CA2153303A1 - Guiding introducer system for use in the treatment of left ventricular tachycardia - Google Patents
Guiding introducer system for use in the treatment of left ventricular tachycardiaInfo
- Publication number
- CA2153303A1 CA2153303A1 CA002153303A CA2153303A CA2153303A1 CA 2153303 A1 CA2153303 A1 CA 2153303A1 CA 002153303 A CA002153303 A CA 002153303A CA 2153303 A CA2153303 A CA 2153303A CA 2153303 A1 CA2153303 A1 CA 2153303A1
- Authority
- CA
- Canada
- Prior art keywords
- guiding introducer
- section
- catheter
- degrees
- heart
- 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
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F15/00—Digital computers in general; Data processing equipment in general
- G06F15/16—Combinations of two or more digital computers each having at least an arithmetic unit, a program unit and a register, e.g. for a simultaneous processing of several programs
- G06F15/163—Interprocessor communication
- G06F15/17—Interprocessor communication using an input/output type connection, e.g. channel, I/O port
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
- H04L61/00—Network arrangements, protocols or services for addressing or naming
- H04L61/50—Address allocation
Abstract
A process for the treatment of ventricular tachycardia in the left ventricle using a retrograde approach by use of ablating and/or mapping catheters guided by a guiding introducer system.
Also disclosed are predetermined shapes for an inner and outer guiding introducers which comprise the guiding introducer system.
Also disclosed are predetermined shapes for an inner and outer guiding introducers which comprise the guiding introducer system.
Description
` 21~3Q~ ~/ I ~3 (a) Title of Invention GUIDING INTRODUCER SYSTE~I FOR USE IN THE TR13ATMENT OF LEFT
VENTRICULAR TACHYCARDIA
(b) This application is a continuation-in-part of application Serial No. 08/389,252 filed 02/16/95.
(c) Backqround of Invention 1. Field of Invention This invention relates to introducers. More particularly, this invention relates to a guiding introducer system for use within the lef t ventricle of the human heart f or the treatment of lef t ventricular tachycardia .
VENTRICULAR TACHYCARDIA
(b) This application is a continuation-in-part of application Serial No. 08/389,252 filed 02/16/95.
(c) Backqround of Invention 1. Field of Invention This invention relates to introducers. More particularly, this invention relates to a guiding introducer system for use within the lef t ventricle of the human heart f or the treatment of lef t ventricular tachycardia .
2. Prior Art Introducers and catheters have been in use for medical procedures for many years. For example, one use has been to convey an electrical stimulus to a selected location within the human body . Another use is to monitor and make measurements f or diagnostic tests within the human body. Catheters may be used by a physician to examine, diagnose and treat while positioned at a specific location within the body which is otherwise inaccessihle without more invasive procedures. In use, catheters may be inserted into a major vein or artery which is near the body surface. These catheters are then guided to the specific location for examination, rl;~noF~;~ or treatment by ~-n;r~ ting the catheter through the artery or vein of the human body.
Catheters have become increasingly useful in remote and dif f icult to reach locations within the body . However, the utilization of these catheters is frequently limited because of the need for the precise rl ;~ ~ of the tip of the catheter at a 2153~0~
specif ic location within the body .
Control of the movement of catheters to achieve such precise pl A~-' L is dif f icult because of the inherent structure of a catheter. The body of a conventional catheter is long and tubular.
To provide sufficient control of the movement of the catheter, it is nec~sAry that its structure be somewhat rigid. Elowever, the catheter must not be 80 rigid as to prevent the bending or curving nec~3Ary for - v~ L through the vein, artery or other body part to arrive at the ~peci f i l~cl location. Further, the catheter must not be 80 rigid as to cause damage to the artery or vein while it is being moved within the body.
While it is important that the catheter not be 80 rigid as to cause injury, it is also important that there be sufficient rigidity in the catheter to ~tf n~ ~te torque control, i.e., the aoility to transmit a twisting f orce along the length of the catheter. Sllffi- ;~ort torque control enables controlled maneuverability of the catheter by the application of a twi3ting force at the proximal end of the catheter that is transmitted along the catheter to its distal end . The need f or greater tor~[ue control often conflicts with the need for reduced rigidity to prevent injury to the body vessel.
Catheters are used increasingly for medical procedure3 involving the human heart. In these procedures a catheter is typically advanced to the heart through veins or arteries and then is positioned at a specified location within the heart. Typically, the catheter is inserted in an artery or vein in the leg, neck, ` 2153303 upper chest or arm of the patient and threaded, often with the aid of a guidewire or introducer, through various arteries or veins until the tip of the catheter reaches the desired location in the heart .
~ he distal end of a catheter used in such a procedure i3 sometimes preformed into a desired curvature 80 that by torquing the catheter about its longitudinal axis, the catheter can be --n;rlllAted to the desired location within the heart or in the arteries or veins associated with the heart. For example, U.S.
Patent No. 4,882,777 discloses a catheter with a complex curvature at its distal end for use in a speclfic procedure in the right ventricle of a human heart. U.S. Patent No. 5,231,994 discloses a guide catheter for guiding a balloon catheter for the dilation of coronary arteries. U.S. Patent No. 4,117,836 r~i~closP~3 a catheter for the selective coronary angiography of the left coronary artery and U.S. Patent Nos. 5,215,540, 5,016,640 and 4,883,058 disclose catheters for selective coronary ~ngi o~r~rhy of the right coronary artery. U.S. patent No. 5,242,441 discloses a deflectable catheter for ablation procedures in the ven~ri~ r chamber. See also U.S.
Patent No. 4,033,031. In addition, U.S. Patent No. 4,898,591 discloses a catheter with inner and outer layers containing braided portions. The '591 patent also disclo3es a number of different curvatures f or intravascular catheters . Thus, there are a number of references which disclose catheters with predetPrminf~d shapes, designed for use during specific medical procedures generally associated wit~ the ~eart or ~e vascular system. Because of ` 21~33(~3 precise physiology of the heart and the vascular system, catheters or introducers with precisely degigned shapeg for predetormi nG.~I
uses within the human heart and vascular system are increasingly important .
In addition to 3ingle catheter with various curvatures, U.S.
Patent No. 4,581,017 discloses an inner and outer guide catheter, (numbers 138 and 132), ~or use with a balloon catheter for treatment of coronary arteries. U.S. Patent No. 5,267,982 discloses a catheter assembly and methods for catheterization of coronary arteries wherein an inner catheter (50) and outer catheter (52) are used in combination for the treatment of right and left coronary angiographic procedures. See also U.S. Patent No.
4,935,017 which discloses a similar device. U.S. Patent No.
5,290,229 discloses a 3traight outer sheath and a preformed inner catheter f or use in the heart . See also U . S . Patent Nos .
5,304,131, 5,120,323, 4,810,244 and 5,279,456.
Catheter ablation of accessory pathways using a long vascular sheath by means of a transseptal or retrograde approach is discussed in Saul, J.P., et al. "Catheter Ablation of Acces30ry Atrioventricular Pathways in Young Patients: Use of long vascular sheaths, the transseptal approach and a retrograde left posterior parallel approach" J. Amer. Coll. Card., Vol. 21, no. 3, pps 571-583 (March 1, lg93). See al~o Swartz, J.F. ~Radiofrequency Endocardial Catheter Ablation of Accessory Atrioventricular Pathway Atrial Insertion Sites Circulation, Vol. 87, no. 2, pps. 487-499 ( February, 19 9 3 ) .
~ 21533~3 U.S. Patent No. 4,641,649 discloses the use of high frequency energy for the treatment of tachycardia or cardiac dysrhythmia.
See also U.S. Patent Nos. 5,246,438 and 4,945,912 for the use of radio frequency energy for ablation of cardiac tissue. In A~lrlitinn~ varioug articleg have disclosed the ablation of specific locations within the heart by use of energy, in particular, radio frequency energy. See, for example, Gallagher, J.J. et al.
"Catheter Technique for Closed-Chest Ablation of the Atrioventricular Conduction System" N. Engl. J. Med. Vol. 306, pp.
194-200 (1982); Horowitz, L.N. "Current Management of Arrhythmia"
pp. 373-378 (1991); Falk, R.H. et al. "Atrial Fibrillation M~nh;lnir~5 and Management" pp. 359-374 (1992); and Singer, I.
~l;ninAl Manual of Electrophysiology" pp. 421-431 (1993~.
In addition, U.S. patent No. 5,172,699 discloses a general process for the identification and ablation of vent~in~
tachycardia sites. See also U.S. Patent Nos. 5,222,501 and 5,242,441.
In addition, the use of radio frequency ablation enerqy for the treatment of Wolff-P;~kin~on-White Syndrome in the left atrium by use of a transseptal sheath is disolosed in Swartz, J. F . et al .
"Radiofrequency ~ndocardial Catheter Ablation of Accessory Atrioventricular Pathway Atrial Insertion Site~ Circulation 87:487-499 (1993). See also Tracey, C.~. "Radio Frequency Catheter Ablation of Ectopic Atrial Tachycardia Using Paced Activation Sequence Mapping" J. Am. Coll. Cardiol- 21:910-917 (19931-Accordingly, it is an object of t~lis invention to prepare a ~ 21S3303 guiding introducer system for 3elected medical pr~ce.luLes in theleft ventricle.
It is a further object of this invention to prepare a guiding introducer syatem for uae in 3elected electrophysiology procedures within the lef t ventricle of the heart .
Another object of this invention is to prepare a guiding introducer system for use in selected ablation procedures within the left ventricle of the heart.
It is a 3till further object of this invention to prepare a guiding introducer system for use in the selected ablation of sites in the left ventricle of the heart for the treatment of left ventricular tachycardia.
These and other objects are obtained by the design of the guiding introducer system disclosed in the instant invention.
(d) Summarv of Invention The instant invention in~ 0s a process for the treatment of ventricular tachycardia within the left ventricle of the heart comprising (a) introducing into the left ventricle a guiding introducer aystem, wherein said guiding introducer system is comprised of an inner and outer guiding introducer, wherein each of the inner and outer guiding introducers contains a lumen running lengthwise therethrough, a proximal and a distal end;
(b) introducing the inner guiding introducer into the lumen of the outer guiding introducer;
( c ) introducing into the lumen of the inner guiding ~ 21~33~
introducer an ablating or - mapping catheter containing a proximal and distal end, wherein said catheter has one or more electrodes located at or near the distal end of the catheter;
(d) guiding the catheter to a selected location within the left ventricle by use of the guiding introducer system; and (e) mapping and/or ablating the selected location within the left ventricle by use of the electrodes of the catheter.
In addition, the instant invention is a guiding introducer system to be used in the left ventricle for treatment of ventricular tachycardia comprising an inner and an outer guiding introducer. Both the inner and outer guidlng introducer3 contain f irst and second sections . The inner guiding introducer is longer than the outer guiding introducerl 80 that it may be extended out from the lumen of the outer guiding introducer to form various curves and shapes for the overall guiding introducer system.
