apparatus and method for diagnosis and therapy of

46
United States Patent US006484727B1 (12) (10) Patent N0.: US 6,484,727 B1 Vaska et al. (45) Date of Patent: *Nov. 26, 2002 (54) APPARATUS AND METHOD FOR 4,736,749 A 4/1988 Lundback DIAGNOSIS AND THERAPY OF L. t t. d t ELECTROPHYSIOLOGICAL DISEASE ( 15 CO“ “me on “X Page“) FOREIGN PATENT DOCUMENTS (75) Inventors: Matthias Vaska, Palo Alto, CA (US); Banjamin Pless, Atherton, CA (US); AU A-70522/96 11/1994 David A. Gallup, Hayward, CA (US); GB 2 094 636 9/1982 Jack E. Ulstad, Jr., Boulder Creek, CA all?) ‘yogi/3195i? A (US); Scott C. Anderson, Sunnyvale, W0 WO 95/1722 6/1995 CA (US); Roxanne L. Richman, Los Gatos, CA (US) (List continued on next page.) (73) Assignee: Epicor, Inc., Sunnyvale, CA (US) OTHER PUBLICATIONS * - _ - - - _ CoX et al., “The Surgical Treatment of Atrial Fibrillation, IV ( ) Nonce' gillifiopstzgglliiilgfn0151116211 63511513112‘; Surgical Technique,”J. T horac Cardiovasc Surg, 1991; 101: 1.53(d), and is subject to the tWenty year 584_592' _ _ _ patent term provisions of 35 U S C Wonnell et al., “Evaluation of Microwave and Radio Fre 154(a)(2) ' ' ' quency Catheter Ablation in a Myocardiurn—Equivalent ' Phantom Model,” IEEE Transactions on Biomedical Engi Subject to any disclaimer, the term of this neering> 1992;39(10):1086_1095~ patent is extended or adjusted under 35 He et al., “Preliminary Results Using Ultrasound Energy for USC 154(k)) by 0 days_ Ablation of the Ventricular Myocardium in Dogs,” Am J Card, 1994;73:1029—1031. (21) APPL NO, 09 /440 823 Elvan et al., “Radiofrequency Catheter Ablation of the Atria Eliminates Pacing—Induced Sustained Atrial Fibrillation and (22) Filedi NOV- 15, 1999 Reduces ConneXin in 43 Dogs,” Circulation, 1997;96(5):1675—1685. Related US. Application Data (List continued on neXt page.) (63) Continuation of application No. 09/356,476, ?led on Jul. 19, 1999, which is a continuation-in-part of application No. Primary Examiner—Michael Pef?ey 09/157,824, ?led on Sep. 21, 1998, now Pat. No. 6,237,605, (74) Attorney Agent Or Firm_HOekendijk & Lynch LLP which is a continuation-in-part of application No. 08/943, ) ) 683, ?led on Oct. 15, 1997, now Pat. No. 6,161,543, which (57) ABSTRACT is a continuation-in-part of application No. 08/735,036, ?led on Oct‘ 22’ 1996’ now abandoned‘ The invention provides apparatus and methods for mapping (51) Int. cl.7 .............................................. .. A61B 19/00 eehduetieh pathways and Creating lesions in the heart Well (52) U.S. Cl. ........................ .. 128/898; 606/41; 607/122 fer the treatment of atrial ?hrilletieh- The apparatus may (58) Field of Search 128/898. 606/41, include at least one epicardial ablation probe having a """"""""""""" "607/101 116 122’ plurality of electrodes for creating a lesion. The apparatus and method facilitate the formation of a lesion Which (56) References Cited electrically isolates the pulmonary veins from the surround U.S. PATENT DOCUMENTS 3,862,627 A 1/1975 Hans, Sr. ing myocardium. 15 Claims, 33 Drawing Sheets

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United States Patent US006484727B1

(12) (10) Patent N0.: US 6,484,727 B1 Vaska et al. (45) Date of Patent: *Nov. 26, 2002

(54) APPARATUS AND METHOD FOR 4,736,749 A 4/1988 Lundback DIAGNOSIS AND THERAPY OF L. t t. d t ELECTROPHYSIOLOGICAL DISEASE ( 15 CO“ “me on “X Page“)

