U.S. patent application number 14/143420 was filed with the patent office on 2014-09-25 for cardiac ablation systems and methods.
This patent application is currently assigned to ESTECH, Inc.. The applicant listed for this patent is ESTECH, Inc.. Invention is credited to Mike J. Banchieri, Tamer Ibrahim, Dwight P. Morejohn.
Application Number | 20140288556 14/143420 |
Document ID | / |
Family ID | 40073106 |
Filed Date | 2014-09-25 |
United States Patent
Application |
20140288556 |
Kind Code |
A1 |
Ibrahim; Tamer ; et
al. |
September 25, 2014 |
CARDIAC ABLATION SYSTEMS AND METHODS
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.
Inventors: |
Ibrahim; Tamer; (Pleasant
Hill, CA) ; Banchieri; Mike J.; (Discovery Bay,
CA) ; Morejohn; Dwight P.; (Davis, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ESTECH, Inc. |
San Ramon |
CA |
US |
|
|
Assignee: |
ESTECH, Inc.
San Ramon
CA
|
Family ID: |
40073106 |
Appl. No.: |
14/143420 |
Filed: |
December 30, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12124743 |
May 21, 2008 |
8628522 |
|
|
14143420 |
|
|
|
|
60939201 |
May 21, 2007 |
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Current U.S.
Class: |
606/49 ;
606/41 |
Current CPC
Class: |
A61B 18/1492 20130101;
A61B 2018/00273 20130101; A61B 2018/00291 20130101; A61B 2018/00363
20130101; A61B 2018/1407 20130101; A61B 2018/00375 20130101; A61B
2018/00577 20130101 |
Class at
Publication: |
606/49 ;
606/41 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 21, further comprising: a tool insertable
through a trocar, the tool being configured for snagging the distal
grasping portion.
27. A system as in claim 26, wherein the distal grasping portion
comprises a ribbon or tape and the tool comprises a tape hook.
28. A system as in claim 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 in claim 26, wherein the tool comprises a moveable
jaw configured for grasping and releasing of the distal grasping
element.
30. A system as in claim 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 in claim 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 in claim 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 in claim 32, wherein the distal grasping element
extends within the introducer and through a distal aperture in the
introducer
34. A system as in claim 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 in claim 34, wherein the distal grasping element
comprises a tape-shaped element and the urging member comprises a
pin.
36. A system as in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] 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
[0002] Embodiments of the present invention related to medical
devices and methods, and in particular to cardiac ablation systems
and methods.
[0003] 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.
[0004] Embodiments of the present invention provide solutions to at
least some of these outstanding needs.
BRIEF SUMMARY OF THE INVENTION
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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
[0017] FIG. 1A illustrates exemplary lesion patterns on a patient
heart according to embodiments of the present invention.
[0018] FIG. 1B illustrates aspects of a box lesion according to
embodiments of the present invention.
[0019] FIGS. 2A-2C illustrate aspects of a spring-loaded free-tip
electrode according to embodiments of the present invention.
[0020] FIGS. 3A-3B show aspects of a flexible backbone
configuration according to embodiments of the present
invention.
[0021] FIGS. 4A-4E show aspects of an obturator ablation system
according to embodiments of the present invention.
[0022] FIGS. 5A-5G show aspects of an obturator ablation system
according to embodiments of the present invention.
[0023] FIGS. 6A-6D illustrate aspects of an ablation system having
a cinching device according to embodiments of the present
invention.
[0024] FIGS. 7A-7C show aspects of ablation system having a
cinching device with guides according to embodiments of the present
invention.
[0025] FIGS. 8A-8E show aspects of an ablation system having a loop
mechanism according to embodiments of the present invention.
[0026] FIGS. 9A-9D show aspects of an ablation system having a
flexible device with a breakaway tip according to embodiments of
the present invention.
[0027] FIGS. 10A-10F show aspects of an ablation system with a
stabilizer mechanism according to embodiments of the present
invention.
[0028] FIGS. 11A-11C show aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0029] FIGS. 12A-12C show aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0030] FIGS. 13A-13C show aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0031] FIGS. 14A-14B show aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0032] FIGS. 15A-15C show aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0033] FIGS. 16A-16C depict aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0034] FIGS. 17A-17F show aspects of an ablation system with a
cinching mechanism according to embodiments of the present
invention.
[0035] FIGS. 18A-18E show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0036] FIGS. 19A-19F show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0037] FIGS. 20A-20B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0038] FIGS. 21A-21B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0039] FIGS. 22A-22B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0040] FIGS. 23A-23B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0041] FIGS. 24A-24C show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0042] FIGS. 25A-25B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0043] FIGS. 26A-26B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0044] FIG. 27 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0045] FIGS. 28A-28C show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0046] FIGS. 29A-29C show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0047] FIGS. 30A-30B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0048] FIG. 31 shows aspects of an ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0049] FIGS. 32A-32D show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0050] FIGS. 33A-33J show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0051] FIGS. 34A-34E show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0052] FIGS. 35A-35G show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0053] FIGS. 36A-36C show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0054] FIGS. 37A-37C show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0055] FIGS. 38A-38B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0056] FIG. 39 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0057] FIG. 40 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0058] FIG. 41 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0059] FIG. 42 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0060] FIG. 43 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0061] FIG. 44 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0062] FIG. 45 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0063] FIG. 46 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0064] FIG. 47 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0065] FIG. 48 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0066] FIG. 49 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0067] FIG. 50 shows aspects of an ablation system with a
stabilizer member according to embodiments of the present
invention.
[0068] FIG. 51 shows aspects of an ablation system with a pusher
according to embodiments of the present invention.
[0069] FIG. 52 shows aspects of an ablation system with a
visualization system according to embodiments of the present
invention.
[0070] FIG. 53 shows aspects of an ablation system with a
visualization system according to embodiments of the present
invention.
[0071] FIG. 54 shows aspects of an ablation system with a
visualization system according to embodiments of the present
invention.
[0072] FIGS. 55A-55B show aspects of ablation systems with a
visualization system according to embodiments of the present
invention.
[0073] FIGS. 56A-56B show aspects of ablation systems with a
visualization system according to embodiments of the present
invention.
[0074] FIG. 57 shows aspects of an ablation system with a
visualization system according to embodiments of the present
invention.
[0075] FIGS. 58A-58C show aspects of ablation systems with a
visualization system according to embodiments of the present
invention.
[0076] FIGS. 59A-59D show aspects of ablation systems with a
visualization system according to embodiments of the present
invention.
[0077] FIGS. 60A-60B show aspects of ablation systems with a
visualization system according to embodiments of the present
invention.
[0078] FIGS. 61A-61B show aspects of ablation systems with a
visualization system according to embodiments of the present
invention.
[0079] FIGS. 62A-62E show aspects of ablation systems forming a
loop closure according to embodiments of the present invention.
[0080] FIGS. 63A-63F show aspects of ablation systems forming a
loop enclosure according to embodiments of the present
invention.
[0081] 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.
[0082] FIG. 65 shows aspects of an ablation system relating to
oval, teardrop, or other loop enclosure configurations according to
embodiments of the present invention.
[0083] FIGS. 66A-66C show aspects of ablation systems relating to
oval, teardrop, or other loop enclosure configurations according to
embodiments of the present invention.
[0084] FIG. 67 shows aspects of an ablation system with an
introducer according to embodiments of the present invention.
[0085] FIGS. 68A-68B show aspects of ablation systems with an
introducer according to embodiments of the present invention.
[0086] FIG. 69 shows aspects of an ablation system with a
stabilizer mechanism according to embodiments of the present
invention.
[0087] FIG. 70 shows aspects of an ablation system with a
stabilizer mechanism according to embodiments of the present
invention.
[0088] FIG. 71 shows aspects of an ablation system with a
stabilizer mechanism according to embodiments of the present
invention.
[0089] FIG. 72 shows aspects of an ablation system with a
stabilizer mechanism according to embodiments of the present
invention.
[0090] FIG. 73 shows aspects of an ablation system with a
stabilizer mechanism according to embodiments of the present
invention.
[0091] FIGS. 74A-74B show aspects of ablation systems with a
stabilizer mechanism according to embodiments of the present
invention.
[0092] FIGS. 75A-75B show aspects of ablation systems with a
stabilizer mechanism according to embodiments of the present
invention.
[0093] FIGS. 76A-76F show aspects of ablation systems with a
coupling mechanism according to embodiments of the present
invention.
[0094] FIG. 77 shows aspects of an ablation system with an
introducer according to embodiments of the present invention.
[0095] FIGS. 78A-78D show aspects of ablation systems with a
stabilizer mechanism according to embodiments of the present
invention.
[0096] FIG. 79 shows aspects of an ablation system with a coupling
mechanism according to embodiments of the present invention.
[0097] FIG. 80 shows aspects of an ablation system with a coupling
mechanism according to embodiments of the present invention.
[0098] FIG. 80A shows aspects of a coupling mechanism of an
ablation system according to embodiments of the present
invention.
[0099] FIG. 81 shows aspects of an ablation system with a coupling
mechanism according to embodiments of the present invention.
[0100] FIGS. 82A-82F show aspects of ablation systems with an
introducer system according to embodiments of the present
invention.
[0101] FIGS. 83A-83F show aspects of ablation systems with an
introducer system according to embodiments of the present
invention.
[0102] FIGS. 84A-84F show aspects of ablation systems with an
introducer system according to embodiments of the present
invention.
[0103] FIGS. 85A-85F show aspects of ablation systems with an
introducer system according to embodiments of the present
invention.
[0104] FIGS. 86A-86B show aspects of ablation systems with a
stabilizer member according to embodiments of the present
invention.
[0105] FIG. 87 shows aspects of an ablation system with a
stabilizer assembly according to embodiments of the present
invention.
[0106] FIG. 88 shows aspects of an ablation system with a
stabilizer assembly according to embodiments of the present
invention.
[0107] FIG. 89 shows aspects of an ablation system with a
stabilizer assembly according to embodiments of the present
invention.
[0108] FIGS. 90A-90J show aspects of ablation systems with a
stabilizer assembly according to embodiments of the present
invention.
[0109] FIG. 91 shows aspects of an ablation system with a
stabilizer assembly according to embodiments of the present
invention.
[0110] 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
[0111] 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.
[0112] Turning now to the drawings, FIG. 1A illustrates exemplary
lesion patterns on a posterior aspect, or base, of a patient heart
100, according to embodiments of the present invention. Patient
heart 100 includes a right pulmonary artery 101, a left pulmonary
artery 102, 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, a left ventricle 107, an aortic arch 108,
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 ventricle 115, and a coronary sinus (CS) 116.
The dashed lines "- - - -" can represent one or more transmural
burn zones on tissue of the heart. For example, lesion 120
represents a left atrial appendage (LAA) connecting lesion, lesion
130 represents a circumferential lesion, or box lesion, about the
pulmonary vein (PV) ostia, lesion 140 represents a juxta coronary
sinus (CS) lesion, lesion 150 represents a transverse right atrium
(RA) lesion, lesion 160 represents an intra-cava lesion, and lesion
170 represents a right atrial lesion. FIG. 1B illustrates another
view of a circum-pv lesion 130, or box lesion, which can be applied
contiguously, or without a break, around the pulmonary veins. In
some cases, a circum-pv lesion 130 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.
[0113] FIGS. 2A-2C illustrate aspects of a spring-loaded free-tip
electrode, according to embodiments of the present invention. FIG.
2A shows an ablation system 200 that involves a sheath containing a
free tip in a parallel position. System 200 includes a distal end
210, a proximal end 220, a sheath 230, a distal element 240, a tip
270, and a trunk section 280. In some embodiments, system 200 may
optionally include a formed or preformed bend or curve 260.
Ablation system 200 also includes an ablation member 290 in
operative association with a placement or stabilizer member 295.
Further, ablation system 200 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
near distal end 210 and a location near proximal end 220. In some
cases, a curvable portion may include a formed bend 260. Tip 270
may be biased to extend laterally or away from trunk section 280,
and can be constrained by sheath 230 so as to be aligned in
parallel with trunk section 280. In use, an operator or surgeon can
advance a distal end 210 of system 200 around a tissue or organ 250
such as a heart, as depicted by A arrows. For example, a surgeon
can advance system 200 through or near a transverse pericardial
sinus 252, circumferentially around the pulmonary veins 254, and
through or near an oblique pericardial sinus 256. The operator can
facilitate placement of system 200 by engaging or grasping distal
element 240 and maneuvering distal end 210. In some embodiments,
distal element 240 includes a string or tape which the operator can
grasp with a maneuvering mechanism such as a pair of forceps.
Optionally, distal end portion 210 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 in FIG. 2B, ablation system 200 can be further
wrapped around tissue 250, as depicted by B arrow, such that bend
260 is disposed at or near the tissue. As shown here, the contour
of bend 260 is similar to or conforms with the shape of the tissue
250. Bend 260 can include a molded curve. In some cases, a
molded-in curve presents a tight radius. As shown in FIG. 2C,
sheath 230 can be partially retracted, withdrawn, or translated
longitudinally relative to other elements of the system as
indicated by arrow C, and free tip 270 can pop out into a
functional position. For example, tip 270 can be biased so that
when constraining forces provided by sheath 230 are removed, tip
270 can extend away from trunk 280 and adopt a shape that conforms
with or is similar to the shape of tissue 250. 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 bend 260
such that it also conforms with the shape of the tissue 250. In
this way, ablation system 200 forms a loop structure 245 that can
be used to administer a circular or closed ablation treatment to
the patient. Releasing tip 270 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 of loop structure 245, and therefore can adjust the
shape or overall circumference of a box lesion that is formed in
the tissue. As noted above, ablation system 200 includes an
ablation member 290 in operative association with a placement or
stabilizer member 295. Placement member 295 can assist in holding
ablation member 290 against or near tissue 250 so as to enhance
lesion formation. In some embodiments, ablation member 290 includes
a radiofrequency cable, and placement member 295 includes a suction
tube. Ablation system 200 is well suited for use in creating
transmural ablations that extend through or affect the entire
thickness of a tissue wall, for example.
[0114] 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 section 300a of an ablation
system according to some embodiments. Curvable section 300a
includes an ablation member 310a, such as an electrode, in
operative association with a placement or stabilizer member 320a.
In this embodiment, curvable section 300a presents a flex
center-line 330a which is co-axially aligned with the ablation
member 310a. For example, a central longitudinal axis 340a of
ablation member 310a can be aligned with flex center-line 330a of
curvable section 300a. 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 or backbone 320a can
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 of stabilizer member 320a presents 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 of stabilizer member 320a can 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 the
stabilizer member 320a is 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.
[0115] FIG. 3B shows a side-view cross-section of a curvable
section 300b of an ablation system according to some embodiments.
Curvable section 300b includes an ablation member 310b, such as an
electrode, in operative association with a placement or stabilizer
member 320b. In this embodiment, curvable section 300b presents a
flex center-line 330b which is axially offset with the ablation
member 310b. For example, a central longitudinal axis 340b of
ablation member 310b can parallel or substantially parallel to, but
axially offset from, flex center-line 330b of curvable section
300b. As shown here, curvable section 300b includes one or more
attachment members 350b, such as o-rings, which couple ablation
member 310b with stabilizer member 320b. 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 member 320b can
include a suction mechanism that allows a surgeon to securely apply
the ablation system to a patient tissue.
[0116] 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 in FIG. 4A, an
obturator system component 450 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 in FIG. 4B, in some
embodiments obturator system 450 includes a pair of curved
obturators or stylets 410, 420 which an operator can slide into a
receptacle or hole of a stabilizer member of the obturator system.
Preformed obturators 410, 420 can have proximal handles 414, 424,
and can present opposing distal bends or molded shapes 412, 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 in FIG. 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 at location 470. In some cases, location 470 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. Obturators 410, 420 can be advanced or
retracted relative to the stabilizer member to shorten or lengthen
the length 430 of a loop or race track structure 480. For example,
an operator can advance the obturators toward the patient tissue by
grasping and pushing handles 414, 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 portions 456, 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
of loop structure 480. When the configuration of loop structure 480
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 at
tissue 440.
[0117] FIG. 4D shows a cross-section view of a portion A-A of FIG.
4A. As depicted here, a stabilizer member 490 of ablation system
450 includes a hole, receptacle, or channel 452 that is configured
to receive an obturator, and a recess or receptacle 454 that is
configured to receive an ablation member or mechanism 460 which may
include an electrode 465. In some cases, electrode 465 is exposed
at one or more locations. Ablation member or mechanism 460 may
include or be coupled with an intermittent loop, such as an o-ring,
that is attached to or coupled with member 490 and holds electrode
465 in a desired orientation. According to the embodiment shown in
FIG. 4E, an obturator 495 can present a double shish kabob
configuration having a single handle 496, or alternatively two
handles, and two preformed tongs 498a, 498b. Such a configuration
can have pivots where tongs cross 497 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
the obturators 495 together to produce a similar motion at tongs
498a and 498b inside 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 of obturators 495 outside the body produce a squeezing
motion at the tongs.
[0118] 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 an obturator 510 having a handle 512
coupled with a tong 513. As shown here, preformed tong 513 includes
a preformed bend 514. FIG. 5B illustrates a steerable sheath 520
having a handle 522 and a flexible casing 524. The flexible casing
may include a preformed curve or bend 526. As depicted in FIG. 5C,
an operator can construct the obturator assembly 500 by inserting
obturator tong 513 into sheath 520. Typically, the obturator tong
is more rigid than the sheath casing. Accordingly, the shape of
casing 524 can conforms with the shape of the bent tong, so as to
provide a complementary bend 524 in the casing. In some cases, both
an obturator and a steerable sheath can be provided in a
pre-assembled configuration. As depicted in FIG. 5D, an ablation
system can slide over the combined sheath and obturator, so as to
create a bend 544 in the ablation system. The ablation system 540
can be inserted across the left atrium of a patient's heart. An
operator can facilitate placement of ablation system 540 by
engaging or grasping distal element 560 and maneuvering a system
distal end 550. In some embodiments, distal or grasping element 560
includes a string or tape which the operator can grasp with a
maneuvering mechanism such as a pair of forceps. FIG. 5E shows that
distal end 550 can be advanced or steered as depicted by arrow E.
In this way, ablation system 540 can be further wrapped around a
patient tissue 565, 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 tissue 565. As shown in FIG. 5F, it
is possible to slide the device around a curve, for example around
a tissue 550, as depicted by arrows F. According to FIG. 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.
