US20140288556A1 - Cardiac ablation systems and methods - Google Patents

Abstract

Cardiac ablation systems and methods of their use and manufacture involve an ablation mechanism, a stabilizer mechanism, and a cinching mechanism that urges the ablation mechanism toward a patient tissue. Embodiments encompass methods for administering epicardial and endocardial lesions, including box lesions and connecting lesions, to patient tissue.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 12/124,743, filed on May 21, 2008, which claims the benefit of U.S. Provisional Patent Application No. 60/939,201 filed May 21, 2007. This application is also related to U.S. Provisional Patent Application No. 61/015,472 filed Dec. 20, 2007. The entire disclosure of each of these filings is incorporated herein by reference for all purposes.
BACKGROUND OF THE INVENTION
• Embodiments of the present invention related to medical devices and methods, and in particular to cardiac ablation systems and methods.
• Certain cardiac surgical procedures involve administering ablative energy to the cardiac tissue in an attempt to create a transmural lesion on the tissue. However, in some cases such methods may not be optimal due to the formation of incomplete lesions, which do not effectively create a conduction block in the tissue. Hence, there continues to be a need for improved systems and methods that can deliver ablative energy to patient tissue in a uniform and reproducible manner.
• Embodiments of the present invention provide solutions to at least some of these outstanding needs.
BRIEF SUMMARY OF THE INVENTION
• Advantageously, embodiments of the present invention provide techniques for applying circumferential lesions to the pulmonary vein (PV) ostia to cause conduction block at the junction of the PV and left atrium as well as other blocking lesions. Such techniques are well suited for use with patients presenting with paroxysmal (focal) atrial fibrillation. Exemplary embodiments involve the administration of precisely controlled ablative energy to create reproducible, uniform transmural lesions during cardiac surgery. Such techniques enable rapid and effective ablative lesions in a variety of clinical situations, including endocardial and epicardial ablations. By forming the transmural ablations, surgeons are able to achieve conduction block in the patient.
• Embodiments of the present invention include introducer systems and instruments equipped with magnetic elements that facilitate one-sided port introduction and can reduce procedure times significantly, in many cases to less than one hour. Embodiments also provide systems with flexible suction probes or stabilizer mechanisms that can be used in conjunction with cinching mechanisms or delivery tubes, which are well suited for use on any patient tissue or anatomy of any size or shape. Cinching mechanisms facilitate length adjustability for variable atria lesion sizes and box lesion sizes, for example. Hence, it is possible to form a complete box lesion with a single device placement with minimal or no gaps. In some embodiments, techniques involve unilateral 10 mm port access. Systems and methods disclosed herein are also well suited for creating Cox Maze lesions. For example, a single device can be used to create a transmural box lesion and a connecting lesion. In some embodiments, a surgeon or operator can use a cinching mechanism such as a delivery or push tube as a placement wand. Suction stabilizer mechanisms can be operatively associated with cinching mechanisms such as delivery tubes to facilitate length adjustability of a stabilizer mechanism, an ablation mechanism, or both. Improved coupling techniques for introducers and introducer retrievers can vastly improve introducer search times, which often can occupy more than half of the entire procedure time. Introducers, stabilizer and ablation assemblies, and other components of the treatment systems described herein can have curved configurations, such as helical curves, for improved routing into the oblique sinus from a transverse sinus, for example. Embodiments also provide single step continuity, whereby a cinching delivery mechanism can easily be used to snare a distal tape to form a continuous box lesion without the need for repositioning or additional instruments. Advantageously, embodiments of the present invention can be used to create complete lesion sets and reliably produce transmural lesions on a beating heart.
• Embodiments also includes ablation systems having an ablation energy source for providing energy to the ablation device. An ablation energy source is typically suited for use with ablation apparatus as described herein using RF energy. With regard to RF ablation, a typical RF ablation system includes a RF generator which feeds current to an ablation device, including those described in this application, containing a conductive electrode for contacting targeted tissue. The electrical circuit can be completed by a return path to the RF generator, provided through the patient and a large conductive plate, which is typically in contact with the patient's back. Embodiments encompass ablation using RF electrodes, including single RF ablation electrodes. Although ablation energy is often described herein in terms of RF energy, it is understood that embodiments are not limited to such ablation modalities, and other kinds of ablation energy sources and ablation devices may be used. Hence, with regard to the ablation techniques disclosed herein, other suitable ablation elements or mechanisms, instead or in addition to an RF electrode, can be used. Embodiments of the present invention therefore encompass any of a variety of ablation techniques, including without limitation infrared lasers, high intensity focused ultrasound (HIFU), microwave, cryoablation (killing or damaging the tissue by freezing), chemical or biological agents, radiation, and the like. In some cases, an ablation mechanism can include an ablation element that transmits or delivers RF energy to patient tissue. Optionally, suitable ablation elements can transmit or deliver infrared laser energy, high intensity focused ultrasound (HIFU) energy, microwave energy, cryoablation energy, chemical agents, biological agents, radiation energy, and the like. Embodiments encompass ablation mechanisms having multiple ablation elements, such as multiple RF electrodes. According to some embodiments, an ablation element may include a monopolar electrode. Relatedly, an ablation element may include a bipolar electrode.
• In one aspect, embodiments of the present invention provide systems for administering an ablation treatment to a patient. Systems may include an ablation assembly having a flexible ablation mechanism configured to ablate a tissue of the patient, and a cinching mechanism configured to constrict the ablation member about the patient tissue. Systems may include a stabilizer mechanism that forms a seal with the tissue of the patient. The ablation mechanism may be at least partially disposed within a recess of the stabilizer member. The cinching mechanism can be configured to cinch the ablation assembly about the patient tissue in a circumferential path. In some cases, a system includes an introducer which may be coupled with the ablation assembly. In some cases, the introducer may include a ribbon or tape. A cinching mechanism may include a trocar, a push tube, a roller, a guide or catch, a breakaway tip, a hinge, or any combination thereof. In some cases, an ablation mechanism includes an electrode.
• In another aspect, embodiments of the present invention encompass methods for ablating a tissue, such as a cardiac tissue, of a patient. Methods may include placing an ablation assembly near the tissue of the patient, cinching the ablation assembly so as to urge an ablation mechanism toward the tissue, and administering an ablation to the tissue via the ablation mechanism to create a lesion in the tissue. In some cases, methods may include forming a transmural lesion, such as a box lesion or a connecting lesion, in cardiac tissue. For example, methods may include creating a lesion in the form of a closed path. According to some methods, an ablation assembly can be disposed at least partially within a stabilizer assembly, and the method may include forming a seal between the stabilizer assembly and the cardiac tissue. Methods may also involve urging the ablation mechanism toward cardiac tissue with a cinching mechanism.
• In some aspects, embodiments encompass systems and methods for treating an epicardial or endocardial tissue of a patient. Exemplary methods may include placing a treatment assembly near the epicardial tissue of the patient, wrapping an ablation mechanism of the treatment assembly about a portion of the epicardial tissue such that the ablation mechanism is disposed near at least one pulmonary vein of the patient, cinching the ablation mechanism toward the epicardial tissue, and delivering an ablative treatment through the ablation mechanism of the ablation assembly toward the epicardial tissue, so as to form a lesion on the epicardial tissue. Some methods may involve creating a seal between the epicardial tissue and a stabilizer mechanism of the treatment assembly. In some cases, the process of placing the ablation mechanism near the epicardial tissue of the patient includes passing the ablation mechanism through a transverse sinus of the patient, through an oblique sinus of the patient, or through both. Methods may include forming or creating a conduction block at a junction of left atrium and a pulmonary vein.
• In another aspect, embodiments encompass systems for administering an ablation treatment to a patient tissue. Systems may include a treatment assembly having a stabilizer mechanism and a flexible ablation mechanism configured to ablate a tissue of the patient. Systems may also include a cinching mechanism configured to constrict the ablation mechanism about the patient tissue. A stabilizer mechanism may include a series of undulating projections. In some case, a stabilizer mechanism includes a body coupled with two opposing sidewalls forming a recess. In some cases, an ablation mechanism is at least partially disposed within the recess of the stabilizer mechanism. A stabilizer mechanism may include a memory shape configuration having a bend. According to some embodiments, a sidewall of the stabilizer mechanism may include a first flap and a second flap that can overlap each other when the stabilizer mechanism is in a bent configuration. In some cases, a stabilizer mechanism includes a tension member. Optionally, a tension member may be disposed within, or at least partially within, a sidewall of the stabilizer mechanism. In some embodiments, a tension member can be disposed within a ridge coupled with or on a sidewall of the stabilizer mechanism. In some cases, a tension member includes a tension strap or a tension cord. Optionally, the body of the stabilizer mechanism may include a one or more support ribs. Relatedly, the body of the stabilizer mechanism may include a thin elastic membrane disposed between two adjacent support ribs. In some cases, a body of the stabilizer mechanism includes a channel configured to receive an obturator. A stabilizer mechanism may be coupled with the ablation mechanism via a loop. A stabilizer mechanism may be coupled with the ablation mechanism via a partial loop. A stabilizer mechanism may be coupled with the ablation mechanism via an adhesive or bonding material.
• In still another aspect, embodiments of the present invention encompass methods for administering an ablation to a patient. Methods may involve placing a treatment assembly near tissue of the patient. The treatment assembly may include a monopolar ablation mechanism and a stabilizer mechanism that presents a suction zone. Methods may also include adjusting a size of the suction zone, and administering an ablation to the tissue via the monopolar ablation mechanism to create a lesion in the tissue. In some cases, the procedure of adjusting the size of the suction zone includes extending a distal portion of the treatment assembly from a cinching mechanism, or retracting a distal a distal portion of the treatment assembly toward the cinching mechanism. In some cases, a cinching mechanism includes a push tube.
• In yet a further aspect, embodiments of the present invention include systems for administering an ablation treatment to a patient tissue. Systems may include a treatment assembly having a stabilizer mechanism and a flexible ablation mechanism configured to ablate a tissue of the patient. Systems may also include a cinching mechanism configured to urge the ablation mechanism toward the patient tissue. A stabilizer mechanism may include an adjustable suction zone. Optionally, a stabilizer mechanism can include a series of undulating projections.
• In another aspect, embodiments of the present invention encompass ablation treatment systems that include an ablation assembly having a flexible ablation member configured to deliver an ablation energy to a tissue of the patient, and a stabilizer member configured to create a seal against the tissue of the patient. Such treatment systems can also include a cinching member that engages the ablation assembly and cinches the ablation assembly about the patient tissue in a circumferential path. In some cases, the ablation member comprises an electrode. The cinching member can include a roller, an ablation segment, a delivery tube, or an ablation protection mechanism, or any combination thereof. Embodiments also encompass methods for delivering an ablative energy to a cardiac tissue. An exemplary method includes placing an ablation assembly against the cardiac tissue of the patient, where the ablation assembly has a stabilizer member coupled with an ablation member, securing the stabilizer member with the patient tissue via a vacuum, and administering the ablative energy to the cardiac tissue via the ablation member to create a transmural lesion in the cardiac tissue. Optionally, methods may include cinching, binding, or squeezing the ablation assembly or ablation member about the cardiac tissue. In some methods, a transmural lesion is formed in the shape of a closed path. Some methods involve contacting a cinching device with the ablation assembly, and cinching the ablation device about the cardiac tissue with the cinching device. Some methods involve separating a proximal section of an ablation member from a distal section of the ablation member with an ablation member protection mechanism.
• In still a further aspect, embodiments of the present invention include systems and methods for treating an epicardial tissue of a patient. An exemplary method may include placing an ablation system near an epicardial tissue of the patient, and wrapping an ablation assembly of the ablation system about a portion of the epicardial tissue, where the ablation assembly includes a stabilizer member and an ablation member. Methods may also include cinching a loop structure of the ablation assembly against the epicardial tissue, securing the ablation assembly against the epicardial tissue by creating a seal between the stabilizer member and the epicardial tissue, and delivering an ablative energy through the ablation member of the ablation assembly toward the epicardial tissue, so as to form a closed path lesion on the epicardial tissue. Some methods involve passing a distal section of the ablation assembly through a catch disposed on a proximal section of the ablation assembly.
• For a fuller understanding of the nature and advantages of the present invention, reference should be had to the ensuing detailed description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1A illustrates exemplary lesion patterns on a patient heart according to embodiments of the present invention.
• FIG. 1B illustrates aspects of a box lesion according to embodiments of the present invention.
• FIGS. 2A-2C illustrate aspects of a spring-loaded free-tip electrode according to embodiments of the present invention.
• FIGS. 3A-3B show aspects of a flexible backbone configuration according to embodiments of the present invention.
• FIGS. 4A-4E show aspects of an obturator ablation system according to embodiments of the present invention.
• FIGS. 5A-5G show aspects of an obturator ablation system according to embodiments of the present invention.
• FIGS. 6A-6D illustrate aspects of an ablation system having a cinching device according to embodiments of the present invention.
• FIGS. 7A-7C show aspects of ablation system having a cinching device with guides according to embodiments of the present invention.
• FIGS. 8A-8E show aspects of an ablation system having a loop mechanism according to embodiments of the present invention.
• FIGS. 9A-9D show aspects of an ablation system having a flexible device with a breakaway tip according to embodiments of the present invention.
• FIGS. 10A-10F show aspects of an ablation system with a stabilizer mechanism according to embodiments of the present invention.
• FIGS. 11A-11C show aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIGS. 12A-12C show aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIGS. 13A-13C show aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIGS. 14A-14B show aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIGS. 15A-15C show aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIGS. 16A-16C depict aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIGS. 17A-17F show aspects of an ablation system with a cinching mechanism according to embodiments of the present invention.
• FIGS. 18A-18E show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 19A-19F show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 20A-20B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 21A-21B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 22A-22B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 23A-23B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 24A-24C show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 25A-25B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 26A-26B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIG. 27 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIGS. 28A-28C show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 29A-29C show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 30A-30B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIG. 31 shows aspects of an ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 32A-32D show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 33A-33J show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 34A-34E show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 35A-35G show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 36A-36C show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 37A-37C show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIGS. 38A-38B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIG. 39 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 40 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 41 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 42 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 43 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 44 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 45 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 46 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 47 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 48 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 49 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 50 shows aspects of an ablation system with a stabilizer member according to embodiments of the present invention.
• FIG. 51 shows aspects of an ablation system with a pusher according to embodiments of the present invention.
• FIG. 52 shows aspects of an ablation system with a visualization system according to embodiments of the present invention.
• FIG. 53 shows aspects of an ablation system with a visualization system according to embodiments of the present invention.
• FIG. 54 shows aspects of an ablation system with a visualization system according to embodiments of the present invention.
• FIGS. 55A-55B show aspects of ablation systems with a visualization system according to embodiments of the present invention.
• FIGS. 56A-56B show aspects of ablation systems with a visualization system according to embodiments of the present invention.
• FIG. 57 shows aspects of an ablation system with a visualization system according to embodiments of the present invention.
• FIGS. 58A-58C show aspects of ablation systems with a visualization system according to embodiments of the present invention.
• FIGS. 59A-59D show aspects of ablation systems with a visualization system according to embodiments of the present invention.
• FIGS. 60A-60B show aspects of ablation systems with a visualization system according to embodiments of the present invention.
• FIGS. 61A-61B show aspects of ablation systems with a visualization system according to embodiments of the present invention.
• FIGS. 62A-62E show aspects of ablation systems forming a loop closure according to embodiments of the present invention.
• FIGS. 63A-63F show aspects of ablation systems forming a loop enclosure according to embodiments of the present invention.
• FIG. 64 shows aspects of an ablation system relating to form oval, teardrop, or other loop enclosure configurations according to embodiments of the present invention.
• FIG. 65 shows aspects of an ablation system relating to oval, teardrop, or other loop enclosure configurations according to embodiments of the present invention.
• FIGS. 66A-66C show aspects of ablation systems relating to oval, teardrop, or other loop enclosure configurations according to embodiments of the present invention.
• FIG. 67 shows aspects of an ablation system with an introducer according to embodiments of the present invention.
• FIGS. 68A-68B show aspects of ablation systems with an introducer according to embodiments of the present invention.
• FIG. 69 shows aspects of an ablation system with a stabilizer mechanism according to embodiments of the present invention.
• FIG. 70 shows aspects of an ablation system with a stabilizer mechanism according to embodiments of the present invention.
• FIG. 71 shows aspects of an ablation system with a stabilizer mechanism according to embodiments of the present invention.
• FIG. 72 shows aspects of an ablation system with a stabilizer mechanism according to embodiments of the present invention.
• FIG. 73 shows aspects of an ablation system with a stabilizer mechanism according to embodiments of the present invention.
• FIGS. 74A-74B show aspects of ablation systems with a stabilizer mechanism according to embodiments of the present invention.
• FIGS. 75A-75B show aspects of ablation systems with a stabilizer mechanism according to embodiments of the present invention.
• FIGS. 76A-76F show aspects of ablation systems with a coupling mechanism according to embodiments of the present invention.
• FIG. 77 shows aspects of an ablation system with an introducer according to embodiments of the present invention.
• FIGS. 78A-78D show aspects of ablation systems with a stabilizer mechanism according to embodiments of the present invention.
• FIG. 79 shows aspects of an ablation system with a coupling mechanism according to embodiments of the present invention.
• FIG. 80 shows aspects of an ablation system with a coupling mechanism according to embodiments of the present invention.
• FIG. 80A shows aspects of a coupling mechanism of an ablation system according to embodiments of the present invention.
• FIG. 81 shows aspects of an ablation system with a coupling mechanism according to embodiments of the present invention.
• FIGS. 82A-82F show aspects of ablation systems with an introducer system according to embodiments of the present invention.
• FIGS. 83A-83F show aspects of ablation systems with an introducer system according to embodiments of the present invention.
• FIGS. 84A-84F show aspects of ablation systems with an introducer system according to embodiments of the present invention.
• FIGS. 85A-85F show aspects of ablation systems with an introducer system according to embodiments of the present invention.
• FIGS. 86A-86B show aspects of ablation systems with a stabilizer member according to embodiments of the present invention.
• FIG. 87 shows aspects of an ablation system with a stabilizer assembly according to embodiments of the present invention.
• FIG. 88 shows aspects of an ablation system with a stabilizer assembly according to embodiments of the present invention.
• FIG. 89 shows aspects of an ablation system with a stabilizer assembly according to embodiments of the present invention.
• FIGS. 90A-90J show aspects of ablation systems with a stabilizer assembly according to embodiments of the present invention.
• FIG. 91 shows aspects of an ablation system with a stabilizer assembly according to embodiments of the present invention.
• FIGS. 92A-92F show examples of various lesion subsets that can be formed by ablation systems according to embodiments of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
• Embodiments of the present invention are well suited for ablating epicardial and other tissue of a patient in need thereof. Exemplary techniques involve placing an ablation system near cardiac tissue of the patient, and can also involve wrapping an ablation assembly of the ablation system about at least a portion of the tissue. The ablation assembly may include a stabilizer member, an ablation member, or both. Techniques can also include cinching or tightening the ablation assembly against the tissue, and optionally securing the ablation assembly against epicardial tissue by creating a seal between a stabilizer member and the tissue. Such approaches also include delivering an ablative energy or procedure through the ablation member to the tissue, so as to form a closed or substantially closed path lesion on the tissue. Embodiments provide various desirable techniques for constricting or tightening an ablation member about or against a patient tissue. Systems and methods can be used to create tissue ablations such as those described in U.S. Pat. Nos. 6,241,754 and 7,115,122, the content of which is incorporated herein by reference.
• Turning now to the drawings,FIG. 1A illustrates exemplary lesion patterns on a posterior aspect, or base, of apatient heart100, according to embodiments of the present invention.Patient heart100 includes a rightpulmonary artery101, a leftpulmonary artery102, a left atrial appendage (LAA)103, a left superior pulmonary vein (PV)104, a left atrium (LA)105, a left inferior pulmonary vein (PV)106, aleft ventricle107, anaortic arch108, a right atrial appendage (RAA)109, a superior vena cava (SVC)110, a right superior pulmonary vein (PV)111, a right atrium (RA)112, a right inferior pulmonary vein (PV)113, an inferior vena cava (IVC)114, a right ventricle115, and a coronary sinus (CS)116. The dashed lines “- - - -” can represent one or more transmural burn zones on tissue of the heart. For example,lesion120 represents a left atrial appendage (LAA) connecting lesion,lesion130 represents a circumferential lesion, or box lesion, about the pulmonary vein (PV) ostia, lesion140 represents a juxta coronary sinus (CS) lesion, lesion150 represents a transverse right atrium (RA) lesion,lesion160 represents an intra-cava lesion, andlesion170 represents a right atrial lesion.FIG. 1B illustrates another view of a circum-pv lesion130, or box lesion, which can be applied contiguously, or without a break, around the pulmonary veins. In some cases, a circum-pv lesion130 length can be within a range from about 18.5 cm to about 22 cm. A cardiothoracic surgical procedure may involve a left thoracotomy approach. Some surgical procedures involve shape-biased suction.
• FIGS. 2A-2C illustrate aspects of a spring-loaded free-tip electrode, according to embodiments of the present invention.FIG. 2A shows anablation system200 that involves a sheath containing a free tip in a parallel position.System200 includes adistal end210, aproximal end220, asheath230, adistal element240, atip270, and atrunk section280. In some embodiments,system200 may optionally include a formed or preformed bend orcurve260.Ablation system200 also includes anablation member290 in operative association with a placement orstabilizer member295. Further,ablation system200 can include one or more curvable sections or portions than can conform to the shape of any of a variety of tissue surfaces. For example, a curvable portion may be disposed along a length of the ablation system, between a location neardistal end210 and a location nearproximal end220. In some cases, a curvable portion may include a formedbend260.Tip270 may be biased to extend laterally or away fromtrunk section280, and can be constrained bysheath230 so as to be aligned in parallel withtrunk section280. In use, an operator or surgeon can advance adistal end210 ofsystem200 around a tissue ororgan250 such as a heart, as depicted by A arrows. For example, a surgeon can advancesystem200 through or near a transversepericardial sinus252, circumferentially around thepulmonary veins254, and through or near an obliquepericardial sinus256. The operator can facilitate placement ofsystem200 by engaging or graspingdistal element240 and maneuveringdistal end210. In some embodiments,distal element240 includes a string or tape which the operator can grasp with a maneuvering mechanism such as a pair of forceps. Optionally,distal end portion210 may include a magnetic material or a material that can be attracted by a magnet, such as iron or steel. In some cases, ablation system can be used in conjunction with an introducer obturator system, and discussed elsewhere herein. As depicted inFIG. 2B,ablation system200 can be further wrapped aroundtissue250, as depicted by B arrow, such thatbend260 is disposed at or near the tissue. As shown here, the contour ofbend260 is similar to or conforms with the shape of thetissue250. Bend260 can include a molded curve. In some cases, a molded-in curve presents a tight radius. As shown inFIG. 2C,sheath230 can be partially retracted, withdrawn, or translated longitudinally relative to other elements of the system as indicated by arrow C, andfree tip270 can pop out into a functional position. For example,tip270 can be biased so that when constraining forces provided bysheath230 are removed,tip270 can extend away fromtrunk280 and adopt a shape that conforms with or is similar to the shape oftissue250. Optionally, this shape can be a preformed or memory shape. The shape may present a radius of curvature in a range from 0.25″ R to 0.3″ R, for example. In some cases, the curvature might be similar to bend260 such that it also conforms with the shape of thetissue250. In this way,ablation system200 forms aloop structure245 that can be used to administer a circular or closed ablation treatment to the patient. Releasingtip270 from the stressed or high energy state, and allowing it to adopt a more low energy state, operates to cinch or tighten an ablation element toward the patient tissue. By encircling or enclosing portion of the patient tissue, the operator can apply energy to create closed ablation pattern. If needed or desired, the operator can adjust the shape or overall circumference ofloop structure245, and therefore can adjust the shape or overall circumference of a box lesion that is formed in the tissue. As noted above,ablation system200 includes anablation member290 in operative association with a placement orstabilizer member295.Placement member295 can assist in holdingablation member290 against or neartissue250 so as to enhance lesion formation. In some embodiments,ablation member290 includes a radiofrequency cable, andplacement member295 includes a suction tube.Ablation system200 is well suited for use in creating transmural ablations that extend through or affect the entire thickness of a tissue wall, for example.
• As noted above, an ablation system can have a plurality of curvable or deformable portions or sections. Curvable sections can facilitate the placement of the ablation system on the tissue.FIGS. 3A and 3B show aspects of a flexible backbone configuration according to embodiments of the present invention.FIG. 3A shows a side-view cross-section of a curvable section300aof an ablation system according to some embodiments. Curvable section300aincludes an ablation member310a, such as an electrode, in operative association with a placement orstabilizer member320a. In this embodiment, curvable section300apresents a flex center-line330awhich is co-axially aligned with the ablation member310a. For example, a centrallongitudinal axis340aof ablation member310acan be aligned with flex center-line330aof curvable section300a. In some cases, the bending center of mass of the curvable section can be aligned with the bending center of mass of the ablation member. Stabilizer member orbackbone320acan include or provide a suction mechanism that allows a surgeon to securely apply the ablation system to a patient tissue. As seen here, the cross-section ofstabilizer member320apresents a serpentine or accordion-like configuration. The profile of the stabilizer member presents a series of undulating, or rising and falling, wave-like projections. The undulating accordion-like configuration allows the stabilizer to be placed against or near any of a variety of curved or irregular surfaces without inducing or increasing distortion or buckling in the stabilizer, as discussed elsewhere herein. Relatedly, the accordion-like configuration can prevent or inhibit distortion or buckling in a molded bend portion of a stabilizer member. Such distortion or buckling can lead to the development of air gaps along the length of the stabilizer member, between the stabilizer member and the patient tissue. Hence, the buckling may prevent a desired seal from forming between the stabilizer member and the patient tissue. The corrugated profile ofstabilizer member320acan reduce the amount of residual stress that may otherwise be created when the stabilizer member is bent. The application of increasing amounts of suction can help to offset of overcome the effects of such residual stress. Hence, relatively little or no suction may be needed to conform the stabilizer with a curved tissue surface when thestabilizer member320ais sufficiently flexible, and this corrugated profile can significantly contribute to such flexibility. In general, is it often desirable to avoid or minimize deformations in the sealing members, whether induced by motion or inherent in the shape of the stabilizer, so that a seal can be created and also so that the seal can be maintained when ‘gross scale’ pushing or tugging movements on the system are incidentally produced during a procedure. In some cases, a curvable portion having a first flexibility over the length of the curvable portion can include a molded curve that has a flexibility over the length of the molded bend, where the length of the curvable portion is greater than the length of the molded bend, and the flexibility over the length of the curvable portion is greater than the flexibility over the length of the molded bend.