FOREIGN PATENT DOCUMENTS (75) Inventors: Matthias Vaska, Palo Alto, CA (US);

Banjamin Pless, Atherton, CA (US); AU A-70522/96 11/1994 David A. Gallup, Hayward, CA (US); GB 2 094 636 9/1982

Jack E. Ulstad, Jr., Boulder Creek, CA all?) ‘yogi/3195i? A (US); Scott C. Anderson, Sunnyvale, W0 WO 95/1722 6/1995 CA (US); Roxanne L. Richman, Los Gatos, CA (US) (List continued on next page.)

(73) Assignee: Epicor, Inc., Sunnyvale, CA (US) OTHER PUBLICATIONS

* - _ - - - _ CoX et al., “The Surgical Treatment of Atrial Fibrillation, IV

( ) Nonce' gillifiopstzgglliiilgfn0151116211 63511513112‘; Surgical Technique,”J. T horac Cardiovasc Surg, 1991; 101: 1.53(d), and is subject to the tWenty year 584_592' _ _ _ patent term provisions of 35 U S C Wonnell et al., “Evaluation of Microwave and Radio Fre 154(a)(2) ' ' ' quency Catheter Ablation in a Myocardiurn—Equivalent

' Phantom Model,” IEEE Transactions on Biomedical Engi

Subject to any disclaimer, the term of this neering> 1992;39(10):1086_1095~ patent is extended or adjusted under 35 He et al., “Preliminary Results Using Ultrasound Energy for USC 154(k)) by 0 days_ Ablation of the Ventricular Myocardium in Dogs,” Am J

Card, 1994;73:1029—1031. (21) APPL NO, 09 /440 823 Elvan et al., “Radiofrequency Catheter Ablation of the Atria

’ Eliminates Pacing—Induced Sustained Atrial Fibrillation and (22) Filedi NOV- 15, 1999 Reduces ConneXin in 43 Dogs,” Circulation,

1997;96(5):1675—1685. Related US. Application Data

(List continued on neXt page.) (63) Continuation of application No. 09/356,476, ?led on Jul. 19,

1999, which is a continuation-in-part of application No. Primary Examiner—Michael Pef?ey 09/157,824, ?led on Sep. 21, 1998, now Pat. No. 6,237,605, (74) Attorney Agent Or Firm_HOekendijk & Lynch LLP which is a continuation-in-part of application No. 08/943, ) ) ’ 683, ?led on Oct. 15, 1997, now Pat. No. 6,161,543, which (57) ABSTRACT is a continuation-in-part of application No. 08/735,036, ?led on Oct‘ 22’ 1996’ now abandoned‘ The invention provides apparatus and methods for mapping

(51) Int. cl.7 .............................................. .. A61B 19/00 eehduetieh pathways and Creating lesions in the heart Well (52) U.S. Cl. ........................ .. 128/898; 606/41; 607/122 fer the treatment of atrial ?hrilletieh- The apparatus may (58) Field of Search 128/898. 606/41, include at least one epicardial ablation probe having a

""""""""""""" "607/101 116 122’ plurality of electrodes for creating a lesion. The apparatus ’ ’ and method facilitate the formation of a lesion Which

(56) References Cited electrically isolates the pulmonary veins from the surround

U.S. PATENT DOCUMENTS

3,862,627 A 1/1975 Hans, Sr.

ing myocardium.

15 Claims, 33 Drawing Sheets

US 6,484,727 B1 Page 2

US. PATENT DOCUMENTS 5,800,482 A 9/1998 PomeranZ et al. 5,810,802 A 9/1998 Panescu et al.

