CA2110309A1 - Catheter for rf ablation with cooled electrode and method - Google Patents
Catheter for rf ablation with cooled electrode and methodInfo
- Publication number
- CA2110309A1 CA2110309A1 CA002110309A CA2110309A CA2110309A1 CA 2110309 A1 CA2110309 A1 CA 2110309A1 CA 002110309 A CA002110309 A CA 002110309A CA 2110309 A CA2110309 A CA 2110309A CA 2110309 A1 CA2110309 A1 CA 2110309A1
- Authority
- CA
- Canada
- Prior art keywords
- electrode
- catheter
- tip
- chamber
- radio frequency
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1402—Probes for open surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00084—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
- A61B2018/00035—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open with return means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00166—Multiple lumina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
- A61B2018/00821—Temperature measured by a thermocouple
Abstract
ABSTRACT OF THE DISCLOSURE
A catheter for radio frequency ablation with a cooled electrode for use in tissue having a surface comprising an elongate member having proximal and distal extremities. A metal conducting electrode secured to the distal extremity of the elongate member and having a chamber therein. A conductor extends through the elongate member from the proximal to the distal extremity for supplying radio frequency energy to the electrode. The elongate member has a lumen in chamber. A coolant is disposed in the chamber and in contact with the electrode for dissipating heat created in the electrode by the application of radio frequency energy thereto.
A catheter for radio frequency ablation with a cooled electrode for use in tissue having a surface comprising an elongate member having proximal and distal extremities. A metal conducting electrode secured to the distal extremity of the elongate member and having a chamber therein. A conductor extends through the elongate member from the proximal to the distal extremity for supplying radio frequency energy to the electrode. The elongate member has a lumen in chamber. A coolant is disposed in the chamber and in contact with the electrode for dissipating heat created in the electrode by the application of radio frequency energy thereto.
Description
211~
~7 : i CATHErER FO~_pF ABL~L0N WITN
qL~ L~3EQ~E ~ND~EcHQ~
This inventlon relates to a catheter for radio ~reguency (RF) ~blation which i8 provided with a cooled l-ctrode and ~ethod Catheters for RF ablation have heretofore been S provided However, difficulties have been encountered ¦with such catheters in that it has been difficult to ~`¦achieve lesions of ~ufficient ~ize Increasing the RF
power to the catheter in an atte~pt to increa~e the ize of the lesions has caused degradation of the blood 10 in the region ~here ablation is ta~ing place Such C -blood degradation has caused products of the degradation to ~e deposited on the electrode surface greatly increasing the i~pedance Tn addition, it has -~-been found that increased power levels create und sirable b ating of the blood which can create blood olot- Ther- i~, th efore, a ne d for a new and l~prov d oathet r for RF ablation which overco~Qs these dl~advantaq--In gen ral, lt 1- an ob~ect of the pr-~ent lnv-ntion to provid- a cath-t r for RF ablation ~hich 1- provid-d ~lth a oool-d lectrode and a ~ethod to ~k- po-~ibl- the fornation of large l-sions Anoth r ob~ect Or tho lnv ntion $~ to provlde a cath~ter and ~thod of the above cbaracter in which the ~ -, .
-catheter i~ provided with a conducting electrode having a chamber therein and in which a cooling i~ provided in the chamber Another object of the invention is to provide a catheter and a ~ethod of the above charactee in which the cooling liguid in the cavity i8 ~aintained at a pressure vhich i~ ~ubstantially equal to th- pres~ure of the blood of the cha~k~r in the heart in which the cath-ter i- di~clo~ed Another ob~ect of tbe invention is to provide a catheter and a ~ethod of the above cbaracter in which a punp i~ provided for introducing the cooling liguid into the cathetQr and a ~eparat- pu~p i~ provided for withdrawing the liguid fron the catheter Another ob~ect of the invention i8 to provide a catheter and ~ethod by which lesions or a necro6is can be for~ed at various depths underlying the electrode with destroy d the surface contacted by the electrode Additional ob~ects and features of the invention vill appear fro~ the following description in Yhich the preferred bodi~ent is ~et forth in detail in conjunction vith tbe acco-panying drawing FIG I is a side elevational view of a catheter for use in radio freguency ablation with a cooled lectrode incorporating the present lnvention and howing the a~e b ing che~atically connected to a pu ping ~y~t-~ for upplying and withdrawing cooling liquid fron the tip of the catheter FIG 2 i- a ¢ro~ ctional vi-v tak n along line 2-2 of FIG
FIG 3 i- a graph howlng th~ po-itiv and n gativ pr---ure at th- cool d tip i- ~ero at or n-ar tb blood pr---ur- range FIG ~ i- a cro~ -ctional vi-w tak-n along the 3S lin- ~-~ Or FIG S howlng anoth r ~bodi~-nt o~ a cool-d tip lncorporatlng the pr---nt inv ntion 2 1 ~ i~ 3 3,! ~
FIG 5 is a cross-sectional view taken along the line 5-5 of FIG 4 FIG 6 i8 a side elevational view of another e~bodi~ent of a catheter for use in radio freguency ablation with a cooled electrode incorporating the present invention ~howing the ~a~e che atioally connect-d to a pumping syste~ for ~upplying a cooling l$guid to the tip of th- cath~ter FIG 7 i~ a partial ~ide elevational view of the di-tal xtr~nity of th eath ter hown ln FIG 6 FIG 8 i- a ide l-v~tional vi~w ~i~ilar to FIG 7 but howing how th- tlp rotatod through 90 FIG 9 1- a ~ide levational view in cross-sectional of another ~bodiDent of a catheter lncorporating th- pr-~ent invention taken along the lin~ 9-9 of FIG 10 FIG 10 iB an end elevational view looking along the line 10-10 of FIG 9 FIG 11 is another embodi~ent of a catheter incorporating the present invention utilizing a pas6ive wick for withdrawing nergy fro~ the tip electrode of the catheter FIG 12 is a cros6-6ectional view taken along the lin~ 12-12 of FIG 11 FIG 13 i~ a cros--~ectional view of the di6tal xtre~ity vith another catheter incorporating the present invention FIG 1~ i- a graph ~howing the te p ratures which ar- ncount r-d ln ti-sue during an ablation proc dure FIGS 15-18 how?graphs showing i~oth~r al eurve~
eomp?aring eool d and uneool d l-etrode~ and th ffect on ti-su- dur~ng ablation In g-n-r~l, th- pr---nt inv-ntion bodi-s a eath-t-r ~or radio ~r gu ney ablation with a eooled 3S l-etrod- for u~- in a beart having a wall forming at ~-a-t on- eb~ ber vith blood th-r-in Th- eath-t-r i6 eompri-ed of a ~l-xibl- longate m~mber ba~ing proximal .- .
~and distal extremities An electrode is mounted on the - distal extremity of the flexible elongate xember and has a cavity therein heane i8 provided which extends - through the flexible elongate ~e~ber fro~ the proximal S to the distal extremity for upplying radio frequency energy to the tip electrode The flexible elongate ~e~ber iB provided with a first lu~en therein extending ~- fro~ the proxi~al extre~ity to the di6tal extremity and being in co~munication with the electrode ~ean6 i6 provided for introducing a cooling liguid into the lunen Th ~Qan~ for introducing th~ cooling liguid into the lu en includQ~ ~an~ for ~d~usting the pre~sure o~ the liguid in the lu~en at the elQctrode 60 th~t it approximate6 the pressure of the blood in the ;~15 chaiber of the heart in which the distal extremity is disposed More in particular, the catheter 11 for RF
~jablation with ~ cooled el~ctrode incorporating the r;pre~ent invention con6iete of a flexible longate ;~20 e~ber 12 having proxiral and distal xtre~itie~ 13 and 14 A hollow tip conductinq electrode 16 ie ~ounted on the di6tal xtre~ity 14 nd iB provided with an internal cavity 17 The flexibly elongate ~e ber 12 i~
for~ed of a ~uitable pla~tic uch as a polyurethane It i~ desirable that the pla~tic utilized be kink-resistant In order to provide additional kink-re~istance, braid 21 of a uitable ~aterial ~ay be provid~d within the flexible ~longate ne~ber 12 during xtru~ion of th- ~ne to reinforc- the elongate neibQr and to provid~ additional ~in~-resi~tance ~he braid 21 can b forn a of ~ uitabl- ~at rial uch ~- Nylon or Xovlar ~h- braid 21 can b- provid d ~t th- di-tal xtr-~ity of th- longat~ xoib-r a- hown ln FIC
or, lr d-~ir-d, can xt nd th- ntir- l ngth of the ~longate u b r 12 Th- hollow tip l-ctrode 16 c n b forn d of a ultable ~t rial uch a8 tainles~ teel and can have ~ .
. .,.~
- 2~ ~3~
a wa'l thicknes6 ranging from 003 to 004 inches The elongate ~e~ber 12 can be provided in uit~ble ~ize as, for ~xa~ple, to provide catheters from 3 to 7 French $n eize The electrode 16 has a generally he~i~pherical configuration and can be secured to the distal extremity of the elongate ~ember 12 by suitable ~eans such as an adhesive (not ~hown) The elongate ~e~ber 12 i6 provided with fir~t ~nd ~econd relatively large liguid carrying lu ens 26 and 27 ~hich xtend fro~ th~ prox~ al xtr-~ity 13 to th~ d$-t~1 xtre-ity 1~ and ar- in cou~unication vlth the cavity 17 of the hollow tlp electrode 16 AB hown, lu ens 26 and 27 can be crescent-shaped in cross-~-ction A central lu~en 28 i- al~o provided which extends from the lS proxi~al xtremity 13 to the distal extre~ity 1~ of the olongate ~e~ber 12 A plur~lity of ~dditional lu~en6 29 are provided vhich are ~paced circuxferentially around the crescent-shaped lu ens 26 and 27 The central lu~en 28 carrie~ a conductor 31 for supplying radio frQquency nergy to the clectrode 16 The conductor 31 also ~erves to secure the tip electrode 16 80 that it reDains ~ecured to the di6tal extremity 14 of the elongate ~e ber 12 ~ ean6 i~ provided for steering the di6tal xtre-ity of the cathet~r 11 and is of the type described in co-pending application, Serial No 07/793,858, fil d Nov ber 18, 1991 As d~scribed th rein, it includes t ring ~ir-s 33, 34 and 36 ~hich aro provided in th- Iu ens 29 and ~hich are paced-ap~rt circu for ntially around thc c~ntral lu~en 28 Or the longata u- b r 12 Th- conductor 31, the t- ring ~ir-~ 33, 3~ and 36 tog-th-r ~ith thc ground r-turn 37 xt nd to th- proxi al xtr-Dity and ~re conn-ct-d through a cabl- 38 to a xalo conn ctor 39 ~hich 1- provld d at th- proxi al xtr--lty Or the longato x~ ber 12 ..
As 6hown, the catheter 11 can be provided with additional radio frequency electrodes as, for example, electrodes 41 and ~2 Yhich are for~ed as spaced-apart bands provided on the exterior of the distal extremity 14 of the elongate e~ber 12 and in relatively close proxi~ity to the hollow tip electrode 16 Such electrodes 41 and ~2 can be connect-d by conductor~ 43 and ~4 extending through lu~ens 29 to the proximal extremity and connected into the eonnector 41 The proxiual xtre~ity 13 of the longate ~eiber 12 is provided with a fitting 51 into Yhich a tubular enber 52 and Yhich another tubular ~ember 53 extends Tubular ~e~ber 52 is in co~nunioation Yith the lu~en 27 and the tubular ~ember 53 i~ in co~un$cation with the lumen 28 The tubular ue~bers 52 and 53 are provided with ~uer locks 56 and 57 of a eonventional type Means is connected to the fitting 56 for introducing a cooling liquid into the lu~en 27 to cause the same to pass through the lu~en to the distal extr~mity into the eavity 17 ~eans ic secured to the fitting 57 for Yithdrawing the cooling liquid fro~ the cavity 17 ~o that the pre~sure of the liquid in the cavity 17 approxi~ates the pressure of the blood in the ehamber of the heart in which a catheter is disposed This ~eans consi~ts of a tank 61 which is provided with a eooled saline ~olution 62 therein having a te~perature ranging fro~ 5 to 10 Centigrade It should be appr ciated other liquids other than a ~aline olution ean b- utiliz d, if de~ir d The ueans provided for upplyinq the aline eooling ~olution to the ritting 56 eon-i t- oS ~ pu p 66 Yhieh i~ eonnected by a tubular - ber 67 into th aline eooling olution 62 in the tank 61 and deliver- the a~e through tubul~r ~oiber 68 whieh i- eonn ct d to the ~itting 56 to provide tho eoolod alino ~olution at ~ pr det-rclned pr--sure Pl a- ~ea-ur-d by th- pre--ur- gaug- 69 Thus, as the pu p 66 1- operated, th- cooled aline : :. ..: .
, .. ~- .