[0119] FIGS. 6A-6D illustrate aspects of an ablation system
according to embodiments of the present invention. FIG. 6A shows
that an ablation system 600 can be wrapped around a patient tissue
605, such as a heart or other cardiovascular tissue, and a distal
end 610 of the system can be pulled or passed through a cinching
device 620. Ablation system 600 includes a flexible ablation
assembly 615 and a cinching device 620. Ablation assembly 615 can
be used to deliver energy to the patient tissue 605 in order to
ablate the tissue. In some embodiments, ablation assembly 615
includes an ablation member 616, such as an electrode, coupled with
a stabilizer member or backbone 617. In some embodiments, ablation
assembly 615 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 member 617
includes a flexible backbone member coupled with the ablation
member. An operator can use cinching device 620 to help increase or
modulate the amount of contact between ablation member 616 and the
patient tissue 605. Cinching device 620 may come in many different
configurations and is not limited to those depicted in the figures.
As shown here, cinching device 620 can include two rollers 630,
coupled with a support or support plate 635. In some embodiments,
support 635 may include one or more support plates. In some
embodiments, cinching device 620 may include a plurality of rollers
630. Optionally, cinching device 620 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 cinching
device 620 may include insulating or non-conducting materials.
[0120] In use, an operator can pass or place ablation assembly 615
through cinching device 620 between rollers 630 a first time, as
indicated by arrow A. The ablation assembly can then be wrapped
around the patient tissue 605 as indicated by arrow B, and distal
end 610 of the ablation assembly can then be pulled back or passed
through cinching device 620 between rollers 630 a second time, as
indicated by arrow C. As shown here, an intermediate portion 611 of
ablation assembly 615 can thus be wrapped around patient tissue
605, which may include a heart or other cardiovascular tissue, and
distal end 610 of the ablation assembly 615 can be pulled or placed
through cinching device 620 such that ablation assembly 615 forms a
loop structure 619.
[0121] As depicted in FIG. 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 structure
619, which typically includes intermediate portion 611, can be
tightened around the patient tissue 605 by advancing the cinching
device 620 along the ablation assembly 615, as indicated by arrow
D. For example, an operator can grasp or control a handle or pull
rod 622 of cinching device 620 so as to move the handle toward the
tissue as indicated by arrow E. Relatedly, an operator can grasp or
control section 610 or section 612 of ablation assembly 615, or
both, so as to positionally fix ablation assembly 615 or provide an
opposing force to the handle operation described above, as
indicated by arrow F. FIGS. 6C and 6D depict the ablation system
600 after the cinching device 620 has been advanced even further
along ablation assembly 615 toward the tissue, so as to increase
contact between ablation assembly 615 and patient tissue 605.
Hence, when the operator has position cinching device 620, the
system is ready to have energy applied through the ablation member
616 of ablation assembly 615, toward patient tissue 605. The
operator can position ablation assembly 615 to make contact with
selected parts of patient tissue 605 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 by FIGS. 6C and 6D. The
position of cinching device 620 relative to ablation assembly 615
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 in FIG. 6D cinching
device 620 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, cinching device 620 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`.
[0122] FIGS. 7A-7C show aspects of ablation systems according to
embodiments of the present invention. An ablation system 700a is
depicted in FIG. 7A. Ablation system 700 includes an ablation
assembly 715a and a cinching device 710a. Ablation assembly 715a
includes an ablation member 716a and a stabilizer member 717a.
Cinching device 710a includes or is coupled with an ablation
segment 720a such as a corner electrode. Cinching device 710a
includes a support 735a and one or more rollers 730a. Ablation
segment 720a can be coupled with support 735a as part of cinching
device 710a. Ablation segment 720a may be positioned on support
735a toward a distal end of cinching device 710a, so that when an
operator or surgeon advances cinching device 710a towards pulmonary
veins (PV) of patient tissue 705a, ablation segment 720a can make
contact with the atria adjacent to the pulmonary veins. In some
embodiments, ablation segment 720a can be used to help insure or
increase the likelihood that the ablation system ablates the
patient tissue 705a in an approximate or complete circle or closed
path around the patient tissue. Ablation segment 720a can be
designed to bridge the gap between opposing sides of ablation
element 716a, so that a loop structure is formed in more of a
smooth circumferential path and in less of a teardrop shaped path.
Ablation segment 720a can thus be used to bridge a gap that might
otherwise exist between ablation member 715a and patient tissue
705a. In some embodiments, ablation member 716a may be coupled with
ablation segment 720a. 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 segment 720a can be positioned
in order to inhibit the ablation assembly 715a from pinching the
patient tissue 705a as depicted in FIG. 6D.
[0123] In some embodiments, the ablation segment 720a may be shaped
in order to maximize contact with the patient tissue 705a. In some
embodiments, the ablation segment 720a may be shaped in order to
minimize or reduce any pinching of the patient tissue 705a.
[0124] Ablation segment 720a may be rigid in some embodiments.
Ablation segment 720a may be flexible in some embodiments. Ablation
segment 720a may make contact with the ablation member 716a.
Optionally, ablation segment 720a may not make contact with the
ablation member 716a. Cinching device 710a can be advanced in a
direction toward the patient tissue 705a as indicated by arrow A1,
to increase the amount of contact between ablation member 717a and
the patient tissue 705a or to help secure the position of ablation
member 717a relative to patient tissue 705a. Similarly, by
advancing cinching device 710a in this direction, an operator can
increase the amount of contact between ablation segment 720a and
the patient tissue 705a or help secure the position of ablation
segment 720a relative to patient tissue 705a. The operator can also
establish or apply an opposing force by grasping or pulling
sections 718a, 719a of ablation assembly 715a in an opposing
direction, as indicated by arrows A2. The operator can position
ablation assembly 715a to make contact with selected parts of
patient tissue 705a 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 cinching device 710a relative to
ablation assembly 715a 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.
Ablation segment 720a in combination with ablation member 716a can
form a continuous circumferential loop that can be used to ablate a
circumferential lesion on the patient tissue.
[0125] As shown in FIGS. 7B and 7C, an ablation system 700b can
include a cinching device 720b and an ablation assembly 715b.
Cinching device 720b can include one or more guides 750b, and can
be used in operative association with an ablation assembly 715b
having an ablation member 716b and a stabilizer member 717b.
Cinching device 720b can also include an ablation member protection
mechanism 745b which can be disposed between portions 770b and 771b
of ablation member 716b. Hence, it is possible to avoid contact
between different portions of an ablation member such as an
electrode. One or more guides 750b, 751b of cinching device 720b
may include a flat or curved retaining wall perpendicularly
attached to, or formed along with, a support 740b of cinching
device 720b. In some embodiments, one or more guides 750b, 751b may
have a curved top edge. The shape of guides 750b, 751b can be
designed in order to help facilitate positioning an ablation
assembly 715b around the patient tissue 705b by keeping distal 771b
and proximal 770b segments of the ablation member 716b close to
each other. In an embodiment with two or more guides, the guides
may be located on opposite sides of a support plate of cinching
device 720b. In one method for using the cinching device 720b with
guides, ablation assembly 715b can be passed through the cinching
device along one guide 750b and then wrapped around the patient
tissue 705b. The ablation assembly 715b can then be pulled through
cinching device 720b in the opposed direction, passing along
another guide 751b. The guides may be made of or include various
semi-rigid or rigid materials. Cinching device 720b can be advanced
in a direction toward the patient tissue 705b as indicated by arrow
B1, to increase the amount of contact between the ablation member
717b and the patient tissue 705b or to help secure the position of
ablation member 717b relative to patient tissue 705b. Similarly, by
advancing cinching device 720b in this direction, an operator can
increase the amount of contact between ablation segment 735b and
the patient tissue 705b or help secure the position of ablation
segment 735b relative to patient tissue 705b. The operator can also
establish or apply an opposing force by grasping or pulling
sections 718b, 719b of ablation assembly 715b in an opposing
direction, as indicated by arrows B2.
[0126] In some embodiments, as cinching device 720b is advanced
towards the patient tissue 705b, a loop structure 711b of the
ablation assembly 715b is reduced in diameter or otherwise
contracted. As shown in FIG. 7B, in some embodiments, an ablation
member protection mechanism 745b can be utilized along with the
cinching device 720b. Cinching device 720b can include ablation
member protection mechanism 745b disposed between guides 750b,
751b. Ablation member protection mechanism 745b can act to keep a
first segment 770a and a second segment 771b of the ablation member
from making contact with each other. Ablation member protection
mechanism 745b may either be fixed or integral to cinching device
720b or separate from cinching device 720b. In some embodiments, an
ablation segment 735b may be attached with cinching device 720b,
such as with a first or distal section 746b of ablation member
protection mechanism 745b. Ablation segment 735b can be utilized to
increase the amount of contact between the ablation assembly 715b
and the patient tissue 705b. Ablation segment 735b can also be
utilized to reduce pinching of the patient tissue 705b that might
otherwise occur if ablation segment 735b were not disposed between
opposing segments of ablation member 716b. The operator can
position ablation assembly 715b to make contact with selected parts
of patient tissue 705b 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 cinching device 720b relative
to ablation assembly 715b 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 segment 735b in combination with ablation member 716b can
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 cinching device 720b which includes ablation
member protection mechanism 745b, guides 750b, 751b, and ablation
segment 735b.
[0127] FIGS. 8A-8E show aspects of an ablation system according to
embodiments of the present invention. FIG. 8A shows ablation system
800 having a distal end 810 and a belt loop 820. Optionally, the
ablation system may include a peel out electrode 830. Distal end
810 of system 800 is disposed through belt loop 820. FIG. 8B shows
a cross-section view of a portion A-A of FIG. 8A. As depicted in
FIG. 8C, ablation system 800 can be disposed about a large atria.
Similarly, as depicted in FIG. 8D, ablation system 800 can be
disposed about a small atria. According to FIG. 8E, ablation system
800 can have a receiving slot 840 adapted to receive peel out
electrode 830. With a more detailed reference now to FIG. 8A,
ablation system 800 includes a flexible ablation member 880, which
may have a peel out portion or electrode 830, an encircling
mechanism or catch 820 such as a belt loop, a hook, a closable
clasp, or the like, and a flexible stabilizer member or bracing 860
having a distal end 810, a proximal end 870, and a recessed
receiving slot or receptacle 840. The combination of the ablation
member and the stabilizer member can collectively be referred to as
an ablation assembly 890. In use, an operator may treat a patient
by wrapping a loop structure 811 of the ablation system around
pulmonary veins of a patient. This may involve passing flexible
bracing distal end 810 circumferentially around the tissue as
indicated arrow A, and through belt loop 820 as indicated by arrow
B. The operator may expand or contract ablation system 800 by
manipulating the flexible stabilizer member distal end 810. Moving
distal end 810 in direction C results in contraction of loop
structure 811 of ablation system 800 in a cinching fashion. Moving
distal end 810 in direction D results in expansion of loop
structure 811 of ablation system 800. Stabilizer member 860 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.
[0128] In some embodiments of use, a surgeon or operator can pass
stabilizer member distal end 810 through catch 820, and expand or
contract ablation system 800 by manipulating the flexible bracing
proximal end 870. Moving proximal end 870 in direction E results in
contraction of loop structure 811 of ablation system 800 in a
cinching fashion. Moving proximal end 870 in direction F results in
expansion of loop structure 811 of ablation system 800. FIG. 8B
depicts a cross-section portion A-A of ablation assembly 890 as
shown in FIG. 8A. As shown here, receiving slot 840 is located
adjacent to ablation member 880. In some cases, receiving slot 840
might be located on either side of ablation member 880. Receiving
slot 840 is adapted to receive a distal section or peel out portion
830 of ablation member 880.
[0129] As shown in FIG. 8C, a surgeon or operator can detach or
separate peel out portion 830 from stabilizer member 860 and insert
portion 830 into receiving slot 840, by grasping and manipulating
the peel out portion with a positioning device 850. In some cases,
a portion of the stabilizer member which is separated from the peel
out portion can be inserted through catch 820. A positioning device
such as a forceps or grasper can be introduced into the patient via
a minimally invasive incision. Positioning device 850 may be used
by the operator to detach peel out section 830 from flexible
bracing 860 and to insert the detached section of peel out section
830 into receiving slot 840 so that ablation member 880
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 device 850 may include opposable jaws, forceps,
clamps or any combination or other suitable means that can be used
by surgeon or operator to grasp or hold distal portion 830 of
ablation member 880. Positioning device 850 may also be used to
position ablation system 800 on the heart or reposition ablation
system 800 to perform ablation in multiple locations on a heart.
With continued reference to FIG. 8C, a surgeon or operator can use
positioning device 850 to insert peel out distal section 830 into
receiving slot 840 on the opposite side of flexible stabilizer
bracing 860. Ablation system 800 can be used to produce a circular,
elliptical, or closed ablation pattern or lesion on a large atria.
As shown in FIG. 8D, ablation system 800 may be used to produce an
ablation pattern or lesion on a small atria. Because the atria is
smaller, a longer section of flexible stabilizer member 860 may be
moved though catch 820 in order to snugly fit the ablation assembly
around the atria. This may involve a longer section of distal
ablation member 830 being inserted into receiving slot 840. By
administering ablative energy through the ablation system and to
the heart, an operator can use ablation system 800 to produce a
circular, elliptical, or closed ablation pattern or lesion on the
small atria.
[0130] FIG. 8E provides a partial view of ablation system 800.
Catch 820 is shown without the distal end of flexible bracing 810
inserted therein. In this embodiment, ablation member section 880
is partial recessed or disposed within a receptacle or slot 850
flexible bracing 860. Receiving slot 840 is shown without a distal
section of peel out electrode 830 inserted therein. Ablation member
880 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).
[0131] Referring now to FIG. 9A, in some embodiments an ablation
system 900 includes a flexible device which includes an encircling
mechanism 905 having a breakaway tip 930, a slit 950, and a living
hinge 980. Ablation system 900 also includes an ablation member 920
in operative association with a stabilizer member. As shown in FIG.
9B, ablation system 900 can be extended around a large atrium of a
patient. In use, a surgeon can insert a stiffening probe 995 into a
distal end 912 of stabilizer member 910. By manipulating distal end
912 of stabilizer member 910, or by adjusting proximal end 914 of
stabilizer member 910 relative to encircling mechanism 905, an
operator can activate hinge 980 and move breakaway tip 930 toward
the atrium. This pushing action causes breakaway tip 930 to move
away from a portion 960 of the stabilizer member that is located on
the opposing side of slit 950. Hence, breakaway tip 930 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, slit 950 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 in FIG.
9C, an operator can use ablation system 900 to apply ablative
energy to a small atrium, in a similar fashion. Stiffening probe
995 can be pushed farther toward the heart, in the direction
indicated by arrow A, which can cause the expansion of a wider
angle defined by slit 950, as hinge 980 opens further and breakaway
tip 930 moves more distally along ablation member 920, as indicated
by arrow B. Hence, breakaway tip 950 can move closer to the atrium,
and ablation member 920 can snugly fit against the atrium. In some
cases, it may be desirable to move proximal end 914 of the
stabilizer member in the direction indicated by arrow C, which can
also effectively move breakaway tip 930 more distally along
ablation member 920, as indicated by arrow B. Optionally, the
surgeon or operator can move distal portion 912 in the direction
indicated by arrow D, or proximal portion 914 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 a loop structure 911 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.
[0132] FIG. 9D provides a close-up view of encircling mechanism 905
of the ablation system, which includes breakaway tip 930, slit 950,
and living hinge 980. In some embodiments, ablation member 920
extends to the distal end or nearly to the distal end of breakaway
tip 930. By manipulating aspects of the system, such the distal end
or the proximal end of an ablation assembly, an operator can adjust
an angle .alpha. of defined by slit 950. 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.
[0133] FIGS. 10A to 10F show partial views of an ablation system
1000 according to embodiments of the present invention. As shown in
FIG. 10A, ablation system 1000 includes a stabilizer member 1010
having a slit 1011, and an ablation member 1020 disposed within a
recess 1012 of the stabilizer member. The stabilizer member also
includes a breakaway tip portion 1014 and a trunk portion or tether
band 1016, whereby the breakaway tip is separated from the trunk
portion by slit 1011. Trunk portion 1016 may be reinforced with a
braid or ribbon material. The ablation system also includes a
retractable sleeve 1030, which can act to constrain or keep
breakaway tip 1014 in close proximity with trunk 1016. Stabilizer
member 1010 can be constructed so that breakaway tip 1014 is biased
to separate or extend laterally from trunk 1016. Hence, as shown in
FIG. 10B, when the retractable sleeve is moved to fully expose slip
1011, breakaway tip 1014 can move or spring away from trunk 1016,
as indicated by arrow A. In this way, breakaway tip 1014 can adopt
a natural or relaxed configuration, whereas breakaway tip 1014 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 and FIG. 10D represents a concentric
positioning that remains in the same plane. As shown in FIG. 10E,
an operator can wrap ablation system 1000 around a patient tissue
or organ 1050 when the sleeve is in an advanced position and
breakaway tip is in the constrained configuration. As shown in FIG.
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.
[0134] As shown in FIGS. 10E and 10F, an operator can use ablation
system 1000 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.
[0135] FIGS. 11A to 11C illustrate aspects of an ablation system
according to embodiments of the present invention. As shown in FIG.
11A, ablation system 1100 includes an ablation member 1110 in
operative association with a stabilizer member 1120. Ablation
member 1110 extends through a first port 1124 of stabilizer member,
along a first recess 1122 of stabilizer member 1120. Stabilizer
member 1120 includes a breakaway tip 1125, and a catch 1126 that is
configured to releasably hold the breakaway tip. Breakaway tip 1125
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 a second recess 1123 of
stabilizer member 1120, as indicated by arrow A. Stabilizer member
1120 may include one or more pressure lines 1127, 1128, which can
be constructed in fluid communication with second recess 1123 via
one or more ports 1123a, 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 seal first recess 1122 with a patient
tissue. Similarly, an operator may apply a vacuum via a pressure
line so as to help seal second recess 1123 with a patient tissue,
or with breakaway tip 1125, or both.