4,802,475 A 2/1989 Weshahy 5,827,216 A 10/1998 Igo 6161. 47815470 A 3/1989 Curtis et @1- 5,836,947 A 11/1998 Fleischman 61 al. 5,108,390 A 4/1992 Potocky 9t a1~ 5,871,523 A 2/1999 Fleischman et al. 5,147,355 A 9/1992 Friedman et al. 5,871,525 A 2/1999 Edwards et 81' 5,224,943 A 7/1993 Goddard 5,879,295 A 3/1999 et 81' 57231995 A 8/1993 Desai 5,879,296 A 3/1999 Ockuly 61 al. 572547116 A 10/1993 Ba?“ et @1- 5,882,346 A 3/1999 PomeranZ 61 al. 57263493 A 11/1993 Avltall 5,885,278 A 3/1999 Fleischman 572817215 A 1/1994 Milder 5,893,848 A * 4/1999 Negusetal. ............... .. 606/41 57295484 A 3/1994 Marcus ct a1~ 5,895,417 A 4/1999 PomeranZ 61 al. 5324284 A 6/1994 1mm“ 5,897,554 A 4/1999 Chia 6161. 5,334,181 A 8/1994 Rubinsky et al. 5,899,899 A 5/1999 Arless et al' 5348554 A 9/1994 1mm“ ct a1~ 5,902,289 A 5/1999 SwartZ 61 al. 5,353,783 A 10/1994 Nakao 61 al. 5916214 A 6/1999 Cosio et 81' 5,385,148 A Lesh 61 al. 5921924 A 7/1999 Avitall 5,405,376 A 4/1995 Mulier et al. 5921982 A 7/1999 Lesh et 81' 54237807 A 6/1995 Milder 5,927,284 A 7/1999 Borstetal. 54237811 A 6/1995 1mm“ 51 @1- 5,928,191 A 7/1999 Houser 61 al. 5,431,649 A 7/1995 Mulier et al. 5,931,810 A 8/1999 Grabek 5,433,708 A NlChOlS 61 al. 5,931,848 A 8/1999 Saadat 5,435,308 A 7/1995 Gallup 9191- 5,954,661 A 9/1999 Greenspoon 61 al. 5,437,651 A Todd 61 al. 5971983 A 10/1999 Lesh 54507843 A 9/1995 M011 et @1- 5,993,447 A 11/1999 Blewett 61 al. 5,465,717 A 11/1995 Imran et al. 6,012,457 A H2000 Lesh 5,478,330 A Imran 61 al. 6,071,279 A 6/2000 Whayne et 61' 57487385 A 1/1996 Avitall 6,142,994 A 11/2000 Swanson 6161. 5,487,757 A 1/1996 Truckai 61 al. 6,161,543 A 12/2000 Cox et 61' 55207682 A 5/1996 Baust et @1- 6,200,303 B1 * 3/2001 Verrio 61 al. .............. .. 604/508 55367267 A 7/1996 Edwards 51 @1- 6,231,518 B1 * 5/2001 Grabek 61 al. . 600/508 55457200 A 8/1996 West et @1- 6,231,570 B1 * 5/2001 Tu 61 al. ..................... .. 606/41 5,549,661 A 8/1996 Kordis et al. 5,555,883 A 9/1996 Avitall FOREIGN PATENT DOCUMENTS 5,560,362 A 10/1996 Sliwa, Jr. et al. 5,571,088 A 11/1996 LennoX et al. W0 WO 95/30380 A 11/1995 5,575,766 A 11/1996 SwartZ et al. W0 WO 97/06727 2/1997 5,575,810 A 11/1996 Swanson et al. W0 WO 97/18853 5/1997 5,578,007 A 11/1996 Imran W0 WO 97/33526 9/1997 5,582,609 A 12/1996 Swanson et al. W0 WO 97/41793 11/1997 5,588,432 A 12/1996 Crowley W0 W0 97/43970 11/1997 5,590,657 A 1/1997 Cain et al. W0 WO 98/17187 4/1998 5,607,462 A 3/1997 Imran WO WQ 98/24488 6/1998 5,617,854 A 4/1997 Munsif W0 WO 98/26724 6/1998 5,630,837 A 5/1997 Crowley W0 WO 98/37822 9/1998 5,643,197 A 7/1997 Brucker et al. W0 WO 98/48881 11/1998 5,656,029 A 8/1997 Imran et al. W0 WO 98/49957 11/1998 5,658,278 A 8/1997 Imran et al. W0 WO 99/02096 1/1999 5,676,662 A 10/ 1997 Fleischhacker et al. W0 WO 99/04696 2/1999 5,676,693 A 10/1997 LaFontaine W0 WO 99/48421 A1 9/1999 5,678,550 A 10/1997 Bassen et al. W0 WO 99/56812 11/1999 5,680,860 A 10/1997 Imran W0 WO 99/59486 11/1999 5,681,278 A 10/1997 Igo 61 al. 5,681,308 A 10/1997 Edwards 61 al. OTHER PUBLICATIONS 5,687,723 A 11/1997 Avitall “ _ _ _

