Patent Abstract:
The present tool and methods embody a percutaneous transluminal ablation (PTA) catheter manipulation tool for holding and positioning a PTA catheter, comprising a handle portion and a PTA catheter support structure. The PTA catheter is securely held in the PTA catheter support structure and the user holds the handle portion to position the PTA catheter against the treatment site. In one embodiment, the tool is made from a rigid material. In another embodiment, the PTA catheter support structure and/or the handle portion are made from a malleable material to facilitate forming to a desired shape. After treating one site, the tool may then be bent to a new desired configuration to treat the same or additional sites. In another embodiment, the PTA catheter manipulation tool incorporates, either internally or externally, a fluid delivery system that provides fluid to cool the PTA catheter support structure and/or the treatment site. In another embodiment, the support structure is pivotally mounted such that when pressed against the treatment site, the support structure will automatically position itself flush with the surface being treated.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATION(S) 
     This application is a continuation of U.S. patent application Ser. No. 09/348,776, filed on Jul. 7, 1999 is now U.S. Pat. No. 6,364,878, the specification of which is hereby incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The present description generally relates to medical tools and methods, and more particularly, a percutaneous transluminal ablation catheter holding tool and method of use. 
     BACKGROUND 
     Percutaneous transluminal ablation (PTA) catheters for tissue ablation are available for the treatment of many conditions of the heart, including atrial fibrillation, atrial and ventricular arrhythmias or dysfunction, as well as others. The PTA catheters are long, slender, and flexible such that they can be inserted through a small incision through the skin into a blood vessel, such as an artery or vein, and advanced to the treatment site near to or inside the heart. Once positioned, the PTA catheter is used to selectively ablate or “burn” selected tissue which results in a change in the physiology of the treatment site. Such treatments may be used to block electrical conduction to correct abnormal cardiac rhythm that interferes with proper organ function. 
     Since its initial description in 1982, catheter ablation has evolved from a highly experimental technique to its present role as first-line therapy for most supraventricular arrhythmias, including atrioventricular nodal reentrant tachycardia, Wolff-Parkinson-White syndrome, focal atrial tachycardia, and atrial flutter. Over the past five years, increasing attention has been focused on the development of catheter ablation techniques and ablation systems to cure atrial fibrillation. J. F. Swartz, et al., is credited with being the first to demonstrate that chronic atrial fibrillation can be cured using catheter ablation techniques (Swartz J F, Perrersels G, Silvers J, Patten L, Cervantez D., A Catheter Based Curative Approach to Atrial Fibrillation in Humans, Circulation. 1994; 90 (suppl 1): 1-335). These authors reported that creation of linear lesions in the right and left atrium results in a progressive increase in the organization of atrial activity until sinus rhythm is restored. M. Haissaguerre, et al., reported successful ablation of atrial fibrillation in a patient with paroxysmal atrial fibrillation by the creation of three linear lesions in the right atrium, two longitudinal and one transverse, that connected the two longitudinal lesions using a specially designed catheter (Haissaguerre M, Gencel L, Fischer B, Metayer P L, Poquet F, Marcus FI, Clementy J., Successful Catheter Ablation of Atrial Fibrillation, J Cardiovasc Electrophysiol 1994;5:1045-1052). 