(e) Brief DescriPtion of the Drawinas Figure lA is a cut away view of the heart ~howing the guiding introducer system supporting a catheter for ablation procedures on the lef t ventricular septal wall .
Figure lB is a cut away view of the heart showing the guiding introducer system for ablation procedures on the left ventricular lateral wall.
Figure 2A is a side view of the inner guiding introducer for use in the treatment of ventricular tachycardia in the left ventricle, wherein the side port tubing attached to the proximal end of the inner guiding introducer Ls located directly behind the 21533~3 first section of the inner guiding introducer.
Figure 213 i3 a side view of the inner guiding introducer rotated 90 clockwise from the position of Figure 2A, when viewed from the perspective of the proximal end of the inner guiding introducer, such that the 8ide port is directed to the left of the inner guiding introducer.
Figure 3A is a side view of the outer guiding introducer f or use in the treatment of ventri r~ r tachycardia in the left ventricle, wherein the side port tubing attached to the proximal end of the outer guiding introducer is located directly behind the f irst section of the outer guiding introducer .
Figure 3~ is a side view of the outer guiding introducer rotated 90 clockwise from the position of Figure 3A, when viewed from the perspective of the proximal end of the outer guiding introducer, such that the side port is directed to the left of the outer guiding introducer.
(f ) ~escriPtion of the Invention. -~
A typical human heart includes a right ventricle, a right atrium, left ventricle and left atrium. The right atrium i~ in fluid c nir~qtion with the superior vena cava and the inferior vena cava. The atrioventrir~ r septum separates the atria from the ventricleg. The tricuspid valve contained within the atrioventricular septum c, ~irates the right atrium with the right ventricle. The mitral valve contained within the atrioventricular septum c lirates the left atrium with the left ventricle. On the inner wall of the right atrium, where it is 21533~3 connected with the left atrium, i8 a recessed portion, the fossa ovalis. Between the fo3sa ovalis and the triauspid valve is the opening or ostium for the coronary 3inus. The coronary sinus i3 a large epiaardial vein which Af _ - ~ ~te8 most of the venous blood which drains from the myocardium into the right atrium.
In the normal heart, contraction and relaxation of the heart muscle (myocardium~ takes place in an organized fashion as electro-t~h~mir~l 8ignalg pasg sequentially through the myocardium from the atrial to the ven~r;~ r tissue along a well defined route which includes the Mi3-Purkinje system. Initial electric impulses are generated at the 3inuatrial ( SA) node and conducted to the atrioventricular (AV) node. The AV node lies near the 03tium of the coronary sinus in the interatrial septum in the right atrium.
The His-Purkinje system begins at the AV node and follow3 along the membranous interatrial septum to~ard the tricuspid valve through the atrioventricular septum and into the membranous interventricular septum. At about the middle of the interventricular septum, the His-Purkinje system 3plits into right and left branches which 3traddle the summit of the muscular part of the interventricular 3eptum.
Sometime3 Ahnnr~-l rhythm# occur in the heart which are referred to as arrhythmia. Por example, patients diagnosed with Wolff-Parkinson-White syndrome have an arrhythmia, the cause of which is believed to be the existence of an anomalous conduction pathway or pathway3 that connect the atrial muscle tissue directly to the ventricular muscle tis3ue, thus by-pas3ing the normal Hi3-Purkinje system. The~e pathways are usually located in the fibrou3tis3uc that connect the atrium and the ventricle.
Another arrhythmia is ventricular tachycardia t "VT" ) . VT is a disease of the heart in which the heart ' s normal arrhythmic contractlon i8 altered. Frequently, the rate of heart beat is too f ast although the conditions of the disease itself are generally quite complex. VT occurs most often in patients following a myocardial infarction. A myocardial infarction, commonly referred to as a heart attack, is a 1088 of blood to a region of the heart causing the myocardial tissue in that region to die and be replaced by an area of scar tissue known as a myocardial infarct.
Frequently, the myocardial infarct is present in the left ventricle .
As _ reYult of the myocardial infarct, circular pathways ( reentry circuits ) are f requently created within the lef t ve~tricle for the conduction of the electrical impulse3 of the heart. These reentry circuits cause the electrical impulses of the heart to travel in circle# about the myocardial infarct, frequently causing an erratic and sometimes accelerated beating of the heart.
These reentry circuits may also occur around discreet element# of the heart, ~uch as valves. In addition, the reentry circuits ~ometime occur around both the myocardial infarct and the discreet elements of the heart.
In the past VT has been treated by the use of drugs ~uch as li~nnAin~ q~ini-linl~ and prQci~in~mi~ . ~ore recently, beta-blocking drugs have been used f or its treatment . In cases where 21 ~303 drug therapy has been ineffective, surgical procedure3 have been used to excise the tis5ue causing the arrhythmia. The treatment involves one of a combination of ~locc:duLes such as Gerard G~i r~ s Full Encircling Endocardlal Ventriculotomy (FEEV), Re8ection (removal of electrically ~hnorr-l tissue) and Peeling (shaving off layers of Ahnt~r~--l endocardlal tissue, until only healthy tissue is exposed). Obviously such procedures are high risk, frequently requiring prolonged periods of hospitalization and recuperation. As an alternative to the3e procedures, cathèters have been used for the ~ nos~ ~ and treatment of cardiac arrhythmias inrl~7~1in~ spe~ifi~lly, VT. See, for example, U.S.
Patent No. 5,222,501.
ndividual applications of ablation energy are f requently lln~v~ceggful at breaking up the reentrant circuit, and the energy applications may have to be repeated several times. This may be because the tip is not positioned correctly at the beginning of the energy application or that the catheter tip moves during the attempted ablation. Another problem can be that even though the tip electrode is located correctly, there may not be enough contact pressure between the tissue and the electrode to facilitate 8~f~ i.ont current to flow through the tissue to properly affect said tissue. This is especially true in the very thick ventricular tissue where the offending tissue may be deep within the myocardium or even epicardial. The procedure may be very time consuming. It may require catheter f.,~hi3nq,-~ to replace a defective or inappropriately selected catheter. Advancing the catheter through ~ . 21533~3 the vasculature to the aortic arch into the LV and mapping to find the appropriate location is very rli~fir~ t with the unaided catheter. To effectively ablate the ventricular tiaaue, the ablation catheter must be po3itioned precisely wLthin the ventricle and maintained in contact with the ventricular tis~ue throughout the energy application. Such procedure3 may require the ablation electrode of the ablation catheter to remain in contact with the ventricular tissue for an extended period of time, well over a minute. This iB particularly difficult when the heart ia beating, sometimes irregularly, during the entire ablation pluoedu e. Thus, it is critical that the ablation electrode be maintained at the desired location and also be constrained from movement relative to the tis~ue being ablated throughout the energy application.
Currently the most common approach to the positioning of an ablation catheter in the left ventricle for ablation procedures is to introduce the catheter into the femoral artery using a standard introducer and advance it toward and through the aorta, acros 8 the aortic valve into the left ventricle and then position the electrode of the catheter adjacent to the wall of the left ventricle which is near the reentry circuita. Tllis is commonly referred to as the "retrograde' approach. Specific locations are choaen ~or the mapping or ablation of the ventricular tissue, including apecifically locations on the lateral freewall, posterior freewall, septal wall and anterior freewall.
Mere introduction of the ablation and mapping catheter into the left ventricle for a retrograde ap~roach ia n~t suficient to 21~33~3 effectively and ~f~iri~ntly perform the ablation procedures on the reentry circuits. The medical practitioner commonly monitors the introduction of the catheter and its progress through the vascular system by a fluoroscope. Such fluoro3copes can not easily identify the specific features of the heart in general, and the ~riticAlly important structures of the left ventricle in specific, thus making placement of the ablation electrode difficult. This pl i~ t is e~pP~ l ly difficult ag the beating heart is in motion. In addition, the catheter will be moving within the left ventricIe as blood is being pumped through the heart throughout the ~Luc:edule.
Also, the aortic valve continues to open and clo3e placing additional strain and pressures on the catheter. Further, because of the difficulty of properly locating the catheter, extended exposure to fluoroscopy may be inevitable. Ilowever, such excessive exposure is certainly undesirable.
The guiding introducer system of the instant invention addresses and solves these problems. Referring now to Figures 2A, 2B, 3A and 3B, the guiding introducer ~ystem of the present invention for use in the left ventricle for the treatment of VT i8 comprised of an inner and an outer guiding introducer. The inner guiding introducer is preferably longer than the outer guiding introducer 80 that its distal end may be extended out from the distal end of the outer guiding introducer to form various curves and shapes. In usc, the inner guiding introducer i3 inserted into the outer guiding introducer until the distal end of the inner guiding introducer extends out from the distal end of the outer ~ ~ 21,~3~3 guiding introducers. The inner and outer guiding introducers are generally each comprised of two section~. (Each section is preferably formed as an integral portion of the entire guiding introducer without discrete divisiona. I~owever, the division of each of the guiding introducers into two different sections for discussion better illustrates the overall 3hape of the guiding introducer3. ) Each of the guiding introducer3 will be 3hown in two views. In each of the views for ease of analysis, the inner and outer guiding introducer will be secured to a valve for attachment to a conventional ~ide port tubing and stop cock. In each ~uch arrangement, the shape of the inner or outer gulding introducer and each of it3 3ections will be de3cribed, making reference to its position in relation to the side port and side port tubing, where the proximal end of the inner and outer guiding introducer i~3 Recured to the side port tubing. In the first referenced figure (Figures 2A and 3A), the side port tubing is generally viewed as if it i# behind the first section of the inner or outer guiding introducer. The l -~nin~ figureR (Figures 2B and 3B) will show the inner or outer guiding catheter af ter clockwise rotation about the axis of the first section of the inner or outer guiding introduccr when viewed from the perspective of the proximal end of the re~pective guiding introduaer#.
The first section of the inner guiding introducer~ i~ a conventional, elongated, hollow, generally straight section of sufficient length for introduction into the patient and for manipulation from the point of insertion to the 13pecific deRired 21 ~33D3 location within the heart . ( The overall length of the f irst section as ~hown in the figures has been reduced for ease of viewing. ) Merged with the distal end of the first section of the inner guiding introducer is the second section which is a smooth, generally flat curve, curving to the left as shown in Figure 2A.
The curve of Eigure 2A has a radius of from about 0 . 5 in. to about 1. 5 in . and pref erably f rom about 0 . 7 in . to about 1. 3 in . The extent of the arc of the curve iB from about 45 to about 135 degrees and preferably from about 60 to about 120 degrees of arc, ending in the distal tip of the inner guiding introducer. Although this second section is preferably a single curve, alternatively two or more separate curved sections each with the same or different curvatures and radii can be used alone or Ln combinatLon with one or more straight sections as long as the combination of separate curves and straight sections creates generally the same overall curvature of this second section of about 45 to about 135 degrees, and preferably from about 60 to about 120 degrees. The first and second sections are prefera~ly coplanar (within about 15 degrees of coplanar ) .