[0136] As shown in FIG. 11B, ablation system 1100 can be extended
around a large atrium of a patient. In use, a surgeon can
manipulate a distal end 1130 of stabilizer member 1120, a proximal
end 1140 of stabilizer member 1120, or both. By manipulating distal
end 1130 of stabilizer member 1120, or by adjusting proximal end
1140 of stabilizer member 1120, an operator can move breakaway tip
1125 toward the atrium. In this way, an operator can urge breakaway
tip 1125 to bridge a gap that may exist between ablation member
1110 and the tissue surface of the atrium, thereby allowing the
ablation member to approximately encircle the tissue. As shown
here, a distal portion of breakaway tip 1125 inserts into or is
placed in close proximity with first recess 1123. 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 in FIG. 11C, an
operator can use ablation system 1100 to apply ablative energy to a
small atrium, in a similar fashion. Distal section 1130 can be
pushed farther toward the heart, in the direction indicated by
arrow A, which can cause breakaway tip 1125 to move more distally
along ablation member 1110, as indicated by arrow B. Hence,
breakaway tip 1125 can move closer to the atrium, and ablation
member 1110 can snugly fit against the atrium. In some cases, it
may be desirable to move proximal end 1140 of the stabilizer member
in the direction indicated by arrow C, which can also effectively
move breakaway tip 1125 more distally along ablation member 1110,
as indicated by arrow B. Optionally, the surgeon or operator can
move distal portion 1130 in the direction indicated by arrow D, or
proximal portion 1140 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 a loop
structure 1111 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.
[0137] FIGS. 12A to 12C illustrate aspects of an ablation system
according to embodiments of the present invention. As shown in FIG.
12A, ablation system 1200 includes an ablation member 1210 in
operative association with a stabilizer member 1220. Ablation
member 1210 extends along a recess 1222 of stabilizer member 1220.
Stabilizer member 1220 includes a breakaway tip 1225, and a catch
1226 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 tip 1225 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 or more
connection mechanisms 1225a, such as suction cups. Stabilizer
member 1220 may also include a flexible platform 1221 that can be
wrapped around the body 1220a of the stabilizer member as shown in
FIG. 12A, or that can be unwrapped and extended away from the body
of the stabilizer member, as shown in FIGS. 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 disengage breakaway tip 1225 from
catch 1226, unwrap platform 1221 from body 1220a, and engage
breakaway tip 1225 with platform 1221. For example, the breakaway
tip can be suctioned onto or coupled with the platform with a
connection mechanism.
[0138] As shown in FIG. 12B, ablation system 1200 can be extended
around a tissue or organ 1205 of a patient. In use, a surgeon can
manipulate a distal portion 1230 of stabilizer member 1220, a
proximal portion 1240 of stabilizer member 1220, or both. By
manipulating distal portion 1230 of stabilizer member 1220, or by
adjusting proximal portion 1240 of stabilizer member 1220, an
operator can move breakaway tip 1225 toward the patient organ or
tissue. In this way, an operator can urge breakaway tip 1225 to
bridge a gap that may exist between ablation member 1210 and the
tissue surface, thereby allowing the ablation member to
approximately encircle the tissue. As shown here, a distal portion
of breakaway tip 1225 can be moved toward a proximal portion 1210a
of the ablation member. When making such adjustments of the
ablation assembly, the connection mechanism may or may not maintain
contact with the platform.
[0139] As shown in FIG. 12C, distal section 1230 can be moved in
the direction indicated by arrow A, which can cause breakaway tip
1225 to move more distally along ablation member 1210 or to move
closer to proximal portion 1210a of ablation member, as indicated
by arrow B. Hence, breakaway tip 1225 can move closer to the
patient tissue, and ablation member 1210 can snugly fit against the
tissue. In some cases, it may be desirable to move proximal end
1240 of the stabilizer member in the direction indicated by arrow
C, which can also effectively move breakaway tip 1225 more distally
along ablation member 1210 or closer to proximal portion 1210a of
ablation member, as indicated by arrow B. Optionally, the surgeon
or operator can move distal portion 1230 in the direction indicated
by arrow D, or proximal portion 1240 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 a loop structure 1211 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 of distal portion 1230
and proximal portion 1240 may be reversed, as compared with the
operational or configurations described above.
[0140] 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 the FIG. 13A cross section, ablation system 1300a includes
an ablation member 1310a in operative association with a stabilizer
member 1320a. Ablation member 1310a extends along a recess of
stabilizer member 1320a, disposed at least partially between a
sidewalls 1324a and an opposing sidewall (not shown) of the
stabilizer member. Recess 1323a is formed by the opposing sidewalls
and body 1325a of stabilizer member 1320a. The stabilizer shape is
similar to the stabilizer shape shown in FIG. 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 member 1320a can include or be coupled
with, for example with a glue or adhesive, one or more loops 1321a
which secure ablation member 1310a relative to stabilizer member
1320a. 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 at 1320a', 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 of stabilizer member 1320a
presents 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. In FIG. 13A this is depicted as all gaps are shown nearly
closed. If curved portion of 1320a were 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
to FIG. 72.
[0141] As shown in the FIG. 13B cross section, ablation system
1300b includes a stabilizer member 1320b, which has a recess 1323b
that can at least partially receive an ablation member. Three-sided
recess 1323b is formed by body 1325b of stabilizer member 1320b, by
side wall 1324b, and by another side wall (not shown in the section
view) opposing side wall 1324b. FIG. 13B shows two bladder features
1301b, 1302b that include individual chambers 1303b, 1304b
connected by a lumen. A first bladder feature 1301b is in a
straight section of the stabilizer and a second bladder feature
1302b is 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 in
FIG. 13B, the straight section can be deflated or under negative
pressure while the curved one is inflated. The thin, flexible,
accordionated outer wall 1305b, 1306b of 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.
[0142] As shown in FIG. 13C, ablation system 1300c includes a
stabilizer member 1320c, which has a recess 1323c that can at least
partially receive an ablation member. Recess 1323c is formed by
opposing sidewalls and body 1325c of stabilizer member 1320c. The
opposing sidewalls can include sidewall 1324c and another side wall
(not shown in the section view) opposing sidewall 1324c. 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 in FIG. 13C, the ablation system can include a bond spot
1340c where 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.
[0143] FIG. 14A depicts an ablation system 1400a having a
stabilizer member 1420a that at least partially houses an ablation
member 1410a. As shown here, when stabilizer member 1420a bends it
may form a bow or buckle 1420a'. 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 an ablation system 1400b having a
stabilizer member 1420b that at least partially houses an ablation
member 1410b. In some embodiments, ablation member 1410b is
disposed within a recess 1423a which is formed by opposing
sidewalls 1424a and body 1425a of stabilizer member 1420a. As shown
here, stabilizer member 1420b includes a section 1420b' that
exhibits little or no bowing or buckling when the stabilizer member
bends. For example, section 1420b' may be heat treated or formed,
or provided with a shape memory, so that when the ablation system
is bent, section 1420b' 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 an ablation system 1500
having a stabilizer member 1520 that at least partially houses an
ablation member 1510 within sidewalls 1524 of the stabilizer
member. In some embodiments, ablation member 1510 is disposed
within a recess 1523 which is formed by opposing sidewalls 1524 and
body 1525 of stabilizer member 1520. As shown here, stabilizer
member 1520 includes a section 1520' that exhibits little or no
bowing or buckling when the stabilizer member bends. For example,
section 1520' includes sidewall flaps 1524' which can overlap when
the stabilizer member bends. Hence, when the ablation system is
bent, section 1520' 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.
[0144] FIGS. 16A to 16C depict an ablation system 1600 having a
stabilizer member 1620 that at least partially houses an ablation
member 1610 within sidewalls 1624 of the stabilizer member. In some
embodiments, ablation member 1610 is disposed within a recess 1623
which is formed by opposing sidewalls 1624 and body 1625 of
stabilizer member 1620. As shown here, stabilizer member 1620
includes a section 1620' that exhibits little or no bowing or
buckling when the stabilizer member bends. For example, section
1620' includes a flexible spine or backbone having alternating
protrusions 1626 and indentions 1627 that allow section 1620' to
flex through a range of motion when the stabilizer member bends.
Hence, when the ablation system is bent, section 1620' presents a
curved shape that conforms to a tissue contour and does not fold or
collapse, or otherwise warp. FIG. 16B illustrates stabilizer member
1620 in a straightened configuration. The flexible spine 1628 of
the stabilizer member presents a serpentine profile, as shown in
the cross section of FIG. 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. In FIGS. 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.
[0145] FIGS. 17A to 17F show aspects of an ablation system 1700
according to embodiments of the present invention. As depicted in
FIG. 17A, ablation system 1700 includes an ablation assembly 1715
having a stabilizer member 1720 in operative association with an
ablation member 1710. Ablation system 1700 also includes a cinching
device 1730. Cinching device 1730 can have one or more guides
1750a, 1750b, and can be used in operative association with an
ablation assembly 1715 having an ablation member 1710 and a
stabilizer member 1720. Cinching device 1730 can also include an
ablation member protection mechanism 1731 which can be disposed
between portions 1770 and 1771 of ablation assembly 1715. 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 or more guides 1750a, 1750b of cinching device
1730 may include a flat or curved retaining wall perpendicularly
attached to, or formed along with, a support 1752 of cinching
device 1730. Accordingly, cinching device 1730 can present a pair
of channels 1753a, 1753b that can receive the ablation assembly.
For example, channel 1753a is disposed between guide 1750a and
ablation member protection mechanism 1731, and channel 1753b is
disposed between guide 1750b and ablation member protection
mechanism 1731. This feature is also illustrated in FIG. 17C, which
depicts a cross section of cinching device corresponding to C-C of
FIG. 17B.
[0146] In some embodiments, one or more guides 1750a, 1750b may
have a curved top edge. The shape of guides 1750 can be designed in
order to help facilitate positioning an ablation assembly 1715
around or against a patient cardiac tissue, which may include one
or more pulmonary veins PV, by keeping distal 1715a and proximal
1715b segments of the ablation member close to each other, as shown
in FIG. 17D. In an embodiment with two or more guides, the guides
may be located on opposite sides of a support plate of cinching
device 1730.
[0147] In one method for using the cinching device 1730 with
guides, ablation assembly 1715 can be passed through the cinching
device along one guide 1750a as depicted by arrow A in FIG. 17B and
wrapped around the patient tissue. The ablation assembly can then
be pulled through cinching device 1730 in the opposed direction as
indicated by arrow B, passing along another guide 1750b. The guides
may be made of or include various semi-rigid or rigid materials.
Cinching device 1730, which may be used as a pusher or a guide
handle, can be advanced in a direction toward the patient tissue
705b as indicated by arrow D, so as to decrease the circumference
of a loop structure 1745 formed by ablation assembly 1715, and to
increase the amount of contact between the ablation member 1710 and
the patient tissue 1705 or to help secure the position of ablation
member 1710 relative to patient tissue 1705. Similarly, by
advancing cinching device 1730 in this direction, an operator can
increase the amount of contact between an ablation segment 1735 of
the cinching device and the patient tissue 1705 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 and distal sections 1715c, 1715d of
ablation assembly 1715 in an opposing direction, as indicated by
arrows E and F, respectively.
[0148] In some embodiments, as cinching device 1730 is advanced
towards the patient tissue 1705, a loop structure 1745 of the
ablation assembly 1715 is reduced in diameter or otherwise
contracted. As shown in FIGS. 17B and 17D, for example, in some
embodiments an ablation member protection mechanism 1731 can be
utilized along with the cinching device 1730. Cinching device 1730
can include ablation member protection mechanism 1731 disposed
toward the center of device 1730, optionally between guides 1750a,
1750b. Ablation member protection mechanism 1731 can operate to
keep a first segment 1710a and a second segment 1710b of the
ablation member from making contact with each other. Ablation
member protection mechanism 1731 may either be fixed or integral to
cinching device 1730 or separate from cinching device 1730. In some
embodiments, an ablation segment 1735, which may include an
electrode or an energy transmission element, can be attached with
cinching device 1730. For example, ablation segment 1735 can be
coupled with or part of a first or distal section 1731a of ablation
member protection mechanism 1731. Ablation segment 1735 can be
utilized to increase the amount of contact between the ablation
assembly 1715 and the patient tissue 1705. Ablation segment 1735
can also be utilized to reduce pinching of the patient tissue 1705
that might otherwise occur if ablation segment 1735 were not
disposed between opposing segments of ablation member 1710. The
operator can position ablation assembly 1715 to make contact with
selected parts of patient tissue 1705 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.
[0149] In this way, energy can be applied by the ablation system to
the tissue. The position of cinching device 1730 relative to
ablation assembly 1715 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 segment 1735 in combination with ablation member 1710 can
form a continuous or closed circumferential loop that can be used
to ablate a circumferential lesion on the patient tissue. In FIG.
17B ablation segment 1735 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 segment
1735 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.
[0150] FIG. 17B shows a perspective view of cinching device 1730
which includes ablation member protection mechanism 1731, guides
1750a, 1750b, ablation segment 1735, and handle 1739. In some
cases, handle 1739 of cinching device 1730 may include a bent or
offset portion 1738. As shown in FIG. 17F, in some embodiments
cinching device 1730 can be folded or rolled into a compact
configuration. FIG. 17F corresponds to the view presented in FIG.
17C, except that in FIG. 17F the device is folded. Device 1730
includes ablation member protection mechanism 1731, guides 1750a,
1750b, and support 1752. As illustrated in FIG. 17D, in some cases
the ablation system may also include a trocar 1780 having a sleeve
1782 coupled with a flange 1784. 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
within channels 1753a, 1753b of the cinching device. FIG. 17E shows
a cross section of trocar sleeve 1782. In some cases, trocar sleeve
1782a can have a first dimension W that is about 25 mm, and a
second dimension H that is about 10 mm.
[0151] FIGS. 18A to 18E show aspects of an ablation system
according to embodiments of the present invention. As depicted in
FIG. 18A, an ablation system 1800 includes an ablation assembly
1810 having an ablation member 1820 coupled with a stabilizer
member 1830, a first port 1840, and a second port 1850. Ablation
member 1820 can include an electrode and stabilizer member 1830 can
include a bladder, according to some embodiments. In use, an
operator can advance a distal portion 1812 of the ablation assembly
through first port 1840 as indicated by arrow A, around a patient
tissue 1805 as indicated by arrow B, and toward second port 1850 as
indicated by arrow C. The patient tissue can encompass cardiac
tissue which may also include one or more pulmonary veins (PV).
Stabilizer member 1830 includes a proximal living hinge 1832
disposed toward a proximal portion 1834 of the stabilizer member,
and a distal living hinge 1836 disposed toward a distal portion
1838 of the stabilizer member. Stabilizer member 1830 may also
include a stiff tube section 1839 disposed toward distal portion
1838. FIG. 18B shows another view of ablation system 1800, which
can include a proximal handle 1816 disposed toward a proximal end
1814 of the ablation assembly. In use, an operator can move handle
1816 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 end 1812 of
the ablation assembly can be advanced through second port 1850.
[0152] FIG. 18C provides an illustration of ablation system 1800.
In use, an operator can contact distal end 1812 of the ablation
assembly with a distal handle or obturator 1818. For example,
distal handle 1818 or stiffening probe can be advanced into a
recess, channel, or other lumen or passage of the distal end 1812,
as indicated by arrow F. An operator can manipulate the distal
handle so as to activate distal living hinge 1836, thereby bringing
a distal section 1822 of the ablation member toward a proximal
section 1824 of the ablation member, as indicated by arrow G. As
shown in FIG. 18D, an operator can also manipulate proximal handle
1816 so as to activate proximal living hinge 1832, thereby bringing
proximal section 1824 of the ablation member toward distal section
1822 of the ablation member, as indicated by arrow H. Hence, the
operator can form a loop structure 1845 with the ablation assembly,
about the patient tissue. Optionally, the operator may move
proximal handle 1816 away from the tissue as indicated by arrow M,
or distal handle 1818 away from the tissue as indicated by arrow N,
so as to bring a distal portion 1845a of the loop structure snug
against the patient tissue, as indicated by arrow O. In some cases,
an operator can manipulate proximal handle 1816, distal handle
1818, or both, as depicted in FIG. 18E, so as to further activate
proximal living hinge 1832, distal living hinge 1836, or both, so
as to dilate or contract loop structure 1845. For example, ablation
member distal portion 1822 can be moved along the loop structure in
a first direction as indicated by arrow I, for example by moving
distal handle 1818 in the direction indicated by arrow L, and
ablation member proximal portion 1824 can be moved along the loop
structure in a second opposing direction as indicated by arrow J,
for example by moving proximal handle 1816 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. Handle 1818 can be easily withdrawn through
second port 1850. 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.
[0153] FIGS. 19A to 19E show aspects of an ablation system
according to embodiments of the present invention. As depicted in
FIG. 19A, an ablation system 1900 can include an ablation assembly
1910 having an ablation member 1920 and a stabilizer member 1930.
Ablation member 1920 can include an electrode and stabilizer member
1930 can include a bladder, according to some embodiments. Ablation
system 1900 also includes a cinching member 1940 having a proximal
handle 1942, an intermediate shaft 1944, and a distal ablation
segment or tip electrode 1946. Cinching member 1940 also includes
one or more collapsible rollers or guides 1950a, 1950b. As shown
here, guides 1950a, 1950b are in an expanded configuration, and are
coupled with a distal support 1948 of the cinching member.
Optionally, guides 1950a, 1950b can be coupled with distal support
1948 via pivots 1960a, 1960b, respectively, such that guide 1950a
can move in an arc as indicated by arrow A, and guide 1950b can
move in an arc as indicated by arrow B. Cinching member 1940
presents a first passage or channel 1940a disposed between first
guide 1950a and distal support 1948, and a second passage or
channel 1940b disposed between second guide 1950b and distal
support 1948. In use, an operator can advance a distal portion 1912
of the ablation assembly through first passage 1940a as indicated
by arrow C, around a patient tissue 1905 as indicated by arrow D,
and through second passage 1940b as indicated by arrow E. An
operator can adjust the positioning or tightness of a loop
structure 1945 formed by the ablation assembly, by advancing
cinching member 1940 toward the patient tissue as indicated by
arrow F, by pulling a proximal section 1914 of the ablation
assembly away from the patient tissue as indicated by arrow G, and
by pulling distal section 1912 of the ablation assembly away from
the patient tissue as indicated by arrow H.
[0154] FIG. 19B illustrates cinching member 1940 partially disposed
within a trocar 1970. Guides 1950a, 1950b of 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, guides 1950a, 1950b can be collapsed such that they are
disposed toward the distal end of the cinching member (not shown).
First guide 1950a is coupled with first pivot 1960a via a first arm
1955a. Second guide 1950b is coupled with second pivot 1960b via a
second arm 1955b. 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 in FIG. 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 a distal end 1976 of the trocar,
guides 1950a, 1950b can expand laterally toward an open or extended
configuration. When the operator pulls cinching member 1940 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 shows trocar 1970 having a flange section 1972 and a shaft
section 1974. FIG. 19D shows a cross section of shaft section 1974.
