US20050288664A1 - Systems and methods for treating tissue regions of the body - Google Patents

Abstract

Systems and methods deploy an electrode from a catheter assembly. The systems and methods provide a catheter handle having a trigger lever adapted to carry an actuator rod. The actuator rod is adapted to cause movement of the electrode between a retracted position and an extended position. A pinion is carried by the trigger lever for engagement with a rack carried by the actuator rod. Compression of the trigger lever moves the rack along the actuator rod between a first position corresponding to the electrodes being in the retracted position and a second position corresponding to either the primed electrode firing position or the electrodes being in an extended position.

Description

RELATED APPLICATION
• This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/581,396, filed Jun. 21, 2004, and entitled “Systems and Methods for Treating Tissue Regions of the Body” which is incorporated herein by reference.
FIELD OF THE INVENTION
• The invention is directed to devices, systems and methods for treating tissue regions of the body.
BACKGROUND OF THE INVENTION
• Catheter-based devices that deploy expandable structures into interior body regions are well known. These structures are typically introduced through a body lumen or vessel in a collapsed, low profile condition. Once at or near the targeted body region, the structures are expanded in situ into an enlarged condition to make contact with tissue. The structures can carry operative elements that, when in contact with tissue, perform a therapeutic or diagnostic function. They can, for example, deliver energy to ablate targeted tissue in the region.
• The operative elements often take the form of electrodes carried by a basket assembly surrounding the expandable structure. A push-pull lever causes the electrodes to slide within lumens in the basket arms between a retracted position and an extended position.
• The need remains for systems and methods for controlling the actuation and deployment of electrodes from a catheter. In particular, the need remains for actuator systems which can be manufactured in a simple and cost-efficient manner and which are easily manipulated in use.
SUMMARY OF THE INVENTION
• The invention provides improved systems and methods for treating a tissue region. On aspect of the invention provides an actuator system for deploying an electrode (or series of electrodes) from a catheter assembly. The actuator system comprises a handle having a trigger lever. The handle carries an actuator rod. The actuator rod is adapted to move the electrode between a retracted position and an extended position. A pinion is carried by a trigger lever for engagement with a rack carried by the actuator rod. The pinion engages the rack upon compression of the trigger lever to move the rack along the actuator rod between a first position corresponding to the electrode being in the retracted position and a second position corresponding to the electrode being in an extended position. In one embodiment, the actuator rod is biased in one of the first and second positions. The actuator rod may be biased in one of the first and second positions by a spring.
• According to another aspect of the invention, the system further comprises a locking element for locking the actuator rod in at least one of the first and second positions. In one embodiment, the locking element is spring-loaded. In one embodiment, the locking element is biased in a latched position. The locking element may be biased in the latched position by a spring.
• According to another aspect of the invention, at least a portion of the locking element rides along a cam surface as the rack is moved between the first and second positions. In one embodiment, the cam surface is carried by the rack. In another embodiment, the cam surface is carried by the trigger lever.
• In one embodiment, the rack includes a detent adapted to receive at least a portion of the locking element in at least one of the first and second positions. In another embodiment, the trigger lever includes a detent adapted to receive at least a portion of the locking element in at least one of the first and second positions.
• According to another aspect of the invention, the system provides improved systems and methods for deploying an electrode (or series of electrodes) from a catheter assembly. The actuator assembly comprises a pinion carried by a trigger lever. The actuator assembly also comprises a rack carried by an actuator rod, whereby the pinion engages the rack upon compression of the trigger lever to move the rack along the actuator rod between a first actuator rod position and a second actuator rod position. In one embodiment, the actuator rod is biased in one of the first and second actuator rod positions, and may be biased by a spring.
• According to yet another aspect of the invention, the assembly further comprises an electrode advancer mandrel operating in a biased relationship to the actuator rod and a locking element for locking the electrode advancer mandrel in at least one of a first and second electrode advancer mandrel position. In one embodiment, the electrode advancer mandrel includes a sear for cooperating with the locking element and a sear release for releasing the sear and allowing the electrode advancer mandrel to advance to an electrode extended position. The assembly may also include a retraction member for moving the actuator rod from the second actuator position back to the first actuator rod position.