~.... i ~olution i~ intro~uce~ into the ~umen 27 ~nd into the cavity 17 In order to reduce the pressure of the cooled liquid in the c~vity 17 ~nd to ~aintain the pre6~ure in the cavity 17 ~o that it i~ sub6tantially ~qual to the pres~ure of the blood in the ch~ ber of the heart in which the catheter i~ dispo~ed, a pump 71 i8 provided for withdrawing th- cool~d liquid from the cavity 17 through the lu en 28 The pump 71 i~
connected by a tubular e~er 72 to the fitting 57 and auppli-o a n gativc pr ~-ur- P2 to the flow p~s~agQ 28 which 1~ ueasured by the pr~-sure gauge 73 The pump 71 r-turns the eool~d liguld wlthdrawn ~ron the cavity 17 through a tubular e ber 7~ lnto the tank 61 ~o that it can be cooled and reused The catheter 11 1- ad~pted to be connected to radlo fr~quency power ~upply and controll r 76 which is connected by cable 77 to a female connector ~8 which i6 adapted to receive the male connector 32 The r~dio freguency power 76 supply can be of a conventional type The controller incorporates as a part thereof apparatu6 which 18 utilized for to~ring the distal extremity of the catheter, of the type described in co~
pending application, Serial No 0~/~93,858, filed Nove~ber 18 1991 Operation and use of the catheter for RF ablation ~ith the cooled tip and the method for us$ng the ~ame ean now be briefly descrlbed as follovs Let it be a~-u ed that it is d~ir d to introduce radio fr guoncy norgy into th~ wall fornlng a cha ber of the hoart to cau-e ablatlon o~ tha nyocardlu~ Al-o l-t it be ~ ~--un d that tho eathet r 1- introduc d lnto the chu b r o~ a h-art in ~ hunan b lng ln ~ eon~ ntlonal n~nn-r ~y utlllzlng tho eontroll-r 76, th- dl-tal xtronlty 1~ 1- t-~r d o that tho tlp l-etrod- 16 1-nov d lnto cont~et ~lth tha nyoeardlun Tho high~r quoncy n rgy can th n ba uppll~d rro. tho RF power upply 7~ to tho tlp 16 through th- eonductor 31 2~
Prior to the aelivery of 6uch radio frequency energy or at the ~ame ti~e, the punps 69 and 73 are placed in operation ~o that a cooled aline ~olution is being introduced into the lu~en 27 and into the cavity 17 of the Qlsctrode 16 to cool ths electrode 16 during the ti~e that radio freguency n-rgy is being applied to the a~s In order to ~eep the pre-sure ~n the lu~en 27 at a relativ ly low valuo and o that the pr-ssure ln the cavity 17 i- ub~tantially th u~ a- the pr-s~ur- of the blood in th- cba ber of th- h-art in which the cath-ter i~ di~po~ed, th- pu~p 73 cr-ate6 a n gative pr--sur- to withdrav the cool-d aline ~olution through th~ pa-s~ge or lu~en 28 and diocharges ths ~ame lnto the tank 61 The operator by observing the gauges 69 and 73 can operate the pu p~ 66 and 71 in a auch a xanner co that the pr-~our- in the cavity 17 i~ oubstantially the ~a~s as the pressure of the blood pool ~urrounding the cavity in which the catheter tip 18 disposed The desir~d pressures Pl and P2 on the gaugss 69 and 73 can be ascertained by first op rating the pump~ 66 and 71 vith the catheter 11 outside of the body and ~easuring the pressure in the cha~ber 17 and then observing the pres~ure~ on the gauges 69 and 73 when the proper pr-ssure i~ present in the cavity 17 Thus, vhen the catheter 11 is introduced into the body and into the heart, the d-sir-a pres~ure ~n the cavity 17 can be achiev-a erely by duplicating the r~adings on the qauge~ 69 nd 73 If desirea, ~ preis~ure transduc r (not ho~n) can be provided within ths cavity 17 ana conn~icted through l-ctric conductor6 ~not hovn) ~t nding to th proxi al xtr nlty Or the cath~t r wh r- t~ pr--~ur can b r ad on n appropriate in~tru~ nt ~not hown) ~ y aintaining th- pr---ur- Or th- alin- olutlon ln th cavity 17, at or n-ar the pr---ure of t~- blood ln which the ai-tal xtr-eity 1~ Or the cath-t r 11 is di-po-ed, th-r- i~ a ~inixal tondency rOr l-akage of 2 1 ~
the saline ~olution from the cavity 17 of the catheter 1 Thi~ i~ re~dily acco~plished even though there i8 a blood pre6gure change fro~ sy6tolic to diastolic as the heart ic pumping blood during the ti~e that an ablation procedure is being perfor~ed This is illustrated in Figure 3 in vhich the blood pressure range between ystolic and diastolic is shovn as ranglng fro~ 60-200 ~llliretoro of ~ercury as approxi~ately 2 p8i. The pre~sur~ changes of the cooled liguid ln the luaono 2~ nd 28 ie hown by the cur~ 81 The inl-t pr-souro provided by the pu~p 66 i- Pl as hown in Figur- 3 Th- prosour~ drops in the lu en 27 becauoe of losseo in the lu en Because of the negative pressure P2 created by pump 71 at the outlet Or the lu~en 28, the preosure continues to drop By appropriate ad~ust~ent of the pr-ssuros Pl and P2 to overcome lu~en losoes, the pressure in the cavity 17 of the tip electrode 16 can be ad~usted ~o that it approxi~ates the pr-ssure of the blood in the cha~ber in which the tip 16 is disposed Thi~ is represented by the curve 81 in Figure 3 which crosses through the blood pressure range at the tip lumen as indicated at 82 A typical example is shows in Figure 3 with a - catheter 150 centi eter6 in length and having lu~ens 010~ in diaDeter A pressur for the cooling liquid at the tip was obtained utilizing a pooitive input pressure Pl of ~0 psi and a negative outlet pr-ssure P2 of n gative ~0 p~i It has b on found that with a cathet r of the pr-~ent invention utilizing the u-thod of the pre~ent inv ntion it ha- b n po -ibl- to achl-v l--ion- of the de-lrod d-pth o* 112 to 1 c-nti eter and a i~ilar width in th ~yocardiu~ utilizing S to 50 watt- of powor 3S ~n addition to controlling th pr---ur in the cavlty 17, it till uay b d-olrabl- to ~ a-ur- the t-~peraturo Or th- tip l-ctrod- 16 This can be . ~ :
' " ', ~ ' .
211~309 -~- accomplished by nounting ~ thermocouple (not 6hown) in close proxi~ity to the tip 16 and by bringing out le~ds (not 6hown) from the ther~ocouple through an additional lunen ~not ~hown) $n the olongate ~e~ber 12 and bringing the leads out to the proxinal extr~ity ~nd connecting the~ into an appropriate instru entation (not hown) to ~ake the te perature reading Thi~ will pro~ide still additional input to the phy6ician or surgeon perfor ing the ablation procedurQ to ~nsure that the cooling i~ adequate and to ee that ~xce~ive te~perature i- not r-ach-d during the ~blation proc dur -In order to nhanc~ tho cooling of a hollow tip l-ctrodQ 16 uch a- chown in FIG 1, th r~ i~ provided a nodified tip electrode 86 in FIGS ~ and 5 as ~hown ther~in, the ~lectrode 86 which can be for ed of a suitable conducting aterial is pro~ided with a plurality of radially ~xtending fins 87 which extend inwardly fro~ the cylindriQ 1 wall 88 of the tip 86 and ~xtend to the distal xtr~aity of the tip as hown particularly in FIG 4 m e fins 87 terainate ~hort of the longitudinal axis of the tip 86 to provide a cylindrical space 89 at the extremities of the fins 87 Thus, it can be seen as a cooled ~aline solution enters the tip 86 in the ~e xanner as saline solution i~
introduced in the tip 16, the additional cooling ~-urfaces of th~ fin~ 87 will cause ~dditional heat tran~f~r fron th l-ctrod- 8~ to th- cooling l-ctrode 86 Thi~ incr a- d heat transfer fro~ the tip to the ¢ool d alino olution xa~- pos~ibl- 108- flo~ of the ~ cool d alin olution or th~ application of additlonal RF n rgy to th l-ctrode during the blation proc-dur- which i- b ing acconpli~h~d Anoth~r nbodix nt Or th ¢ath-t r for radio fr gu-ncy abl~tion with a cool d l-ctrod- i- hown in FIGS 6-8 Tb- ¢ th t r 91 con-i-t- of a fl-xibl~
olongat~ r b r having proxi al ~nd di~tal xtr-nitie~
:, ... . ; .. - .
.. .. . .
- 2lla~s 13 and 14 The catheter 92 i8 of a suitable length as for example 150 centi~eters and is provided with a flow pa~sage 96 The di6tal extremity 94 is provided with a port$on 92a of reduced dia eter and a flow passage 97 therein which is in co~aunication with the passage 96 The flexible elongate xe~ber 92 $8 also provided with the tapered portion 92b whieh ~or-~ a transition betwoen the di~tal xtreaity 9~ and the portion 92a of rQ~ucod dia~eter Tho pa~s~ge 97 i~ in co~aunication ~ -~ith eha~er 98 provided within a cup-shaped l-ctrode 99 ~or~ed o~ a ultabl- eonductiv ~at~rial uch as ~llvor whioh -rvo~ a- a hollov tip conducting lectrode The eup-~hap d l-ctrodo 99 has a proxiaal xtre~ity 101 s~cured to the distal oxtremity 94 of the ~loxible elongate xe~ber 92 by suitable ~eans ~uoh as an adhesive 102 The electrodo 99 is provided with a heaispherical distal extreaity 103 having a plurality of ~paced-apart hole~ 106 In addition, the electrode 99 is provided with a pair of xoon-shaped spacea-apart slots 107 and 108 as ~ho~n in FIGS 7 and 8 which are inclined proYi~ally to extend at an angle of approxi~ately ~5 vith respeot to the axis of the tip 99 . .
Means i~ provided for ~upplying a cooling liguid to tho eha~er 98, in the ~lectrode 99 and eonsi~t~ of a ves~el 111 having a cooled aline solution therein ~hioh oan be replonished when desired ~eans is provided for upplying th- eool d ~alin~ olution ~roa tho tanX or v ~ol 111 to tho pa--ago 96 of the eatheter 11 and oon-l-t- Or an lnlet plp 112 whioh 18 eonn ¢t d to a pu p 113 Th pu-p 113 1- eonn-otod through a top eoek 11~ whloh 1- provld d Yith a handlo 116 rOr aoving th- aa b tv n op n ~nd elo-ed po-ltion- to provid- a thr---way valv Tho top eock 11~ i- conn ¢t-d to rl xlbl- plplng 117 eonn-et-d to a ~lttlng 118 -¢ur d to th- proxl~al xtr-nlty 93 of th-rloxlblo longat- a -b-r 92;
.
,:
211~3~
In addition ~eans i6 provided for supplying r~dio freguency energy to the tip 99 and consists of a radio frequency power supply 121 which provided with a power supply cord 122 connected to a connector 123 The eonnector 123 iB connected to another eonnector 124 which i6 connected to a cord 126 that i8 connected into the fitting 118 The eord i~ eonducted by an in~ulated wir- 127 to the lectrode 99 by ~older 128 Operation and use Or the eooled tip catheter ~s hown ln FIGS 6 through 8 ay now b d ~erib d as rollows The one-way pu~p 113 erv 8 to pu~p the cooled ~aline ~olution fro~ the vessel 111 and ~upplies it under pre~sure through the passag- 96, through the pas~age 97 and into the ehaiber 98 The eooled allne olution rath-r than being reeirculated a~ in the ~bedi~ent shown in FIG 1 is diseharged from the l-ctrode 99 by ~et~ 131 of eooling liquid pa~sing from the electrode 99 after the eooled liquid has eoae into eontact with the electrode T}lus, it can be een that ~hen the tip 99 ie in eontaet with the wall of the heart, the ~ets will per~eate the interface between the tip 99 and the wall of the heart to produce additional eooling Although the cooled ~aline ~olution ~ay have been war~ed slightly by the tenperature of the tip 99, the ~ets 131 will still be cooler than the s~rrounding blood and therefore provide additional cooling at the interface to help prevent eoagulation of the blood at the interface bet~een the tip 99 and the wall of the heart In addition to the ~ets 131, they vill be additional ~-t~ indieat~d by the arrow~ 132 direet-d proxi ally froa th lot 107 and 108 whieh vill oreate a forc- that urg - t~ I-otrode 99 into eontaet with th- wall Or th- h art In oth-r words, ~-ts 132 will er-ate a eount r fore- to the ~et- 131 to eau~- the l-etrode tip 99 to r--ain in eontaet with the wall of the h-art t .. . . . . .
. . . .
~:... .. . . -~ .
2 1 1 ~
Fr~ the foregoing it can be ~een that for a given ~ize catheter it is pos~ible to pro~ide a ~uch larger lu~en extending to the distal extremity 94 because only one lu~en is required for the one-way flow of the cooled saline ~olution Thi~ incr~ased flow rate of the ~aline solution akes it possible to increase the radio frequ~ncy power doliver-d to the tip electrode 99 to nake it possible to create l~rger lesions in the wall of the heart when desirod The introduetion of tho aline olution into th blood 1- not ob~-ctional bGcau~e it i~ alr ady don- in a nu b r of other n dical proc-dur-s.
