e n s o r de e s tile te cu a n d o el e s tile te 130 se hace a v a n z a r m ás a llá de la re g ió n g en e ra l d e l h o m b ro del b razo en el que se in se rta n el e s tile te y el ca té te r. T a l a va n ce p e rm itirá que el c o n ju n to de s e n s o r de e s tile te d e tec te la o nda P ca m b ia n te a m e d id a que el e s tile te se a ce rca al n odo S A de l co razón 1350 del p ac ie n te (fig u ra 12). P o r tan to , en la p re se n te re a liza c ió n , las e tapas 1230, 1232, 1234, 1236 y 1240 se e jecu tan de m a ne ra s im ila r a la descrita a n te r io rm e n te en re lac ió n con la d e sc rip c ió n de la fig u ra 6 m ie n tra s se usa la señ a l de E C G de n ive l in ic ia l (p a rte de los d a tos 1212 de se ñ a le s de E C G in travascu la r) d e te c ta d a p o r el co n ju n to de s e n so r de e s tile te tra s la inse rc ión in ic ia l del c a té te r 72 e in c lu id o el e s tile te 130 en la v a s c u la tu ra p ero a n te s de a va n z a r m ás a llá de la re g ión d e l h o m b ro del b razo en el q ue se inse rtan el c a té te r y el estile te .
C ab e d e s ta c a r q ue el uso y el a n á lis is de una se ñ a l de E C G de n ive l in ic ia l e in tra v a s c u la r que se o rig in a n a m b a s a p a rtir de la d e te cc ió n p o r un co m p o n e n te de s e n s o r de E C G in tra v a s c u la r (es dec ir, el co n ju n to de s e n s o r de e s tile te de l e s tile te 130) ta l com o se d e sc rib e en re la c ió n con la fig u ra 11, p e rm ite en una re a liza c ió n la ca p a c id a d de q ue un m é d ico c lín ico o b se rve co n d ic io n e s que pueden re s u lta r e v id e n te s só lo en la señ a l de E C G in tra v a s c u la r y no se r e v id e n te s en u na señ a l de E C G e x te rn o d e te c ta d a a tra v é s de un co m p o n e n te de s e n s o r de E C G e x te rn o , ta l co m o
los e le c tro d o s 136 e x te rn o s de la fig u ra 2. Un e je m p lo de ta l con d ic ió n inc lu ye b lo q u e o s in tra a u ricu la re s , p o r e jem p lo .
Las re a liza c io n e s d ivu lg a d a s en el p rese n te d o cu m e n to pueden in c lu ir un o rd e n a d o r de p rop ó s ito e sp e c ia l o de p ro p ó s ito g en e ra l que inc lu ye h a rd w a re in fo rm á tico , ta l com o se c o m e n ta con m a yo r d e ta lle a co n tin u a c ió n . Las re a liza c io n e s den tro del a lca nce de la p rese n te d ivu lga c ió n ta m b ié n inc luyen m e d io s leg ib le s p o r o rd e n a d o r para p o rta r o te n e r in s tru cc io n e s e je cu ta b le s p or o rd e n a d o r o e s tru c tu ra s de da tos a lm a ce n a d a s en los m ism os . D ich os m e d io s leg ib le s p o r o rd e n a d o r pueden se r cu a lq u ie r m e d io d isp on ib le al que pueda a cce d e r un o rd e n a d o r de p rop ó s ito g en era l o de p ro p ó s ito e sp ec ia l. A m o do de e je m p lo , y sin lim ita c ió n , los m e d io s le g ib le s p o r o rd e n a d o r p ue de n c o m p re n d e r m e d io s de a lm a ce n a m ie n to fís icos (o de tip o g ra b a b le ) le g ib le s p o r o rde n ad or, ta le s com o R AM , R O M , E E P R O M , C D -R O M u o tro a lm a c e n a m ie n to de d isco óptico , a lm a ce n a m ie n to de e s ta d o só lido , a lm a ce n a m ie n to de d isco m a gn é tico u o tros d isp o s itivo s de a lm a c e n a m ie n to m a gn é tico , o cu a lq u ie r o tro m e d io que p ueda u sa rse para a lm a c e n a r los m e d io s de cód igo de p ro g ra m a d e se a d o s en fo rm a de in s tru cc io n e s e je cu ta b le s p o r o rd e n a d o r o e s tru c tu ra s de da tos y a las que p uede a cce d e r un o rd e n a d o r de p ro p ó s ito g e n e ra l o de p ro p ó s ito espec ia l.