     Currently available ablation systems are limited because they can only create singular spot lesions or short drag lesions, requiring a significant amount of time to perform biatrial lesions. Systems that can create linear lesions are currently undergoing investigation at this time and hold exciting promise for the future. One such system currently under clinical investigation is the Guidant&#39;s Heart Rhythm Technology&#39;s (HRT; Guidant Corporation, Cardiac Rhythm Management Group, St. Paul, Minn.) Linear Phased Radio Frequency Ablation System consisting of a 7 Fr., 5-mm tipped quadripolar deflectable electrode catheter and multiple pre-shaped steerable linear catheters which incorporate 12-3-mm platinum band electrodes with an inter-electrode spacing of 4 mm. Thermocouples are positioned on the outside curvature of the catheter to allow for temperature monitoring during radio frequency (RF) delivery. A variety of 3-dimensional catheter shapes, are designed to be used in conjunction with sheaths to achieve specific linear lesions within the right and left atria. The pre-shaped steerable linear catheters are created by means of a pre-shaped Nitinol stylet embedded within the shaft. These catheters are used in conjunction with the Guidant HRT Linear Phased RF Ablation Generator, which is a multi-channel RF generator capable of delivering phased RF energy at a frequency of 540 kHz to selected electrodes, in order to modify the lesion length, from localized, spot lesions to lesions which are 8 cm in length. When using the multi-electrode catheters, by delivering RF energy at adjacent electrodes out of phase with each other, a voltage gradient is created between electrodes and also to the back plate. This results in current paths both between electrodes and also to the return electrode (back plate), thereby creating a continuous linear lesion. The generator has the ability to continuously monitor the impedance and temperature of each active band electrode. Power output for pre-shaped linear catheters can be varied from 0 to 20 Watts per electrode. Power delivery is in the form of a duty cycle with a constant output amplifier with power variability controlled by varying the amount of time energy is delivered. This approach to power delivery allows for electrode cooling during the off cycle. Adjustments in the power output can be made to all electrodes at once or in three zones of four electrodes each. The generator incorporates additional safety features if excessive temperature or impedance is detected. The generator automatically shuts down power delivery to any band electrode if the impedance of that circuit exceeds a pre-set limit, or if the temperature exceeds a preset value. For the 5-mm tip ablation catheter, the RF generator will deliver RF energy with a maximal power output of 50 Watts to the tip only, while continuously monitoring the impedance and temperature of the tip electrode. Ablation duration can be adjusted from 5 seconds to 5 minutes. 
     Successful ablation therapy is defined as a return to normal sinus rhythm. To achieve this, lesions need to be continuous, transmural, and connected with other lesions or anatomical structures that cause blockage of atrial conduction. The seven recommended lesions are as follows: 1) right atrial isthmus ablation: linear lesion applied to the right atrium between the tricuspid annulus and the eustachian ridge, 2) right atrial inter-caval ablation: linear lesion applied along the posterior wall of the right atrium, between the superior vena cava and the inferior vena cava, 3) right pulmonary vein ablation (RPV): linear lesion applied to the left atrium, beginning below Bachmann&#39;s bundle, across the right superior pulmonary vein (RSPV) to the right inferior pulmonary vein (RIPV) and adjoining the mitral annulus, 4) left pulmonary vein ablation (LPV): linear lesion applied to the left atrium, beginning below Bachmann&#39;s bundle, across the left superior pulmonary vein (LSPV) to the left inferior pulmonary vein (LIPV) and reaching the mitral annulus, 5) superior pulmonary vein ablation (SPV): linear lesion applied to the left atrium, across the right superior pulmonary vein to the left superior pulmonary vein, 6) left atrial roof ablation (ROOF): linear lesion applied from the trigone, across the roof of the left atrium, to the left superior pulmonary vein, and 7) left atrial septal ablation (SEP): linear lesion applied to the foramen ovale to the right superior pulmonary vein. During creation of the right atrial inter-caval line, pacing is performed from each pair of electrodes at high output to assure the absence of diaphragmatic stimulation. 
     PTA catheters use any of a number of methods to deliver ablative energy to the tissue. Some of these methods include electric heating, microwave radiation, ultrasound radiation, and cryogenics. The energy delivery component of the PTA catheter, sometimes referred to as an electrode, is located either at the distal tip or along a portion of the distal end of the PTA catheter. When the PTA catheter is advanced through the blood vessel to the treatment site, either the tip or the side of the PTA catheter, depending on electrode type, is pressed against the tissue to be ablated. 