The thr~o-way valve or top cock 11~ provided ~ake~ it possible to drain any air out of the catheter 91 to insure that no air bubbles will be pu~ped by the pu~p 113 when pu~ping the coolod ~aline solution into th- catheter 91 As ~oon a6 the air has been exhau6ted fro~ the sy6te~, the handle 116 can be turned 80 that the eooled saline olution is ~upplied to the flow pa~sage 96 8y providing the eatheter 91 with a eooled ablation electrode which ean acco~modate ~ore radio frequency energy, it i6 po66ible to perfor~ ablation procedures other than in t~e heart For xa ple, it ean be utilized to treat eertain tu~or6 It al~o ean b- utilized in oleetrocaut ry nd olocL~06urg ry which nay n~ko it possible to l-~ve the urface intact while tr ~ting the tissue underlying the ourface without dbeaging tho bonding of the urface to the tis~ue Thu-, in tr-ating n organ through a vein or rt rial ~all, lt 1- po -ibl- to do thi- whll- till pro- rving th v in or rt rlal ~all ~lthout daa~ging th linlng ot th wall Thi- ean b r adily aeooqpli-hod by the eool d tlp wlth th- -lln olutlon tloving trou the ~ao a- hown in FIG 4 to pr-v nt dar~g- to th wall Suoh proo-dur-- r partieulnrly pplie~bl- tor gall bladd-r, urology, and gyn-eology : ., 2 i ~ O ~ ~ 3 .
In order to prevent blood from entering into the holes 106 and the slots 107 and 108 during the introduction of the cathet-r 91 into th- ve~6el of the patient, it nay be desirable to have the cooled saline solution under a slight positive pressure as the catheter 91 i~ introduced into the passage 96 ~o that saline solution will be flowing out of the holes 106 ~nd the slots 107 and 108 Another alternative would be to ~pply the cooling aline olution through the pa-~gQi 96 befor RF n rgy i- ~ppli~d to t~ tip 99 Thi- will h-lp to n-ur- that any blood within the oatheter will be forc-d out lnto the blood pool in which th- cath-t-r i~ di~po~-d Thi~ will prevent blood from becoming coagulated within the small holes 106 or th~ slots 107 and 108 when RF energy is applied and the tip electrode 99 i~ h~ated Another e~bodi~ent of a catheter incorporating the pro~-nt invention naking it xore difficult for the blood to enter into the interior of the Q theter i8 shown in FIGS 9-10 A~ ~hown therein, the Q theter 136 consists of a flexible elongate tubular ~e~ber 137 which is provided with a flow pa~sage 138 A tip electrode 141 for~ed of a suitable conducting ~aterial is adhered to the distal extre~ity 142 of the tubular ~e~ber 137 by ~uitable ~eans ~uch a~ adhesive 143 A
tubular ins-rt 144 of a ~uitable ~aterial ~uch as plastic i~ provided with a flared proxi~al extre~ity 144a ~-cured to th- interior wall of the fl-xible longate xe~ber 137 by uitable xeans uch as an adh-sive 146 AJ Q n be een in FIG 9, the tubular in--rt 144 i- pro~id d with a di-tal xtr-aity 147 which t-r inat-~ hort ot the h~ i~pherical portion of th- tip lectrod- 141 to pro~ide a pac- or cha~k~r 148 ~ithin th- l-ctr,od- 141 Th- tubular ln- rt 144 i-3S provid-d with a ~low pa--ag- 149 which op n- through th di-tal xtr-~lty 147 and which i- in co~unication with th- ch~ bar 148 Th- ~low pa-sage 149 i- al-o ln .. ,.. ~ - , - - . -., `:` "~', -`: . ` , ' - . . -co~munication with the flow passage 138 in the flexible elongate ~e~ber 137 A pair of dia~etrically opposed holes 151 are provided in the distal extre~ity 142 of the flexible elongate tubular ~ember 137 Valve ~eans in the form of a cylindrical valve sleQvQ 153 formed of a suitable ~lasto~eric ~aterial iB disposed in recess 154 provided in tho distal oxtre~ity 1~2 of the flexible longate tubular nember 137 m e valve ~leeve 153 1~ provided vith annular r~inforcing ribs 156 which xtend circu f-r-ntially around the leeve 153 Slits 157 xtending longitudinally of the tubular in~ert 144 ar- provided vhich ov rll- th hol~s 151 and serve to form loafl-t- lS3a and 153b yi-ldably r~tained in a ealed position to close the l$t 157 It can be se~n that when a cooled saline ~olution i- lntroduced through the passage 138 in the catheter 136, the solution vill pa~s through the passage 149 as indicated by the arrows 157 into the chamber 148 vhere it vill cool the tip 1~1 after its cooling function has been p rfor-ed, the ~lightly heatod cooled liquid will pa~ proxi~ally as indicated by the arrows 157 and be discharged into the blood pool under positive pre~sure through the hole~ 151 and through the ~lits 157 by urging outvardly the leaflets 153a and 153b provided ln the valve ~leeve 153 m iS vill permit additional cooled ~allne solution to be introduced into the tip electrode 1~1 to continue cooling of the oloctrode Thus, lt can be een that uch a valve ~le-ve 153 per it~ the u~- of a cooled ~aline olution 30 ~hil~ pr-v nting blood ~urrounding the cath~t r 136 ~rom nt ring into the int rlor of th- cath-t-r ~h n a allno olutlon 1- not b ing ~uppli-d to the catheter In o-rtaln applicatlons, it nay b po~-lblo to forogo th- u-- of activ coollng a~ for exa~pl- a~ by th provlding of th cool-d ~aline ~olutlon as ~eroinb for- do-orib d and to roly upon passive cooling 2 ~ ~ ~ 7;~
` for the tip of the c~theter while it is being utilized for RF ablation Such a eatheter 171 iB hown in FIGS
11 and 12 and consists of a flexible elongate tubular e ber 172 for ed of the plastic hereinbefore de6cribed which is provided with a flow pas6age 173 extending therethrough The tubular xenber 172 iB eonnected to eylindrical ~etal d oeve 176 for~ed of a ~uitable eonducting raterial ~ueh as ~ilver The sleeve can havo a uitabl~ longth a~ for exa~ple fro~ 2 to 5 ¢enti eters The leev 176 i~ providod with a bore 177 xtending ther-through The other nd of the l-evo 176 i~ eonnect d to another tubular ~e ber 179 forued of a ~uitablo insulating ~aterial ~uch as plastie The tubular ~ouber 179 is provided with a lS large eentral lu~en 181 and a plurality of additional lu ens 181 through 187 which are7 ~pacial eircumferentially around the lumen 181 The lu~ens 182, 184, and 185 have elements 191, 192, and 193 extending therethrough which are eonnected to the distal extremity of the tubular eDber 179 These ele~ents 191, 192 and 193 are for~ed of a uaterial ~uch a6 Nitinol having a negative eoeffieient of expan~ion a ground return eonductor 194 i8 provided in the lu~en 183 A conductor 196 i8 provided in the lumen 186 and is connected to a he ispherical tip electrode 197 ror~ed of a conducting ~aterial and ~ecured to the distal extre~ity of the tubular ~h~r 179 by ~uitable ean6 uch as an adh-sive (not hown) Passive heat eonduction ~eans 201 i8 provided withln th- di-tal xtr eity o~ tho eath ter 171 and eon i-t- o~ ~ uit~bl- ribrou- at rial ueh eotton ~ib r~ which hav boen i pr gnat-d with ~ h at ab-orbing ~luid a- ~or x~ ple water or a aline olution Thi- h-at eonduot$ng xatorial 201 xt-nds fro~ th- d$~tal xtr-nity o~ the tubular u~ ber 172 t~rough the pa--ag- 177 ln th- xetal 1-eVQ 176 and 18 in lnt$~te eontaet wlth the u tal leeve 176 ~he 2110`~
nater'al 201 al60 extends through the lu~en 181 provided in the tubular ~e~ber 179 ~nd into the interior of the tip electrode 197 as can be ~een from FIG 11, the various conductors and lQ~ents hereinbefore described in the lu~ens 182 through 186 extend through the pa66ive heat conducting ~aterial 201 and pas~ through an adhesive 206 then through the passage 173 to the proxinal xtre~ity of the catheter 181 where they are connected to appropriate control~ of th- type hor-inbefor de-cribed In U8Q of tho cath-t-r 171 aa hown in FIGS 11 ~nd 12, th- application of radio ~r guoncy norgy to th- olectrode 197 heats the ol-ctrod- 197 to cause the llguid within the passive heat conducting ~ean~ 201 to heat up and to trav l by convoction towards th- cooler r-gion of the paissive heat conductive ~eans 201 This in turn will cause the cooler liguid to circulate and take it~ place The liguid which has been heated will ~ove through the wick-like heat conductive aterial 201 20 and will co~e into contact with the ~etal ~leeve 176 ~ ~ -which will cause cooling to occur by having heat pass therethrough into the blood passing the cleeve 176 --The cooled liquid will then return to the tip to continue the convective flow as hereinbefore described Additionally, if additional heat dissipation is desired, a construction ~uch a- th~t cbown in FIG 13 can be used Radially xtending boat conducting fins 211 of ~otal ar- ithor older-d on or forned integral - -vith the ~lo-v 176 on the outer urface thereof ~y providing th rln~ 211, addit$onal b at di~ipating urfac- ar-a i- providod whicb incr a-e- the c~pabilitio~ for di--ipating b-at into th- blood circulating ~round tb- d oov 1~6 ~nd tho ~in~ 21~
~h functioning o~ th- cath-ter- b-reinbefore d-~crib d in con~unction vitb ablation by tb- U-Q of radio ~rogu-ncy n-rgy can bo uor cl-arly undor~tood by rof-ronco to FIG 1~ FIG 1~ i~ a graph which -., 2 ~ 3~ ~ ~
.
~ along the horizontal axis ~hows the depth of the lesion created during the ablation procedure $n aillireter6 with respect to te~perature in degrees centigrade as hown by the vertical axis of the graph ~0~ on the graph is eguivalent to the surface of the tip of the electrode which iB in contact with the tissue Going to the right of the graph as shown in FIG 1~, the depth into the tissue incr-a~es Three curv 6 A, B, and C are ~hown in the qr~ph for three different power l-v l- of radlo fr quency n rgy b ing delivered into th- ti--ue The t-eperatur- on the graph goes to 100 C The 100 C ~a- b n hown becau-e it 18 con~idered to be an upper liait for te~p rature or sliqhtly less than that because at approxi~ately 90 C
blood begins to boil and coagulate on the electrode tip qreatly increasing its iDpedance and comprising its ability to create lesions Thus, it is de~irable to bave the te~per~ture of the l-ctrode or tip r-uain b low 90 C if possibl~ At 50 C a line 216 hac been hown on the qraph because this is the terperature below which necrosis of the y ocardial as well as connective tissue will cease Curve a shown in FIG 14 i~ divided into three ~gnents Al, A2, and A3 The broken line ~eg~ent a2 r-pre~ents a continuation of the xponential curve A3 when no cooling appli d to the lectrode Thus it can be een fro~ the power level of 5 watts repres nted by the curve A that ~roa the tip t-~perature of 80 C
hown at the cor~enc- ent of the curve, the te~p rature d creasQ- xpon ntially a- the di-tance fro~ the urrac- of th ti--u- lncr-a--- A- hown, t~ curve A3 cro---- th 50 C necro-$- boundary r-pr-- nt d by th lin- 216 at a d-ptb of 5 ~illia-ter- Th~ ion created would bav a d-pth of approxiaat-ly S
ailli~ t r- a- r-pr-- nt d by tb di-tanc- dl Further ablatlon would top at tbl- pow r l-v l If the tip l-ctrode being uppll-d wlth the pow-r l-vel - represented by the curve A 16 actively coolea in a anner hereinbefore de~cribed, the tip electrode te~perature drops to a uuch lower level, as for example C as represented by the eurve Al at the tip of okin S interface at 0 ~illi Qters in d$stance Sinee this te~perature is below the necrosis te~perature, ablation will not begin to oecur until a di-tanee of d2 at the point where the eurvo A2 erosses the neerosi6 line at 50 C, as for examplo a depth of 3 willi~eter6 fro~ the ur~ace N~erosis vill oeeur at a depth fro~ 3 ~illi~etors to S willi~et-r~ a~ represented by the di-tane- d3 8uch a oool d ablatlon proe dur- 1~ very advantageou~ becauso it pernits n-orosis to oceur bo~ow thc oontact ~urfaoe vithout de~troying the eontact cur~ace and the ti-sue iD ediately underlying the ~ame This 18 particularly desirable in applications, for xa~ple in the heart, in whioh it is desirod to ablate certain tissues to dostroy sites cireuit~ ~hich are causing arrhyth~ias in the heart without destroying the ~urface lining of the heart The eurve B r~pr ~ents what oeeurs with and vithout cooling of the electrode tip at a higher power level for exi~ple, 10 vatti~ of radio frequeney nergy for cau~ing I~R heating inside the ti~sue Seg~ent B2 of eurve B represents a eontinuation of the exponential ourve of the Seg~ent B3 AB ean be seen, the te~perature at the tip-skin interfaee approaehes 100 C
vhieh i8 very ob~-etionable b~eause that i~ a t-ap ratur- whieh boiling of the blood and eoagulation of the blood on th- lectrod- uaking it- i p danee high nd eo~pri~ing th- ~bility to er-ate l-~ion- By providing activ- eooling to th- tip leetrodc, the eurva Bl i~ g-n-rat-d whieh hows the te~perature at the kln-tip int-r~ee drop- to approxinatelyi~0 C and e~u-ing n-ero-i- to oecur ~ro~ the depth o~ two ~illi~et-r- ~ repre~ent d by di~ and xt nding to a depth o~ approxi ately 8 ~illln-t r~ wher- tha eurv- B3 211~ ~3 .