En esta d e sc rip c ió n y en las s ig u ie n te s re iv in d ica c io n e s , una “ re d ” se d e fine com o uno o m ás e n la ce s de d a tos que p e rm ite n la tra n s m is ió n de d a to s e le c tró n ico s e n tre s is te m a s in fo rm á tico s y /o m ó du los . C u a n d o la in fo rm a c ió n se tra n s fie re o se p ro p o rc io n a a tra vé s de una red u o tra con e x ió n de c o m u n ica c io n e s (ya sea p o r cab le, in a lá m b rica o una co m b in a c ió n de p o r cab le o in a lá m b rica ) a un o rde n ad or, el o rd e n a d o r ve co rre c ta m e n te la con e x ió n com o un m e d io leg ib le p o r o rde n ad or. P o r tan to , a m o do de e je m p lo y sin lim itac ión , los m e d ios leg ib le s p o r o rd e n a d o r ta m b ié n pueden c o m p re n d e r una red o e n la ce s de d a tos que p ueden u sa rse para p o rta r o a lm a c e n a r m e d io s de cód igo de p ro g ra m a d e se a d o s en fo rm a de in s tru cc io n e s e je cu ta b le s p o r o rd e n a d o r o e s tru c tu ra s de d a tos y a las que puede a cce d e r un o rd e n a d o r de p ro p ó s ito g e n e ra l o de p ro p ó s ito e sp ec ia l.
Las in s tru cc io n e s e je cu ta b le s p o r o rd e n a d o r inc luyen , p o r e jem p lo , in s tru cc io n e s y d a tos que hacen que un o rd e n a d o r de p ro p ó s ito g en era l, o rd e n a d o r de p ro p ó s ito e sp ec ia l o d isp o s itivo de p ro ce sa m ie n to de p ro p ó s ito e sp e c ia l re a lice una d e te rm in a d a fu n c ió n o g rup o de fun c ion es . Las in s tru cc io n e s e je cu ta b le s p o r o rd e n a d o r pueden ser, p o r e jem p lo , in s tru cc io n e s b ina rias , de fo rm a to in te rm e d io , ta l co m o len g ua je e nsa m b la d o r, o inc lu so cód igo fue n te . A u n q u e el co n te n id o se ha descrito en un lengua je e sp ec ífico p ara c a ra c te rís tica s e s tru c tu ra le s y /o a cc io n e s m e to d o ló g ica s , debe e n te n d e rse q ue el co n te n id o d e fin id o en las re iv in d ica c io n e s a d ju n ta s no se lim ita n e ce sa ria m e n te a las c a ra c te rís tica s o a cc io n e s d e sc rita s a n te rio rm e n te . M ás bien, las c a ra c te rís tica s y a cc io n e s d e sc rita s se d ivu lg a n com o fo rm a s de e je m p lo de im p le m e n ta c ió n de las re iv ind ica c ion es .
Los e xp e rto s en la té c n ic a a p re c ia rán que las re a liza c io n e s de l p rese n te d o cu m e n to pueden p on e rse en p rá c tica en e n to rn o s de co m p u ta c ió n en red con m u ch o s tip o s de co n fig u ra c io n e s de s is te m a s in fo rm á tico s , in c lu ye n d o o rd e n a d o re s pe rso na les , o rd e n a d o re s de e sc rito rio , o rd e n a d o re s p o rtá tiles , p ro ce sa d o re s de m e nsa je s , d isp o s itivo s de m ano, s is te m a s m u ltip ro ce sa d o r, e le c tró n ica de con su m o b a sa d a en m ic ro p ro c e s a d o r o p ro g ra m a b le , P C en red, m in io rd e n a d o re s , o rd e n a d o re s cen tra le s , te lé fo n o s m óviles , PD A, b u sca p e rso n a s y s im ila res . Las re a liza c io n e s ta m b ié n pueden p o n e rse en p rác tica en e n to rn o s de s is te m a s d is tr ib u id o s en los q ue s is te m a s in fo rm á tico s loca les y rem otos, q ue están v in c u la d o s (ya sea m e d ia n te e n la ce s de da tos p o r cab le, e n la ce s de datos in a lá m b rico s o m e d ia n te una co m b in a c ió n de e n la ce s de da tos p o r cab le e in a lá m b rico s ) a tra vé s de una red, a m bo s re a liza n ta re a s . En un e n to rn o de s is te m a s d is trib u id os , los m ó d u lo s de p ro g ra m a pueden u b ica rse en d isp o s itivo s de a lm a c e n a m ie n to de m e m o ria ta n to loca les com o rem otos.
