U.S. patent application number 11/695467 was filed with the patent office on 2008-01-10 for transseptal left atrial access and septal closure.
This patent application is currently assigned to CoAptus Medical Corporation. Invention is credited to David C. Auth, Robert L. Barry, Robert S. Schwartz, Robert A. Van Tassel.
Application Number | 20080009859 11/695467 |
Document ID | / |
Family ID | 38444987 |
Filed Date | 2008-01-10 |
United States Patent
Application |
20080009859 |
Kind Code |
A1 |
Auth; David C. ; et
al. |
January 10, 2008 |
TRANSSEPTAL LEFT ATRIAL ACCESS AND SEPTAL CLOSURE
Abstract
Methods, systems, and devices for transseptal access into the
left atrium of a heart. In one embodiment an apparatus for
transseptal left atrial access comprised of a catheter adapted for
insertion into a vessel and one or more RF devices adapted to be
extendable from the distal end of said catheter and configured for
the penetration or sealing of septal tissue.
Inventors: |
Auth; David C.; (Kirkland,
WA) ; Barry; Robert L.; (Kirkland, WA) ;
Schwartz; Robert S.; (Inner Grove Heights, MN) ; Van
Tassel; Robert A.; (Exelsior, MN) |
Correspondence
Address: |
PERKINS COIE LLP;PATENT-SEA
P.O. BOX 1247
SEATTLE
WA
98111-1247
US
|
Assignee: |
CoAptus Medical Corporation
Redmond
WA
|
Family ID: |
38444987 |
Appl. No.: |
11/695467 |
Filed: |
April 2, 2007 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10856475 |
May 28, 2004 |
|
|
|
11695467 |
Apr 2, 2007 |
|
|
|
10754790 |
Jan 8, 2004 |
|
|
|
11695467 |
Apr 2, 2007 |
|
|
|
60474055 |
May 28, 2003 |
|
|
|
60474055 |
May 28, 2003 |
|
|
|
60447760 |
Feb 13, 2003 |
|
|
|
Current U.S.
Class: |
606/48 ; 606/45;
606/49 |
Current CPC
Class: |
A61B 2017/00575
20130101; A61B 2018/00261 20130101; A61B 2018/00029 20130101; A61B
2018/0022 20130101; A61B 18/1492 20130101; A61B 2018/00619
20130101; A61B 2018/00351 20130101; A61B 2018/1407 20130101 |
Class at
Publication: |
606/048 ;
606/045; 606/049 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1-29. (canceled)
30. A method for treating a patient, comprising: introducing a
catheter into a patient's right atrium; forming an opening in
septal tissue between the patient's right atrium and the patient's
left atrium; passing at least one of a diagnostic device and a
therapeutic device through the opening; performing at least one of
a diagnostic process and a therapeutic process in the left atrium
with the at least one device; and removing the at least one device
through the opening.
31. The method of claim 30, further comprising sealing the
opening.
32. The method of claim 31, wherein sealing the opening includes
sealing the opening from the right atrium.
33. The method of claim 31, wherein sealing the opening includes
sealing the opening with RF energy.
34. The method of claim 30, further comprising sealing a PFO.
35. The method of claim 30, further comprising tightening loose
septal tissue.
36. The method of claim 30, wherein forming an opening includes
forming an opening with RF energy.
37. The method of claim 36, wherein forming an opening includes
forming an opening with a monopolar RF electrode.
38. The method of claim 30, wherein forming an opening includes
forming an opening with a bipolar RF electrode.
39. The method of claim 30, wherein forming an opening includes
forming at least one slit.
40. The method of claim 39, wherein forming at least one slit
includes forming a single slit.
41. The method of claim 30, wherein forming at least one slit
includes forming multiple slits.
42. The method of claim 30, further comprising immobilizing the
septal tissue while forming an opening in the septal tissue.
43. The method of claim 30, further comprising sensing a
characteristic of the septal tissue.
44. The method of claim 43, wherein sensing a characteristic of the
septal tissue includes sensing a tissue impedance.
45. The method of claim 43, wherein sensing a characteristic of the
septal tissue includes sensing a tissue temperature.
46. The method of claim 30, further comprising eluting at least one
of a cooling fluid and an electrically conductive fluid from the
catheter.
47. A device for treating a patient comprising: an intravenous
catheter configured to be introduced into a patient's right atrium,
the catheter having a distal portion and a proximal portion; a
tissue penetrating device carried by the catheter, the tissue
penetrating device including an RF electrode deployable from the
distal portion of the catheter and configured to make an opening in
septal tissue between the patient's right atrium and left atrium;
an RF energy source coupled to the tissue penetrating device at the
proximal portion of the catheter; and at least one of a diagnostic
device and a therapeutic device carried by the catheter and
deployable from the distal portion through the opening made by the
tissue penetrating device and into the left atrium.