cro6ses the 50 necrosis line 216 a~ represented by d5 Thus it can ~e seen that it i~ pos6ible to provide a ~uch deeper and larger lesion using the high~r power level without reaching an undesirable bigh te~perature which could cause eoagulation of the blood on the tip of the lectrode As shown, it is still possible to co~encQ the for ation at the lesion below the ~urface ~o that the urface need not be destroyed thu~
facilitating early recovery by the patiant from a tr atr nt ln accordanc- with th- pr-- nt lnv ntlon Curv C r-pr---nt- a till high r power l-v l, as ror xa~pl- 40 watt~ ln which th- e w e 1~ r-pr-~ented by eguent~ Cl, C2, and C3 ~he brok n line egeent C2 which is a continuation of the xponential eurve C3 how~ that the t--perature at the electrode ~kin ~nterface far xce ds the 100 C and would be unusable xc~pt with active cooling provid-d in accordanc~ with thQ present invention With active cooling, it can be ~een that the te perature at the ~kin electrode interface approaches 80 C and gradually increa~es and approaches near 95 and then drops off exponentially to cro~s the necrosis line 216 at a distance of 15 ~illi~eter6 fro~ the surface of the ~kin represented by the distance d6 In ~iew of the fact that the ~tarting te~perature 18 -above the S0 necrosl~ llne 216, necrosis will occur fro~ the urfaee of the ~kin to the 15 ~illi~eter depth to provide large and deep lesions The results whleh are reflee~ d in the graph in FIG 1~ ar- al-o r-inrorc d by the th r al eontour ap~
hown ln FIGS 16-18, whieh how for eool d l-etrodes that th- hlgh t- p ratur-- r- only r-aeh d at d pth~
~hlch ar- dl-tant rrou th- l-ctrod- kin int rraee FIGS 15, 16, 17 and 1~ r- graph- whleh w re d rived ~ro~ ~ eorput r i ulation utillzlng the f$nlte 3S l-- nt analy-l- progran ANSYS The graph- how eo~put-r g-n-rated l-otheraal eurv-~ howlng the t-~p ratur-- which ar- r-ach-d at the l-ctrode 16 at the tip of the distal extremity of the flexible elongate ~e~ber 12 of the catheter 11 and at different depths in the tis~ue fro~ the electrode-tissue interference for different conditions FIG 15 represents the situation where 10 watts of power are applied to the electrode 16 vith no chilling FIG 16 iJ for the ~ e 10 watts of power applied to the electrode 16 with cooling in the for~ of io CCB per rinute of a saline ~olution deliver d to the electrode at 5-C FIG 17 i~ for a ituation vhere ~0 vatts of pow i- appli d to th- l-ctrod- 16 without chilling vher-as FIG 18 1- for the ituation where the a~e 40 watts ot power are applied to the olectrode with cooling being applied to the electrode by 20 CC8 per ~inute of a saline olution at a te~perature of 5C
m e graphs or diagra~s hovn in FIGS 16-18 only represent one-half of the te~perature profiles or contours extending radially away fro~ the longitudinal axis of the di~tal xtre ity of the flexible elongate ~e~ber 12 of the electrode tip 16 In the graphs sho~n in FIGS 15-18 it iB assu~ed that the electrode tip 16 is in contact ~ith tissue such as in contact with the ~yocardiu~ of the hu~an heart The ~yocardiu~ i8 identified as 231 with the blood in the heart being identified a~ 232 AB can be seen fro~ the graphs in FIGS 15 through 18 the isother~al CUrVOB are identified by letters of the alphabet The i-other al curves ~hown in FI6 15 r-pr ~ent the following te-peratureJ at d grees centigrade for an lectrode 16 without cooling a - 37 811- c ntigrade B - 39 ~33- c ntigrade C - 41 056 c ntigrade D - ~2 678 c ntigrade P - 4~ 300 c ntigrad-P - ~S 923 c ntiqrad-G - ~7 545 c-ntigrade 2 1 1 ~
H ~ 49 167 centigrade I e 50 789 eentigrade J - 52 ~12 eent$grade K ~ 54 034~ centigrade L - 55 656 eentigrade M ~ 57 279 centigrade N - 58 901 eentigrade o - 60 523 eont$grade P - 62 145 eentigrade R - 65 390 centigrade Th- eurve H idontlfi-d ~bov that r-pr--ents a to~poraturo of approxiaat-ly 50 C which 1~ a t~perature at which per~anent necro~is occurs in the tl-sue as for exa~ple in the ryoeardium In other words, irrQversible da~age occur~ at temperatures higher than this te~perature Below that temperature the dema i~ te~porary and typically reverse~ The te~peratures represented by the eurves I, J, X, L
through R r-present t~peratures ~bove 50 at which necrosis would ta~e plaee Thus, because of the temperatures reached, there would be necro~is oc ring fro~ the tip 16 out to a distance or depth represented by the eurve ~ in FIG 15 In contrast, by utilizing eooling of the lectrode 16 as shown in FIG 16, the ~other al curves have the following teJperatures A - 19 518 e ntigrade B - 21 ~25 e ntigrade C - 23 333 e nt$grad-D - 2S 2~0 e nt$grad~
E - 27 1~8 e ntigr~d-F - 29 055 e~nt$grad-G - 30 963 e ntlgr~d~
H - 32 870 e ntigrada I - 34 778 e ntlgrado J - 36 68S e-ntigrade ""..
2 ~
K - 38 593 centigrade L e 40 sooo centigrade M ~ 42 408 centigrade ~ -N - 44 315 centigrade 0 ~ 47 228 centigrade P ~ 48 130 centigrade -R - 51 945 centigr~de From the isoth~rmal curves lt can be 6een that the S0 C iootheraal curve i~ paced froa the electrode tip that the teaperature only b gin~ to xc ed ~9-50 C in th- vicinity o~ the l-oth-rs curv R Thu- it ca~ ~e e~n that a portion of th- ~yocardiu~ ixaediately ad~cont to the tip is ~aved In other words, necrosis ~ - -do~s not appear in the fir6t portion of the ayocardium bec~use of the cooled tip necrosis does not occur until a certain distance as for exaaple 1 or 2 ailliaeters below the surface of the ayocardiua as presentQd by the curves P and R Thus it can be ~en that the cooli~g ~ - -of the ablation tip ~erves to pr ~erve the ~urface of 20 the ayocardium at the ~aae ti~e the cooled tip serves ~ -to prevent coagulation of the blood which could inhibit power delivery into the y ocardiua In the graph shown in FIG 17, the isothermal -~
curves have the follo~ing te peratures A ~ 40 160 centigrade ~ -~
B ~ ~6 ~79 centigrade C ~ 52 798 c~ntigrade D - 59 117 c-ntigrade ~ - 65 ~36- c~ntigrade F - 71 756 c~ntiqr~d-G - 78 075- c ntiqrad-H - 84 394 c ntigrad-I - 90 713- centiqrade J - 97 032 c ntigrade X - 103 352 c ntigrade L - 109 671- c-ntigrade '~
2~193~9 M = 1115 990 centigrade N = 122 309 centigrade 0 - 128 629 centigrade P ~ 134 943 centigrade R - 147 586 centigrade Here it can be seen that relati~ely high te~peratures are reached which are ~ubstantially above the 100 C at which blood coagulates on the electrode urface Although a 49 C i~other al is not hown in FIG 17, it would be betweon i~oth-r al curv - B ~nd C Thus, but ~or the coagulation o~ the blood at the electrode tip necrosi~ hould occur to a d-pth rQpr-sented by a curve betwoen the curvQs C and D Thi~ iB theoretical only because with temperatures ~o high blood coagulation would occur on tho tip and greatly interfere with the transfer of power from the tip to the tissue in the Dyocardium.
In the graph hown in FIG 18, the isotber~al curves have the following tomperatures a - 32 980 centigrade B - 38 589 centigrade C - 44 197 centigrade D - 49 806 centigrade E ~ 55 415 centigrade F ~ 61 024 centigrade G - 66 633 centigrade - 72 242 c~ntigrade I - 77 851 centigrade J - 83 ~60 c-ntigrade K - 89 069 c~ntigr~d~
L - 94 678 c ntigrade M - 100 386 centigrade N - 105 895 c ntigrad-0 - 111 50~ c-ntlgrade 3S P - 117 113 c ntigrade R ~ 128 331 centigrade , .
` ` ' ' ` . ' . ' ' Z l 1 ~
From these curve6 $t can be ~een that curve D is an isother~al curve repre6enting the region at which necrosis would ~top From the isothermal curves in FIG 18 it can be seen that the temperature~ at the surface of the electrode are ~ubstantially below 100 and therefore coagulation of blood i6 inhibited from taking place Thus it i~ possible to achieve relatively deep and wide le-ions utili~ing a cooled ablation electrode wh$ch heretofore was not possible to achi-ve without cooling Without the use of cooling for the ablation tip lectrod-, the aaount of power which can be ~upplied to the tip ~lectrode i8 greatly r-duc-d b cau-- oth-rwi-- th- tip l-ctrod- t--p rature ri-es very rapidly cau~ing coagulation of blood on the tip which prevents or at l-ast inhibits the transfer of power from the electrode to the tissue in contact with the electrode From the foregoing it can be ~een that the provision of a cooled ablation electrode has a nuiber of unexpected results The use of the cooled electrode akes it pos6ible to create necrose6 well below the urface being contacted by the electrode This is particularly desirable for treating arrhythmias which are created by ~ub- ndocardial arrhyth~ogenic foci, this makes it po~ible to spare the ndocardium m u6 it i8 possible to achieve lesions which are ~everal nilli~eters below the ti~sue surface making it possible to tr-at tu~or c~ vhich und rlie the akin ~urface vithout d~ aging or br-~ing the ~ln urface This i8 _ 30 a gr-at aid in preventing pot ntial inf ction- in a vound It al-o racilitat-- fa-t r h aling rOr the pati nt around th- n cro-i- vhlch ha- b n cr-~ted Thu- ln aocordanc- vith the pr--ent lnvention, it is po-~ibl- to provid- ~ ry o~ll l--ions for x~opl- 2 3S ~nd 3 ~illi~et r dlam t l--lon- ln th- nlddl- of the ~yocardiu~ By th ~pproprl~t- ~pplication Or power and the appropriat- r-ooval of heat from the lectrode it is possible to achieve lesion~ ae any desired depth in tissue without the surface being damaged by the electrode Although the present invention i8 pri~arily been S de~cribed in connection with ablation of the heart, it should be appreciated that also has other applications a~ for exa plQ lectrosurgery It also Q n be us-d for tr-ating tu~ors underly$ng the kin a~ for xample breast Q ncer and prostatic cancer In view of th- for going, it can b -en that thsre has be-n provld-d a catheter which is partlcularly ~ultabl- for radlo ~r guency ablatlon that i~ provided with a cool-d l-ctrode and a ~ thod for using the a~e which nako~ po~ible to ablat- the ~yocardiu~ of the h-art wlthout creating undue heating of the blood in th- ~icinity of the region where the ablation is being perfor~ed and without Q using blood d-gradation This Q n be acconplished by the u~e of a cooled saline ~olution vhich is naintained at a pr-ssure at the tip of the catheter which i6 ubstantially equal to the pre~sure of the blood at the tip .
26 ~
~7 : i CATHErER FO~_pF ABL~L0N WITN
qL~ L~3EQ~E ~ND~EcHQ~
This inventlon relates to a catheter for radio ~reguency (RF) ~blation which i8 provided with a cooled l-ctrode and ~ethod Catheters for RF ablation have heretofore been S provided However, difficulties have been encountered ¦with such catheters in that it has been difficult to ~`¦achieve lesions of ~ufficient ~ize Increasing the RF
power to the catheter in an atte~pt to increa~e the ize of the lesions has caused degradation of the blood 10 in the region ~here ablation is ta~ing place Such C -blood degradation has caused products of the degradation to ~e deposited on the electrode surface greatly increasing the i~pedance Tn addition, it has -~-been found that increased power levels create und sirable b ating of the blood which can create blood olot- Ther- i~, th efore, a ne d for a new and l~prov d oathet r for RF ablation which overco~Qs these dl~advantaq--In gen ral, lt 1- an ob~ect of the pr-~ent lnv-ntion to provid- a cath-t r for RF ablation ~hich 1- provid-d ~lth a oool-d lectrode and a ~ethod to ~k- po-~ibl- the fornation of large l-sions Anoth r ob~ect Or tho lnv ntion $~ to provlde a cath~ter and ~thod of the above cbaracter in which the ~ -, .