In some embodiments, shaft section 1974 has a first dimension W of
about 25 mm, and a second dimension H of about 10 mm. FIG. 19E
shows another view of cinching member 1940 according to embodiments
of the present invention. Second guide 1950b is coupled with second
pivot 1960b via a second arm 1955b. As depicted here, intermediate
shaft 1944 includes an offset bend or S-curve 1943. Such a bend
configuration in the intermediate shaft of the cinching member can
allow an operator to grasp and pull an ablation assembly 1910 that
is disposed at or near the intermediate shaft 1944 or handle 1942,
without interfering with the shaft or handle. In some cases, handle
1942 includes a plug in 1942a for providing energy to tip electrode
or distal ablation segment 1946. FIG. 19F shows a cross section of
a trocar 1980 according to some embodiments. In some instances,
trocar 1980 can have a diameter of about 10 mm.
[0155] FIGS. 20A-B, 21A-B, 22A-B, 23A-B, 24A-C, 25A-B, 26A-B, and
27 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.
[0156] FIGS. 20A and 20B illustrate aspects of an ablation assembly
according to embodiments of the present invention. As seen in the
cross section view of FIG. 20A, ablation assembly 2000 includes a
stabilizer member 2010 having a body 2012 and opposing sidewalls
2014, 2016. Stabilizer member 2010 presents a channel or recess
2018 that is bordered by body 2012 and sidewalls or side bars 2014,
2016. Ablation assembly 2000 also includes an ablation member 2020
disposed at least partially within channel 2018. As seen in the
perspective view of FIG. 20B, an outer surface 2012a of stabilizer
member body 2012 includes a plurality of notches 2012b and teeth
2012c. Optionally, the sidewalls may include a depression or
section where the length of the sidewall is reduced. For example,
sidewall 2016 can include a depression 2016a. This carve-out
portion 2016a presents a reduced height:width ratio for the
stabilizer member cross section.
[0157] FIGS. 21A and 21B illustrate aspects of an ablation assembly
according to embodiments of the present invention. As seen in the
cross section view of FIG. 21A, ablation assembly 2100 includes a
stabilizer member 2110 having a body 2112 and opposing sidewalls
2114, 2116. Stabilizer member 2110 presents a channel or recess
2118 that is bordered by body 2112 and sidewalls or side bars 2114,
2116. Ablation assembly 2000 also includes an ablation member 2120
disposed at least partially within channel 2118. As seen in the
perspective view of FIG. 21B, an outer surface 2012a of stabilizer
member body 2012 provides a flat profile. Optionally, the sidewalls
may include a depression or section where the length of the
sidewall is reduced. For example, sidewall 2116 can include a
depression 2116a. This carve-out portion 2116a presents a reduced
height:width ratio for the stabilizer member cross section.
[0158] FIGS. 22A and 22B illustrate aspects of an ablation assembly
according to embodiments of the present invention. As seen in the
cross section view of FIG. 22A, ablation assembly 2200 includes a
stabilizer member 2210 having a body 2212 and opposing sidewalls
2214, 2216. Stabilizer member 2210 presents a channel or recess
2218 that is bordered by body 2212 and sidewalls or side bars 2214,
2216. Ablation assembly 2200 also includes an ablation member 2220
disposed at least partially within channel 2218. As seen in the
perspective view of FIG. 22B, an outer surface 2212a of stabilizer
member body 2212 includes a plurality of molded thin elastic
windows 2212a that are substantially coplanar with the profile of
body 2210. Outer surface 2212a also includes a plurality of support
ribs 2212b. Optionally, the sidewalls may include a depression or
section where the length of the sidewall is reduced. For example,
sidewall 2216 can include a depression 2216a. This carve-out
portion 2216a presents a reduced height:width ratio for the
stabilizer member cross section.
[0159] Sidewalls 2214, 2216 can also include or be coupled with
tension straps 2217, 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.
[0160] FIGS. 23A and 23B illustrate aspects of an ablation assembly
according to embodiments of the present invention. As seen in the
cross section view of FIG. 23A, ablation assembly 2300 includes a
stabilizer member 2310 having a body 2312 and opposing sidewalls
2314, 2316. Stabilizer member 2310 presents a channel or recess
2318 that is bordered by body 2312 and sidewalls or side bars 2314,
2316. Ablation assembly 2300 also includes an ablation member 2320
disposed at least partially within channel 2318. As seen in the
perspective view of FIG. 23B, an outer surface 2312a of stabilizer
member body 2312 includes a plurality of molded thin elastic
windows 2312a that extend or puff away from the recess 2318, and a
plurality of support ribs 2312b. Sidewalls 2314, 2216 can include
ridges 2313, 2315 which contain or are coupled with tension cords
2317, 2319, respectively. As shown here, the tension cords are
disposed within the sidewall ridges. In some embodiments, ridges
2313, 2315 are disposed at a neutral bending plane. Accordingly,
the center of mass of the stabilizer member can be aligned with the
probe.
[0161] FIGS. 24A to 24C illustrate aspects of an ablation assembly
according to embodiments of the present invention. As seen in the
cross section view of FIG. 24A, ablation assembly 2400 includes a
stabilizer member 2410 having a body 2412 and opposing sidewalls
2414, 2416. Stabilizer member 2410 presents a channel or recess
2418 that is bordered by body 2412 and sidewalls or side bars 2414,
2416. Ablation assembly 2400 also includes an ablation member 2420
disposed at least partially within channel 2418. As seen in the
perspective view of FIG. 24B, an outer portion 2412a of stabilizer
member body 2412 includes a plurality of molded thin elastic
windows 2412a that extend or are biased inward toward the recess
2418, and a plurality of support ribs 2412b. Sidewalls 2414, 2416
can include ridges 2413, 2415 which contain or are coupled with
tension cords 2417, 2419, respectively. As shown here, the tension
cords are disposed within the sidewall ridges. As seen in FIG. 24C,
the stabilizer member can be bent under tension. The stabilizer
member can have elastic features on the backbone.
[0162] FIGS. 25A and 25B illustrate aspects of an ablation assembly
according to embodiments of the present invention. As seen in the
perspective view of FIG. 25A, ablation assembly 2500 includes a
stabilizer member 2510 having a body 2512 and opposing sidewalls
2514, 2516. Stabilizer member 2510 presents a channel or recess
2518 that is bordered by body 2512 and sidewalls or side bars 2514,
2516. An outer portion 2512a of stabilizer member body 2512
includes a plurality of molded thin elastic windows 2512a that
extend or are biased away from the recess 2518, and a plurality of
support ribs 2512b. Ablation assembly 2500 presents a low neutral
bending zone 2530. 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 shows ablation
assembly 2500 in a bent or curved configuration. As seen in FIG.
25B, the stabilizer member can be bent under tension. Elastic
membrane windows 2512a are 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.
[0163] FIGS. 26A and 26B illustrate aspects of an ablation assembly
according to embodiments of the present invention. As seen in the
perspective view of FIG. 26A, ablation assembly 2600 includes a
stabilizer member 2610 having a body 2612 and opposing sidewalls
2614, 2616. Stabilizer member 2610 presents a channel or recess
2618 that is bordered by body 2612 and sidewalls or side bars 2614,
2616. An outer portion 2612a of stabilizer member body 2612
includes a plurality of molded thin elastic windows 2612a that
extend or puff away from the recess 2618, and a plurality of
support ribs 2612b. Sidewalls 2614, 2616 can include ridges 2613,
2615 which contain or are coupled with tension cords 2617, 2619,
respectively. As shown here, the tension cords are disposed within
the sidewall ridges. Ablation assembly 2600 presents a bend plane
2630 that is low, at the level of the tension cords. FIG. 26B shows
ablation assembly 2600 in a bent or curved configuration. As seen
in FIG. 26B, the stabilizer member can be bent under tension.
Elastic membrane windows 2612a are 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. In FIG. 27, the 3-4 bubbles on the
right side are pushed into this shape by tissue.
[0164] FIGS. 28A to 28C show aspects of an ablation system
according to embodiments of the present invention. FIG. 28A shows
ablation system 2800 having a distal end 2810, a catch or belt loop
2820, an ablation member 2830, a stabilizer member 2840, a trocar
2850, and a proximal end 2870. In some embodiments, trocar or
introducer 2850 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 of ablation system 2800, where
distal end 2810 is disposed in trocar 2850 and catch 2820. As
depicted in FIG. 28C, ablation system 2800 can be disposed about a
patient tissue, such as a heart 2860 and pulmonary veins (PV). With
a more detailed reference now to FIG. 28A, ablation system 2800
includes a flexible ablation member 2830, an encircling mechanism
or catch 2820 such as a belt loop, a hook, a closable clasp, or the
like, and a flexible stabilizer member or bracing 2840 having a
distal end 2842, a proximal end 2844, and a recessed receiving slot
or receptacle 2846. Ablation member 2830 is disposed at least
partially within receptacle 2846. The combination of the ablation
member and the stabilizer member can collectively be referred to as
an ablation assembly 2890. In use, an operator may treat a patient
by wrapping a loop structure 2811 of the ablation system around
pulmonary veins of a patient. This may involve passing distal end
2810 circumferentially around the tissue as indicated arrow A, and
through trocar 2850 and catch 2820 as indicated by arrow B in FIG.
28B. In this way, the ablation system can form a lasso about the
patient tissue. The operator may expand or contract loop structure
2811 of ablation system 2800 by manipulating distal end 2810,
proximal end 2870, or trocar 2850. Moving distal end 2810 in
direction C, as shown in FIG. 28C, results in contraction of loop
structure 2811 of ablation system 2800 in a cinching fashion.
Moving distal end 2810 in direction D results in expansion of loop
structure 2811 of ablation system 2800. In this way, the operator
can adjust the sizing of loop structure 2811 to accommodate any of
a variety of anatomical configurations in the patient tissue. As
shown here, loop structure 2811 can be adjusted to settle securely
and snugly around the pulmonary veins. Stabilizer member 2840 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.
[0165] In some embodiments of use, a surgeon or operator can pass
stabilizer member distal end 2810 through catch 2820, and expand or
contract ablation system 2800 by manipulating the proximal end
2870. Moving proximal end 2870 in direction E results in
contraction of loop structure 2811 of ablation system 2800 in a
cinching fashion. Moving proximal end 2870 in direction F results
in expansion of loop structure 2811 of ablation system 2800. Catch
2820 is typically formed so that it can receive distal end 2810 and
maintain the position of a portion of distal end 2810 relative to a
portion of proximal end 2870. Catch 2820 may include a loop, a
hook, an aperture, an eyelet, a channel, a recess, or the like. As
shown in FIGS. 28A to 28C, catch 2820 can be integral with proximal
end 2870. In some embodiments, catch 2820 is coupled with proximal
end 2870. In some embodiments, a catch is coupled with or integral
to distal end 2810, and adapted to receive proximal end 2870
therethrough.
[0166] As shown in FIG. 28C, a surgeon or operator can advance
catch 2820 through trocar 2850, so that catch 2820 is disposed on a
distal side of trocar 2850. Ablation member 2830 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 wherein distal end 2810 is
threaded or passed through catch 2820.
[0167] FIGS. 29A to 29C show aspects of an ablation system
according to embodiments of the present invention. FIG. 29A shows
ablation system 2900 having a distal end 2910, a catch or belt loop
2920, an ablation member 2930, a stabilizer member 2940, a distal
or grasping element 2950, and a proximal end 2970. A pair of
forceps can be used to grab the distal element. Ablation system
2900 can be introduced toward a patient tissue via a first port
2902, and the forceps 2955 can be introduced toward the ablation
system via a second port 2904. FIG. 29B shows another view of
ablation system 2900, where distal end 2910 is attached with
proximal end 2970 via catch 2920. A pair of forceps can be used to
hook the catch over the proximal end. As depicted in FIG. 29C,
ablation system 2900 can be disposed about a patient tissue, such
as a heart 2960 and pulmonary veins (PV), and can include a sleeve
2980. Proximal end 2970 can be pulled in one direction, and sleeve
2980 can be pushed in an opposing direction, so as to tighten the
ablation assembly about a patient tissue. With a more detailed
reference now to FIGS. 29A and 29B, ablation system 2900 includes a
flexible ablation member 2930, an encircling mechanism or catch
2920 such as a belt loop, a hook, a closable clasp, or the like,
and a flexible stabilizer member or bracing 2940 having a distal
end 2942, a proximal end 2970, and a recessed receiving slot or
receptacle 2946. Ablation member 2930 is disposed at least
partially within receptacle 2946. The combination of the ablation
member and the stabilizer member can collectively be referred to as
an ablation assembly 2990. In use, an operator may treat a patient
by wrapping a loop structure 2911 of the ablation system around
pulmonary veins of a patient. This may involve passing distal end
2910 circumferentially around the tissue as indicated arrow A, and
securing catch 2920 with proximal end 2970.
[0168] The operator can facilitate placement of system 2900 by
engaging or grasping distal element 2950 and maneuvering distal end
2942. In some embodiments, distal element 2950 includes a string or
tape which the operator can grasp with a maneuvering mechanism or
positioning device 2955, such as a pair of forceps. FIGS. 29A and
29B show that distal end 2942 can be advanced or steered as
depicted by arrow B. In this way, ablation system 2900 can be
further wrapped around the patient tissue, so as to encircle or
lasso the tissue. Positioning device 2955 can be introduced into
the patient via a minimally invasive incision. Positioning device
2955 may be used by the operator to grasp distal element 2950 and
maneuver distal end 2942 as desired. As shown in FIG. 29C, an
operator can advance sleeve 2980 along proximal end 2970 toward
distal end 2942 as indicated by arrow C, so as to force catch 2920
along proximal end 2970 toward distal end 2942 as indicated by
arrow D, and thereby cinch or contract loop structure 2911. Hence,
the loop structure can conform with anatomical features of the
heart 2860, so as to provide enhanced lesion continuity.
Conversely, an operator may allow loop structure 2911 to expand or
relax by moving sleeve in a direction opposite of arrow C. In this
way, the operator can adjust the sizing of loop structure 2911 to
accommodate any of a variety of anatomical configurations in the
patient tissue. As shown here, loop structure 2911 can be adjusted
to settle securely and snugly around the pulmonary veins.
Stabilizer member 2940 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.
[0169] In some embodiments of use, a surgeon or operator can pass
stabilizer member distal end 2910 through catch 2920, and expand or
contract ablation system 2900 by manipulating the proximal end
2970. Moving proximal end 2970 in direction E results in
contraction of loop structure 2911 of ablation system 2900 in a
cinching fashion. Moving proximal end 2970 in direction F results
in expansion of loop structure 2911 of ablation system 2900. Catch
2920 is typically formed so that it can receive proximal end 2944
and maintain the position of a portion of distal end 2910 relative
to a portion of proximal end 2970. Catch 2920 may include a loop, a
hook, an aperture, an eyelet, a channel, a recess, or the like. As
shown in FIGS. 29A to 29C, catch 2820 can be integral with distal
end 2942. In some embodiments, catch 2920 is coupled with distal
end 2942. In some embodiments, a catch is coupled with or integral
to proximal end 2970, and adapted to receive distal end 2942
therethrough.
[0170] Ablation member 2930 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 device 2955 may include
opposable jaws, forceps, clamps or any combination or other
suitable means that can be used by surgeon or operator to grasp or
hold distal element 2950. Positioning device 2955 may also be used
to position ablation system 2900 on the heart or reposition
ablation system 2900 to perform ablation in multiple locations on a
heart.
[0171] FIGS. 30A and 30B show aspects of an ablation system
according to embodiments of the present invention. Ablation system
3000 can be wrapped around a patient tissue 3005 of a patient
3005a, such as a heart or other cardiovascular tissue, as indicated
by arrow A. A distal end 3010 of the system can be pulled or passed
through a cinching device 3020, as indicated by arrow B. Ablation
system 3000 can include a flexible ablation assembly 3015, a
cinching device 3020, and a trocar 3007. Ablation assembly 3015 can
be used to deliver energy to the patient tissue 3005 in order to
ablate the tissue. In some embodiments, ablation assembly 3015
includes an ablation member 3016, such as an electrode, coupled
with a stabilizer member or backbone 3017. In some embodiments,
ablation assembly 3015 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 member 3017 includes a flexible backbone member coupled
with the ablation member. An operator can use cinching device 3020
to help increase or modulate the amount of contact between ablation
member 3016 and the patient tissue 3005. FIG. 30B shows a
cross-section view of cinching device 3020, corresponding to the
A-A line depicted in FIG. 30A. Cinching device 3020 may come in
many different configurations and is not limited to those depicted
in the figures. As shown here, cinching device 3020 can include a
tubular member 3022, a proximal flange, 3024, and an internal
divider 3026. Cinching device 3020 can define a first lumen or
passage 3027a and a second lumen or passage 3027b. In some cases,
elements of cinching device 3020 may include insulating or
non-conducting materials.
[0172] In use, an operator can pass or place ablation assembly 3015
through first passage 3027a of cinching device 3020, as indicated
by arrow C. The ablation assembly can then be wrapped around the
patient tissue 3005 as indicated by arrow A, and distal end 3010 of
the ablation assembly can then be pulled back or passed through
second passage 3027b of cinching device 3020, as indicated by arrow
B. As shown here, the ablation member can thus be wrapped around
patient tissue 3005, which may include a heart or other
cardiovascular tissue, and distal end 3010 of the ablation assembly
can be pulled or placed through cinching device 3020 such that
ablation assembly 3015 forms a loop structure 3019.
[0173] Loop structure 3019 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 or control flange 3024 of cinching
device 3020 so as to move the cinching device toward the tissue as
indicated by arrow D. Relatedly, an operator can grasp or control
distal section 3010 of the ablation assembly, a proximal section
3012 of the ablation assembly, or both, so as to positionally fix
ablation assembly 3015 or provide an opposing force to the cinching
operation described above, as indicated by arrows E and F. Cinching
device 3020 can be advanced along ablation assembly 3015 toward or
away from the tissue, so as to increase or decrease contact between
ablation assembly 3015 and patient tissue 3005. When the assembly
is in the desired location, energy can be applied through the
ablation member 3016 of ablation assembly 3015, toward patient
tissue 3005. The operator can position ablation assembly 3015 to
make contact with selected parts of patient tissue 3005 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
cinching device 3020 relative to ablation assembly 3015 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 in FIG. 30A.