     There is a need to have the capability to apply ablation therapy non-transluminally, such as during open heart surgery, on either epicardium or endocardium. For example, some patients having surgery for the treatment of atrioventricular valve disease would benefit from ablation therapy in order to correct cardiac arrhythmias of the atria or ventricle. Up to 40% of patients requiring mitral valve replacement have concurrent atrial fibrillation (fast atrial arrhythmia) which can be treated by creation of long linear ablation lines in the atria. Since PTA catheters are currently available, there is a need to use PTA catheters non-transluminally. 
     SUMMARY 
     In general, the present tool and methods embody a percutaneous transluminal ablation (PTA) catheter manipulation tool for holding and positioning a PTA catheter, comprising a handle portion and a PTA catheter support structure. The PTA catheter is securely held in the PTA catheter support structure and the user holds the handle portion to position the PTA catheter against the treatment site. In one embodiment, the tool is made from a rigid material. In another embodiment, the PTA catheter support structure and/or the handle portion are made from a malleable material to facilitate forming to a desired shape. After treating one site, the tool may then be bent to a new desired configuration to treat the same or additional sites. In another embodiment, the PTA catheter manipulation tool incorporates, either internally or externally, a fluid delivery system that provides fluid to cool the PTA catheter support structure and/or the treatment site. In another embodiment, the support structure is pivotally mounted such that when pressed against the treatment site, the support structure will automatically position itself flush with the surface being treated. 
     This summary is a brief overview of some embodiments of the tool and methods of using a PTA catheter manipulation tool for holding and positioning a PTA catheter and is not intended to be exclusive or limiting and the scope of the invention is provided by the attached claims and their equivalents. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of one embodiment of an ablation PTA catheter manipulation tool. 
     FIG. 2 is a perspective view of one embodiment of an ablation PTA catheter manipulation tool with PTA catheter attached. 
     FIG. 3A is a cross-sectional view of one embodiment of an PTA catheter manipulation tool PTA catheter support structure with PTA catheter attached. 
     FIG. 3B is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with cooling capability, with PTA catheter attached. 
     FIG. 3C is a perspective view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with cooling capability. 
     FIG. 4A is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with PTA catheter attached. 
     FIG. 4B is an end view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure. 
     FIG. 4C is cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with suturable lips. 
     FIG. 4D is cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with hold-down members and loops. 
     FIG. 4E is a perspective view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with hold-down members. 
     FIG. 4F is a perspective view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with hold-down member. 
     FIG. 5A is an end view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with hold-down latches. 
     FIG. 5B is cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with hold-down clips. 
     FIG. 5C is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with hold-down bands. 
     FIG. 6A is an end view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with attached PTA catheter. 
     FIG. 6B is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with cooling capability and attached PTA catheter. 
     FIG. 6C is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with cooling capability. 
     FIG. 6D is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with shaft attachment means. 
     FIG. 7 is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure. 
     FIG. 8A is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with PTA catheter. 
     FIG. 8B is a cross-sectional view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with cooling capability and PTA catheter. 
     FIG. 8C is a top view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with PTA catheter. 
     FIG. 8D is a top view of one embodiment of a PTA catheter manipulation tool PTA catheter support structure with PTA catheter. 
     FIG. 9 is prospective view of one embodiment of a PTA catheter manipulation tool. 
     FIG. 10 is a partial cross-sectional perspective view of one embodiment of an ablation PTA catheter manipulation tool with cooling capability. 
     FIG. 11 is a perspective view of one embodiment of a PTA catheter manipulation tool with cooling capability. 
     FIG. 12 is a perspective view of one embodiment of a PTA catheter manipulation tool with cooling capability. 
     FIG. 13A is an exploded top view of one embodiment of a PTA catheter manipulation tool. 
     FIG. 13B is a side view of one embodiment of a PTA catheter manipulation tool with PTA catheter. 