-catheter i~ provided with a conducting electrode having a chamber therein and in which a cooling i~ provided in the chamber Another object of the invention is to provide a catheter and a ~ethod of the above charactee in which the cooling liguid in the cavity i8 ~aintained at a pressure vhich i~ ~ubstantially equal to th- pres~ure of the blood of the cha~k~r in the heart in which the cath-ter i- di~clo~ed Another ob~ect of tbe invention is to provide a catheter and a ~ethod of the above cbaracter in which a punp i~ provided for introducing the cooling liguid into the cathetQr and a ~eparat- pu~p i~ provided for withdrawing the liguid fron the catheter Another ob~ect of the invention i8 to provide a catheter and ~ethod by which lesions or a necro6is can be for~ed at various depths underlying the electrode with destroy d the surface contacted by the electrode Additional ob~ects and features of the invention vill appear fro~ the following description in Yhich the preferred bodi~ent is ~et forth in detail in conjunction vith tbe acco-panying drawing FIG I is a side elevational view of a catheter for use in radio freguency ablation with a cooled lectrode incorporating the present lnvention and howing the a~e b ing che~atically connected to a pu ping ~y~t-~ for upplying and withdrawing cooling liquid fron the tip of the catheter FIG 2 i- a ¢ro~ ctional vi-v tak n along line 2-2 of FIG
FIG 3 i- a graph howlng th~ po-itiv and n gativ pr---ure at th- cool d tip i- ~ero at or n-ar tb blood pr---ur- range FIG ~ i- a cro~ -ctional vi-w tak-n along the 3S lin- ~-~ Or FIG S howlng anoth r ~bodi~-nt o~ a cool-d tip lncorporatlng the pr---nt inv ntion 2 1 ~ i~ 3 3,! ~
FIG 5 is a cross-sectional view taken along the line 5-5 of FIG 4 FIG 6 i8 a side elevational view of another e~bodi~ent of a catheter for use in radio freguency ablation with a cooled electrode incorporating the present invention ~howing the ~a~e che atioally connect-d to a pumping syste~ for ~upplying a cooling l$guid to the tip of th- cath~ter FIG 7 i~ a partial ~ide elevational view of the di-tal xtr~nity of th eath ter hown ln FIG 6 FIG 8 i- a ide l-v~tional vi~w ~i~ilar to FIG 7 but howing how th- tlp rotatod through 90 FIG 9 1- a ~ide levational view in cross-sectional of another ~bodiDent of a catheter lncorporating th- pr-~ent invention taken along the lin~ 9-9 of FIG 10 FIG 10 iB an end elevational view looking along the line 10-10 of FIG 9 FIG 11 is another embodi~ent of a catheter incorporating the present invention utilizing a pas6ive wick for withdrawing nergy fro~ the tip electrode of the catheter FIG 12 is a cros6-6ectional view taken along the lin~ 12-12 of FIG 11 FIG 13 i~ a cros--~ectional view of the di6tal xtre~ity vith another catheter incorporating the present invention FIG 1~ i- a graph ~howing the te p ratures which ar- ncount r-d ln ti-sue during an ablation proc dure FIGS 15-18 how?graphs showing i~oth~r al eurve~
eomp?aring eool d and uneool d l-etrode~ and th ffect on ti-su- dur~ng ablation In g-n-r~l, th- pr---nt inv-ntion bodi-s a eath-t-r ~or radio ~r gu ney ablation with a eooled 3S l-etrod- for u~- in a beart having a wall forming at ~-a-t on- eb~ ber vith blood th-r-in Th- eath-t-r i6 eompri-ed of a ~l-xibl- longate m~mber ba~ing proximal .- .
~and distal extremities An electrode is mounted on the - distal extremity of the flexible elongate xember and has a cavity therein heane i8 provided which extends - through the flexible elongate ~e~ber fro~ the proximal S to the distal extremity for upplying radio frequency energy to the tip electrode The flexible elongate ~e~ber iB provided with a first lu~en therein extending ~- fro~ the proxi~al extre~ity to the di6tal extremity and being in co~munication with the electrode ~ean6 i6 provided for introducing a cooling liguid into the lunen Th ~Qan~ for introducing th~ cooling liguid into the lu en includQ~ ~an~ for ~d~usting the pre~sure o~ the liguid in the lu~en at the elQctrode 60 th~t it approximate6 the pressure of the blood in the ;~15 chaiber of the heart in which the distal extremity is disposed More in particular, the catheter 11 for RF
~jablation with ~ cooled el~ctrode incorporating the r;pre~ent invention con6iete of a flexible longate ;~20 e~ber 12 having proxiral and distal xtre~itie~ 13 and 14 A hollow tip conductinq electrode 16 ie ~ounted on the di6tal xtre~ity 14 nd iB provided with an internal cavity 17 The flexibly elongate ~e ber 12 i~
for~ed of a ~uitable pla~tic uch as a polyurethane It i~ desirable that the pla~tic utilized be kink-resistant In order to provide additional kink-re~istance, braid 21 of a uitable ~aterial ~ay be provid~d within the flexible ~longate ne~ber 12 during xtru~ion of th- ~ne to reinforc- the elongate neibQr and to provid~ additional ~in~-resi~tance ~he braid 21 can b forn a of ~ uitabl- ~at rial uch ~- Nylon or Xovlar ~h- braid 21 can b- provid d ~t th- di-tal xtr-~ity of th- longat~ xoib-r a- hown ln FIC
or, lr d-~ir-d, can xt nd th- ntir- l ngth of the ~longate u b r 12 Th- hollow tip l-ctrode 16 c n b forn d of a ultable ~t rial uch a8 tainles~ teel and can have ~ .
. .,.~
- 2~ ~3~
a wa'l thicknes6 ranging from 003 to 004 inches The elongate ~e~ber 12 can be provided in uit~ble ~ize as, for ~xa~ple, to provide catheters from 3 to 7 French $n eize The electrode 16 has a generally he~i~pherical configuration and can be secured to the distal extremity of the elongate ~ember 12 by suitable ~eans such as an adhesive (not ~hown) The elongate ~e~ber 12 i6 provided with fir~t ~nd ~econd relatively large liguid carrying lu ens 26 and 27 ~hich xtend fro~ th~ prox~ al xtr-~ity 13 to th~ d$-t~1 xtre-ity 1~ and ar- in cou~unication vlth the cavity 17 of the hollow tlp electrode 16 AB hown, lu ens 26 and 27 can be crescent-shaped in cross-~-ction A central lu~en 28 i- al~o provided which extends from the lS proxi~al xtremity 13 to the distal extre~ity 1~ of the olongate ~e~ber 12 A plur~lity of ~dditional lu~en6 29 are provided vhich are ~paced circuxferentially around the crescent-shaped lu ens 26 and 27 The central lu~en 28 carrie~ a conductor 31 for supplying radio frQquency nergy to the clectrode 16 The conductor 31 also ~erves to secure the tip electrode 16 80 that it reDains ~ecured to the di6tal extremity 14 of the elongate ~e ber 12 ~ ean6 i~ provided for steering the di6tal xtre-ity of the cathet~r 11 and is of the type described in co-pending application, Serial No 07/793,858, fil d Nov ber 18, 1991 As d~scribed th rein, it includes t ring ~ir-s 33, 34 and 36 ~hich aro provided in th- Iu ens 29 and ~hich are paced-ap~rt circu for ntially around thc c~ntral lu~en 28 Or the longata u- b r 12 Th- conductor 31, the t- ring ~ir-~ 33, 3~ and 36 tog-th-r ~ith thc ground r-turn 37 xt nd to th- proxi al xtr-Dity and ~re conn-ct-d through a cabl- 38 to a xalo conn ctor 39 ~hich 1- provld d at th- proxi al xtr--lty Or the longato x~ ber 12 ..
As 6hown, the catheter 11 can be provided with additional radio frequency electrodes as, for example, electrodes 41 and ~2 Yhich are for~ed as spaced-apart bands provided on the exterior of the distal extremity 14 of the elongate e~ber 12 and in relatively close proxi~ity to the hollow tip electrode 16 Such electrodes 41 and ~2 can be connect-d by conductor~ 43 and ~4 extending through lu~ens 29 to the proximal extremity and connected into the eonnector 41 The proxiual xtre~ity 13 of the longate ~eiber 12 is provided with a fitting 51 into Yhich a tubular enber 52 and Yhich another tubular ~ember 53 extends Tubular ~e~ber 52 is in co~nunioation Yith the lu~en 27 and the tubular ~ember 53 i~ in co~un$cation with the lumen 28 The tubular ue~bers 52 and 53 are provided with ~uer locks 56 and 57 of a eonventional type Means is connected to the fitting 56 for introducing a cooling liquid into the lu~en 27 to cause the same to pass through the lu~en to the distal extr~mity into the eavity 17 ~eans ic secured to the fitting 57 for Yithdrawing the cooling liquid fro~ the cavity 17 ~o that the pre~sure of the liquid in the cavity 17 approxi~ates the pressure of the blood in the ehamber of the heart in which a catheter is disposed This ~eans consi~ts of a tank 61 which is provided with a eooled saline ~olution 62 therein having a te~perature ranging fro~ 5 to 10 Centigrade It should be appr ciated other liquids other than a ~aline olution ean b- utiliz d, if de~ir d The ueans provided for upplyinq the aline eooling ~olution to the ritting 56 eon-i t- oS ~ pu p 66 Yhieh i~ eonnected by a tubular - ber 67 into th aline eooling olution 62 in the tank 61 and deliver- the a~e through tubul~r ~oiber 68 whieh i- eonn ct d to the ~itting 56 to provide tho eoolod alino ~olution at ~ pr det-rclned pr--sure Pl a- ~ea-ur-d by th- pre--ur- gaug- 69 Thus, as the pu p 66 1- operated, th- cooled aline : :. ..: .
, .. ~- .