The outer guiding introducer (Figures 3A and 3B) is designed f or use with the inner guiding introducer in the treatment of lef t ventricular tachycardia in the lef t ventricle . The outer guiding introducer is also divided into two separate sections. q'he first section Ls a conventional, generally elongated, hollow, straight section of sufficient length for Lntroduction into the patient and ~, 2~S~3 for ~-nirlllAtion from the point of insertion to the specific desired location within the heart. ~erged with the distal end of the first section of the outer guiding introducer is the second section which i3 comprised of a curved section, curving to the left as shown in Figure 3A. The curve of Figure 3A has a radius of ab~ut 1.0 to about 2.0 in. and preferably from about 1.3 to about 1. 7 in. The extent of the arc of the curve is from about 135 to 225 degrees, and preferably from about 160 to about 200 degrees ending in the distal tip of the outer guiding introducer. A8 with the inner guLding introducer, the arc of the curve is preferably a single curve, although alternatively two or more curved sections, each with the same or different curvatures and radii which may also incorporate one or more straight sections, can ~e used in combination as long as the combination of separate curvatures, radii and straight sections creates the same overall curvature of the second section of about 135 to about 225 degrees and preferably from about 160 to about 200 degrees. The first and second sections are prefera~ly coplanar (within about 15 degrees of coplanar).
The distal tip of the inner and outer guiding introducer may be, and preferably will be, tapered to form a good transition with a dilator. This tapering is preferably less than 10 and more pref erably about 4 to about 7 . The inner and outer guiding introducers preferably also contain one or a multitude of radiopaque tip marker bands near the distal tip of the inner and outer guiding introducers. These inner and outer guiding introducers also preferably contain one or a plurality of vents 21~33~3 near the distal tip of the inner and outer guiding introducers, preferably three or four such vents. The vents are preferably located no more than about 1.00 in. from the distal tip of the inner and outer guiding introducer and more preferably 0 . lO to about 1.00 in. from the distal tip. The size of these vent3 ahould be in the range of about 40 to about 60/1000 of an inch in diameter. The~e vents are designed to prevent air from entering the guiding introducer system caused by the withdrawal of the catheter contained within the inner guiding introducer in the event the distal end of the guiding introducer system is occluded. For example, if the tip of the inner or outer guiding introducer is placed against the myocardium and the catheter located within the guiding introducer is withdrawn, a vacuum may be created within the guiding introducer system if no vents are provided. If sucll vacuum i3 formed, air may be forced back into the guiding introducer sy~tem by the reintroduction of a catheter into the lumen of the inner guiding introducer . Such air could cause signif icant problems in the patient, including the possibitlity of a stroke, heart attack or other such problems common with air embolisms. The addition of vents near the distal tip of the inner and outer guiding introducers prevents the ~ormation of such vacuum by permitting fluid, presumably blood, to be drawn into the lumen of the inner and outer guiding introducer as the catheter is being removed from the inner guiding introducer, thus preventing the creation of a vacuum which could cause air to enter the guiding introducer system.
21~33~3 The inner and outer guiding introducers may be made of any material 3uitable for u3e in humans which ha~ a memory or permit3 distortion from, and substantial return to, the desired three dimen3ional 3hape. For the purpose o illu3tration and not limitation, the internal diameter of the inner and outer guiding introducer may vary from about 6 to about 12 "French" re3pectively ( 1 French equal3 1/3 of a m; 11 i l.er) . Such inner and oùter guiding introducer3 can also accept dilator3 and approprLate guidewires. Obviously, if larger or ~maller dilators or catheters are u3ed in conjunction with the guiding introducer system of the instant invention, ';fi~ations in size or shape can be made to the inner and outer guiding introducers.
Variation3 in size and shape of t~le inner and outer guiding introducers are al30 intended to F.n~ pediatrlc uses, although the preferred use~ are for adult human hearts. It is well recognized that pediatric uses may require reductions in size of the various sections of the inner and outer guiding introducer, in particular the fir~t section, but without any ~l~nif~ nt ---'ifi~ ation to the 3hape or curve of the inner and outer guiding introducer .
In addition, variation~ in size or shape of the inner and outer guiding introducers are al~o intended to ~nr~ the specialized 3ituations that sometimes occur in patients with enlarged or rotated hearts.
sy extending the di~tal tip of the inner guiding introducer away from the di3tal tip of the outer guiding introducer and by . ~ 2~33~3 rotating the inner guiding introducer with respect to the outer gulding introducer, a variety of ahapes of the overall guiding introducer system are formed which are helpful in directing the mapping and/or ablating catheter toward the site within the lef t ventricle of interest. These shapes permit ablation procedures within the left ventricle to be p2rformed, for example, located on the lateral freewall, posterior freewall, septal freewall and anterior freewall. See Figures lA and lB. The various locations can be treated by extendlng the inner guiding introducer away f rom the outer guiding introducer which forms a different overall shape and/or by rotating the inner guiding introducer with respect to the outer guiding introducer. In addition, by Tn~nirulAtion of the inner guiding introducer within the outer guiding introducer, additional procedures can be performed within the left ventricle.
Being able to extend the inner guiding introducer within the outer guiding introducer and to rotate the inner guiding introducer within the outer guiding introducer permits a wide variety of overall shapes, which i5 particularly useful to medical practitioners. The medical practitioner ia able to determine the relative location of the inner and outer guiding introducers because of the tip markers located near the distal tip of both the inner and outer guiding introducers.
The relative diameter of the outer guiding introducer in relation to that of the inner guiding introducer should be sufficient to permit the inner guiding introducer to be torqued or rotated within the outer guiding introducer without undue 21~303 restriction on such - v~ t. Preferably, the difference in size between the inner and outer guiding introducer should be at least about 3 French. For example, in one preferred ~ , the outer guiding introducer is 11 French in size and the inner guiding introducer i8 8 French. By this dlfference in diameterl there is approximately 1 French unit of space available between the outer surface of the inner guidiug introducer and the inner surface of the outer guidiug introducer. Preferably, this space between the inner and outer guiding introducer is filled with a biocompatible solution, such a3 a saline solution, preferably a heparinized 3aline solution. Thi~ ~aline solution al~o provides lubricity to the inner and outer guiding introducers, allowing more accurate torquing of the inner guiding introducer within the outer guiding introducer. In addition, it is preferablc that the structure of both the inner and the outer guiding introduccr have a high torsional constant to allow for the full utilization of the various shapes available by rotation and extension of the inner guiding introducer in relation to the outer guiding introducer. To permit this high torsional constant, in one preferred embodiment the inner guiding introducer i~ braided to provide further strength and structural stability.
In operation, a 'ifi.~CI Seldinger technique is normally used f or the insertion of the catheter into the f emoral artery . The appropriate vessel is accessed by needle puncture. A soft flexible tip of an appropriately sized guidewire is then inserted through and a short distance beyond the needle into the vessel. Firmly 2~33~3 holding the guidewire in place, the needle i8 removed. The guidewire is then advanced through the artery up to the aorta, acroGs the aortic valve into the left ventricle. With the guidewire ln place, a dilator i6 then placed over the guidewire with the guiding introducer system placed over the dilator. The dilator and guiding introducer system g~n~rAl ly form an assembly to be advanced together along the guidewire into the lef t ventricle .
After insertion of the assembly, the guidewire and dilator are then withdrawn. The catheter to be used for treatment of let ventricular tachycardia i6 advanced through the lumen of the inner guiding introducer and is placed at an appropriate ln~ ion in the left ventricle.
sy extending and withdrawing the inner guiding introducer in relation to the outer guiding introducer and by rotating the inner guiding introducer within the outer guiding introducer, variances in the overall 6hape and location of the guiding introducer s~rstem can be achieved.
sy v, ~ of the inner guiding introducer within the outer guiding introducer in conjunction with fluoro3copic viewing, the distal portion of the outer guiding introducer can be manipulated to direct the distal end of a catheter placed within the lumen of the inner guiding introducer to a specific internal surface within the left ventricle. In addition, by providing ~ufficient rigidity, the distal end of the inner guiding catheter can be maintained in that fixed location or surface position of the endocardial 6tructure to permit the appropriate procedures to be per~ormed. If 21 5~303 3ensing procedures are involved, the guiding introducer system is maneuvered to the desired location. At that point, the electrical activity of the heart p~r~ r to that location can be precisely determined by use of an electrophy3iology catheter placed within the guiding introducer system. Further, as the guiding introducer system permit3 precLse location of catheters, an ablation catheter may be placed at a precise location for de3truction of the cardiac tissue by the use of energy, for example, radio frequency, thermal, laser or direct current (high energy direct, low energy direct and fulgutronization procedures). Preferably, r~dio frequency energy is utilized f or the ablation procedure .
The preci6e placement of the ablation catheter electrode is important as there will be no dilution of the energy delivered due to unfocused energy being dis3ipated over the entire cardiac chamber and lost in the oirculating blood by a constantly moving tip of the ablating catheter. This sy3tem permit3 a 3ignificantly reduced amount of energy to be applied while 3till achieving efficient ablation. Further, time used to perform the procedure i3 Ri~n i f i rAntly reduced over procedures where no guiding introducer system is used. This reduction in time al~o reduces the amount of fluorosoopy that iB necessary for the procedure. The precise rl ar~ L of the ablation catheter within the lef t ventricle is particularly important because of the ~iffirllties associated with the ablation of lef t ventricular tachycardia .
Ablation procedures for the treatment of tachycardia in the left ventricle may require ~nifi--~ntly longer time because the 2~
~1 S33~3 ~all of the left ventricle Ls ~i~nifjcAntly thicker than other tissue in the heart. It has been determined that the time of ablation must be 3ubstantially lengthened to achieve not only two dimensional ablation but al30 the three ~ n5~l ablation that is nPcp~ry for the ablation of left ventricular tissue. Thus, not only is the precise location of the ablation electrodc necessary, but continuous contact of the ablation electrode with the left ventricle is also necessary. Larger or longer electrodes of the ablation catheter may be nerP~Ary to achieve efficient and effective blation. Furthcr, other types of energy than radio frequency may be neces~ary for the extensive ablation necessary for the elimination of the location within the ventricle.
It will be apparent from the foregoing that while particular forms of the invention have been illustrated and r1P~rr;hedr various -rl;firationg can be made without departing from the ~pirit and scope of the invention. Accordingly, it is not intended that this invention be limited except as by the ~rpPn~lPrl claims.
Catheters have become increasingly useful in remote and dif f icult to reach locations within the body . However, the utilization of these catheters is frequently limited because of the need for the precise rl ;~ ~ of the tip of the catheter at a 2153~0~
specif ic location within the body .
