U.S. patent application number 16/173991 was filed with the patent office on 2019-05-02 for scope and magnetic introducer systems and methods.
This patent application is currently assigned to AtriCure, Inc.. The applicant listed for this patent is AtriCure, Inc.. Invention is credited to Michael J. BANCHIERI, Tamer IBRAHIM, Dwight P. MOREJOHN, Tony WONG.
Application Number | 20190125400 16/173991 |
Document ID | / |
Family ID | 43731225 |
Filed Date | 2019-05-02 |
View All Diagrams
United States Patent
Application |
20190125400 |
Kind Code |
A1 |
IBRAHIM; Tamer ; et
al. |
May 2, 2019 |
SCOPE AND MAGNETIC INTRODUCER SYSTEMS AND METHODS
Abstract
Exemplary scope systems and methods involve a cannula assembly,
a sheath assembly, and a tubing set. A cannula assembly, which may
be a non-magnetic scope cap assembly, can include a cannula body, a
proximal housing having a strap, an optical window, and a luer for
suction or flushing. A cannula body may include a first lumen or
scope channel for receiving a visualization device such as an
endoscope or laparoscope, a distal end having suction or flushing
flush apertures, and a second lumen for providing fluid
communication between the apertures and the luer. Exemplary
magnetic introducer systems and methods involve a cannula assembly,
a sheath assembly, a tubing set. In some cases, the cannula
assembly of a magnetic introducer system can be a magnetic scope
cap assembly. In addition to cannula and sheath assemblies,
magnetic introducer systems can include a magnetic introducer
tubing assembly and a stylet assembly.
Inventors: |
IBRAHIM; Tamer; (Danville,
CA) ; BANCHIERI; Michael J.; (Discovery Bay, CA)
; WONG; Tony; (Tracy, CA) ; MOREJOHN; Dwight
P.; (Davis, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AtriCure, Inc. |
Mason |
OH |
US |
|
|
Assignee: |
AtriCure, Inc.
Mason
OH
|
Family ID: |
43731225 |
Appl. No.: |
16/173991 |
Filed: |
October 29, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12879106 |
Sep 10, 2010 |
10123821 |
|
|
16173991 |
|
|
|
|
61241297 |
Sep 10, 2009 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/347 20130101;
A61M 1/0084 20130101; A61B 1/3132 20130101; A61B 1/00154 20130101;
A61B 2217/005 20130101; A61B 17/3462 20130101; A61B 2217/007
20130101; A61B 2017/00243 20130101; A61B 17/3421 20130101 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61B 1/313 20060101 A61B001/313; A61B 1/00 20060101
A61B001/00 |
Claims
1. A device for placing a treatment device at a location within a
patient comprising: a cannula assembly having a first lumen and a
second lumen, wherein the first lumen extends into a distal portion
of the cannula assembly, wherein the first lumen is adapted for
receiving, and providing an optical window for, an endoscope,
laparoscope, or other imaging device, and wherein the second lumen
includes an aperture near a distal section of the cannula assembly;
a connection at the proximal end of the cannula assembly to provide
fluid communication for flushing or suction at the second lumen
aperture; and an attachment mechanism for removably attaching the
cannula assembly to a treatment device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation U.S. patent application
Ser. No. 12/879,106 filed Sep. 10, 2010, which claims benefit of
U.S. Provisional Patent Application No. 61/241,297 filed Sep. 10,
2009, the contents of which are incorporated herein by reference in
their entirety. This application is also related to U.S. Patent
Application No. 60/939,201 filed May 21, 2007, U.S. Patent
Application No. 61/015,472 filed Dec. 20, 2007, U.S. patent
application Ser. No. 12/124,743 file May 21, 2008, U.S. patent
application Ser. No. 12/124,766 filed May 21, 2008, U.S. patent
application Ser. No. 12/339,331 filed Dec. 19, 2008, and U.S.
Patent Application No. 61/179,564 filed May 19, 2009. The entire
content of each of these filings is incorporated herein by
reference for all purposes.
BACKGROUND OF THE INVENTION
[0002] Embodiments of the present invention relate generally to
medical devices and methods, and in particular to positioning
systems and methods for cardiac ablation procedures.
[0003] Medical treatment and surgical methods typically involve a
surgeon or operator placing a treatment device at a desired
location within a patient. For example, a surgeon can position a
cardiac ablation device in the vicinity of a patient's heart, and
apply an ablative energy to the epicardial tissue to treat atrial
fibrillation and other arrhythmias. Often, treatment devices are
difficult to accurately position at an effective location within
the patient. Relatedly, surgeons may find it difficult to
adequately secure a treatment device at a desired location in the
patient. Another shortcoming of currently available surgical
techniques is the difficulty of gaining optimal visualization of a
surgical or treatment site on the heart or of structures in and
around the surgical site. In other words, gaining sufficient
visualization to allow the surgeon to accurately manipulate,
ablate, or otherwise operate at a specific location within the
patient's body is sometimes challenging using current methods and
devices. Oftentimes, visualization devices and surgical instruments
collide or simply overcrowd a surgical site, reducing a surgeon's
room to work in and visualize the surgical site.