~.... i ~olution i~ intro~uce~ into the ~umen 27 ~nd into the cavity 17 In order to reduce the pressure of the cooled liquid in the c~vity 17 ~nd to ~aintain the pre6~ure in the cavity 17 ~o that it i~ sub6tantially ~qual to the pres~ure of the blood in the ch~ ber of the heart in which the catheter i~ dispo~ed, a pump 71 i8 provided for withdrawing th- cool~d liquid from the cavity 17 through the lu en 28 The pump 71 i~
connected by a tubular e~er 72 to the fitting 57 and auppli-o a n gativc pr ~-ur- P2 to the flow p~s~agQ 28 which 1~ ueasured by the pr~-sure gauge 73 The pump 71 r-turns the eool~d liguld wlthdrawn ~ron the cavity 17 through a tubular e ber 7~ lnto the tank 61 ~o that it can be cooled and reused The catheter 11 1- ad~pted to be connected to radlo fr~quency power ~upply and controll r 76 which is connected by cable 77 to a female connector ~8 which i6 adapted to receive the male connector 32 The r~dio freguency power 76 supply can be of a conventional type The controller incorporates as a part thereof apparatu6 which 18 utilized for to~ring the distal extremity of the catheter, of the type described in co~
pending application, Serial No 0~/~93,858, filed Nove~ber 18 1991 Operation and use of the catheter for RF ablation ~ith the cooled tip and the method for us$ng the ~ame ean now be briefly descrlbed as follovs Let it be a~-u ed that it is d~ir d to introduce radio fr guoncy norgy into th~ wall fornlng a cha ber of the hoart to cau-e ablatlon o~ tha nyocardlu~ Al-o l-t it be ~ ~--un d that tho eathet r 1- introduc d lnto the chu b r o~ a h-art in ~ hunan b lng ln ~ eon~ ntlonal n~nn-r ~y utlllzlng tho eontroll-r 76, th- dl-tal xtronlty 1~ 1- t-~r d o that tho tlp l-etrod- 16 1-nov d lnto cont~et ~lth tha nyoeardlun Tho high~r quoncy n rgy can th n ba uppll~d rro. tho RF power upply 7~ to tho tlp 16 through th- eonductor 31 2~
Prior to the aelivery of 6uch radio frequency energy or at the ~ame ti~e, the punps 69 and 73 are placed in operation ~o that a cooled aline ~olution is being introduced into the lu~en 27 and into the cavity 17 of the Qlsctrode 16 to cool ths electrode 16 during the ti~e that radio freguency n-rgy is being applied to the a~s In order to ~eep the pre-sure ~n the lu~en 27 at a relativ ly low valuo and o that the pr-ssure ln the cavity 17 i- ub~tantially th u~ a- the pr-s~ur- of the blood in th- cba ber of th- h-art in which the cath-ter i~ di~po~ed, th- pu~p 73 cr-ate6 a n gative pr--sur- to withdrav the cool-d aline ~olution through th~ pa-s~ge or lu~en 28 and diocharges ths ~ame lnto the tank 61 The operator by observing the gauges 69 and 73 can operate the pu p~ 66 and 71 in a auch a xanner co that the pr-~our- in the cavity 17 i~ oubstantially the ~a~s as the pressure of the blood pool ~urrounding the cavity in which the catheter tip 18 disposed The desir~d pressures Pl and P2 on the gaugss 69 and 73 can be ascertained by first op rating the pump~ 66 and 71 vith the catheter 11 outside of the body and ~easuring the pressure in the cha~ber 17 and then observing the pres~ure~ on the gauges 69 and 73 when the proper pr-ssure i~ present in the cavity 17 Thus, vhen the catheter 11 is introduced into the body and into the heart, the d-sir-a pres~ure ~n the cavity 17 can be achiev-a erely by duplicating the r~adings on the qauge~ 69 nd 73 If desirea, ~ preis~ure transduc r (not ho~n) can be provided within ths cavity 17 ana conn~icted through l-ctric conductor6 ~not hovn) ~t nding to th proxi al xtr nlty Or the cath~t r wh r- t~ pr--~ur can b r ad on n appropriate in~tru~ nt ~not hown) ~ y aintaining th- pr---ur- Or th- alin- olutlon ln th cavity 17, at or n-ar the pr---ure of t~- blood ln which the ai-tal xtr-eity 1~ Or the cath-t r 11 is di-po-ed, th-r- i~ a ~inixal tondency rOr l-akage of 2 1 ~
the saline ~olution from the cavity 17 of the catheter 1 Thi~ i~ re~dily acco~plished even though there i8 a blood pre6gure change fro~ sy6tolic to diastolic as the heart ic pumping blood during the ti~e that an ablation procedure is being perfor~ed This is illustrated in Figure 3 in vhich the blood pressure range between ystolic and diastolic is shovn as ranglng fro~ 60-200 ~llliretoro of ~ercury as approxi~ately 2 p8i. The pre~sur~ changes of the cooled liguid ln the luaono 2~ nd 28 ie hown by the cur~ 81 The inl-t pr-souro provided by the pu~p 66 i- Pl as hown in Figur- 3 Th- prosour~ drops in the lu en 27 becauoe of losseo in the lu en Because of the negative pressure P2 created by pump 71 at the outlet Or the lu~en 28, the preosure continues to drop By appropriate ad~ust~ent of the pr-ssuros Pl and P2 to overcome lu~en losoes, the pressure in the cavity 17 of the tip electrode 16 can be ad~usted ~o that it approxi~ates the pr-ssure of the blood in the cha~ber in which the tip 16 is disposed Thi~ is represented by the curve 81 in Figure 3 which crosses through the blood pressure range at the tip lumen as indicated at 82 A typical example is shows in Figure 3 with a - catheter 150 centi eter6 in length and having lu~ens 010~ in diaDeter A pressur for the cooling liquid at the tip was obtained utilizing a pooitive input pressure Pl of ~0 psi and a negative outlet pr-ssure P2 of n gative ~0 p~i It has b on found that with a cathet r of the pr-~ent invention utilizing the u-thod of the pre~ent inv ntion it ha- b n po -ibl- to achl-v l--ion- of the de-lrod d-pth o* 112 to 1 c-nti eter and a i~ilar width in th ~yocardiu~ utilizing S to 50 watt- of powor 3S ~n addition to controlling th pr---ur in the cavlty 17, it till uay b d-olrabl- to ~ a-ur- the t-~peraturo Or th- tip l-ctrod- 16 This can be . ~ :
' " ', ~ ' .
211~309 -~- accomplished by nounting ~ thermocouple (not 6hown) in close proxi~ity to the tip 16 and by bringing out le~ds (not 6hown) from the ther~ocouple through an additional lunen ~not ~hown) $n the olongate ~e~ber 12 and bringing the leads out to the proxinal extr~ity ~nd connecting the~ into an appropriate instru entation (not hown) to ~ake the te perature reading Thi~ will pro~ide still additional input to the phy6ician or surgeon perfor ing the ablation procedurQ to ~nsure that the cooling i~ adequate and to ee that ~xce~ive te~perature i- not r-ach-d during the ~blation proc dur -In order to nhanc~ tho cooling of a hollow tip l-ctrodQ 16 uch a- chown in FIG 1, th r~ i~ provided a nodified tip electrode 86 in FIGS ~ and 5 as ~hown ther~in, the ~lectrode 86 which can be for ed of a suitable conducting aterial is pro~ided with a plurality of radially ~xtending fins 87 which extend inwardly fro~ the cylindriQ 1 wall 88 of the tip 86 and ~xtend to the distal xtr~aity of the tip as hown particularly in FIG 4 m e fins 87 terainate ~hort of the longitudinal axis of the tip 86 to provide a cylindrical space 89 at the extremities of the fins 87 Thus, it can be seen as a cooled ~aline solution enters the tip 86 in the ~e xanner as saline solution i~
introduced in the tip 16, the additional cooling ~-urfaces of th~ fin~ 87 will cause ~dditional heat tran~f~r fron th l-ctrod- 8~ to th- cooling l-ctrode 86 Thi~ incr a- d heat transfer fro~ the tip to the ¢ool d alino olution xa~- pos~ibl- 108- flo~ of the ~ cool d alin olution or th~ application of additlonal RF n rgy to th l-ctrode during the blation proc-dur- which i- b ing acconpli~h~d Anoth~r nbodix nt Or th ¢ath-t r for radio fr gu-ncy abl~tion with a cool d l-ctrod- i- hown in FIGS 6-8 Tb- ¢ th t r 91 con-i-t- of a fl-xibl~
olongat~ r b r having proxi al ~nd di~tal xtr-nitie~
:, ... . ; .. - .
.. .. . .
- 2lla~s 13 and 14 The catheter 92 i8 of a suitable length as for example 150 centi~eters and is provided with a flow pa~sage 96 The di6tal extremity 94 is provided with a port$on 92a of reduced dia eter and a flow passage 97 therein which is in co~aunication with the passage 96 The flexible elongate xe~ber 92 $8 also provided with the tapered portion 92b whieh ~or-~ a transition betwoen the di~tal xtreaity 9~ and the portion 92a of rQ~ucod dia~eter Tho pa~s~ge 97 i~ in co~aunication ~ -~ith eha~er 98 provided within a cup-shaped l-ctrode 99 ~or~ed o~ a ultabl- eonductiv ~at~rial uch as ~llvor whioh -rvo~ a- a hollov tip conducting lectrode The eup-~hap d l-ctrodo 99 has a proxiaal xtre~ity 101 s~cured to the distal oxtremity 94 of the ~loxible elongate xe~ber 92 by suitable ~eans ~uoh as an adhesive 102 The electrodo 99 is provided with a heaispherical distal extreaity 103 having a plurality of ~paced-apart hole~ 106 In addition, the electrode 99 is provided with a pair of xoon-shaped spacea-apart slots 107 and 108 as ~ho~n in FIGS 7 and 8 which are inclined proYi~ally to extend at an angle of approxi~ately ~5 vith respeot to the axis of the tip 99 . .
Means i~ provided for ~upplying a cooling liguid to tho eha~er 98, in the ~lectrode 99 and eonsi~t~ of a ves~el 111 having a cooled aline solution therein ~hioh oan be replonished when desired ~eans is provided for upplying th- eool d ~alin~ olution ~roa tho tanX or v ~ol 111 to tho pa--ago 96 of the eatheter 11 and oon-l-t- Or an lnlet plp 112 whioh 18 eonn ¢t d to a pu p 113 Th pu-p 113 1- eonn-otod through a top eoek 11~ whloh 1- provld d Yith a handlo 116 rOr aoving th- aa b tv n op n ~nd elo-ed po-ltion- to provid- a thr---way valv Tho top eock 11~ i- conn ¢t-d to rl xlbl- plplng 117 eonn-et-d to a ~lttlng 118 -¢ur d to th- proxl~al xtr-nlty 93 of th-rloxlblo longat- a -b-r 92;
.
,:
211~3~
In addition ~eans i6 provided for supplying r~dio freguency energy to the tip 99 and consists of a radio frequency power supply 121 which provided with a power supply cord 122 connected to a connector 123 The eonnector 123 iB connected to another eonnector 124 which i6 connected to a cord 126 that i8 connected into the fitting 118 The eord i~ eonducted by an in~ulated wir- 127 to the lectrode 99 by ~older 128 Operation and use Or the eooled tip catheter ~s hown ln FIGS 6 through 8 ay now b d ~erib d as rollows The one-way pu~p 113 erv 8 to pu~p the cooled ~aline ~olution fro~ the vessel 111 and ~upplies it under pre~sure through the passag- 96, through the pas~age 97 and into the ehaiber 98 The eooled allne olution rath-r than being reeirculated a~ in the ~bedi~ent shown in FIG 1 is diseharged from the l-ctrode 99 by ~et~ 131 of eooling liquid pa~sing from the electrode 99 after the eooled liquid has eoae into eontact with the electrode T}lus, it can be een that ~hen the tip 99 ie in eontaet with the wall of the heart, the ~ets will per~eate the interface between the tip 99 and the wall of the heart to produce additional eooling Although the cooled ~aline ~olution ~ay have been war~ed slightly by the tenperature of the tip 99, the ~ets 131 will still be cooler than the s~rrounding blood and therefore provide additional cooling at the interface to help prevent eoagulation of the blood at the interface bet~een the tip 99 and the wall of the heart In addition to the ~ets 131, they vill be additional ~-t~ indieat~d by the arrow~ 132 direet-d proxi ally froa th lot 107 and 108 whieh vill oreate a forc- that urg - t~ I-otrode 99 into eontaet with th- wall Or th- h art In oth-r words, ~-ts 132 will er-ate a eount r fore- to the ~et- 131 to eau~- the l-etrode tip 99 to r--ain in eontaet with the wall of the h-art t .. . . . . .
. . . .
~:... .. . . -~ .
2 1 1 ~
Fr~ the foregoing it can be ~een that for a given ~ize catheter it is pos~ible to pro~ide a ~uch larger lu~en extending to the distal extremity 94 because only one lu~en is required for the one-way flow of the cooled saline ~olution Thi~ incr~ased flow rate of the ~aline solution akes it possible to increase the radio frequ~ncy power doliver-d to the tip electrode 99 to nake it possible to create l~rger lesions in the wall of the heart when desirod The introduetion of tho aline olution into th blood 1- not ob~-ctional bGcau~e it i~ alr ady don- in a nu b r of other n dical proc-dur-s.
The thr~o-way valve or top cock 11~ provided ~ake~ it possible to drain any air out of the catheter 91 to insure that no air bubbles will be pu~ped by the pu~p 113 when pu~ping the coolod ~aline solution into th- catheter 91 As ~oon a6 the air has been exhau6ted fro~ the sy6te~, the handle 116 can be turned 80 that the eooled saline olution is ~upplied to the flow pa~sage 96 8y providing the eatheter 91 with a eooled ablation electrode which ean acco~modate ~ore radio frequency energy, it i6 po66ible to perfor~ ablation procedures other than in t~e heart For xa ple, it ean be utilized to treat eertain tu~or6 It al~o ean b- utilized in oleetrocaut ry nd olocL~06urg ry which nay n~ko it possible to l-~ve the urface intact while tr ~ting the tissue underlying the ourface without dbeaging tho bonding of the urface to the tis~ue Thu-, in tr-ating n organ through a vein or rt rial ~all, lt 1- po -ibl- to do thi- whll- till pro- rving th v in or rt rlal ~all ~lthout daa~ging th linlng ot th wall Thi- ean b r adily aeooqpli-hod by the eool d tlp wlth th- -lln olutlon tloving trou the ~ao a- hown in FIG 4 to pr-v nt dar~g- to th wall Suoh proo-dur-- r partieulnrly pplie~bl- tor gall bladd-r, urology, and gyn-eology : ., 2 i ~ O ~ ~ 3 .