• Other features and advantages of the inventions are set forth in the following Description and drawings, as well as in the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic view of a system for treating tissue.
• FIG. 2 is an enlarged view of the treatment device, with parts broken away and in section, that is associated with the system shown inFIG. 1, the treatment device comprising basket structure that carries selectively deployable electrode elements and that expands in response to inflation of an interior balloon structure,FIG. 2 showing the basket in a collapsed condition with the electrode elements retracted.
• FIG. 3 is an enlarged view of the treatment device shown inFIG. 2, with the basket expanded due to inflation of interior balloon structure and the electrode elements still retracted.
• FIG. 4 is an enlarged view of the treatment device shown inFIG. 2, with the basket expanded due to inflation of interior balloon structure and the electrode elements extended for use,FIG. 4 also showing the passage of irrigation fluid from the basket to cool the surface tissue while radio-frequency energy is applied by the electrode elements to subsurface tissue.
• FIGS.5 to7 are simplified anatomic views showing the use of the treatment device shown in FIGS.2 to4 deployed in the region of the lower esophageal sphincter to form an array of lesions.
• FIG. 8 is a side sectional view of the catheter handle illustrating a rack and pinion trigger mechanism for moving treatment electrodes between a retracted position and an extended position and illustrating the rack in a first position and the locking mechanism unlatched.
• FIG. 9 is a view similar toFIG. 8 illustrating the rack in a second position and the locking mechanism latched.
• FIG. 10 is a view similar toFIG. 8 illustrating the release of the locking mechanism.
• FIG. 11 is a perspective view of an alternative embodiment of a catheter handle having a rack and pinion trigger mechanism.
• FIG. 12 is a side sectional view of the handle shown inFIG. 11 and illustrating the rack in a first position and the locking mechanism unlatched.
• FIG. 13 is a view similar toFIG. 12 illustrating the rack in a second position and the locking mechanism latched.
• FIG. 13A is a detailed view of the locking mechanism as shown inFIG. 13.
• FIG. 14 is a view similar toFIG. 13 illustrating the release of the locking mechanism.
• FIG. 14A is a detailed view of the locking mechanism as shown inFIG. 13.
• FIG. 15 is a perspective view of an alternative embodiment of a catheter handle having a rack and pinion trigger mechanism, a spring-loaded firing mechanism, and a retraction pull bar.
• FIG. 16 is a side sectional view of an the alternative embodiment of the catheter handle shown inFIG. 15, and showing the rack and pinion trigger mechanism, the spring-loaded firing mechanism, and the retraction pull bar, and illustrating the rack in a first position and the spring-loaded firing mechanism in the battery position.
• FIG. 17 is a view similar toFIG. 16 illustrating the rack in a second position and the spring-loaded firing mechanism in the firing position.
• FIG. 18 is a view similar toFIG. 17 illustrating the release of the locking mechanism.
• FIG. 19 is a view similar toFIG. 16 illustrating the retraction process with the rack returned to the first position and the locking mechanism returned to the locked position.
• The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• This Specification discloses various catheter-based systems and methods for treating dysfunction in various locations in an animal body. For example, the various aspects of the invention have application in procedures requiring treatment of sphincters and adjoining tissue regions in the body, or hemorrhoids, or incontinence, or obesity, or restoring compliance to or otherwise tightening interior tissue or muscle regions. The systems and methods that embody features of the invention are also adaptable for use with systems and surgical techniques that are not necessarily catheter-based.
• The systems and methods are particularly well suited for treating dysfunctions in the upper gastrointestinal tract, e.g., in the lower esophageal sphincter and adjacent cardia of the stomach. For this reason, the systems and methods will be described in this context. Still, it should be appreciated that the disclosed systems and methods are applicable for use in treating other dysfunctions elsewhere in the body, which are not necessarily sphincter-related.
• I. Overview
• Atissue treatment device10 and associatedsystem36 are shown inFIG. 1.
• Thedevice10 includes ahandle12 made, e.g., from molded plastic. Thehandle12 carries aflexible catheter tube14 constructed, for example, by extrusion using standard flexible, medical grade plastic materials, like Pebax™ plastic material, vinyl, nylon, poly(ethylene), ionomer, poly(urethane), poly(amide), and poly(ethylene terephthalate). Thehandle12 is sized to be conveniently held by a physician, to introduce thecatheter tube14 into the tissue region targeted for treatment. Thecatheter tube14 may be deployed with or without the use of a guide wire.