Control of the movement of catheters to achieve such precise pl A~-' L is dif f icult because of the inherent structure of a catheter. The body of a conventional catheter is long and tubular.
To provide sufficient control of the movement of the catheter, it is nec~sAry that its structure be somewhat rigid. Elowever, the catheter must not be 80 rigid as to prevent the bending or curving nec~3Ary for - v~ L through the vein, artery or other body part to arrive at the ~peci f i l~cl location. Further, the catheter must not be 80 rigid as to cause damage to the artery or vein while it is being moved within the body.
While it is important that the catheter not be 80 rigid as to cause injury, it is also important that there be sufficient rigidity in the catheter to ~tf n~ ~te torque control, i.e., the aoility to transmit a twisting f orce along the length of the catheter. Sllffi- ;~ort torque control enables controlled maneuverability of the catheter by the application of a twi3ting force at the proximal end of the catheter that is transmitted along the catheter to its distal end . The need f or greater tor~[ue control often conflicts with the need for reduced rigidity to prevent injury to the body vessel.
Catheters are used increasingly for medical procedure3 involving the human heart. In these procedures a catheter is typically advanced to the heart through veins or arteries and then is positioned at a specified location within the heart. Typically, the catheter is inserted in an artery or vein in the leg, neck, ` 2153303 upper chest or arm of the patient and threaded, often with the aid of a guidewire or introducer, through various arteries or veins until the tip of the catheter reaches the desired location in the heart .
~ he distal end of a catheter used in such a procedure i3 sometimes preformed into a desired curvature 80 that by torquing the catheter about its longitudinal axis, the catheter can be --n;rlllAted to the desired location within the heart or in the arteries or veins associated with the heart. For example, U.S.
Patent No. 4,882,777 discloses a catheter with a complex curvature at its distal end for use in a speclfic procedure in the right ventricle of a human heart. U.S. Patent No. 5,231,994 discloses a guide catheter for guiding a balloon catheter for the dilation of coronary arteries. U.S. Patent No. 4,117,836 r~i~closP~3 a catheter for the selective coronary angiography of the left coronary artery and U.S. Patent Nos. 5,215,540, 5,016,640 and 4,883,058 disclose catheters for selective coronary ~ngi o~r~rhy of the right coronary artery. U.S. patent No. 5,242,441 discloses a deflectable catheter for ablation procedures in the ven~ri~ r chamber. See also U.S.
Patent No. 4,033,031. In addition, U.S. Patent No. 4,898,591 discloses a catheter with inner and outer layers containing braided portions. The '591 patent also disclo3es a number of different curvatures f or intravascular catheters . Thus, there are a number of references which disclose catheters with predetPrminf~d shapes, designed for use during specific medical procedures generally associated wit~ the ~eart or ~e vascular system. Because of ` 21~33(~3 precise physiology of the heart and the vascular system, catheters or introducers with precisely degigned shapeg for predetormi nG.~I
uses within the human heart and vascular system are increasingly important .
In addition to 3ingle catheter with various curvatures, U.S.
Patent No. 4,581,017 discloses an inner and outer guide catheter, (numbers 138 and 132), ~or use with a balloon catheter for treatment of coronary arteries. U.S. Patent No. 5,267,982 discloses a catheter assembly and methods for catheterization of coronary arteries wherein an inner catheter (50) and outer catheter (52) are used in combination for the treatment of right and left coronary angiographic procedures. See also U.S. Patent No.
4,935,017 which discloses a similar device. U.S. Patent No.
5,290,229 discloses a 3traight outer sheath and a preformed inner catheter f or use in the heart . See also U . S . Patent Nos .
5,304,131, 5,120,323, 4,810,244 and 5,279,456.
Catheter ablation of accessory pathways using a long vascular sheath by means of a transseptal or retrograde approach is discussed in Saul, J.P., et al. "Catheter Ablation of Acces30ry Atrioventricular Pathways in Young Patients: Use of long vascular sheaths, the transseptal approach and a retrograde left posterior parallel approach" J. Amer. Coll. Card., Vol. 21, no. 3, pps 571-583 (March 1, lg93). See al~o Swartz, J.F. ~Radiofrequency Endocardial Catheter Ablation of Accessory Atrioventricular Pathway Atrial Insertion Sites Circulation, Vol. 87, no. 2, pps. 487-499 ( February, 19 9 3 ) .
~ 21533~3 U.S. Patent No. 4,641,649 discloses the use of high frequency energy for the treatment of tachycardia or cardiac dysrhythmia.
See also U.S. Patent Nos. 5,246,438 and 4,945,912 for the use of radio frequency energy for ablation of cardiac tissue. In A~lrlitinn~ varioug articleg have disclosed the ablation of specific locations within the heart by use of energy, in particular, radio frequency energy. See, for example, Gallagher, J.J. et al.
"Catheter Technique for Closed-Chest Ablation of the Atrioventricular Conduction System" N. Engl. J. Med. Vol. 306, pp.
194-200 (1982); Horowitz, L.N. "Current Management of Arrhythmia"
pp. 373-378 (1991); Falk, R.H. et al. "Atrial Fibrillation M~nh;lnir~5 and Management" pp. 359-374 (1992); and Singer, I.
~l;ninAl Manual of Electrophysiology" pp. 421-431 (1993~.
In addition, U.S. patent No. 5,172,699 discloses a general process for the identification and ablation of vent~in~
tachycardia sites. See also U.S. Patent Nos. 5,222,501 and 5,242,441.
In addition, the use of radio frequency ablation enerqy for the treatment of Wolff-P;~kin~on-White Syndrome in the left atrium by use of a transseptal sheath is disolosed in Swartz, J. F . et al .
"Radiofrequency ~ndocardial Catheter Ablation of Accessory Atrioventricular Pathway Atrial Insertion Site~ Circulation 87:487-499 (1993). See also Tracey, C.~. "Radio Frequency Catheter Ablation of Ectopic Atrial Tachycardia Using Paced Activation Sequence Mapping" J. Am. Coll. Cardiol- 21:910-917 (19931-Accordingly, it is an object of t~lis invention to prepare a ~ 21S3303 guiding introducer system for 3elected medical pr~ce.luLes in theleft ventricle.
It is a further object of this invention to prepare a guiding introducer syatem for uae in 3elected electrophysiology procedures within the lef t ventricle of the heart .
Another object of this invention is to prepare a guiding introducer system for use in selected ablation procedures within the left ventricle of the heart.
It is a 3till further object of this invention to prepare a guiding introducer system for use in the selected ablation of sites in the left ventricle of the heart for the treatment of left ventricular tachycardia.
These and other objects are obtained by the design of the guiding introducer system disclosed in the instant invention.
(d) Summarv of Invention The instant invention in~ 0s a process for the treatment of ventricular tachycardia within the left ventricle of the heart comprising (a) introducing into the left ventricle a guiding introducer aystem, wherein said guiding introducer system is comprised of an inner and outer guiding introducer, wherein each of the inner and outer guiding introducers contains a lumen running lengthwise therethrough, a proximal and a distal end;
(b) introducing the inner guiding introducer into the lumen of the outer guiding introducer;
( c ) introducing into the lumen of the inner guiding ~ 21~33~
introducer an ablating or - mapping catheter containing a proximal and distal end, wherein said catheter has one or more electrodes located at or near the distal end of the catheter;
(d) guiding the catheter to a selected location within the left ventricle by use of the guiding introducer system; and (e) mapping and/or ablating the selected location within the left ventricle by use of the electrodes of the catheter.
In addition, the instant invention is a guiding introducer system to be used in the left ventricle for treatment of ventricular tachycardia comprising an inner and an outer guiding introducer. Both the inner and outer guidlng introducer3 contain f irst and second sections . The inner guiding introducer is longer than the outer guiding introducerl 80 that it may be extended out from the lumen of the outer guiding introducer to form various curves and shapes for the overall guiding introducer system.
(e) Brief DescriPtion of the Drawinas Figure lA is a cut away view of the heart ~howing the guiding introducer system supporting a catheter for ablation procedures on the lef t ventricular septal wall .
Figure lB is a cut away view of the heart showing the guiding introducer system for ablation procedures on the left ventricular lateral wall.
Figure 2A is a side view of the inner guiding introducer for use in the treatment of ventricular tachycardia in the left ventricle, wherein the side port tubing attached to the proximal end of the inner guiding introducer Ls located directly behind the 21533~3 first section of the inner guiding introducer.
Figure 213 i3 a side view of the inner guiding introducer rotated 90 clockwise from the position of Figure 2A, when viewed from the perspective of the proximal end of the inner guiding introducer, such that the 8ide port is directed to the left of the inner guiding introducer.
Figure 3A is a side view of the outer guiding introducer f or use in the treatment of ventri r~ r tachycardia in the left ventricle, wherein the side port tubing attached to the proximal end of the outer guiding introducer is located directly behind the f irst section of the outer guiding introducer .
Figure 3~ is a side view of the outer guiding introducer rotated 90 clockwise from the position of Figure 3A, when viewed from the perspective of the proximal end of the outer guiding introducer, such that the side port is directed to the left of the outer guiding introducer.
(f ) ~escriPtion of the Invention. -~
A typical human heart includes a right ventricle, a right atrium, left ventricle and left atrium. The right atrium i~ in fluid c nir~qtion with the superior vena cava and the inferior vena cava. The atrioventrir~ r septum separates the atria from the ventricleg. The tricuspid valve contained within the atrioventricular septum c, ~irates the right atrium with the right ventricle. The mitral valve contained within the atrioventricular septum c lirates the left atrium with the left ventricle. On the inner wall of the right atrium, where it is 21533~3 connected with the left atrium, i8 a recessed portion, the fossa ovalis. Between the fo3sa ovalis and the triauspid valve is the opening or ostium for the coronary 3inus. The coronary sinus i3 a large epiaardial vein which Af _ - ~ ~te8 most of the venous blood which drains from the myocardium into the right atrium.
In the normal heart, contraction and relaxation of the heart muscle (myocardium~ takes place in an organized fashion as electro-t~h~mir~l 8ignalg pasg sequentially through the myocardium from the atrial to the ven~r;~ r tissue along a well defined route which includes the Mi3-Purkinje system. Initial electric impulses are generated at the 3inuatrial ( SA) node and conducted to the atrioventricular (AV) node. The AV node lies near the 03tium of the coronary sinus in the interatrial septum in the right atrium.
The His-Purkinje system begins at the AV node and follow3 along the membranous interatrial septum to~ard the tricuspid valve through the atrioventricular septum and into the membranous interventricular septum. At about the middle of the interventricular septum, the His-Purkinje system 3plits into right and left branches which 3traddle the summit of the muscular part of the interventricular 3eptum.