• FIG. 3B shows a side-view cross-section of acurvable section300bof an ablation system according to some embodiments.Curvable section300bincludes anablation member310b, such as an electrode, in operative association with a placement orstabilizer member320b. In this embodiment,curvable section300bpresents a flex center-line330bwhich is axially offset with theablation member310b. For example, a centrallongitudinal axis340bofablation member310bcan parallel or substantially parallel to, but axially offset from, flex center-line330bofcurvable section300b. As shown here,curvable section300bincludes one ormore attachment members350b, such as o-rings, whichcouple ablation member310bwithstabilizer member320b. In some embodiments, an attachment member includes silicone retention loop. An attachment member can include a partial ring that is coupled with the ablation member and the stabilizer member. For example, an attachment member can include one half of an o-ring, or a 210 degree section of an o-ring. In some cases, the o-ring may contact the tissue during treatment. Due to current spread, convective heat, and wedge effects, an ablation system can deliver ablative treatment to patient tissue even where an ablation member is separated from the patient tissue by an attachment member.Stabilizer member320bcan include a suction mechanism that allows a surgeon to securely apply the ablation system to a patient tissue.
• FIGS. 4A-4E show aspects of an obturator ablation system according to embodiments of the present invention. In some cases, an obturator system can include an over-wrapped mold with double obturators. An obturator ablation system can also include an ablation member and a stabilizer member. As shown inFIG. 4A, anobturator system component450 can present a standard shape, and a curved length can provide a “push-pull” ability. The hash marks indicate the location or presence of an ablation member, such as an electrode, on that side of the system. As shown inFIG. 4B, in someembodiments obturator system450 includes a pair of curved obturators orstylets410,420 which an operator can slide into a receptacle or hole of a stabilizer member of the obturator system.Preformed obturators410,420 can haveproximal handles414,424, and can present opposing distal bends or moldedshapes412,422. Typically, the obturators or stylets are more rigid than the stabilizer member. Thus, the preformed stylets are inserted into a flexible stabilizer member, the stabilizer member conforms with the shape of the stylets. As shown inFIG. 4C, an obturator can be advanced into a stabilizer member to a depth so as to curve or form the flexible stabilizer or suction member into close proximity with itself atlocation470. In some cases,location470 may be disposed on the side of the left atrium (LA) nearest to a thoracotomy. The obturator ablation system can be used within a patient in accordance with the techniques described in U.S. Provisional Patent Application No. 61/015,472 filed Dec. 20, 2007, the contents of which are incorporated herein by reference for all purposes. It is further understood that in some cases the obturators can be inserted one at a time into the stabilizer after the stabilizer is routed around the tissue.Obturators410,420 can be advanced or retracted relative to the stabilizer member to shorten or lengthen thelength430 of a loop orrace track structure480. For example, an operator can advance the obturators toward the patient tissue by grasping and pushinghandles414,424 in the direction indicated by arrows B. Similarly, the operator can fix or retract the stabilizer member relative to the obturators by grasping and holding or pulling end portions456,458 of the stabilizer member as indicated by arrows C. In this way, the operator can slide the obturators deeper into the stabilizer member so as to adjust the configuration ofloop structure480. When the configuration ofloop structure480 is adjusted as desired or needed and the ablation member is placed at or near the tissue, the operator can transmit ablative energy through the obturator ablation system to create a box lesion attissue440.
• FIG. 4D shows a cross-section view of a portion A-A ofFIG. 4A. As depicted here, astabilizer member490 ofablation system450 includes a hole, receptacle, orchannel452 that is configured to receive an obturator, and a recess orreceptacle454 that is configured to receive an ablation member ormechanism460 which may include anelectrode465. In some cases,electrode465 is exposed at one or more locations. Ablation member ormechanism460 may include or be coupled with an intermittent loop, such as an o-ring, that is attached to or coupled withmember490 and holdselectrode465 in a desired orientation. According to the embodiment shown inFIG. 4E, anobturator495 can present a double shish kabob configuration having a single handle496, or alternatively two handles, and two preformed tongs498a,498b. Such a configuration can have pivots where tongs cross497 or at another spot or in multiple spots to provide a spreading or clamping action at the pulmonary veins. Pivoted designs can enable the operator to squeeze theobturators495 together to produce a similar motion at tongs498aand498binside the body. Multiple pivots may give a ‘motion vs. distance traveled’ advantage or a lower profile outside the body. According to some embodiments, an unpivoted design can produce the opposite motion at the tongs such that a spreading motion ofobturators495 outside the body produce a squeezing motion at the tongs.
• FIGS. 5A-5G show aspects of an obturator ablation system according to embodiments of the present invention. Such systems can involve a stationary curve based on a steerable sheath and an obturator.FIG. 5A illustrates anobturator510 having a handle512 coupled with a tong513. As shown here, preformed tong513 includes a preformed bend514.FIG. 5B illustrates asteerable sheath520 having ahandle522 and aflexible casing524. The flexible casing may include a preformed curve or bend526. As depicted inFIG. 5C, an operator can construct theobturator assembly500 by inserting obturator tong513 intosheath520. Typically, the obturator tong is more rigid than the sheath casing. Accordingly, the shape ofcasing524 can conforms with the shape of the bent tong, so as to provide acomplementary bend524 in the casing. In some cases, both an obturator and a steerable sheath can be provided in a pre-assembled configuration. As depicted inFIG. 5D, an ablation system can slide over the combined sheath and obturator, so as to create a bend544 in the ablation system. Theablation system540 can be inserted across the left atrium of a patient's heart. An operator can facilitate placement ofablation system540 by engaging or graspingdistal element560 and maneuvering a systemdistal end550. In some embodiments, distal or graspingelement560 includes a string or tape which the operator can grasp with a maneuvering mechanism such as a pair of forceps.FIG. 5E shows thatdistal end550 can be advanced or steered as depicted by arrow E. In this way,ablation system540 can be further wrapped around a patient tissue565, such that the bend is disposed at or near the tissue. As shown here, the contour of the bend is similar to or conforms with the shape of the tissue565. As shown inFIG. 5F, it is possible to slide the device around a curve, for example around atissue550, as depicted by arrows F. According toFIG. 5G, a distal end of the assembly or system can be pushed in to make or enhance tissue contact. The obturator can be pushed or manipulated to move the curve against one or more PVs. The obturator ablation system can be used within a patient in accordance with the techniques described in U.S. Provisional Patent Application No. 61/015,472 filed Dec. 20, 2007, the contents of which are incorporated herein by reference for all purposes.
• FIGS. 6A-6D illustrate aspects of an ablation system according to embodiments of the present invention.FIG. 6A shows that anablation system600 can be wrapped around apatient tissue605, such as a heart or other cardiovascular tissue, and adistal end610 of the system can be pulled or passed through acinching device620.Ablation system600 includes aflexible ablation assembly615 and acinching device620.Ablation assembly615 can be used to deliver energy to thepatient tissue605 in order to ablate the tissue. In some embodiments,ablation assembly615 includes anablation member616, such as an electrode, coupled with a stabilizer member orbackbone617. In some embodiments,ablation assembly615 might include any suitable ablation mechanism designed to deliver different forms of energy, including, but without limitation to, RF, thermoelectric, cryogenic, microwave, laser, ultrasound or the like. In some embodiments,stabilizer member617 includes a flexible backbone member coupled with the ablation member. An operator can use cinchingdevice620 to help increase or modulate the amount of contact betweenablation member616 and thepatient tissue605.Cinching device620 may come in many different configurations and is not limited to those depicted in the figures. As shown here, cinchingdevice620 can include tworollers630, coupled with a support orsupport plate635. In some embodiments,support635 may include one or more support plates. In some embodiments, cinchingdevice620 may include a plurality ofrollers630. Optionally, cinchingdevice620 may include a first support and a second support plate, and a plurality of rollers disposed at least partially therebetween. Accordingly, support plates can provide support to the rollers. In some cases, elements of cinchingdevice620 may include insulating or non-conducting materials.
• In use, an operator can pass orplace ablation assembly615 through cinchingdevice620 between rollers630 a first time, as indicated by arrow A. The ablation assembly can then be wrapped around thepatient tissue605 as indicated by arrow B, anddistal end610 of the ablation assembly can then be pulled back or passed through cinchingdevice620 between rollers630 a second time, as indicated by arrow C. As shown here, anintermediate portion611 ofablation assembly615 can thus be wrapped aroundpatient tissue605, which may include a heart or other cardiovascular tissue, anddistal end610 of theablation assembly615 can be pulled or placed through cinchingdevice620 such thatablation assembly615 forms aloop structure619.
• As depicted inFIG. 6B, a loop structure around the patient tissue can be tightened by a cinching procedure, for example by advancing the cinching device toward the tissue.Loop structure619, which typically includesintermediate portion611, can be tightened around thepatient tissue605 by advancing thecinching device620 along theablation assembly615, as indicated by arrow D. For example, an operator can grasp or control a handle or pull rod622 of cinchingdevice620 so as to move the handle toward the tissue as indicated by arrow E. Relatedly, an operator can grasp orcontrol section610 orsection612 ofablation assembly615, or both, so as to positionally fixablation assembly615 or provide an opposing force to the handle operation described above, as indicated by arrow F.FIGS. 6C and 6D depict theablation system600 after thecinching device620 has been advanced even further alongablation assembly615 toward the tissue, so as to increase contact betweenablation assembly615 andpatient tissue605. Hence, when the operator hasposition cinching device620, the system is ready to have energy applied through theablation member616 ofablation assembly615, towardpatient tissue605. The operator can positionablation assembly615 to make contact with selected parts ofpatient tissue605 such that when ablative energy is transmitted through the ablation assembly, it is possible to create an approximately circular or closed ablation pattern or lesion on the tissue. In this way, energy can be applied by the ablation system to the tissue, as indicated byFIGS. 6C and 6D. The position of cinchingdevice620 relative toablation assembly615 can be adjusted by the operator. For example, the cinching device may be advanced or refracted to differing degrees in order to increase or decrease an amount of contact between the ablation assembly and the patient tissue. As shown inFIG.6D cinching device620 may pinch portions of the patient tissue if used or designed improperly due to improper positional placement, application of excessive force, or the like, as depicted by the cross sections of the compressed pulmonary veins. In some cases, the device may temporarily flatten a portion of the vessel walls together at the area where they join the atrial heart chamber so that a transmural lesion can be produced. According to some embodiments, the stabilizer placement may be preferably only on the atrial walls encircling the PVs, although this may not always be the case. If the suction stabilizer includes a portion of the root of one or more vessels as the stabilizer enters the cinching device, a continuous lesion may still be achieved by flattening the vessel walls together. For example, cinchingdevice620 may impinge upon pulmonary veins (PV) of the patient, so as to pinch or squeeze them to a teardrop or collapsed shape. In some cases, if the cinching device is not placed sufficiently close to the patient tissue or if the loop structure does not sufficiently encircle the patient tissue, a discontinuous gap will occur in the tissue lesion after the ablative energy is applied. In some embodiments, a deeply transmural technique can offset or minimize what could otherwise be significant gaps in an ablation pattern when released. According to some embodiments, a transmural lesion can be defined as a lesion that extends all the way through a tissue wall. In some cases, a transmural lesion guarantees a break in the propagation an the aberrant electrical signal. According to some embodiments, a surgical procedure can involve forming a lesion that is both transmural and continuous. If the device must cross the vessel even just partially, it may be desirable to collapse the walls to create transmurality across the double wall thicknesses. It may also be desirable to stay off the PV's proper but to create a lesion on the atria close to their ‘roots’.
• FIGS. 7A-7C show aspects of ablation systems according to embodiments of the present invention. Anablation system700ais depicted inFIG. 7A. Ablation system700 includes an ablation assembly715aand acinching device710a. Ablation assembly715aincludes an ablation member716aand astabilizer member717a.Cinching device710aincludes or is coupled with an ablation segment720asuch as a corner electrode.Cinching device710aincludes a support735aand one or more rollers730a. Ablation segment720acan be coupled with support735aas part of cinchingdevice710a. Ablation segment720amay be positioned on support735atoward a distal end of cinchingdevice710a, so that when an operator or surgeonadvances cinching device710atowards pulmonary veins (PV) of patient tissue705a, ablation segment720acan make contact with the atria adjacent to the pulmonary veins. In some embodiments, ablation segment720acan be used to help insure or increase the likelihood that the ablation system ablates the patient tissue705ain an approximate or complete circle or closed path around the patient tissue. Ablation segment720acan be designed to bridge the gap between opposing sides of ablation element716a, so that a loop structure is formed in more of a smooth circumferential path and in less of a teardrop shaped path. Ablation segment720acan thus be used to bridge a gap that might otherwise exist between ablation member715aand patient tissue705a. In some embodiments, ablation member716amay be coupled with ablation segment720a. In some embodiments, the ablation segment or member may include a material that is capable of transmitting different forms of energy, including but not limited to RF, thermoelectric, cryogenic, microwave, laser, ultrasound, or the like. In some embodiments, ablation segment720acan be positioned in order to inhibit the ablation assembly715afrom pinching the patient tissue705aas depicted inFIG. 6D.
• In some embodiments, the ablation segment720amay be shaped in order to maximize contact with the patient tissue705a. In some embodiments, the ablation segment720amay be shaped in order to minimize or reduce any pinching of the patient tissue705a.
• Ablation segment720amay be rigid in some embodiments. Ablation segment720amay be flexible in some embodiments. Ablation segment720amay make contact with the ablation member716a. Optionally, ablation segment720amay not make contact with the ablation member716a.Cinching device710acan be advanced in a direction toward the patient tissue705aas indicated by arrow A1, to increase the amount of contact betweenablation member717aand the patient tissue705aor to help secure the position ofablation member717arelative to patient tissue705a. Similarly, by advancingcinching device710ain this direction, an operator can increase the amount of contact between ablation segment720aand the patient tissue705aor help secure the position of ablation segment720arelative to patient tissue705a. The operator can also establish or apply an opposing force by grasping or pulling sections718a,719aof ablation assembly715ain an opposing direction, as indicated by arrows A2. The operator can position ablation assembly715ato make contact with selected parts of patient tissue705asuch that when ablative energy is transmitted through the ablation assembly, it is possible to create an approximately circular or closed ablation pattern or lesion on the tissue. In this way, energy can be applied by the ablation system to the tissue. The position of cinchingdevice710arelative to ablation assembly715acan be adjusted by the operator. For example, the cinching device may be advanced or refracted to differing degrees in order to increase or decrease an amount of contact between the ablation assembly and the patient tissue. Ablation segment720ain combination with ablation member716acan form a continuous circumferential loop that can be used to ablate a circumferential lesion on the patient tissue.
• As shown inFIGS. 7B and 7C, an ablation system700bcan include acinching device720band anablation assembly715b.Cinching device720bcan include one or more guides750b, and can be used in operative association with anablation assembly715bhaving anablation member716band a stabilizer member717b.Cinching device720bcan also include an ablation member protection mechanism745bwhich can be disposed between portions770band771bofablation member716b. Hence, it is possible to avoid contact between different portions of an ablation member such as an electrode. One ormore guides750b,751bof cinchingdevice720bmay include a flat or curved retaining wall perpendicularly attached to, or formed along with, a support740bof cinchingdevice720b. In some embodiments, one ormore guides750b,751bmay have a curved top edge. The shape ofguides750b,751bcan be designed in order to help facilitate positioning anablation assembly715baround the patient tissue705bby keeping distal771band proximal770bsegments of theablation member716bclose to each other. In an embodiment with two or more guides, the guides may be located on opposite sides of a support plate of cinchingdevice720b. In one method for using thecinching device720bwith guides,ablation assembly715bcan be passed through the cinching device along one guide750band then wrapped around the patient tissue705b. Theablation assembly715bcan then be pulled through cinchingdevice720bin the opposed direction, passing along anotherguide751b. The guides may be made of or include various semi-rigid or rigid materials.Cinching device720bcan be advanced in a direction toward the patient tissue705bas indicated by arrow B1, to increase the amount of contact between the ablation member717band the patient tissue705bor to help secure the position of ablation member717brelative to patient tissue705b. Similarly, by advancingcinching device720bin this direction, an operator can increase the amount of contact between ablation segment735band the patient tissue705bor help secure the position of ablation segment735brelative to patient tissue705b. The operator can also establish or apply an opposing force by grasping or pulling sections718b,719bofablation assembly715bin an opposing direction, as indicated by arrows B2.
• In some embodiments, as cinchingdevice720bis advanced towards the patient tissue705b, aloop structure711bof theablation assembly715bis reduced in diameter or otherwise contracted. As shown inFIG. 7B, in some embodiments, an ablation member protection mechanism745bcan be utilized along with thecinching device720b.Cinching device720bcan include ablation member protection mechanism745bdisposed betweenguides750b,751b. Ablation member protection mechanism745bcan act to keep a first segment770aand a second segment771bof the ablation member from making contact with each other. Ablation member protection mechanism745bmay either be fixed or integral to cinchingdevice720bor separate from cinchingdevice720b. In some embodiments, an ablation segment735bmay be attached with cinchingdevice720b, such as with a first ordistal section746bof ablation member protection mechanism745b. Ablation segment735bcan be utilized to increase the amount of contact between theablation assembly715band the patient tissue705b. Ablation segment735bcan also be utilized to reduce pinching of the patient tissue705bthat might otherwise occur if ablation segment735bwere not disposed between opposing segments ofablation member716b. The operator can positionablation assembly715bto make contact with selected parts of patient tissue705bsuch that when ablative energy is transmitted through the ablation assembly, it is possible to create an approximately circular or closed ablation pattern or lesion on the tissue. In this way, energy can be applied by the ablation system to the tissue. The position of cinchingdevice720brelative toablation assembly715bcan be adjusted by the operator. For example, the cinching device may be advanced or retracted to differing degrees in order to increase or decrease an amount of contact between the ablation assembly and the patient tissue. Ablation segment735bin combination withablation member716bcan form a continuous circumferential loop that can be used to ablate a circumferential lesion on the patient tissue.FIG. 7C shows a perspective view of cinchingdevice720bwhich includes ablation member protection mechanism745b, guides750b,751b, and ablation segment735b.
• FIGS. 8A-8E show aspects of an ablation system according to embodiments of the present invention.FIG. 8A showsablation system800 having adistal end810 and abelt loop820. Optionally, the ablation system may include a peel outelectrode830.Distal end810 ofsystem800 is disposed throughbelt loop820.FIG. 8B shows a cross-section view of a portion A-A ofFIG. 8A. As depicted inFIG. 8C,ablation system800 can be disposed about a large atria. Similarly, as depicted inFIG. 8D,ablation system800 can be disposed about a small atria. According toFIG. 8E,ablation system800 can have a receivingslot840 adapted to receive peel outelectrode830. With a more detailed reference now toFIG. 8A,ablation system800 includes aflexible ablation member880, which may have a peel out portion orelectrode830, an encircling mechanism or catch820 such as a belt loop, a hook, a closable clasp, or the like, and a flexible stabilizer member or bracing860 having adistal end810, aproximal end870, and a recessed receiving slot orreceptacle840. The combination of the ablation member and the stabilizer member can collectively be referred to as anablation assembly890. In use, an operator may treat a patient by wrapping aloop structure811 of the ablation system around pulmonary veins of a patient. This may involve passing flexible bracingdistal end810 circumferentially around the tissue as indicated arrow A, and throughbelt loop820 as indicated by arrow B. The operator may expand orcontract ablation system800 by manipulating the flexible stabilizer memberdistal end810. Movingdistal end810 in direction C results in contraction ofloop structure811 ofablation system800 in a cinching fashion. Movingdistal end810 in direction D results in expansion ofloop structure811 ofablation system800.Stabilizer member860 may be made of or include any suitable flexible material, such as a silicone, polyurethane, polycarbonate, another suitable polymer, or combination of polymers or the like.
• In some embodiments of use, a surgeon or operator can pass stabilizer memberdistal end810 throughcatch820, and expand orcontract ablation system800 by manipulating the flexible bracingproximal end870. Movingproximal end870 in direction E results in contraction ofloop structure811 ofablation system800 in a cinching fashion. Movingproximal end870 in direction F results in expansion ofloop structure811 ofablation system800.FIG. 8B depicts a cross-section portion A-A ofablation assembly890 as shown inFIG. 8A. As shown here, receivingslot840 is located adjacent toablation member880. In some cases, receivingslot840 might be located on either side ofablation member880. Receivingslot840 is adapted to receive a distal section or peel outportion830 ofablation member880.
• As shown inFIG. 8C, a surgeon or operator can detach or separate peel outportion830 fromstabilizer member860 andinsert portion830 into receivingslot840, by grasping and manipulating the peel out portion with apositioning device850. In some cases, a portion of the stabilizer member which is separated from the peel out portion can be inserted throughcatch820. A positioning device such as a forceps or grasper can be introduced into the patient via a minimally invasive incision.Positioning device850 may be used by the operator to detach peel outsection830 from flexible bracing860 and to insert the detached section of peel outsection830 into receivingslot840 so thatablation member880 approximately encircles tissue of a heart. An operator can administer ablative energy through the ablation member to produce a circular or closed ablation pattern or lesion on the patient tissue.Positioning device850 may include opposable jaws, forceps, clamps or any combination or other suitable means that can be used by surgeon or operator to grasp or holddistal portion830 ofablation member880.Positioning device850 may also be used to positionablation system800 on the heart or repositionablation system800 to perform ablation in multiple locations on a heart. With continued reference toFIG. 8C, a surgeon or operator can usepositioning device850 to insert peel outdistal section830 into receivingslot840 on the opposite side of flexible stabilizer bracing860.Ablation system800 can be used to produce a circular, elliptical, or closed ablation pattern or lesion on a large atria. As shown inFIG. 8D,ablation system800 may be used to produce an ablation pattern or lesion on a small atria. Because the atria is smaller, a longer section offlexible stabilizer member860 may be moved thoughcatch820 in order to snugly fit the ablation assembly around the atria. This may involve a longer section ofdistal ablation member830 being inserted into receivingslot840. By administering ablative energy through the ablation system and to the heart, an operator can useablation system800 to produce a circular, elliptical, or closed ablation pattern or lesion on the small atria.
• FIG. 8E provides a partial view ofablation system800. Catch820 is shown without the distal end of flexible bracing810 inserted therein. In this embodiment,ablation member section880 is partial recessed or disposed within a receptacle or slot850 flexible bracing860. Receivingslot840 is shown without a distal section of peel outelectrode830 inserted therein.Ablation member880 may include one or more mechanisms for providing various types of ablation energy, including RF, thermoelectric, cryogenic, microwave, laser, ultrasound or the like. In one embodiment, ablation may be achieved or enhanced by delivery of one or more drugs to the tissue, and drug delivery can be carried out by any of the systems disclosed herein. Drug delivery can be achieved through mechanical surface contact, chemical reaction or a particular feature set like fine, short ‘needle-like’ structures that penetrate the surface, for example. Drug delivery may also be enhanced by the surface pressure of the device, the heat generated, the RF energy itself or even the changed physiology of the tissue of the lesion (e.g. via apoptosis, desiccation, cytolysis, etc).
• Referring now toFIG. 9A, in some embodiments anablation system900 includes a flexible device which includes anencircling mechanism905 having abreakaway tip930, aslit950, and aliving hinge980.Ablation system900 also includes anablation member920 in operative association with a stabilizer member. As shown inFIG. 9B,ablation system900 can be extended around a large atrium of a patient. In use, a surgeon can insert astiffening probe995 into adistal end912 ofstabilizer member910. By manipulatingdistal end912 ofstabilizer member910, or by adjustingproximal end914 ofstabilizer member910 relative toencircling mechanism905, an operator can activate hinge980 and movebreakaway tip930 toward the atrium. This pushing action causesbreakaway tip930 to move away from aportion960 of the stabilizer member that is located on the opposing side ofslit950. Hence,breakaway tip930 can bridge a gap that may exist between the ablation member and the tissue surface of the atrium, thereby allowing the ablation member to approximately encircle the tissue. In some cases, slit950 extends about half way through a cross section of the stabilizer member. An operator can transmit ablative energy through the ablation member to the tissue, so as to produce an approximately circular, elliptical, or closed ablation pattern or lesion. As shown inFIG. 9C, an operator can useablation system900 to apply ablative energy to a small atrium, in a similar fashion. Stiffeningprobe995 can be pushed farther toward the heart, in the direction indicated by arrow A, which can cause the expansion of a wider angle defined byslit950, ashinge980 opens further andbreakaway tip930 moves more distally alongablation member920, as indicated by arrow B. Hence,breakaway tip950 can move closer to the atrium, andablation member920 can snugly fit against the atrium. In some cases, it may be desirable to moveproximal end914 of the stabilizer member in the direction indicated by arrow C, which can also effectively movebreakaway tip930 more distally alongablation member920, as indicated by arrow B. Optionally, the surgeon or operator can movedistal portion912 in the direction indicated by arrow D, orproximal portion914 in the direction indicated by arrow E, so as to move the breakaway tip more proximally along the ablation member, as indicated by arrow F. In this way, by manipulating aspects of the system such as the distal end or the proximal end of a stabilizer member, an operator can adjust the size of aloop structure911 provided by the ablation system. In some instances, the ablation member may be adjusted to contact epicardial tissue directly adjacent to the base or ostia of one or more pulmonary veins. In some instances, the ablation member may be adjusted so that a gap exists between the ablation member and the pulmonary veins.
• FIG. 9D provides a close-up view ofencircling mechanism905 of the ablation system, which includesbreakaway tip930, slit950, and livinghinge980. In some embodiments,ablation member920 extends to the distal end or nearly to the distal end ofbreakaway tip930. By manipulating aspects of the system, such the distal end or the proximal end of an ablation assembly, an operator can adjust an angle α of defined byslit950. Hence, it is possible to conform the ablation member with a contour presented by a patient tissue. When the ablation member is placed at or near the tissue, ablative energy can be transmitted through the ablation member to the tissue, thus ablating at least a portion of the tissue to form one or more lesions.
• FIGS. 10A to 10F show partial views of anablation system1000 according to embodiments of the present invention. As shown inFIG. 10A,ablation system1000 includes astabilizer member1010 having aslit1011, and anablation member1020 disposed within arecess1012 of the stabilizer member. The stabilizer member also includes abreakaway tip portion1014 and a trunk portion ortether band1016, whereby the breakaway tip is separated from the trunk portion byslit1011.Trunk portion1016 may be reinforced with a braid or ribbon material. The ablation system also includes aretractable sleeve1030, which can act to constrain or keepbreakaway tip1014 in close proximity withtrunk1016.Stabilizer member1010 can be constructed so thatbreakaway tip1014 is biased to separate or extend laterally fromtrunk1016. Hence, as shown inFIG. 10B, when the retractable sleeve is moved to fully exposeslip1011,breakaway tip1014 can move or spring away fromtrunk1016, as indicated by arrow A. In this way,breakaway tip1014 can adopt a natural or relaxed configuration, whereasbreakaway tip1014 may be stressed or constrained when housed within the retractable sleeve. Breakaway tip provides a preformed spring loaded free tip that can be releasably contained in the sleeve.FIG. 10C represents an overlapped configuration andFIG. 10D represents a concentric positioning that remains in the same plane. As shown inFIG. 10E, an operator can wrapablation system1000 around a patient tissue or organ1050 when the sleeve is in an advanced position and breakaway tip is in the constrained configuration. As shown inFIG. 10F, an operator can retract the sleeve in a distal direction, and the breakaway tip can relax toward the heart tissue, and thus the ablation member can form a circumferential loop or closed path about the patient tissue. In this way, an ablation element can be cinched or tightened toward the patient tissue. In some embodiments, an operator can keep the retractable sleeve in a fixed position when applying ablative energy through the ablation member to the patient tissue. As shown here, an operator can slide the retractable sleeve longitudinally along a distal length of the stabilizer member.
• As shown inFIGS. 10E and 10F, an operator can useablation system1000 to apply ablative energy to cardiac tissue. The retractable sleeve can be pulled further away from the heart, which can allow the breakaway tip to release and adopt its low energy configuration or memory shape. Hence, the breakaway tip can more closer to the atrium, and in a cinching fashion the ablation element is moved toward the patient tissue. As the ablation member is brought snugly against the heart, the desired contact or proximity between the ablation member and the cardiac tissue is achieved. In some instances, the ablation member may be adjusted to contact epicardial tissue directly adjacent to the base or ostia of one or more pulmonary veins. In some instances, the ablation member may be adjusted so that a gap exists between the ablation member and the pulmonary veins. When the ablation member is placed at or near the tissue, ablative energy can be transmitted through the ablation member to the tissue, thus ablating at least a portion of the tissue to form one or more lesions. Such lesions may be formed in the shape of a loop, and ellipse, a circle, or some other closed path configuration. Exemplary techniques also encompass the application of ablative energy or treatment to create a circumferential lesion or box lesion.