48. The device of claim 47, wherein the RF electrode is shaped to
make a slit in the septal tissue.
49. The device of claim 47, further comprising a tissue sealing
member carried by the catheter.
50. The device of claim 47, wherein the electrode includes a
monopolar electrode.
51. The device of claim 47, wherein the electrode includes a
bipolar electrode.
52. The device of claim 47, further comprising a tissue sensor
carried by the catheter.
Description
COPYRIGHT NOTICE
[0001] A portion of this patent document contains material that is
subject to copyright protection. The copyright owner does not
object to the facsimile reproduction of the patent document as it
appears in the U.S. Patent and Trademark Office patent file or
records but otherwise reserves all copyright rights whatsoever.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the medical arts
and specifically to transseptal methods, devices, and systems for
accessing the left atrium of a patient's heart and for sealing
closed an opening in the septum and/or for sealing septal tissue
together.
BACKGROUND OF THE INVENTION
[0003] With recent advances in the cardiovascular arts, there's a
renewed interest in finding safe and uncomplicated methods for
accessing the left atrium of a patient's heart. Currently, a
retrograde transaortal technique is most often and involves
advancing a catheter through the aorta, into the left ventricle,
accessing the left atrium from the left ventricle. However, this
path into the left atrium is tortuous. A simple and more attractive
alternative is accessing the left atrium directly from the right
atrium by crossing the interatrial septum ("septum") that divides
the two atrial chambers of the heart. The right atrium can be
easily accessed and crossing the septum is the only requirement to
entering the left atrium.
[0004] The left atrium can be accessed by puncturing across the
septum of the heart at the fossa ovalis membrane, typically the
thinnest part of the septum, with a needle-like device such as a
Brockenbough needle. While this technique has been widely known
since the 1950's, it has not been used largely because the
technique has not proven reliable or secure. Misalignment or the
incorrect orientation of the needle against the septum, for
example, may have severe consequences for the patient, including
perforation of the left atrium of the heart or perforation of a
patient's aorta. Inadvertent perforations of the inferior vena cava
and the coronary sinus have also been reported as a possible
complication of this technique. Therefore, rapid, precise and
controlled methods and devices for crossing the interatrial septum
are needed. The present invention meets these, as well as other,
needs.
SUMMARY OF THE INVENTION
[0005] Broadly, the invention is directed at methods and
radiofrequency (RF) devices for crossing an interatrial septum and
sealing an opening in it closed.
[0006] In yet another aspect of the invention, methods, RF systems
and devices for sealing septal tissue are provided.
[0007] In yet another aspect of the invention, methods, RF systems,
and devices for sealing closed an naturally occurring opening in a
heart is a provided.
[0008] These, as well as other additional embodiments and features
of the invention, will appear in the following description in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIGS. 1A-1C are schematics illustrating the types of opening
and closure patterns that can be created in the interatrial septum
in accordance with the present invention.
[0010] FIGS. 2-4 illustrate various embodiments of RF penetrating
probes in accordance with the present invention.
[0011] FIGS. 5-6 illustrate various embodiments of RF sealing
probes in accordance with the present invention.
DESCRIPTION OF THE EMBODIMENTS
[0012] Broadly, methods, systems and RF devices for crossing the
septum 1 and creating openings 3 of a specified size and pattern
are provided. Methods, systems and RF devices for closing these
openings 3 and joining septal tissue are also provided. Openings 3
in a wide variety of patterns and sizes can be created in the
septum 1 in accordance with the present invention, including but
not limited to: single slits 5 (FIG. 1A), radial slits 7 (FIG. 1B)
and a plurality of bisecting slits 9 (FIG. 1C) as illustrated in
FIGS. 1A-1C. The specific shape or pattern of the opening 3 is
determined by the configuration of the wire(s) or electrodes(s)
located on the distal end of an RF penetrating device or catheter
as described herein. FIG. 1 further illustrates yet another aspect
of the invention involving the use of an adaptively shaped RF
sealing device or catheter to close the various types of openings
3. The dotted lines in FIG. 1 depict the shapes of various RF
sealing devices or catheters that can be preferentially used to
close septal openings 3 and join septal tissues 1 flaps
together.
[0013] Turing now to the other figures, FIGS. 2, 3 and 4
illustrates various embodiments of RF penetrating devices 11. The
various RF penetrating devices 11 are comprised of an RF
penetrating probe 13 located at a distal end 15. The RF penetrating
probe 13 is comprised of one or more wires 17 arranged in a
particular shape. In a preferred embodiment, the RF penetrating
probes 13 are made of shape memory wires 17 (such as Nitinol) to
ensure the correct formation of the desired shape when the RF
penetrating probe 13 is exposed inside the right atrium. The
correct shape and orientation of the RF penetrating probe 13 and
wires 17 against the septum 1 will determine the pattern of the
opening 3 created in the septum 1 by the RF penetrating probe 13.
When energized, the wires 17 or electrodes will supply sufficient
RF energy to affect tissue penetration upon contact in the pattern
dictated by the arrangement of the RF probe 13.
[0014] Each wire 17 of an RF penetrating probe 13 can be configured
as a wire electrode, or in yet another implementation, each wire
may be comprised of one or more spaced RF electrodes located within
insulated shape memory wires. The electrodes of an RF penetrating
probe 11 can be configured to operate as monopolar or bipolar
electrodes delivering sufficient RF current to electrosurgically
penetrate septal tissue 1 on contact. As will be readily
appreciated by one skilled in the art, various strategies can be
implemented to prevent sticking of tissues to the RF penetrating
probes 13, wires 17 or electrodes described herein. In one possible
implementation, various fluids or gels (either cooling and/or
electrically conductive) may be used to prevent sticking of tissues
during the penetration procedure. Yet another possible
implementation may include a fluid (cooling or conductive) eluted
from one or more ports located on a guide catheter. Alternatively,
a fluid, coating or gel can be used on the RF probes 13, wires 17,
or electrodes themselves to prevent tissue adhesion to the devices.
In addition, one or more feedback sensors may be incorporated the
present invention, preferably located adjacent to the RF
penetration probes 13 to prevent unintended injury. The one or more
feedback sensors can be configured to measure tissue impedances,
temperatures, etc. as a means of preventing or controlling tissue
heating, overheating or excessive tissue adhesion caused by heat
generation.
[0015] FIG. 2 illustrates one embodiment of an RF penetration probe
13 for creating a slit-like opening 5 in the septum 1 of a
patient's heart. As shown, the RF probe 13 comprises a relatively
straight RF wire 17. RF wire 17 is attached to a connection member
23, which secures it to the distal end 15 of the RF penetration
catheter 11. A described above, RF wire 17 can be configured as a
wire electrode or can be comprised of a electrode located
preferably in the middle of wires 17 wherein the ends of wire are
insulated as illustrated. The size of the RF wire 17 or the
electrode will depend on the desired size of the septal opening 3;
if a longer slit 5 is desired a larger RF wires 17 or electrode may
be employed. Though not illustrated, RF wire 17 is operationally
connected by lead wires, or other like means, to an RF generator or
energy source (not shown).
[0016] FIG. 3 illustrates yet another embodiment of an RF
penetration probe 13. In this embodiment, RF penetration probe 13
is comprised of a plurality of wires 17 radiating from center point
0. The wires 17 of the RF penetration probe 13, which are
preferably straight, are secured to connection member at center
point 0. This RF penetration probe 13 illustrated in FIG. may be
used to create the type of opening 7 depicted in FIG. 1B.
[0017] FIG. 4 illustrates yet another embodiment of the present
invention wherein RF penetration probe 13 comprise a plurality of
bisecting RF wires 17 that can be used to affect an opening 9 of
the type illustrated in FIG. 1C. Each wire 17 in these embodiments
may be configured as a wire electrode 17 or portions of the wire
may be insulated 21.
[0018] Turing to FIGS. 5 and 6, yet another aspect of the
invention, is provided. In this aspect, various RF tissue sealing
devices or catheters 31 comprising a distally located RF sealing
probe 33, are illustrated. The RF sealing probe 33 is comprised of
one or more wires 17 arranged in a pre-determined shape. Similar to
the RF penetrating devices 11, the RF tissue sealing devices 31 can
be configured as separate catheter device insertable into a guide
catheter, or alternatively, can adapted to extend from the distal
end of a guide catheter by use of a manipulator. For example,
movement of a manipulator may control extension or retraction of
both an RF penetrating device 11 and an RF sealing device 31 from
the distal end of a guide catheter. To affect closure, RF wires 17,
or electrodes of a RF sealing device 31, are configured to be
operable at less intense modalities than the electrodes of an RF
penetrating device 11 or probe 13. Specifically, the RF sealing
probes 33 and the electrodes comprised therein are configured to
heat, melt or coagulate tissues coming in contact with it. In
addition, as provided in the art, heating of tissues at less
intense parameters will trigger a healing response in the RF heated
tissues, which will contribute and further promote closure of an
opening and promote sealing of septal tissues.