Sometime3 Ahnnr~-l rhythm# occur in the heart which are referred to as arrhythmia. Por example, patients diagnosed with Wolff-Parkinson-White syndrome have an arrhythmia, the cause of which is believed to be the existence of an anomalous conduction pathway or pathway3 that connect the atrial muscle tissue directly to the ventricular muscle tis3ue, thus by-pas3ing the normal Hi3-Purkinje system. The~e pathways are usually located in the fibrou3tis3uc that connect the atrium and the ventricle.
Another arrhythmia is ventricular tachycardia t "VT" ) . VT is a disease of the heart in which the heart ' s normal arrhythmic contractlon i8 altered. Frequently, the rate of heart beat is too f ast although the conditions of the disease itself are generally quite complex. VT occurs most often in patients following a myocardial infarction. A myocardial infarction, commonly referred to as a heart attack, is a 1088 of blood to a region of the heart causing the myocardial tissue in that region to die and be replaced by an area of scar tissue known as a myocardial infarct.
Frequently, the myocardial infarct is present in the left ventricle .
As _ reYult of the myocardial infarct, circular pathways ( reentry circuits ) are f requently created within the lef t ve~tricle for the conduction of the electrical impulse3 of the heart. These reentry circuits cause the electrical impulses of the heart to travel in circle# about the myocardial infarct, frequently causing an erratic and sometimes accelerated beating of the heart.
These reentry circuits may also occur around discreet element# of the heart, ~uch as valves. In addition, the reentry circuits ~ometime occur around both the myocardial infarct and the discreet elements of the heart.
In the past VT has been treated by the use of drugs ~uch as li~nnAin~ q~ini-linl~ and prQci~in~mi~ . ~ore recently, beta-blocking drugs have been used f or its treatment . In cases where 21 ~303 drug therapy has been ineffective, surgical procedure3 have been used to excise the tis5ue causing the arrhythmia. The treatment involves one of a combination of ~locc:duLes such as Gerard G~i r~ s Full Encircling Endocardlal Ventriculotomy (FEEV), Re8ection (removal of electrically ~hnorr-l tissue) and Peeling (shaving off layers of Ahnt~r~--l endocardlal tissue, until only healthy tissue is exposed). Obviously such procedures are high risk, frequently requiring prolonged periods of hospitalization and recuperation. As an alternative to the3e procedures, cathèters have been used for the ~ nos~ ~ and treatment of cardiac arrhythmias inrl~7~1in~ spe~ifi~lly, VT. See, for example, U.S.
Patent No. 5,222,501.
ndividual applications of ablation energy are f requently lln~v~ceggful at breaking up the reentrant circuit, and the energy applications may have to be repeated several times. This may be because the tip is not positioned correctly at the beginning of the energy application or that the catheter tip moves during the attempted ablation. Another problem can be that even though the tip electrode is located correctly, there may not be enough contact pressure between the tissue and the electrode to facilitate 8~f~ i.ont current to flow through the tissue to properly affect said tissue. This is especially true in the very thick ventricular tissue where the offending tissue may be deep within the myocardium or even epicardial. The procedure may be very time consuming. It may require catheter f.,~hi3nq,-~ to replace a defective or inappropriately selected catheter. Advancing the catheter through ~ . 21533~3 the vasculature to the aortic arch into the LV and mapping to find the appropriate location is very rli~fir~ t with the unaided catheter. To effectively ablate the ventricular tiaaue, the ablation catheter must be po3itioned precisely wLthin the ventricle and maintained in contact with the ventricular tis~ue throughout the energy application. Such procedure3 may require the ablation electrode of the ablation catheter to remain in contact with the ventricular tissue for an extended period of time, well over a minute. This iB particularly difficult when the heart ia beating, sometimes irregularly, during the entire ablation pluoedu e. Thus, it is critical that the ablation electrode be maintained at the desired location and also be constrained from movement relative to the tis~ue being ablated throughout the energy application.
Currently the most common approach to the positioning of an ablation catheter in the left ventricle for ablation procedures is to introduce the catheter into the femoral artery using a standard introducer and advance it toward and through the aorta, acros 8 the aortic valve into the left ventricle and then position the electrode of the catheter adjacent to the wall of the left ventricle which is near the reentry circuita. Tllis is commonly referred to as the "retrograde' approach. Specific locations are choaen ~or the mapping or ablation of the ventricular tissue, including apecifically locations on the lateral freewall, posterior freewall, septal wall and anterior freewall.
Mere introduction of the ablation and mapping catheter into the left ventricle for a retrograde ap~roach ia n~t suficient to 21~33~3 effectively and ~f~iri~ntly perform the ablation procedures on the reentry circuits. The medical practitioner commonly monitors the introduction of the catheter and its progress through the vascular system by a fluoroscope. Such fluoro3copes can not easily identify the specific features of the heart in general, and the ~riticAlly important structures of the left ventricle in specific, thus making placement of the ablation electrode difficult. This pl i~ t is e~pP~ l ly difficult ag the beating heart is in motion. In addition, the catheter will be moving within the left ventricIe as blood is being pumped through the heart throughout the ~Luc:edule.
Also, the aortic valve continues to open and clo3e placing additional strain and pressures on the catheter. Further, because of the difficulty of properly locating the catheter, extended exposure to fluoroscopy may be inevitable. Ilowever, such excessive exposure is certainly undesirable.
The guiding introducer system of the instant invention addresses and solves these problems. Referring now to Figures 2A, 2B, 3A and 3B, the guiding introducer ~ystem of the present invention for use in the left ventricle for the treatment of VT i8 comprised of an inner and an outer guiding introducer. The inner guiding introducer is preferably longer than the outer guiding introducer 80 that its distal end may be extended out from the distal end of the outer guiding introducer to form various curves and shapes. In usc, the inner guiding introducer i3 inserted into the outer guiding introducer until the distal end of the inner guiding introducer extends out from the distal end of the outer ~ ~ 21,~3~3 guiding introducers. The inner and outer guiding introducers are generally each comprised of two section~. (Each section is preferably formed as an integral portion of the entire guiding introducer without discrete divisiona. I~owever, the division of each of the guiding introducers into two different sections for discussion better illustrates the overall 3hape of the guiding introducer3. ) Each of the guiding introducer3 will be 3hown in two views. In each of the views for ease of analysis, the inner and outer guiding introducer will be secured to a valve for attachment to a conventional ~ide port tubing and stop cock. In each ~uch arrangement, the shape of the inner or outer gulding introducer and each of it3 3ections will be de3cribed, making reference to its position in relation to the side port and side port tubing, where the proximal end of the inner and outer guiding introducer i~3 Recured to the side port tubing. In the first referenced figure (Figures 2A and 3A), the side port tubing is generally viewed as if it i# behind the first section of the inner or outer guiding introducer. The l -~nin~ figureR (Figures 2B and 3B) will show the inner or outer guiding catheter af ter clockwise rotation about the axis of the first section of the inner or outer guiding introduccr when viewed from the perspective of the proximal end of the re~pective guiding introduaer#.
The first section of the inner guiding introducer~ i~ a conventional, elongated, hollow, generally straight section of sufficient length for introduction into the patient and for manipulation from the point of insertion to the 13pecific deRired 21 ~33D3 location within the heart . ( The overall length of the f irst section as ~hown in the figures has been reduced for ease of viewing. ) Merged with the distal end of the first section of the inner guiding introducer is the second section which is a smooth, generally flat curve, curving to the left as shown in Figure 2A.
The curve of Eigure 2A has a radius of from about 0 . 5 in. to about 1. 5 in . and pref erably f rom about 0 . 7 in . to about 1. 3 in . The extent of the arc of the curve iB from about 45 to about 135 degrees and preferably from about 60 to about 120 degrees of arc, ending in the distal tip of the inner guiding introducer. Although this second section is preferably a single curve, alternatively two or more separate curved sections each with the same or different curvatures and radii can be used alone or Ln combinatLon with one or more straight sections as long as the combination of separate curves and straight sections creates generally the same overall curvature of this second section of about 45 to about 135 degrees, and preferably from about 60 to about 120 degrees. The first and second sections are prefera~ly coplanar (within about 15 degrees of coplanar ) .
The outer guiding introducer (Figures 3A and 3B) is designed f or use with the inner guiding introducer in the treatment of lef t ventricular tachycardia in the lef t ventricle . The outer guiding introducer is also divided into two separate sections. q'he first section Ls a conventional, generally elongated, hollow, straight section of sufficient length for Lntroduction into the patient and ~, 2~S~3 for ~-nirlllAtion from the point of insertion to the specific desired location within the heart. ~erged with the distal end of the first section of the outer guiding introducer is the second section which i3 comprised of a curved section, curving to the left as shown in Figure 3A. The curve of Figure 3A has a radius of ab~ut 1.0 to about 2.0 in. and preferably from about 1.3 to about 1. 7 in. The extent of the arc of the curve is from about 135 to 225 degrees, and preferably from about 160 to about 200 degrees ending in the distal tip of the outer guiding introducer. A8 with the inner guLding introducer, the arc of the curve is preferably a single curve, although alternatively two or more curved sections, each with the same or different curvatures and radii which may also incorporate one or more straight sections, can ~e used in combination as long as the combination of separate curvatures, radii and straight sections creates the same overall curvature of the second section of about 135 to about 225 degrees and preferably from about 160 to about 200 degrees. The first and second sections are prefera~ly coplanar (within about 15 degrees of coplanar).
The distal tip of the inner and outer guiding introducer may be, and preferably will be, tapered to form a good transition with a dilator. This tapering is preferably less than 10 and more pref erably about 4 to about 7 . The inner and outer guiding introducers preferably also contain one or a multitude of radiopaque tip marker bands near the distal tip of the inner and outer guiding introducers. These inner and outer guiding introducers also preferably contain one or a plurality of vents 21~33~3 near the distal tip of the inner and outer guiding introducers, preferably three or four such vents. The vents are preferably located no more than about 1.00 in. from the distal tip of the inner and outer guiding introducer and more preferably 0 . lO to about 1.00 in. from the distal tip. The size of these vent3 ahould be in the range of about 40 to about 60/1000 of an inch in diameter. The~e vents are designed to prevent air from entering the guiding introducer system caused by the withdrawal of the catheter contained within the inner guiding introducer in the event the distal end of the guiding introducer system is occluded. For example, if the tip of the inner or outer guiding introducer is placed against the myocardium and the catheter located within the guiding introducer is withdrawn, a vacuum may be created within the guiding introducer system if no vents are provided. If sucll vacuum i3 formed, air may be forced back into the guiding introducer sy~tem by the reintroduction of a catheter into the lumen of the inner guiding introducer . Such air could cause signif icant problems in the patient, including the possibitlity of a stroke, heart attack or other such problems common with air embolisms. The addition of vents near the distal tip of the inner and outer guiding introducers prevents the ~ormation of such vacuum by permitting fluid, presumably blood, to be drawn into the lumen of the inner and outer guiding introducer as the catheter is being removed from the inner guiding introducer, thus preventing the creation of a vacuum which could cause air to enter the guiding introducer system.