• FIGS. 11A to 11C illustrate aspects of an ablation system according to embodiments of the present invention. As shown inFIG. 11A,ablation system1100 includes anablation member1110 in operative association with astabilizer member1120.Ablation member1110 extends through afirst port1124 of stabilizer member, along afirst recess1122 ofstabilizer member1120.Stabilizer member1120 includes abreakaway tip1125, and acatch1126 that is configured to releasably hold the breakaway tip.Breakaway tip1125 may present a portion of an ablation assembly that is free to move or extend away from an adjacent portion of a stabilizer member. The breakaway tip may include a distal end of an ablation member that is partially housed by a stem section of a stabilizer member. In use, an operator may disengage the breakaway tip from the catch, so that the breakaway tip extends toward asecond recess1123 ofstabilizer member1120, as indicated by arrowA. Stabilizer member1120 may include one or more pressure lines1127,1128, which can be constructed in fluid communication withsecond recess1123 via one or more ports1123a, or with first recess via one or more ports (not shown), or with both the first recess and the second recess. The pressure in the pressure lines can be adjusted so as to provide a positive or negative pressure to the tissue via the ports and recesses. For example, in use an operator may apply a vacuum via a pressure line so as to help sealfirst recess1122 with a patient tissue. Similarly, an operator may apply a vacuum via a pressure line so as to help sealsecond recess1123 with a patient tissue, or withbreakaway tip1125, or both.
• As shown inFIG. 11B,ablation system1100 can be extended around a large atrium of a patient. In use, a surgeon can manipulate adistal end1130 ofstabilizer member1120, aproximal end1140 ofstabilizer member1120, or both. By manipulatingdistal end1130 ofstabilizer member1120, or by adjustingproximal end1140 ofstabilizer member1120, an operator can movebreakaway tip1125 toward the atrium. In this way, an operator can urgebreakaway tip1125 to bridge a gap that may exist betweenablation member1110 and the tissue surface of the atrium, thereby allowing the ablation member to approximately encircle the tissue. As shown here, a distal portion ofbreakaway tip1125 inserts into or is placed in close proximity withfirst recess1123. An operator can transmit ablative energy through the ablation member toward the tissue, so as to produce an approximately circular, elliptical, or closed ablation pattern or lesion. As shown inFIG. 11C, an operator can useablation system1100 to apply ablative energy to a small atrium, in a similar fashion.Distal section1130 can be pushed farther toward the heart, in the direction indicated by arrow A, which can causebreakaway tip1125 to move more distally alongablation member1110, as indicated by arrow B. Hence,breakaway tip1125 can move closer to the atrium, andablation member1110 can snugly fit against the atrium. In some cases, it may be desirable to moveproximal end1140 of the stabilizer member in the direction indicated by arrow C, which can also effectively movebreakaway tip1125 more distally alongablation member1110, as indicated by arrow B. Optionally, the surgeon or operator can movedistal portion1130 in the direction indicated by arrow D, orproximal portion1140 in the direction indicated by arrow E, so as to move the breakaway tip more proximally along the ablation member, as indicated by arrow F. In this way, by manipulating aspects of the system such as the distal end or the proximal end of a stabilizer member, an operator can adjust the size of aloop structure1111 provided by the ablation system. In some instances, the ablation member may be adjusted to contact epicardial tissue directly adjacent to the base or ostia of one or more pulmonary veins. In some instances, the ablation member may be adjusted so that a gap exists between the ablation member and the pulmonary veins. When the ablation member is placed at or near the tissue, ablative energy can be transmitted through the ablation member to the tissue, thus ablating at least a portion of the tissue to form one or more lesions. Such lesions may be formed in the shape of a loop, an ellipse, a circle, or some other closed path or circumferential configuration.
• FIGS. 12A to 12C illustrate aspects of an ablation system according to embodiments of the present invention. As shown inFIG. 12A,ablation system1200 includes anablation member1210 in operative association with astabilizer member1220.Ablation member1210 extends along arecess1222 ofstabilizer member1220.Stabilizer member1220 includes abreakaway tip1225, and acatch1226 that is configured to releasably hold the breakaway tip. For example, the catch may include a recessed portion or cap that can hold the breakaway tip, and from which the breakaway tip may be released so as to extend toward a proximal portion of the ablation assembly.Breakaway tip1225 may present a portion of an ablation assembly that is free to move or extend away from an adjacent portion of a stabilizer member. The breakaway tip may include a distal end of an ablation member that is partially housed by a stem section of a stabilizer member, and may include one ormore connection mechanisms1225a, such as suction cups.Stabilizer member1220 may also include aflexible platform1221 that can be wrapped around thebody1220aof the stabilizer member as shown inFIG. 12A, or that can be unwrapped and extended away from the body of the stabilizer member, as shown inFIGS. 12B and 12C. In some embodiments, the platform is wrapped around the stabilizer member body when the ablation assembly is inserted into the patient via a port. In use, an operator may disengagebreakaway tip1225 fromcatch1226,unwrap platform1221 frombody1220a, and engagebreakaway tip1225 withplatform1221. For example, the breakaway tip can be suctioned onto or coupled with the platform with a connection mechanism.
• As shown inFIG. 12B,ablation system1200 can be extended around a tissue ororgan1205 of a patient. In use, a surgeon can manipulate adistal portion1230 ofstabilizer member1220, aproximal portion1240 ofstabilizer member1220, or both. By manipulatingdistal portion1230 ofstabilizer member1220, or by adjustingproximal portion1240 ofstabilizer member1220, an operator can movebreakaway tip1225 toward the patient organ or tissue. In this way, an operator can urgebreakaway tip1225 to bridge a gap that may exist betweenablation member1210 and the tissue surface, thereby allowing the ablation member to approximately encircle the tissue. As shown here, a distal portion ofbreakaway tip1225 can be moved toward aproximal portion1210aof the ablation member. When making such adjustments of the ablation assembly, the connection mechanism may or may not maintain contact with the platform.
• As shown inFIG. 12C,distal section1230 can be moved in the direction indicated by arrow A, which can causebreakaway tip1225 to move more distally alongablation member1210 or to move closer toproximal portion1210aof ablation member, as indicated by arrow B. Hence,breakaway tip1225 can move closer to the patient tissue, andablation member1210 can snugly fit against the tissue. In some cases, it may be desirable to moveproximal end1240 of the stabilizer member in the direction indicated by arrow C, which can also effectively movebreakaway tip1225 more distally alongablation member1210 or closer toproximal portion1210aof ablation member, as indicated by arrow B. Optionally, the surgeon or operator can movedistal portion1230 in the direction indicated by arrow D, orproximal portion1240 in the direction indicated by arrow E, so as to move the breakaway tip more proximally along the ablation member, as indicated by arrow F. In this way, by manipulating aspects of the system such as the distal end or the proximal end of a stabilizer member, an operator can reposition the connection mechanism on the platform so as to adjust the size or shape of aloop structure1211 provided by the ablation system. In some instances, the ablation member may be adjusted to contact epicardial tissue directly adjacent to the base or ostia of one or more pulmonary veins. In some instances, the ablation member may be adjusted so that a gap exists between the ablation member and the pulmonary veins. When the ablation member is placed at or near the tissue, ablative energy can be transmitted through the ablation member to the tissue, thus ablating at least a portion of the tissue to form one or more lesions. Hence, an operator can transmit ablative energy through the ablation member toward the tissue, so as to produce an approximately circular, elliptical, or circumferential or closed ablation pattern or lesion. It is understood that in some embodiments, aspects ofdistal portion1230 andproximal portion1240 may be reversed, as compared with the operational or configurations described above.
• FIGS. 13A to 13C show aspects of an ablation system according to embodiments of the present invention. Exemplary ablation systems provide a flexible stabilizer member that can adhere to a tissue surface via the application of a vacuum or suction pressure, while at the same time exhibiting little or no bowing or buckling in sidewalls of the stabilizer member itself. As shown in theFIG. 13A cross section, ablation system1300aincludes anablation member1310ain operative association with astabilizer member1320a.Ablation member1310aextends along a recess ofstabilizer member1320a, disposed at least partially between a sidewalls1324aand an opposing sidewall (not shown) of the stabilizer member.Recess1323ais formed by the opposing sidewalls and body1325aofstabilizer member1320a. The stabilizer shape is similar to the stabilizer shape shown inFIG. 14A but has notches cut into the inside top wall to enable bending in the direction shown, which can be assisted by the application of a vacuum inside the suction stabilizer when it is attached to tissue, as discussed elsewhere herein.Stabilizer member1320acan include or be coupled with, for example with a glue or adhesive, one ormore loops1321awhichsecure ablation member1310arelative tostabilizer member1320a. In some cases, such accordion features or loops help to relieve strain or residual stress when the ablation system undergoes bending or flexing. As depicted is this illustration, the natural bending plane of the stabilizer is at the outside of the curve of the stabilizer which can be at odds with the natural bending plane of the electrode which lies at a significantly smaller radius in the curve. In a curved state, this could result in much tension and stretching of the outside edge of the stabilizer and compression of the electrode and bowing and buckling of the skirt of the stabilizer along the inside edge of the curve as shown at1320a′, which may negatively impact the ability of the stabilizer member to adhere to a tissue surface contour due to deformation of the skirt edge. Such distortion or buckling can lead to the development of air gaps along the length of the stabilizer member, between the stabilizer member and the patient tissue. Other embodiments shown display more ability to conform easily to a curved surface. In some embodiments, a vacuum in the suction chamber inside the stabilizer and surrounding the electrode can assist in the bending. The cross-section ofstabilizer member1320apresents a configuration with a smooth outside surface and deeply notched inside surface. The profile of the stabilizer member presents a series of rising and falling wave-like cuts or notches into the inner surface of the upper wall. The notched configuration allows the stabilizer to be placed against or near any of a variety of curved or irregular surfaces and curve more readily than if it did not have these features. Relatedly, the cut or notched features, depending on the gap of the feature, can prevent or inhibit curving in a portion of a stabilizer member as the adjacent walls of the notches may contact each other, acting as motion limiters. InFIG. 13A this is depicted as all gaps are shown nearly closed. If curved portion of1320awere straightened, the gaps or notches in this section would open up to allow vacuum within. A suction skirt can also assist in creating dependable suction inside a seal surface or flat floor of a lumen of a push tube for the portion of a suction stabilizer that remains inside the push tube while a procedure is performed, as described herein with reference toFIG. 72.
• As shown in theFIG. 13B cross section,ablation system1300bincludes astabilizer member1320b, which has arecess1323bthat can at least partially receive an ablation member. Three-sided recess1323bis formed bybody1325bofstabilizer member1320b, by side wall1324b, and by another side wall (not shown in the section view) opposing side wall1324b.FIG. 13B shows two bladder features1301b,1302bthat include individual chambers1303b,1304bconnected by a lumen. A first bladder feature1301bis in a straight section of the stabilizer and a second bladder feature1302bis in the curved section. The two bladders can be separately inflated/deflated with air or saline through separate lumen paths to assist in producing the desired stabilizer curves. As shown inFIG. 13B, the straight section can be deflated or under negative pressure while the curved one is inflated. The thin, flexible, accordionated outer wall1305b,1306bof each individual chamber has enough length to it so that it becomes relatively straight when the chamber is inflated, unlike the thin but unaccordionated inner or bottom wall of each chamber, causing the stabilizer to curve as the chambers inflate. The center of mass of the suction stabilizer can be configured to coincide with the center of mass of the probe when assembled.
• As shown inFIG. 13C,ablation system1300cincludes astabilizer member1320c, which has arecess1323cthat can at least partially receive an ablation member.Recess1323cis formed by opposing sidewalls andbody1325cofstabilizer member1320c. The opposing sidewalls can include sidewall1324cand another side wall (not shown in the section view) opposing sidewall1324c. A steel or NiTi wire or ribbon can be fixed or coupled with the distal end of the stabilizer. In use, the distal end can be deflected by pushing, pulling, or otherwise manipulating the wire at the proximal end. As shown inFIG. 13C, the ablation system can include a bond spot1340cwhere two ribbons are attached to the stabilizer. The bond spot is shown toward the center of a flexible portion, indicated by the extents of the notched backside of the stabilizer. The stabilizer is shown with only one curve developed, making the stabilizer off-center with regard to the relative length of the two straight sections. If the curve shown were relaxed and the other one simultaneously formed (to the right of the ‘bond spot’) the curve would effectively translate down the length of the stabilizer, or alternately, the curve could stay in the same place on the anatomy and the stabilizer could translate lengthwise around the anatomy by translating its curve. The way the curve is formed is through the interaction of tension in the cable (or lack thereof) and the length of the stabilizer as measured along its natural bending plane (which is inside, or below, the ribbon). When a ribbon is tensioned by pulling on the end (not shown) and pushing on the end of the stabilizer (not shown), the notches collapse and the stabilizer straightens. When the ribbon is relaxed, it allows the stabilizer to curve and the ribbon end (not shown) slides into the end of the stabilizer (not shown) as it may need more length to lie around the curve.
• FIG. 14A depicts anablation system1400ahaving astabilizer member1420athat at least partially houses anablation member1410a. As shown here, whenstabilizer member1420abends it may form a bow or buckle1420a′. In some cases, such bowing or buckling may be undesirable because it can lead to a loss of a contact seal or suction between a stabilizer member and a patient tissue.FIG. 14B depicts anablation system1400bhaving a stabilizer member1420bthat at least partially houses an ablation member1410b. In some embodiments, ablation member1410bis disposed within arecess1423awhich is formed by opposing sidewalls1424aand body1425aofstabilizer member1420a. As shown here, stabilizer member1420bincludes a section1420b′ that exhibits little or no bowing or buckling when the stabilizer member bends. For example, section1420b′ may be heat treated or formed, or provided with a shape memory, so that when the ablation system is bent, section1420b′ presents a curved shape that conforms to a tissue contour and does not fold or collapse, or otherwise warp. In some cases, if a stabilizer member has an overly rigid curve or form it may be difficult to insert the stabilizer member through a tube or catheter. If the curve is too rigid, it can cause friction as the stabilizer member passes through the tube. In some cases, the rigid curve may prevent the stabilizer member from passing through the tube.FIGS. 15A to 15C depict anablation system1500 having astabilizer member1520 that at least partially houses anablation member1510 within sidewalls1524 of the stabilizer member. In some embodiments,ablation member1510 is disposed within arecess1523 which is formed by opposing sidewalls1524 and body1525 ofstabilizer member1520. As shown here,stabilizer member1520 includes asection1520′ that exhibits little or no bowing or buckling when the stabilizer member bends. For example,section1520′ includessidewall flaps1524′ which can overlap when the stabilizer member bends. Hence, when the ablation system is bent,section1520′ presents a curved shape that conforms to a tissue contour and does not fold or collapse, or otherwise warp.FIG. 15B shows the ablation system in a straightened configuration, where sidewall flaps are slightly overlapped. These flaps can allow a stabilizer member to bend when the member is passed through a tube, so that the member does not create excessive friction. In some cases, the stabilizer member will not have a shape memory for a curve or arc. The formation of the flaps allow the stabilizer member to bend, to seal with a patient tissue, and to expand and contract against variations in the contour of the patient tissue.FIG. 15C shows an original molded configuration of a stabilizer member according to embodiments of the present invention.
• FIGS. 16A to 16C depict anablation system1600 having astabilizer member1620 that at least partially houses anablation member1610 within sidewalls1624 of the stabilizer member. In some embodiments,ablation member1610 is disposed within arecess1623 which is formed by opposing sidewalls1624 andbody1625 ofstabilizer member1620. As shown here,stabilizer member1620 includes asection1620′ that exhibits little or no bowing or buckling when the stabilizer member bends. For example,section1620′ includes a flexible spine or backbone having alternating protrusions1626 andindentions1627 that allowsection1620′ to flex through a range of motion when the stabilizer member bends. Hence, when the ablation system is bent,section1620′ presents a curved shape that conforms to a tissue contour and does not fold or collapse, or otherwise warp.FIG. 16B illustratesstabilizer member1620 in a straightened configuration. The flexible spine1628 of the stabilizer member presents a serpentine profile, as shown in the cross section ofFIG. 16C. Hence, the center of mass can be moved toward the recess opening, and can be aligned with the center of the probe. When something like a beam bends, the outside of that beam stretches and the inside compresses. But the middle of the beam is doing neither; it is the area of least stress and no length change. According to embodiments of the present invention, one configuration is to have the stabilizer neutral bending plane be aligned with the electrode neutral bending plane to minimize stress when it bends. This may also mean that the electrode and stabilizer are not changing overall length relative to each other whether straight or bent. InFIGS. 16B and C, the stabilizer, which also happens to be easily moldable in this shape, has a bending plane right about where the electrode lies.
• FIGS. 17A to 17F show aspects of anablation system1700 according to embodiments of the present invention. As depicted inFIG. 17A,ablation system1700 includes anablation assembly1715 having astabilizer member1720 in operative association with anablation member1710.Ablation system1700 also includes acinching device1730.Cinching device1730 can have one ormore guides1750a,1750b, and can be used in operative association with anablation assembly1715 having anablation member1710 and astabilizer member1720.Cinching device1730 can also include an ablationmember protection mechanism1731 which can be disposed betweenportions1770 and1771 ofablation assembly1715. Hence, it is possible to avoid contact between different portions of an ablation member such as an electrode, where the ablation member protection mechanism is disposed between adjacent portions of the ablation member. One ormore guides1750a,1750bofcinching device1730 may include a flat or curved retaining wall perpendicularly attached to, or formed along with, asupport1752 of cinchingdevice1730. Accordingly,cinching device1730 can present a pair ofchannels1753a,1753bthat can receive the ablation assembly. For example, channel1753ais disposed betweenguide1750aand ablationmember protection mechanism1731, andchannel1753bis disposed betweenguide1750band ablationmember protection mechanism1731. This feature is also illustrated inFIG. 17C, which depicts a cross section of cinching device corresponding to C-C ofFIG. 17B.
• In some embodiments, one ormore guides1750a,1750bmay have a curved top edge. The shape ofguides1750 can be designed in order to help facilitate positioning anablation assembly1715 around or against a patient cardiac tissue, which may include one or more pulmonary veins PV, by keeping distal1715aand proximal1715bsegments of the ablation member close to each other, as shown inFIG. 17D. In an embodiment with two or more guides, the guides may be located on opposite sides of a support plate of cinchingdevice1730.
• In one method for using thecinching device1730 with guides,ablation assembly1715 can be passed through the cinching device along oneguide1750aas depicted by arrow A inFIG. 17B and wrapped around the patient tissue. The ablation assembly can then be pulled throughcinching device1730 in the opposed direction as indicated by arrow B, passing along anotherguide1750b. The guides may be made of or include various semi-rigid or rigid materials.Cinching device1730, which may be used as a pusher or a guide handle, can be advanced in a direction toward the patient tissue705bas indicated by arrow D, so as to decrease the circumference of aloop structure1745 formed byablation assembly1715, and to increase the amount of contact between theablation member1710 and thepatient tissue1705 or to help secure the position ofablation member1710 relative topatient tissue1705. Similarly, by advancingcinching device1730 in this direction, an operator can increase the amount of contact between anablation segment1735 of the cinching device and thepatient tissue1705 or help secure the position of the ablation segment relative to the patient tissue. The operator can also establish or apply an opposing force by grasping or pulling proximal anddistal sections1715c,1715dofablation assembly1715 in an opposing direction, as indicated by arrows E and F, respectively.
• In some embodiments, as cinchingdevice1730 is advanced towards thepatient tissue1705, aloop structure1745 of theablation assembly1715 is reduced in diameter or otherwise contracted. As shown inFIGS. 17B and 17D, for example, in some embodiments an ablationmember protection mechanism1731 can be utilized along with thecinching device1730.Cinching device1730 can include ablationmember protection mechanism1731 disposed toward the center ofdevice1730, optionally betweenguides1750a,1750b. Ablationmember protection mechanism1731 can operate to keep a first segment1710aand a second segment1710bof the ablation member from making contact with each other. Ablationmember protection mechanism1731 may either be fixed or integral to cinchingdevice1730 or separate from cinchingdevice1730. In some embodiments, anablation segment1735, which may include an electrode or an energy transmission element, can be attached withcinching device1730. For example,ablation segment1735 can be coupled with or part of a first ordistal section1731aof ablationmember protection mechanism1731.Ablation segment1735 can be utilized to increase the amount of contact between theablation assembly1715 and thepatient tissue1705.Ablation segment1735 can also be utilized to reduce pinching of thepatient tissue1705 that might otherwise occur ifablation segment1735 were not disposed between opposing segments ofablation member1710. The operator can positionablation assembly1715 to make contact with selected parts ofpatient tissue1705 such that when ablative energy is transmitted through the ablation assembly, it is possible to create an approximately circular or closed ablation pattern or lesion on the tissue.
• In this way, energy can be applied by the ablation system to the tissue. The position of cinchingdevice1730 relative toablation assembly1715 can be adjusted by the operator. For example, the cinching device may be advanced or retracted to differing degrees in order to increase or decrease an amount of contact between the ablation assembly and the patient tissue.Ablation segment1735 in combination withablation member1710 can form a continuous or closed circumferential loop that can be used to ablate a circumferential lesion on the patient tissue. InFIG.17B ablation segment1735 may have ‘arrowhead’ shape as shown or another configuration, perhaps a ‘U’ shape as if to scoop up the vessel tissue as it advances against the tissue instead of trying to part the two pulmonary vessels or ablate partway between them by physical separation by the arrowhead-like shape.Ablation segment1735 may also have a flat shape, a convex shape, a concave shape, or any other desired shape so as to contact or manipulate tissue. In some embodiments, ablation segment includes a flexible material that conforms readily with the tissue.
• FIG. 17B shows a perspective view ofcinching device1730 which includes ablationmember protection mechanism1731, guides1750a,1750b,ablation segment1735, and handle1739. In some cases, handle1739 of cinchingdevice1730 may include a bent or offsetportion1738. As shown inFIG. 17F, in someembodiments cinching device1730 can be folded or rolled into a compact configuration.FIG. 17F corresponds to the view presented inFIG. 17C, except that inFIG. 17F the device is folded.Device1730 includes ablationmember protection mechanism1731, guides1750a,1750b, andsupport1752. As illustrated inFIG. 17D, in some cases the ablation system may also include atrocar1780 having asleeve1782 coupled with aflange1784. In use, an operator may place the ablation assembly and cinching device through the trocar, such that the trocar assists in keeping the ablation assembly snugly situated withinchannels1753a,1753bof the cinching device.FIG. 17E shows a cross section oftrocar sleeve1782. In some cases, trocar sleeve1782acan have a first dimension W that is about 25 mm, and a second dimension H that is about 10 mm.
• FIGS. 18A to 18E show aspects of an ablation system according to embodiments of the present invention. As depicted inFIG. 18A, anablation system1800 includes anablation assembly1810 having an ablation member1820 coupled with astabilizer member1830, afirst port1840, and asecond port1850. Ablation member1820 can include an electrode andstabilizer member1830 can include a bladder, according to some embodiments. In use, an operator can advance adistal portion1812 of the ablation assembly throughfirst port1840 as indicated by arrow A, around apatient tissue1805 as indicated by arrow B, and towardsecond port1850 as indicated by arrow C. The patient tissue can encompass cardiac tissue which may also include one or more pulmonary veins (PV).Stabilizer member1830 includes aproximal living hinge1832 disposed toward aproximal portion1834 of the stabilizer member, and adistal living hinge1836 disposed toward adistal portion1838 of the stabilizer member.Stabilizer member1830 may also include astiff tube section1839 disposed towarddistal portion1838.FIG. 18B shows another view ofablation system1800, which can include aproximal handle1816 disposed toward aproximal end1814 of the ablation assembly. In use, an operator can move handle1816 toward the patient tissue as indicated by arrow D, such that the ablation assembly continues to advance around the patient tissue as indicated by arrow E. Consequently,distal end1812 of the ablation assembly can be advanced throughsecond port1850.
• FIG. 18C provides an illustration ofablation system1800. In use, an operator can contactdistal end1812 of the ablation assembly with a distal handle orobturator1818. For example,distal handle1818 or stiffening probe can be advanced into a recess, channel, or other lumen or passage of thedistal end1812, as indicated by arrow F. An operator can manipulate the distal handle so as to activatedistal living hinge1836, thereby bringing adistal section1822 of the ablation member toward aproximal section1824 of the ablation member, as indicated by arrow G. As shown inFIG. 18D, an operator can also manipulateproximal handle1816 so as to activateproximal living hinge1832, thereby bringingproximal section1824 of the ablation member towarddistal section1822 of the ablation member, as indicated by arrow H. Hence, the operator can form aloop structure1845 with the ablation assembly, about the patient tissue. Optionally, the operator may moveproximal handle1816 away from the tissue as indicated by arrow M, ordistal handle1818 away from the tissue as indicated by arrow N, so as to bring a distal portion1845aof the loop structure snug against the patient tissue, as indicated by arrow O. In some cases, an operator can manipulateproximal handle1816,distal handle1818, or both, as depicted inFIG. 18E, so as to further activateproximal living hinge1832,distal living hinge1836, or both, so as to dilate orcontract loop structure1845. For example, ablation memberdistal portion1822 can be moved along the loop structure in a first direction as indicated by arrow I, for example by movingdistal handle1818 in the direction indicated by arrow L, and ablation memberproximal portion1824 can be moved along the loop structure in a second opposing direction as indicated by arrow J, for example by movingproximal handle1816 in the direction indicated by arrow K. In this way, an operator can cinch the ablation member about the tissue. The loop structure can be adjusted so that the ablation member maintains continuous contact the tissue. The operator can transmit ablation member to the tissue via the ablation member, so as to form a closed path ablation or lesion on the tissue.Handle1818 can be easily withdrawn throughsecond port1850. Accordingly, embodiments of the present invention provide techniques that include port access in addition to open sternotomy, as well as techniques that can be used to form a complete loop for lesion formation. Further, such embodiments may provide ease of vision and maneuverability, and can be easily manufactured.
• FIGS. 19A to 19E show aspects of an ablation system according to embodiments of the present invention. As depicted inFIG. 19A, anablation system1900 can include anablation assembly1910 having anablation member1920 and astabilizer member1930.Ablation member1920 can include an electrode andstabilizer member1930 can include a bladder, according to some embodiments.Ablation system1900 also includes a cinchingmember1940 having aproximal handle1942, anintermediate shaft1944, and a distal ablation segment ortip electrode1946.Cinching member1940 also includes one or more collapsible rollers or guides1950a,1950b. As shown here, guides1950a,1950bare in an expanded configuration, and are coupled with adistal support1948 of the cinching member. Optionally, guides1950a,1950bcan be coupled withdistal support1948 viapivots1960a,1960b, respectively, such thatguide1950acan move in an arc as indicated by arrow A, and guide1950bcan move in an arc as indicated by arrowB. Cinching member1940 presents a first passage orchannel1940adisposed betweenfirst guide1950aanddistal support1948, and a second passage or channel1940bdisposed betweensecond guide1950banddistal support1948. In use, an operator can advance adistal portion1912 of the ablation assembly throughfirst passage1940aas indicated by arrow C, around apatient tissue1905 as indicated by arrow D, and through second passage1940bas indicated by arrow E. An operator can adjust the positioning or tightness of aloop structure1945 formed by the ablation assembly, by advancing cinchingmember1940 toward the patient tissue as indicated by arrow F, by pulling aproximal section1914 of the ablation assembly away from the patient tissue as indicated by arrow G, and by pullingdistal section1912 of the ablation assembly away from the patient tissue as indicated by arrow H.
• FIG. 19B illustrates cinchingmember1940 partially disposed within atrocar1970.Guides1950a,1950bof the cinching member are in a collapsed or low profile configuration, and are disposed toward the proximal end or handle of the cinching member. Optionally, guides1950a,1950bcan be collapsed such that they are disposed toward the distal end of the cinching member (not shown).First guide1950ais coupled withfirst pivot1960avia a first arm1955a.Second guide1950bis coupled withsecond pivot1960bvia asecond arm1955b. In some embodiments, the arms can include a biasing mechanism, such as a spring or an elastomer, such that the guides are biased toward an open or laterally extended configuration. Due to the pivotable nature of the guides, they can swing in or collapse to allow the cinching member or device to fit inside of the trocar. Guides can be collapsed in either a forward orientation or a reverse orientation, which allows cinching member to be easily passed into and out of the trocar. For example, the guides shown inFIG. 19C extend toward the proximal end of the cinching member. If the guide member is passed through the trocar such that the guides extend beyond adistal end1976 of the trocar, guides1950a,1950bcan expand laterally toward an open or extended configuration. When the operator pulls cinchingmember1940 back through the trocar, the guides can adopt a collapsed configuration such that they extend toward the distal end of the cinching member.FIG. 19C showstrocar1970 having aflange section1972 and ashaft section1974.FIG. 19D shows a cross section ofshaft section1974. In some embodiments,shaft section1974 has a first dimension W of about 25 mm, and a second dimension H of about 10 mm.FIG. 19E shows another view of cinchingmember1940 according to embodiments of the present invention.Second guide1950bis coupled withsecond pivot1960bvia asecond arm1955b. As depicted here,intermediate shaft1944 includes an offset bend or S-curve1943. Such a bend configuration in the intermediate shaft of the cinching member can allow an operator to grasp and pull anablation assembly1910 that is disposed at or near theintermediate shaft1944 or handle1942, without interfering with the shaft or handle. In some cases, handle1942 includes a plug in1942afor providing energy to tip electrode ordistal ablation segment1946.FIG. 19F shows a cross section of atrocar1980 according to some embodiments. In some instances,trocar1980 can have a diameter of about 10 mm.