     FIG. 14 is a top view of one embodiment of a PTA catheter manipulation tool. 
    
    
     DETAILED DESCRIPTION 
     In the following detailed description, reference is made to the accompanying drawings, which are not necessarily to scale, which form a part hereof, and in which is shown by way of illustrating specific embodiments in which the device may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the device, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes may be made without departing from the spirit and scope. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined by the appended claims and their equivalents. In the drawings, like numerals describe substantially similar components throughout the several views. 
     The present apparatus and methods will be described in applications involving biomedical applications. However, it is understood that the present apparatus and methods may be employed in other environments and uses. 
     FIG. 1 is a perspective view of an embodiment of a PTA catheter manipulation tool  110  illustrating generally, by way of example, but not by way of limitation, one embodiment of a PTA catheter manipulation tool. More in particular, the tool  110  comprises a PTA catheter support structure  130  and a handle portion  120 . The PTA catheter support structure  130  is shaped to accept a PTA catheter. In the embodiment shown, the support structure  130  is in the form of a concave channel. Generally, support structure  130  comprises an elongated shape since PTA catheters are usually elongated in shape. 
     In one embodiment, PTA catheter support structure  130  is a relatively stiff member that is manufactured into a desired shape. The desired shape is dependent on its use such that the PTA catheter is held to create the desired lesion shape and that the handle portion facilitates access to the treatment site. In another embodiment, PTA catheter support structure  130  and/or handle portion  120  are made from a relatively malleable material or have malleable properties to facilitate bending into a desired shape, such as a curve or straight position, and retain that shape during use. In some embodiments, the malleability feature of support structure  130  and/or handle portion  120  is a property of the material that it is made. In other embodiments, the malleability feature of support structure  130  and/or handle portion  120  is facilitated by imbedding a spine of malleable material (such as a wire, rod or sheet) into flexible material that makes up the bulk of support structure  130 . In another embodiment, the support structure  130  may consist of a material that can be trimmed, such as with a scalpel or scissors, to a desired length. 
     The handle portion  120  is of any shape that would facilitate the grasping and using the tool  110 . The handle portion  120  and the PTA catheter support structure  130  may be one integral unit. In another embodiment, the handle portion  120  is detachable from the support structure  130 . 
     FIG. 2 is a perspective view of an embodiment of a PTA catheter manipulation tool  210  illustrating generally, by way of example, but not by way of limitation, one embodiment of a PTA catheter manipulation tool having a PTA catheter attached. More in particular, FIG. 2 shows an embodiment of the tool  210  consisting of a handle portion  220 , two shafts  222  and a PTA catheter support structure  230 . A PTA catheter  290  is shown mounted to support structure  230  in such a way that the PTA catheter electrodes  292  are held within the support structure  230 . In use, the user would hold the tool  210  by grasping the handle portion  220  and pressing the PTA catheter  290  against the treatment site. 
     The handle portion  220  is of any shape that would facilitate the holding and using the tool  210 . In some embodiments, the handle portion  220  is connected to the PTA catheter support structure  230  with more than one shaft  222 . The handle portion  220 , the one or more shafts  222 , and the support structure  230  may be formed as a single unit, or one or more of the entities may be detachable. 
     In embodiments where the support structure  230  and/or the one or more shafts  222  are made from rigid material, one shaft  222  may be sufficient to effectively transmit force applied on the handle portion  220  to the support structure  230 . The one or more shafts  222  and/or the support structure  230  may be of a material that is relatively malleable to facilitate bending the tool  210  to a desired shape. If the support structure  230  and/or the one or more shafts  222  are made from a relatively flexible or malleable material, more shafts  222  may be needed to uniformly transfer force from the handle portion  220  to the support structure  230 . The one or more shafts  222  may be made from a shape memory material that, upon the application of heat, such as with autoclaving, the one or more shafts  222  return to their manufactured shape. This would facilitate the reuse of tool  210 . The detachability of the one or more shafts  222  from the support structure  230  allows for disposal of the support structure  230 , or separate processing, such as sterilization. 