[0004] Therefore, there continues to be a need for devices,
systems, and methods for positioning a treatment device at a
desired location in the patient. In some embodiments, devices and
methods would provide enhanced techniques for viewing within the
body of the patient to facilitate placement of the treatment
devices, without crowding the surgical site. Optionally,
embodiments may involve improved techniques for attaching or
securing a treatment device at a location within a patient.
Further, it would be desirable for such methods and devices to be
minimally invasive. At least some of these objectives will be met
by embodiments of the present invention.
BRIEF SUMMARY OF THE INVENTION
[0005] Embodiments of the present invention provide techniques that
are well suited for placing a treatment device at a location within
a patient. Such techniques involve the use of introducer devices
having coupling mechanisms, and optionally integrated visualization
mechanisms, whereby an operator can efficiently and effectively
manipulate the introducer devices within the patient's body so as
to position a treatment device at a desired location.
Advantageously, such techniques can be performed in a minimally
invasive procedure without crowding the surgical site.
[0006] In one aspect, embodiments of the present invention
encompass devices and methods for placing a treatment device at a
location within a patient. A placement device can include a cannula
assembly having a first lumen and a second lumen, wherein the first
lumen extends into a distal portion of the cannula assembly,
wherein the first lumen is adapted for receiving, and providing an
optical window for, an endoscope, laparoscope, or other imaging
device, and wherein the second lumen includes an aperture near a
distal section of the cannula assembly. The placement device can
also include a connection at the proximal end of the cannula
assembly to provide fluid communication for flushing or suction at
the second lumen aperture, and an attachment mechanism for
removably attaching the cannula assembly to a treatment device. In
some cases, the attachment mechanism operates to connect the
treatment device to the distal end of the cannula assembly. In some
cases, the attachment mechanism uses magnetic force to attach the
treatment device to the cannula assembly. Optionally, a seal is
provided to inhibit fluid ingress into the first lumen after the
imaging device is inserted into the cannula assembly. According to
some embodiments, a magnet is located within the distal section of
the cannula assembly. A retention mechanism can maintain the
imaging device at a stable location within the first lumen. A
retaining means can include a strap. In some cases, an attachment
mechanism operates to connect to an ablation device. In some cases,
an attachment mechanism operates to connect to pacing electrodes.
Optionally, the distal end of the cannula assembly can carry pacing
electrodes. Relatedly, the distal end of the cannula assembly can
carry ablation elements. In some cases, the distal end of the
cannula assembly can carry ablation elements. The ablation elements
may heat tissue using radiofrequency energy, microwave energy, or
ultrasonic energy. In some cases, the ablation elements freeze
tissue to achieve ablation.
[0007] In another aspect, embodiments of the present invention
encompass magnetic introducer systems and methods. Exemplary
magnetic introducer systems include a cannula assembly, a sheath
assembly, a tubing set, a magnetic introducer tubing assembly, and
a stylet assembly. In some cases, the cannula assembly includes a
magnetic scope cap assembly. In some cases, the magnetic introducer
tubing assembly includes a pre-formed shape or bend. Optionally,
the sheath assembly can be configured to receive a distal end of
the magnetic introducer tubing.
[0008] 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 SEVERAL VIEWS OF THE DRAWINGS
[0009] FIGS. 1A and 1B illustrate aspects of scope and magnetic
introducer systems and methods according to embodiments of the
present invention.
[0010] FIG. 2 shows aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0011] FIG. 3 depicts aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0012] FIG. 4 shows aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0013] FIG. 5 depicts aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0014] FIG. 6 illustrates aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0015] FIG. 7 shows aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0016] FIG. 8 shows aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0017] FIG. 9 illustrates aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0018] FIG. 10 depicts aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0019] FIG. 11 illustrates aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0020] FIG. 12 illustrates aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0021] FIG. 13 shows aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0022] FIG. 14 depicts aspects of scope and magnetic introducer
systems and methods according to embodiments of the present
invention.
[0023] FIGS. 15A, 15B, 15C, and 15D show aspects of scope and
magnetic introducer systems and methods according to embodiments of
the present invention.
[0024] FIGS. 16A, 16B, 16C, 16D, and 16E illustrate aspects of
scope and magnetic introducer systems and methods according to
embodiments of the present invention.
[0025] FIGS. 17A, 17B, 17C, and 17D show aspects of scope and
magnetic introducer systems and methods according to embodiments of
the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0026] Embodiments of the present invention encompass scope and
magnetic introducer systems and methods for their use in surgical
procedures.
[0027] Scope Systems and Methods
[0028] Exemplary scope systems include a cannula assembly, a sheath
assembly, and a tubing set.
[0029] A cannula assembly, which in some cases may be a
non-magnetic scope cap assembly, may include a cannula body, a
proximal housing having a strap, an optical window, and a luer for
suction or flushing. A cannula body may include a first lumen or
scope channel for receiving a visualization device such as an
endoscope or laparoscope, a distal end having suction or flushing
flush apertures, and a second lumen for providing fluid
communication between the apertures and the luer. The cannula body
can be sealed to prevent or inhibit liquid and tissue from
contacting the visualization device or scope. The proximal housing
may include a scope port for a visualization device such as an
endoscope. The optical window may include a non-magnetic distal
cap. The suction or flushing luer may include a service port on a
proximal end having female luer connector that can accommodate
standard or vacuum source or that can be used for flushing
purposes. In some cases, the luer can be configured to interface
with a standard luer syringe and standard wall vacuum source, for
example when flushing or suction features are being used.