21~33~3 The inner and outer guiding introducers may be made of any material 3uitable for u3e in humans which ha~ a memory or permit3 distortion from, and substantial return to, the desired three dimen3ional 3hape. For the purpose o illu3tration and not limitation, the internal diameter of the inner and outer guiding introducer may vary from about 6 to about 12 "French" re3pectively ( 1 French equal3 1/3 of a m; 11 i l.er) . Such inner and oùter guiding introducer3 can also accept dilator3 and approprLate guidewires. Obviously, if larger or ~maller dilators or catheters are u3ed in conjunction with the guiding introducer system of the instant invention, ';fi~ations in size or shape can be made to the inner and outer guiding introducers.
Variation3 in size and shape of t~le inner and outer guiding introducers are al30 intended to F.n~ pediatrlc uses, although the preferred use~ are for adult human hearts. It is well recognized that pediatric uses may require reductions in size of the various sections of the inner and outer guiding introducer, in particular the fir~t section, but without any ~l~nif~ nt ---'ifi~ ation to the 3hape or curve of the inner and outer guiding introducer .
In addition, variation~ in size or shape of the inner and outer guiding introducers are al~o intended to ~nr~ the specialized 3ituations that sometimes occur in patients with enlarged or rotated hearts.
sy extending the di~tal tip of the inner guiding introducer away from the di3tal tip of the outer guiding introducer and by . ~ 2~33~3 rotating the inner guiding introducer with respect to the outer gulding introducer, a variety of ahapes of the overall guiding introducer system are formed which are helpful in directing the mapping and/or ablating catheter toward the site within the lef t ventricle of interest. These shapes permit ablation procedures within the left ventricle to be p2rformed, for example, located on the lateral freewall, posterior freewall, septal freewall and anterior freewall. See Figures lA and lB. The various locations can be treated by extendlng the inner guiding introducer away f rom the outer guiding introducer which forms a different overall shape and/or by rotating the inner guiding introducer with respect to the outer guiding introducer. In addition, by Tn~nirulAtion of the inner guiding introducer within the outer guiding introducer, additional procedures can be performed within the left ventricle.
Being able to extend the inner guiding introducer within the outer guiding introducer and to rotate the inner guiding introducer within the outer guiding introducer permits a wide variety of overall shapes, which i5 particularly useful to medical practitioners. The medical practitioner ia able to determine the relative location of the inner and outer guiding introducers because of the tip markers located near the distal tip of both the inner and outer guiding introducers.
The relative diameter of the outer guiding introducer in relation to that of the inner guiding introducer should be sufficient to permit the inner guiding introducer to be torqued or rotated within the outer guiding introducer without undue 21~303 restriction on such - v~ t. Preferably, the difference in size between the inner and outer guiding introducer should be at least about 3 French. For example, in one preferred ~ , the outer guiding introducer is 11 French in size and the inner guiding introducer i8 8 French. By this dlfference in diameterl there is approximately 1 French unit of space available between the outer surface of the inner guidiug introducer and the inner surface of the outer guidiug introducer. Preferably, this space between the inner and outer guiding introducer is filled with a biocompatible solution, such a3 a saline solution, preferably a heparinized 3aline solution. Thi~ ~aline solution al~o provides lubricity to the inner and outer guiding introducers, allowing more accurate torquing of the inner guiding introducer within the outer guiding introducer. In addition, it is preferablc that the structure of both the inner and the outer guiding introduccr have a high torsional constant to allow for the full utilization of the various shapes available by rotation and extension of the inner guiding introducer in relation to the outer guiding introducer. To permit this high torsional constant, in one preferred embodiment the inner guiding introducer i~ braided to provide further strength and structural stability.
In operation, a 'ifi.~CI Seldinger technique is normally used f or the insertion of the catheter into the f emoral artery . The appropriate vessel is accessed by needle puncture. A soft flexible tip of an appropriately sized guidewire is then inserted through and a short distance beyond the needle into the vessel. Firmly 2~33~3 holding the guidewire in place, the needle i8 removed. The guidewire is then advanced through the artery up to the aorta, acroGs the aortic valve into the left ventricle. With the guidewire ln place, a dilator i6 then placed over the guidewire with the guiding introducer system placed over the dilator. The dilator and guiding introducer system g~n~rAl ly form an assembly to be advanced together along the guidewire into the lef t ventricle .
After insertion of the assembly, the guidewire and dilator are then withdrawn. The catheter to be used for treatment of let ventricular tachycardia i6 advanced through the lumen of the inner guiding introducer and is placed at an appropriate ln~ ion in the left ventricle.
sy extending and withdrawing the inner guiding introducer in relation to the outer guiding introducer and by rotating the inner guiding introducer within the outer guiding introducer, variances in the overall 6hape and location of the guiding introducer s~rstem can be achieved.
sy v, ~ of the inner guiding introducer within the outer guiding introducer in conjunction with fluoro3copic viewing, the distal portion of the outer guiding introducer can be manipulated to direct the distal end of a catheter placed within the lumen of the inner guiding introducer to a specific internal surface within the left ventricle. In addition, by providing ~ufficient rigidity, the distal end of the inner guiding catheter can be maintained in that fixed location or surface position of the endocardial 6tructure to permit the appropriate procedures to be per~ormed. If 21 5~303 3ensing procedures are involved, the guiding introducer system is maneuvered to the desired location. At that point, the electrical activity of the heart p~r~ r to that location can be precisely determined by use of an electrophy3iology catheter placed within the guiding introducer system. Further, as the guiding introducer system permit3 precLse location of catheters, an ablation catheter may be placed at a precise location for de3truction of the cardiac tissue by the use of energy, for example, radio frequency, thermal, laser or direct current (high energy direct, low energy direct and fulgutronization procedures). Preferably, r~dio frequency energy is utilized f or the ablation procedure .
The preci6e placement of the ablation catheter electrode is important as there will be no dilution of the energy delivered due to unfocused energy being dis3ipated over the entire cardiac chamber and lost in the oirculating blood by a constantly moving tip of the ablating catheter. This sy3tem permit3 a 3ignificantly reduced amount of energy to be applied while 3till achieving efficient ablation. Further, time used to perform the procedure i3 Ri~n i f i rAntly reduced over procedures where no guiding introducer system is used. This reduction in time al~o reduces the amount of fluorosoopy that iB necessary for the procedure. The precise rl ar~ L of the ablation catheter within the lef t ventricle is particularly important because of the ~iffirllties associated with the ablation of lef t ventricular tachycardia .
Ablation procedures for the treatment of tachycardia in the left ventricle may require ~nifi--~ntly longer time because the 2~
~1 S33~3 ~all of the left ventricle Ls ~i~nifjcAntly thicker than other tissue in the heart. It has been determined that the time of ablation must be 3ubstantially lengthened to achieve not only two dimensional ablation but al30 the three ~ n5~l ablation that is nPcp~ry for the ablation of left ventricular tissue. Thus, not only is the precise location of the ablation electrodc necessary, but continuous contact of the ablation electrode with the left ventricle is also necessary. Larger or longer electrodes of the ablation catheter may be nerP~Ary to achieve efficient and effective blation. Furthcr, other types of energy than radio frequency may be neces~ary for the extensive ablation necessary for the elimination of the location within the ventricle.
It will be apparent from the foregoing that while particular forms of the invention have been illustrated and r1P~rr;hedr various -rl;firationg can be made without departing from the ~pirit and scope of the invention. Accordingly, it is not intended that this invention be limited except as by the ~rpPn~lPrl claims.
Claims (27)
1. A process for the treatment of ventricular tachycardia within the left ventricle of the heart comprising (a) introducing into the left ventricle a guiding introducer system, comprising an inner and an outer guiding introducer, wherein each guiding introducer contains a lumen running lengthwise therethrough, a proximal and a distal end, (b) introducing the inner guiding introducer into the lumen of the outer guiding introducer, (c) introducing into the lumen of the inner guiding introducer an ablating or mapping catheter containing a proximal and distal end, wherein said catheter has one or more electrodes located at or near the distal end of the catheter, (d) guiding the catheter to a selected location within the left ventricle by use of the guiding introducer system, and (e) mapping or ablating the selected location within the left ventricle of the heart by use of the electrodes of the catheter.
2. The process of Claim 1 wherein the ablating utilizes one of the following sources of energy: direct current, including high energy direct current, low energy direct current or fulgutronization procedures, microwave, ultrasound, laser, and radio frequency.
3. The process of Claim 1 wherein the inner guiding introducer is comprised of a first and second section.
4. The process of Claim 3 wherein the first section of the inner guiding introducer is an elongated, hollow, generally straight section of sufficient length for introduction into the patient and for manipulation from the point of insertion through to a desired location within the heart.
5. The process of Claim 3 wherein the second section of the inner guiding introducer is a generally curved section with an overall radius of about 0.5 in. to about 1.5 in. and an overall arc from about 45 to about 135 degrees.
6. The process of Claim 3 wherein the second section of the inner guiding introducer is a curved section with a radius of about 0.8 in. to about 1.2 in. and an arc from about 60 to about 120 degrees.
7. The process of Claim 3 wherein the second section of the inner guiding introducer is a curved section with an overall arc, comprising one or more individual curved portions, wherein the overall arc is from about 45 to about 135 degrees.
8. The process of Claim 7 wherein one or more generally straight portions are incorporated with the one or more curved portions.
9. The process of Claim 1 wherein the outer guiding introducer is comprised of a first and second section.
10. The process of Claim 9 wherein the first section of the outer guiding introducer is an elongated, hollow, generally straight section of sufficient length for introduction into the patient and for manipulation from the point of insertion through to a desired location within the heart.
11. The process of Claim 9 wherein the second section of the outer guiding introducer is a generally curved section with an overall radius of about 1.0 in. to about 2.0 in. and an overall arc of the curve from about 135 to about 225 degrees.
12. The process of Claim 9 wherein the second section of the outer guiding introducer is a curved section with a radius of about 1.3 in. to about 1.7 in. and an arc of the curve from about 160 to about 200 degrees.
13. The process of Claim 9 wherein the second section of the outer guiding introducer is a curved section with an overall arc, comprising one or more individual curved portions, wherein the overall arc is from about 135 to about 225 degrees.
14. The process of Claim 9 wherein one or more generally straight portion are incorporated with the one or more individual curved portions of the curved section.
15. A guiding introducer system for use with an ablating catheter for the treatment of ventricular tachycardia in the left ventricle of the heart, comprising an inner and outer guiding introducer, wherein each contains a lumen running lengthwise therethrough, a proximal and a distal end.
16. The guiding introducer system of Claim 15 wherein the inner guiding introducer comprises a first and a second section.
17. The guiding introducer of Claim 16 wherein the first section is an elongated, hollow, generally straight section of sufficient length for introduction into the patient and for manipulation from the point of insertion through to a desired location within the heart.