Claims (12)
- REIVINDICACIONESi. S is te m a para g u ia r un d isp o s itivo m é d ico hasta una u b icac ión d e se a d a d en tro de la va s c u la tu ra de un p ac ien te , q ue com p re nd e :al m e no s un s e n s o r de E C G in tra v a s c u la r para d e te c ta r una se ñ a l de E C G in tra v a s c u la r de l pac ien te ; un p ro c e sa d o r c o n fig u ra d o para re c ib ir la señ a l de E C G in tra va scu la r, e s ta n d o el p ro c e sa d o r co n fig u ra d o a d e m á s para:id e n tif ic a r una o nd a P de una fo rm a de o nd a de la señ a l de E C G in tra va scu la r, v a r ia n d o la o nd a P seg ún la p ro x im id a d de l d isp o s itivo m é d ico a la u b ica c ió n d eseada ;d e te rm in a r si la o nd a P id e n tifica d a e stá e le vad a ;d e te rm in a r un v a lo r de d e sv ia c ió n de la o nda P id e n tif ica d a cu a n d o la o nd a P id e n tifica d a e stá e le vad a ; y n o tif ica r in fo rm a c ión re la c io n a d a con una u b ica c ió n del d isp o s itivo m é d ico den tro de la va s c u la tu ra del p ac ie n te al m e no s p a rc ia lm e n te según el v a lo r de d e sv ia c ió n d e te rm in a d o de la o nd a P e le vad a ; y un d isp o s itivo de sa lid a co n fig u ra d o p ara n o tif ica r la in fo rm a c ió n re la c io n a d a con la u b ica c ió n del d isp o s itivo m édico ,en el que la d e te rm in a c ió n de si una o n d a P de una fo rm a de o nd a de la se ñ a l de E C G in tra v a s c u la r está e le va d a se basa en una p lu ra lida d de u m b ra le s p re d e te rm in a d o s , v a r ia n d o la o nda de P seg ún la d is ta nc ia de l c o m p o n e n te de s e n s o r de E C G in tra v a s c u la r d esde la p arte de e m is ió n de se ñ a le s de l co razón , e s ta n d o los u m b ra le s p re d e te rm in a d o s re la c io n a d o s con al m e no s lo s igu ien te :(a ) una a m p litu d de la o nd a P de la señ a l de E C G in tra v a s c u la r d en tro de un ra ng o p red e te rm in ad o ;(b ) una p e n d ie n te de la o nd a P de la señ a l de E C G in tra v a s c u la r d e n tro de un rango p re d e te rm in a d o ; y (c) una co m p o n e n te de ru ido de la señ a l de E C G in tra v a s c u la r d en tro de un rango p red e te rm in ad o .
- 2. S is te m a para el g u ia do seg ún la re iv in d ica c ió n 1, en el que el p ro c e sa d o r que d e te rm in a si la o nda P id e n tifica d a e stá e le va d a inc lu ye ade m ás:d e te rm in a r si al m e n o s uno de una fre cu e n c ia y una a m p litu d de la o nd a P id e n tifica d a se e n cu e n tra d en tro de un ra ng o p re d e te rm in a d o ; yd e te rm in a r si una c o m p o n e n te de ru ido de la señ a l de E C G in tra v a s c u la r se e n cu e n tra d en tro de un ra ng o p re d e te rm in a d o .
- 3. S is te m a para el g u ia d o seg ún la re iv in d ica c ió n 1, en el q ue el d isp o s itivo de sa lid a inc lu ye una p an ta lla de v isu a liz a c ió n de l s is tem a.
- 4. S is te m a p ara el g u ia d o seg ún la re iv in d ica c ió n 3, en el q ue el p ro c e sa d o r e stá co n fig u ra d o p ara e je c u ta r un á rbo l de d e c is io n e s , d e te rm in a n d o el á rb o l de d e c is io n e s cu á n d o n o tifica r la in fo rm a c ió n re la c io n a d a con la u b ica c ió n de l d isp o s itivo m édico .
- 5. S is te m a según la re iv in d ica c ió n 4, en el q ue e l s is te m a inc lu ye a d e m á s al m e n o s una de una m o d a lid a d de se g u im ie n to m a g n é tico y una m o da lida d de o b ten c ión de im á ge ne s p o r u ltrason ido s .
- 6. S is te m a seg ún una de las re iv in d ica c io n e s a n te rio res , e s ta nd o el s is te m a d isp u e s to parad e te c ta r una señ a l de E C G e x te rn o de l pac ien te ;id e n tif ic a r una o nda P e x te rn a de una fo rm a de o nd a de la señ a l de E C G e xte rno ; yu sa r la o nd a P e x te rn a id e n tifica d a para id e n tif ic a r la o nd a P de la se ñ a l de E C G in travascu la r, en el q ue id e n tif ic a r la o nda P e x te rn a in c lu ye a d e m á s p re fe rib lem e n te :id e n tif ic a r un co m p le jo Q R S de la fo rm a de o nd a de la señ a l de E C G exte rno ; id e n tif ic a r una o nda T de la fo rm a de o nd a de la se ñ a l de E C G exte rno ; y d e te rm in a r un in te rva lo RR e n tre fo rm a s de o nd a su ce s iva s de la se ñ a l de E C G exte rno .