[0030] A sheath assembly may include a sheath body and a flange. In
some cases, the sheath body may be a removable sheath. The sheath
body can be configured to slide over the cannula. The distal end of
the sheath may terminate just proximal to the viewing window of the
cannula assembly so as to remain out of view or alternatively may
extend beyond the window. The sheath tip may be blunted and
comprise an alternate soft, flexible material as compared to the
material of the body of the sheath. The flange may be configured to
be easily removed from the sheath body. In some cases, the flange
can be easily snapped on or off.
[0031] In use, the cannula, with the endoscope or visualization
device, and the sheath are positioned in the patient. The cannula
and visualization device can be removed, leaving the sheath
positioned within the patient. Subsequently, medical treatment
devices can be inserted or introduced within the sheath.
[0032] Magnetic Introducer Systems and Methods
[0033] Exemplary magnetic introducer systems include a cannula
assembly, a sheath assembly, a tubing set, as described above in
relation to the scope systems. In some cases, the cannula assembly
of a magnetic introducer system can be a magnetic scope cap
assembly. In addition to cannula and sheath assemblies, magnetic
introducer systems can include a magnetic introducer tubing
assembly and a stylet assembly.
[0034] A magnetic introducer tubing assembly can have a pre-formed
shape or bend, and can be used in conjunction with an obturator or
stylet. According to some embodiments, after a cannula assembly is
removed from a sheath assembly, a distal end of a magnetic
introducer tubing is inserted into the sheath assembly. The cannula
assembly can be used through a different port or access site.
Exemplary techniques can also involve using a distal visualization
tip of the cannula assembly to visualize and attach with the
magnetic introducer tubing or other instrument. Methods can also
include withdrawing the magnetic cannula, thus pulling the
introducer tubing along. It is possible to attach treatment devices
with the introducer tubing which can then be advanced into the
patient. Certain surgical approaches may also involve the use of a
cannula assembly to confirm the placement of the treatment
device.
[0035] A stylet can be configured to interface with the magnetic
introducer tubing assembly. In some cases, the stylet is configured
as an obturator.
[0036] Tubing Set
[0037] As noted above, scope systems as well as magnetic introducer
systems may include a tubing set. According to some embodiments, a
tubing set includes a first tubing assembly that provides fluid
communication between a vacuum source and a canister, a second
tubing assembly that provides fluid communication between a
canister and a sterile field, a third tubing assembly that is
configured to couple with a stopcock, and a fourth tubing assembly
that provides fluid communication between a stopcock and a
treatment device. In some cases, the fourth tubing assembly may
include a stopcock.
[0038] In some cases, the first tubing assembly may include a
suction tubing having a length of about three feet, an inner
diameter (ID) of about 0.25 inches, and an outer diameter (OD) of
about 0.375 inches.
[0039] In some cases, the second tubing assembly may include a
suction tubing having a length of about twelve feet and an inner
diameter (ID) of about 0.25 inches.
[0040] In some cases, the third tubing assembly may include a
suction tubing having a length of about three feet, an inner
diameter (ID) of about 0.125 inches, and an outer diameter (OD) of
about 0.25 inches. The third tubing assembly may provide a
connection between the second tubing assembly and a stopcock.
[0041] In some cases, the first tubing assembly may include a
suction tubing having a length of about one foot and an inner
diameter (ID) of about 0.125 inches. The fourth tubing assembly can
provide fluid communication between a stopcock and a treatment
device. In some cases, the fourth tubing assembly includes or is
attached with a stopcock.
Exemplary Embodiments (Section 1)
[0042] Scope systems are well suited for use in minimally invasive
surgery and provide access for delivery and placement of surgical
instruments such as suction stabilizers or pacing probes. Scope
systems can be used for treating patients that may benefit from
blunt dissection of tissue including structures in the thoracic
space.
[0043] Magnetic introducer systems are well suited for use in
minimally invasive surgery and provide access for delivery and
placement of surgical instruments such as ablation probes, suction
stabilizers, or pacing probes. Magnetic introducer systems can be
used for treating patients that may benefit from blunt dissection
of tissue including structures in the thoracic space.
[0044] Scope systems and magnetic introducer systems can be
configured to interface with a standard luer syringe and standard
wall vacuum source when suction or flush features are being used.
Introducer system can be compatible with suction stabilizers in
terms of introducer routing and retrieval. Scope systems and
magnetic introducer systems can be used for general visualization
and dissection with any of a variety of treatment devices. Scope
systems and magnetic introducer systems may be packaged sterile
(EtO), for single use. Individual components of scope systems and
magnetic introducer systems can be snap fitted into a tray and
double pouched in Tyvek/poly peel pouches.