     The PTA catheter support structure  230  is shaped to accept a PTA catheter  290 . In the embodiment shown in FIG. 2, the support structure  230  is in the form of an elongated concave channel. Depending on the type of PTA catheter used, the support structure  230  may need to possess thermal, electrical, or both thermal and electrical insulating properties. 
     In one embodiment, the support structure  230  is pivotally mounted to the one or more shafts  222  which allows the support structure  230  to self align when pressed against the treatment site. 
     FIGS. 3A-C are views, illustrating generally, by way of example, but not by way of limitation, of embodiments of portions of the PTA catheter support structure. These embodiments may also incorporate fluid channels and orifices to allow cooling of the treatment site. More in particular, FIG. 3A shows a cross-sectional view of a support structure  332 . The PTA catheter support structure  332  comprises a concave channel having a base  331 , spaced lips  333  extending from one side of the base  331  forming a cavity  338 , each lip having a free end,  335  and  337  respectively. In one embodiment, cavity  338  has a substantially circular cross section substantially conforming to and engaging a major portion of the outer surface of the PTA catheter  390 . The lips  333 , extending from the base  331 , partially overlap the PTA catheter  390  in order to retain the PTA catheter  390  with in the cavity  338 . A portion of the PTA catheter  390 , when placed within the cavity  338 , is exposed beyond the lips  333 . In one embodiment, the support structure  332  is made from a relatively rigid material and the PTA catheter  390  is slidably inserted into the cavity  338 . The PTA catheter  390  is held in place by friction or other means. 
     In another embodiment, lips  333  are made from a relatively resilient material which allows for the flexing or opening of the lips  333  away from each other to allow the PTA catheter  390  to be inserted into the cavity  338 , and once the flexing force is released, to allow the lips  333  to close in around the PTA catheter  390  to hold it in place. 
     The PTA catheter support structure  334  may incorporate a fluid delivery capability. This fluid delivery capability comprises one or more fluid passages in fluid communication with one or more fluid orifices. FIG. 3B shows a cross-sectional view of an embodiment of a support structure  334 , which incorporates fluid orifices  340  in fluid communication with internal fluid passages  342  which allow cooling fluid to exit the support structure  334  near the PTA catheter  390  to provide for cooling of the treatment site. FIG. 3C shows a top view of an embodiment of a cooled support structure  336 , which incorporates fluid orifices  341  along the length which allows cooling fluid to exit the support structure  336  to provide for cooling the treatment site. 
     FIGS. 4A-F are views, illustrating generally, by way of example, but not by way of limitation, of embodiments of portions of the PTA catheter holding support structure. These embodiments may also incorporate fluid orifices to allow cooling of the treatment site. More in particular, FIG. 4A shows a cross-sectional view of a support structure  430 . The PTA catheter support structure  430  comprises a concave channel having a base  431 , spaced lips  433  extending from one side of the base  431  forming a cavity  438 . In one embodiment, cavity  438  has a substantially circular cross section substantially conforming to and engaging a portion of the outer surface of the PTA catheter  490 . The lips  433 , extending from the base  431 , partially surrounds the PTA catheter  490 . PTA catheter  490  may be held in cavity  438  with an adhesive means. 
     FIG. 4B shows a cross-sectional view of support structure  432  further comprising a gripping surface  435 , within cavity  438 , which is provided to engage and frictionally grip the PTA catheter. This gripping surface  435  may consist of a plurality of resilient ridges or bumps  439  provided to “grab hold” of the PTA catheter  490  when inserted into the cavity  438  of the support structure  430 . In one embodiment, the support structure  432  is be made from a resilient material, such that lips  433  may be flexed or opened up away from each other to allow the insertion of the PTA catheter  490 . Once inserted, the expansion force would be relieved and the bumps or ridges  439  would “grasp” the PTA catheter  490  while the lips  433  are closed around it. 