- 7. S is te m a seg ún la re iv in d ica c ió n 6, q ue co m p re n d e a d e m á s un p a r de e le c tro d o s e x te rno s , en el q ue la seña l de E C G e x te rn o debe d e te c ta rse p o r un p a r de e le c tro d o s e x te rn o s c o lo ca d o s en la p ie l de l pac ien te .
- 8. S is te m a según una de las re iv in d ica c io n e s a n te rio re s , c o m p re n d ie n d o el s is te m a un e stile te re c ib id o de m a n e ra re tira b le d en tro de l d isp o s itivo m éd ico , en el q ue la señ a l in tra v a s c u la r de l E C G d eb e d e te c ta rse p o r un c o m p o n e n te de s e n s o r inc lu ido con el estile te .
- 9. S is te m a seg ún una de las re iv in d ica c io n e s a n te rio re s , en el q ue id e n tifica r una o nda P, d e te rm in a r si la onda P id e n tifica d a está e le va d a y d e te rm in a r el v a lo r de d esv ia c ió n están d isp u e s to s para e je cu ta rse p o r un p ro c e sa d o r de un s is te m a co n e c ta d o o p e ra tiva m e n te con el d isp o s itivo m éd ico ,en el q ue p re fe rib le m e n te , id e n tif ic a r una o nda P, d e te rm in a r si la o nda P id e n tifica d a e stá e le va d a y d e te rm in a r el v a lo r de d e sv ia c ió n e s tán d isp u e s to s para e je cu ta rse de m a n e ra ite ra tiva p o r el p roce sa d or.
- 10. S is te m a seg ún una de las re iv in d ica c io n e s an te rio res , en el q ue el d isp o s itivo m é d ico inc lu ye un c a té te r y en el que la u b ica c ió n d e se a d a es p ró x im a a una p arte in fe rio r de una ve n a cava s u p e r io r del co razón del pac ien te .
- 11. S is te m a seg ún una de las re iv in d ica c io n e s a n te rio re s , en el que n o tif ica r in fo rm a c ió n re la c io n a d a con la u b ica c ió n de l d isp o s itivo m é d ico inc lu ye n o tifica r una de una p lu ra lida d de zon as , e s ta n d o cad a zo n a re la c io n a d a con la p rox im id ad del d isp o s itivo m é d ico a un nodo de e m is ió n de se ñ a le s del co razón del p a c ie n te y /oen el que n o tifica r in fo rm a c ió n re la c io n a d a con una u b icac ión del d isp o s itivo m é d ico inc lu ye e m itir la in fo rm a c ió n a al m e no s uno de un d isp o s itivo de a ud io y un d isp o s itivo de v isu a liza c ió n , y /oen el que n o tif ica r in fo rm a c ió n re la c io n a d a con una u b icac ión de l d isp o s itivo m é d ico inc luye e m itir in fo rm a c ión g rá fica a un d isp o s itivo de v isu a liz a c ió n de un s is te m a de co lo ca c ió n para el d isp o s itivo m édico , en el q ue la in fo rm a c ió n g rá fica inc lu ye p re fe rib le m e n te una p lu ra lid a d de icon os que co rre sp o n d e n a la p ro x im id a d de l d isp o s itivo m é d ico a un n odo de e m is ió n de se ñ a le s del co razón del pac ien te .
- 12. S is te m a según una de las re iv in d ica c io n e s a n te rio re s , e s ta n d o el s is te m a e stá d isp u e s to para re p re se n ta r una pos ic ión del d isp o s itivo m é d ico b a sá n d o se en el v a lo r de d esv ia c ión en el que, p re fe rib le m e n te , un p ro c e sa d o r del s is te m a está d isp u e s to para e je c u ta r un á rbo l de d ec is io ne s , d e te rm in a n d o el á rbo l de d e c is io n e s un a sp e c to de re p re se n ta c ió n de la p os ic ión del d isp o s itivo m édico ,en el que, m á s p re fe rib le m e n te , el á rbo l de d e c is io n e s con su lta de m a ne ra ite ra tiva un c o n ju n to de d a to s de una p lu ra lida d de in fo rm e s de zo n a h as ta que se a d q u ie re n al m e n o s 50 in fo rm e s de z o n a oen el q ue el p ro c e sa d o r e stá d isp u e s to para re p re s e n ta r la p os ic ió n de l d isp o s itivo m é d ico cu a n d o en tre s de c in co in fo rm e s de zo n a del co n ju n to de d a to s son idén ticos.
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| US9839372B2 (en) | 2017-12-12 |
| CN105979868A (zh) | 2016-09-28 |
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| EP3073910A2 (en) | 2016-10-05 |
| WO2015120256A3 (en) | 2015-11-12 |
| CN105979868B (zh) | 2020-03-10 |
| EP3073910A4 (en) | 2017-07-19 |
| EP3073910B1 (en) | 2020-07-15 |
| US20180103869A1 (en) | 2018-04-19 |
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