[0045] Scope and magnetic introducer systems can be used in any
thoracoscopic or laparoscopic procedure, and particularly in those
for which visualization in tight spaces is needed or desired. Scope
and magnetic introducer systems can also be used in procedures
which benefit from the retrieval of introducers or instruments that
could be simplified by the use of magnets. Exemplary techniques may
involve the use of RF ablation procedures using thoracotomy and
port access approaches. For example, a thoracotomy procedure may
involve creating an incision having a length of about 1-15 cm, at
or near the second, third, or fourth intercostal space, located as
medial as the nipple, and optionally more lateral. Scope and
magnetic introducer systems may benefit from right sided access
when used with suction stabilizers or pacing probes. If the surgeon
so desires, a device can be inserted into a left sided access
location for additional visualization or alternate routing
techniques. Left sided access may be desired if a surgeon wishes to
manage the left atrial appendage. Other uses of a visualization and
magnetic introducer system can involve a snaring system to mobilize
the aorta for proximal anastamosis during minimally invasive valve
surgery, delivery of a left atrial appendage closure clip or snare,
or delivery of an aortic closure clip or snare.
[0046] Surgical techniques can involve accessing sites within the
patient via selected port locations. According to some embodiments,
three port locations are used, including a lateral port in each of
the second/third and fifth/sixth intercostals spaces, and a more
medial port in the third/fourth intercostals space. In some cases,
three valved ports may be used, the two lateral ports may be a
minimum of 11 mm and the medial port can be as small as 5 mm if a
secondary laparoscope is used for bird's eye visualization, or 11
mm to allow for use of a cannula assembly according to embodiments
of the present invention.
[0047] Scope and magnetic introducer systems may in some cases only
require right sided access when used with suction stabilizers or
pacing probes, and if the surgeon desires, components of the system
can be inserted into left sided ports for additional visualization
or alternate routing techniques. The two lateral ports can be used
for the entry and exit of the a magnetic introducer system and
ablation device, for example. The medial port can be used for a
general or bird's eye visualization of the surgical site,
additional tissue dissection tools, or for inserting a scope
cannula to confirm device placement.
[0048] Scope and magnetic introducer techniques can involve
dissection for device access to the heart. For example, the
pericardium can be opened 1-2 cm anterior to the phrenic nerve from
the superior vena cava (SVC) down toward the diaphragm. Blunt
dissection between the inferior pulmonary vein and the inferior
vena cava (IVC) under the left atrium can be used to enter the
oblique sinus. Blunt dissection under the SVC can be used to enter
the transverse sinus. When using left-sided ports or thoracotomy,
the pericardium can be entered posterior to the left phrenic nerve
and the incision extended to enable unencumbered access to the base
of the left atrial appendage. Throughout the surgical procedure,
care is typically taken to avoid cutting, stretching, or grasping
the phrenic nerves.
[0049] Exemplary surgical methods can involve inserting a 5 to 5.5
mm endoscope into the opening on the proximal end of the cannula
assembly and installing the sheath onto the cannula. A camera and
light guide cable can be connected to the endoscope. The female
luer can be connected to standard wall suction and/or flush tubing.
The scope system can be introduced through a superior, lateral port
or thoracotomy, and navigated into the transverse sinus and across
until the left side of the pericardium is visualized. The cannula
can be detached from the sheath and withdrawn using reasonable
force while holding to sheath in place. In order to maintain
insufflation pressures it may be desirable for the sheath to
include an expandable seal at its proximal end to allow for the
accumulation of pressure inside the chest as instruments are
introduced through the seal. The seal may be configured to have an
inner diameter (ID) appropriately sized such that accumulation of
the pressure remains possible if no instrument is inserted into the
seal, for example <2 mm in diameter. Such a seal can be
integrated into the sheath or alternatively can be a separate
snap-in component that is inserted once the cannula is removed. The
distal end of the magnetic introducer tubing can be inserted into
the sheath and advanced until a second ring mark on the magnetic
introducer tubing is aligned with the entrance of the sheath. Once
separated, the cannula and sheath may be advanced along side one
another. The sheath may be clear or transparent such that a scope
may be introduced directly into it and visualization provided.
Depth markings may be placed along the length of the sheath for
aiding introduction and making it more easily visible by the scope.
Alternatively, the sheath may be translucent. The cannula can be
inserted (with sheath detached) into the inferior, lateral port or
thoracotomy and navigated into the oblique sinus.
[0050] The tip of the magnetic introducer tubing can be visualized
and retrieved with either the magnetic cannula or another
instrument. The magnetic cannula or instrument can be withdrawn
while advancing the introducer until the proximal end of the
introducer nears the entrance to the port.
[0051] When a magnetic introducer system is used in conjunction
with a suction stabilizer, it may be beneficial to attach a distal
tubing of the suction stabilizer to the proximal end of the
magnetic introducer tubing, for example to ensure that the stripe
on both tubes is aligned. Using reasonable force, it is possible to
continue pulling the magnetic introducer tubing out of the
port/incision, while advancing the suction stabilizer. When a
distal tubing of the suction stabilizer is out of the chest wall,
it is possible to disconnect the magnetic introducer tubing from
the device. After the suction stabilizer or other device has been
placed, the cannula can be reinserted into any of the ports to
confirm placement of the device. If desired, a stylet can be used
during the introduction of a magnetic introducer tubing into a luer
of a sheath.
[0052] Scope and magnetic introducer systems may in some cases be
compatible with 0 degree, 5-5.5 mm laparoscopes with a minimum
working length of 30 cm. Various other scopes are suitable. The
size of the cannula can be adjusted to accommodate scopes of
various lengths and diameters. Additional various angled scopes can
be used such as a 30 or 45 degree scope providing a more lateral
view of adjacent tissues or even 120-180 degree scopes that
integrate mirror technology to provide a hindsight view to the
system. Exemplary magnetic introducer systems can be configured to
fit through a 10 mm port. According to some techniques, clear
visualization can be provided within the chest wall. Cannulas can
provide a port for suction/flushing. A distal window of a cannula
can be sealed to prevent liquid and tissue from contacting the
scope. In some cases, a distal end of a magnetic introducer tubing
can be pre-formed into a 270.degree., 1.5'' bend radius with 1.33''
helical pitch. Magnetic introducer tubing can be configured to
return to an original bend radius when the obturator is withdrawn
from introducer tube or when the introducer is fully projected out
of the sheath using markings as described above. Introducer tubing
may have a linear marking along its lengths to properly align
components during connection. An introduction system may include a
means for easily retrieving a distal tip. In some cases, a magnetic
introducer system can be designed for single use. Optionally,
introducer tubing can have indication marks to determine the
location of a magnetic tip relative to the tip of the sheath.
[0053] Scope and introducer systems can be packaged with tube sets
which include tubes of various configurations. An exemplary tube
set includes a 3' length of 1/4'' ID for connection from wall
source to canister, a 12' length of 1/4'' ID for connection from
canister to sterile field, a 3' length of 1/8'' ID to connect from
12' length to stopcock, and a 1' length of 1/8'' ID to connect from
stopcock to device. Scope and introducer systems can be packaged in
a thermoformed tray, double pouched, and inserted into a chipboard
unit box.
Exemplary Embodiments (Section 2)
[0054] As depicted in FIGS. 1A and 1B, magnetic introducer systems
can include an introducer assembly and a scope cap assembly. As
shown here, magnetic introducer system 100 includes an introducer
assembly such as a magnetic introducer 110A or an introducer 110B.
Magnetic introducer system 100 also includes a scope cap assembly
such as a magnetic scope cannula 120B or a scope cap 120B.
[0055] Table 1 depicts various attributes of introducer devices
according to embodiments of the present invention.
TABLE-US-00001 TABLE 1 Attribute Introducer Design A Introducer
Design B Tubing material Braided PUR Unbraided Pebax Tubing
dimensions OD: .198, ID: .155 OD: .250, ID: .125 Tip retrieval
design Surgical tape Magnet Tip diameter .300'' .233'' Bend radius
1'' 1.50'' Helical pitch none none 1.33'' Proximal connection
Barbed connector Barbed connector Orientation indicator Axial
stripe Axial Stripe
[0056] According to some embodiments, it is desirable to use a
smaller diameter tubing for an introducer. Relatedly, it may be
desirable to provide adequate magnet strength with, for example, a
0.250 OD magnet. In some cases, a smaller diameter tubing (e.g.
0.187'') may be used, and the distal tip of the introducer (magnet)
can be larger in diameter than the tubing, for a particular
magnetic tip introducer set. Alternatively, it is possible to make
the OD of the tubing the same diameter as the OD of the magnet. The
introducer tubing can still be smaller than the ablation device
which follows it. Therefore, having a slightly larger introducer
tubing may benefit introduction by providing some dilation of the
transverse and oblique sinus spaces.
[0057] To adjust the perception of the distal end of the
introducer, a taper can be added (0.233'' dia. at the tip to
0.250'' dia. at the proximal end of the exposed magnet (0.500''
from the distal tip). The taper typically does not have a
significant impact on the magnetic coupling strength between the
scope cap and the introducer. The Pebax material used on Design B
may be silicone coated to increase lubricity to aid in insertion.
The stylet can still be included in the system, although it may not
be necessary if the scope cap sheath is used as described
below.
[0058] As depicted in FIG. 2, a scope cap assembly 200 can include
two main components. The first component can be embodied as a scope
cap such as a magnetic scope cannula 210 that houses the magnet,
distal window, scope channel, and suction/flushing port. The second
component can be embodied as a sheath 220, which slides over the
scope cap or magnetic scope cannula 210. In use, the sheath can be
assembled over the scope cap. It is thus possible to dissect across
the transverse sinus under endoscopic visualization, and then
remove the scope cap 210 while keeping the sheath 220 in place. The
sheath 220 then provides a channel to advance an introducer
assembly, such as magnetic introducer 110A depicted in FIG. 1A or
introducer 110E depicted in FIG. 1B, across the transverse
sinus.
[0059] FIG. 3 illustrates additional aspects of treatment systems
according to embodiments of the present invention. As shown here, a
cannula or scope cap assembly can include a scope cap 310 having a
magnet 320, a distal window 330, and one or more suction/flushing
apertures or ports 340 disposed at a distal section of the scope
cap. Scope cap 310 may also include a cone 350. Further, scope cap
310 may include a scope channel 360 and a suction/flushing port 370
disposed at a proximal end of the scope cap. Suction/flushing
apertures may be in fluid communication with suction/flushing
port.
[0060] According to some embodiments, a scope cap can be configured
to fit in a minimum 11 mm port. A scope cap can provide a channel
for suction/flushing. A scope cap may also be configured to work
with 5 mm laparoscopes, and accommodate up to a 5.5 mm laparoscope.
Scope caps may be compatible with scopes having a minimum working
length of 30 cm. In some cases, a scope cap may have a working
length of 28.4 cm (from port to tip of scope) and 31.7 cm (from
port to tip of magnet).