5,687,737 A * 11/1997 Branham et aL _________ __ 128/710 He et al., Application of Ultrasound Energy for Intracardrac 5,690,611 A 11/1997 swam et a1_ Ablation of Arrhythrnias,” The European Society of Cardi 5,697,925 A 12/1997 Taylor OlOgy, 1995;16Z961—966. 57697927 A 12/1997 Imran ct a1~ Zirnrner et al., “The Feasibility of Using Ultrasound for

2 * 1;; $1001“ ‘:1'1 """"""" " 606/41 Cardiac Ablation,” IEEE Transactions on Biomedical Engi , , a lIlS y e a . - _ _ _

5,718,241 A 2/1998 Ben-Haim e161. ”ee_””g’1995’42(9)'891 897'_ _ _ _ _ 5,718,701 A 2/1998 Shai et aL Avitall et al., “A Thoracoscopic to Ablate Atrial Fibrillation 5,720,775 A 2/1998 Lanard Via Linear Radiofrequency Lesion Generation on the Epi 5,730,074 A 3/1998 Peter cardiurn of Both Atria,” PACE, 1996;19(Part II): 626,#241. 57307127 A 3/1998 Avltall Fieguth et al., “Inhibition of Artial Fibrillation by Pulornary 5’73O’7O4 A 3/1998 Avltall Vein Isolation and Auricular Resection—EXperirnental 5’733’280 A 3/1998 Avltall Study in a Sheep Model,”Eur0peanJ0urnal 0fCardi0—Th0 5,755,760 A 5/1998 Magurre et al. . S 1997_11_714_721 5,769,846 A 6/1998 Edwards 61 al. mac Wge’y’ > - -

5,782,828 A * 7/1998 Chen et al. ................. .. 606/42 Pfeiffer 9t 41-, “Epicardial Neodymium - - - Am Heart],

5,800,428 A 9/1998 Nelson et al. 1996;94(12)Z3221—3225.

US 6,484,727 B1 Page 3

Hynynen et al., “Cylindrical Ultrasonic Transducers for Cardiac Catheter Ablation,” IEEE Transactions on Biomedi cal Engineering, 1997;44(2):144—151. Elvan et al., “Radiofrequency Catheter Ablation of the Atria Elirninated Pacing—Induced Sustained Atrial Fibrillation and Reduces ConneXin 43 in Dogs,” Circulation95z5, Sep. 2, 1997, pp. 1675—1685. Olgin et al., “Electrophysical Effects of Long. Linear Atrial Lesions Placed Under Intracardiac Ultrasound Guidance,” Circulation, 1997;96(8):2715—2721. Weber, “Laser versus Radiofrequency Catheter Ablation of Ventricular Myocardiurn in Dogs: A Comparative Test,” Cardiology, 1997: 88:346—352. Inoue et al., “Video Assisted Thoracoscopic and Cardio scopic Radiofrequency MaZe Ablation,” ASAIO Journal, 1997;43—334—337.

Sosa et al., “Radiofrequency Catheter Ablation of Ventricu lar Tachycardia Guided by Nonsurgical Epicardial Mapping in Chronic Chagasic heart Disease,” PACE, Jan. 1992; 22 (Part I), 128—130.

Chevalier, et al., “Thoracoscopic Epicardial Radiofrequency Ablation for Vagal Atrial Fibrillation in Dogs,” PACE Jun. 1999; 22 (Part I), 880—886.

CoX et al., “The MaZe III Procedure for Treatment of Atrial Fibrillation,” Cardiac Arrhythmias, 78: 460—475.

Stone et al., “Ablation of Atrial Fibrillation by the MaZe Procedure,” Surgical Forum, Cardiothoracic Surgery, date unknown, 213—215.

* cited by eXarniner

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