• Thecatheter tube14 carries on its distal end anoperative element16. Theoperative element16 can take different forms and can be used for either therapeutic purposes, or diagnostic purposes, or both. Theoperative element16 can support, for example, a device for imaging body tissue, such as an endoscope, or an ultrasound transducer. Theoperative element16 can also support a device to deliver a drug or therapeutic material to body tissue. Theoperative element16 can also support a device for sensing a physiological characteristic in tissue, such as electrical activity, or for transmitting energy to stimulate tissue or to form lesions in tissue.
• In the embodiment shown in FIGS.2 to4, theoperative element16 comprises a three-dimensional basket18. Thebasket18 includes an array ofarms20. Thearms20 are desirably made from extruded or molded plastic, but they could also be formed from stainless steel or nickel titanium alloy. As shown inFIG. 2, thearms20 are assembled together between adistal tip22 and aproximal base element24.
• AsFIGS. 3 and 4 show, anexpandable structure26 comprising, e.g., a balloon, is located within thebasket18. Theexpandable balloon structure26 can be made, e.g., from a Polyethylene Terephthalate (PET) material, or a polyamide (non-compliant) material, or a radiation cross-linked polyethylene (semi-compliant) material, or a latex material, or a silicone material, or a C-Flex (highly compliant) material. Non-compliant materials offer the advantages of a predictable size and pressure feedback when inflated in contact with tissue. Compliant materials offer the advantages of variable sizes and shape conformance to adjacent tissue geometries.
• Theballoon structure26 presents a normally, generally collapsed condition, asFIG. 2 shows. In this condition, thebasket18 is also normally collapsed about theballoon structure26, presenting a low profile for deployment into the targeted tissue region.
• Expansion of theballoon structure26, e.g., by the introduction of air through asyringe32 andplunger33 coupled to a one-way check valve fitting42 on the handle12 (seeFIG. 3), urges thearms20 of thebasket18 to open and expand, asFIG. 3 shows. The force exerted by theballoon structure26 upon thebasket arms20, when expanded, is sufficient to exert an opening force upon the tissue surrounding thebasket18.
• For the purpose of illustration (seeFIGS. 5 and 6), the targeted tissue region comprises the lower esophageal sphincter (LES) and cardia of the stomach. When deployed in this or any sphincter region, the opening force exerted by theballoon structure26 serves to dilate the sphincter region, asFIG. 6 shows.
• Eachbasket arm20 carries anelectrode element28. A trigger-type lever30 on the handle (seeFIG. 4) is mechanically coupled through thecatheter tube14 to theelectrode elements28, as will be described in detail later. In use, squeezing pressure on thelever30 causes theelectrode elements28 to slide within the lumens in thebasket arms20 between a retracted position (shown in theFIG. 3) and an extended position (shown inFIG. 4). AsFIG. 4 shows, theelectrode element28, when extended, projects through anopening56 in the basket arm. When deployed in the tissue region (seeFIG. 6), theextended electrode element28 pierces tissue. AsFIG. 4 shows, temperature sensing elements82 (e.g., thermocouples) are desirably carried by thearms20 near theelectrode elements28 to sense tissue temperature conditions.
• In a desired arrangement, theelectrode elements28 deliver radio frequency energy, e.g., energy having a frequency in the range of about 400 kHz to about 10 mHz. A return path is established, e.g., by an external patch electrode, also called an indifferent electrode. In this arrangement, the application of radio frequency energy serves to ohmically heat tissue in the vicinity of theelectrode elements28, to thermally injure the tissue and form thelocalized sub-surface lesions164, which are shown inFIG. 6. Of course, tissue heating can be accomplished by other means, e.g., by coherent or incoherent light; heated or cooled fluid; resistive heating; microwave; ultrasound; a tissue heating fluid; or cryogenic fluid.
• In this arrangement, the natural healing of subsurface lesions or pattern of subsurface lesions created by the applied energy leads to a physical tightening of the sphincter and/or adjoining cardia and/or a reduction in the compliance of these tissues. The subsurface lesions can also result in the interruption of aberrant electrical pathways that may cause spontaneous sphincter relaxation. In any event, the treatment can restore normal closure function to the sphincter.
• Theelectrode elements28 can be formed from various energy transmitting materials. For deployment in the esophagus or cardia of the stomach, theelectrode elements28 are formed, e.g., from nickel titanium. Theelectrode elements28 can also be formed from stainless steel, e.g., 304 stainless steel, or a combination of nickel titanium and stainless steel.
• In this arrangement, theelectrode element28 may comprise a hybrid of materials comprising stainless steel for the proximal portion and nickel titanium alloy for the distal portion.
• The exterior surface of eachelectrode element28 can carry an electrical insulating material, except at its distal region, where the radio frequency energy is applied to tissue. The presence of the insulating material serves to preserve and protect the mucosal tissue surface from exposure to the radio frequency energy, and, thus, from thermal damage. The insulating material can comprise, e.g., a Polyethylene Terephthalate (PET) material, or a polyimide or polyamide material.