     FIG. 4C is a cross-sectional view showing an embodiment of support structure  434  where the lip free ends  441  have the ability to be sutured into, such that suture  450  could be used to form hold-downs  450  that would hold the PTA catheter  490  onto the cavity  438 . FIG. 4D is a cross-sectional view showing an embodiment of PTA catheter support structure  436  where the lips  437  incorporate suture loops  460  to facilitate the use of suture or other hold-down material to form hold-downs  452 . FIG. 4E shows a top view of a portion of the support structure  434  with multiple single suture hold-downs  450 . FIG. 4F shows a top view of a portion of the support structure  434  with a single running lace hold-down  454 . 
     FIGS. 5A-E are views, illustrating generally, by way of example, but not by way of limitation, of embodiments of portions of the PTA catheter holding support structure. These embodiments may also incorporate fluid orifices to allow cooling of the treatment site. FIG. 5A is an end view of an embodiment of PTA catheter support structure  530  having one or more clips  554 . IN this embodiment, the PTA catheter is attached to support structure  530  by clips  554 . Clips  554  may incorporate a hinge means  551  attaching clips  554  to the other lip  537 . Clips  554  may incorporate a latch means  553  which engages a catch means  555  on lip  535 . Clips  554  may be made from a rigid material or a resilient material. Clips  554  and support structure  530  may be made as a single unit or as separate entities. 
     FIG. 5B is a cross-sectional view of an embodiment of a PTA catheter support structure  534  that has one or more clips  542 . In this embodiment, the PTA catheter is attached to support structure  534  by one or more clips  542  that are shaped to substantially conform to the shape of the PTA catheter. In one embodiment, one or more clips  542  is slidably inserted over the support structure  534 . In another embodiment the one or more clips  542  are resilient or spring-like to allow flexing or opening up such that it can be placed over the PTA catheter  540  and support structure  534  and “clamped” around the support structure  534  holding the PTA catheter to the support structure  534 . In one embodiment, lips  545  have an attachment means  565  that engages attachment means  567  on the one or more clips  542 . 
     FIG. 5C is a cross-sectional view of another embodiment of the PTA catheter support structure  536 . In this embodiment, PTA catheter  590  is held to the support structure  536  by use of one or more resilient bands  544 . 
     FIGS. 6A-D are views, illustrating generally, by way of example, but not by way of limitation, of embodiments of portions of the PTA catheter holding support structure. These embodiments may also incorporate fluid orifices to allow cooling of the treatment site. FIG. 6A is a end view of an embodiment of the support structure  630  comprising a V cup having a base  631 , spaced lips  633  extending from one side of the base  631  forming a cavity  638 . Cavity  638  provides that the support structure  630  can accommodate various sizes (i.e., diameters) of PTA catheters  690 . A portion of the PTA catheter  690 , when placed within the cavity  638 , is exposed above the lips  633 . In one embodiment, the support structure  630  is made from a relatively rigid material. In one embodiment, the support structure  630  is malleable. 
     In one embodiment, the resilient force of the support structure  630  clamping down or squeezing is enough to hold the PTA catheter  690  in place. Hold-downs  490 ,  450 ,  452 ,  444 ,  554 ,  542 , and  544  like the ones in FIGS. 4C,  4 D,  4 E,  4 F, SA,  5 B and  5 C respectively, may also be used as well as the use of bumps or ridges  439  as shown in FIG.  4 B. 
     FIG. 6B shows a cross-sectional view of another embodiment of the support structure  632  that incorporates one or more fluid orifices  640  and one or more fluid passages  632 . FIG. 6C shows a cross-sectional view of another embodiment of the support structure  634  that incorporates fluid orifices  642 . FIG. 6D shows a cross-sectional view of another embodiment of the support structure  636  that shows how removable or permanent attachment means of shaft  622  may be made; on the support structure side  637  and/or the support structure back  639 . 