• FIGS. 20A-B,21A-B,22A-B,23A-B,24A-C,25A-B,26A-B, and27 generally show various embodiments of a stabilizer that can bend along the same plane as the electrode yet keep a suction space open around the electrode, that can keep a large surface of tissue exposed to both tissue and electrode, and that can be easily manufactured. For example, the stabilizer can have proportions that are wider than tall, and provide support to keep suction chamber from collapsing under vacuum.
• FIGS. 20A and 20B illustrate aspects of an ablation assembly according to embodiments of the present invention. As seen in the cross section view ofFIG. 20A,ablation assembly2000 includes astabilizer member2010 having a body2012 and opposing sidewalls2014,2016.Stabilizer member2010 presents a channel or recess2018 that is bordered by body2012 and sidewalls or side bars2014,2016.Ablation assembly2000 also includes an ablation member2020 disposed at least partially within channel2018. As seen in the perspective view ofFIG. 20B, an outer surface2012aof stabilizer member body2012 includes a plurality of notches2012band teeth2012c. Optionally, the sidewalls may include a depression or section where the length of the sidewall is reduced. For example, sidewall2016 can include a depression2016a. This carve-out portion2016apresents a reduced height:width ratio for the stabilizer member cross section.
• FIGS. 21A and 21B illustrate aspects of an ablation assembly according to embodiments of the present invention. As seen in the cross section view ofFIG. 21A, ablation assembly2100 includes a stabilizer member2110 having a body2112 and opposing sidewalls2114,2116. Stabilizer member2110 presents a channel or recess2118 that is bordered by body2112 and sidewalls or side bars2114,2116.Ablation assembly2000 also includes an ablation member2120 disposed at least partially within channel2118. As seen in the perspective view ofFIG. 21B, an outer surface2012aof stabilizer member body2012 provides a flat profile. Optionally, the sidewalls may include a depression or section where the length of the sidewall is reduced. For example, sidewall2116 can include a depression2116a. This carve-out portion2116apresents a reduced height:width ratio for the stabilizer member cross section.
• FIGS. 22A and 22B illustrate aspects of an ablation assembly according to embodiments of the present invention. As seen in the cross section view ofFIG. 22A, ablation assembly2200 includes a stabilizer member2210 having a body2212 and opposing sidewalls2214,2216. Stabilizer member2210 presents a channel or recess2218 that is bordered by body2212 and sidewalls or side bars2214,2216. Ablation assembly2200 also includes an ablation member2220 disposed at least partially within channel2218. As seen in the perspective view ofFIG. 22B, an outer surface2212aof stabilizer member body2212 includes a plurality of molded thin elastic windows2212athat are substantially coplanar with the profile of body2210. Outer surface2212aalso includes a plurality of support ribs2212b. Optionally, the sidewalls may include a depression or section where the length of the sidewall is reduced. For example, sidewall2216 can include a depression2216a. This carve-out portion2216apresents a reduced height:width ratio for the stabilizer member cross section.
• Sidewalls2214,2216 can also include or be coupled with tension straps2217,2219, respectively. As shown here, the tension straps are disposed within the sidewalls. Tension straps can operate to provide additional torsional rigidity to the stabilizer member. And while rigidity in torsion can be enhanced by these straps, the straps can also function to keep the trimmed-down, reduced-mass stabilizer from stretching under tension. A braided or woven strap may not detract from the flexibility of the stabilizer and can provides strength in tension. According to some embodiments, it is desirable to minimize the degree to which the stabilizer stretches, as this can also minimize the degree to which tension is transferred to the electrode.
• FIGS. 23A and 23B illustrate aspects of an ablation assembly according to embodiments of the present invention. As seen in the cross section view ofFIG. 23A, ablation assembly2300 includes a stabilizer member2310 having a body2312 and opposing sidewalls2314,2316. Stabilizer member2310 presents a channel or recess2318 that is bordered by body2312 and sidewalls or side bars2314,2316. Ablation assembly2300 also includes an ablation member2320 disposed at least partially within channel2318. As seen in the perspective view ofFIG. 23B, an outer surface2312aof stabilizer member body2312 includes a plurality of molded thin elastic windows2312athat extend or puff away from the recess2318, and a plurality of support ribs2312b. Sidewalls2314,2216 can include ridges2313,2315 which contain or are coupled with tension cords2317,2319, respectively. As shown here, the tension cords are disposed within the sidewall ridges. In some embodiments, ridges2313,2315 are disposed at a neutral bending plane. Accordingly, the center of mass of the stabilizer member can be aligned with the probe.
• FIGS. 24A to 24C illustrate aspects of an ablation assembly according to embodiments of the present invention. As seen in the cross section view ofFIG. 24A,ablation assembly2400 includes astabilizer member2410 having abody2412 and opposing sidewalls2414,2416.Stabilizer member2410 presents a channel orrecess2418 that is bordered bybody2412 and sidewalls orside bars2414,2416.Ablation assembly2400 also includes an ablation member2420 disposed at least partially withinchannel2418. As seen in the perspective view ofFIG. 24B, anouter portion2412aofstabilizer member body2412 includes a plurality of molded thinelastic windows2412athat extend or are biased inward toward therecess2418, and a plurality ofsupport ribs2412b.Sidewalls2414,2416 can includeridges2413,2415 which contain or are coupled withtension cords2417,2419, respectively. As shown here, the tension cords are disposed within the sidewall ridges. As seen inFIG. 24C, the stabilizer member can be bent under tension. The stabilizer member can have elastic features on the backbone.
• FIGS. 25A and 25B illustrate aspects of an ablation assembly according to embodiments of the present invention. As seen in the perspective view ofFIG. 25A,ablation assembly2500 includes astabilizer member2510 having abody2512 and opposing sidewalls2514,2516.Stabilizer member2510 presents a channel orrecess2518 that is bordered bybody2512 and sidewalls orside bars2514,2516. Anouter portion2512aofstabilizer member body2512 includes a plurality of molded thinelastic windows2512athat extend or are biased away from therecess2518, and a plurality ofsupport ribs2512b.Ablation assembly2500 presents a low neutral bending zone2530. According to some embodiments, the upper portion of the stabilizer flexes easily, and doesn't compress the lower section to compensate, it just bends it.FIG. 25B showsablation assembly2500 in a bent or curved configuration. As seen inFIG. 25B, the stabilizer member can be bent under tension.Elastic membrane windows2512aare drawn taut, and in some cases can stretch when the ablation assembly bends. The stabilizer member shown here can have some extra material built in or included in the backbone so as to reduce or modulate the elasticity.
• FIGS. 26A and 26B illustrate aspects of an ablation assembly according to embodiments of the present invention. As seen in the perspective view ofFIG. 26A,ablation assembly2600 includes astabilizer member2610 having abody2612 and opposing sidewalls2614,2616.Stabilizer member2610 presents a channel orrecess2618 that is bordered bybody2612 and sidewalls orside bars2614,2616. Anouter portion2612aofstabilizer member body2612 includes a plurality of molded thinelastic windows2612athat extend or puff away from therecess2618, and a plurality ofsupport ribs2612b.Sidewalls2614,2616 can includeridges2613,2615 which contain or are coupled withtension cords2617,2619, respectively. As shown here, the tension cords are disposed within the sidewall ridges.Ablation assembly2600 presents abend plane2630 that is low, at the level of the tension cords.FIG. 26B showsablation assembly2600 in a bent or curved configuration. As seen inFIG. 26B, the stabilizer member can be bent under tension.Elastic membrane windows2612aare drawn taut, and in some cases can stretch when the ablation assembly bends. The stabilizer member can have elastic features on the backbone. Material under the bending plane is compressing/shortening in length. The small flexible portions do not resist that and are small enough to not bow or buckle away from tissue so much that an air gap is created which can lead to loss of suction. As the stabilizer is passed or dragged through tissue planes, the thin soft bubbles fold into soft scale-like flaps that protect tissue from potential damage caused by the stiffer vertical ribs. InFIG. 27, the 3-4 bubbles on the right side are pushed into this shape by tissue.
• FIGS. 28A to 28C show aspects of an ablation system according to embodiments of the present invention.FIG. 28A showsablation system2800 having adistal end2810, a catch orbelt loop2820, anablation member2830, astabilizer member2840, atrocar2850, and aproximal end2870. In some embodiments, trocar orintroducer2850 can have an inside diameter of about 10 mm. The trocar can present a stiff tube that is placed through the body wall that the entire ablation system or portions thereof are passed through.FIG. 28B shows another view ofablation system2800, wheredistal end2810 is disposed introcar2850 andcatch2820. As depicted inFIG. 28C,ablation system2800 can be disposed about a patient tissue, such as aheart2860 and pulmonary veins (PV). With a more detailed reference now toFIG. 28A,ablation system2800 includes aflexible ablation member2830, an encircling mechanism or catch2820 such as a belt loop, a hook, a closable clasp, or the like, and a flexible stabilizer member or bracing2840 having adistal end2842, aproximal end2844, and a recessed receiving slot orreceptacle2846.Ablation member2830 is disposed at least partially withinreceptacle2846. The combination of the ablation member and the stabilizer member can collectively be referred to as anablation assembly2890. In use, an operator may treat a patient by wrapping aloop structure2811 of the ablation system around pulmonary veins of a patient. This may involve passingdistal end2810 circumferentially around the tissue as indicated arrow A, and throughtrocar2850 and catch2820 as indicated by arrow B inFIG. 28B. In this way, the ablation system can form a lasso about the patient tissue. The operator may expand orcontract loop structure2811 ofablation system2800 by manipulatingdistal end2810,proximal end2870, ortrocar2850. Movingdistal end2810 in direction C, as shown inFIG. 28C, results in contraction ofloop structure2811 ofablation system2800 in a cinching fashion. Movingdistal end2810 in direction D results in expansion ofloop structure2811 ofablation system2800. In this way, the operator can adjust the sizing ofloop structure2811 to accommodate any of a variety of anatomical configurations in the patient tissue. As shown here,loop structure2811 can be adjusted to settle securely and snugly around the pulmonary veins.Stabilizer member2840 may be made of or include any suitable flexible material, such as a silicone, polyurethane, polycarbonate, another suitable polymer, or combination of polymers or the like.
• In some embodiments of use, a surgeon or operator can pass stabilizer memberdistal end2810 throughcatch2820, and expand orcontract ablation system2800 by manipulating theproximal end2870. Movingproximal end2870 in direction E results in contraction ofloop structure2811 ofablation system2800 in a cinching fashion. Movingproximal end2870 in direction F results in expansion ofloop structure2811 ofablation system2800.Catch2820 is typically formed so that it can receivedistal end2810 and maintain the position of a portion ofdistal end2810 relative to a portion ofproximal end2870.Catch2820 may include a loop, a hook, an aperture, an eyelet, a channel, a recess, or the like. As shown inFIGS. 28A to 28C,catch2820 can be integral withproximal end2870. In some embodiments,catch2820 is coupled withproximal end2870. In some embodiments, a catch is coupled with or integral todistal end2810, and adapted to receiveproximal end2870 therethrough.
• As shown inFIG. 28C, a surgeon or operator can advancecatch2820 throughtrocar2850, so thatcatch2820 is disposed on a distal side oftrocar2850.Ablation member2830 may include one or more mechanisms for providing various types of ablation energy, including RF, thermoelectric, cryogenic, microwave, laser, ultrasound or the like. An operator can administer ablative energy through the ablation member to produce a circular or closed ablation pattern or lesion on the patient tissue. Accordingly, embodiments encompass techniques whereindistal end2810 is threaded or passed throughcatch2820.
• FIGS. 29A to 29C show aspects of an ablation system according to embodiments of the present invention.FIG. 29A showsablation system2900 having a distal end2910, a catch orbelt loop2920, anablation member2930, astabilizer member2940, a distal or graspingelement2950, and aproximal end2970. A pair of forceps can be used to grab the distal element.Ablation system2900 can be introduced toward a patient tissue via afirst port2902, and theforceps2955 can be introduced toward the ablation system via asecond port2904.FIG. 29B shows another view ofablation system2900, where distal end2910 is attached withproximal end2970 viacatch2920. A pair of forceps can be used to hook the catch over the proximal end. As depicted inFIG. 29C,ablation system2900 can be disposed about a patient tissue, such as a heart2960 and pulmonary veins (PV), and can include a sleeve2980.Proximal end2970 can be pulled in one direction, and sleeve2980 can be pushed in an opposing direction, so as to tighten the ablation assembly about a patient tissue. With a more detailed reference now toFIGS. 29A and 29B,ablation system2900 includes aflexible ablation member2930, an encircling mechanism or catch2920 such as a belt loop, a hook, a closable clasp, or the like, and a flexible stabilizer member or bracing2940 having adistal end2942, aproximal end2970, and a recessed receiving slot or receptacle2946.Ablation member2930 is disposed at least partially within receptacle2946. The combination of the ablation member and the stabilizer member can collectively be referred to as anablation assembly2990. In use, an operator may treat a patient by wrapping aloop structure2911 of the ablation system around pulmonary veins of a patient. This may involve passing distal end2910 circumferentially around the tissue as indicated arrow A, and securingcatch2920 withproximal end2970.
• The operator can facilitate placement ofsystem2900 by engaging or graspingdistal element2950 and maneuveringdistal end2942. In some embodiments,distal element2950 includes a string or tape which the operator can grasp with a maneuvering mechanism orpositioning device2955, such as a pair of forceps.FIGS. 29A and 29B show thatdistal end2942 can be advanced or steered as depicted by arrow B. In this way,ablation system2900 can be further wrapped around the patient tissue, so as to encircle or lasso the tissue.Positioning device2955 can be introduced into the patient via a minimally invasive incision.Positioning device2955 may be used by the operator to graspdistal element2950 and maneuverdistal end2942 as desired. As shown inFIG. 29C, an operator can advance sleeve2980 alongproximal end2970 towarddistal end2942 as indicated by arrow C, so as to forcecatch2920 alongproximal end2970 towarddistal end2942 as indicated by arrow D, and thereby cinch orcontract loop structure2911. Hence, the loop structure can conform with anatomical features of theheart2860, so as to provide enhanced lesion continuity. Conversely, an operator may allowloop structure2911 to expand or relax by moving sleeve in a direction opposite of arrow C. In this way, the operator can adjust the sizing ofloop structure2911 to accommodate any of a variety of anatomical configurations in the patient tissue. As shown here,loop structure2911 can be adjusted to settle securely and snugly around the pulmonary veins.Stabilizer member2940 may be made of or include any suitable flexible material, such as a silicone, polyurethane, polycarbonate, another suitable polymer, or combination of polymers or the like.
• In some embodiments of use, a surgeon or operator can pass stabilizer member distal end2910 throughcatch2920, and expand orcontract ablation system2900 by manipulating theproximal end2970. Movingproximal end2970 in direction E results in contraction ofloop structure2911 ofablation system2900 in a cinching fashion. Movingproximal end2970 in direction F results in expansion ofloop structure2911 ofablation system2900.Catch2920 is typically formed so that it can receive proximal end2944 and maintain the position of a portion of distal end2910 relative to a portion ofproximal end2970.Catch2920 may include a loop, a hook, an aperture, an eyelet, a channel, a recess, or the like. As shown inFIGS. 29A to 29C,catch2820 can be integral withdistal end2942. In some embodiments,catch2920 is coupled withdistal end2942. In some embodiments, a catch is coupled with or integral toproximal end2970, and adapted to receivedistal end2942 therethrough.
• Ablation member2930 may include one or more mechanisms for providing various types of ablation energy, including RF, thermoelectric, cryogenic, microwave, laser, ultrasound or the like. An operator can administer ablative energy through the ablation member to produce a circular or closed ablation pattern or lesion on the patient tissue.Positioning device2955 may include opposable jaws, forceps, clamps or any combination or other suitable means that can be used by surgeon or operator to grasp or holddistal element2950.Positioning device2955 may also be used to positionablation system2900 on the heart or repositionablation system2900 to perform ablation in multiple locations on a heart.
• FIGS. 30A and 30B show aspects of an ablation system according to embodiments of the present invention.Ablation system3000 can be wrapped around apatient tissue3005 of a patient3005a, such as a heart or other cardiovascular tissue, as indicated by arrow A. Adistal end3010 of the system can be pulled or passed through acinching device3020, as indicated by arrowB. Ablation system3000 can include aflexible ablation assembly3015, acinching device3020, and atrocar3007.Ablation assembly3015 can be used to deliver energy to thepatient tissue3005 in order to ablate the tissue. In some embodiments,ablation assembly3015 includes an ablation member3016, such as an electrode, coupled with a stabilizer member orbackbone3017. In some embodiments,ablation assembly3015 might include any suitable ablation mechanism designed to deliver different forms of energy, including, but without limitation to, RF, thermoelectric, cryogenic, microwave, laser, ultrasound or the like. In some embodiments,stabilizer member3017 includes a flexible backbone member coupled with the ablation member. An operator can usecinching device3020 to help increase or modulate the amount of contact between ablation member3016 and thepatient tissue3005.FIG. 30B shows a cross-section view ofcinching device3020, corresponding to the A-A line depicted inFIG. 30A.Cinching device3020 may come in many different configurations and is not limited to those depicted in the figures. As shown here, cinchingdevice3020 can include atubular member3022, a proximal flange,3024, and aninternal divider3026.Cinching device3020 can define a first lumen orpassage3027aand a second lumen orpassage3027b. In some cases, elements of cinchingdevice3020 may include insulating or non-conducting materials.
• In use, an operator can pass orplace ablation assembly3015 throughfirst passage3027aofcinching device3020, as indicated by arrow C. The ablation assembly can then be wrapped around thepatient tissue3005 as indicated by arrow A, anddistal end3010 of the ablation assembly can then be pulled back or passed throughsecond passage3027bofcinching device3020, as indicated by arrow B. As shown here, the ablation member can thus be wrapped aroundpatient tissue3005, which may include a heart or other cardiovascular tissue, anddistal end3010 of the ablation assembly can be pulled or placed throughcinching device3020 such thatablation assembly3015 forms aloop structure3019.
• Loop structure3019 can be tightened around the patient tissue by a cinching procedure, for example by advancing the cinching device toward the tissue as indicated by arrow D. For example, an operator can grasp orcontrol flange3024 of cinchingdevice3020 so as to move the cinching device toward the tissue as indicated by arrow D. Relatedly, an operator can grasp or controldistal section3010 of the ablation assembly, aproximal section3012 of the ablation assembly, or both, so as to positionally fixablation assembly3015 or provide an opposing force to the cinching operation described above, as indicated by arrows E andF. Cinching device3020 can be advanced alongablation assembly3015 toward or away from the tissue, so as to increase or decrease contact betweenablation assembly3015 andpatient tissue3005. When the assembly is in the desired location, energy can be applied through the ablation member3016 ofablation assembly3015, towardpatient tissue3005. The operator can positionablation assembly3015 to make contact with selected parts ofpatient tissue3005 such that when ablative energy is transmitted through the ablation assembly, it is possible to create an approximately circular or closed ablation pattern or lesion on the tissue. In this way, energy can be applied by the ablation system to the tissue. The position of cinchingdevice3020 relative toablation assembly3015 can be adjusted by the operator. For example, the cinching device may be advanced or refracted to differing degrees in order to increase or decrease an amount of contact between the ablation assembly and the patient tissue. As the stabilizer is dragged around the path around the heart from a port access, drag can be minimized or reduced if two sides of the stabilizer are pulled at once as inFIG. 30A.
• FIG. 31 shows aspects of an ablation system according to embodiments of the present invention.Ablation system3100 has adistal end3110, a catch orbelt loop3120, anablation member3130, astabilizer member3140, a distal or graspingelement3150, and aproximal end3170. A pair of forceps can be used to grab the distal element.Ablation system3100 can be introduced toward a patient tissue via a first port ortrocar3102, and theforceps3155 can be introduced toward the ablation system via a second port ortrocar3104.Distal end3110 can be attached withproximal end3170 viacatch3120. A pair of forceps can be used to hook the catch over the proximal end.Ablation system3100 can be disposed about a patient tissue, such as a heart3160 and pulmonary veins (PV), and can include apush tube3180.Proximal end3170 can be pulled in one direction, andsleeve3180 can be pushed in an opposing direction, so as to tighten the ablation assembly about a patient tissue. With a more detailed reference now toFIG. 31,ablation system3100 includes aflexible ablation member3130, an encircling mechanism or catch3120 such as a belt loop, a hook, a closable clasp, or the like, and a flexible stabilizer member or bracing3140 having adistal end3142, aproximal end3144, and a recessed receiving slot orreceptacle3146.Ablation member3130 is disposed at least partially withinreceptacle3146. The combination of the ablation member and the stabilizer member can collectively be referred to as anablation assembly3190. In use, an operator may treat a patient by wrapping aloop structure3111 of the ablation system around pulmonary veins of a patient. This may involve passingdistal end3110 circumferentially around the tissue as indicated arrow A, and securingcatch3120 withproximal end3170.
• The operator can facilitate placement ofsystem3100 by engaging or graspingdistal element3150 and maneuveringdistal end3142. In some embodiments,distal element3150 includes a string or tape which the operator can grasp with a maneuvering mechanism orpositioning device3155, such as a pair of forceps.Distal end3142 can be advanced or steered as depicted by arrow B. In this way,ablation system3100 can be further wrapped around the patient tissue, so as to encircle or lasso the tissue.Positioning device3155 can be introduced into the patient via a minimally invasive incision.Positioning device3155 may be used by the operator to graspdistal element3150 and maneuverdistal end3142 as desired.
• An operator can advancesleeve3180 alongproximal end3170 towarddistal end3142 as indicated by arrow C, so as to forcecatch3120 alongproximal end3170 towarddistal end3142 as indicated by arrow D, and thereby cinch orcontract loop structure3111. Conversely, an operator may allowloop structure3111 to expand or relax by moving sleeve in a direction opposite of arrow C. In this way, the operator can adjust the sizing ofloop structure3111 to accommodate any of a variety of anatomical configurations in the patient tissue. As shown here,loop structure3111 can be adjusted to settle securely and snugly around the pulmonary veins.Stabilizer member3140 may be made of or include any suitable flexible material, such as a silicone, polyurethane, polycarbonate, another suitable polymer, or combination of polymers or the like.
• In some embodiments of use, a surgeon or operator can pass stabilizer memberdistal end3110 throughcatch3120, and expand orcontract ablation system3100 by manipulating theproximal end3170. Movingproximal end3170 in direction E results in contraction ofloop structure3111 ofablation system3100 in a cinching fashion. Movingproximal end3170 in direction F results in expansion ofloop structure3111 ofablation system3100.Catch3120 is typically formed so that it can receiveproximal end3144 and maintain the position of a portion ofdistal end3110 relative to a portion ofproximal end3170.Catch3120 may include a loop, a hook, an aperture, an eyelet, a channel, a recess, or the like.Catch3120 can be integral withdistal end3142. In some embodiments,catch3120 is coupled withdistal end3142. In some embodiments, a catch is coupled with or integral toproximal end3170, and adapted to receivedistal end3142 therethrough.
• Ablation member3130 may include one or more mechanisms for providing various types of ablation energy, including RF, thermoelectric, cryogenic, microwave, laser, ultrasound or the like. An operator can administer ablative energy through the ablation member to produce a circular or closed ablation pattern or lesion on the patient tissue.Positioning device3155 may include opposable jaws, forceps, clamps or any combination or other suitable means that can be used by surgeon or operator to grasp or holddistal element3150.Positioning device3155 may also be used to positionablation system3100 on the heart or repositionablation system3100 to perform ablation in multiple locations on a heart.
• FIGS. 32A to 32D show aspects of ablation systems according to embodiments of the present invention. An ablation system can be wrapped around a patient tissue, such as a heart or other cardiovascular tissue, as indicated by arrow A. A distal end of the system can be pulled or passed through a cinching device, as indicated by arrow B. As illustrated inFIG. 32A, anablation system3200acan include a flexible ablation assembly3215a, a cinching device3220a, and atrocar3207a. Ablation assembly3215acan be used to deliver energy to the patient tissue in order to ablate the tissue. In some embodiments, ablation assembly3215aincludes an ablation member3216a, such as an electrode, coupled with a stabilizer member orbackbone3217a. In some embodiments, ablation assembly3215amight include any suitable ablation mechanism designed to deliver different forms of energy, including, but without limitation to, RF, thermoelectric, cryogenic, microwave, laser, ultrasound or the like. In some embodiments, stabilizer member3017aincludes a flexible backbone member coupled with the ablation member. An operator can use cinching device3020ato help increase or modulate the amount of contact between ablation member3016aand the patient tissue. As shown here, cinching device3220acan include aproximal flange3222a, a central portion or moveable center blade3224a, and a distal portion3226awhich is adapted to contact the ablation member. Cinching device3220a, in combination withtrocar3207a, can define a first lumen orpassage3227aand a second lumen or passage3228a. In some cases, elements of cinching device3220amay include insulating or non-conducting materials.
• In use, an operator can pass or place ablation assembly3215athroughfirst passage3227aof cinching device3220a, as indicated by arrow C. The ablation assembly can then be wrapped around the patient tissue as indicated by arrow A, and distal end3210aof the ablation assembly can then be pulled back or passed through second passage3228aof cinching device3220a, as indicated by arrow B. As shown here, the ablation member can thus be wrapped around patient tissue, which may include a heart or other cardiovascular tissue. Distal end3210aof the ablation assembly,proximal end3270aof the ablation assembly, or both, can be pulled or otherwise positioned such that ablation assembly3215aforms aloop structure3219aabout the patient tissue.
• Loop structure3219acan be tightened around the patient tissue by a cinching procedure, for example by advancing the cinching device toward the tissue as indicated by arrow D. For example, an operator can grasp orcontrol flange3222aof cinching device3220aso as to move the cinching device toward the tissue as indicated by arrow D. Relatedly, an operator can grasp or control distal section3210aof the ablation assembly, aproximal section3270aof the ablation assembly, or both, so as to positionally fix ablation assembly3215aor provide an opposing force to the cinching operation described above, as indicated by arrows E and F. Accordingly, an operator can engage adistal ablation tip3218awith distal portion3226a, thedistal ablation tip3218ahas been separated fromstabilizer member3217a. Cinching device3220acan be advanced along ablation assembly3215atoward or away from the tissue, so as to increase or decrease contact between ablation assembly3215aand patient tissue3205a. When the assembly is in the desired location, energy can be applied through the ablation member3216aof ablation assembly3215a, toward patient tissue3205a. The operator can position ablation assembly3215ato make contact with selected parts of patient tissue3205asuch that when ablative energy is transmitted through the ablation assembly, it is possible to create an approximately circular or closed ablation pattern or lesion on the tissue. In this way, energy can be applied by the ablation system to the tissue. The position of cinching device3220arelative to ablation assembly3215acan be adjusted by the operator. For example, the cinching device may be advanced or retracted to differing degrees in order to increase or decrease an amount of contact between the ablation assembly and the patient tissue.
• As illustrated inFIG. 32B, an ablation system3200bcan include a flexible ablation assembly3215band acinching device3220b. Ablation assembly3215bcan be used to deliver energy to the patient tissue in order to ablate the tissue. In some embodiments, ablation assembly3215bincludes anablation member3216b, such as an electrode, coupled with a stabilizer member orbackbone3217b. As shown here, cinchingdevice3220bcan include a proximal flange3222b, a central portion orcenter blade3224b, and adistal portion3226bwhich is adapted to contact the ablation member. As shown inFIG. 32C,cinching device3220bcan define a first lumen orpassage3227band a second lumen or passage3228b. A cross-section of these passages may present a “double-D” profile, and thecinching device3220bcan be manufactured via an extrusion procedure.
• In use, an operator can pass or place ablation assembly3215bthroughfirst passage3227bofcinching device3220b, as indicated by arrow C. The ablation assembly can then be wrapped around the patient tissue as indicated by arrow A, anddistal end3210bof the ablation assembly can then be pulled back or passed through second passage3228bofcinching device3220b, as indicated by arrow B. As shown here, the ablation member can thus be wrapped around patient tissue, which may include a heart or other cardiovascular tissue.Distal end3210bof the ablation assembly, proximal end3270bof the ablation assembly, or both, can be pulled or otherwise positioned such that ablation assembly3215bforms a loop structure3219babout the patient tissue.
• Loop structure3219bcan be tightened around the patient tissue by a cinching procedure, for example by advancing the cinching device toward the tissue as indicated by arrow D. For example, an operator can grasp or control flange3222bofcinching device3220bso as to move the cinching device toward the tissue as indicated by arrow D. Relatedly, an operator can grasp or controldistal section3210bof the ablation assembly, a proximal section3270bof the ablation assembly, or both, so as to positionally fix ablation assembly3215bor provide an opposing force to the cinching operation described above, as indicated by arrows E and F. Accordingly, an operator can engage adistal ablation tip3218awith distal portion3226a, thedistal ablation tip3218ahas been separated fromstabilizer member3217a. This separated portion ofablation member3216bcan be urged toward or against a moreproximal section3216b′ of the ablation member, so as to form a more circular or circumferential loop structure. As shown here, distal ablation tip3218bcan be disposed in close proximity with a more proximal section of the ablation member. In some cases, distal ablation tip321b8 includes or is coupled with a distal guide3213bhaving a recess3212bthat is contoured to receive the more proximal section of the ablation member.
• Cinching device3220bcan be advanced along ablation assembly3215btoward or away from the tissue, so as to increase or decrease contact between ablation assembly3215band patient tissue3205b. The operator can position ablation assembly3215bandablation member3216bto make contact with selected parts of patient tissue3205bsuch that when ablative energy is transmitted through the ablation assembly, it is possible to create an approximately circular or closed ablation pattern or lesion on the tissue. The position of cinchingdevice3220brelative to ablation assembly3215bcan be adjusted by the operator. For example, the cinching device may be advanced or retracted to differing degrees in order to increase or decrease an amount of contact between the ablation assembly or the ablation member and the patient tissue.
• As shown inFIG. 32D, as an ablation assembly3215dis advanced about a patient tissue3205d, in the direction indicated by arrow A, adistal ablation tip3218dof an ablation member3216dremains associated with astabilizer member3217d. This is shown at section D′. Then, as ablation assembly3215dis advanced further about the tissue, and into acinching device3220d, in the direction indicated by arrow B, the changing curvature of the stabilizer member, from a concave bend to a convex bend, facilitates the separation ofdistal ablation tip3218dfromstabilizer member3217d. This is shown at section D″.
• FIGS. 33A to 33J illustrate aspects of ablation systems according to embodiments of the present invention. As shown inFIG. 33A, anablation system3300 presents a proximal section orend3302 and a distal section orend3304.Ablation system3300 includes an ablation assembly3315 having an ablation member3316 and astabilizer member3317.Proximal section3302 includes afirst lumen3302′ configured to receive the ablation member, and asecond lumen3302″ configured to fluidly couple the stabilizer member with a suction source. In some embodiments,ablation system3300 can present a “U” or loop shaped configuration, which can be placed near or applied to a path which surrounds or travels about the pulmonary veins (PV) of apatient tissue3305.Distal section3304 may include adistal element3307 such as a ribbon, or the like. In use, an operator can facilitate placement of the ablation system by graspingdistal element3307 and maneuvering a systemdistal end3304. In some embodiments, distal or graspingelement3307 includes a string or tape which the operator can grasp with a maneuvering mechanism such as a pair of forceps.
• Ablation system3300 can be cinched about the pulmonary veins, so as to form an oval or loop shape. For example, adistal engagement member3303 such as a ball disposed ondistal end3304 ofsystem3300 can be advanced toward aproximal engagement member3308, such as slot or channel, disposed on a moreproximal section3301 ofsystem3300. In some cases,distal engagement member3303 can be urged towardslot3308 by an operator using anintroducer instrument3310, as shown inFIG. 33B. Whendistal engagement member3303 engagesproximal engagement member3308, the distal engagement member can be moved along the proximal engagement member, either distally or proximally, so as to respectively tighten or loosen a loop enclosure or structure3319 formed by the ablation system. In some cases, the proximal engagement member includes a track which has a shape that is complementary to the shape of the distal engagement member. In some cases, the position ofdistal engagement member3303 alongproximal engagement member3308 can be incrementally adjusted, so as to achieve any desired loop structure circumference. Patients may present tissues of varying dimensions and sizes, and it may be desirable to configureablation system3300 so as to provide discrete stopping points or attraction points fordistal engagement member3303 along a length ofproximal engagement member3308. This allows an operator to select from a multiplicity of stable connection points, so as to form loop closures or ovals which are customized or dimensioned for a particular patient's anatomy.
• FIGS. 33B and 33C show aspects of anintroducer instrument3310 according to embodiments of the present invention.Introducer instrument3310 can include ansleeve3312, and anobturator3314 which can be inserted into the sleeve.Sleeve3312 may have adistal catch3313 adapted to releasably couple with adistal engagement member3303 of an ablation system. For example, a distal catch or introducer tip can be used to grasp a distal engagement member or conductive ball. In use, an operator may insert the obturator into the sleeve in a distal direction or fashion, such that the distal end of the obturator forces the distal engagement member out or away from the distal catch.Distal catch3313 may include arecess3313′ that allows astem3303′ ofball3303 to swing or rotate, as indicated by arrow A, which allowsball3303 to be directed toward or injected intoslot3308.
• FIG. 33D shows features of aproximal engagement member3301daccording to embodiments of the present invention.Proximal engagement member3301dincludes acircular aperture3322dand an elongate track3324d. In some embodiments,proximal engagement member3301dpresents a keyhole and slot configuration.FIG. 33E shows a cross-section of a proximal portion of anablation system3300e, including a body3340e, aproximal engagement member3301e, an ablation member3316e, and a vacuum lumen3330e. Body3340ecan be made of molded silicone, for example, andproximal engagement member3301ecan be made of a harder material such as polycarbonate or polypropylene, for example.FIG. 33F shows a cross-section of a proximal portion body3340faccording to embodiments of the present invention. Body3340fcan be made of molded silicone, for example.FIG. 33G shows a cross-section of an ablation assembly3300g, which includes a distal end3304gand a proximal end3302g. Distal end3304gincludes an ablation member3316gdisposed within a stabilizer member3317g, and a distal engagement member3303g. Proximal end3302gincludes abody3340g, aproximal engagement member3301g, an ablation member3316g, and a vacuum orfluid lumen3330gsuch as an air tube. Body3340ecan be made of molded silicone, for example.FIG. 33H shows a cross-section of aproximal portion body3340haccording to embodiments of the present invention.Body3340hcan be made of molded silicone, for example.
• FIG. 33J shows a proximal section body3340jaccording to embodiments of the present invention. Proximal section body3340jincludes an ablation member engagement section3342jsuch as a recess or channel configured to receive an ablation member, a proximal engagement member3344jsuch as a recess or channel configured to receive a distal engagement member, and a lumen or passage3346j. As shown here, body3340jincludes a proximal barb fitting3362jand a distal barb fitting3364j.FIG. 33I shows a cross-section of a proximal section body3340iaccording to embodiments of the present invention. Proximal section body3340iincludes an ablation member engagement section3342isuch as a recess or channel configured to receive an ablation member, a proximal engagement member3344isuch as a recess or channel configured to receive a distal engagement member, and a lumen or passage3346i. Hence, the proximal engagement member can present a track or slot that allows the operator to adjust the size of the loop structure, and to change the shape of the loop structure, for example from a teardrop shape to a more circular shape. The distal engagement member can include a conductive element, such as a stainless steel ball. The proximal engagement member may present discrete stopping points for the distal engagement member.
• Proximal section3302 includes afirst lumen3302′ configured to receive the ablation member, and asecond lumen3302″ configured to fluidly couple the stabilizer member with a suction or fluid source.FIG. 33A shows thatablation system3300 can be disposed about four pulmonary veins (PV), so as to form a loop enclosure. As shown inFIG. 33J, proximal section body3340jcan include a proximal section channel or slot3344jwhich is configured to receive a distal engagement member, and an ablation member path3342jwhich is configured to receive an ablation member. In use, an operator can move wrap or place the ablation system about a patient tissue, and insert the distal engagement member into slot3344j. By adjusting the position of the distal engagement member distally or proximally along the length of slot3344j, the operator can respectively tighten or loosen a loop enclosure formed by the ablation system so as to form loops of various circumferences or configurations.
• As shown inFIG. 33A,stabilizer member3317 can include aninterface3317′ that is configured to contact the patient tissue. Often,interface3317′ presents aconcave channel3317′″ with two opposingsidewalls3317″. Ablation member3316 can be at least partially disposed within the concave channel, between the two sidewalls. The concave channel can be in fluid communication withsecond lumen3302″. Accordingly, a fluid or vacuum can be applied to a patient tissue via the second lumen and concave channel. For example, the sidewalls may create a seal with the tissue, and a vacuum can be applied through the concave channel so as to suction the stabilizer member against the patient tissue. As shown inFIG. 33J, the fluid or vacuum can be applied through lumen or passage3346jand through luers or fittings3346j,3364jwhich collectively provide a conduit between the proximal portion second lumen and the concave channel. In this way, an operator can create any desired pressure or material through the concave channel to the tissue.
• FIGS. 34A to 34E illustrate aspects of ablation systems according to embodiments of the present invention. As shown inFIG. 34A, anablation system3400 presents a proximal section orend3402 and a distal section orend3404.Ablation system3400 includes anablation assembly3415 having an ablation member3416 and a stabilizer member orbladder3417.Proximal section3402 includes afirst lumen3402′ configured to receive the ablation member, and asecond lumen3402″ configured to fluidly couple the stabilizer member with a suction source. In some embodiments,ablation system3400 can present a “U” or loop shaped configuration, which can be placed near or applied to a path which surrounds or travels about the pulmonary veins (PV) of apatient tissue3405.Distal section3404 may include adistal element3407 such as a ribbon, or the like. In use, an operator can facilitate placement of the ablation system by graspingdistal element3407 and maneuvering a systemdistal end3404. In some embodiments, distal or graspingelement3407 includes a string or tape which the operator can grasp with a maneuvering mechanism such as a pair of forceps.Ablation system3400 can be cinched about the pulmonary veins, so as to form an oval or loop shape. For example, a distal engagement member such as a ball disposed ondistal end3404 ofsystem3400 can be advanced toward aproximal engagement member3408, which may include akeyhole3408′ andslot3408″, disposed on a moreproximal section3401 ofsystem3400. When the distal engagement member engagesproximal engagement member3408, the distal engagement member can be moved along the proximal engagement member, either distally or proximally, so as to respectively tighten or loosen a loop enclosure or structure3419 formed by the ablation system. In some cases, the proximal engagement member includes a track which has a shape that is complementary to the shape of the distal engagement member. In some cases, the position ofdistal engagement member3403 alongproximal engagement member3408 can be incrementally adjusted, so as to achieve any desired loop structure circumference. Patients may present tissues of varying dimensions and sizes, and it may be desirable to configureablation system3400 so as to provide discrete stopping points or attraction points fordistal engagement member3403 along a length ofproximal engagement member3408. This allows an operator to select from a multiplicity of stable connection points, so as to form loop closures or ovals which are customized or dimensioned for a particular patient's anatomy.
• FIG. 34B shows aspects of proximal section body3440b, couplings orfittings3462b,3464b, andablation assembly3415b, according to embodiments of the present invention.Ablation assembly3415 includes astabilizer member3417band anablation member3416b.Stabilizer member3417bcan include aninterface3417b′ that is configured to contact the patient tissue. Often,interface3417b′ presents aconcave channel3417b′″ with two opposingsidewalls3417b″.Ablation member3416bcan be at least partially disposed within the concave channel, between the two sidewalls. The concave channel can be in fluid communication with a proximal lumen3402bof the stabilizer member. Accordingly, a fluid or vacuum can be applied to a patient tissue via the proximal lumen and concave channel.
• For example, the sidewalls may create a seal with the tissue, and a vacuum can be applied through the concave channel so as to suction the stabilizer member against the patient tissue.
• Proximal section body3340bcan include an ablationmember engagement section3342bsuch as a recess or channel configured to receive an ablation member, aproximal engagement member3344bsuch as a recess or channel configured to receive a distal engagement member, and a lumen orpassage3346b. As shown here, body3340jincludes a proximal fitting3362band a distal fitting3364b.FIG. 34A shows thatablation system3400 can be disposed about four pulmonary veins (PV), so as to form a loop enclosure. As shown inFIG. 34B,proximal section body3340bcan include a proximal section channel orslot3344bwhich is configured to receive a distal engagement member, and anablation member path3342bwhich is configured to receive an ablation member. In use, an operator can move wrap or place the ablation system about a patient tissue, and insert the distal engagement member intoslot3344b. By adjusting the position of the distal engagement member distally or proximally along the length ofslot3344b, the operator can respectively tighten or loosen a loop enclosure formed by the ablation system so as to form loops of various circumferences or configurations. A fluid or vacuum can be applied through lumen orpassage3346band through luers orfittings3346b,3364bwhich collectively provide a conduit between the proximal portion second lumen and the concave channel. In this way, an operator can create any desired pressure or material through the concave channel to the tissue.
• FIG. 34C shows a coupling section3401c′ that can be connected with a proximal section body. Coupling section3401c′ can include afirst lumen3402′ configured to couple with a first lumen of the proximal section body, and asecond lumen3402″ configured to couple with a second lumen of the proximal section body. As shown here,first lumen3402′ may be configured to receive an ablation member3416ctherethrough. Coupling section3401c′ can also include aproximal engagement member3408c′ that is configured to receive a distal engagement member. FIG.34D1 shows a partial cross-section view of aproximal engagement member3408d, and FIG.34D2 shows a partial perspective view of theproximal engagement member3408d, according to embodiments of the present invention.Proximal engagement member3408dmay include akeyhole3408d′, aslot3408″, and a plurality ofposition detents3408d′″ which can act to inhibit motion of a distal engagement member along the proximal engagement member. In some cases, a position detent may include a silicone plug. In use, an operator can use the position detents to incrementally adjust the position of the distal engagement member along a length of the proximal engagement member, so as to achieve any desired loop closure circumference. Patients may present tissues of varying dimensions and sizes, and it may be desirable to configure an ablation system so as to provide discrete stopping points or resistance points along a length of the proximal engagement member. This allows an operator to select from a multiplicity of stable connection points, so as to form loop closures or ovals which are customized or dimensioned for a particular patient's anatomy.FIG. 34E shows a cross-section view of astabilizer member3417ejuxtaposed with a cross-section view of a proximal section body3440e. As depicted here,stabilizer member3417eincludes an opposing pair ofside walls3417e″ and achannel3417e′ disposed therebetween. Proximal section body3440eincludes an ablationmember engagement section3442esuch as a recess or channel configured to receive an ablation member, aproximal engagement member3444bsuch as a recess or channel configured to receive a distal engagement member, and a lumen orpassage3446e.
• FIG. 35A shows an associative cooperation between adistal engagement member3503 and aproximal engagement member3508 of anablation system3500, according to embodiments of the present invention. As shown here, agap3516′ may exist between adistal tip3516″ and aproximal section3516′″ of anablation member3516, when the system is wrapped about apatient tissue3505. In some embodiments, the distal engagement member may include abridge element3503′ that spansgap3516′ and provides electrical or ablative conductivity acrossgap3516′ betweendistal tip3516″ and aproximal section3516′″. As shown inFIGS. 35B and 35C, anablation member3516bcan include one or more lumens3575bhaving openings at adistal tip3516″. In use, a cooling fluid can be passed through lumens3575b, such that the fluid exits one lumen and enters another lumen as indicated by arrow A.FIGS. 35D and 35E depict a distal section of an ablation system that presents an offset angle α between alongitudinal axis3580ddefine by anablation member3516dand alongitudinal axis3582ddefined by adistal engagement member3503d.FIGS. 35F and 35G depict a distal section of an ablation system that presents an offset angle α between alongitudinal axis3580fdefine by an ablation member3516fand a longitudinal axis3582fdefined by adistal engagement member3503f. Such offset angles can enhance or facilitate the cooperative association between a distal engagement member and a proximal engagement member. For example, the offset angle can make it easier to couple the distal engagement member with the proximal engagement member. [notes indicate:
• FIGS. 36A to 36C shows aspects of adistal engagement member3603 according to embodiments of the present invention. As shown in these figures,distal engagement member3603 can include apivot mechanism3690, such as an aperture, a pin, a hinge, or the like, that allows the distal engagement member and an ablation assembly3615 to pivot relative to each other.Distal engagement member3603 can include aball3692 which can be inserted into a slot of aproximal engagement member3608.Distal engagement member3603 can also include a graspingtab3694. In use, an operator may grasp the grasping tab with forceps or another grasping mechanism, and manipulate the position of the distal engagement member along a length of the proximal engagement member. As the distal engagement member slides along the length of the proximal engagement member, the ablation assembly and the distal engagement member can pivot relative to each other, as indicated by arrow A inFIG. 36A. Hence, the pivoting or hinge mechanism can allow an ablation assembly to be cinched or otherwise expanded or contracted, so as to form a loop structure about a patient tissue.
• FIG. 37A shows adistal engagement member3703aaccording to embodiments of the present invention.Distal engagement member3703aincludes acylindrical stem3703a′ and aspherical head3703a″.FIG. 37B shows adistal engagement member3703baccording to embodiments of the present invention.Distal engagement member3703bincludes a flat orplanar stem3703b′ and aspherical head3703b″.FIG. 37C shows adistal engagement member3703caccording to embodiments of the present invention.Distal engagement member3703cincludes a flat orplanar stem3703c′ and acylindrical head3703c″. These different configurations can allow a distal section of the ablation assembly or stabilizer member to roll or swing to varying degrees. For example,distal engagement member3703aofFIG. 37A allows for substantial roll as indicated by arrow A′, and for substantial swing as indicated by arrow A″.Distal engagement member3703bofFIG. 37B allows for little or no roll as indicated by arrow B′, and for substantial swing as indicated by arrow B″.Distal engagement member3703cofFIG. 37C allows for little or no roll as indicated by arrow C′, and for little or no swing as indicated by arrow C″. In some embodiments, the long axis of3703c″ may be something other than 90° to the long axis of the stabilizer to help establish a desired angle of mating.
• FIG. 38A shows a posterior view of apatient heart3800. An ablationsystem insertion path3810 is shown by arrows A. In an exemplary procedure, an operator can advance an ablation system along ablationsystem insertion path3810, so as to place the ablation system in the desired location for ablating the patient tissue.FIG. 38B shows an anterior view of a posteriorpericardial lining3820 of a patient. InFIG. 38B, the heart is swung out 180° relative to the view shown inFIG. 38A. Ablationsystem insertion path3810 is shown by arrows A. In an exemplary procedure, an operator can advance an ablation system along ablationsystem insertion path3810, so as to place the ablation system in the desired location for ablating the patient tissue.FIG. 39, provides a left lateral view of a patient. Arrows A indicate an ablationsystem insertion path3910. In an exemplary procedure, an operator can advance an ablation system along ablationsystem insertion path3910, so as to place the ablation system in the desired location for ablating the patient tissue.
• FIGS. 40 to 51 illustrate aspects of an exemplary method for inserting anablation system4000 into a patient.FIG. 40 shows apusher4005 and atape hook4020 according to embodiments of the present invention. As shown inFIG. 41, an operator can place afirst trocar4002 and asecond trocar4006 into apatient4004. Aguide tube4008 may be disposed throughfirst trocar4002. In some cases, a guide tube may include an internal obturator. An operator can advance anablation assembly4010 throughtrocar4002 and guidetube4008, between a pulmonary vein (PV) and a superior vena cava (SVC) of the patient, and about theheart4012 as indicated by arrows A and B. The operator can also advance a graspingmechanism4014 through second trocar, between a pulmonary vein (PV) and an inferior vena cava (IVC), as indicated by arrow C. As depicted inFIG. 43, the operator can also advancetape hook4020 through first trocar, and can grasp a distalgrasping element4016 of the ablation system. The operator can manipulate the grasping mechanism so as to move the distal grasping element toward the tape hook. In some cases, the operator can retractguide tube4008 fromfirst trocar4002 prior to or subsequent to inserting the tape hook. In some cases,trocar4002 can provide access through an oblique or transverse sinus. Similarly,trocar4006 can provide access to or through an oblique or transverse sinus.FIG. 42 shows how distal graspingelement4016 can be coupled with or snagged bytape hook4020. As illustrated inFIG. 44, the operator can retracttape hook4020 throughfirst trocar4002, thereby drawing or retrieving distalgrasping element4016 and a distal section ofablation assembly4010 throughfirst trocar4002 as well. In some cases, the proximal end of the bladder can be advanced further through push tube from the outside to allow it to slide around the anatomy as the distal end is pulled out.
• FIG. 45 provides a close up view of a distal section ofablation assembly4010. As shown here,ablation assembly4010 includes a bladder orstabilizer member4020, anablation member4022, anintroducer4024 having a pin4026, and distalgrasping element4016. Distal graspingelement4016 can be anchored withstabilizer member4020, for example atattachment point4028. The distal grasping element can be disposed around the pin and back through the bladder atpoint4030, and through adistal aperture4032 ofintroducer4024. In use, an operator can pull on distalgrasping element4016 so as to pushintroducer4024 ontostabilizer member4020, for example by urging pin4026 towardstabilizer member4020. In some cases,introducer4024 has a preformed or preset shape. In some cases, introducer can have a bias toward a curve or arc shape. According to some embodiments, the action of pulling on the tape keeps introducer and stabilizer forced together but releasing the grasp on the tape and pulling the introducer away from stabilizer can separate the two and the tape slides around pin in introducer and through slot in end of stabilizer. As shown inFIG. 46,introducer4024 can be pulled along distalgrasping element4016, away fromstabilizer member4020, in the direction indicated by arrow C.FIG. 47 shows that distal grasping element can be threaded through aloop4007 ofpusher4005. An operator can advancepusher4005 throughfirst trocar4002 in a direction D, as depicted inFIG. 48. The operator can adjust the position ofpusher4005 alongablation assembly4010 so as to tighten or loosen aloop structure4019 of the ablation assembly about thepatient tissue4012, as shown inFIG. 49. A close up view ofpusher4005,pusher loop4007,first trocar4002, distal graspingelement4016,stabilizer member4020, andablation member4022 is illustrated inFIG. 50. An operator can snug up or cinch adistal section4023 ofablation member4022 againstpatient tissue4012 by movingpusher4005 toward the tissue as indicated by arrow E, by pullingablation assembly4010 proximally throughpusher4005 away from the tissue, or both, as depicted inFIG. 51.
• FIG. 52 shows a cross-section of a visualization system5200 which can be used for providing or enhancing device placement visualization. For example, such visualization can be carried out in conjunction with a tissue ablation treatment. Visualization system5200 can include ascope5210 and a cap orsheath5220. In some embodiments, the terms cap and sheath may be used interchangeably.Scope5210 includes adistal end5212, which in some cases is beveled at an angle α. In some embodiments, angle α can be within a range from about 30 degrees to about 45 degrees.Scope5210 can be a straight scope, a rigid scope, or both, for example. In some embodiments,scope5210 includes an endoscope.Sheath5220 can include a tip having a bullet shape, a cone shape, a dome shape, and the like. In some embodiments,sheath5220 may present an asymmetric shape. Optionally, a sheath may be shaped for optimized visualization of a tissue. Often,sheath5220 includes a clear or transparent portion through which a lens ofscope5210 can visualize the surrounding environment. In this way,sheath5220 can operate to expand the visualization capacity, or the field of view, ofscope5210. In use,sheath5220 can be advanced into or against tissue, and can separate tissue. Accordingly, tissue which presses onsheath5220, or is otherwise nearsheath5220, can be visualized.Sheath5220 can allow a user or operator to visualize an increased amount of tissue, or an increased surface area of tissue, as compared to a similar scope which does not includesheath5220. In some cases, an operator can use visualization system5200 for orientation purposes, for treatment purposes, for therapeutic purposes, and the like.Sheath5220 allows an operator to gain an enhanced awareness of an operating space within a patient's body. For example, an operator may use visualization system5200 to determine how close a particular instrument or device is to a pulmonary vein. Such techniques can be helpful when applying a treatment to a site that is near, but not on, a pulmonary vein.
• Sheath5220 may include a stop5224. In use, stop5224 typically contactsdistal end5212 ofscope5210 whensheath5220 is disposed onscope5210. The location or position of stop5224 onsheath5220 can be selected so as to control or adjust the distance between a distal end, or some other visualization portion, ofsheath5220, and a lens ofscope5210. Different scopes may have different focal lengths, and selection of a desired stop5224 configuration can allowsheath5220 to provide a particular viewing effect on a patient's tissue. For example, by placing stop5224 at a certain distance from a distal end or viewing portion ofsheath5220, it may be possible to allow an operator to view tissue which contacts the distal end or viewing portion ofsheath5220 with a maximum clarity or distinctness, so that the tissue is in focus.
• Sheath5220 can protect a lens ofscope5210 from unwanted contact with fluid. Toward this end,sheath5220 may include one ormore sealing mechanism5222. For example,sealing mechanism5222 may include an o-ring.Sheath5220 may be releasably attached withscope5210. For example, it may be possible to snap together, and to snap apart,sheath5220 andscope5210. In some cases,sheath5220 includes anattachment mechanism5226, which can be used to attach or couple visualization system5200 with another device or implement. This attachment or coupling can be a releasable attachment. In use,sheath5220 of visualization system5200 allows an operator to visualize an operating space within a patient. When an operator views a device or implement to which the operator wishes to couple with visualization system5200, the operator can utilizeattachment mechanism5226 so as to couple visualization system5200 with the desired device or implement. For example,attachment mechanism5226 can include a magnet, and the device or implement can include a material which is attracted to the magnet. The operator can advance or place the magnet near the device or implement, so as to create a releasable coupling between the magnet and the device or implement.
• FIG. 53 shows a cross-section of avisualization system5300 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment.Visualization system5300 can include ascope5310 and asheath5320.Scope5310 includes a distal end5312, which in some cases is not beveled at an angle α. In some embodiments, angle α can be about 0 degrees.Scope5310 can also include a flexible zone orportion5314.Scope5310 can be a curved scope, a flexible scope, or both, for example. In some embodiments,scope5310 includes an endoscope.Sheath5320 can include a tip having a bullet shape, a cone shape, a dome shape, and the like. In some embodiments, sheath3220 may present an asymmetric shape. Optionally, a sheath may be shaped for optimized visualization of a tissue. Often,sheath5320 includes a clear or transparent portion through which a lens ofscope5310 can visualize the surrounding environment. In this way,sheath5320 can operate to expand the visualization capacity, or the field of view, ofscope5310. In use,sheath5320 can be advanced into or against tissue, and can separate tissue. Accordingly, tissue which presses onsheath5320, or is otherwise nearsheath5320, can be visualized.Sheath5320 can allow a user or operator to visualize an increased amount of tissue, or an increased surface area of tissue, as compared to a similar scope which does not includesheath5320. In some cases, an operator can usevisualization system5300 for orientation purposes, for treatment purposes, for therapeutic purposes, and the like.Sheath5320 allows an operator to gain an enhanced awareness of an operating space within a patient's body. For example, an operator may usevisualization system5300 to determine how close a particular instrument or device is to a pulmonary vein. Such techniques can be helpful when applying a treatment to a site that is near, but not on, a pulmonary vein.
• Sheath5320 may include a stop5324. In use, stop5324 typically contacts distal end5312 ofscope5310 whensheath5320 is disposed onscope5310. The location or position of stop5324 onsheath5320 can be selected so as to control or adjust the distance between a distal end, or some other visualization portion, ofsheath5320, and a lens ofscope5310. Different scopes may have different focal lengths, and selection of a desired stop5324 configuration can allowsheath5320 to provide a particular viewing effect on a patient's tissue. For example, by placing stop5324 at a certain distance from a distal end or viewing portion ofsheath5320, it may be possible to allow an operator to view tissue which contacts the distal end or viewing portion ofsheath5320 with a maximum clarity or distinctness, so that the tissue is in focus.
• Sheath5320 can protect a lens ofscope5310 from unwanted contact with fluid. Toward this end,sheath5320 may include one ormore sealing mechanism5322. For example,sealing mechanism5322 may include an o-ring.Sheath5320 may be releasably attached withscope5310. For example, it may be possible to snap together, and to snap apart,sheath5320 andscope5310. In some cases,sheath5320 includes anattachment mechanism5326, which can be used to attach orcouple visualization system5300 with another device or implement. This attachment or coupling can be a releasable attachment. In use,sheath5320 ofvisualization system5300 allows an operator to visualize an operating space within a patient. When an operator views a device or implement to which the operator wishes to couple withvisualization system5300, the operator can utilizeattachment mechanism5326 so as to couplevisualization system5300 with the desired device or implement. For example,attachment mechanism5326 can include a magnet, and the device or implement can include a material which is attracted to the magnet. The operator can advance or place the magnet near the device or implement, so as to create a releasable coupling between the magnet and the device or implement.
• FIG. 54 shows a cross-section of a visualization system5400 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment. Visualization system5400 can include ascope5410 and asheath5420.Scope5410 includes adistal end5412, which in some cases is not beveled at an angle α. In some embodiments, angle α can be about 30 degrees to about 45 degrees.Scope5310 can be a straight scope, a rigid scope, or both, for example. In some embodiments,scope5410 includes an endoscope.Sheath5420 can include a tip having a bullet shape, a cone shape, a dome shape, and the like. In some embodiments, sheath3420 may present an asymmetric shape. Optionally, a sheath may be shaped for optimized visualization of a tissue. Often,sheath5420 includes a clear or transparent portion through which a lens ofscope5410 can visualize the surrounding environment. In this way,sheath5420 can operate to expand the visualization capacity, or the field of view, ofscope5410. In use,sheath5420 can be advanced into or against tissue, and can separate tissue. Accordingly, tissue which presses onsheath5420, or is otherwise nearsheath5420, can be visualized.Sheath5420 can allow a user or operator to visualize an increased amount of tissue, or an increased surface area of tissue, as compared to a similar scope which does not includesheath5420. In some cases, an operator can use visualization system5400 for orientation purposes, for treatment purposes, for therapeutic purposes, and the like.Sheath5420 allows an operator to gain an enhanced awareness of an operating space within a patient's body. For example, an operator may use visualization system5400 to determine how close a particular instrument or device is to a pulmonary vein. Such techniques can be helpful when applying a treatment to a site that is near, but not on, a pulmonary vein.Sheath5420 can be moved relative toscope5410 or relative to body tissue. In some cases,sheath5420 can be rotated relative toscope5410 or relative to body tissue. An operator may effect such movement via ahandle5428 ofsheath5420.
• Sheath5420 may include astop5424. In use, stop5424 can contactdistal end5412 ofscope5410 whensheath5420 is disposed onscope5410. The location or position ofstop5424 onsheath5420 can be selected so as to control or adjust the distance between a distal end, or some other visualization portion, ofsheath5420, and a lens ofscope5410. Different scopes may have different focal lengths, and selection of a desiredstop5424 configuration can allowsheath5420 to provide a particular viewing effect on a patient's tissue. For example, by placingstop5424 at a certain distance from a distal end or viewing portion ofsheath5420, it may be possible to allow an operator to view tissue which contacts the distal end or viewing portion ofsheath5420 with a maximum clarity or distinctness, so that the tissue is in focus.
• Sheath5420 can protect a lens ofscope5410 from unwanted contact with fluid. Toward this end, as shown here the length ofsheath5420 can be such that fluid is not present at aproximal end5429 ofsheath5420.Sheath5420 may be releasably attached withscope5410. For example, it may be possible to snap together, and to snap apart,sheath5420 andscope5410. In some cases,sheath5420 includes an attachment mechanism or instrument mount5426, which can be used to attach or couple visualization system5400 with another device or implement. This attachment or coupling can be a releasable attachment. In use,sheath5420 of visualization system5400 allows an operator to visualize an operating space within a patient. When an operator views a device or implement to which the operator wishes to couple with visualization system5400, the operator can utilize attachment mechanism5426 so as to couple visualization system5400 with the desired device or implement. For example, attachment mechanism5426 can include a magnet, and the device or implement can include a material which is attracted to the magnet. The operator can advance or place the magnet near the device or implement, so as to create a releasable coupling between the magnet and the device or implement. In some embodiments, all or part ofsheath5420 can be constructed of a flexible material, such as an elastomer. In some embodiments,sheath5420 is rigid. Similarly,scope5410 may be flexible or rigid. In some embodiments, a distal end ofsheath5420 is rigid, and a proximal end ofsheath5420 is flexible.
• FIGS. 55A and 55B show aspects of avisualization system5500 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment.Visualization system5500 can include ascope5510 and asheath5520.Scope5510 andsheath5520 can include any feature or component of the scopes and sheaths discussed herein, for example the scopes and sheaths depicted inFIGS. 52 to 54. As shown here,sheath5520 can include anattachment mechanism channel5521 adapted to receive an attachment mechanism such as a graspingdevice5540.Grasping device5540 can include a pair of spring loadedjaws5542,5544. When pushed against a spring force as depicted inFIG. 55B, graspingdevice5540 can protrude out ofchannel5521, andjaws5542,5544 can open or separate. When retracted as depicted inFIG. 55A,jaws5542,5544 close together, and graspingdevice5540 withdraws intochannel5521. In use, an operator can advance graspingdevice5540 out ofsheath5520 and placeopen jaws5542,5544 on a desired item to be grasped. The operator can then withdrawn graspingdevice5540 intosheath5520, thereby clampingjaws5542,5544 on the item.
• In some embodiments, an operator can pushgrasping device5540 against a spring force so that graspingdevice5540 protrudes out ofsheath channel5521, thereby opening the jaws. The jaws can be used to grasp a hook, or a fabric, or a component on a device or introducer for a device which the operator wishes to grasp. Often, the operator may grasp a distal end of such a device or introducer. Accordingly,visualization system5500 can be used in a minimally invasive surgical procedure by an operator to find a device, attach to the device, and then to manipulate or retract the device.
• FIGS. 56A and 56B show aspects of avisualization system5600 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment.Visualization system5600 can include ascope5610 and a sheath5620.Scope5610 and sheath5620 can include any feature or component of the scopes and sheaths discussed herein, for example the scopes and sheaths depicted inFIGS. 52 to 54. As shown here, the visualization system can include a graspingdevice5640, such as a fin or wedge. In use, an operator can place graspingdevice5640 near a distal grasping element or introducer tape5650, and rotate the grasping device as indicated by arrow A. In this way, the grasping device can securely attach with the distal grasping element. As shown inFIG. 56A, when tape5650 comes into view grasping device5650 can be rolled to snag tape on a hook or fin of the device, which can then be rolled back to produce a roll of tape. As shown inFIG. 56B, grasping device5650 can include a wedging shape that holds the tape under tension. Accordingly,visualization system5600 can be used in a minimally invasive surgical procedure by an operator to find a device, attach to the device, and then to manipulate or retract the device.
• FIG. 57 shows aspects of a visualization system5700 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment. Visualization system5700 can include a scope5710 and asheath5720. Scope5710 andsheath5720 can include any feature or component of the scopes and sheaths discussed herein, for example the scopes and sheaths depicted inFIGS. 52 to 54. As shown inFIG. 57, a concave shape ofsheath5720 can facilitate use of a workingchannel5715 of scope5710. In some cases,sheath5720 can operate to protect a lens contained therein.
• FIGS. 58A-58C illustrate aspects of a visualization system5800 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment. Visualization system5800 can include ascope5810 and a sheath orcap5820.Scope5810 and sheath orcap5820 can include any feature or component of the scopes and sheaths or caps discussed herein, for example the scopes and sheaths depicted inFIGS. 52 to 54. As shown inFIG. 58A, the body of sheath orcap5820 includes a grasping portion5823a, and ajaw5825 of sheath orcap5820 includes a corresponding or complementary graspingportion5823b. The body of sheath orcap5820 is coupled withjaw5825 via a hinge orpivot5827, as depicted inFIG. 58C. According toFIGS. 58A-58C, a pocket, pivot, orattachment point5829 ofjaw5825 can be aligned with a workingchannel5819 ofscope5810, and a push pull mechanism oraxial member5850 can be disposed in workingchannel5819. Whenaxial member5850 is advanced distally through workingchannel5819, for example, the distal section ofaxial member5850 can contact and transmit force tojaw divot5829, thereby closing the bringing the graspingportions5823a,5823btoward each other. In some embodiments, this configuration may be well suited for use with an angled scope, as compared to a forward looking scope, due to the desired field of view provided by sheath orcap5820. In use, pushpull mechanism5850 can be pulled or retracted as indicated by arrow A so as to openjaw5825. An operator can manipulatejaw5825 and the body of cap orsheath5820 about a tape or distal end of a device or introducer. Pushpull mechanism5850 can then be pushed or advanced as indicated by arrow B so as to closejaw5825, thereby grasping the tape, device, introducer, or other implement5824.
• FIGS. 59A-59D illustrate aspects of avisualization system5900 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment.Visualization system5900 can include ascope5910 and asheath5920.Scope5910 andsheath5920 can include any feature or component of the scopes and sheaths discussed herein, for example the scopes and sheaths depicted inFIGS. 52 to 54. According toFIG. 59A,sheath5920 includes a retractableunderslung jaw5925, shown here in a closed or retracted position.FIG. 59B provides a cross section side view ofvisualization system5900.Jaw5925 can have apush pull mechanism5950 attached thereto, and disposed within a working channel5919 ofscope5910.
• In use, pushpull mechanism5950 can be advanced so as to openjaw5925, as shown inFIGS. 59C and 59D. An operator can manipulatejaw5925 so as to snag a tape or distal end of a device or introducer. Pushpull mechanism5950 can then be retracted so as to closejaw5925, thereby firmly grasping the tape, device, introducer, or other implement. In some embodiments,visualization system5900 includes ananti-roll guidance rib5905. In some embodiments, the body ofsheath5920 includes a toothed configuration which is complementary to the toothed configuration ofjaw5925.
• FIGS. 60A and 60B illustrate aspects of avisualization system6000 which can be used for providing or enhancing device placement visualization. For example, such visualization can be performed in conjunction with a tissue ablation treatment.Visualization system6000 can include ascope6010 and asheath6020.Scope6010 andsheath6020 can include any feature or component of the scopes and sheaths discussed herein, for example the scopes and sheaths depicted inFIGS. 52 to 54. According toFIGS. 60A,sheath6020 includes a pivoting overhungtoothed jaw6025, shown here in a closed or retracted position.Jaw6025 can have an activatingmechanism6050 or a similar axial member attached thereto, and disposed within a working channel6019 ofscope6010.
• In use,sheath6020 includes apivot6029 that is configured to provide a neutral jaw position under tension, such that there is no tendency forjaw6025 to open. Activatingmechanism6050 can be advanced distally, as shown inFIG. 60B, so as to swingjaw6025 aboutpivot6029, toward an open configuration. In this configuration,jaw6025 is disposed outside of the external cone or dome shaped contour of the sheath body. An operator can manipulatejaw6025 so as to snag a tape or distal end of a device or introducer. Activatingmechanism6050 can then be retracted so as to allowjaw6025 to close, thereby firmly grasping the tape, device, introducer, or other implement. In some embodiments, the body ofsheath6020 includes a toothed configuration which is complementary to the toothed configuration ofjaw6025.
• Many of the visualization system embodiments disclosed herein include a scope having a working channel, and an activating mechanism or push pull rod which can sit at least partially within the working channel. An operator can cause the activating mechanism to retract or advance, so as to open and close a distal grasping mechanism of the visualization system. In exemplary embodiments, the visualization system includes a sheath having a bullet, dome, cone, or similar profile. For example, a sheath may present a flat top bullet profile, or a truncated cone profile. In some cases, a sheath may present a bulged profile or a mushroom profile. Typically, sheath includes a rounded or blunted distal section, so as to not avoid cutting tissue when placed within a patient's body. In some cases, a sheath is integrated with the scope. In some cases, the sheath can be releasably attached with the scope. Often, a scope includes a working channel, and the visualization system includes an activating mechanism that can be disposed at least partially within the working channel. Activating mechanisms can be operated to manipulate grasping members or mechanisms of the visualization system. Often, a sheath, a grasping mechanism, an activating mechanism, or any combination thereof, can be configured such that the activating mechanism can be aligned within the working channel when the sheath is coupled with the scope. In addition to grasping or attaching mechanisms, any of a variety of other tools may be disposed on or coupled with the sheath body, and activated or controlled via an activating mechanism housed at least partially within a working channel of the scope.
• FIGS. 61A and 61B illustrate how an ablation system can be used in a tissue environment of a patient. Anablation system6100 includes avisualization system6110 having a probe or scope.Ablation system6100 also includes adevice6120, which may have an introducer. As with any of the visualization systems disclosed herein,visualization system6110 can include a magnetically or mechanically attaching mechanism, whereby a distal end ofvisualization system6110 can be attached or coupled with a distal end ofdevice6120. Such configurations can be used in a minimally invasive surgical procedure, so as to position or manipulate an ablation mechanism within the body of a patient. For example,visualization system6110 can be used to move an ablation device about a patient's pulmonary veins (PV). As shown inFIG. 61A,device6120 can be advanced within a patient, such that the device enters a first cavity such as a transverse sinus. Similarly,visualization system6110 can be advanced within a patient, such that the visualization system enters a second cavity such as an oblique sinus. According to some embodiments,device6120 can be advanced through an oblique sinus andvisualization system6110 can be advanced through a transverse sinus. Optionally,device6120 orvisualization system6110 can be introduced via a subzyphoid incision or approach. In use, features of the ablation system can be used to encircle a single PV, or a desired set of multiple PVs. The distal end of the device, the distal end of the visualization system, or both, can be manipulated so as to couple one with the other. For example, the device may include a first magnet6122 and the visualization system may include asecond magnet6110. As shown inFIG. 61B, the magnets can have self aligning faces, and the distal ends ofdevice6120 andvisualization system6110 can have rounded or blunted edges. Typically, a magnet has a dipolar magnetic field, and therefore opposite ends of magnets are attracted to each other. Due to the self aligning configuration, the magnetic dipole of first magnet6122 tends to align or orient itself with the opposed polarity of the magnetic dipole of the second magnet. In use, when an operator determines that the distal ends ofdevice6120 andvisualization system6110 are coupled, the operator can manipulate the ablation system to a position as desired. In some cases, an operator can determine that the distal ends are coupled by visual confirmation. In some cases, an operator can hear or feel the distal ends snap together.
• FIG. 62A illustrates aspects of anablation system6200 having a magnetic loop closure, according to embodiments of the present invention.Ablation system6200 includes a proximal end6202 and adistal end6204.Ablation system6200 also includes anablation electrode6206 and a magnet ormagnet array6208. In some embodiments,ablation system6200 can present a “U” shaped configuration, which can be placed near or applied to a path which surrounds or travels about the pulmonary veins of a patient.Ablation system6200 can be cinched about the pulmonary veins, so as to form an oval shape. For example, amagnet6203 disposed ondistal end6204 ofsystem6200 can be advanced toward magnet ormagnet array6208. In some cases,magnet6203 is urged towardmagnet6208 by an operator using an instrument. Whenmagnet6203 couples withmagnet6208,magnet6203 can be moved alongmagnet6208, either distally or proximally, so as to respectively tighten or loosen the loop enclosure formed by the ablation system. In some cases, the body ofablation system6200 includes atrack6210 which has a shape that is complementary to the shape ofmagnet6203. In some cases, the attractive force betweenmagnet6203 andmagnet6208 provides a self cinching effect. In some cases,magnet6208 includes an array of magnets, such that the position ofmagnet6203 alongmagnet6208 can be incrementally adjusted, so as to achieve any desired loop closure circumference. Patients may present tissues of varying dimensions and sizes, and it may be desirable to configureablation system6200 so as to provide discrete stopping points or attraction points along a length ofmagnet6208. This allows an operator to select from a multiplicity of stable connection points, so as to form loop closures or ovals which are customized or dimensioned for a particular patient's anatomy.
• FIGS. 62B to 62E show aspects of ablation device introducers and scopes or probes, according to embodiments of the present invention.FIG. 62B shows that a magnet or other attachment mechanism can be disposed at or toward a distal end of a device introducer.FIG. 62C shows that a magnet or other attachment mechanism can be disposed at or toward a distal end of a scope. The position of the magnet or attachment mechanism may be offset. According toFIG. 62D, a magnet or attachment mechanism can be disposed at or toward a distal end of a probe. In some cases, a probe may be malleable. In some embodiments, the terms “probe”, “scope”, and “visualization system” may be used interchangeably. According toFIG. 62E, a magnet or attachment mechanism can be disposed at or near a distal end of an oversheath. As noted above, the position of a magnet or attachment mechanism may be offset. In some cases, offsetting the position of the magnet or attachment mechanism can provide an operator with an optimized field of view, depending on the geometric configuration of a visualization system.
• FIGS. 63A to 63F show anablation system6300 according to embodiments of the present invention. As depicted here,ablation system6300 can present a keyhole slot and ball configuration.FIG. 63A showsablation system6300 disposed about four pulmonary veins (PV), so as to form a loop enclosure.Ablation system6300 can include apush sheath6302.
• Ablation system6300 can be used to form an oval shaped lesion on a patient tissue with an ablation probe of the system. As seen inFIGS. 63B and 63D,ablation system6300 can include a proximal end channel orslot6304, which is configured to receive aball6306 of asuction chamber terminator6308, and an electrode path6305, which is configured to receive an electrode. In use, an operator can move wrap or place the ablation system about a patient tissue, and insertball6306 ofsuction chamber6308 intokeyhole6303 andslot6304. By advancingball6306 distally or proximally along the length ofslot6304, the operator can respectively tighten or loosen a loop enclosure formed by the ablation system, so as to form loops of various circumferences.Suction chamber terminator6308, for example as shown inFIGS. 63E and 63F, may include a metallic conductor.Terminator6308 can include areceptacle6309 adapted to receive a distal electrode tip. Accordingly,ablation system6300 can create a continuous lesion along the oval or loop. As shown inFIG. 63D,suction chamber terminator6308 can be perpendicular or substantially perpendicular to slot6304, for example after the ablation system is routed around the pulmonary veins. The coupling between the chamber terminator and the slot can be characterized by multiple discrete stabilization points. In some cases, the coupling can be characterized by an interference fit or a press fit, whereby the relative positions of the chamber terminator and the slot are maintained without additional attachment mechanisms. As shown inFIG. 63D,ablation assembly6300 can include a suction chamber6312, disposed on a distal end of anelectrode support6314. In some embodiments, suction chamber6312 presents a more flexible configuration, whereaselectrode support6314 presents a more rigid configuration. The suction chamber can be configured to provide an oval shape which can be applied to a patient tissue. For example, suction chamber6312 can be placed on or about the pulmonary veins of a patient. Suction chamber or bladder6312 can be maintained in position relative to the patient tissue via a mechanical stabilization, via a vacuum, or a combination thereof. Typically, suction chamber6312 is coupled withsuction chamber terminator6308. According toFIGS. 63B,63C, and63D,ablation system6300 may also include a vacuum luer or fitting6316 which can transit a vacuum from a vacuum source to suction bladder6312.
• FIGS. 64,65,66A,66B, and66C illustrate aspects of ablation systems which can form oval, teardrop, or other loop enclosure configurations, according to embodiments of the present invention. According toFIG. 64, anablation system6400 can include adistal portion6410 and aproximal portion6420, which can be coupled by atrocar6430. An operator can cinch or uncinch a loop structure6440 by slidingtrocar6430 along the distal and proximal portions, as indicated by arrow A. In use,distal portion6410 can be looped around the pulmonary veins (PV) of a patient, and placed throughtrocar6430 which is loaded onproximal portion6420, so as form loop structure6440. The trocar can be adjusted so as to cinch the loop structure about the pulmonary veins of the patient to the desired circumference or configuration, and press an electrode against the patient tissue.
• According toFIG. 65, anablation system6500 can include adistal portion6510 and aproximal portion6520, which can be coupled by atrocar6540. An operator can cinch or uncinch aloop structure6540 by slidingtrocar6530 along the distal and proximal portions, as indicated by arrow A. In use,distal portion6510 can be looped around the pulmonary veins (PV) of a patient, and placed throughtrocar6530 which is loaded onproximal portion6520, so asform loop structure6540. The trocar can be adjusted so as to cinch the loop structure about the pulmonary veins of the patient to the desired circumference or teardrop configuration, and press an electrode against the patient tissue. As shown here,trocar6530 can present a divided configuration so as to separate the proximal and distal portions.Trocar6530 can include an extension which urges an electrode tip against the patient tissue. For example, an operator can use the trocar to push the tip of an ablation probe or electrode forward, out of a suction stabilizer or bladder, so as to form a continuous loop. Thus, a tear drop shape defined by the electrode can be made more circular, as the electrode tip is pushed out of the suction bladder and against or closer to the patient tissue. Similar features and configurations are disclosed herein at, for example,FIGS. 32A to 32D.
• According toFIGS. 66A to 66C, anablation system6600 can include a pull tape and pusher configuration. As shown inFIG. 66A,ablation system6600 includes apull tape6610 and apusher6620 having a pusher loop6622.Ablation system6600 also includes aproximal portion6630 and adistal portion6640.Tape6610 can include a fabric, an elastomer, or the like. Adistal end6612 oftape6610 is attached withdistal portion6640. In use, an operator can advancetape6610, and thusdistal portion6640, along a desired path through a patient's anatomy. The tape can then be threaded through pusher loop6622 ofpusher6620. Hence, this threading action can be performed while the ablation system is inside the chest cavity of a patient. Optionally, this threading can be done while theablation system6600 is outside of the patient's body. The operator can pull the tape through the loop to the extent desired, so as to urgedistal portion6640 towardproximal portion6630, as depicted inFIGS. 66B and 66C. In this way, the ablation system can be positioned circumferentially about the anatomical features of the heart, such that a continuous lesion can be formed. Further, the operator can advancepusher mechanism6620 distally towarddistal portion6640, or relative to a suction chamber, so as to cinch the ablation system about the pulmonary veins of the patient, and reduce the circumference of a loopingstructure6650. According to some embodiments, the operator can holdpusher mechanism6620 in a fixed position while adjusting theproximal end6670 of the ablation assembly so as to adjust the loop size. For example,proximal end6670 can be pulled or withdrawn away frompusher mechanism6620 as indicated by arrow A, so as to downsize the loop. Similarly,proximal end6670 can be advanced into or towardpusher mechanism6620 as indicated by arrow B, so as to increase the loop size. As shown inFIG. 66C,distal portion6640 can be urged againstproximal portion6630 to as to form an orthogonal connection therewith. Similar features and configurations are disclosed herein at, for example,FIGS. 50 and 51.
• Thus,FIG. 64 presents an embodiment wherein both an electrode and a suction member can be shaped in an oval or teardrop configuration.FIG. 65 present an embodiment wherein an electrode can be cinched toward a circular configuration, and a suction member can be shaped in an oval or teardrop configuration.FIGS. 66A-66C present an embodiment wherein an electrode and a suction member can be cinched toward a circular configuration. In some cases, a suction member or bladder may not include suction apertures along the entire length of the bladder. That is, a suction bladder may contain suction apertures along only a partial length of the bladder. For example, a suction bladder of the ablation system shown inFIG. 64 may only include suction apertures on a circumferential portion that extends from a five o'clock position, clockwise, to a one o'clock position. Relatedly it may be desirable to omit suction apertures from the pointed region of the teardrop shape.
• FIG. 67 illustrates anexemplary treatment system6700 according to embodiments of the present invention.Treatment system6700 includes a treatment device orablation assembly6710 releasably coupled with an introducer6720. For example, aproximal portion6722 of introducer6720 can be releasably coupled with adistal portion6712 oftreatment device6710. Adistal portion6714 ofintroducer6714 can include a magnet or a coupling device that can be used to navigate the treatment system within the patient's anatomy, for example as described in U.S. Patent Application No. 61/015,472 filed Dec. 20, 2007, the content of which is incorporated herein by reference.Treatment device6710 may include a flexible ablation member or mechanism, a stabilizer member or mechanism, and a cinching mechanism such as a trocar or push tube. Optionally,treatment system6700 can include or be used in conjunction with one or more obturators or additional introducers.
• FIG. 68A shows aspects of anexemplary treatment system6800 according to embodiments of the present invention.Treatment system6800 includes a treatment device orablation assembly6810 releasably coupled with anintroducer6820. For example, aproximal portion6822 ofintroducer6820 can be releasably coupled with adistal portion6812 oftreatment device6810.Treatment device6810 may include a flexible ablation member ormechanism6817, a stabilizer member ormechanism6818, and a cinching mechanism.Distal portion6812 of the treatment device includes a treatmentdevice coupling mechanism6816, andproximal portion6822 of the introducer includes anintroducer coupling mechanism6826. As depicted inFIG. 68B, treatmentdevice coupling mechanism6816 may include one or more female snap features6816athat are configured to receive or couple with one or moremale features6826aofintroducer coupling mechanism6826. Optionally, the introducer coupling mechanism may also include a sleeve or clasp6826bthat can be translated or moved along a length of the introducer, as indicated by arrow A, so as to help secure a coupling between snap features6816aand6826a. For example, sleeve6826bcan be moved toward the treatment device so as to keep amale feature6826aengaged with a female feature6816a. Additional features of exemplary introducers are discussed elsewhere herein, for example with reference toFIGS. 79-81.
• FIG. 69 depicts features of anexemplary treatment system6900 according to embodiments of the present invention.Treatment system6900 can include anablation mechanism6917 and astabilizer mechanism6918. As shown here,stabilizer mechanism6918 may include aproximal skirt termination6918a.FIG. 70 depicts features of anexemplary treatment system7000 according to embodiments of the present invention.Treatment system7000 can include an ablation mechanism7017 and a stabilizer mechanism7018. As shown here, stabilizer mechanism7018 may include a skirt7018bconfigured to contact the tissue of a patient, which can help form asuction area7018c.FIG. 71 depicts features of anexemplary treatment system7100 according to embodiments of the present invention.Treatment system7100 can include anablation mechanism7117 and astabilizer mechanism7118. As shown here,stabilizer mechanism7118 may include a skirt7118bconfigured to contact the tissue of a patient.Stabilizer mechanism7118 may also include a coupling mechanism having coupling arms7118dthat are configured to couple with, secure, or otherwise contact the ablation mechanism.
• FIG. 72 depicts features of an exemplary treatment system7200 according to embodiments of the present invention. Treatment system7200 can include anablation mechanism7217 and astabilizer mechanism7218. As shown here,ablation mechanism7217 andstabilizer mechanism7218 are disposed at least partially within acinching mechanism7230 such as a trocar or push tube.Stabilizer mechanism7218 may include a skirt7218bconfigured to contact the tissue of a patient.Stabilizer mechanism7218 may also include a coupling mechanism having coupling arms7218dthat are configured to couple with, secure, or otherwise contact the ablation mechanism.Cinching mechanism7230 may include aseal surface7231 that forms a seal with or otherwise contacts skirt7218b.FIG. 73 depicts features of anexemplary treatment system7300 according to embodiments of the present invention.Treatment system7300 can include anablation mechanism7317 and astabilizer mechanism7318. As shown here,ablation mechanism7317 andstabilizer mechanism7318 are disposed at least partially within acinching mechanism7330 such as a trocar or push tube.Stabilizer mechanism7318 may include askirt7318bconfigured to contact the tissue of a patient.Stabilizer mechanism7318 may also include a coupling mechanism having coupling arms7318dthat are configured to couple with, secure, or otherwise contact the ablation mechanism.Cinching mechanism7330 may include aseal surface7331 that forms a seal with or otherwise contacts skirt7318b. A suction skirt can assist in creating dependable suction againstseal surface7331 of a lumen withincinching mechanism7330 for the portion of a suction stabilizer that remains inside the cinching mechanism tube while an ablation procedure is performed. The seal surface can allow the stabilizer mechanism to be extended to any desired length, for example when creating box or connection lesions.
• FIGS. 74A and 74B illustrate anexemplary treatment system7400 according to embodiments of the present invention.Treatment system7400 includes a treatment device or ablation assembly7410 having aflexible ablation mechanism7417, astabilizer mechanism7418, and acinching mechanism7430 such as a trocar or push tube. As shown here,ablation mechanism7417 andstabilizer mechanism7418 are disposed at least partially withincinching mechanism7430, in a retracted position.FIGS. 75A and 75B illustrate anexemplary treatment system7500 according to embodiments of the present invention.Treatment system7500 includes a treatment device or ablation assembly7510 having aflexible ablation mechanism7517, astabilizer mechanism7518, and acinching mechanism7530 such as a trocar or push tube. As shown here,ablation mechanism7517 andstabilizer mechanism7518 are disposed at least partially withincinching mechanism7530, in an extended position.
• FIGS. 76A-76F show aspects of atreatment system7600 as used in an exemplary cinching method. As depicted inFIG. 76A, methods may involve introducing a grasping or coupling mechanism through areceptacle7632aof a proximal portion7632 of acinching mechanism7630 such as a trocar or push tube.Coupling mechanism7640 can be advanced along or throughcinching mechanism7630 as shown inFIG. 76B, for example by advancing aproximal control element7642 of the coupling mechanism toward thecinching mechanism7630 as indicated by arrow A. Optionally, relative translational movement betweencinching mechanism7630 andcoupling mechanism7640 can be effected by movingcinching mechanism7630 in a proximal direction towardproximal control element7642 as indicated by arrow B. With reference toFIG. 76C, adistal portion7642 ofcoupling mechanism7640 can be advanced distally, or extended, beyond adistal portion7634 of cinchingmechanism trocar7630 as indicated by arrow A, and can be maneuvered so as to catch or couple with a ribbon or tape, or some other coupleable introducer mechanism or implement7650. Optionally, the desired maneuvering ofdistal portion7634 may include the inducement of translational movement ofcinching mechanism7630 alongablation mechanism7617 andstabilizer mechanism7618, as indicated by arrow B. As shown inFIGS. 76D and 76E, once distal portion7642 (shown here as a loop) is coupled or engaged withintroducer mechanism7650,distal portion7642 ofcoupling mechanism7640 can be advanced proximally, or retracted, toward and intodistal portion7634 of cinchingmechanism trocar7630 as indicated by arrow A. Optionally, the desired retraction ofdistal portion7634 may include the inducement of translational movement ofcinching mechanism7630 alongablation mechanism7617 andstabilizer mechanism7618. For example,cinching mechanism7630 can be advanced distally relative toablation mechanism7617 andstabilizer mechanism7618, as indicated by arrow B. As indicated inFIG. 76F, introducer implement7650 can be drawn proximally throughreceptacle7632aofcinching mechanism7630, and secured or fixed with a proximal catch or clasp7632bof the cinching mechanism. In some cases, this can involve wrapping a tape around a knob to secure the tape therewith.FIG. 77 shows anexemplary treatment system7700, wherein introducer implement or tape7750 is drawn proximally relative to cinching mechanism ortrocar7730, or optionally trocar7730 is advanced distally relative to introducer tape7750, or both, so as to form a closed or partially closed loop withablation mechanism7717 andstabilizer mechanism7718. The treatment system can be configured to provide any desired angle α between the distal end of the probe, which may include the ablation mechanism, stabilizer mechanism, or both, and a more proximal section of the probe. The angle can be configured so as to provide a desired amount of contact with the tissue. In some cases, the angle can be configured so that the stabilizer mechanism can provide a desired amount of suction to the tissue. The termination of the suction bladder or stabilizer mechanism proximal to the distal end of the ablation mechanism can be configured to minimize or prevent leaks at that junction.
• FIG. 78A shows a perspective view of an ablation mechanism7817aand astabilizer mechanism7818aaccording to embodiments of the present invention. Ablation mechanism7817acan be coupled withstabilizer mechanism7818aat one ormore locations7819awith an adhesive material.FIG. 78B shows a perspective view of anablation mechanism7817band astabilizer mechanism7818baccording to embodiments of the present invention. By applying an adhesive material to one ormore locations7819balongablation mechanism7817b, or optionally by applying an adhesive material to one ormore locations7820balongstabilizer mechanism7818b, it is possible to couple theablation mechanism7817bwith thestabilizer mechanism7818b.FIG. 78C shows a perspective view of anablation mechanism7817cand astabilizer mechanism7818caccording to embodiments of the present invention.Ablation mechanism7817ccan be coupled withstabilizer mechanism7818cby placing or rolling one or more O-rings7819contoablation mechanism7817c, and coupling or bonding the O-rings with troughs7820cof thestabilizer mechanism7818c.FIG. 78D shows a cross section view of anablation mechanism7817dand astabilizer mechanism7818daccording to embodiments of the present invention.Ablation mechanism7817dcan be coupled withstabilizer mechanism7818dby snapping or placing the ablation mechanism into place betweenarms7820dof the stabilizer mechanism, as indicated by arrow A. Optionally, the ablation mechanism can be held in place within or relative to the stabilizer mechanism by one or more loops.
• FIG. 79 illustrates an introducer assembly ormechanism7900 according to embodiments of the present invention.Introducer assembly7900 includes a distal portion7910 that includes adistal coupling mechanism7920, and aproximal portion7930 that includes aproximal coupling mechanism7940.Introducer assembly7900 can also include, for example, a flexible body ortubular shaft7960, and a ribbon, wire, ortape7950 disposed within thebody7960. In use,introducer assembly7900 can be positioned in a desired location within the body, for example, in a manner similar to that illustrated inFIG. 43 orFIG. 61A, or as generally described herein with reference toFIGS. 82A to 85F, or as described in previously incorporated U.S. Provisional Patent Application No. 61/015,472 filed Dec. 20, 2007.Proximal coupling mechanism7940 can be coupled with an ablation mechanism, stabilizer mechanism, or any desired component of a treatment system, as described for example with reference toFIGS. 68A and 68B herein.
• FIG. 80 illustrates an introducer assembly ormechanism8000 according to embodiments of the present invention.Introducer assembly8000 includes adistal portion8010 that includes adistal coupling mechanism8020.Introducer assembly8000 can also include, for example, a flexible body ortubular shaft8060, and a ribbon, wire, ortape8050 disposed within thebody8060. In some cases,introducer assembly8000 can be constructed by applying tension to the distal end of thetape8050, and then gluing or fixing acap8022 onto the distal end of the body or tubing. As shown inFIG. 80A, a proximal portion8022aofcap8022 may overlap or encompass adistal portion8060aofbody8060.FIG. 81 shows aproximal portion8130 of anintroducer assembly8100 according to embodiments of the present invention.Proximal portion8130 includes acoupling mechanism8140 that can be coupled with acoupling mechanism8170 of a treatment device having an ablation mechanism and a stabilizer mechanism. In some cases, tension ontape8150 can operate to hold atape anchor8142 ofcoupling mechanism8140 in place relative to theintroducer assembly body8160. Hence, the introducer assembly can be constructed such thatcoupling mechanism8140 andbody8160 are otherwise freely dissociable when there is reduced tension intape8150. In use, after theintroducer assembly8100 has been placed in the desired position while maintaining tension ontape8150, the operator or surgeon can sever tape at a distal end, for example by cutting the entire distal end off the introducer assembly at location A as shown inFIG. 80. Severing oftape8150 removes the tension, and thereby allowscoupling mechanism8140 andbody8160 to separate from each other, as indicated by arrows A and B, respectively, inFIG. 81.Tape8150 remains coupled with or attached tocoupling mechanism8140 viaanchor8142, which in turn remains coupled with or attached tocoupling mechanism8170 of an ablation and stabilizer assembly. The operator or surgeon can then reveal a length oftape8150 by advancingbody8160 in a distal direction along introducer implement8150, as indicated by arrow C. Hence, ribbon ortape8150 becomes exposed, and can be engaged with a grasping mechanism, as described herein for example with reference toFIGS. 76A-76F.
• FIGS. 82A-82F show atreatment system8200 and method of use according to embodiments of the present invention.FIG. 82A depicts a front or anterior view of apatient8201 and anintroducer system8210 placed at a location within the body of a patient. The patient anatomy includes a superior vena cava (SVC), an aorta (A), a pericardial sac (PS) shown here in an opened configuration, a pulmonary artery (PA), a transverse sinus (TS) located posterior to the aorta, a ventricle (V), an oblique sinus (OS) located posterior the ventricle, an inferior vena cava (IVC), a left atrial appendage (LAA), pulmonary veins (PV) extending in a posterior direction from the heart, a thoracic or abdominal aorta (T/AA), and a pericardial wall (PW). In use, an operator can employ the introducer system to position the ablation andstabilizer assemblies8220 at a desired location in the patient. As shown here, the pericardial sac has been opened by way of a sternotomy.Introducer system8210 can be advanced through the OS, through the PW, generally passing from the left side (L) of the patient toward the right side (R) of the patient. As shown inFIGS. 82B and 82C, aproximal portion8211 of theintroducer system8210 can be placed posterior to the LAA and against or near the roots of the left PVs, and a distal portion8212 of the introducer system can be directed toward and passed through the TS. As shown inFIG. 82D, ablation andstabilizer assemblies8220 are coupled withintroducer system8210, and therefore can be drawn or passed through the patient following the path taken by the introducer system. Anaccessory device8280 having acatch8281 can be inserted into the distal portion of thepush tube8230.
• The accessory device orsternotomy adapter8280 can be configured to maintain a desired angle between the distal portion and a more proximal section of the ablation and stabilizer assemblies, as discussed elsewhere herein, for example with reference toFIG. 77. As depicted inFIG. 82E, tape orribbon8250 can be placed throughcatch8281 of the accessory device, and drawn toward the proximal end of thepush tube8230 as indicated by arrow B. Cinching mechanism or pushtube8230 can be advanced distally along ablation andstabilizer assemblies8220, as indicated by arrow A. In this way, the surgeon or operator can cinch or tighten the ablation andstabilizer assemblies8220 about the roots of the PVs, thereby tightening a cincture encircling the PVs. One or more PVs may be encompassed by the ablation andstabilizer assemblies8220. As shown inFIG. 82F, the tape orribbon8250 coupled with the distal end of the ablation andstabilizer assemblies8220 can be drawn further taut, thereby contracting or constricting the ablation andstabilizer assemblies8220 about the PVs. The tape orribbon8250 can be fixed with or wrapped around a proximal cleat or catch8231 of the push tube ortrocar8230, so that the ablation andstabilizer assemblies8220 remain taut around the PV roots. Thereafter, suction may be applied through a stabilizer assembly, ablation energy can be applied through an ablation assembly, and a transmural lesion can be formed.
• FIGS. 83A-83F show a treatment system8300 and method of use according to embodiments of the present invention.FIG. 83A depicts a front or anterior view of apatient8301 and anintroducer system8310 placed at a location within the body of a patient. The surgeon or operator may advance theintroducer system8310 though asubzyphoid incision8302, through the pericardium (PC), the oblique sinus (OS), the pericardial wall (PW), and toward the transverse sinus (TS). Optionally, the surgeon or operator may place a guidingintroducer8390 through asecondary port8391 to assist with placement of theintroducer system8310. As shown inFIG. 83B, asecond introducer8315 can be introduced into the patient, optionally throughincision8302, and coupled with theintroducer system8310. Embodiments may include any of a variety of similar introducer techniques, such as those disclosed in previously incorporated U.S. Provisional Patent Application No. 61/015,472 filed Dec. 20, 2007. For example, the operator may use stiffening stylets or obturators in conjunction with or as part of the introducers. As shown inFIG. 83C, the second or retrieving introducer8315 can be withdrawn from the patient as indicated by arrow A, thus pullingintroducer system8310 in a desired path around the patient heart. Ablation andstabilizer assembly8320, which is coupled withintroducer system8310, can follow the path taken by theintroducer system8310, as indicated by arrow B. As described elsewhere herein, the ablation andstabilizer assembly8320 can be encircled about the roots of the PVs. The surgeon or operator may then advance push tube8330 along the ablation andstabilizer assembly8320 so as to constrict the ablation andstabilizer assembly8320 about the PVs, as illustrated inFIG. 83D. As shown inFIG. 83E, in some cases the ablation andstabilizer assembly8320 can be wrapped around the right PVs. As shown inFIG. 83F, in some cases the ablation andstabilizer assembly8320 can be wrapped around the left PVs.
• FIGS. 84A-84F show atreatment system8400 and method of use according to embodiments of the present invention.FIG. 84A depicts a front or anterior view of apatient8401 and anintroducer system8410 placed at a location within the body of a patient. The surgeon or operator may advance theintroducer system8410 though a first port orthoracotomy incision8411 disposed on the patient's right side, through oblique sinus (OS). As shown inFIG. 84B, a second or retrieving introducer8415 can be introduced into the patient, through a second port orincision8412 and through transverse sinus (TS), and coupled with theintroducer system8410. Embodiments may include any of a variety of similar introducer techniques, such as those disclosed in previously incorporated U.S. Provisional Patent Application No. 61/015,472 filed Dec. 20, 2007. In some cases,introducer system8410 and retrievingintroducer8415 may be inserted into the patient via a common port orincision8413. As shown inFIG. 84C, the second or retrieving introducer8415 can be withdrawn from the patient as indicated by arrow A, thus pullingintroducer system8410 in a desired path around the patient heart. Ablation andstabilizer assembly8420, which is coupled withintroducer system8410, can follow the path taken by theintroducer system8410, as indicated by arrow B. As described elsewhere herein, the ablation andstabilizer assembly8420 can be encircled about the roots of the PVs. The surgeon or operator may then remove a portion ofintroducer system8410. For example, as described above with reference toFIGS. 80 and 81, atubular body8460 of the introducer can be removed while an exposed ribbon ortape8450 remains attached with a distal portion of ablation andstabilizer assembly8420. As shown inFIG. 84E, the surgeon can grasp a portion of the exposed ribbon or tape, for example as described above with reference toFIGS. 76A-76F, and withdrawn the ribbon ortape8450 through a proximal portion of the push tube or trocar, thereby forming a looping or circular configuration with ablation andstabilizer assembly8420. The surgeon can advancepush tube8430 along the ablation andstabilizer assembly8420 as indicated by arrow A so as to constrict the ablation andstabilizer assembly8420 about the PVs, as illustrated inFIG. 83F. Optionally, this cinching procedure may involve withdrawing a proximal portion of the ablation and stabilizer assembly out ofpush tube8430 as indicated by arrow B. Optionally, tape orribbon8450 can be drawn further taut. Hence, the surgeon can contract or constrict ablation andstabilizer assembly8420 about the PVs. The tape orribbon8450 can be fixed with or wrapped around a proximal cleat or catch of the push tube ortrocar8430 as described elsewhere herein, so that the ablation andstabilizer assembly8420 remains taut around the PV roots. Thereafter, suction may be applied through a stabilizer assembly, ablation energy can be applied through an ablation assembly, and a transmural lesion can be formed.
• FIGS. 85A-85F show atreatment system8500 and method of use according to embodiments of the present invention.FIG. 85A depicts a front or anterior view of apatient8501 and anintroducer system8510 placed at a location within the body of a patient. The surgeon or operator may advance theintroducer system8510 though a first port orthoracotomy incision8511 disposed on the patient's right side, through transverse sinus (TS).
• As shown inFIG. 85B, a second or retrieving introducer8515 can be introduced into the patient, through a second port orincision8512, and coupled with theintroducer system8510. Embodiments may include any of a variety of similar introducer techniques, such as those disclosed in previously incorporated U.S. Provisional Patent Application No. 61/015,472 filed Dec. 20, 2007. In some cases,introducer system8510 and retrievingintroducer8515 may be inserted into the patient via a common port orincision8513 and through. As shown inFIG. 85C, the second or retrieving introducer8515 can be withdrawn from the patient as indicated by arrow A, thus pullingintroducer system8510 in a desired path around the patient heart. Ablation andstabilizer assembly8520, which is coupled withintroducer system8510, can follow the path taken by theintroducer system8510, as indicated by arrow B. As described elsewhere herein, the ablation andstabilizer assembly8520 can be encircled about the roots of the PVs. The surgeon or operator may then remove a portion ofintroducer system8510. For example, as described above with reference toFIGS. 80 and 81, atubular body8560 of the introducer can be removed while an exposed ribbon ortape8550 remains attached with a distal portion of ablation andstabilizer assembly8520. As shown inFIG. 85E, the surgeon can grasp a portion of the exposed ribbon or tape, for example as described above with reference toFIGS. 76A-76F, and withdrawn the ribbon ortape8550 through a proximal portion of the push tube ortrocar8530, thereby forming a looping or circular configuration with ablation andstabilizer assembly8520. The surgeon can advancepush tube8530 along the ablation andstabilizer assembly8520 as indicated by arrow A so as to constrict the ablation andstabilizer assembly8520 about the PVs, as illustrated inFIG. 85F. Optionally, this cinching procedure may involve withdrawing a proximal portion of the ablation and stabilizer assembly out ofpush tube8530 as indicated by arrow B. Optionally, tape orribbon8550 can be drawn further taut. Hence, the surgeon can contract or constrict ablation andstabilizer assembly8520 about the PVs. The tape orribbon8550 can be fixed with or wrapped around a proximal cleat or catch of the push tube ortrocar8530 as described elsewhere herein, so that the ablation andstabilizer assembly8520 remains taut around the PV roots. Thereafter, suction may be applied through a stabilizer assembly, ablation energy can be applied through an ablation assembly, and a transmural lesion can be formed.
• In addition to box lesions, embodiments of the present invention are well suited for use in forming connecting or linear lesions.FIG. 86A shows a portion of a treatment system that includes astabilizer member8610, trocar or pushtube8620, and a connectinglesion adapter8630. The cross-hatched area ofstabilizer member8610 represents asuction zone8612 that can be applied to and secured or sealed against a patient tissue. The stabilizer member or mechanism typically also houses an ablation member or mechanism (not shown). Connectinglesion adapter8630 includes adistal sealing edge8632 that, in cooperation with asealing edge8614 ofstabilizer member8610, can operate to form a seal against the tissue. Hence, when suction is applied viasuction zone8612, an ablation mechanism housed instabilizer member8610 can remain in place as desired against the patient tissue.FIG. 86B shows a treatment system without the connecting lesion adapter. As depicted in these figures, and as illustrated elsewhere herein, the treatment device can be effectively operated when the ablation and stabilizer assembly is adjusted to extend at any desired distance from the distal end of the push tube or cinching mechanism. In some embodiments, when one or more connecting lesions are being created, a cinching mechanism may not be in use. For example, a distal tape may be cut about an inch from the end of the suction stabilizer and used as an implement to hold on to by graspers to position and hold the end of the extended suction stabilizer. In some cases, about 1 to 3 inches of a suction stabilizer is exposed when creating a connecting lesion. The suction sealing features, such asdistal sealing edge8632 or sealing edge orskirt8614, form a seal between the stabilizer mechanism and the patient tissue. In some embodiments, an ablation system may include a flexible valve at a proximal end of a push tube, for example in a handle or body of the tube, which may operate as a vacuum seal for a suction stabilizer.
• FIG. 87 shows aspects of atreatment system8700 and method for forming a connection lesion. As illustrated here,treatment system8700 includes an ablation andstabilizer assembly8710, a connectinglesion adapter8720, and a trocar or pushtube8730. In use, the operator or surgeon can advance or extend a distal portion of ablation andstabilizer assembly8710 out fromtrocar8730 to expose a desired length of the ablation and stabilizer assembly. The surgeon can place the exposed ablation and stabilizer assembly against an area of the patient tissue, optionally with the assistance of a graspingmechanism8740 such as forceps. As shown here, ablation andstabilizer assembly8710 includes a distal tape orribbon8750 that can be grasped and maneuvered as desired by the operator.
• Connection lesion adapter8720 can operate to extend a floor ofpush tube8730 distally to facilitate suction. In use, the surgeon can operatetreatment system8700 to form an of a variety of epicardial connectinglesions8760 on the patient tissue. In the embodiment shown here, the patient anatomy includes a superior vena cava (SVC), an aorta (A), a pulmonary artery (PA), an inferior vena cava (IVC), a right atrial appendage (RAA), pulmonary veins (PV), a left atrium (LA), and a right atrium (RA).
• FIG. 88 shows aspects of atreatment system8800 and method for forming an endoablation. As illustrated here,treatment system8800 includes an ablation andstabilizer assembly8810, a connectinglesion adapter8820, and a trocar or pushtube8830. Ablation andstabilizer assembly8810 includes anablation mechanism8812 and a stabilizer mechanism8814. In use, the operator or surgeon can advance or extend a distal portion of ablation andstabilizer assembly8810 out fromtrocar8830 to expose a desired length of the ablation and stabilizer assembly. The surgeon can place the exposed ablation and stabilizer assembly against an area of the patient tissue, optionally with the assistance of a graspingmechanism8840 such as forceps. As shown here, ablation andstabilizer assembly8810 includes a distal tape orribbon8850 that can be grasped and maneuvered as desired by the operator.Connection lesion adapter8820 can operate to extend a floor ofpush tube8830 distally to facilitate suction. In use, the surgeon can operatetreatment system8800 to form any of a variety of endocardial lesions on the patient tissue. As shown here,treatment system8800 is advanced through an incision or opening in the left atrium, wherein a lesion may be formed. The wall of the left atrium (LA) is shown transparently inFIG. 88, for the sake of clarity. In the embodiment shown here, the patient anatomy includes a superior vena cava (SVC), an aorta (A), a pulmonary artery (PA), an inferior vena cava (IVC), a right atrial appendage (RAA), pulmonary veins (PV), a left atrium (LA), and a right atrium (RA).
• FIG. 89 shows aspects of atreatment system8900 and method for forming an epiablation. As illustrated here,treatment system8900 includes an ablation andstabilizer assembly8910 and a trocar or pushtube8830. Ablation andstabilizer assembly8910 includes an ablation mechanism and a stabilizer mechanism. In use, the operator or surgeon can advance or extend a distal portion of ablation andstabilizer assembly8910 out fromtrocar8930 to expose a desired length of the ablation and stabilizer assembly. The surgeon can place the exposed ablation and stabilizer assembly against an area of the patient tissue, optionally with the assistance of a graspingmechanism8940 such as forceps. As shown here, ablation andstabilizer assembly8910 includes a distal tape orribbon8950 that can be grasped and maneuvered as desired by the operator. As depicted here, the ablation and stabilizer assembly is capable of forming a “forward curve” configuration where the ablation mechanism is on a concave side of the assembly. The assembly is also capable of forming a “backward curve” configuration where the ablation mechanism is on a convex side of the assembly. The assembly is also capable of twisting and side-bending, as desired. In the embodiment shown here, the patient anatomy includes a superior vena cava (SVC), an aorta (A), a pulmonary artery (PA), an inferior vena cava (IVC), a right atrial appendage (RAA), pulmonary veins (PV), a left atrium (LA), and a right atrium (RA).
• FIGS. 90A to 90J show aspects of atreatment system9000 and methods for forming lesions on patient tissue. As illustrated inFIGS. 90A and 90B, an ablation andstabilizer assembly9010 of the system can be wrapped about the patient tissue, so as to form abox lesion9030 at or near theroots9090 of the pulmonary veins (PVs), where the PVs extend from the atrium. As depicted inFIGS. 90B to 90J, ablation andstabilizer assembly9010 may include a distal tape or implement9012, and an operator can manipulate or position ablation andstabilizer assembly9010 with a grasping or manipulatingmechanism9020, such as forceps, to form additional connectinglesions9040 as desired to the patient tissue.
• FIG. 91 illustrates aspects of a treatment system9100 and methods for forming a box lesion on patient tissue. Treatment system9100 includes an ablation and stabilizer assembly9110 and a push tube or trocar9120. Treatment system can also include a sternotomy or sternal adapter as described herein with reference toFIGS. 82A to 82F. As depicted here, push tube9120 extends through a chest opening9130 at or near the patient's sternum. The push tube sternal adapter can hold the distal end of the stabilizer mechanism in the desired position, so the left atrium can be encircled from the sternal access position. In the embodiment shown here, the patient anatomy includes a superior vena cava (SVC), an aorta (A), an esophagus (E), a left pulmonary artery (LPA), a right pulmonary artery (RPA), an inferior vena cava (IVC), a right atrial appendage (RAA), a left atrial appendage (LAA), pulmonary veins (PV), a left atrium (LA), a trachea (T), a left ventricle (LV), a right ventricle (RV), and a right atrium (RA).
• FIGS. 92A to 92F show examples of various lesion subsets that can be formed with system and method embodiments of the present invention. As depicted inFIG. 92A, systems and methods may be used to form afirst lesion9210aabout the roots of a patient's right pulmonary veins9220a, and asecond lesion9230aabout the roots of a patient's left pulmonary veins9240a. As depicted inFIG. 92B, systems and methods may be used to form a first lesion9210babout the roots of a patient's superiorpulmonary veins9220b, and a second lesion9230babout the roots of a patient's inferiorpulmonary veins9240b. As depicted inFIG. 92C, systems and methods may be used to form a first diagonal lesion9210cabout the roots of a patient's right superior pulmonary vein9222cand left inferiorpulmonary vein9224c, and a second diagonal lesion9230cabout the roots of a patient's left superior pulmonary vein9242cand right inferior pulmonary vein9244c. In this way, the surgeon can create five small isolated areas. As depicted inFIG. 92D, systems and methods may be used to form a lesion9210dabout the roots of any three of the patient's PVs. As depicted in FIG.92E, systems and methods may be used to form alesion9210eabout the root of any individual PV. As shown inFIG. 92F, systems and methods may be used to form any combination of lesions or lesion subsets described herein. For example, systems and methods can be used to form a first lesion9210fabout the root of an individual PV, and asecond lesion9220fabout the roots of three other PVs.
• Cinching Devices and Methods of Use and Construction
• Embodiments of the present invention encompass ablation devices which have cinching configurations, and methods for their use and construction. For example, a flexible ablation device can include a distal member of the device which attaches to a proximal end of the device, so as to facilitate a closed loop or a belt loop type of cinching, forming a closed or substantially closed loop. Cinching embodiments may include an attachment mechanism, such as a distal hook mechanism which can be inserted into a sliding proximal collar. An attachment mechanism can include an open distal hook mechanism into which the proximal end of the device is inserted, providing a mechanical lock. In some embodiments, the interfaces can be magnetized. An attachment mechanism can be a releasable snap or interference fit mechanism. In some cases, an attachment mechanism can be a proximal loop into which a distal end of a device inserts. In some cases, an attachment mechanism can angle an interface between a distal and a proximal end such that the resultant loop is continuous or substantially continuous.
• A cinching embodiment can use suction or mechanical tension to contact tissue. An ablative member can extend to a distal extremity of a device to insure a complete and contiguous lesion. In some cases, an excess ablative member can be withdrawn through the mechanism at the proximal end to facilitate lesion continuity and provide a variable adjustment of lesion length. A flexible ablation device may have an active monopolar ablation element within a flexible trough like, energy shielding housing. An edge of a trough structure of a flexible ablation device can have at least one embedded pacing lead to function as described herein. In some cinching embodiments, one or more integrated pacing leads and connectors to an electrocardiogram (EKG) can facilitate feedback to an energy delivery generator. In some cases, it may be desirable to cease energy delivery when a pacing stimulus cannot be captured.
• Introducer Devices and Methods of Use and Construction
• Embodiments of the present invention encompass ablation devices which have introducer devices, and methods for their use and construction. For example, a mechanism for delivering a device in a minimally invasive surgery can include a device introducer that is steerable, flexible, malleable, rigid, or deflectable. A distal end of an introducer can encompass a magnet, and can also encompass a light, a suction lumen, or a working channel. An introducer can be used in combination with one or more like introducers such that one can magnetically attach to another in order to facilitate one pushing or pulling the other around a tissue structure from one side of the patient. A proximal end of one of the introducers can be attached to a device to be passed or advanced to a desired location. One or more of the introducers can also take the form of or include a scope with a blunted polymeric transparent cap, where the tip of the cap can house a magnet with a polarity opposite to a polarity of a magnet in a cap tip of another introducer. In this way it is possible for one introducer to seek or look for another introducer and attach. An introducer tip may include a light.
• In some cases, a blunted polymeric transparent cap can be a standalone device, and can be fitted with a mechanism for sealing or preventing fluid from migrating to a lens of the scope, such as with an o-ring sealing mechanism that can fit on a variety rigid or flexible endoscopes and prevent fluids from communicating with a scope lens. An endoscope can navigate to find the introducer, contact it with opposite polarity magnets, and be retracted to lead the introducer and surgical instrument. The magnetic attachment mechanism can be replaced with or supplemented with a threaded male and female connector, a mechanical snap connector, a hook and collar connector, or a lasso connector. In some embodiments, an attachment mechanism can be advanced and retracted. In some embodiments, an attachment mechanism can include an integrated mechanism, or can include separate mechanisms. Such mechanisms can be adjacent to or within a blunted lens cap.
• Convertible Ablation Devices and Methods of Use and Construction
• Embodiments of the present invention encompass ablation devices which are convertible between bipolar and monopolar configurations, and methods for their use and construction. In some instances, a bipolar ablation device can be more effective than a monopolar ablation device. For example, it may be possible to creating transmural lesions with a bipolar ablation device more quickly than with a monopolar ablation device. However, when creating a complex lesion set on a beating heart, it may be desirable to use a monopolar device. Embodiments of the present invention encompass devices that can be used as either a monopolar or bipolar device.
• In some cases, a convertible device includes opposing parallel jaws, with an active member and an indifferent member that can be separated. Thus, embodiments provide clamp devices having a means of detaching one jaw from another jaw, so that an active ablation element can be used independently from an indifferent element. Such configurations allow a surgeon to use the active element as a monopolar probe in conjunction with standard dispersive electrode pads, before creating bipolar lesions, after creating bipolar lesions, or both before and after creating bipolar lesions.
• In some embodiments, an active jaw includes a polymeric trough structure in which a monopolar ablation device can be inserted or removed. An active jaw can be malleable or have a mechanism to change the orientation of jaw with respect to its shaft. As such, a monopolar ablation member can operate or be used as a monopolar wand or hand held device, for example when disconnected from an indifferent electrode part of a clamp. In some cases, an active ablation member or device passes through an o-ring or other sealing mechanism such that suction can be facilitated to draw tissue into the trough structure or device and in contact with the ablation member. An ablation device can be internally irrigated or the trough structure can have apertures to spray saline or other fluid in order to keep local tissue temperatures lower or otherwise modulate or control tissue temperature. Saline or other fluid can be cleared from the field via a suction mechanism or means in the device. In some embodiments, a trough structure or and edge thereof can include one or more embedded pacing leads.
• System and method embodiments disclosed herein may include one or more integrated pacing leads and connectors to an electrocardiogram (EKG) which can facilitate feedback to an energy delivery generator. In some cases, it may be desirable to cease energy delivery when a pacing stimulus cannot be captured. In some cases, it may be desirable to use a device in a monopolar mode whereby the indifferent electrode only utilizes temperature sensing to provide transmurality feedback that a temperature has reach a certain level on the opposite side of a tissue from the active electrode. Embodiments also contemplate use of features disclosed herein in conjunction with a steerable scissor type clamp.
• Lesion Test Systems and Methods of Use and Manufacture
• Embodiments of the present invention encompass systems for testing the effectiveness of one or more cardiac ablation lesions, and methods for their use and manufacture. For example, a method of testing the effectiveness of one or more cardiac ablation lesions can insure that one or more lesions prevent or inhibit electrical excitation across a lesion. In some cases, this can be performed by a separate hand-held device after use of an ablation device. According to embodiments of the present invention, this feature can be integrated into an ablation device, in a bipolar or monopolar configuration. For example, in a bipolar embodiment, an edge of a trough structure can have at least one embedded pacing lead. The element can be oriented such that the pacing leads can lie between the ablative element and the region of tissue to be electrically isolated. After a designated period of ablation, or prior to or at the onset of ablation, the device can begin exciting the tissue. A device used to monitor the excitation of tissue, such as an electrocardiogram (EKG or ECG), can be used as a feedback tool to determine when the stimulus is no longer being captured across the ablation line, which can be an indication that one or more lesions created are effective. Such pacing can occur simultaneously with the creation of the one or more ablation lesions, or separately. An energy delivery algorithm can be controlled with a feedback loop such that energy delivery can be ceased when a pacing stimulus cannot be detected outside of the region to be electrically isolated. Embodiments of the present invention are well suited for implementing conduction block techniques such as those disclosed in U.S. Patent Application No. 61/051,975 filed May 9, 2008, the entire content of which is incorporated herein by reference for all purposes.
• Embodiments of the present invention also encompass techniques for testing the effectiveness of one or more cardiac ablation lesions to insure that tissue within the area of the lesion or lesions is transmural or that cytotoxic temperatures are reached across the full thickness of the tissue. A clamp mechanism, which may be bipolar, can be used in monopolar mode, whereby an indifferent electrode element, or jaw opposite an active ablation element, utilizes temperature sensing features to provide transmurality feedback that a temperature has reach a certain level on the opposite side of tissue from the active electrode. Any of the testing techniques disclosed herein can be facilitated in various shaped clamps, included clamps in which jaws remain parallel, scissor style clamps, steerable or malleable jaw clamps, and the like.
• While the exemplary embodiments have been described in some detail, by way of example and for clarity of understanding, those of skill in the art will recognize that a variety of modification, adaptations, and changes may be employed. Hence, the scope of the present invention should be limited solely by the claims.

Claims (26)

1.-20. (canceled)

21. A system for administering an ablation treatment to a patient, comprising:

an ablation assembly having a flexible ablation mechanism configured to ablate a tissue of the patient;

a cinching mechanism configured to constrict the ablation member about the patient tissue; and

an introducer coupleable with the ablation assembly of the introducer and having a distal grasping element to facilitate placement of and/or cinching of the flexible ablation mechanism about the tissue.

22. A system as inclaim 21, wherein the introducer is coupleable with the ablation assembly of the introducer along a length of the introducer proximal of the distal grasping portion.

23. A system as inclaim 21, wherein the distal grasping element comprises a string or tape accessible for grasping by an operator with a minimally invasive tool.

24. A system as inclaim 21, wherein the distal grasping element comprises a tape or ribbon shape to facilitate maneuvering and/or positioning of the ablation assembly coupled to the introducer.

25. A system as inclaim 24, wherein the introducer is configured such that a width of the tape or ribbon shaped distal grasping element is aligned with a width of the introducer so as to facilitate maneuvering and/or positioning of the ablation assembly through the introducer coupled to the ablation assembly by manipulation of the distal grasping element.

26. A system as inclaim 21, further comprising:

a tool insertable through a trocar, the tool being configured for snagging the distal grasping portion.

27. A system as inclaim 26, wherein the distal grasping portion comprises a ribbon or tape and the tool comprises a tape hook.

28. A system as inclaim 26, wherein the tool comprises a distal fin or wedge configured to snag the distal grasping element when twisted adjacent the distal grasping element.

29. A system as inclaim 26, wherein the tool comprises a moveable jaw configured for grasping and releasing of the distal grasping element.

30. A system as inclaim 26, wherein the tool further comprises a scope for visualizing one or both of the distal grasping element and the flexible ablation member so as to facilitate placement and/or cinching of the flexible ablation member by manipulation of the distal grasping member.

31. A system as inclaim 23, wherein a portion of the introducer comprises a bias towards a curve or arc shape comprises a ribbon or tape and the tool comprises a tape hook.

32. A system as inclaim 21, further comprising a stabilizer mechanism coupled to the flexible ablation member, wherein the distal grasping element is attached to a distal portion of the stabilizer mechanism

33. A system as inclaim 32, wherein the distal grasping element extends within the introducer and through a distal aperture in the introducer

34. A system as inclaim 33, wherein the distal grasping element extends alongside a moveable urging element disposed within the introducer such that tension on the distal grasping element moves or maintains the urging element at least partially within the stabilizing member to force the introducer and stabilize together, while releasing tension on the distal grasping element allows the introducer and stabilizer to be separated.

35. A system as inclaim 34, wherein the distal grasping element comprises a tape-shaped element and the urging member comprises a pin.

36. A system as inclaim 32, wherein the stabilizer mechanism that forms a seal with the tissue of the patient, wherein the ablation mechanism is at least partially disposed within a recess of the stabilizer member.

37. A method for ablating a cardiac tissue of a patient, comprising:

inserting an ablation assembly through a minimally invasive aperture in the patient so as to position a flexible ablation member tissue near the tissue;

urging the flexible ablation member bout the tissue by guiding a distal introducer coupled to the flexible ablation member about the tissue;

grasping a distal grasping element extending from the introducer; and

maneuvering the flexible ablation member to a desired placement or position about the tissue by manipulating the distal grasping element; and

administering an ablation to the cardiac tissue via the ablation mechanism to create a lesion in the cardiac tissue.

38. A method as inclaim 37, wherein grasping the distal grasping element comprises snagging the distal grasping element with a tool inserted through the minimally invasive aperture or through another minimally invasive aperture.

39. A method as inclaim 38, wherein grasping the distal grasping element comprises twisting the tool such that a fin, curved portion or hook of the tool snags the distal grasping element.

40. A method as inclaim 38, wherein grasping the distal grasping element comprises visualizing the distal grasping element with a scope incorporate into a shaft of the grasping tool.

41. A method as inclaim 37, wherein the distal grasping element comprises a tape or ribbon and manipulating the distal grasping element comprises any of pulling, releasing and twisting the distal grasping element or any combination thereof so as to provide the desired placement or position of the flexible ablation member about the tissue.

42. A method as inclaim 37, wherein grasping the distal grasping element comprises snagging the ribbon or tape by twisting a tool such that a fin or curved portion snags the ribbon or tape and wraps around a sheath of the tool so as to facilitate manipulation of the ribbon or tape with the tool.

43. A method as inclaim 37, wherein the ablation assembly is disposed at least partially within a stabilizer member, the method further comprising:

forming a seal between the stabilizer assembly and the cardiac tissue.

44. A method as inclaim 43 wherein the introducer includes an urging member that couples the introducer and stabilizer member when the distal grasping element is tensioned, the method further comprising:

tensioning the distal grasping element during manipulating of the distal grasping element so that the stabilizer member and introducer remain coupled during maneuvering of the flexible ablation member.

45. A method as inclaim 43 further comprising:

releasing the distal grasping element so as to decouple the introducer and a stabilizing member of the flexible ablation assembly after maneuvering of the flexible ablation member; and

removing the introducer through the minimally invasive aperture.

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