• AsFIG. 1 shows, thetreatment device10 desirably operates as part of asystem36. Thesystem36 includes agenerator38 to supply the treatment energy to theoperative element16. In the illustrated embodiment, thegenerator38 supplies radio frequency energy to theelectrodes28. Acable40 plugged into aconnector41 on thehandle12 electrically couples theelectrode elements28 to thegenerator38. Electrode supply wires pass through thecatheter tube14 from the handle to theelectrode elements28.
• Thesystem36 can also include certain auxiliary processing equipment. In the illustrated embodiment, the processing equipment comprises an external fluid delivery orirrigation apparatus44. In the illustrated embodiment, thefluid delivery apparatus44 comprises an integrated, self priming peristaltic pump rotor that is carried on a side panel of thegenerator38. Other types of non-invasive pumping mechanisms can be used, e.g., a syringe pump, a shuttle pump, or a diaphragm pump.
• A luer fitting48 on thehandle12 couples totubing34 to connect thetreatment device10 to thefluid delivery apparatus44. Irrigation supply tubing in thecatheter tube14 conveys irrigation fluid through a lumen in eachbasket arm20 for discharge through irrigation openings56 (seeFIG. 4) by or near theelectrode elements28. This provides localized cooling of surface tissue. In the illustrated embodiment, the irrigation fluid (designated F inFIG. 4) is discharged directly at the base of eachelectrode element28. In this arrangement, the irrigation fluid is conveyed through the same basket arm lumen and is discharged through the samebasket arm opening56 as theelectrode element28. Of course, other irrigation paths can be used.
• In this arrangement, the processing equipment desirably includes anaspiration source46. Another luer fitting50 on thehandle12couples tubing51 to connect thetreatment device10 to theaspiration source46. Theaspiration source46 draws irrigation fluid discharged by or near theelectrodes28 away from the tissue region. Theaspiration source46 can comprise, for example, a vacuum source, which is typically present in a physician's suite.
• Thesystem36 also desirably includes acontroller52. Thecontroller52 is linked to thegenerator38 and thefluid delivery apparatus44. Thecontroller52, which preferably includes an onboard central processing unit, governs the power levels, cycles, and duration that the radio frequency energy is distributed to theelectrodes28, to achieve and maintain temperature levels appropriate to achieve the desired treatment objectives. In tandem, thecontroller52 also desirably governs the delivery of irrigation fluid.
• Thecontroller52 desirably includes an input/output (I/O)device54. The I/O device54, which can employ a graphical user interface, allows the physician to input control and processing variables, to enable the controller to generate appropriate command signals.
• In use (see FIGS.5 to7), theoperative element16 can be deployed at or near the lower esophageal sphincter (LES) for the purpose of treating GERD. A physician can use the visualization functions of, e.g., an endoscope to obtain proper position and alignment of theoperative element16 with the LES.
• Once proper position and alignment are achieved (seeFIG. 6), the physician can expand theballoon structure16 and extend theelectrode elements16 into piercing contact with tissue at or near the LES. Application of ablation energy forms thelesions164. Retraction of theelectrode elements28 and collapsing of theballoon structure16 allows the physician to reposition theoperative element16 and perform one or more additional ablation sequences (seeFIG. 7). In this way, the physician forms a desired pattern of circumferentially and axially spacedlesions164 at or near the LES and cardia.
• II. Handle
• Thehandle12 can provide any of a variety of different mechanisms to selectively control the advancement and retraction of theelectrodes28. FIGS.8 to10 further illustrate thehandle12, which employs a trigger-type mechanism. While the trigger-type mechanism will be described in relation to actuating and controlling advancement and retraction ofelectrodes28, it is to be understood that the mechanism is also suitable for use in the deployment or actuation of a variety of other medical and non-medical devices.
• Thehandle12 permits passage ofaspiration tubing51A,irrigation tubing34A, andelectrical conduit40A from thecatheter14 through thehandle12 to permit coupling oftubing51A,tubing34A, andconduit40A to aspiration leur fitting50, fluid source leur fitting48, andelectrical cable connector41 respectively.
• In the illustrated embodiment, thehandle12 includes a “rack and pinion” type control mechanism. Apinion200 is carried by the trigger lever orarm30. Acomplementary rack202 is carried by anactuator rod204. Thepinion200 controls fore and aft movement of therack202 along therod204 between a first (retracted) position (shown inFIG. 8) and a second (extended) position (shown inFIG. 9).
• Compression of the arm30 (e.g., by squeezing) causes thepinion200 to engage therack202 and advance therack202 along therod204. Advancement of therack202 moves theelectrodes28 from the retracted position (shown inFIG. 3) to the extended position (shown inFIG. 4). Release of pressure on thearm30 causes therack202 to be moved in the reverse direction to move theelectrodes28 from the extended to the retracted position.
• A control element can be provided to bias therack202 in either the first or second position. In the illustrated embodiment, the control element takes the form of anactuator spring206. Thespring206 is compressed by movement of therod204 in a first direction and relaxes upon movement of therod204 in the reverse direction.
• In a preferred embodiment, thespring206 is normally biased in the relaxed position (shown inFIG. 8), in which therack202 is in the first position and theelectrodes28 are retracted. Advancement of therack202 compresses thespring206 to overcome the bias and advance therod204 to the second position to extend theelectrodes28.
• A locking mechanism is desirably provided to secure the rack and pinion mechanism in a desired position. In the illustrated embodiment, the locking mechanism takes the form of a spring-loadedpawl lock208. Thepawl lock208 travels along acam surface201 on therack202 and falls into adetent210 at the proximal end of therack202 to latch and secure therack202 in the second position (in which theelectrodes28 are extended).
• Thelock208 is normally biased in this latched position (shown inFIG. 9). Slight compression of thearm30 releases the tension of thelock208 within thedetent210 to permit manipulation of a tab212 (e.g., upward pressure on thetab212 by a thumb or finger) to release thelock208 from the detent210 (shown inFIG. 10) and automatically returns therack202 to the first position (in which theelectrodes28 are retracted) . In the illustrated embodiment, thetab212 is desirably positioned to permit single-handed compression of thetrigger arm30 and manipulation of thelock208, allowing the other hand of the physician to remain free.
• In use, with theelectrodes28 in the retracted position, the physician advances thetreatment device10 to the targeted tissue region. The physician gently squeezes thetrigger arm30 to advance therack202 to the second position and extend theelectrodes28. The physician maintains squeezing pressure on thearm30 until thelock208 is secured in the latched position. The desired treatment is then administered. The physician then applies gentle pressure to thearm30 while simultaneously applying upward pressure to thelocking tab212 to release thelock208. This returns therack202 to the first position and retracts theelectrodes28. Thetreatment device10 can then be repositioned to administer additional treatment or thedevice10 can be withdrawn.
• FIGS.11 to14A illustrate an alternative embodiment of ahandle12′ employing a trigger-type mechanism. Thehandle12′ shares many features of the first embodiment of thehandle12 just described. Like structural elements are therefore assigned like reference numbers.
• Like thehandle12 previously described, thehandle12′ employs a rack and pinion mechanism to control extension and retraction of theelectrodes28. Also like the embodiment previously described, advancement of therack202 compresses theactuator spring206 to overcome the bias and advance therod204 from the first position to the second position and extend theelectrodes28.
• Also similar to the embodiment previously described, thehandle12′ provides a spring-loaded locking mechanism. In the illustrated embodiment, alocking pin214 is carried within a bore orrecess216 within the handle housing. Thetrigger arm30 desirably provides aspring218 within adetent220 for engaging thepin214. The spring-loaded locking mechanism may also include a latching mechanism to assist in maintaining the position of the locking pin214 (seeFIGS. 13A and 14A). Desirably, the lockingpin214 may include a detent or groove215 positioned near the trigger arm engaging end, and thedetent220 within thetrigger arm30 may include amating latch221. It is to be appreciated other latching mechanism configurations may be used, such as thedetent220 may include the detent or groove and thelocking pin214 may include the mating latch.
• In use, with theelectrodes28 in the retracted position, the physician advances thetreatment device10 to the targeted tissue region. As can be seen inFIG. 13, the physician then compresses thetrigger30 while simultaneously applying slight pressure on thepin214. Thepin214 is desirably positioned to permit single-handed compression of thetrigger arm30 and manipulation of thepin214. Thepin214 travels along anarcuate cam surface222 of thearm30 as thepinion200 moves along therack202 and then falls into thedetent220 on thearm30 to latch and secure therack202 in the second position (in which theelectrodes28 are extended).
• The latching means allows the lock to be normally biased in this latched position (shown inFIGS. 13 and 13A). Slight compression of thearm30 to an intermediate position (seeFIG. 14) allows the compressive force on thespring218 to overcome the latching mechanism's hold on thepin214, and thus allows the release of thepin214 from the detent220 (shown inFIGS. 14 and 14A). The physician then releases the trigger allowing therack202 to automatically return to the first position (shown inFIG. 12) to retract theelectrodes28.
• FIGS.15 to19 illustrate an additional alternative embodiment of ahandle12″ employing a trigger-type mechanism, a spring-loaded firing mechanism, and a retraction pull bar. Thehandle12″ shares many features of the embodiments of thehandle12 and12′ just described. Like structural elements are therefore assigned like reference numbers. While thehandle12″ will be described in relation to actuating and controlling advancement and retraction ofelectrodes28, it is to be understood that the handle and mechanisms are also suitable for use in the deployment or actuation of a variety of other medical and non-medical devices.
• Thehandle12″ may also permit passage of additional operative elements such as those shown in FIGS.8 to14. The operative elements may include, but are not limited to, aspiration tubing, irrigation tubing, and electrical conduit from thecatheter14 through thehandle12″ for incorporation with thesystem36.
• Like thehandles12 and12′ previously described, thehandle12″ employs a rack and pinion mechanism. In this embodiment, the rack and pinion mechanism serves to prime the spring-loaded firing mechanism. Apinion200 is carried by the trigger lever orarm30. Acomplementary rack202 is carried by anactuator rod204. Thepinion200 controls fore and aft movement of therack202 along therod204 between a first (electrode retracted) position (shown inFIG. 16) and a second (primed firing mechanism) position (shown inFIG. 17). A trigger orsear latch238, which may pivot on apin241, is now ready to be moved or rotated from a first position to a second position in order to fire theelectrodes28 from a retracted position to an extended position.
• In this illustrated embodiment, compression of thetrigger arm30 advances therack202 androd204 from the first position to the second position and compresses theactuator spring206. The rack and pinion design and the length of thetrigger arm30 provides a mechanical advantage to overcome the bias of a trigger spring, such as atorsion spring230, and theactuator spring206. It is to be appreciated that the actuator spring may provide a compressive force or an extension force, or the spring may be replaced with other means, such a fluid force or a magnetic force, as non-limiting examples.
• Also similar to the embodiments previously described, thehandle12″ provides a sear type locking mechanism. As can be seen inFIGS. 16 and 17, a sear232 is coupled to the proximal end of a needle orelectrode advancer mandrel234. Asear release236, which optionally may be spring biased237, engages the sear232 to maintain a first position of theelectrode advancer mandrel234 until the operator moves thesear latch238 from the first (locked) position to the second (unlocked) position to release the sear232. Thesear latch238 may also optionally be spring biased239 to return the sear latch to a locked or pre-firing position.
• In use, with theelectrodes28 in the retracted position, the physician advances thetreatment device10 to the targeted tissue region. The physician then compresses thetrigger arm30.Cam slot240 oftrigger arm30 moves searrelease safety rod242 distally to clear thesear release236. Aspring plunger244 is coupled to the electrode advancer mandrel distally to theactuator spring206. Compression of thetrigger arm30 causes therod204 to move from the first position to the second position, which compresses theactuator spring206 against thespring plunger244. Thesear release236 restricts sear232 andspring plunger244 from forward, or distal movement against the force of the actuator spring.
• With the operators thumb, thesear latch238 is moved downwardly, forcingsear release236 to clear sear232 (seeFIG. 18). Once the restriction of thesear release236 is removed from the sear232, the stored energy of theactuator spring206 propels the sear232, thespring plunger244, and the coupledelectrode advancer mandrel234 distally until thespring plunger244 abuts the stop andelectrode length adjuster248. Theelectrodes28 are now extended. The stop andelectrode length adjuster248 may be moved proximally or distally allowing for more or less travel of thespring plunger244, which allows for more or less extension of theelectrodes28. Thesear latch238 is desirably positioned to permit single-handed compression of thetrigger arm30 and manipulation of the sear latch.
• After treatment is complete and thetrigger arm30 has been released, the trigger arm may partially retract due to the biasing of thetorsion spring230. Thesear release spring237 and thesear latch spring239 urge thesear release236 and thesear latch238 back to the pre-firing position. Due to possible high retraction forces, it may also be necessary to assist the retraction process by pulling on theretraction pull bar250. During the retraction process, the distal end of the retraction pull bar engages therod204, causing therack202 androd204 to be returned to the first position (shown inFIG. 19) and theelectrodes28 to be retracted. The retraction process moves therod204 andbushing252 proximally and will force the sear232 to the battery position. In an alternative embodiment, thesear release236 and thesear latch238 may also serve to lock the electrode advancer mandrel in a second (electrode extended) position, requiring the physician to move thesear latch238 in order to allow theretraction pull bar250 to return therack202 androd204 to the first position.
• Sear release spring237 urges thesear release236 back to the pre-firing position, and allows thesear release236 to engage sear232. Thecam slot240 of thetrigger arm30 desirably moves the searrelease safety rod242 to move under thesear release236. Thehandle12″ may then be repositioned and the process repeated.
• The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.

Claims (48)

1. An actuator assembly comprising

a pinion carried by a trigger lever,

a rack carried by an actuator rod, the pinion engaging the rack upon compression of the trigger lever to move the rack along the actuator rod between a first position and a second position, the actuator rod being biased in one of the first and second positions, and

a locking element for locking the actuator rod in at least one of the first and second positions.

2. An actuator assembly as inclaim 1

wherein the locking element is spring-loaded.

3. An actuator assembly as inclaim 1

wherein the locking element is biased in a latched position.

4. An actuator assembly as inclaim 1

wherein at least a portion of the locking element rides along a cam surface as the rack is moved between the first and second positions.

5. An actuator assembly as inclaim 4

wherein the cam surface is carried by the rack.

6. An actuator assembly as inclaim 4

wherein the cam surface is carried by the trigger lever.

7. An actuator assembly as inclaim 1

wherein the rack includes a detent adapted to receive at least a portion of the locking element in at least one of the first and second positions.

8. An actuator assembly as inclaim 1

wherein the trigger lever includes a detent adapted to receive at least a portion of the locking element in at least one of the first and second positions.

9. An actuator assembly as inclaim 1

wherein the actuator rod is biased in one of the first and second positions by a spring.

10. An actuator assembly as inclaim 3

wherein a spring biases the locking element in the latched position.

11. An actuator system for deploying an electrode from a catheter assembly comprising

a handle having a trigger lever and adapted to carry an actuator rod, the actuator rod being adapted to move the electrode between a retracted position and an extended position,

a pinion carried by the trigger lever, and

a rack carried by the actuator rod, the pinion engaging the rack upon compression of the trigger lever to move the rack along the actuator rod between a first position corresponding to the electrodes being in the retracted position and a second position corresponding to the electrodes being in an extended position.

12. An actuator system as inclaim 11

wherein the actuator rod is biased in one of the first and second positions.

13. An actuator system as inclaim 11, further comprising

a locking element for locking the actuator rod in at least one of the first and second positions.

14. An actuator system as inclaim 13

wherein the locking element is spring-loaded.

15. An actuator system as inclaim 13

wherein the locking element is biased in a latched position.

16. An actuator system as inclaim 13

wherein at least a portion of the locking element rides along a cam surface as the rack is moved between the first and second positions.

17. An actuator system as inclaim 16

wherein the cam surface is carried by the rack.

18. An actuator system as inclaim 16

wherein the cam surface is carried by the trigger lever.

19. An actuator system as inclaim 13

wherein the rack includes a detent adapted to receive at least a portion of the locking element in at least one of the first and second positions.

20. An actuator system as inclaim 13

wherein the trigger lever includes a detent adapted to receive at least a portion of the locking element in at least one of the first and second positions.

21. An actuator system as inclaim 12

wherein the actuator rod is biased in one of the first and second positions by a spring.

22. An actuator system as inclaim 15

wherein a spring biases the locking element in the latched position.

23. An actuator assembly comprising:

a pinion carried by a trigger lever,

a rack carried by an actuator rod, the pinion engaging the rack upon compression of the trigger lever to move the rack along the actuator rod between a first actuator rod position and a second actuator rod position, the actuator rod being biased in one of the first and second actuator rod positions,

an electrode advancer mandrel operating in a biased relationship to the actuator rod, and

a locking element for locking the electrode advancer mandrel in at least one of the first and second electrode advancer mandrel positions.

24. An actuator assembly as inclaim 23

wherein the locking element is spring loaded.

25. An actuator assembly as inclaim 23

wherein the actuator rod is biased in one of the first and second actuator rod positions by a spring.

26. An actuator assembly as inclaim 23

including a retraction member for moving the actuator rod from the second actuator rod position back to the first actuator rod position.

27. An actuator assembly as inclaim 23

wherein the electrode advancer mandrel includes a sear for cooperating with the locking element.

28. An actuator assembly as inclaim 27

wherein the locking element includes a sear release member for restraining and releasing the sear.

29. An actuator assembly as inclaim 28

further comprising a sear latch, the sear latch being moved from a first sear latch position to a second sear latch position to move the sear release.

30. An actuator assembly as inclaim 23

wherein the locking element is biased in a latched position.

31. An actuator assembly as inclaim 30

wherein a spring biases the locking element in the latched position.

32. An actuator assembly as inclaim 23

further including an actuator spring, the actuator rod applying a force to the actuator spring when the actuator rod is moved from the first actuator rod position to the second actuator rod position.

33. An actuator assembly as inclaim 32

wherein the locking mechanism holds the electrode advancer mandrel in at least one of the first and second electrode advancer mandrel position against the force of the actuator spring.

34. An actuator assembly as inclaim 32

wherein the actuator spring is a compression spring.

35. An actuator system for deploying an electrode from a catheter assembly comprising

a handle having a trigger lever and adapted to carry an actuator rod,

a pinion carried by the trigger lever,

a rack carried by the actuator rod, the pinion engaging the rack upon compression of the trigger lever to move the rack along the actuator rod between a first actuator rod position and a second actuator rod position,

the actuator rod applying a force to an electrode advancer mandrel when the actuator rod is moved between the first actuator rod position and the second actuator rod position, and

the electrode advancer mandrel being adapted to move the electrode between a first retracted position and a second extended position.

36. An actuator system as inclaim 35

wherein the actuator rod is biased in one of the first and second actuator rod positions.

37. An actuator system as inclaim 35

wherein the actuator rod is biased in one of the first and second actuator rod positions by a spring.

38. An actuator assembly as inclaim 35

including a retraction member for moving the actuator rod from the second actuator rod position back to the first actuator rod position.

39. An actuator system as inclaim 35, further comprising

a locking element for locking the electrode advancer mandrel in at least one of the first and second electrode advancer mandrel positions.

40. An actuator system as inclaim 39

wherein the locking element is spring-loaded.

41. An actuator system as inclaim 39

wherein the locking element is biased in a latched position.

42. An actuator system as inclaim 41

wherein a spring biases the locking element in the latched position.

43. An actuator system as inclaim 39

wherein the electrode advancer mandrel includes a sear for cooperating with the locking element.

44. An actuator system as inclaim 43

wherein the locking element includes a sear release member for restraining and releasing the sear.

45. An actuator system as inclaim 44

further comprising a sear latch, the sear latch being moved from a first sear latch position to a second sear latch position to move the sear release.

46. An actuator assembly as inclaim 37

further including an actuator spring, the actuator rod applying a force to the actuator spring when the actuator rod is moved from the first actuator rod position to the second actuator rod position.

47. An actuator assembly as inclaim 46

wherein the locking mechanism holds the electrode advancer mandrel in at least one of the first and second electrode advancer mandrel positions against the force of the actuator spring.

48. An actuator assembly as inclaim 46

wherein the actuator spring is a compression spring.

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