     FIG. 7 is a cross-sectional view, illustrating generally, by way of example, but not by way of limitation, of an embodiment of a portion of the PTA catheter holding support structure. This embodiment may also incorporate fluid orifices to allow cooling of the treatment site. FIG. 7 show a cross-sectional view of an embodiment of support structure  730  that has one or more malleable members  770 . One or more malleable members  770 , or substructure, are made from a material, and are sized and numbered, such that they impart a bend and stay property to the support structure  730  which would be made from a complementary material that allows the support structure  730  to be bendable. One or more malleable members  770  may be wires, rods, and flat sheet, among others. The one or more malleable members  770  are used in PTA catheter holding support structures of any shape; including those having a circular, V-shaped, and rectangular cross section. 
     FIGS. 8A-D are views, illustrating generally, by way of example, but not by way of limitation, of embodiments of portions of the PTA catheter holding support structure. These embodiments may also incorporate fluid orifices to allow cooling of the treatment site. FIG. 8A is a cross-sectional view of an embodiment that has a flat-shaped support structure  830 . The PTA catheter  890  is held onto the support structure  830  with the use of one or more hold-downs  850 , such as suture, clips, bands, and the like. In one embodiment, the hold-downs  850  are integrally molded loops or rings that the PTA catheter is threaded through. In other embodiments, elastic loops, adhesive, and the like may be used to attach the PTA catheter  890  to the support structure  830 . In one embodiment, the hold-downs  850  pass through the support structure  830  and are tied-off, or first passed through pledget  852  and then tied off. The pledget  852  helps to reinforce and resist suture-knot pull-out. FIG. 8B shows a cross-section of PTA catheter support structure  832  further comprising one or more fluid orifices  840  and one or more fluid passages  842 . 
     FIGS. 8C and D are top views showing an embodiment of a flat-shaped support structure  832  having notch features  838  which facilitates the support structure  832  to be straight (FIG. 8C) or bent (FIG.  8 D). PTA catheter  890  may be held onto the support structure  890  by the use of elastic bands, suture ties, and other hold-downs  853 , wrapping the PTA catheter  890  and the support structure  832  in the notch feature  838 . In one embodiment, the hold-downs  853  are one continuous piece wrapped around at least one notch feature  838  and the PTA catheter  890 . In other embodiments, singular hold-downs  853  at each notch feature  838  and PTA catheter  890  location are used. 
     FIG. 9 is a perspective view of an embodiment of an PTA catheter manipulation tool  910  illustrating generally, by way of example, but not by way of limitation, one embodiment of an PTA catheter manipulation tool. More in particular, FIG. 9 shows an embodiment of the tool  910  consisting of a handle portion  920 , two shafts  922  and a PTA catheter support structure  930 . Support structure  930  further comprises loops  956  forming a substantially tubular shape through which a PTA catheter may be slidably inserted. A PTA catheter would be mounted to support structure  230  in such a way that the PTA catheter electrodes are exposed between the loops  956 . In use, the user would hold the tool  910  by grasping the handle portion  920  and pressing the attached PTA catheter  990  against the treatment site. 
     FIG. 10 is a top view, illustrating generally, by way of example, but not by way of limitation, of an embodiment of portions of the PTA catheter manipulation tool. In particular FIG. 10 shows an embodiment of a PTA catheter manipulation tool  1010  that has cooling capability. Fluid is supplied to the support structure  1030  from a fluid supply system  1059  via a fluid supply line  1050  that attaches to the handle portion  1020  that has an internal fluid channel  1052  in fluid communication with internal support structure fluid channels in fluid communication with a plurality of orifices  1056  which allow the cooling fluid to exit the orifices  1056  and drench the PTA catheter  1090  and the surrounding area. 
     FIG. 11 is a top view, illustrating generally, by way of example, but not by way of limitation, of an embodiment of portions of the PTA catheter manipulation tool. In particular FIG. 11 shows an embodiment of a PTA catheter manipulation tool  1110  that has cooling capability. The fluid is supplied to the support structure  1130  from a fluid supply system  1159  via a fluid supply line  1150  that may or may not attach to the handle portion  1120 . The fluid supply line  1150  attaches to a connection means  1153  on the support structure  1130 . The fluid line  1150  is in fluid communication with internal passages in the support structure  1130 . The passages in the support structure  1130  are in fluid communication with a return fluid line  1151  that returns fluid to the supply system  1159  in a recirculating manner. The fluid flowing through the passages cools the support structure  1130  during use. 
     FIG. 12 is a top view, illustrating generally, by way of example, but not by way of limitation, of an embodiment of portions of the PTA catheter manipulation tool. In particular FIG. 12 shows an embodiment of a PTA catheter manipulation tool  1210  that has cooling capability. The fluid is supplied to the support structure  1230  from a fluid supply system  1259  via a fluid supply line  1250  that may or may not attach to the handle portion  1220 . The fluid supply line  1250  attaches to a connection means  1253  on the support structure  1230 . The fluid line  1250  is in fluid communication with internal passages in the support structure  1230 . The passages in the support structure  1230  are in fluid communication with orifices  1256  which allow the cooling fluid to exit the orifices  1256  and drench the PTA catheter and the surrounding area. 
     FIGS. 13A and 13B present a top and side view, respectively, illustrating generally, by way of example, but not by way of limitation, embodiments of the PTA catheter manipulation tool. In particular FIGS. 13A and B are exploded views showing an embodiment of the PTA catheter manipulation tool  1310  having multiple shafts  1322 , handle portion  1320 , and a PTA catheter holding support structure  1330 . Attachment means  1324  on the shafts  1322  interrelate with attachment means  1328  on the support structure  1330  for a temporary or permanent connection. Attachment means  1324  and  1328  is a snap fitting, a screw fitting, a ratchet fitting, or any other means to temporarily or permanently connect the shafts  1322  to the support structure  1330 . FIG. 13B shows a side view of the embodiment in FIG. 13A with the addition of PTA catheter  1390 . PTA catheter  1390  may or may not be attached to the handle portion  1320  for support. 
     FIG. 14 presents a top view illustrating generally, by way of example, but not by way of limitation, embodiments of the PTA catheter manipulation tool. In particular FIG. 14 shows an embodiment of the PTA catheter manipulation tool  1410  having a handle portion  1420 , multiple independently bendable and adjustable shafts  1422 , each shaft  1422  having a PTA catheter holding support structure  1430 . The PTA catheter holding support structures  1430  may incorporate clips  1424 , such as those shown in FIG. 5, for a temporary or permanent connection of a PTA catheter to the holding support structure  1430 . 
     Operation and use of an embodiment of a PTA catheter manipulation tool can now be briefly described as follows. This example is not intended to be exclusive or limiting and the scope of the invention is provided by the attached claims and their equivalents. Let it be assumed that it is desired to introduce radio frequency energy into the wall forming a chamber of the heart to cause ablation of the myocardium. Also let it be assumed that the tool is introduced into the chamber of the heart in a human being in a conventional open heart procedure. By using operator experience and preference, the tool is bent and formed into a desired shape to allow convenient assess to the ablation site by the PTA catheter and to produce a lesion of the desired shape. The PTA catheter is attached to the PTA catheter holding support structure. The support structure is pressed against the tissue such that the PTA catheter is touching the tissue. Radio frequency is applied to the electrode which ablates the tissue. Fluid flows from the fluid supply system through the supply line and out the orifices in the support structure effectively cooling the surrounding tissue to minimize collateral tissue damage. 
     It is to be understood that the above description is intended to be illustrative, and not restrictive. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Technology Classification (CPC): 0