[0061] In some instances, there may be a relationship between
working length maximization and scope compatibility. For example, a
5 mm laparoscope can range in working length from 28 to 33 cm. In
order to accommodate a short working length scope, it may be
desirable to adjust or reduce the working length of the scope cap
to allow the scope to fit properly. Conversely, in order to
accommodate a long working length scope, it may be desirable to
adjust or increase the working length of the scope cap to allow the
scope to fit properly. According to some embodiments, a treatment
system can accommodate a minimum scope working length of about 30
mm. Such configurations may present a compromise between scope cap
working length and scope compatibility. In some cases, the working
length can be added by increasing the length of the window.
Variations in window length may be associated with variations in
the length or distance between the magnet and the tip of the scope.
In some cases, such variations can affect maneuverability or
visualization of the magnet.
[0062] Exemplary scope caps may be configured to accommodate
laparoscopes ranging from 5 to 5.5 mm in actual diameter. In some
cases, other scope sizes may be employed. Scope caps may also be
configured to accommodate suction/flushing capabilities. According
to some embodiments, a small port size is used to make a procedure
less invasive. Embodiments may also involve using a scope with a
scope cap having a suction channel, and fitting the device through
a port (e.g. 11 mm), such that the device includes a sufficiently
sized magnet for performance.
[0063] Aspects of an exemplary treatment or introducer system are
illustrated in FIG. 4. As shown here, a magnetic introducer system
400 may include a magnetic scope cap 405 with sheath 410, a
Magnetic Introducer Tubing 415, a Stylet 420, a 1 foot length of
1/4'' OD suction tubing with attached stopcock 425, a 3 foot length
of 1/4'' OD suction tubing 430, a 12 foot length of 3/8'' OD
suction tubing 435, and a 3 foot length of 3/8'' OD suction tubing
440 (canister to wall suction connection). The system can be
packaged in a thermoformed tray and double pouched.
[0064] According to some embodiments, a scope system may include a
non-magnetic scope cap with sheath, a 1 foot length of 1/4'' OD
suction tubing with attached stopcock, a 3 foot length of 1/4'' OD
suction tubing, a 12 foot length of 3/8'' OD suction tubing, and a
3 foot length of 3/8'' OD suction tubing (canister to wall suction
connection). The system can be packaged in a thermoformed tray and
double pouched.
Exemplary Embodiments (Section 3)
[0065] Scope systems may be configured for use with introducer
systems or other treatment devices. For example, scope systems may
be configured for use with a multiple-electrode,
temperature-controlled RF ablation technology device. Such devices
may employ precisely controlled RF energy to create reproducible,
uniform transmural lesions during cardiac surgery, such as
endocardial or epicardial ablations. In some cases, a scope system
may be used as a stand-alone device. Scope systems can be
configured to accommodate endoscopes of various sizes. Scope
systems may include features such as an optical window, a proximal
housing with a strap and luer for suction or flushing, an easy snap
on/off flange and removable sheath. The service port on the
proximal end of the product may have a female luer connector that
can accommodate a standard OR vacuum source or can be used for
insufflation or flushing/irrigation purposes, as depicted in FIG.
5. As shown here, treatment system 500 includes a removable sheath
510, and a cannula or scope cap assembly 515 having a non-magnetic
distal cap 520, a suction/flushing port 530, and a scope strap 540.
Built-in suction/flush apertures at the distal end of the system
are also depicted at FIG. 6. As shown here, treatment system 600
includes one or more suction/flushing apertures 610. An exemplary
scope system 700 is also shown in FIG. 7, including a cannula or
scope 710 with an assembled sheath 720.
[0066] Scope and introducer systems may be indicated for minimally
invasive surgery, and can allow access and visibility for
delivery/placement of surgical instruments such as ablation
devices. In some cases, scope and introducer systems may be
indicated for patients who may benefit from blunt dissection of
tissue including structures in the thoracic space.
[0067] In use, an exemplary treatment method may include inserting
an endoscope (e.g. 5 mm) into an opening on the proximal end of the
scope system a desired distance, for example until the endoscope
can no longer advance. Advantageously, such a stop mechanism can be
helpful to "seat" or locate the scope and ensure that the distal
lens of the scope seats at the same location regardless of scope
length used therefore providing a relatively consistent image for
various length scopes. FIG. 8 depicts a treatment system 800 having
a sheath 805 and a cannula or scope cap assembly 810. As shown
here, scope cap assembly 810 includes a scope port 820 at a scope
port location at a proximal end of a scope system 800. The surgeon
or operator may pull the strap located on the proximal end of the
device outward, and then over the light post of the endoscope and
secure it over the designated button. The strap can include an
elastomeric material, such that it can stretch to accommodate
scopes of various lengths. As such, a custom scope may not be
required and a variety of scopes may be accommodated. The operator
may also connect the camera and light guide cable to the endoscope,
and connect the female luer to standard wall suction or flush
tubing. In some cases, methods may involve using a port, such as an
11 mm port, to introduce the system into the chest cavity, for
example if insufflation is required or desired. if insufflation is
not required or desired, an incision may be used instead of a port.