[0019] Like the RF penetration probes 13, the RF sealing probes 33
of the present invention can be configured in a variety of shapes
and sizes depending on the opening 3 to be closed. As illustrated
in FIG., RF sealing probe 33 may be a circular wire 35 or a
straight wire 37. Circular or straight type wires 35, 37 can be
used to seal an opening 3 having several different patterns; for
example, a circularly shaped RF sealing probe 35 can be used to
seal a radial 7 or slit type 5 opening as illustrated in FIG.
1.
[0020] The various devices of the invention can be used similarly.
The RF devices (including the tissue penetrating 11, 13 and sealing
devices, catheters, probes 31, 33) can be delivered as a component
of a catheter assembly system. The catheter assembly can comprise:
a conventional guide or sheath catheter that can be introduced over
a guidewire (not shown), an RF penetrating device 11 and/or an RF
sealing device 31. First, the catheter assembly can be introduced
into the right atrium from a number of access points using well
known catheterization techniques. For example, to gain access to a
patient's vasculature and the right atrium of the heart,
commercially available introducers can be inserted into a vessel
such as into the femoral vein or artery. The introducer can be of a
variety of sizes, 4-14 French. The guide catheter should be readily
insertable into an introducer and extend from the access point to
the septum; this will require use of a guide catheter about 80-120
cm long and about 4-14 French. The guide catheter can be
manufactured in accordance with a variety of known techniques,
including as an extrusion of an appropriate material, such as high
density polyethylenes (HDPE), polytetrafluoroethylenes, nylons,
polyether-block amides, polyurethanes, polyimides, polyolefin
copolyester and the like. However, other catheter materials well
known in the catheter art, as well as various braiding techniques,
may be employed depending on the desired catheter performance
characteristics. In one embodiment, the guide catheter can be
manufactured to be self-positioning to a desired location on a
septum 3. For example, the guide catheter can be adapted so its
distal tip preferentially locates to pre-determined position (such
as at the fossa ovalis or above it), in which case the appropriate
braiding technique can be used to affect preferential positioning
of the distal tip of the catheter. Other component of the catheter
assembly, in addition to a guide catheter, can include one or more
of the following: an RF penetrating device 11, an RF sealing device
31, a guidewire, imaging components and the like. These components
can be configured to be inserted into and extend out of the distal
end of a guide catheter. Alternatively, these components, such as
the RF devices 11, 31 can be configured to be extendable from the
distal tip of guide catheter via a manipulator or other like means
located at a proximal end of the guide catheter. In addition, these
devices 11, 31 can be configured to extend only to pre-determined
distances from the distal end of a guide catheter to ensure
accurate penetration of the interatrial septum 1.
[0021] An RF penetrating device or catheter 5 can then be advanced
into the guide catheter 43 and an RF penetrating probe 13 extended
from its distal end. The RF penetration probe 43 should be placed
into contact against the septum 1, and the electrodes energized to
affect penetration. Pressure exerted on the proximal end of the RF
penetration device or catheter 11 can used to ensure contact of
septal tissue and the RF penetration probe 13. Other possible
implementations include configuring the guide catheter to include a
vacuum or suction port to help immobilize septal tissue against the
RF penetration probe 13 during septal penetration.
[0022] Once a desired opening 3 has been created, the RF
penetrating device or catheter 11 can be withdrawn from the guide
catheter and replaced with other diagnostic or therapeutic devices
or catheters. Once the left atrium has been sufficiently accessed
and the other devices and catheters withdrawn, the closing or
sealing procedure can be initiated using the RF sealing device or
catheter 31 of the present invention. To affect closure or sealing
of an atrial opening 3, a RF sealing probe 33 should be delivered
into the right atrium and the RF wire or electrodes 17 energized.
As previously described, activation of the RF sealing probe 33 will
cause tissue and collagen melting, as well as coagulation, around
the tissue flaps 1 of a septal opening 3. In addition, a
heat-induced healing process, including scar formation and cell
proliferation, will further contribute to of the septal closure and
adhesion of the septal tissues.
[0023] As will be readily appreciated by one skilled in the art,
the RF sealing devices and catheters 31 may be configured and used
not only to seal actively created openings 3 but also those that
occur naturally (ASDs, PFOs, floppy or aneurismal septums or PFOs).
In one method of treatment, the distal end of an RF treatment
catheter can be delivered adjacent an aneurismal or floppy PFO and
RF energy applied to tighten the loose or septal tissue.
[0024] While this invention has been described in terms of specific
embodiments, other embodiments will become apparent to those
skilled in the art. Accordingly, the scope of the present invention
is not intended to be limited by the specific embodiments disclosed
herein, but rather, by the full scope of the claims.
* * * * *