[0174] FIG. 31 shows aspects of an ablation system according to
embodiments of the present invention. Ablation system 3100 has a
distal end 3110, a catch or belt loop 3120, an ablation member
3130, a stabilizer member 3140, a distal or grasping element 3150,
and a proximal end 3170. A pair of forceps can be used to grab the
distal element. Ablation system 3100 can be introduced toward a
patient tissue via a first port or trocar 3102, and the forceps
3155 can be introduced toward the ablation system via a second port
or trocar 3104. Distal end 3110 can be attached with proximal end
3170 via catch 3120. A pair of forceps can be used to hook the
catch over the proximal end. Ablation system 3100 can be disposed
about a patient tissue, such as a heart 3160 and pulmonary veins
(PV), and can include a push tube 3180. Proximal end 3170 can be
pulled in one direction, and sleeve 3180 can be pushed in an
opposing direction, so as to tighten the ablation assembly about a
patient tissue. With a more detailed reference now to FIG. 31,
ablation system 3100 includes a flexible ablation member 3130, an
encircling mechanism or catch 3120 such as a belt loop, a hook, a
closable clasp, or the like, and a flexible stabilizer member or
bracing 3140 having a distal end 3142, a proximal end 3144, and a
recessed receiving slot or receptacle 3146. Ablation member 3130 is
disposed at least partially within receptacle 3146. The combination
of the ablation member and the stabilizer member can collectively
be referred to as an ablation assembly 3190. In use, an operator
may treat a patient by wrapping a loop structure 3111 of the
ablation system around pulmonary veins of a patient. This may
involve passing distal end 3110 circumferentially around the tissue
as indicated arrow A, and securing catch 3120 with proximal end
3170.
[0175] The operator can facilitate placement of system 3100 by
engaging or grasping distal element 3150 and maneuvering distal end
3142. In some embodiments, distal element 3150 includes a string or
tape which the operator can grasp with a maneuvering mechanism or
positioning device 3155, such as a pair of forceps. Distal end 3142
can be advanced or steered as depicted by arrow B. In this way,
ablation system 3100 can be further wrapped around the patient
tissue, so as to encircle or lasso the tissue. Positioning device
3155 can be introduced into the patient via a minimally invasive
incision. Positioning device 3155 may be used by the operator to
grasp distal element 3150 and maneuver distal end 3142 as
desired.
[0176] An operator can advance sleeve 3180 along proximal end 3170
toward distal end 3142 as indicated by arrow C, so as to force
catch 3120 along proximal end 3170 toward distal end 3142 as
indicated by arrow D, and thereby cinch or contract loop structure
3111. Conversely, an operator may allow loop structure 3111 to
expand or relax by moving sleeve in a direction opposite of arrow
C. In this way, the operator can adjust the sizing of loop
structure 3111 to accommodate any of a variety of anatomical
configurations in the patient tissue. As shown here, loop structure
3111 can be adjusted to settle securely and snugly around the
pulmonary veins. Stabilizer member 3140 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.
[0177] In some embodiments of use, a surgeon or operator can pass
stabilizer member distal end 3110 through catch 3120, and expand or
contract ablation system 3100 by manipulating the proximal end
3170. Moving proximal end 3170 in direction E results in
contraction of loop structure 3111 of ablation system 3100 in a
cinching fashion. Moving proximal end 3170 in direction F results
in expansion of loop structure 3111 of ablation system 3100. Catch
3120 is typically formed so that it can receive proximal end 3144
and maintain the position of a portion of distal end 3110 relative
to a portion of proximal end 3170. Catch 3120 may include a loop, a
hook, an aperture, an eyelet, a channel, a recess, or the like.
Catch 3120 can be integral with distal end 3142. In some
embodiments, catch 3120 is coupled with distal end 3142. In some
embodiments, a catch is coupled with or integral to proximal end
3170, and adapted to receive distal end 3142 therethrough.
[0178] Ablation member 3130 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 device 3155 may include
opposable jaws, forceps, clamps or any combination or other
suitable means that can be used by surgeon or operator to grasp or
hold distal element 3150. Positioning device 3155 may also be used
to position ablation system 3100 on the heart or reposition
ablation system 3100 to perform ablation in multiple locations on a
heart.
[0179] 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 in FIG. 32A, an ablation
system 3200a can include a flexible ablation assembly 3215a, a
cinching device 3220a, and a trocar 3207a. Ablation assembly 3215a
can be used to deliver energy to the patient tissue in order to
ablate the tissue. In some embodiments, ablation assembly 3215a
includes an ablation member 3216a, such as an electrode, coupled
with a stabilizer member or backbone 3217a. In some embodiments,
ablation assembly 3215a 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 member 3017a includes a flexible backbone member coupled
with the ablation member. An operator can use cinching device 3020a
to help increase or modulate the amount of contact between ablation
member 3016a and the patient tissue. As shown here, cinching device
3220a can include a proximal flange 3222a, a central portion or
moveable center blade 3224a, and a distal portion 3226a which is
adapted to contact the ablation member. Cinching device 3220a, in
combination with trocar 3207a, can define a first lumen or passage
3227a and a second lumen or passage 3228a. In some cases, elements
of cinching device 3220a may include insulating or non-conducting
materials.
[0180] In use, an operator can pass or place ablation assembly
3215a through first passage 3227a of cinching device 3220a, as
indicated by arrow C. The ablation assembly can then be wrapped
around the patient tissue as indicated by arrow A, and distal end
3210a of the ablation assembly can then be pulled back or passed
through second passage 3228a of cinching device 3220a, 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 end 3210a of the ablation assembly,
proximal end 3270a of the ablation assembly, or both, can be pulled
or otherwise positioned such that ablation assembly 3215a forms a
loop structure 3219a about the patient tissue.
[0181] Loop structure 3219a 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 or control flange 3222a of cinching
device 3220a so as to move the cinching device toward the tissue as
indicated by arrow D. Relatedly, an operator can grasp or control
distal section 3210a of the ablation assembly, a proximal section
3270a of the ablation assembly, or both, so as to positionally fix
ablation assembly 3215a or provide an opposing force to the
cinching operation described above, as indicated by arrows E and F.
Accordingly, an operator can engage a distal ablation tip 3218a
with distal portion 3226a, the distal ablation tip 3218a has been
separated from stabilizer member 3217a. Cinching device 3220a can
be advanced along ablation assembly 3215a toward or away from the
tissue, so as to increase or decrease contact between ablation
assembly 3215a and patient tissue 3205a. When the assembly is in
the desired location, energy can be applied through the ablation
member 3216a of ablation assembly 3215a, toward patient tissue
3205a. The operator can position ablation assembly 3215a to make
contact with selected parts of patient tissue 3205a 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 cinching
device 3220a relative to ablation assembly 3215a 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.
[0182] As illustrated in FIG. 32B, an ablation system 3200b can
include a flexible ablation assembly 3215b and a cinching device
3220b. Ablation assembly 3215b can be used to deliver energy to the
patient tissue in order to ablate the tissue. In some embodiments,
ablation assembly 3215b includes an ablation member 3216b, such as
an electrode, coupled with a stabilizer member or backbone 3217b.
As shown here, cinching device 3220b can include a proximal flange
3222b, a central portion or center blade 3224b, and a distal
portion 3226b which is adapted to contact the ablation member. As
shown in FIG. 32C, cinching device 3220b can define a first lumen
or passage 3227b and a second lumen or passage 3228b. A
cross-section of these passages may present a "double-D" profile,
and the cinching device 3220b can be manufactured via an extrusion
procedure.
[0183] In use, an operator can pass or place ablation assembly
3215b through first passage 3227b of cinching device 3220b, as
indicated by arrow C. The ablation assembly can then be wrapped
around the patient tissue as indicated by arrow A, and distal end
3210b of the ablation assembly can then be pulled back or passed
through second passage 3228b of cinching device 3220b, 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 end 3210b of the ablation assembly,
proximal end 3270b of the ablation assembly, or both, can be pulled
or otherwise positioned such that ablation assembly 3215b forms a
loop structure 3219b about the patient tissue.
[0184] Loop structure 3219b 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 or control flange 3222b of cinching
device 3220b so as to move the cinching device toward the tissue as
indicated by arrow D. Relatedly, an operator can grasp or control
distal section 3210b of the ablation assembly, a proximal section
3270b of the ablation assembly, or both, so as to positionally fix
ablation assembly 3215b or provide an opposing force to the
cinching operation described above, as indicated by arrows E and F.
Accordingly, an operator can engage a distal ablation tip 3218a
with distal portion 3226a, the distal ablation tip 3218a has been
separated from stabilizer member 3217a. This separated portion of
ablation member 3216b can be urged toward or against a more
proximal section 3216b' of the ablation member, so as to form a
more circular or circumferential loop structure. As shown here,
distal ablation tip 3218b can be disposed in close proximity with a
more proximal section of the ablation member. In some cases, distal
ablation tip 321b8 includes or is coupled with a distal guide 3213b
having a recess 3212b that is contoured to receive the more
proximal section of the ablation member.
[0185] Cinching device 3220b can be advanced along ablation
assembly 3215b toward or away from the tissue, so as to increase or
decrease contact between ablation assembly 3215b and patient tissue
3205b. The operator can position ablation assembly 3215b and
ablation member 3216b to make contact with selected parts of
patient tissue 3205b 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. The position of cinching device 3220b relative to ablation
assembly 3215b 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 or the ablation member and the patient
tissue.
[0186] As shown in FIG. 32D, as an ablation assembly 3215d is
advanced about a patient tissue 3205d, in the direction indicated
by arrow A, a distal ablation tip 3218d of an ablation member 3216d
remains associated with a stabilizer member 3217d. This is shown at
section D'. Then, as ablation assembly 3215d is advanced further
about the tissue, and into a cinching device 3220d, 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 of distal ablation tip 3218d from
stabilizer member 3217d. This is shown at section D''.
[0187] FIGS. 33A to 33J illustrate aspects of ablation systems
according to embodiments of the present invention. As shown in FIG.
33A, an ablation system 3300 presents a proximal section or end
3302 and a distal section or end 3304. Ablation system 3300
includes an ablation assembly 3315 having an ablation member 3316
and a stabilizer member 3317. Proximal section 3302 includes a
first lumen 3302' configured to receive the ablation member, and a
second lumen 3302'' configured to fluidly couple the stabilizer
member with a suction source. In some embodiments, ablation system
3300 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 a patient tissue 3305. Distal section
3304 may include a distal element 3307 such as a ribbon, or the
like. In use, an operator can facilitate placement of the ablation
system by grasping distal element 3307 and maneuvering a system
distal end 3304. In some embodiments, distal or grasping element
3307 includes a string or tape which the operator can grasp with a
maneuvering mechanism such as a pair of forceps.
[0188] Ablation system 3300 can be cinched about the pulmonary
veins, so as to form an oval or loop shape. For example, a distal
engagement member 3303 such as a ball disposed on distal end 3304
of system 3300 can be advanced toward a proximal engagement member
3308, such as slot or channel, disposed on a more proximal section
3301 of system 3300. In some cases, distal engagement member 3303
can be urged toward slot 3308 by an operator using an introducer
instrument 3310, as shown in FIG. 33B. When distal engagement
member 3303 engages proximal engagement member 3308, 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 structure 3319 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
of distal engagement member 3303 along proximal engagement member
3308 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 configure
ablation system 3300 so as to provide discrete stopping points or
attraction points for distal engagement member 3303 along a length
of proximal engagement member 3308. 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.
[0189] FIGS. 33B and 33C show aspects of an introducer instrument
3310 according to embodiments of the present invention. Introducer
instrument 3310 can include an sleeve 3312, and an obturator 3314
which can be inserted into the sleeve. Sleeve 3312 may have a
distal catch 3313 adapted to releasably couple with a distal
engagement member 3303 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 catch 3313 may
include a recess 3313' that allows a stem 3303' of ball 3303 to
swing or rotate, as indicated by arrow A, which allows ball 3303 to
be directed toward or injected into slot 3308.
[0190] FIG. 33D shows features of a proximal engagement member
3301d according to embodiments of the present invention. Proximal
engagement member 3301d includes a circular aperture 3322d and an
elongate track 3324d. In some embodiments, proximal engagement
member 3301d presents a keyhole and slot configuration. FIG. 33E
shows a cross-section of a proximal portion of an ablation system
3300e, including a body 3340e, a proximal engagement member 3301e,
an ablation member 3316e, and a vacuum lumen 3330e. Body 3340e can
be made of molded silicone, for example, and proximal engagement
member 3301e can be made of a harder material such as polycarbonate
or polypropylene, for example. FIG. 33F shows a cross-section of a
proximal portion body 3340f according to embodiments of the present
invention. Body 3340f can be made of molded silicone, for example.
FIG. 33G shows a cross-section of an ablation assembly 3300g, which
includes a distal end 3304g and a proximal end 3302g. Distal end
3304g includes an ablation member 3316g disposed within a
stabilizer member 3317g, and a distal engagement member 3303g.
Proximal end 3302g includes a body 3340g, a proximal engagement
member 3301g, an ablation member 3316g, and a vacuum or fluid lumen
3330g such as an air tube. Body 3340e can be made of molded
silicone, for example. FIG. 33H shows a cross-section of a proximal
portion body 3340h according to embodiments of the present
invention. Body 3340h can be made of molded silicone, for
example.
[0191] FIG. 33J shows a proximal section body 3340j according to
embodiments of the present invention. Proximal section body 3340j
includes an ablation member engagement section 3342j such as a
recess or channel configured to receive an ablation member, a
proximal engagement member 3344j such as a recess or channel
configured to receive a distal engagement member, and a lumen or
passage 3346j. As shown here, body 3340j includes a proximal barb
fitting 3362j and a distal barb fitting 3364j. FIG. 33I shows a
cross-section of a proximal section body 3340i according to
embodiments of the present invention. Proximal section body 3340i
includes an ablation member engagement section 3342i such as a
recess or channel configured to receive an ablation member, a
proximal engagement member 3344i such as a recess or channel
configured to receive a distal engagement member, and a lumen or
passage 3346i. 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.
[0192] Proximal section 3302 includes a first lumen 3302'
configured to receive the ablation member, and a second lumen
3302'' configured to fluidly couple the stabilizer member with a
suction or fluid source. FIG. 33A shows that ablation system 3300
can be disposed about four pulmonary veins (PV), so as to form a
loop enclosure. As shown in FIG. 33J, proximal section body 3340j
can include a proximal section channel or slot 3344j which is
configured to receive a distal engagement member, and an ablation
member path 3342j which 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 slot 3344j. By adjusting the position of the distal
engagement member distally or proximally along the length of slot
3344j, 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.
[0193] As shown in FIG. 33A, stabilizer member 3317 can include an
interface 3317' that is configured to contact the patient tissue.
Often, interface 3317' presents a concave channel 3317''' with two
opposing sidewalls 3317''. Ablation member 3316 can be at least
partially disposed within the concave channel, between the two
sidewalls. The concave channel can be in fluid communication with
second lumen 3302''. 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 in FIG.
33J, the fluid or vacuum can be applied through lumen or passage
3346j and through luers or fittings 3346j, 3364j which 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.
[0194] FIGS. 34A to 34E illustrate aspects of ablation systems
according to embodiments of the present invention. As shown in FIG.
34A, an ablation system 3400 presents a proximal section or end
3402 and a distal section or end 3404. Ablation system 3400
includes an ablation assembly 3415 having an ablation member 3416
and a stabilizer member or bladder 3417. Proximal section 3402
includes a first lumen 3402' configured to receive the ablation
member, and a second lumen 3402'' configured to fluidly couple the
stabilizer member with a suction source. In some embodiments,
ablation system 3400 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 a patient
tissue 3405. Distal section 3404 may include a distal element 3407
such as a ribbon, or the like. In use, an operator can facilitate
placement of the ablation system by grasping distal element 3407
and maneuvering a system distal end 3404. In some embodiments,
distal or grasping element 3407 includes a string or tape which the
operator can grasp with a maneuvering mechanism such as a pair of
forceps. Ablation system 3400 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 on distal end 3404 of
system 3400 can be advanced toward a proximal engagement member
3408, which may include a keyhole 3408' and slot 3408'', disposed
on a more proximal section 3401 of system 3400. When the distal
engagement member engages proximal engagement member 3408, 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 structure 3419 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
of distal engagement member 3403 along proximal engagement member
3408 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 configure
ablation system 3400 so as to provide discrete stopping points or
attraction points for distal engagement member 3403 along a length
of proximal engagement member 3408. 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.
[0195] FIG. 34B shows aspects of proximal section body 3440b,
couplings or fittings 3462b, 3464b, and ablation assembly 3415b,
according to embodiments of the present invention. Ablation
assembly 3415 includes a stabilizer member 3417b and an ablation
member 3416b. Stabilizer member 3417b can include an interface
3417b' that is configured to contact the patient tissue. Often,
interface 3417b' presents a concave channel 3417b''' with two
opposing sidewalls 3417b''. Ablation member 3416b can be at least
partially disposed within the concave channel, between the two
sidewalls. The concave channel can be in fluid communication with a
proximal lumen 3402b of the stabilizer member. Accordingly, a fluid
or vacuum can be applied to a patient tissue via the proximal lumen
and concave channel.
[0196] 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.
[0197] Proximal section body 3340b can include an ablation member
engagement section 3342b such as a recess or channel configured to
receive an ablation member, a proximal engagement member 3344b such
as a recess or channel configured to receive a distal engagement
member, and a lumen or passage 3346b. As shown here, body 3340j
includes a proximal fitting 3362b and a distal fitting 3364b. FIG.
34A shows that ablation system 3400 can be disposed about four
pulmonary veins (PV), so as to form a loop enclosure. As shown in
FIG. 34B, proximal section body 3340b can include a proximal
section channel or slot 3344b which is configured to receive a
distal engagement member, and an ablation member path 3342b which
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 slot 3344b. By
adjusting the position of the distal engagement member distally or
proximally along the length of slot 3344b, 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 or
passage 3346b and through luers or fittings 3346b, 3364b which
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.
[0198] FIG. 34C shows a coupling section 3401c' that can be
connected with a proximal section body. Coupling section 3401c' can
include a first lumen 3402' configured to couple with a first lumen
of the proximal section body, and a second lumen 3402'' configured
to couple with a second lumen of the proximal section body. As
shown here, first lumen 3402' may be configured to receive an
ablation member 3416c therethrough. Coupling section 3401c' can
also include a proximal engagement member 3408c' that is configured
to receive a distal engagement member. FIG. 34D1 shows a partial
cross-section view of a proximal engagement member 3408d, and FIG.
34D2 shows a partial perspective view of the proximal engagement
member 3408d, according to embodiments of the present invention.
Proximal engagement member 3408d may include a keyhole 3408d', a
slot 3408'', and a plurality of position detents 3408d''' 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 a stabilizer member 3417e juxtaposed with a cross-section view
of a proximal section body 3440e. As depicted here, stabilizer
member 3417e includes an opposing pair of side walls 3417e'' and a
channel 3417e' disposed therebetween. Proximal section body 3440e
includes an ablation member engagement section 3442e such as a
recess or channel configured to receive an ablation member, a
proximal engagement member 3444b such as a recess or channel
configured to receive a distal engagement member, and a lumen or
passage 3446e.
[0199] FIG. 35A shows an associative cooperation between a distal
engagement member 3503 and a proximal engagement member 3508 of an
ablation system 3500, according to embodiments of the present
invention. As shown here, a gap 3516' may exist between a distal
tip 3516'' and a proximal section 3516''' of an ablation member
3516, when the system is wrapped about a patient tissue 3505. In
some embodiments, the distal engagement member may include a bridge
element 3503' that spans gap 3516' and provides electrical or
ablative conductivity across gap 3516' between distal tip 3516''
and a proximal section 3516'''. As shown in FIGS. 35B and 35C, an
ablation member 3516b can include one or more lumens 3575b having
openings at a distal tip 3516''. In use, a cooling fluid can be
passed through lumens 3575b, 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 .alpha. between a longitudinal axis 3580d define by an
ablation member 3516d and a longitudinal axis 3582d defined by a
distal engagement member 3503d. FIGS. 35F and 35G depict a distal
section of an ablation system that presents an offset angle .alpha.
between a longitudinal axis 3580f define by an ablation member
3516f and a longitudinal axis 3582f defined by a distal engagement
member 3503f. 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:
[0200] FIGS. 36A to 36C shows aspects of a distal engagement member
3603 according to embodiments of the present invention. As shown in
these figures, distal engagement member 3603 can include a pivot
mechanism 3690, such as an aperture, a pin, a hinge, or the like,
that allows the distal engagement member and an ablation assembly
3615 to pivot relative to each other. Distal engagement member 3603
can include a ball 3692 which can be inserted into a slot of a
proximal engagement member 3608. Distal engagement member 3603 can
also include a grasping tab 3694. 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 in FIG. 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.
[0201] FIG. 37A shows a distal engagement member 3703a according to
embodiments of the present invention. Distal engagement member
3703a includes a cylindrical stem 3703a' and a spherical head
3703a''. FIG. 37B shows a distal engagement member 3703b according
to embodiments of the present invention. Distal engagement member
3703b includes a flat or planar stem 3703b' and a spherical head
3703b''. FIG. 37C shows a distal engagement member 3703c according
to embodiments of the present invention. Distal engagement member
3703c includes a flat or planar stem 3703c' and a cylindrical head
3703c''. 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 member 3703a of
FIG. 37A allows for substantial roll as indicated by arrow A', and
for substantial swing as indicated by arrow A''. Distal engagement
member 3703b of FIG. 37B allows for little or no roll as indicated
by arrow B', and for substantial swing as indicated by arrow B''.
Distal engagement member 3703c of FIG. 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 of
3703c'' may be something other than 90.degree. to the long axis of
the stabilizer to help establish a desired angle of mating.
[0202] FIG. 38A shows a posterior view of a patient heart 3800. An
ablation system insertion path 3810 is shown by arrows A. In an
exemplary procedure, an operator can advance an ablation system
along ablation system insertion path 3810, so as to place the
ablation system in the desired location for ablating the patient
tissue. FIG. 38B shows an anterior view of a posterior pericardial
lining 3820 of a patient. In FIG. 38B, the heart is swung out
180.degree. relative to the view shown in FIG. 38A. Ablation system
insertion path 3810 is shown by arrows A. In an exemplary
procedure, an operator can advance an ablation system along
ablation system insertion path 3810, 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 ablation system insertion path 3910. In an exemplary
procedure, an operator can advance an ablation system along
ablation system insertion path 3910, so as to place the ablation
system in the desired location for ablating the patient tissue.
[0203] FIGS. 40 to 51 illustrate aspects of an exemplary method for
inserting an ablation system 4000 into a patient. FIG. 40 shows a
pusher 4005 and a tape hook 4020 according to embodiments of the
present invention. As shown in FIG. 41, an operator can place a
first trocar 4002 and a second trocar 4006 into a patient 4004. A
guide tube 4008 may be disposed through first trocar 4002. In some
cases, a guide tube may include an internal obturator. An operator
can advance an ablation assembly 4010 through trocar 4002 and guide
tube 4008, between a pulmonary vein (PV) and a superior vena cava
(SVC) of the patient, and about the heart 4012 as indicated by
arrows A and B. The operator can also advance a grasping mechanism
4014 through second trocar, between a pulmonary vein (PV) and an
inferior vena cava (IVC), as indicated by arrow C. As depicted in
FIG. 43, the operator can also advance tape hook 4020 through first
trocar, and can grasp a distal grasping element 4016 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 retract guide tube 4008 from first
trocar 4002 prior to or subsequent to inserting the tape hook. In
some cases, trocar 4002 can provide access through an oblique or
transverse sinus. Similarly, trocar 4006 can provide access to or
through an oblique or transverse sinus. FIG. 42 shows how distal
grasping element 4016 can be coupled with or snagged by tape hook
4020. As illustrated in FIG. 44, the operator can retract tape hook
4020 through first trocar 4002, thereby drawing or retrieving
distal grasping element 4016 and a distal section of ablation
assembly 4010 through first trocar 4002 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.
[0204] FIG. 45 provides a close up view of a distal section of
ablation assembly 4010. As shown here, ablation assembly 4010
includes a bladder or stabilizer member 4020, an ablation member
4022, an introducer 4024 having a pin 4026, and distal grasping
element 4016. Distal grasping element 4016 can be anchored with
stabilizer member 4020, for example at attachment point 4028. The
distal grasping element can be disposed around the pin and back
through the bladder at point 4030, and through a distal aperture
4032 of introducer 4024. In use, an operator can pull on distal
grasping element 4016 so as to push introducer 4024 onto stabilizer
member 4020, for example by urging pin 4026 toward stabilizer
member 4020. In some cases, introducer 4024 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 in
FIG. 46, introducer 4024 can be pulled along distal grasping
element 4016, away from stabilizer member 4020, in the direction
indicated by arrow C. FIG. 47 shows that distal grasping element
can be threaded through a loop 4007 of pusher 4005. An operator can
advance pusher 4005 through first trocar 4002 in a direction D, as
depicted in FIG. 48. The operator can adjust the position of pusher
4005 along ablation assembly 4010 so as to tighten or loosen a loop
structure 4019 of the ablation assembly about the patient tissue
4012, as shown in FIG. 49. A close up view of pusher 4005, pusher
loop 4007, first trocar 4002, distal grasping element 4016,
stabilizer member 4020, and ablation member 4022 is illustrated in
FIG. 50. An operator can snug up or cinch a distal section 4023 of
ablation member 4022 against patient tissue 4012 by moving pusher
4005 toward the tissue as indicated by arrow E, by pulling ablation
assembly 4010 proximally through pusher 4005 away from the tissue,
or both, as depicted in FIG. 51.
[0205] FIG. 52 shows a cross-section of a visualization system 5200
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
system 5200 can include a scope 5210 and a cap or sheath 5220. In
some embodiments, the terms cap and sheath may be used
interchangeably. Scope 5210 includes a distal end 5212, which in
some cases is beveled at an angle .alpha.. In some embodiments,
angle .alpha. can be within a range from about 30 degrees to about
45 degrees. Scope 5210 can be a straight scope, a rigid scope, or
both, for example. In some embodiments, scope 5210 includes an
endoscope. Sheath 5220 can include a tip having a bullet shape, a
cone shape, a dome shape, and the like. In some embodiments, sheath
5220 may present an asymmetric shape. Optionally, a sheath may be
shaped for optimized visualization of a tissue. Often, sheath 5220
includes a clear or transparent portion through which a lens of
scope 5210 can visualize the surrounding environment. In this way,
sheath 5220 can operate to expand the visualization capacity, or
the field of view, of scope 5210. In use, sheath 5220 can be
advanced into or against tissue, and can separate tissue.
Accordingly, tissue which presses on sheath 5220, or is otherwise
near sheath 5220, can be visualized. Sheath 5220 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 include sheath 5220. In some cases, an operator can
use visualization system 5200 for orientation purposes, for
treatment purposes, for therapeutic purposes, and the like. Sheath
5220 allows an operator to gain an enhanced awareness of an
operating space within a patient's body. For example, an operator
may use visualization system 5200 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.
[0206] Sheath 5220 may include a stop 5224. In use, stop 5224
typically contacts distal end 5212 of scope 5210 when sheath 5220
is disposed on scope 5210. The location or position of stop 5224 on
sheath 5220 can be selected so as to control or adjust the distance
between a distal end, or some other visualization portion, of
sheath 5220, and a lens of scope 5210. Different scopes may have
different focal lengths, and selection of a desired stop 5224
configuration can allow sheath 5220 to provide a particular viewing
effect on a patient's tissue. For example, by placing stop 5224 at
a certain distance from a distal end or viewing portion of sheath
5220, it may be possible to allow an operator to view tissue which
contacts the distal end or viewing portion of sheath 5220 with a
maximum clarity or distinctness, so that the tissue is in
focus.
[0207] Sheath 5220 can protect a lens of scope 5210 from unwanted
contact with fluid. Toward this end, sheath 5220 may include one or
more sealing mechanism 5222. For example, sealing mechanism 5222
may include an o-ring. Sheath 5220 may be releasably attached with
scope 5210. For example, it may be possible to snap together, and
to snap apart, sheath 5220 and scope 5210. In some cases, sheath
5220 includes an attachment mechanism 5226, which can be used to
attach or couple visualization system 5200 with another device or
implement. This attachment or coupling can be a releasable
attachment. In use, sheath 5220 of visualization system 5200 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 system 5200, the operator can
utilize attachment mechanism 5226 so as to couple visualization
system 5200 with the desired device or implement. For example,
attachment mechanism 5226 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.
[0208] FIG. 53 shows a cross-section of a visualization system 5300
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 system
5300 can include a scope 5310 and a sheath 5320. Scope 5310
includes a distal end 5312, which in some cases is not beveled at
an angle .alpha.. In some embodiments, angle .alpha. can be about 0
degrees. Scope 5310 can also include a flexible zone or portion
5314. Scope 5310 can be a curved scope, a flexible scope, or both,
for example. In some embodiments, scope 5310 includes an endoscope.
Sheath 5320 can include a tip having a bullet shape, a cone shape,
a dome shape, and the like. In some embodiments, sheath 3220 may
present an asymmetric shape. Optionally, a sheath may be shaped for
optimized visualization of a tissue. Often, sheath 5320 includes a
clear or transparent portion through which a lens of scope 5310 can
visualize the surrounding environment. In this way, sheath 5320 can
operate to expand the visualization capacity, or the field of view,
of scope 5310. In use, sheath 5320 can be advanced into or against
tissue, and can separate tissue. Accordingly, tissue which presses
on sheath 5320, or is otherwise near sheath 5320, can be
visualized. Sheath 5320 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 include
sheath 5320. In some cases, an operator can use visualization
system 5300 for orientation purposes, for treatment purposes, for
therapeutic purposes, and the like. Sheath 5320 allows an operator
to gain an enhanced awareness of an operating space within a
patient's body. For example, an operator may use visualization
system 5300 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.
[0209] Sheath 5320 may include a stop 5324. In use, stop 5324
typically contacts distal end 5312 of scope 5310 when sheath 5320
is disposed on scope 5310. The location or position of stop 5324 on
sheath 5320 can be selected so as to control or adjust the distance
between a distal end, or some other visualization portion, of
sheath 5320, and a lens of scope 5310. Different scopes may have
different focal lengths, and selection of a desired stop 5324
configuration can allow sheath 5320 to provide a particular viewing
effect on a patient's tissue. For example, by placing stop 5324 at
a certain distance from a distal end or viewing portion of sheath
5320, it may be possible to allow an operator to view tissue which
contacts the distal end or viewing portion of sheath 5320 with a
maximum clarity or distinctness, so that the tissue is in
focus.
[0210] Sheath 5320 can protect a lens of scope 5310 from unwanted
contact with fluid. Toward this end, sheath 5320 may include one or
more sealing mechanism 5322. For example, sealing mechanism 5322
may include an o-ring. Sheath 5320 may be releasably attached with
scope 5310. For example, it may be possible to snap together, and
to snap apart, sheath 5320 and scope 5310. In some cases, sheath
5320 includes an attachment mechanism 5326, which can be used to
attach or couple visualization system 5300 with another device or
implement. This attachment or coupling can be a releasable
attachment. In use, sheath 5320 of visualization system 5300 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 system 5300, the operator can
utilize attachment mechanism 5326 so as to couple visualization
system 5300 with the desired device or implement. For example,
attachment mechanism 5326 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.
[0211] FIG. 54 shows a cross-section of a visualization system 5400
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 system
5400 can include a scope 5410 and a sheath 5420. Scope 5410
includes a distal end 5412, which in some cases is not beveled at
an angle .alpha.. In some embodiments, angle .alpha. can be about
30 degrees to about 45 degrees. Scope 5310 can be a straight scope,
a rigid scope, or both, for example. In some embodiments, scope
5410 includes an endoscope. Sheath 5420 can include a tip having a
bullet shape, a cone shape, a dome shape, and the like. In some
embodiments, sheath 3420 may present an asymmetric shape.
Optionally, a sheath may be shaped for optimized visualization of a
tissue. Often, sheath 5420 includes a clear or transparent portion
through which a lens of scope 5410 can visualize the surrounding
environment. In this way, sheath 5420 can operate to expand the
visualization capacity, or the field of view, of scope 5410. In
use, sheath 5420 can be advanced into or against tissue, and can
separate tissue. Accordingly, tissue which presses on sheath 5420,
or is otherwise near sheath 5420, can be visualized. Sheath 5420
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 include sheath 5420. In some cases, an
operator can use visualization system 5400 for orientation
purposes, for treatment purposes, for therapeutic purposes, and the
like. Sheath 5420 allows an operator to gain an enhanced awareness
of an operating space within a patient's body. For example, an
operator may use visualization system 5400 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. Sheath 5420 can be moved
relative to scope 5410 or relative to body tissue. In some cases,
sheath 5420 can be rotated relative to scope 5410 or relative to
body tissue. An operator may effect such movement via a handle 5428
of sheath 5420.
[0212] Sheath 5420 may include a stop 5424. In use, stop 5424 can
contact distal end 5412 of scope 5410 when sheath 5420 is disposed
on scope 5410. The location or position of stop 5424 on sheath 5420
can be selected so as to control or adjust the distance between a
distal end, or some other visualization portion, of sheath 5420,
and a lens of scope 5410. Different scopes may have different focal
lengths, and selection of a desired stop 5424 configuration can
allow sheath 5420 to provide a particular viewing effect on a
patient's tissue. For example, by placing stop 5424 at a certain
distance from a distal end or viewing portion of sheath 5420, it
may be possible to allow an operator to view tissue which contacts
the distal end or viewing portion of sheath 5420 with a maximum
clarity or distinctness, so that the tissue is in focus.
[0213] Sheath 5420 can protect a lens of scope 5410 from unwanted
contact with fluid. Toward this end, as shown here the length of
sheath 5420 can be such that fluid is not present at a proximal end
5429 of sheath 5420. Sheath 5420 may be releasably attached with
scope 5410. For example, it may be possible to snap together, and
to snap apart, sheath 5420 and scope 5410. In some cases, sheath
5420 includes an attachment mechanism or instrument mount 5426,
which can be used to attach or couple visualization system 5400
with another device or implement. This attachment or coupling can
be a releasable attachment. In use, sheath 5420 of visualization
system 5400 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 system 5400,
the operator can utilize attachment mechanism 5426 so as to couple
visualization system 5400 with the desired device or implement. For
example, attachment mechanism 5426 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 of sheath 5420 can be constructed of a flexible material, such
as an elastomer. In some embodiments, sheath 5420 is rigid.
Similarly, scope 5410 may be flexible or rigid. In some
embodiments, a distal end of sheath 5420 is rigid, and a proximal
end of sheath 5420 is flexible.
[0214] FIGS. 55A and 55B show aspects of a visualization system
5500 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 system
5500 can include a scope 5510 and a sheath 5520. Scope 5510 and
sheath 5520 can include any feature or component of the scopes and
sheaths discussed herein, for example the scopes and sheaths
depicted in FIGS. 52 to 54. As shown here, sheath 5520 can include
an attachment mechanism channel 5521 adapted to receive an
attachment mechanism such as a grasping device 5540. Grasping
device 5540 can include a pair of spring loaded jaws 5542, 5544.
When pushed against a spring force as depicted in FIG. 55B,
grasping device 5540 can protrude out of channel 5521, and jaws
5542, 5544 can open or separate. When retracted as depicted in FIG.
55A, jaws 5542, 5544 close together, and grasping device 5540
withdraws into channel 5521. In use, an operator can advance
grasping device 5540 out of sheath 5520 and place open jaws 5542,
5544 on a desired item to be grasped. The operator can then
withdrawn grasping device 5540 into sheath 5520, thereby clamping
jaws 5542, 5544 on the item.
[0215] In some embodiments, an operator can push grasping device
5540 against a spring force so that grasping device 5540 protrudes
out of sheath channel 5521, 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 system 5500 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.
[0216] FIGS. 56A and 56B show aspects of a visualization system
5600 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 system
5600 can include a scope 5610 and a sheath 5620. Scope 5610 and
sheath 5620 can include any feature or component of the scopes and
sheaths discussed herein, for example the scopes and sheaths
depicted in FIGS. 52 to 54. As shown here, the visualization system
can include a grasping device 5640, such as a fin or wedge. In use,
an operator can place grasping device 5640 near a distal grasping
element or introducer tape 5650, 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 in FIG. 56A, when
tape 5650 comes into view grasping device 5650 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 in FIG. 56B, grasping
device 5650 can include a wedging shape that holds the tape under
tension. Accordingly, visualization system 5600 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.
[0217] FIG. 57 shows aspects of a visualization system 5700 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 system
5700 can include a scope 5710 and a sheath 5720. Scope 5710 and
sheath 5720 can include any feature or component of the scopes and
sheaths discussed herein, for example the scopes and sheaths
depicted in FIGS. 52 to 54. As shown in FIG. 57, a concave shape of
sheath 5720 can facilitate use of a working channel 5715 of scope
5710. In some cases, sheath 5720 can operate to protect a lens
contained therein.
[0218] FIGS. 58A-58C illustrate aspects of a visualization system
5800 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 system
5800 can include a scope 5810 and a sheath or cap 5820. Scope 5810
and sheath or cap 5820 can include any feature or component of the
scopes and sheaths or caps discussed herein, for example the scopes
and sheaths depicted in FIGS. 52 to 54. As shown in FIG. 58A, the
body of sheath or cap 5820 includes a grasping portion 5823a, and a
jaw 5825 of sheath or cap 5820 includes a corresponding or
complementary grasping portion 5823b. The body of sheath or cap
5820 is coupled with jaw 5825 via a hinge or pivot 5827, as
depicted in FIG. 58C. According to FIGS. 58A-58C, a pocket, pivot,
or attachment point 5829 of jaw 5825 can be aligned with a working
channel 5819 of scope 5810, and a push pull mechanism or axial
member 5850 can be disposed in working channel 5819. When axial
member 5850 is advanced distally through working channel 5819, for
example, the distal section of axial member 5850 can contact and
transmit force to jaw divot 5829, thereby closing the bringing the
grasping portions 5823a, 5823b toward 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 or cap 5820. In use, push
pull mechanism 5850 can be pulled or retracted as indicated by
arrow A so as to open jaw 5825. An operator can manipulate jaw 5825
and the body of cap or sheath 5820 about a tape or distal end of a
device or introducer. Push pull mechanism 5850 can then be pushed
or advanced as indicated by arrow B so as to close jaw 5825,
thereby grasping the tape, device, introducer, or other implement
5824.
[0219] FIGS. 59A-59D illustrate aspects of a visualization system
5900 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 system
5900 can include a scope 5910 and a sheath 5920. Scope 5910 and
sheath 5920 can include any feature or component of the scopes and
sheaths discussed herein, for example the scopes and sheaths
depicted in FIGS. 52 to 54. According to FIG. 59A, sheath 5920
includes a retractable underslung jaw 5925, shown here in a closed
or retracted position. FIG. 59B provides a cross section side view
of visualization system 5900. Jaw 5925 can have a push pull
mechanism 5950 attached thereto, and disposed within a working
channel 5919 of scope 5910.
[0220] In use, push pull mechanism 5950 can be advanced so as to
open jaw 5925, as shown in FIGS. 59C and 59D. An operator can
manipulate jaw 5925 so as to snag a tape or distal end of a device
or introducer. Push pull mechanism 5950 can then be retracted so as
to close jaw 5925, thereby firmly grasping the tape, device,
introducer, or other implement. In some embodiments, visualization
system 5900 includes an anti-roll guidance rib 5905. In some
embodiments, the body of sheath 5920 includes a toothed
configuration which is complementary to the toothed configuration
of jaw 5925.
[0221] FIGS. 60A and 60B illustrate aspects of a visualization
system 6000 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 system 6000 can include a scope 6010 and a sheath
6020. Scope 6010 and sheath 6020 can include any feature or
component of the scopes and sheaths discussed herein, for example
the scopes and sheaths depicted in FIGS. 52 to 54. According to
FIGS. 60A, sheath 6020 includes a pivoting overhung toothed jaw
6025, shown here in a closed or retracted position. Jaw 6025 can
have an activating mechanism 6050 or a similar axial member
attached thereto, and disposed within a working channel 6019 of
scope 6010.
[0222] In use, sheath 6020 includes a pivot 6029 that is configured
to provide a neutral jaw position under tension, such that there is
no tendency for jaw 6025 to open. Activating mechanism 6050 can be
advanced distally, as shown in FIG. 60B, so as to swing jaw 6025
about pivot 6029, toward an open configuration. In this
configuration, jaw 6025 is disposed outside of the external cone or
dome shaped contour of the sheath body. An operator can manipulate
jaw 6025 so as to snag a tape or distal end of a device or
introducer. Activating mechanism 6050 can then be retracted so as
to allow jaw 6025 to close, thereby firmly grasping the tape,
device, introducer, or other implement. In some embodiments, the
body of sheath 6020 includes a toothed configuration which is
complementary to the toothed configuration of jaw 6025.
[0223] 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.
[0224] FIGS. 61A and 61B illustrate how an ablation system can be
used in a tissue environment of a patient. An ablation system 6100
includes a visualization system 6110 having a probe or scope.
Ablation system 6100 also includes a device 6120, which may have an
introducer. As with any of the visualization systems disclosed
herein, visualization system 6110 can include a magnetically or
mechanically attaching mechanism, whereby a distal end of
visualization system 6110 can be attached or coupled with a distal
end of device 6120. 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 system 6110 can be used to move an ablation device
about a patient's pulmonary veins (PV). As shown in FIG. 61A,
device 6120 can be advanced within a patient, such that the device
enters a first cavity such as a transverse sinus. Similarly,
visualization system 6110 can be advanced within a patient, such
that the visualization system enters a second cavity such as an
oblique sinus. According to some embodiments, device 6120 can be
advanced through an oblique sinus and visualization system 6110 can
be advanced through a transverse sinus. Optionally, device 6120 or
visualization system 6110 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 magnet 6122 and
the visualization system may include a second magnet 6110. As shown
in FIG. 61B, the magnets can have self aligning faces, and the
distal ends of device 6120 and visualization system 6110 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 magnet 6122 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 of device 6120 and visualization system 6110 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.
[0225] FIG. 62A illustrates aspects of an ablation system 6200
having a magnetic loop closure, according to embodiments of the
present invention. Ablation system 6200 includes a proximal end
6202 and a distal end 6204. Ablation system 6200 also includes an
ablation electrode 6206 and a magnet or magnet array 6208. In some
embodiments, ablation system 6200 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 system 6200 can be cinched about the pulmonary veins, so
as to form an oval shape. For example, a magnet 6203 disposed on
distal end 6204 of system 6200 can be advanced toward magnet or
magnet array 6208. In some cases, magnet 6203 is urged toward
magnet 6208 by an operator using an instrument. When magnet 6203
couples with magnet 6208, magnet 6203 can be moved along magnet
6208, either distally or proximally, so as to respectively tighten
or loosen the loop enclosure formed by the ablation system. In some
cases, the body of ablation system 6200 includes a track 6210 which
has a shape that is complementary to the shape of magnet 6203. In
some cases, the attractive force between magnet 6203 and magnet
6208 provides a self cinching effect. In some cases, magnet 6208
includes an array of magnets, such that the position of magnet 6203
along magnet 6208 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
configure ablation system 6200 so as to provide discrete stopping
points or attraction points along a length of magnet 6208. 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.
[0226] 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 to FIG. 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 to FIG. 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.
[0227] FIGS. 63A to 63F show an ablation system 6300 according to
embodiments of the present invention. As depicted here, ablation
system 6300 can present a keyhole slot and ball configuration. FIG.
63A shows ablation system 6300 disposed about four pulmonary veins
(PV), so as to form a loop enclosure. Ablation system 6300 can
include a push sheath 6302.
[0228] Ablation system 6300 can be used to form an oval shaped
lesion on a patient tissue with an ablation probe of the system. As
seen in FIGS. 63B and 63D, ablation system 6300 can include a
proximal end channel or slot 6304, which is configured to receive a
ball 6306 of a suction chamber terminator 6308, and an electrode
path 6305, which is configured to receive an electrode. In use, an
operator can move wrap or place the ablation system about a patient
tissue, and insert ball 6306 of suction chamber 6308 into keyhole
6303 and slot 6304. By advancing ball 6306 distally or proximally
along the length of slot 6304, 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
terminator 6308, for example as shown in FIGS. 63E and 63F, may
include a metallic conductor. Terminator 6308 can include a
receptacle 6309 adapted to receive a distal electrode tip.
Accordingly, ablation system 6300 can create a continuous lesion
along the oval or loop. As shown in FIG. 63D, suction chamber
terminator 6308 can be perpendicular or substantially perpendicular
to slot 6304, 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 in
FIG. 63D, ablation assembly 6300 can include a suction chamber
6312, disposed on a distal end of an electrode support 6314. In
some embodiments, suction chamber 6312 presents a more flexible
configuration, whereas electrode support 6314 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 chamber 6312 can be placed on or about the pulmonary veins
of a patient. Suction chamber or bladder 6312 can be maintained in
position relative to the patient tissue via a mechanical
stabilization, via a vacuum, or a combination thereof. Typically,
suction chamber 6312 is coupled with suction chamber terminator
6308. According to FIGS. 63B, 63C, and 63D, ablation system 6300
may also include a vacuum luer or fitting 6316 which can transit a
vacuum from a vacuum source to suction bladder 6312.
[0229] FIGS. 64, 65, 66A, 66B, and 66C illustrate aspects of
ablation systems which can form oval, teardrop, or other loop
enclosure configurations, according to embodiments of the present
invention. According to FIG. 64, an ablation system 6400 can
include a distal portion 6410 and a proximal portion 6420, which
can be coupled by a trocar 6430. An operator can cinch or uncinch a
loop structure 6440 by sliding trocar 6430 along the distal and
proximal portions, as indicated by arrow A. In use, distal portion
6410 can be looped around the pulmonary veins (PV) of a patient,
and placed through trocar 6430 which is loaded on proximal portion
6420, so as form loop structure 6440. 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.
[0230] According to FIG. 65, an ablation system 6500 can include a
distal portion 6510 and a proximal portion 6520, which can be
coupled by a trocar 6540. An operator can cinch or uncinch a loop
structure 6540 by sliding trocar 6530 along the distal and proximal
portions, as indicated by arrow A. In use, distal portion 6510 can
be looped around the pulmonary veins (PV) of a patient, and placed
through trocar 6530 which is loaded on proximal portion 6520, so as
form loop structure 6540. 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, trocar 6530
can present a divided configuration so as to separate the proximal
and distal portions. Trocar 6530 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.
[0231] According to FIGS. 66A to 66C, an ablation system 6600 can
include a pull tape and pusher configuration. As shown in FIG. 66A,
ablation system 6600 includes a pull tape 6610 and a pusher 6620
having a pusher loop 6622. Ablation system 6600 also includes a
proximal portion 6630 and a distal portion 6640. Tape 6610 can
include a fabric, an elastomer, or the like. A distal end 6612 of
tape 6610 is attached with distal portion 6640. In use, an operator
can advance tape 6610, and thus distal portion 6640, along a
desired path through a patient's anatomy. The tape can then be
threaded through pusher loop 6622 of pusher 6620. 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 the ablation system 6600 is outside of the
patient's body. The operator can pull the tape through the loop to
the extent desired, so as to urge distal portion 6640 toward
proximal portion 6630, as depicted in FIGS. 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 advance pusher mechanism
6620 distally toward distal portion 6640, 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 looping
structure 6650. According to some embodiments, the operator can
hold pusher mechanism 6620 in a fixed position while adjusting the
proximal end 6670 of the ablation assembly so as to adjust the loop
size. For example, proximal end 6670 can be pulled or withdrawn
away from pusher mechanism 6620 as indicated by arrow A, so as to
downsize the loop. Similarly, proximal end 6670 can be advanced
into or toward pusher mechanism 6620 as indicated by arrow B, so as
to increase the loop size. As shown in FIG. 66C, distal portion
6640 can be urged against proximal portion 6630 to as to form an
orthogonal connection therewith. Similar features and
configurations are disclosed herein at, for example, FIGS. 50 and
51.
[0232] 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 in FIG. 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.
[0233] FIG. 67 illustrates an exemplary treatment system 6700
according to embodiments of the present invention. Treatment system
6700 includes a treatment device or ablation assembly 6710
releasably coupled with an introducer 6720. For example, a proximal
portion 6722 of introducer 6720 can be releasably coupled with a
distal portion 6712 of treatment device 6710. A distal portion 6714
of introducer 6714 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 device 6710 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 system 6700 can include or be used in
conjunction with one or more obturators or additional
introducers.
[0234] FIG. 68A shows aspects of an exemplary treatment system 6800
according to embodiments of the present invention. Treatment system
6800 includes a treatment device or ablation assembly 6810
releasably coupled with an introducer 6820. For example, a proximal
portion 6822 of introducer 6820 can be releasably coupled with a
distal portion 6812 of treatment device 6810. Treatment device 6810
may include a flexible ablation member or mechanism 6817, a
stabilizer member or mechanism 6818, and a cinching mechanism.
Distal portion 6812 of the treatment device includes a treatment
device coupling mechanism 6816, and proximal portion 6822 of the
introducer includes an introducer coupling mechanism 6826. As
depicted in FIG. 68B, treatment device coupling mechanism 6816 may
include one or more female snap features 6816a that are configured
to receive or couple with one or more male features 6826a of
introducer coupling mechanism 6826. Optionally, the introducer
coupling mechanism may also include a sleeve or clasp 6826b that
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
features 6816a and 6826a. For example, sleeve 6826b can be moved
toward the treatment device so as to keep a male feature 6826a
engaged with a female feature 6816a. Additional features of
exemplary introducers are discussed elsewhere herein, for example
with reference to FIGS. 79-81.
[0235] FIG. 69 depicts features of an exemplary treatment system
6900 according to embodiments of the present invention. Treatment
system 6900 can include an ablation mechanism 6917 and a stabilizer
mechanism 6918. As shown here, stabilizer mechanism 6918 may
include a proximal skirt termination 6918a. FIG. 70 depicts
features of an exemplary treatment system 7000 according to
embodiments of the present invention. Treatment system 7000 can
include an ablation mechanism 7017 and a stabilizer mechanism 7018.
As shown here, stabilizer mechanism 7018 may include a skirt 7018b
configured to contact the tissue of a patient, which can help form
a suction area 7018c. FIG. 71 depicts features of an exemplary
treatment system 7100 according to embodiments of the present
invention. Treatment system 7100 can include an ablation mechanism
7117 and a stabilizer mechanism 7118. As shown here, stabilizer
mechanism 7118 may include a skirt 7118b configured to contact the
tissue of a patient. Stabilizer mechanism 7118 may also include a
coupling mechanism having coupling arms 7118d that are configured
to couple with, secure, or otherwise contact the ablation
mechanism.
[0236] FIG. 72 depicts features of an exemplary treatment system
7200 according to embodiments of the present invention. Treatment
system 7200 can include an ablation mechanism 7217 and a stabilizer
mechanism 7218. As shown here, ablation mechanism 7217 and
stabilizer mechanism 7218 are disposed at least partially within a
cinching mechanism 7230 such as a trocar or push tube. Stabilizer
mechanism 7218 may include a skirt 7218b configured to contact the
tissue of a patient. Stabilizer mechanism 7218 may also include a
coupling mechanism having coupling arms 7218d that are configured
to couple with, secure, or otherwise contact the ablation
mechanism. Cinching mechanism 7230 may include a seal surface 7231
that forms a seal with or otherwise contacts skirt 7218b. FIG. 73
depicts features of an exemplary treatment system 7300 according to
embodiments of the present invention. Treatment system 7300 can
include an ablation mechanism 7317 and a stabilizer mechanism 7318.
As shown here, ablation mechanism 7317 and stabilizer mechanism
7318 are disposed at least partially within a cinching mechanism
7330 such as a trocar or push tube. Stabilizer mechanism 7318 may
include a skirt 7318b configured to contact the tissue of a
patient. Stabilizer mechanism 7318 may also include a coupling
mechanism having coupling arms 7318d that are configured to couple
with, secure, or otherwise contact the ablation mechanism. Cinching
mechanism 7330 may include a seal surface 7331 that forms a seal
with or otherwise contacts skirt 7318b. A suction skirt can assist
in creating dependable suction against seal surface 7331 of a lumen
within cinching mechanism 7330 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.
[0237] FIGS. 74A and 74B illustrate an exemplary treatment system
7400 according to embodiments of the present invention. Treatment
system 7400 includes a treatment device or ablation assembly 7410
having a flexible ablation mechanism 7417, a stabilizer mechanism
7418, and a cinching mechanism 7430 such as a trocar or push tube.
As shown here, ablation mechanism 7417 and stabilizer mechanism
7418 are disposed at least partially within cinching mechanism
7430, in a retracted position. FIGS. 75A and 75B illustrate an
exemplary treatment system 7500 according to embodiments of the
present invention. Treatment system 7500 includes a treatment
device or ablation assembly 7510 having a flexible ablation
mechanism 7517, a stabilizer mechanism 7518, and a cinching
mechanism 7530 such as a trocar or push tube. As shown here,
ablation mechanism 7517 and stabilizer mechanism 7518 are disposed
at least partially within cinching mechanism 7530, in an extended
position.
[0238] FIGS. 76A-76F show aspects of a treatment system 7600 as
used in an exemplary cinching method. As depicted in FIG. 76A,
methods may involve introducing a grasping or coupling mechanism
through a receptacle 7632a of a proximal portion 7632 of a cinching
mechanism 7630 such as a trocar or push tube. Coupling mechanism
7640 can be advanced along or through cinching mechanism 7630 as
shown in FIG. 76B, for example by advancing a proximal control
element 7642 of the coupling mechanism toward the cinching
mechanism 7630 as indicated by arrow A. Optionally, relative
translational movement between cinching mechanism 7630 and coupling
mechanism 7640 can be effected by moving cinching mechanism 7630 in
a proximal direction toward proximal control element 7642 as
indicated by arrow B. With reference to FIG. 76C, a distal portion
7642 of coupling mechanism 7640 can be advanced distally, or
extended, beyond a distal portion 7634 of cinching mechanism trocar
7630 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 implement 7650. Optionally, the desired
maneuvering of distal portion 7634 may include the inducement of
translational movement of cinching mechanism 7630 along ablation
mechanism 7617 and stabilizer mechanism 7618, as indicated by arrow
B. As shown in FIGS. 76D and 76E, once distal portion 7642 (shown
here as a loop) is coupled or engaged with introducer mechanism
7650, distal portion 7642 of coupling mechanism 7640 can be
advanced proximally, or retracted, toward and into distal portion
7634 of cinching mechanism trocar 7630 as indicated by arrow A.
Optionally, the desired retraction of distal portion 7634 may
include the inducement of translational movement of cinching
mechanism 7630 along ablation mechanism 7617 and stabilizer
mechanism 7618. For example, cinching mechanism 7630 can be
advanced distally relative to ablation mechanism 7617 and
stabilizer mechanism 7618, as indicated by arrow B. As indicated in
FIG. 76F, introducer implement 7650 can be drawn proximally through
receptacle 7632a of cinching mechanism 7630, and secured or fixed
with a proximal catch or clasp 7632b of the cinching mechanism. In
some cases, this can involve wrapping a tape around a knob to
secure the tape therewith. FIG. 77 shows an exemplary treatment
system 7700, wherein introducer implement or tape 7750 is drawn
proximally relative to cinching mechanism or trocar 7730, or
optionally trocar 7730 is advanced distally relative to introducer
tape 7750, or both, so as to form a closed or partially closed loop
with ablation mechanism 7717 and stabilizer mechanism 7718. The
treatment system can be configured to provide any desired angle
.alpha. 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.
[0239] FIG. 78A shows a perspective view of an ablation mechanism
7817a and a stabilizer mechanism 7818a according to embodiments of
the present invention. Ablation mechanism 7817a can be coupled with
stabilizer mechanism 7818a at one or more locations 7819a with an
adhesive material. FIG. 78B shows a perspective view of an ablation
mechanism 7817b and a stabilizer mechanism 7818b according to
embodiments of the present invention. By applying an adhesive
material to one or more locations 7819b along ablation mechanism
7817b, or optionally by applying an adhesive material to one or
more locations 7820b along stabilizer mechanism 7818b, it is
possible to couple the ablation mechanism 7817b with the stabilizer
mechanism 7818b. FIG. 78C shows a perspective view of an ablation
mechanism 7817c and a stabilizer mechanism 7818c according to
embodiments of the present invention. Ablation mechanism 7817c can
be coupled with stabilizer mechanism 7818c by placing or rolling
one or more O-rings 7819c onto ablation mechanism 7817c, and
coupling or bonding the O-rings with troughs 7820c of the
stabilizer mechanism 7818c. FIG. 78D shows a cross section view of
an ablation mechanism 7817d and a stabilizer mechanism 7818d
according to embodiments of the present invention. Ablation
mechanism 7817d can be coupled with stabilizer mechanism 7818d by
snapping or placing the ablation mechanism into place between arms
7820d of 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.
[0240] FIG. 79 illustrates an introducer assembly or mechanism 7900
according to embodiments of the present invention. Introducer
assembly 7900 includes a distal portion 7910 that includes a distal
coupling mechanism 7920, and a proximal portion 7930 that includes
a proximal coupling mechanism 7940. Introducer assembly 7900 can
also include, for example, a flexible body or tubular shaft 7960,
and a ribbon, wire, or tape 7950 disposed within the body 7960. In
use, introducer assembly 7900 can be positioned in a desired
location within the body, for example, in a manner similar to that
illustrated in FIG. 43 or FIG. 61A, or as generally described
herein with reference to FIGS. 82A to 85F, or as described in
previously incorporated U.S. Provisional Patent Application No.
61/015,472 filed Dec. 20, 2007. Proximal coupling mechanism 7940
can be coupled with an ablation mechanism, stabilizer mechanism, or
any desired component of a treatment system, as described for
example with reference to FIGS. 68A and 68B herein.
[0241] FIG. 80 illustrates an introducer assembly or mechanism 8000
according to embodiments of the present invention. Introducer
assembly 8000 includes a distal portion 8010 that includes a distal
coupling mechanism 8020. Introducer assembly 8000 can also include,
for example, a flexible body or tubular shaft 8060, and a ribbon,
wire, or tape 8050 disposed within the body 8060. In some cases,
introducer assembly 8000 can be constructed by applying tension to
the distal end of the tape 8050, and then gluing or fixing a cap
8022 onto the distal end of the body or tubing. As shown in FIG.
80A, a proximal portion 8022a of cap 8022 may overlap or encompass
a distal portion 8060a of body 8060. FIG. 81 shows a proximal
portion 8130 of an introducer assembly 8100 according to
embodiments of the present invention. Proximal portion 8130
includes a coupling mechanism 8140 that can be coupled with a
coupling mechanism 8170 of a treatment device having an ablation
mechanism and a stabilizer mechanism. In some cases, tension on
tape 8150 can operate to hold a tape anchor 8142 of coupling
mechanism 8140 in place relative to the introducer assembly body
8160. Hence, the introducer assembly can be constructed such that
coupling mechanism 8140 and body 8160 are otherwise freely
dissociable when there is reduced tension in tape 8150. In use,
after the introducer assembly 8100 has been placed in the desired
position while maintaining tension on tape 8150, 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 in FIG. 80. Severing of tape 8150 removes the tension, and
thereby allows coupling mechanism 8140 and body 8160 to separate
from each other, as indicated by arrows A and B, respectively, in
FIG. 81. Tape 8150 remains coupled with or attached to coupling
mechanism 8140 via anchor 8142, which in turn remains coupled with
or attached to coupling mechanism 8170 of an ablation and
stabilizer assembly. The operator or surgeon can then reveal a
length of tape 8150 by advancing body 8160 in a distal direction
along introducer implement 8150, as indicated by arrow C. Hence,
ribbon or tape 8150 becomes exposed, and can be engaged with a
grasping mechanism, as described herein for example with reference
to FIGS. 76A-76F.
[0242] FIGS. 82A-82F show a treatment system 8200 and method of use
according to embodiments of the present invention. FIG. 82A depicts
a front or anterior view of a patient 8201 and an introducer system
8210 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 and stabilizer assemblies 8220 at a desired
location in the patient. As shown here, the pericardial sac has
been opened by way of a sternotomy. Introducer system 8210 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 in FIGS. 82B and 82C, a proximal portion 8211 of
the introducer system 8210 can be placed posterior to the LAA and
against or near the roots of the left PVs, and a distal portion
8212 of the introducer system can be directed toward and passed
through the TS. As shown in FIG. 82D, ablation and stabilizer
assemblies 8220 are coupled with introducer system 8210, and
therefore can be drawn or passed through the patient following the
path taken by the introducer system. An accessory device 8280
having a catch 8281 can be inserted into the distal portion of the
push tube 8230.
[0243] The accessory device or sternotomy adapter 8280 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 to FIG. 77. As depicted in FIG. 82E, tape or ribbon 8250
can be placed through catch 8281 of the accessory device, and drawn
toward the proximal end of the push tube 8230 as indicated by arrow
B. Cinching mechanism or push tube 8230 can be advanced distally
along ablation and stabilizer assemblies 8220, as indicated by
arrow A. In this way, the surgeon or operator can cinch or tighten
the ablation and stabilizer assemblies 8220 about the roots of the
PVs, thereby tightening a cincture encircling the PVs. One or more
PVs may be encompassed by the ablation and stabilizer assemblies
8220. As shown in FIG. 82F, the tape or ribbon 8250 coupled with
the distal end of the ablation and stabilizer assemblies 8220 can
be drawn further taut, thereby contracting or constricting the
ablation and stabilizer assemblies 8220 about the PVs. The tape or
ribbon 8250 can be fixed with or wrapped around a proximal cleat or
catch 8231 of the push tube or trocar 8230, so that the ablation
and stabilizer assemblies 8220 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.
[0244] FIGS. 83A-83F show a treatment system 8300 and method of use
according to embodiments of the present invention. FIG. 83A depicts
a front or anterior view of a patient 8301 and an introducer system
8310 placed at a location within the body of a patient. The surgeon
or operator may advance the introducer system 8310 though a
subzyphoid incision 8302, 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 guiding
introducer 8390 through a secondary port 8391 to assist with
placement of the introducer system 8310. As shown in FIG. 83B, a
second introducer 8315 can be introduced into the patient,
optionally through incision 8302, and coupled with the introducer
system 8310. 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 in FIG. 83C, the second or retrieving
introducer 8315 can be withdrawn from the patient as indicated by
arrow A, thus pulling introducer system 8310 in a desired path
around the patient heart. Ablation and stabilizer assembly 8320,
which is coupled with introducer system 8310, can follow the path
taken by the introducer system 8310, as indicated by arrow B. As
described elsewhere herein, the ablation and stabilizer assembly
8320 can be encircled about the roots of the PVs. The surgeon or
operator may then advance push tube 8330 along the ablation and
stabilizer assembly 8320 so as to constrict the ablation and
stabilizer assembly 8320 about the PVs, as illustrated in FIG. 83D.
As shown in FIG. 83E, in some cases the ablation and stabilizer
assembly 8320 can be wrapped around the right PVs. As shown in FIG.
83F, in some cases the ablation and stabilizer assembly 8320 can be
wrapped around the left PVs.
[0245] FIGS. 84A-84F show a treatment system 8400 and method of use
according to embodiments of the present invention. FIG. 84A depicts
a front or anterior view of a patient 8401 and an introducer system
8410 placed at a location within the body of a patient. The surgeon
or operator may advance the introducer system 8410 though a first
port or thoracotomy incision 8411 disposed on the patient's right
side, through oblique sinus (OS). As shown in FIG. 84B, a second or
retrieving introducer 8415 can be introduced into the patient,
through a second port or incision 8412 and through transverse sinus
(TS), and coupled with the introducer system 8410. 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 system 8410 and retrieving introducer 8415 may be
inserted into the patient via a common port or incision 8413. As
shown in FIG. 84C, the second or retrieving introducer 8415 can be
withdrawn from the patient as indicated by arrow A, thus pulling
introducer system 8410 in a desired path around the patient heart.
Ablation and stabilizer assembly 8420, which is coupled with
introducer system 8410, can follow the path taken by the introducer
system 8410, as indicated by arrow B. As described elsewhere
herein, the ablation and stabilizer assembly 8420 can be encircled
about the roots of the PVs. The surgeon or operator may then remove
a portion of introducer system 8410. For example, as described
above with reference to FIGS. 80 and 81, a tubular body 8460 of the
introducer can be removed while an exposed ribbon or tape 8450
remains attached with a distal portion of ablation and stabilizer
assembly 8420. As shown in FIG. 84E, the surgeon can grasp a
portion of the exposed ribbon or tape, for example as described
above with reference to FIGS. 76A-76F, and withdrawn the ribbon or
tape 8450 through a proximal portion of the push tube or trocar,
thereby forming a looping or circular configuration with ablation
and stabilizer assembly 8420. The surgeon can advance push tube
8430 along the ablation and stabilizer assembly 8420 as indicated
by arrow A so as to constrict the ablation and stabilizer assembly
8420 about the PVs, as illustrated in FIG. 83F. Optionally, this
cinching procedure may involve withdrawing a proximal portion of
the ablation and stabilizer assembly out of push tube 8430 as
indicated by arrow B. Optionally, tape or ribbon 8450 can be drawn
further taut. Hence, the surgeon can contract or constrict ablation
and stabilizer assembly 8420 about the PVs. The tape or ribbon 8450
can be fixed with or wrapped around a proximal cleat or catch of
the push tube or trocar 8430 as described elsewhere herein, so that
the ablation and stabilizer assembly 8420 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.
[0246] FIGS. 85A-85F show a treatment system 8500 and method of use
according to embodiments of the present invention. FIG. 85A depicts
a front or anterior view of a patient 8501 and an introducer system
8510 placed at a location within the body of a patient. The surgeon
or operator may advance the introducer system 8510 though a first
port or thoracotomy incision 8511 disposed on the patient's right
side, through transverse sinus (TS).
[0247] As shown in FIG. 85B, a second or retrieving introducer 8515
can be introduced into the patient, through a second port or
incision 8512, and coupled with the introducer system 8510.
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 system 8510 and retrieving introducer
8515 may be inserted into the patient via a common port or incision
8513 and through. As shown in FIG. 85C, the second or retrieving
introducer 8515 can be withdrawn from the patient as indicated by
arrow A, thus pulling introducer system 8510 in a desired path
around the patient heart. Ablation and stabilizer assembly 8520,
which is coupled with introducer system 8510, can follow the path
taken by the introducer system 8510, as indicated by arrow B. As
described elsewhere herein, the ablation and stabilizer assembly
8520 can be encircled about the roots of the PVs. The surgeon or
operator may then remove a portion of introducer system 8510. For
example, as described above with reference to FIGS. 80 and 81, a
tubular body 8560 of the introducer can be removed while an exposed
ribbon or tape 8550 remains attached with a distal portion of
ablation and stabilizer assembly 8520. As shown in FIG. 85E, the
surgeon can grasp a portion of the exposed ribbon or tape, for
example as described above with reference to FIGS. 76A-76F, and
withdrawn the ribbon or tape 8550 through a proximal portion of the
push tube or trocar 8530, thereby forming a looping or circular
configuration with ablation and stabilizer assembly 8520. The
surgeon can advance push tube 8530 along the ablation and
stabilizer assembly 8520 as indicated by arrow A so as to constrict
the ablation and stabilizer assembly 8520 about the PVs, as
illustrated in FIG. 85F. Optionally, this cinching procedure may
involve withdrawing a proximal portion of the ablation and
stabilizer assembly out of push tube 8530 as indicated by arrow B.
Optionally, tape or ribbon 8550 can be drawn further taut. Hence,
the surgeon can contract or constrict ablation and stabilizer
assembly 8520 about the PVs. The tape or ribbon 8550 can be fixed
with or wrapped around a proximal cleat or catch of the push tube
or trocar 8530 as described elsewhere herein, so that the ablation
and stabilizer assembly 8520 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.
[0248] 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 a stabilizer member 8610, trocar or push tube 8620, and a
connecting lesion adapter 8630. The cross-hatched area of
stabilizer member 8610 represents a suction zone 8612 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). Connecting lesion adapter 8630
includes a distal sealing edge 8632 that, in cooperation with a
sealing edge 8614 of stabilizer member 8610, can operate to form a
seal against the tissue. Hence, when suction is applied via suction
zone 8612, an ablation mechanism housed in stabilizer member 8610
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 as distal
sealing edge 8632 or sealing edge or skirt 8614, 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.
[0249] FIG. 87 shows aspects of a treatment system 8700 and method
for forming a connection lesion. As illustrated here, treatment
system 8700 includes an ablation and stabilizer assembly 8710, a
connecting lesion adapter 8720, and a trocar or push tube 8730. In
use, the operator or surgeon can advance or extend a distal portion
of ablation and stabilizer assembly 8710 out from trocar 8730 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 grasping mechanism 8740 such as forceps. As shown
here, ablation and stabilizer assembly 8710 includes a distal tape
or ribbon 8750 that can be grasped and maneuvered as desired by the
operator.
[0250] Connection lesion adapter 8720 can operate to extend a floor
of push tube 8730 distally to facilitate suction. In use, the
surgeon can operate treatment system 8700 to form an of a variety
of epicardial connecting lesions 8760 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).
[0251] FIG. 88 shows aspects of a treatment system 8800 and method
for forming an endoablation. As illustrated here, treatment system
8800 includes an ablation and stabilizer assembly 8810, a
connecting lesion adapter 8820, and a trocar or push tube 8830.
Ablation and stabilizer assembly 8810 includes an ablation
mechanism 8812 and a stabilizer mechanism 8814. In use, the
operator or surgeon can advance or extend a distal portion of
ablation and stabilizer assembly 8810 out from trocar 8830 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 grasping mechanism 8840 such as forceps. As shown
here, ablation and stabilizer assembly 8810 includes a distal tape
or ribbon 8850 that can be grasped and maneuvered as desired by the
operator. Connection lesion adapter 8820 can operate to extend a
floor of push tube 8830 distally to facilitate suction. In use, the
surgeon can operate treatment system 8800 to form any of a variety
of endocardial lesions on the patient tissue. As shown here,
treatment system 8800 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 in FIG. 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).
[0252] FIG. 89 shows aspects of a treatment system 8900 and method
for forming an epiablation. As illustrated here, treatment system
8900 includes an ablation and stabilizer assembly 8910 and a trocar
or push tube 8830. Ablation and stabilizer assembly 8910 includes
an ablation mechanism and a stabilizer mechanism. In use, the
operator or surgeon can advance or extend a distal portion of
ablation and stabilizer assembly 8910 out from trocar 8930 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 grasping mechanism 8940 such as forceps. As shown
here, ablation and stabilizer assembly 8910 includes a distal tape
or ribbon 8950 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).
[0253] FIGS. 90A to 90J show aspects of a treatment system 9000 and
methods for forming lesions on patient tissue. As illustrated in
FIGS. 90A and 90B, an ablation and stabilizer assembly 9010 of the
system can be wrapped about the patient tissue, so as to form a box
lesion 9030 at or near the roots 9090 of the pulmonary veins (PVs),
where the PVs extend from the atrium. As depicted in FIGS. 90B to
90J, ablation and stabilizer assembly 9010 may include a distal
tape or implement 9012, and an operator can manipulate or position
ablation and stabilizer assembly 9010 with a grasping or
manipulating mechanism 9020, such as forceps, to form additional
connecting lesions 9040 as desired to the patient tissue.
[0254] FIG. 91 illustrates aspects of a treatment system 9100 and
methods for forming a box lesion on patient tissue. Treatment
system 9100 includes an ablation and stabilizer assembly 9110 and a
push tube or trocar 9120. Treatment system can also include a
sternotomy or sternal adapter as described herein with reference to
FIGS. 82A to 82F. As depicted here, push tube 9120 extends through
a chest opening 9130 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).
[0255] 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 in FIG. 92A, systems and methods may
be used to form a first lesion 9210a about the roots of a patient's
right pulmonary veins 9220a, and a second lesion 9230a about the
roots of a patient's left pulmonary veins 9240a. As depicted in
FIG. 92B, systems and methods may be used to form a first lesion
9210b about the roots of a patient's superior pulmonary veins
9220b, and a second lesion 9230b about the roots of a patient's
inferior pulmonary veins 9240b. As depicted in FIG. 92C, systems
and methods may be used to form a first diagonal lesion 9210c about
the roots of a patient's right superior pulmonary vein 9222c and
left inferior pulmonary vein 9224c, and a second diagonal lesion
9230c about the roots of a patient's left superior pulmonary vein
9242c and right inferior pulmonary vein 9244c. In this way, the
surgeon can create five small isolated areas. As depicted in FIG.
92D, systems and methods may be used to form a lesion 9210d about
the roots of any three of the patient's PVs. As depicted in FIG.
92E, systems and methods may be used to form a lesion 9210e about
the root of any individual PV. As shown in FIG. 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 lesion 9210f about the root of an individual
PV, and a second lesion 9220f about the roots of three other
PVs.
[0256] Cinching Devices and Methods of Use and Construction
[0257] 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.
[0258] 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.
[0259] Introducer Devices and Methods of Use and Construction
[0260] 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.
[0261] 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.
[0262] Convertible Ablation Devices and Methods of Use and
Construction
[0263] 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.
[0264] 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.
[0265] 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.
[0266] 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.
[0267] Lesion Test Systems and Methods of Use and Manufacture
[0268] 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.
[0269] 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.
[0270] 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.
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