18. The guiding introducer system of Claim 16 wherein the second section is a generally curved section with an overall radius of about 0.5 in. to about 1.5 in. and an overall arc from about 45 to about 135 degrees.
19. The guiding introducer system of Claim 16 wherein the second section is a curved section with a radius of about 0.8 in.
to about 1.2 in. and an arc of the curve from about 60 to about 120 degrees.
to about 1.2 in. and an arc of the curve from about 60 to about 120 degrees.
20. The process of Claim 16 wherein the second section is a curved section with an overall arc, comprising one or more individual curved portions, wherein the overall arc is from about 45 to about 135 degrees.
21. The process of Claim 20 wherein one or more generally straight portions are included with the one or more individual curved portions of the curved section.
22. The guiding introducer system of Claim 15 wherein the outer guiding introducer is comprised of a first and second section.
23. The guiding introducer system of Claim 22 wherein the first section of the guiding introducer is an elongated, hollow, generally straight section of sufficient length for introduction into the patient and for manipulation from the point of insertion through to a desired location within the heart.
24. The guiding introducer system of Claim 22 wherein the second section of the outer guiding introducer is a generally curved section with an overall radius of about 1.0 in. to about 2.0 in. and an overall arc from about 135 to about 225 degrees.
25. The guiding introducer system of Claim 22 wherein the second section is a curved section with a radius of about 1.3 in.
to about 1.7 in. and an arc from about 160 to about 200 degrees.
to about 1.7 in. and an arc from about 160 to about 200 degrees.
26. The guiding introducer system of Claim 22 wherein the second section is a curved section with an overall arc, comprising one or more individual curved portions, wherein the overall arc is from about 135 to about 225 degrees.
27. The guiding introducer system of Claim 26 wherein one or more generally straight portions are included with the one or more curved portions of the curved section.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/389,252 | 1995-02-16 | ||
| US08/389,252 US5722400A (en) | 1995-02-16 | 1995-02-16 | Guiding introducers for use in the treatment of left ventricular tachycardia |
| US08/422,702 | 1995-04-14 | ||
| US08/422,702 US5833673A (en) | 1994-11-02 | 1995-04-14 | Guiding introducer system for use in the treatment of left ventricular tachycardia |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2153303A1 true CA2153303A1 (en) | 1996-08-17 |
Family
ID=27012615
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002153303A Abandoned CA2153303A1 (en) | 1995-02-16 | 1995-07-05 | Guiding introducer system for use in the treatment of left ventricular tachycardia |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US5833673A (en) |
| EP (1) | EP0727236A1 (en) |
| JP (1) | JP3166597B2 (en) |
| CA (1) | CA2153303A1 (en) |
Families Citing this family (81)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6251104B1 (en) | 1995-05-10 | 2001-06-26 | Eclipse Surgical Technologies, Inc. | Guiding catheter system for ablating heart tissue |
| US6322548B1 (en) | 1995-05-10 | 2001-11-27 | Eclipse Surgical Technologies | Delivery catheter system for heart chamber |
| US6190379B1 (en) * | 1995-06-06 | 2001-02-20 | Sun Star Technology, Inc. | Hot tip catheter |
| WO1997026038A1 (en) * | 1996-01-19 | 1997-07-24 | Scimed Life Systems, Inc. | Increasing radius curve catheter |
| US5810746A (en) * | 1996-11-21 | 1998-09-22 | Daig Corporation | Guiding introducer for endomyocardial biopsy procedures |
| US6066126A (en) * | 1997-12-18 | 2000-05-23 | Medtronic, Inc. | Precurved, dual curve cardiac introducer sheath |
| US6200315B1 (en) | 1997-12-18 | 2001-03-13 | Medtronic, Inc. | Left atrium ablation catheter |
| US6464716B1 (en) | 1998-01-23 | 2002-10-15 | Innercool Therapies, Inc. | Selective organ cooling apparatus and method |
| US6096068A (en) * | 1998-01-23 | 2000-08-01 | Innercool Therapies, Inc. | Selective organ cooling catheter and method of using the same |
| US6261312B1 (en) | 1998-06-23 | 2001-07-17 | Innercool Therapies, Inc. | Inflatable catheter for selective organ heating and cooling and method of using the same |
| US6585752B2 (en) | 1998-06-23 | 2003-07-01 | Innercool Therapies, Inc. | Fever regulation method and apparatus |
| US6312452B1 (en) | 1998-01-23 | 2001-11-06 | Innercool Therapies, Inc. | Selective organ cooling catheter with guidewire apparatus and temperature-monitoring device |
| US6379378B1 (en) | 2000-03-03 | 2002-04-30 | Innercool Therapies, Inc. | Lumen design for catheter |
| US6231595B1 (en) | 1998-03-31 | 2001-05-15 | Innercool Therapies, Inc. | Circulating fluid hypothermia method and apparatus |
| US7371254B2 (en) | 1998-01-23 | 2008-05-13 | Innercool Therapies, Inc. | Medical procedure |
| US6325818B1 (en) | 1999-10-07 | 2001-12-04 | Innercool Therapies, Inc. | Inflatable cooling apparatus for selective organ hypothermia |
| US7291144B2 (en) | 1998-03-31 | 2007-11-06 | Innercool Therapies, Inc. | Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation |
| US6602276B2 (en) | 1998-03-31 | 2003-08-05 | Innercool Therapies, Inc. | Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation |
| US7001378B2 (en) * | 1998-03-31 | 2006-02-21 | Innercool Therapies, Inc. | Method and device for performing cooling or cryo-therapies, for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation employing tissue protection |
| US6685732B2 (en) | 1998-03-31 | 2004-02-03 | Innercool Therapies, Inc. | Method and device for performing cooling- or cryo-therapies for, e.g., angioplasty with reduced restenosis or pulmonary vein cell necrosis to inhibit atrial fibrillation employing microporous balloon |
| US6338727B1 (en) | 1998-08-13 | 2002-01-15 | Alsius Corporation | Indwelling heat exchange catheter and method of using same |
| US7128073B1 (en) | 1998-11-06 | 2006-10-31 | Ev3 Endovascular, Inc. | Method and device for left atrial appendage occlusion |
| US7044134B2 (en) | 1999-11-08 | 2006-05-16 | Ev3 Sunnyvale, Inc | Method of implanting a device in the left atrial appendage |
| US6371955B1 (en) * | 1999-08-10 | 2002-04-16 | Biosense Webster, Inc. | Atrial branding iron catheter and a method for treating atrial fibrillation |
| US6994092B2 (en) | 1999-11-08 | 2006-02-07 | Ev3 Sunnyvale, Inc. | Device for containing embolic material in the LAA having a plurality of tissue retention structures |
| US6650923B1 (en) | 2000-04-13 | 2003-11-18 | Ev3 Sunnyvale, Inc. | Method for accessing the left atrium of the heart by locating the fossa ovalis |
| US7056294B2 (en) * | 2000-04-13 | 2006-06-06 | Ev3 Sunnyvale, Inc | Method and apparatus for accessing the left atrial appendage |
| US6719723B2 (en) | 2000-12-06 | 2004-04-13 | Innercool Therapies, Inc. | Multipurpose catheter assembly |
| US6450987B1 (en) | 2001-02-01 | 2002-09-17 | Innercool Therapies, Inc. | Collapsible guidewire lumen |
| US7588568B2 (en) | 2002-07-19 | 2009-09-15 | Biosense Webster, Inc. | Atrial ablation catheter and method for treating atrial fibrillation |
| US20040220461A1 (en) * | 2003-04-29 | 2004-11-04 | Yitzhack Schwartz | Transseptal facilitation using sheath with electrode arrangement |
| US8801746B1 (en) | 2004-05-04 | 2014-08-12 | Covidien Lp | System and method for delivering a left atrial appendage containment device |
| US20050273096A1 (en) * | 2004-05-27 | 2005-12-08 | Roop John A | Anchoring introducer sheath with distal slots for catheter delivery and translation |
| US8273285B2 (en) | 2005-01-10 | 2012-09-25 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Steerable catheter and methods of making the same |
| EP1887981A2 (en) * | 2005-06-09 | 2008-02-20 | The University Of Miami | Papillary muscle attachement for left ventricular reduction |
| US7972359B2 (en) | 2005-09-16 | 2011-07-05 | Atritech, Inc. | Intracardiac cage and method of delivering same |
| US20070299403A1 (en) * | 2006-06-23 | 2007-12-27 | Crowe John E | Directional introducer |
| DE102007043830A1 (en) | 2007-09-13 | 2009-04-02 | Lozonschi, Lucian, Madison | Heart valve stent |
| US8388549B2 (en) | 2008-12-29 | 2013-03-05 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Anatomical thermal sensing device and method |
| US8317810B2 (en) | 2008-12-29 | 2012-11-27 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Tissue puncture assemblies and methods for puncturing tissue |
| EP2509538B1 (en) | 2009-12-08 | 2017-09-20 | Avalon Medical Ltd. | Device and system for transcatheter mitral valve replacement |
| US8696620B2 (en) | 2010-07-30 | 2014-04-15 | St. Jude Medical, Atrial Fibrillation Division, Inc. | Catheter with a mechanism for omni-directional deflection of a catheter shaft |
| CA2957442C (en) | 2011-08-11 | 2019-06-04 | Tendyne Holdings, Inc. | Improvements for prosthetic valves and related inventions |
| US9827092B2 (en) | 2011-12-16 | 2017-11-28 | Tendyne Holdings, Inc. | Tethers for prosthetic mitral valve |
| WO2014022124A1 (en) | 2012-07-28 | 2014-02-06 | Tendyne Holdings, Inc. | Improved multi-component designs for heart valve retrieval device, sealing structures and stent assembly |
| WO2014021905A1 (en) | 2012-07-30 | 2014-02-06 | Tendyne Holdings, Inc. | Improved delivery systems and methods for transcatheter prosthetic valves |
| US10463489B2 (en) | 2013-04-02 | 2019-11-05 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
| US9486306B2 (en) | 2013-04-02 | 2016-11-08 | Tendyne Holdings, Inc. | Inflatable annular sealing device for prosthetic mitral valve |
| US11224510B2 (en) | 2013-04-02 | 2022-01-18 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems and methods for delivering the same |