The operator may introduce the system through the chest wall, and
use the system to navigate/dissect tissue to reach the desired
location in the thoracic space. If desired, the surgeon may detach
the scope system from the sheath and withdraw it while holding the
sheath in place during withdrawal. Optionally, the sheath can be
used to deliver one or more desired surgical instruments or
devices. In some cases, a scope system may be used in conjunction
with an introducer system, an ablation device, or both. FIG. 9
depicts a treatment system 900 having a cannula or scope system 910
with a removable sheath 920 according to embodiments of the present
invention. As shown here, removable sheath 920 includes a proximal
section having an ergonomic flange 930.
Exemplary Embodiments (Section 4)
[0068] Magnetic introducer systems may be configured for use with
ablation devices or as stand alone systems. An exemplary introducer
system may include a scope system with a sheath, a magnetic
introducer, and a stylet. In some cases, a magnetic introducer
system or cannula can be configured to accommodate an endoscope
(e.g. 5 mm). Introducer systems or cannulas may include features
such as an optical window with magnet, a proximal housing with
strap and luer for suction or flushing, an easy snap on/off flange
and removable sheath. A service port on the proximal end of the
system can have a female connector that can accommodate standard OR
vacuum source or can be used for flushing purposes. FIG. 10 depicts
features of an introducer system 1000 according to embodiments of
the present invention. Introducer system 1000 includes a removable
sheath 1010 and a scope system or cannula 1020. The removable
sheath 1010 is configured to slidably received the scope system or
cannula 1020. As shown here, scope system or cannula 1020 can
include a scope strap 1022, a suction/flush port 1024, and a
magnetic distal cap 1026. Introducer systems may include built-in
suction/flush apertures at the distal end of the product. For
example, as shown in FIG. 11, introducer system or cannula 1100
includes one or more suction/flush apertures 1110. Such apertures
can be disposed at a distal section or end of a scope system.
[0069] As depicted in FIG. 12, an introducer system 1200 may
include a magnetic introducer or cannula 1210 with an assembled
sheath 1220, a magnetic introducer tubing 1230, and a stylet 1240.
An introducer system may be indicated for minimally invasive
surgery, and may provide access and visibility for
delivery/placement of surgical instruments such as an ablation
device. In some cases, an introducer system can be indicated for
patients that may benefit from blunt dissection of tissue including
structures in the thoracic space.
[0070] In use, an exemplary treatment method may include inserting
an endoscope (e.g. 5 mm) into the opening on the proximal end of
the a scope system or cannula, for example until the endoscope can
no longer advance. FIG. 13 depicts a treatment system 1300 having a
scope system or cannula 1305 configured for slidable placement
within a sheath 1315. Scope system 1305 includes a scope port 1310
at a scope port location on a proximal location of a scope system
or cannula 1305 according to embodiments of the present invention.
The surgeon or operator may pull a strap 1320 located on the
proximal end of the device or cannula 1305 outward, and then over
the light post of the endoscope and secure it over the designated
button. The operator may also connect the camera and light guide
cable to the endoscope, and connect the female luer to standard
wall suction or flush tubing. In some cases, methods may involve
using a port, such as an 11 mm port, to introduce the system into
the chest cavity, for example if insufflation is required or
desired. If insufflation is not required or desired, an incision
may be used instead of a port. The operator may introduce the
system through the chest wall, and use the system to
navigate/dissect tissue to reach the desired location in the
thoracic space, for advancement of the magnetic introducer tubing.
If desired, the surgeon may detach the magnetic scope system or
cannula from the sheath and withdraw it while holding the sheath
1315 in place during withdrawal.
[0071] The operator may insert the distal end of the magnetic
introducer tubing into the sheath 1315 and advance it until the
second ring mark on the magnetic introducer tubing is aligned with
the entrance of the sheath 1315. Utilizing a second port, the
operator may introduce a scope system (with sheath detached) into
the chest wall and navigate through the thoracic space to locate
the distal-tip of the magnetic introducer tubing. When the magnetic
scope system couples with the distal tip of the magnetic introducer
tubing the operator can begin to slowly pull the magnetic scope
system out of the port or created incision while advancing the
magnetic introducer tubing into the other port.
[0072] If a magnetic introducer system is used in conjunction with
a treatment device such as an ablation assembly, a distal portion
of the treatment device or ablation assembly can be attached with a
proximal section of the magnetic introducer tubing. In some cases,
the operator may ensure that the stripe on both tubes is aligned.
The operator may continue to pull the magnetic introducer tubing
out of the port/incision, while advancing the treatment device or
ablation assembly. When the distal portion or tubing of the
ablation assembly is out of the chest wall, the operator can
disconnect the magnetic introducer tubing from the device. In some
cases, it may be desirable to use a stylet during the introduction
of the magnetic introducer tubing in the luer of the sheath. FIG.
14 shows a treatment system 1400 such as a magnetic introducer
system having a scope assembly or cannula 1410 with a removable
sheath 1420 according to embodiments of the present invention. As
shown here, scope assembly or cannula 1410 includes a magnetic
distal cap 1412 and removable sheath 1420 includes an ergonomic
flange 1422.
Exemplary Embodiments (Section 5)
[0073] FIGS. 15A, 15B, 15C, and 15D illustrate aspects of a cannula
assembly or scope cap assembly 1500 according to embodiments of the
present invention. In some cases, embodiments encompass a system
for coupling a scope to a cannula assembly which protects its lens
in wet or dry environments and additionally allows for fluid
infusion, evacuation of fluids from the field, and instrument
delivery and retrieval.
[0074] Exemplary coupling mechanisms may include an elastic strap
which connects from one end of the proximal cannula assembly to the
other around the scope, a light source cable, or a camera allowing
for varying scope lengths and retaining scopes within the assembly
under tension. O-rings sized to provide a frictional fit at the
proximal end of the assembly to retrain the scope may be included
as well.
[0075] FIGS. 16A, 16B, 16C, 16D, and 16E illustrate aspects of a
coupling mechanism 1600 that can be used to connect a cannula
assembly 1610 with a visualization or monitoring device such as a
scope.
[0076] FIGS. 17A, 17B, 17C, and 17D illustrate aspects of a
coupling mechanism 1700 that can be used to connect a cannula
assembly 1710 with a visualization or monitoring device such as a
scope.
[0077] According to some embodiments, as depicted in one or more of
FIGS. 15A, 15B, 15C, 15I), 16A, 16B, 16C, 16D, 16E, 17A, 17B, 17C,
and 17D, systems may include a cam-like locking assembly wherein a
locking lever applies force to or compresses an o-ring or soft
member against the scope shaft to increase pressure and friction. A
luer fitting at the proximal end of the device may be capable of
coupling with a syringe or tubing and can communicate through an
internal lumen and terminate at the distal end of the device with a
single or multiple port array to communicate saline irrigation or
vacuum to clear the field of fluids near the visualization end of
the device. A central lumen can be sealed to distal and proximal
ports such that a second lumen allowing passage of the endoscope is
sealed from communication with fluid.
[0078] In some instances, a magnet at the tip of the window can be
capable of retrieving instruments and introducers. In alternate
embodiments the magnet can be wired as an ablation electrode to
visualize a region to be ablated, press the window against said
tissue and ablate. An electrode embedded in the visualization
window can take many forms/geometries such as a protruding
spherical lead or ribbon type lead. Alternatively, the electrode
can be a lead or strip integrated directly into the window such
that the region being ablated can be more readily observed directly
contacting the window. Such a window can be designed to have
multiple leads/electrodes for ablating and also for pacing or
sensing to assess electrical activity and the adequacy of lesions
created in the treatment of arrhythmias. Spacing of multiple
electrodes can provide for electrical isolation from one electrode
to another. In other embodiments, these integrated ablation and
pacing/sensing electrodes can be integrated into the sheath either
directly over the window or just proximal or distal to the viewing
window.
[0079] A cone may protrude from the tip of the visualization window
to deflect light from the endoscope and minimize reflection and
glare. Such features may be particularly useful with windows
terminating in a large zone which is perpendicular to the light
source. Various alternate geometries are also possible with the
similar objective of minimizing the area of the tip of the viewing
window that is perpendicular to the scope and its light source and
deflecting or scattering the light. Such a mechanism can create an
optical illusion in certain configurations such as a cone whereby
the image viewed through the window is reflected back onto the cone
resulting in the perception or appearance that the cone is
transparent.
[0080] Systems may include a coaxial exchange sheath such that an
assembly is passed into place, a cannula/visualization assembly is
withdrawn leaving the sheath through which a guiding introducer can
be passed into place. A sheath can be withdrawn over the
introducer. A proximal end of the introducer can be coupled with an
ablation or treatment device. The distal end can be retrieved with
a magnetic visualization cannula. In some cases, a sheath can have
a soft membrane at its tip to minimize potential abrasion.
[0081] As noted above, exemplary scope or introducer systems can be
used with ablation assemblies and other treatment devices.
Alternate systems can be equivalently designed on a smaller scale
and can be used intravascularly or endocardially. Such embodiments
can utilize flexible fiber optic or equivalent visualization
technologies and miniature viewing windows with integrated ablating
or pacing/sensing leads, flushing/suction ports, and magnetic tips
as desired. Such configurations can allow a catheter to view the
inside of the heart tissue as it abuts against it to ablate, pace,
or sense electrical activity. A magnet of opposite polarity can
guide such a device from outside the heart. When such a magnet is
in contact with the epicardial tissue, it can be configured to also
be an ablating and viewing element as described elsewhere herein.
This approach can create a bipolar ablating element using an
endocardial ablation catheter with integrated magnetic
visualization and an epicardial ablation probe with integrated
magnetic visualization tip. Such integrated visualization can be
useful in more traditional epicardial ablation probes and clamps
for small incision introduction.
[0082] Exemplary ablation systems can include 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. Any of these modalities is well suited for use
in epicardial or endocardial ablation techniques resulting in
electrical isolation and transmurality.
Exemplary Embodiments (Section 6)
[0083] In some cases, embodiments encompass systems and methods
that involve the use of two introducers with ends carrying magnets
of opposite polarities so that the ends join with an audible click
as the ends approach one another. In some instances, no optical
windows are used and the connection can be made with the surgeons
blind to the connection region. As described elsewhere herein, a
first introducer can placed into the oblique sinus and a second
introducer can be placed into the transverse sinus, with both
devices being introduced from the right side. The connection
between the first and second introducers can be established near
the left pulmonary veins. This approach has been observed to
provide a simplified procedure for placing an ablation device its
proper or desired location.
[0084] 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.
* * * * *