In order to prevent blood from entering into the holes 106 and the slots 107 and 108 during the introduction of the cathet-r 91 into th- ve~6el of the patient, it nay be desirable to have the cooled saline solution under a slight positive pressure as the catheter 91 i~ introduced into the passage 96 ~o that saline solution will be flowing out of the holes 106 ~nd the slots 107 and 108 Another alternative would be to ~pply the cooling aline olution through the pa-~gQi 96 befor RF n rgy i- ~ppli~d to t~ tip 99 Thi- will h-lp to n-ur- that any blood within the oatheter will be forc-d out lnto the blood pool in which th- cath-t-r i~ di~po~-d Thi~ will prevent blood from becoming coagulated within the small holes 106 or th~ slots 107 and 108 when RF energy is applied and the tip electrode 99 i~ h~ated Another e~bodi~ent of a catheter incorporating the pro~-nt invention naking it xore difficult for the blood to enter into the interior of the Q theter i8 shown in FIGS 9-10 A~ ~hown therein, the Q theter 136 consists of a flexible elongate tubular ~e~ber 137 which is provided with a flow pa~sage 138 A tip electrode 141 for~ed of a suitable conducting ~aterial is adhered to the distal extre~ity 142 of the tubular ~e~ber 137 by ~uitable ~eans ~uch a~ adhesive 143 A
tubular ins-rt 144 of a ~uitable ~aterial ~uch as plastic i~ provided with a flared proxi~al extre~ity 144a ~-cured to th- interior wall of the fl-xible longate xe~ber 137 by uitable xeans uch as an adh-sive 146 AJ Q n be een in FIG 9, the tubular in--rt 144 i- pro~id d with a di-tal xtr-aity 147 which t-r inat-~ hort ot the h~ i~pherical portion of th- tip lectrod- 141 to pro~ide a pac- or cha~k~r 148 ~ithin th- l-ctr,od- 141 Th- tubular ln- rt 144 i-3S provid-d with a ~low pa--ag- 149 which op n- through th di-tal xtr-~lty 147 and which i- in co~unication with th- ch~ bar 148 Th- ~low pa-sage 149 i- al-o ln .. ,.. ~ - , - - . -., `:` "~', -`: . ` , ' - . . -co~munication with the flow passage 138 in the flexible elongate ~e~ber 137 A pair of dia~etrically opposed holes 151 are provided in the distal extre~ity 142 of the flexible elongate tubular ~ember 137 Valve ~eans in the form of a cylindrical valve sleQvQ 153 formed of a suitable ~lasto~eric ~aterial iB disposed in recess 154 provided in tho distal oxtre~ity 1~2 of the flexible longate tubular nember 137 m e valve ~leeve 153 1~ provided vith annular r~inforcing ribs 156 which xtend circu f-r-ntially around the leeve 153 Slits 157 xtending longitudinally of the tubular in~ert 144 ar- provided vhich ov rll- th hol~s 151 and serve to form loafl-t- lS3a and 153b yi-ldably r~tained in a ealed position to close the l$t 157 It can be se~n that when a cooled saline ~olution i- lntroduced through the passage 138 in the catheter 136, the solution vill pa~s through the passage 149 as indicated by the arrows 157 into the chamber 148 vhere it vill cool the tip 1~1 after its cooling function has been p rfor-ed, the ~lightly heatod cooled liquid will pa~ proxi~ally as indicated by the arrows 157 and be discharged into the blood pool under positive pre~sure through the hole~ 151 and through the ~lits 157 by urging outvardly the leaflets 153a and 153b provided ln the valve ~leeve 153 m iS vill permit additional cooled ~allne solution to be introduced into the tip electrode 1~1 to continue cooling of the oloctrode Thus, lt can be een that uch a valve ~le-ve 153 per it~ the u~- of a cooled ~aline olution 30 ~hil~ pr-v nting blood ~urrounding the cath~t r 136 ~rom nt ring into the int rlor of th- cath-t-r ~h n a allno olutlon 1- not b ing ~uppli-d to the catheter In o-rtaln applicatlons, it nay b po~-lblo to forogo th- u-- of activ coollng a~ for exa~pl- a~ by th provlding of th cool-d ~aline ~olutlon as ~eroinb for- do-orib d and to roly upon passive cooling 2 ~ ~ ~ 7;~
` for the tip of the c~theter while it is being utilized for RF ablation Such a eatheter 171 iB hown in FIGS
11 and 12 and consists of a flexible elongate tubular e ber 172 for ed of the plastic hereinbefore de6cribed which is provided with a flow pas6age 173 extending therethrough The tubular xenber 172 iB eonnected to eylindrical ~etal d oeve 176 for~ed of a ~uitable eonducting raterial ~ueh as ~ilver The sleeve can havo a uitabl~ longth a~ for exa~ple fro~ 2 to 5 ¢enti eters The leev 176 i~ providod with a bore 177 xtending ther-through The other nd of the l-evo 176 i~ eonnect d to another tubular ~e ber 179 forued of a ~uitablo insulating ~aterial ~uch as plastie The tubular ~ouber 179 is provided with a lS large eentral lu~en 181 and a plurality of additional lu ens 181 through 187 which are7 ~pacial eircumferentially around the lumen 181 The lu~ens 182, 184, and 185 have elements 191, 192, and 193 extending therethrough which are eonnected to the distal extremity of the tubular eDber 179 These ele~ents 191, 192 and 193 are for~ed of a uaterial ~uch a6 Nitinol having a negative eoeffieient of expan~ion a ground return eonductor 194 i8 provided in the lu~en 183 A conductor 196 i8 provided in the lumen 186 and is connected to a he ispherical tip electrode 197 ror~ed of a conducting ~aterial and ~ecured to the distal extre~ity of the tubular ~h~r 179 by ~uitable ean6 uch as an adh-sive (not hown) Passive heat eonduction ~eans 201 i8 provided withln th- di-tal xtr eity o~ tho eath ter 171 and eon i-t- o~ ~ uit~bl- ribrou- at rial ueh eotton ~ib r~ which hav boen i pr gnat-d with ~ h at ab-orbing ~luid a- ~or x~ ple water or a aline olution Thi- h-at eonduot$ng xatorial 201 xt-nds fro~ th- d$~tal xtr-nity o~ the tubular u~ ber 172 t~rough the pa--ag- 177 ln th- xetal 1-eVQ 176 and 18 in lnt$~te eontaet wlth the u tal leeve 176 ~he 2110`~
nater'al 201 al60 extends through the lu~en 181 provided in the tubular ~e~ber 179 ~nd into the interior of the tip electrode 197 as can be ~een from FIG 11, the various conductors and lQ~ents hereinbefore described in the lu~ens 182 through 186 extend through the pa66ive heat conducting ~aterial 201 and pas~ through an adhesive 206 then through the passage 173 to the proxinal xtre~ity of the catheter 181 where they are connected to appropriate control~ of th- type hor-inbefor de-cribed In U8Q of tho cath-t-r 171 aa hown in FIGS 11 ~nd 12, th- application of radio ~r guoncy norgy to th- olectrode 197 heats the ol-ctrod- 197 to cause the llguid within the passive heat conducting ~ean~ 201 to heat up and to trav l by convoction towards th- cooler r-gion of the paissive heat conductive ~eans 201 This in turn will cause the cooler liguid to circulate and take it~ place The liguid which has been heated will ~ove through the wick-like heat conductive aterial 201 20 and will co~e into contact with the ~etal ~leeve 176 ~ ~ -which will cause cooling to occur by having heat pass therethrough into the blood passing the cleeve 176 --The cooled liquid will then return to the tip to continue the convective flow as hereinbefore described Additionally, if additional heat dissipation is desired, a construction ~uch a- th~t cbown in FIG 13 can be used Radially xtending boat conducting fins 211 of ~otal ar- ithor older-d on or forned integral - -vith the ~lo-v 176 on the outer urface thereof ~y providing th rln~ 211, addit$onal b at di~ipating urfac- ar-a i- providod whicb incr a-e- the c~pabilitio~ for di--ipating b-at into th- blood circulating ~round tb- d oov 1~6 ~nd tho ~in~ 21~
~h functioning o~ th- cath-ter- b-reinbefore d-~crib d in con~unction vitb ablation by tb- U-Q of radio ~rogu-ncy n-rgy can bo uor cl-arly undor~tood by rof-ronco to FIG 1~ FIG 1~ i~ a graph which -., 2 ~ 3~ ~ ~
.
~ along the horizontal axis ~hows the depth of the lesion created during the ablation procedure $n aillireter6 with respect to te~perature in degrees centigrade as hown by the vertical axis of the graph ~0~ on the graph is eguivalent to the surface of the tip of the electrode which iB in contact with the tissue Going to the right of the graph as shown in FIG 1~, the depth into the tissue incr-a~es Three curv 6 A, B, and C are ~hown in the qr~ph for three different power l-v l- of radlo fr quency n rgy b ing delivered into th- ti--ue The t-eperatur- on the graph goes to 100 C The 100 C ~a- b n hown becau-e it 18 con~idered to be an upper liait for te~p rature or sliqhtly less than that because at approxi~ately 90 C
blood begins to boil and coagulate on the electrode tip qreatly increasing its iDpedance and comprising its ability to create lesions Thus, it is de~irable to bave the te~per~ture of the l-ctrode or tip r-uain b low 90 C if possibl~ At 50 C a line 216 hac been hown on the qraph because this is the terperature below which necrosis of the y ocardial as well as connective tissue will cease Curve a shown in FIG 14 i~ divided into three ~gnents Al, A2, and A3 The broken line ~eg~ent a2 r-pre~ents a continuation of the xponential curve A3 when no cooling appli d to the lectrode Thus it can be een fro~ the power level of 5 watts repres nted by the curve A that ~roa the tip t-~perature of 80 C
hown at the cor~enc- ent of the curve, the te~p rature d creasQ- xpon ntially a- the di-tance fro~ the urrac- of th ti--u- lncr-a--- A- hown, t~ curve A3 cro---- th 50 C necro-$- boundary r-pr-- nt d by th lin- 216 at a d-ptb of 5 ~illia-ter- Th~ ion created would bav a d-pth of approxiaat-ly S
ailli~ t r- a- r-pr-- nt d by tb di-tanc- dl Further ablatlon would top at tbl- pow r l-v l If the tip l-ctrode being uppll-d wlth the pow-r l-vel - represented by the curve A 16 actively coolea in a anner hereinbefore de~cribed, the tip electrode te~perature drops to a uuch lower level, as for example C as represented by the eurve Al at the tip of okin S interface at 0 ~illi Qters in d$stance Sinee this te~perature is below the necrosis te~perature, ablation will not begin to oecur until a di-tanee of d2 at the point where the eurvo A2 erosses the neerosi6 line at 50 C, as for examplo a depth of 3 willi~eter6 fro~ the ur~ace N~erosis vill oeeur at a depth fro~ 3 ~illi~etors to S willi~et-r~ a~ represented by the di-tane- d3 8uch a oool d ablatlon proe dur- 1~ very advantageou~ becauso it pernits n-orosis to oceur bo~ow thc oontact ~urfaoe vithout de~troying the eontact cur~ace and the ti-sue iD ediately underlying the ~ame This 18 particularly desirable in applications, for xa~ple in the heart, in whioh it is desirod to ablate certain tissues to dostroy sites cireuit~ ~hich are causing arrhyth~ias in the heart without destroying the ~urface lining of the heart The eurve B r~pr ~ents what oeeurs with and vithout cooling of the electrode tip at a higher power level for exi~ple, 10 vatti~ of radio frequeney nergy for cau~ing I~R heating inside the ti~sue Seg~ent B2 of eurve B represents a eontinuation of the exponential ourve of the Seg~ent B3 AB ean be seen, the te~perature at the tip-skin interfaee approaehes 100 C
vhieh i8 very ob~-etionable b~eause that i~ a t-ap ratur- whieh boiling of the blood and eoagulation of the blood on th- lectrod- uaking it- i p danee high nd eo~pri~ing th- ~bility to er-ate l-~ion- By providing activ- eooling to th- tip leetrodc, the eurva Bl i~ g-n-rat-d whieh hows the te~perature at the kln-tip int-r~ee drop- to approxinatelyi~0 C and e~u-ing n-ero-i- to oecur ~ro~ the depth o~ two ~illi~et-r- ~ repre~ent d by di~ and xt nding to a depth o~ approxi ately 8 ~illln-t r~ wher- tha eurv- B3 211~ ~3 .
cro6ses the 50 necrosis line 216 a~ represented by d5 Thus it can ~e seen that it i~ pos6ible to provide a ~uch deeper and larger lesion using the high~r power level without reaching an undesirable bigh te~perature which could cause eoagulation of the blood on the tip of the lectrode As shown, it is still possible to co~encQ the for ation at the lesion below the ~urface ~o that the urface need not be destroyed thu~
facilitating early recovery by the patiant from a tr atr nt ln accordanc- with th- pr-- nt lnv ntlon Curv C r-pr---nt- a till high r power l-v l, as ror xa~pl- 40 watt~ ln which th- e w e 1~ r-pr-~ented by eguent~ Cl, C2, and C3 ~he brok n line egeent C2 which is a continuation of the xponential eurve C3 how~ that the t--perature at the electrode ~kin ~nterface far xce ds the 100 C and would be unusable xc~pt with active cooling provid-d in accordanc~ with thQ present invention With active cooling, it can be ~een that the te perature at the ~kin electrode interface approaches 80 C and gradually increa~es and approaches near 95 and then drops off exponentially to cro~s the necrosis line 216 at a distance of 15 ~illi~eter6 fro~ the surface of the ~kin represented by the distance d6 In ~iew of the fact that the ~tarting te~perature 18 -above the S0 necrosl~ llne 216, necrosis will occur fro~ the urfaee of the ~kin to the 15 ~illi~eter depth to provide large and deep lesions The results whleh are reflee~ d in the graph in FIG 1~ ar- al-o r-inrorc d by the th r al eontour ap~
hown ln FIGS 16-18, whieh how for eool d l-etrodes that th- hlgh t- p ratur-- r- only r-aeh d at d pth~
~hlch ar- dl-tant rrou th- l-ctrod- kin int rraee FIGS 15, 16, 17 and 1~ r- graph- whleh w re d rived ~ro~ ~ eorput r i ulation utillzlng the f$nlte 3S l-- nt analy-l- progran ANSYS The graph- how eo~put-r g-n-rated l-otheraal eurv-~ howlng the t-~p ratur-- which ar- r-ach-d at the l-ctrode 16 at the tip of the distal extremity of the flexible elongate ~e~ber 12 of the catheter 11 and at different depths in the tis~ue fro~ the electrode-tissue interference for different conditions FIG 15 represents the situation where 10 watts of power are applied to the electrode 16 vith no chilling FIG 16 iJ for the ~ e 10 watts of power applied to the electrode 16 with cooling in the for~ of io CCB per rinute of a saline ~olution deliver d to the electrode at 5-C FIG 17 i~ for a ituation vhere ~0 vatts of pow i- appli d to th- l-ctrod- 16 without chilling vher-as FIG 18 1- for the ituation where the a~e 40 watts ot power are applied to the olectrode with cooling being applied to the electrode by 20 CC8 per ~inute of a saline olution at a te~perature of 5C
m e graphs or diagra~s hovn in FIGS 16-18 only represent one-half of the te~perature profiles or contours extending radially away fro~ the longitudinal axis of the di~tal xtre ity of the flexible elongate ~e~ber 12 of the electrode tip 16 In the graphs sho~n in FIGS 15-18 it iB assu~ed that the electrode tip 16 is in contact ~ith tissue such as in contact with the ~yocardiu~ of the hu~an heart The ~yocardiu~ i8 identified as 231 with the blood in the heart being identified a~ 232 AB can be seen fro~ the graphs in FIGS 15 through 18 the isother~al CUrVOB are identified by letters of the alphabet The i-other al curves ~hown in FI6 15 r-pr ~ent the following te-peratureJ at d grees centigrade for an lectrode 16 without cooling a - 37 811- c ntigrade B - 39 ~33- c ntigrade C - 41 056 c ntigrade D - ~2 678 c ntigrade P - 4~ 300 c ntigrad-P - ~S 923 c ntiqrad-G - ~7 545 c-ntigrade 2 1 1 ~
H ~ 49 167 centigrade I e 50 789 eentigrade J - 52 ~12 eent$grade K ~ 54 034~ centigrade L - 55 656 eentigrade M ~ 57 279 centigrade N - 58 901 eentigrade o - 60 523 eont$grade P - 62 145 eentigrade R - 65 390 centigrade Th- eurve H idontlfi-d ~bov that r-pr--ents a to~poraturo of approxiaat-ly 50 C which 1~ a t~perature at which per~anent necro~is occurs in the tl-sue as for exa~ple in the ryoeardium In other words, irrQversible da~age occur~ at temperatures higher than this te~perature Below that temperature the dema i~ te~porary and typically reverse~ The te~peratures represented by the eurves I, J, X, L
through R r-present t~peratures ~bove 50 at which necrosis would ta~e plaee Thus, because of the temperatures reached, there would be necro~is oc ring fro~ the tip 16 out to a distance or depth represented by the eurve ~ in FIG 15 In contrast, by utilizing eooling of the lectrode 16 as shown in FIG 16, the ~other al curves have the following teJperatures A - 19 518 e ntigrade B - 21 ~25 e ntigrade C - 23 333 e nt$grad-D - 2S 2~0 e nt$grad~
E - 27 1~8 e ntigr~d-F - 29 055 e~nt$grad-G - 30 963 e ntlgr~d~
H - 32 870 e ntigrada I - 34 778 e ntlgrado J - 36 68S e-ntigrade ""..
2 ~
K - 38 593 centigrade L e 40 sooo centigrade M ~ 42 408 centigrade ~ -N - 44 315 centigrade 0 ~ 47 228 centigrade P ~ 48 130 centigrade -R - 51 945 centigr~de From the isoth~rmal curves lt can be 6een that the S0 C iootheraal curve i~ paced froa the electrode tip that the teaperature only b gin~ to xc ed ~9-50 C in th- vicinity o~ the l-oth-rs curv R Thu- it ca~ ~e e~n that a portion of th- ~yocardiu~ ixaediately ad~cont to the tip is ~aved In other words, necrosis ~ - -do~s not appear in the fir6t portion of the ayocardium bec~use of the cooled tip necrosis does not occur until a certain distance as for exaaple 1 or 2 ailliaeters below the surface of the ayocardiua as presentQd by the curves P and R Thus it can be ~en that the cooli~g ~ - -of the ablation tip ~erves to pr ~erve the ~urface of 20 the ayocardium at the ~aae ti~e the cooled tip serves ~ -to prevent coagulation of the blood which could inhibit power delivery into the y ocardiua In the graph shown in FIG 17, the isothermal -~
curves have the follo~ing te peratures A ~ 40 160 centigrade ~ -~
B ~ ~6 ~79 centigrade C ~ 52 798 c~ntigrade D - 59 117 c-ntigrade ~ - 65 ~36- c~ntigrade F - 71 756 c~ntiqr~d-G - 78 075- c ntiqrad-H - 84 394 c ntigrad-I - 90 713- centiqrade J - 97 032 c ntigrade X - 103 352 c ntigrade L - 109 671- c-ntigrade '~
2~193~9 M = 1115 990 centigrade N = 122 309 centigrade 0 - 128 629 centigrade P ~ 134 943 centigrade R - 147 586 centigrade Here it can be seen that relati~ely high te~peratures are reached which are ~ubstantially above the 100 C at which blood coagulates on the electrode urface Although a 49 C i~other al is not hown in FIG 17, it would be betweon i~oth-r al curv - B ~nd C Thus, but ~or the coagulation o~ the blood at the electrode tip necrosi~ hould occur to a d-pth rQpr-sented by a curve betwoen the curvQs C and D Thi~ iB theoretical only because with temperatures ~o high blood coagulation would occur on tho tip and greatly interfere with the transfer of power from the tip to the tissue in the Dyocardium.
In the graph hown in FIG 18, the isotber~al curves have the following tomperatures a - 32 980 centigrade B - 38 589 centigrade C - 44 197 centigrade D - 49 806 centigrade E ~ 55 415 centigrade F ~ 61 024 centigrade G - 66 633 centigrade - 72 242 c~ntigrade I - 77 851 centigrade J - 83 ~60 c-ntigrade K - 89 069 c~ntigr~d~
L - 94 678 c ntigrade M - 100 386 centigrade N - 105 895 c ntigrad-0 - 111 50~ c-ntlgrade 3S P - 117 113 c ntigrade R ~ 128 331 centigrade , .
` ` ' ' ` . ' . ' ' Z l 1 ~
From these curve6 $t can be ~een that curve D is an isother~al curve repre6enting the region at which necrosis would ~top From the isothermal curves in FIG 18 it can be seen that the temperature~ at the surface of the electrode are ~ubstantially below 100 and therefore coagulation of blood i6 inhibited from taking place Thus it i~ possible to achieve relatively deep and wide le-ions utili~ing a cooled ablation electrode wh$ch heretofore was not possible to achi-ve without cooling Without the use of cooling for the ablation tip lectrod-, the aaount of power which can be ~upplied to the tip ~lectrode i8 greatly r-duc-d b cau-- oth-rwi-- th- tip l-ctrod- t--p rature ri-es very rapidly cau~ing coagulation of blood on the tip which prevents or at l-ast inhibits the transfer of power from the electrode to the tissue in contact with the electrode From the foregoing it can be ~een that the provision of a cooled ablation electrode has a nuiber of unexpected results The use of the cooled electrode akes it pos6ible to create necrose6 well below the urface being contacted by the electrode This is particularly desirable for treating arrhythmias which are created by ~ub- ndocardial arrhyth~ogenic foci, this makes it po~ible to spare the ndocardium m u6 it i8 possible to achieve lesions which are ~everal nilli~eters below the ti~sue surface making it possible to tr-at tu~or c~ vhich und rlie the akin ~urface vithout d~ aging or br-~ing the ~ln urface This i8 _ 30 a gr-at aid in preventing pot ntial inf ction- in a vound It al-o racilitat-- fa-t r h aling rOr the pati nt around th- n cro-i- vhlch ha- b n cr-~ted Thu- ln aocordanc- vith the pr--ent lnvention, it is po-~ibl- to provid- ~ ry o~ll l--ions for x~opl- 2 3S ~nd 3 ~illi~et r dlam t l--lon- ln th- nlddl- of the ~yocardiu~ By th ~pproprl~t- ~pplication Or power and the appropriat- r-ooval of heat from the lectrode it is possible to achieve lesion~ ae any desired depth in tissue without the surface being damaged by the electrode Although the present invention i8 pri~arily been S de~cribed in connection with ablation of the heart, it should be appreciated that also has other applications a~ for exa plQ lectrosurgery It also Q n be us-d for tr-ating tu~ors underly$ng the kin a~ for xample breast Q ncer and prostatic cancer In view of th- for going, it can b -en that thsre has be-n provld-d a catheter which is partlcularly ~ultabl- for radlo ~r guency ablatlon that i~ provided with a cool-d l-ctrode and a ~ thod for using the a~e which nako~ po~ible to ablat- the ~yocardiu~ of the h-art wlthout creating undue heating of the blood in th- ~icinity of the region where the ablation is being perfor~ed and without Q using blood d-gradation This Q n be acconplished by the u~e of a cooled saline ~olution vhich is naintained at a pr-ssure at the tip of the catheter which i6 ubstantially equal to the pre~sure of the blood at the tip .
26 ~
Claims (10)
1. In a catheter for radio frequency ablation with a cooled electrode for use in tissue having a surface, an elongate member having proximal and distal extremities, a metal conducting electrode secured to the distal extremity of the elongate member and having a chamber therein and adapted to make contact with the tissue, conductor means extending through the elongate member from the proximal to the distal extremity for supplying radio frequency energy to the electrode, said elongate member having a lumen in the distal extremity and being in communication with the chamber, cooling means disposed in said chamber and in contact with the electrode for dissipating heat created in the electrode by the application of radio frequency energy thereto, means for measuring the temperature of the tissue in contact with the electrode and means responsive to the temperature measured to control the amount of radio frequency energy supplied to the electrode so that temperature at the surface of the tissue does not exceed 90 C whereby deeper and wider lesions can be formed in the tissue than would be formed without the use of the cooling means.
2. A catheter as in Claim 1, wherein said cooling means in the form of a passive cooling means in which convection currents are created.
3. A catheter as in Claim 2, wherein said electrode is provided with plurality of outwardly extending fins formed of a conductive material secured to the electrode.
4. A catheter as in Claim 1, wherein said cooling means is in the form of active cooling means in which cooled liquid is supplied into the chamber.
5. A catheter as in Claim 4, together with inwardly extending fins carried by the electrode and extending into the chamber and in contact with the cooled liquid
6. A catheter as in Claim 1, wherein said electrode is a tip electrode having a rounds tip having orifices therein through which the cooled liquid can pass from the chamber.
7. A catheter as in Claim 6, wherein said tip electrode has a longitudinally extending axis and wherein said tip electrode is provided with an additional orifice inclined proximally in a direction extending away from the axis of the tip electrode through which the cooled liquid can escape to create jets which create forces to urge the electrode into engagement with the surface.
8. A catheter as in Claim 4, together with valve means carried by the tubular member proximal of the electrode, means within the tubular member and the chamber in the electrode for causing the cooled liquid to be discharged into the chamber and then to pass proximally from the chamber and to exit through the valve means, said valve means serving to prevent liquid such as blood from entering into the catheter.
9. A catheter as in Claim 1, wherein said elongate member is provided with an additional lumen extending into the chamber in the electrode together with the means for supplying the cooled liquid through the first named lumen and withdrawing the cooled liquid from the additional lumen.
10. In a method for performing an ablation in the myocardium of the heart, utilizing a catheter having a distal extremity with a conductive electrode mounted thereon, introducing the catheter into the heart so that the electrode is in close proximity to the myocardium, supplying radio frequency energy to the electrode and supplying radio frequency energy to the positive pressure to the electrode for cooling the electrode during the time that the radio frequency energy is being supplied to the tip and withdrawing the cooing liquid from the tip at a negative pressure.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US07/983,732 | 1992-12-01 | ||
US07/983,732 US5348554A (en) | 1992-12-01 | 1992-12-01 | Catheter for RF ablation with cooled electrode |
Publications (1)
Publication Number | Publication Date |
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CA2110309A1 true CA2110309A1 (en) | 1994-06-02 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CA002110309A Abandoned CA2110309A1 (en) | 1992-12-01 | 1993-11-30 | Catheter for rf ablation with cooled electrode and method |
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US (4) | US5348554A (en) |
EP (1) | EP0608609B1 (en) |
JP (1) | JP2562861B2 (en) |
AT (1) | ATE206032T1 (en) |
AU (1) | AU673015B2 (en) |
CA (1) | CA2110309A1 (en) |
DE (1) | DE69330821T2 (en) |
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1995
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