| US10478293B2 (en) | 2013-04-04 | 2019-11-19 | Tendyne Holdings, Inc. | Retrieval and repositioning system for prosthetic heart valve |
| US9610159B2 (en) | 2013-05-30 | 2017-04-04 | Tendyne Holdings, Inc. | Structural members for prosthetic mitral valves |
| CN108814772B (en) | 2013-06-25 | 2020-09-08 | 坦迪尼控股股份有限公司 | Thrombus management and structural compliance features for prosthetic heart valves |
| AU2014296087B2 (en) | 2013-08-01 | 2019-08-01 | Tendyne Holdings, Inc. | Epicardial anchor devices and methods |
| WO2015058039A1 (en) | 2013-10-17 | 2015-04-23 | Robert Vidlund | Apparatus and methods for alignment and deployment of intracardiac devices |
| EP3656353A1 (en) | 2013-10-28 | 2020-05-27 | Tendyne Holdings, Inc. | Prosthetic heart valve and systems for delivering the same |
| US9526611B2 (en) | 2013-10-29 | 2016-12-27 | Tendyne Holdings, Inc. | Apparatus and methods for delivery of transcatheter prosthetic valves |
| WO2015120122A2 (en) | 2014-02-05 | 2015-08-13 | Robert Vidlund | Apparatus and methods for transfemoral delivery of prosthetic mitral valve |
| US9986993B2 (en) | 2014-02-11 | 2018-06-05 | Tendyne Holdings, Inc. | Adjustable tether and epicardial pad system for prosthetic heart valve |
| CN106068109B (en) | 2014-03-10 | 2019-07-23 | 坦迪尼控股股份有限公司 | Device and method for positioning and monitoring the tether load of prosthetic mitral valve |
| JP6826035B2 (en) | 2015-01-07 | 2021-02-03 | テンダイン ホールディングス，インコーポレイテッド | Artificial mitral valve, and devices and methods for its delivery |
| CN107896484B (en) | 2015-02-05 | 2020-09-08 | 坦迪尼控股股份有限公司 | Expandable epicardial pad and delivery devices and methods therefor |
| JP6694948B2 (en) | 2015-04-16 | 2020-05-20 | テンダイン ホールディングス，インコーポレイテッド | Device and method for delivery, repositioning and retrieval of a transcatheter prosthetic valve |
| US10327894B2 (en) | 2015-09-18 | 2019-06-25 | Tendyne Holdings, Inc. | Methods for delivery of prosthetic mitral valves |
| CN108430391B (en) | 2015-12-03 | 2020-09-08 | 坦迪尼控股股份有限公司 | Frame features for prosthetic mitral valves |
| CN108366859B (en) | 2015-12-28 | 2021-02-05 | 坦迪尼控股股份有限公司 | Atrial capsular bag closure for prosthetic heart valves |
| US10470877B2 (en) | 2016-05-03 | 2019-11-12 | Tendyne Holdings, Inc. | Apparatus and methods for anterior valve leaflet management |
| WO2017218375A1 (en) | 2016-06-13 | 2017-12-21 | Tendyne Holdings, Inc. | Sequential delivery of two-part prosthetic mitral valve |
| CN109640887B (en) | 2016-06-30 | 2021-03-16 | 坦迪尼控股股份有限公司 | Prosthetic heart valve and apparatus and method for delivering same |
| EP3484411A1 (en) | 2016-07-12 | 2019-05-22 | Tendyne Holdings, Inc. | Apparatus and methods for trans-septal retrieval of prosthetic heart valves |
| US11432809B2 (en) | 2017-04-27 | 2022-09-06 | Boston Scientific Scimed, Inc. | Occlusive medical device with fabric retention barb |
| US11154399B2 (en) | 2017-07-13 | 2021-10-26 | Tendyne Holdings, Inc. | Prosthetic heart valves and apparatus and methods for delivery of same |
| JP7291124B2 (en) | 2017-08-28 | 2023-06-14 | テンダイン ホールディングス，インコーポレイテッド | Heart valve prosthesis with tethered connections |
| WO2019195282A1 (en) | 2018-04-02 | 2019-10-10 | Cardiac Pacemakers Inc | Bundle of his lead delivery catheter, system and method |
| CN112714632A (en) | 2018-08-21 | 2021-04-27 | 波士顿科学医学有限公司 | Barbed protruding member for cardiovascular devices |
| WO2021011694A1 (en) | 2019-07-17 | 2021-01-21 | Boston Scientific Scimed, Inc. | Left atrial appendage implant with continuous covering |
| CN114340516A (en) | 2019-08-30 | 2022-04-12 | 波士顿科学医学有限公司 | Left atrial appendage implant with sealing disk |
| EP3831343B1 (en) | 2019-12-05 | 2024-01-31 | Tendyne Holdings, Inc. | Braided anchor for mitral valve |
| US11648114B2 (en) | 2019-12-20 | 2023-05-16 | Tendyne Holdings, Inc. | Distally loaded sheath and loading funnel |
| US11903589B2 (en) | 2020-03-24 | 2024-02-20 | Boston Scientific Scimed, Inc. | Medical system for treating a left atrial appendage |
| US11951002B2 (en) | 2020-03-30 | 2024-04-09 | Tendyne Holdings, Inc. | Apparatus and methods for valve and tether fixation |
| WO2022039853A1 (en) | 2020-08-19 | 2022-02-24 | Tendyne Holdings, Inc. | Fully-transseptal apical pad with pulley for tensioning |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE390886B (en) * | 1975-06-23 | 1977-01-31 | Siemens Elema Ab | CATHETER FOR SELECTIVE CORONAR ARTERIOGRAPHY OF LEFT CORONAR SPECIES |
| US4033331A (en) * | 1975-07-17 | 1977-07-05 | Guss Stephen B | Cardiac catheter and method of using same |
| US4581017B1 (en) * | 1983-03-07 | 1994-05-17 | Bard Inc C R | Catheter systems |
| US4641649A (en) * | 1985-10-30 | 1987-02-10 | Rca Corporation | Method and apparatus for high frequency catheter ablation |
| EP0277366A1 (en) * | 1987-01-06 | 1988-08-10 | Advanced Cardiovascular Systems, Inc. | Guiding catheter assembly and method for making it |
| US4882777A (en) * | 1987-04-17 | 1989-11-21 | Narula Onkar S | Catheter |
| US5231994A (en) * | 1987-10-27 | 1993-08-03 | Dietrich Harmjanz | Hose or tubular guide catheter |
| US4810244B1 (en) * | 1987-12-17 | 1998-06-16 | Thomas C Allen | Trocar assembly for drawing fluids from a body part |
| US5016640A (en) * | 1988-01-06 | 1991-05-21 | Sherwood Medical Company | Angiographic catheter for use in the right coronary artery |
| US4883058A (en) * | 1988-01-06 | 1989-11-28 | Sherwood Medical Company | Right coronary angiographic method |
| US4935017A (en) * | 1988-04-29 | 1990-06-19 | C. R. Bard, Inc. | Variable shaped catheter system and method for catheterization |
| US4898591A (en) * | 1988-08-09 | 1990-02-06 | Mallinckrodt, Inc. | Nylon-PEBA copolymer catheter |
| US4945912A (en) * | 1988-11-25 | 1990-08-07 | Sensor Electronics, Inc. | Catheter with radiofrequency heating applicator |
| US5120323A (en) * | 1990-01-12 | 1992-06-09 | Schneider (Usa) Inc. | Telescoping guide catheter system |
| US5279546A (en) * | 1990-06-27 | 1994-01-18 | Lake Region Manufacturing Company, Inc. | Thrombolysis catheter system |
| US5172699A (en) * | 1990-10-19 | 1992-12-22 | Angelase, Inc. | Process of identification of a ventricular tachycardia (VT) active site and an ablation catheter system |
| EP0568624B1 (en) * | 1991-01-23 | 2001-10-04 | VODA, Jan | Guide catheter construction |
| WO1992019307A1 (en) * | 1991-04-24 | 1992-11-12 | Myers Gene E | Aortic branch internal thoracic artery catheter |
| US5304131A (en) * | 1991-07-15 | 1994-04-19 | Paskar Larry D | Catheter |
| US5290229A (en) * | 1991-07-15 | 1994-03-01 | Paskar Larry D | Transformable catheter and method |
| US5215540A (en) * | 1992-01-31 | 1993-06-01 | St. Jude Medical, Inc. | Right coronary catheter |
| US5222501A (en) * | 1992-01-31 | 1993-06-29 | Duke University | Methods for the diagnosis and ablation treatment of ventricular tachycardia |
| US5242441A (en) * | 1992-02-24 | 1993-09-07 | Boaz Avitall | Deflectable catheter with rotatable tip electrode |
| US5575766A (en) * | 1993-11-03 | 1996-11-19 | Daig Corporation | Process for the nonsurgical mapping and treatment of atrial arrhythmia using catheters guided by shaped guiding introducers |
| US5497774A (en) * | 1993-11-03 | 1996-03-12 | Daig Corporation | Guiding introducer for left atrium |
| US5628316A (en) * | 1993-11-03 | 1997-05-13 | Swartz; John F. | Guiding introducer system for use in the right atrium |
-
1995
- 1995-04-14 US US08/422,702 patent/US5833673A/en not_active Expired - Lifetime
- 1995-07-05 CA CA002153303A patent/CA2153303A1/en not_active Abandoned
-
1996
- 1996-02-14 EP EP96102203A patent/EP0727236A1/en not_active Withdrawn
- 1996-02-15 JP JP02813296A patent/JP3166597B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| US5833673A (en) | 1998-11-10 |
| JP3166597B2 (en) | 2001-05-14 |
| JPH08266551A (en) | 1996-10-15 |
| EP0727236A1 (en) | 1996-08-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US5833673A (en) | Guiding introducer system for use in the treatment of left ventricular tachycardia | |
| US7248913B2 (en) | Guiding introducer system for use in medical procedures in the left ventricle | |
| US5868733A (en) | Guiding introducer system for use in the treatment of accessory pathways around the mitral valve using a retrograde approach | |
| US5879296A (en) | Guiding introducers for use in the treatment of left ventricular tachycardia | |
| US6540755B2 (en) | Guiding introducers for use in the treatment of accessory pathways around the mitral valve using a retrograde approach | |
| US6203531B1 (en) | Guiding introducers for use in the treatment of accessory pathways around the mitral valve using a retrograde approach | |
| US5628316A (en) | Guiding introducer system for use in the right atrium | |
| US5564440A (en) | Method for mopping and/or ablation of anomalous conduction pathways | |
| US5846223A (en) | Diagnosis and treatment of atrial flutter in the right atrium | |
| EP0711573B1 (en) | Catheter guided by shaped guiding introducers for mapping the atria | |
| US5715818A (en) | Method of using a guiding introducer for left atrium | |
| US5814027A (en) | Guiding introducer used for medical procedures within the right ventricle associated with the right ventricular outflow track | |
| EP0738518A2 (en) | Guiding introducers used for medical procedures within the right ventricle associated with the tricuspid valve | |
| EP0737486A2 (en) | Guiding introducer used for medical procedures within the right ventricle associated with the right ventricular outflow track | |
| EP0745407B1 (en) | Guiding introducer for use in the treatment of atrial flutter | |
| EP0727238A2 (en) | Guiding introducer system for use in the treatment of accessory pathways around the mitral valve using a retrograde approach | |
| WO1999025411A1 (en) | Catheter guiding introducers for use in pediatric hearts |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |