U.S. patent application number 13/958773 was filed with the patent office on 2015-11-26 for apparatus for safe performance of transseptal technique and placement and positioning of an ablation catheter.
The applicant listed for this patent is TODD J. COHEN. Invention is credited to TODD J. COHEN.
Application Number | 20150335383 13/958773 |
Document ID | / |
Family ID | 44914967 |
Filed Date | 2015-11-26 |
United States Patent
Application |
20150335383 |
Kind Code |
A9 |
COHEN; TODD J. |
November 26, 2015 |
APPARATUS FOR SAFE PERFORMANCE OF TRANSSEPTAL TECHNIQUE AND
PLACEMENT AND POSITIONING OF AN ABLATION CATHETER
Abstract
A steerable catheter system to perform a transseptal puncture
procedure comprises a steerable catheter shaft with at least one
inner lumen, and an inner element slidably positioned within a
shaft lumen, wherein the distal tip of the shaft can be deflected,
counter-deflected, rotated, and counter-rotated and wherein the
inner element can be deployed or retracted. In one embodiment, a
single steerable catheter is capable of performing an intended
procedure and a transseptal procedure all in one, wherein the
catheter comprises an outer steerable catheter and an inner element
which can be deployed to perform a transseptal puncture, and
wherein, once the inner element crosses the inter-atrial septum,
the catheter itself can slide forward without advancement of the
inner element.
Inventors: |
COHEN; TODD J.; (Port
Washington, NY) |
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Applicant: |
Name |
City |
State |
Country |
Type |
COHEN; TODD J. |
Port Washington |
NY |
US |
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Prior
Publication: |
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Document Identifier |
Publication Date |
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US 20150038962 A1 |
February 5, 2015 |
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Family ID: |
44914967 |
Appl. No.: |
13/958773 |
Filed: |
August 5, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13105820 |
May 11, 2011 |
8500768 |
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13958773 |
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61333307 |
May 11, 2010 |
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Current U.S.
Class: |
606/41 |
Current CPC
Class: |
A61B 2018/00351
20130101; A61B 2218/002 20130101; A61M 25/0133 20130101; A61B
18/1492 20130101; A61M 25/0127 20130101; A61B 2018/00839 20130101;
A61B 34/73 20160201 |
International
Class: |
A61B 18/14 20060101
A61B018/14 |
Claims
1. A steerable catheter system to perform a transseptal puncture
procedure, comprising: a steerable catheter shaft having a proximal
portion, a distal portion, and at least one inner lumen; and an
inner element slidably positioned within a shaft lumen, wherein the
distal tip of the shaft can he deflected, counter-deflected,
rotated, and counter-rotated and wherein the inner element can be
deployed or retracted.
2. The catheter system of claim 1, which has a control handle
integral with the proximal portion.
3. The catheter system of claim 1, wherein deployment or retraction
of the inner element is controlled via a knob, button, lever, or
switch on the catheter handle.
4. The catheter system of claim 1, wherein deployment or retraction
of the inner element is controlled without a switch.
5. The catheter system of claim 1 in which the inner element which
is designed to safely engage and traverse the inter-atrial
septum.
6. The catheter system of claim 1 in which the inner element has
sensors to determine the appropriate location of the tip of the
inner element.
7. The catheter system of claim 6 in which the inner element
employs feedback from said sensors to guide the positioning of the
inner element and the delivery of the ablation catheter.
8. The catheter system of claim 6, wherein the sensors are magnetic
sensors to facilitate magnetic navigation of the distal portion of
the catheter.
9. The catheter system of claim 1 in which said inner element is
capable of recording and/or displaying essential information to
assure appropriate placement.
10. The catheter system of claim 1 in which said inner element
would be radio-opaque and trackable on fluoroscopy.
11. The catheter system of claim 1, wherein said inner element is a
needle comprising a tapered end, a guide wire, a stylet, or a probe
with an energy modality capable of generating a hole in the
septum.
12. The catheter system of claim 1, wherein said inner element is
conical and/or cylindrical.
13. The catheter system of claim 1, wherein said inner element
contains electrodes for recording contact with heart tissue.
14. The catheter system of claim 1 comprising a steerable catheter
with a shaft and handle and an inner element which when deployed
creates a target and protective shield larger than the tip of the
catheter and which is intended to guide another device on the other
side of the heart across the inter-atrial septum.
15. The catheter system of claim 14, wherein the catheter contains
one or more electrodes to electrically locate structures via a
myriad of imaging means (electrically, fluoroscopically,
nonfluoroscopically, and/or via intracardiac echocardiography).
16. The catheter system of claim 14, which, once the distal tip of
the catheter is positioned adjacent the inter-atrial septum, is
capable of deploying the inner element and of deploying a large
protective shield and target is deployed.
17. The catheter system of claim 16, wherein as on one side of the
heart a transseptal procedural system is delivered towards the
target and shield, the intent is to mate the two and at the same
time protect the inner element (including a transseptal
needle/stylet) from going beyond the shield and puncturing the wall
of the left atrium.
18. A single steerable catheter intended to perform an intended
procedure and a transseptal procedure all in one, wherein the
catheter comprises an outer steerable catheter with a control
handle and an inner element which can be deployed to perform a
transseptal puncture, and wherein, once the inner element crosses
the atrial septum, the catheter itself can slide forward without
advancement of the inner element.
19. The catheter of claim 18, wherein control on the handle can
deploy an inner element to cross the atrial septum and then allow
advancement over the inner element via said catheter.
20. A system which comprises a steerable catheter specifically
designed to deploy a barrier or shield to provide a target for a
transseptal needle, guide wire, stylet, or other puncture element
crossing from one side of the heart to the other side and to
protect cardiac tissue from damage.
21. The system of claim 20 which also comprises a steerable
catheter with a shaft and optionally a handle and an inner element
which when deployed creates a target and protective shield larger
than the tip of the catheter and which is intended to guide another
device on the other side of the heart across the inter-atrial
septum.
22. The system of claim 21, wherein the catheter contains one or
more electrodes to electrically locate structures via an imaging
modality.
23. The system of claim 22, wherein the image modality is
electrically, fluoroscopically, non-fluoroscopically, 3-D mapping,
intracardiac echocardiography, or a combination of two or more
thereof.
24. The system of claim 21, which, once the distal tip of the
catheter is positioned adjacent the inter-atrial septum, is capable
of deploying the inner element and of deploying a large protective
shield and target.
25. The system of claim 21, wherein as on one side of the heart a
transseptal procedural system is delivered towards the target and
shield, the intent is to mate the target and shield and at the same
time protect the inner element from going beyond the shield and
puncturing the wall of the left atrium.
26. The system of claim 25, wherein the inner element is a
transseptal needle, guide wire, or stylet.
27. A cardiac transseptal system comprising: a first catheter for
deploying a transseptal element and crossing the inter-atrial
septum and having a distal end, and a second catheter for providing
protection and covering the element and having a distal end,
wherein each catheter has one or more coils at its distal end and
the magnetic fields of the distal ends of the two catheters are
configured to draw both catheters together at or near the
inter-atrial septum.
28. The system of claim 27 wherein one catheter is an ablation
catheter and the other catheter is an introducer sheath.
29. The system of claim 27, wherein the catheters are configured
such that one catheter can slide into the other and the larger
catheter can cross the septum and provide access through its inner
lumen to the other side of the heart.
30. A method to safely perform transseptal puncture which comprises
crossing an apparatus from the left-atrium across the inter-atrial
septum into the right atrium.
31. A method for safely transversing an inter-atrial septum, which
comprises: advancing a distal end of a catheter having a lumen into
the left atrium of a patient so that the distal end contacts the
inter-atrial septum; advancing a distal end of a guide wire through
the distal end of the catheter across the inter-atrial septum into
the patient's right atrium; advancing the distal end of the guide
wire distally to a point where a sheath having a distal end can he
engaged; and advancing the sheath over the guide wire so that the
distal end of the sheath enters the left atrium.
32. The method of claim 31, wherein magnetic navigation is used to
position the distal end of the catheter in the left atrium.
33. The method of claim 31, wherein the catheter is advanced across
the inter-atrial septum and the sheath is advanced over the
catheter.
34. The method of claim 31, wherein the guide wire and/or catheter
are withdrawn.
35. The method of claim 31, wherein the sheath is a long,
right-sided transseptal sheath.
36. The method of claim 31, wherein a guide wire, needle, stylet,
or RF or other modality punctures the inter-atrial septum.
37. A method for safely transversing an inter-atrial septum, which
comprises: advancing a distal end of a first catheter having
magnetic coils and having a lumen into the left atrium of a patient
so that the distal end contacts the inter-atrial septum; advancing
a distal end of second catheter having magnetic coils and a lumen
into the right atrium of a patient so that the distal end of the
catheter contacts the inter-atrial septum; advancing a guide wire
through the distal end of the first catheter across the
inter-atrial septum into the lumen of the second catheter;
advancing the distal end of the guide wire distally to a point
where a sheath or dilator having a distal end can be engaged; and
advancing the sheath or dilator over the guide wire so that the
distal end of the sheath or dilator enters the left atrium,
38. The method of claim 37, wherein magnetic navigation is used to
position the distal ends of the catheters.
39. The method of claim 37, wherein the first catheter is advanced
across the inter-atrial septum and the sheath or dilator is
advanced over the catheter.
40. The method of claim 37, wherein the guide wire and/or first
catheter are withdrawn.
41. The method of claim 37, wherein the sheath is a long,
right-sided transseptal sheath.
42. The method of claim 37, wherein a guide wire, needle, stylet,
or RF modality punctures the inter-atrial septum.
43. A steerable catheter system to perform a transseptal puncture,
mapping, and ablation procedure, comprising: a steerable catheter
shaft having a proximal portion, a distal portion, and at least one
inner lumen; a control handle integral with the proximal portion;
and an inner element slidably positioned within a shaft lumen,
wherein the distal tip of the shaft can be deflected,
counter-deflected, rotated, and/or counter-rotated and wherein the
inner element can be deployed or retracted.
44. The catheter system of claim 43, wherein deployment or
retraction of the inner element is controlled via a knob, button,
lever, or switch on the catheter handle.
45. The catheter system of claim 43, wherein deployment or
retraction of the inner element is controlled without a switch.
46. The catheter system of claim 43 in which said catheter contains
at least one distal electrode
47. The catheter system of claim 43 in which said catheter contains
at least two recording electrodes
48. The catheter system of claim 47 in which said distal electrode
permits the passage of an inner element for the purpose of crossing
the inter-atrial septum.
49. The catheter system of claim 47 in which at least one of the
electrodes could be used to perform a catheter ablation
procedure.
50. The catheter system of claim 47 in which the distal electrode
is enlarged and/or irrigated to perform radiofrequency catheter
ablation.
51. The catheter system of claim 43 in which an inner element which
is designed to safely engage and traverse the inter-atrial
septum.
52. The catheter system of claim 43 in which the distal electrode
has a central lumen for passage of the inner element.
53. The catheter system of claim 43 in which the inner element is
designed for easy and safe passage across the inter-atrial
septum.
54. The catheter system of claim 53 in which the inner element has
sensors to determine the appropriate location of the tip of the
inner element.
55. The catheter system of claim 53 in which the inner element
employs feedback from said sensors to guide the positioning of the
inner element and the delivery of the ablation catheter.
56. The catheter system of claim 43 in which said inner element
could record and help display essential information to assure
appropriate placement.
57. The catheter system of claim 43 in which said inner element
would be radio-opaque and trackable on fluoroscopy.
58. The catheter system of claim 43, wherein said inner element is
a needle consisting of a tapered end.
59. The catheter system of claim 43, wherein said inner element is
conical or cylindrical.
60. The catheter system of claim 43, wherein said inner element
contains electrodes for recording contact with heart tissue.
61. The system of claim 43, wherein a steerable catheter with inner
deployable and retractable inner transseptal element is delivered
via an arterial approach via the retrograde aortic approach (male
component) and the tip is placed in the left atrium; wherein a
right-sided, larger inner diameter female mating guide catheter is
positioned from the venous approach and placed in the right atrium;
wherein the two catheters are guided towards one another to
identify the inter-atrial septum; wherein, once identified, the
steerable left-sided catheter's transseptal member is deployed
across the septum and within the right-sided guide catheter;
wherein the steerable catheter is then advanced (without advancing
the inner element) into the guide catheter and then the guide
catheter is advanced across the septum into the left atrium; and
wherein the left-sided catheter is then removed, and an ablation
catheter is then placed into the right-sided guide catheter and
delivered into the left atrium.
62. A single steerable catheter intended to perform catheter
ablation and the transseptal procedure all in one, wherein the
ablation catheter comprises an outer steerable catheter with a
controllable handle and an inner element which can be deployed to
perform a transseptal puncture, and wherein, once the inner element
crosses the atrial septum, the catheter itself can slide forward
without advancement of the inner element.
63. The catheter of claim 62, wherein control on the handle can
deploy an inner element to cross the atrial septum and then allow
advancement over the inner element via said catheter.
64. An apparatus which comprises a steerable catheter specifically
designed to deploy a barrier or shield to provide a target for a
transseptal needle or element crossing from one side of the heart
to the other and to protect cardiac tissue from damage.
65. A cardiac transseptal system comprising: a catheter for
deploying a transseptal element and crossing the inter-atrial
septum; and a catheter for providing protection and covering the
element, wherein each catheter has one or more coils at its distal
end and the magnetic fields of the two catheters are configured to
draw both catheters together at or near the inter-atrial
septum.
66. The system of claim 65, wherein one catheter is an ablation
catheter and the other catheter is an introducer sheath.
67. The system of claim 65, wherein the catheters are configured
such that one catheter can slide into the other and the larger
catheter can cross the septum and provide access through its inner
lumen to the other side of the heart.
68. A system and method to safely perform transseptal puncture in
which an apparatus is designed and employed from the left-atrium
across the atrial septum into the right atrium.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of co-pending, commonly
assigned, U.S. patent application Ser. No. 13/105,820, filed May
11, 2011, which in turn is based upon and claims the benefit of the
filing date of U.S. Provisional Patent Application Ser. No.
61/333,307, filed May 11, 2010, each of which is incorporated
herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] This application is directed to safe performance of
transseptal technique. More particularly, this invention relates to
the safe performance of transseptal technique and the placement and
positioning of a left-side therapy and/or device such as an
ablation catheter, left atrial appendage occlusive device,
percutaneous valve or clip, or some other left-sided cardiac
procedure, such as valvuloplasty.
BACKGROUND OF THE INVENTION
[0003] The performance of a transseptal procedure is an essential
part of a number of left-sided procedures for left-side therapy
and/or device such as an ablation catheter, left atrial appendage
occlusive device, percutaneous valve or clip, or some other
left-sided cardiac procedure, such as valvuloplasty although
currently used most frequently for percutaneous catheter ablation
of atrial fibrillation. To successfully ablate and isolate the
pulmonary veins (and other structures within the left atrium), a
transseptal needle is typically advanced from the femoral vein into
the right atrium and across the inter-atrial septum to place a long
sheath into the left atrium. Such a sheath is necessary to position
an ablation catheter in the left atrium and access left atrium
tissue, including the pulmonary veins.
[0004] Many of these transseptal and ablation procedures are
performed under administration of therapeutic warfarin, which
subjects the patient to additional bleeding risks from the
transseptal and/or ablation procedures. Even if anatomical
landmarks are used with fluoroscopic guidance (i.e., catheter
visualization) and intracardiac echocardiography, there are
significant risks. Cardiac perforation with resultant life
threatening cardiac tamponade (the filling of fluid into the sac
around the heart which impedes blood flow out of the heart) has
been reported in one percent of these patients.
[0005] Patients with paroxysmal atrial fibrillation may have fairly
normal cardiac substrates with normal sized left atriums. The
pressure that results from tenting of the foramena of the
inter-atrial septum and the recoil of the needle (and lack of
control as it penetrates cardiac tissue) has lead to the research
and development of safer approaches for the transseptal and
catheter ablation procedures.
[0006] In one approach a small needle within a J wire is used with
the hope of blunting needle access in the left atrium. Even with
this approach it is still possible to puncture the aorta or some
other inadvertent tissue.
[0007] One problem with the standard transseptal approach is the
mere fact that the needle travels from the safer right side of the
heart to the more precarious left side of the heart. Structures
that are at risk include: (1) the aorta, its root, and structures;
(2) the left atrial wall; and (3) a coronary artery or vein.
[0008] A number of newer procedures may be performed by cardiac
interventionalists who are much more comfortable with the
retrograde aortic approach to the left heart than a standard
right-sided septal approach. These doctors will want to place left
atrial occlusive devices (such as the WATCHMAN.RTM. left atrial
appendage closure technology from Boston Scientic Corporation) and
perform left-sided valve procedures percutaneously (clips/valve
repairs or replacements). A simple and safe retrograde approach
would allow these doctors to utilize their left-sided skills and
thereby minimize complications rather than learn and perform the
more risky and right-sided transseptal approach.
OBJECTS OF THE INVENTION
[0009] It is an object of this invention to provide a safer
transseptal technique.
[0010] It is also an object of this invention to provide a method
and device for positioning and placement of an ablation catheter,
or any other left atrial/left heart device placement, therapy, or
procedure.
[0011] It is a further object of this invention to provide a system
and method of simultaneously operating on both sides of the heart
(right and left), with the potential to "mate" both sides to
enhance the safety and performance of a transseptal procedure and
improve on the stability of a catheter (or catheters) within the
heart. The mating can use fluoroscopy. 3-D mapping, tracers,
transducers, and/or magnetic guidance/coupling.
[0012] This and other objects of the invention will become more
apparent in the discussion below.
SUMMARY OF THE INVENTION
[0013] According to the invention, the risk of inadvertent
perforation or the aorta, the left atrium, and other structures,
can be minimized. To accomplish this goal, a catheter according to
the invention incorporates a retractable inner element into, for
example, an ablation catheter itself. This catheter is similar to a
standard radiofrequency ablation catheter. However, the catheter
comprises an inner element which can be advanced and/or retracted
to perform the transseptal procedure within a single system. Such a
catheter vastly simplifies the procedure and permits a safe,
controlled transseptal approach (perhaps without the need for a
long introducer sheath). This system places the catheter in a more
standard fashion (i.e., from the right side).
[0014] An ablation catheter useful according to the invention has
distal electrodes and is positioned in the right atrium near the
foramen ovule. Good atrial contract is confirmed via an atrial
electrogram as well as fluoroscopic position. Intracardiac
echocardiography and/or non-fluoroscopic 3-D mapping can also
assure the location. Once the foramen ovule is tented, a lever in
the middle of the catheter control handle is slid forward to
advance a firm inner element of small diameter, which can puncture
the septum in a controlled fashion. Once across the septum the
catheter can be advanced without advancing the inner element (the
inner element maintains its position within the catheter lumen).
Finally, the inner element can he retracted, which facilitates safe
manipulation of the catheter and placement of the procedural and/or
therapy device directly into the left atrium. This catheter itself
could be an ablation catheter with a self-contained controllable
transseptal puncture mechanism.
[0015] In another embodiment of the invention, a left-side
"protective" catheter is designed to guide, shield, and protect
left-sided heart structures during a standard transseptal needle
puncture (performed from the right side of the heart). In essence,
the left-sided catheter can help with left atrial imaging and
location and serve as a protective shield to guide and "catch" a
needle, stylet, or wire as it is delivered across the inter-atrial
septum. Placement of this "protective" catheter using the standard
imaging techniques will not be in the aorta and could abut up
against the inter-atrial septum from the left side and can press
against the septum and/or sheath, catheter, and/or transseptal
puncture system on the right side to assure a septal location.
[0016] The protective catheter can be steered manually or
robotically (i.e., remote mechanical or magnetic navigation) from
the femoral artery (or another artery) up the aorta via the
retrograde aortic approach using fluoroscopic guidance or some
other imaging means across the aortic valve, and into the left
ventricle. The catheter would then be positioned across the mitral
valve into the left atrium and steered towards the inter-atrial
septum on the left side. A protective shield would be deployed from
the distal tip of the protective catheter and the location used to
guide and protect the delivery of the transseptal needle from the
right atrium to the left atrium. Once the needle crosses the
septum, it could safely hit the deployed shield. The
guidewire/sheath could be safely placed, and left atrial and aortic
perforation is thereby minimized. Alternatively, a protective
catheter could be placed on the right side to protect the reverse
transseptal procedure initialed from the left side as described
below. Also, a protective catheter on one side could interact with
a magnetically driven or robotically driven protective system on
the other side of the heart.
[0017] In another embodiment of the invention, the transseptal
approach could be performed via an entirely different approach,
namely, from the left side. A catheter with a lumen or a
retractable right atrial access system could be placed via standard
steerable means including manual manipulation or remote mechanical
or magnetic navigation (via the retrograde aortic approach) into
the left atrium and positioned towards the inter-atrial septum. One
embodiment of the catheter could generate a signal from a distal
tip electrode to confirm the electrical position (although the
electrode is not an absolute requirement). Fluoroscopy or an
internal imaging system (such as intracardiac echocardiography) or
non-fluoroscopic 3-D imaging could record the catheter's location.
Once in position, and pointed towards the right atrium, an inner
element from a transseptal access system can be deployed and safely
enter the right atrium. This inner element could be a retractable
needle/stylet, or a guidewire, needle, or a combination thereof, or
some other access system which can generate a hole in the atrial
system in order to place an introducer sheath to permit placement
of a therapy device with easy maneuverability within the left
atrium. Once this occurs and entry is confirmed, a long introducer
sheath introduced into the right atrium can be engaged, the
catheter/wire can slide into the sheath, and the sheath could be
advanced into the left atrium. The left atrial to right atrial
directionality of a transseptal procedure would require a new set
of tools (herein described) and provide a potentially safer
procedure (due to the force vector of septal perforation pointing
towards safer lower pressured structures).
[0018] A male/female left/right heart apparatus could be designed
for protective and safe access in which the transseptal procedure
is initiated on the left side. A needle or fine guide wire or
stylet/steerable catheter system designed for steerability on the
left side of the heart with at least the ability to steer and
deflect a catheter across two cardiac valves via the retrograde
aortic approach can be utilized. Such a catheter can consist of a
distal electrode to confirm specific type of tissue contact and the
degree of contact. An inner deployable element can be used to
perform the transseptal puncture. Once performed the catheter can
be advanced into the female (long sheath) on the right side of the
heart and the needle inside the catheter retracted. The sheath than
can slide forward over the catheter into the left atrium and the
inner left-sided catheter could then be withdrawn.
[0019] The above system has the following unique elements: First,
the transseptal approach is from the left to the right side of the
heart (which is opposite of the standard approach). And second, the
catheter designed for transseptal puncture has specific
steerability that would allow precise deflection
(counter-deflection) and rotation (and counterclockwise rotation).
This catheter could also be designed for magnetic navigation with
an inner lumen or inner or distal puncture mechanism to facilitate
the transseptal puncture or access. The catheter could be advanced
through a standard vascular introducer sheath. The central core of
the catheter design will be hollow to either encompass a separate
deployable/retractable transseptal system. This system could he
contained within the design of said catheter, and its deployment
and retraction could be precisely controlled with a lever, knob,
switch or controller contained within the handle. The transseptal
system could have a limited access cable/wire/needle in which the
needle and not the catheter is advanced by a predetermined
distance. An element within the cable/wire/needle could test for
pressure/flow/0.sub.2 saturation and confirm right atrium entry. In
addition, the inner element/lumen could be a stylet and/or needle
and could be switched out for a guide wire, or a combination
thereof.
[0020] Ultrasound imaging is also possible from this inner guide.
This inner element also has similar recording elements and
properties for the systems described. Once across in the right
atrium the catheter could be advanced into a long sheath or
steerable sheath which would mate with the catheter. The sheath
could then advance across the atrial septum into the left atrium,
and the left atrial catheter could then be removed.
[0021] An essential element of this system is the need for right
and left-sided apparatuses to "mate." It is even conceivable that
the left-sided system could cross over to the right and secure a
right-sided element and pull it across into the left atrium. Once
across, the sheath can than be advanced across the septum over the
apparatus which served as a guide. For example, two magnetically
coupled right and left sided devices could be used to draw the male
and female elements into close proximity to facilitate a
transseptal procedure. A magnetic long sheath (with or without
steerability) could be placed from the right side in the atrium and
a catheter (possibly magnetically driven and navigated) for
performing the transeptal could be placed on the left side of the
heart. The magnetic fields created by the two devices (at least one
being magnetic or the other ferro-magnetic, i.e., magnet to magnet
or magnet to a metal attracted to a magnet) could pull the tips
together at the inter-atrial septum. The transseptal procedure
could then be performed, the two devices coupled, and the
introducer slid over the catheter or a guide wire in order to
provide an entry access point for an ablation catheter into the
left atrium. Alternatively, mechanical mechanisms for the
attachment and release of the right and left sided catheters may
help with either the transseptal or ablation procedure.
[0022] A control handle located at the proximal end of an ablation
catheter having an inner element will have a catheter lever which
can be used to control the delivery of the inner element to perform
a transseptal procedure. When the catheter lever is polled
backward, the inner element is retracted from the tip of the
catheter. When the catheter lever is pushed forward, the inner
element is deployed such that a transseptal procedure is performed.
The lever could also work in the reverse direction. A stiff inner
element of small diameter could easily pierce the inter-atrial
septum and facilitate catheter access across the septum.
[0023] In another embodiment of the invention, a steerable catheter
system to perform a transseptal puncture procedure, comprises:
[0024] a steerable catheter shaft having a proximal portion, a
distal portion, and at least one inner lumen, [0025] optionally a
control handle integral with the proximal portion, and [0026] an
inner element slidably positioned within a shaft lumen, [0027]
wherein the distal tip of the shaft can be deflected,
counter-deflected, rotated, and counter-rotated and wherein the
inner element can he deployed, or retracted.
[0028] In another embodiment of a catheter system of the invention,
deployment or retraction of the inner element is controlled via a
knob, button, lever, or switch on the catheter handle.
[0029] In another embodiment of a catheter system of the invention,
deployment or retraction of the inner element is controlled without
a switch.
[0030] In another embodiment of a catheter system of the invention,
the inner element which is designed to safely engage and traverse
the inter-atrial septum.
[0031] In another embodiment of a catheter system of the invention,
the inner element has sensors to determine the appropriate location
of the tip of the inner element.
[0032] In another embodiment of a catheter system of the invention,
the inner element employs feedback from said sensors to guide the
positioning of the inner element and the delivery of the ablation
catheter.
[0033] In another embodiment of a catheter system of the invention,
the sensors are magnetic sensors to facilitate magnetic navigation
of the distal portion of the catheter.
[0034] In another embodiment of a catheter system of the invention,
the inner element is capable of recording and/or displaying
essential information to assure appropriate placement.
[0035] In another embodiment of a catheter system of the invention,
the inner element would be radio-opaque and trackable on
fluoroscopy.
[0036] In another embodiment of a catheter system of the invention,
the inner element is a needle comprising a tapered end, a guide
wire, a stylet, or a modality capable of generating a hole such as
an RF, laser, or other energy probe.
[0037] In another embodiment of a catheter system of the invention,
the inner element is conical and/or cylindrical.
[0038] In another embodiment of a catheter system of the invention,
the inner element contains electrodes for recording contact with
heart tissue.
[0039] In another embodiment of the invention, a single steerable
catheter is intended to perform an intended procedure and a
transseptal procedure all in one, wherein the catheter comprises an
outer steerable catheter optionally with a control handle and an
inner element which can be deployed to perform a transseptal
puncture, and wherein, once the inner element crosses the
inner-atrial septum, the catheter itself can slide forward without
advancement of the inner element.
[0040] In another embodiment of a catheter of the invention,
control on the handle can deploy an inner element to cross the
atrial septum and then allow advancement over the Inner element via
said catheter.
[0041] In another embodiment of the invention, a system safely
performs transseptal puncture in which an apparatus is capable of
being employed from the left-atrium across the atrial septum into
the right atrium.
[0042] In another embodiment of a system of the invention, the
system comprises: [0043] a steerable catheter with an inner
deployable and retractable transseptal element, and [0044] a
right-sided, larger inner diameter female mating guide catheter,
[0045] wherein the two catheters are capable of being guided
towards one another to identify the inter-atrial septum, the
steerable left-sided catheter's transseptal member being deployed
across the septum and within the right-sided guide catheter, the
steerable catheter then being advanced, without advancing the inner
element, into the guide catheter, and then the guide catheter is
advanced across the septum into the left atrium.
[0046] In another embodiment of an apparatus of the invention, an
apparatus comprises a steerable catheter specifically designed to
deploy a harrier or shield to provide a target for a transseptal
needle, guide wire, stylet, or other puncture element crossing from
one side of the heart to the other and to protect cardiac tissue
from damage.
[0047] In another embodiment of a catheter system of the invention,
the system comprises a steerable catheter with a shaft and optional
handle and an inner element which when deployed creates a target
and protective shield larger than the tip of the catheter and which
is intended to guide another device on the other side of the heart
across the inter-atrial septum.
[0048] In another embodiment of a catheter system of the invention,
the catheter contains one or more electrodes to electrically locate
structures via an imaging modality.
[0049] In another embodiment of a catheter system of the invention,
the image modality is electrically, fluoroscopically,
non-fluoroscopically, intracardiac echocardiography, or a
combination of two or more thereof.
[0050] In another embodiment of a catheter system of the invention,
once the distal tip of the catheter is positioned adjacent the
inter-atrial septum, the system is capable of deploying the inner
element and of deploying a large protective shield and target is
deployed.
[0051] In another embodiment of a catheter system of the invention,
wherein as on one side of the heart a transseptal procedural system
is delivered towards the target and shield, the intent is to mate
the two and at the same time protect the inner element from going
beyond the shield and puncturing the wall of the left atrium.
[0052] In another embodiment of a catheter system of the invention,
the inner element is a transseptal needle, guide wire, or stylet or
an energy-generating probe capable of creating a hole, such as an
RF or laser probe.
[0053] In another embodiment of the invention, a cardiac
transseptal system comprises: [0054] a first catheter for deploying
a transseptal element and crossing the inter-atrial septum and
having a distal end, and [0055] a second catheter for providing
protection and covering the element and having a distal end, [0056]
wherein each catheter has one or more coils at its distal end and
the magnetic fields of the distal ends of the two catheters are
configured to draw both catheters together at or near the
inter-atrial septum.
[0057] In another embodiment of a transseptal system of the
invention, one catheter is an ablation catheter and the other
catheter is an introducer sheath.
[0058] In another embodiment of a transseptal system of the
invention, the catheters are configured such that one catheter can
slide into the other and the larger catheter can cross the septum
and provide access through its inner lumen to the other side of the
heart.
[0059] In another embodiment of the invention, a system to safely
perform transseptal puncture comprises an apparatus capable of
crossing from the left-atrium across the inter-atrial septum into
the right atrium.
[0060] In another embodiment of invention, a method to safely
perform transseptal puncture comprises crossing an apparatus from
the left-atrium across the inter-atrial septum into the right
atrium, or vice versa.
[0061] In another embodiment of a catheter system of the invention,
the system comprises a pair of right and left heart catheters
designed to mechanically mate, wherein the two catheters are
configured to draw both catheters together at or near the
inter-atrial septum, wherein a mechanical element from a catheter
on one side of the heart can grab and pull a second element from
the other side of the heart to enhance the performance of a
specific function, and wherein once the task is performed the
pulling catheter can release the second catheter and both catheters
can perform independent tasks or be withdrawn from the heart and
circulatory system.
[0062] In another embodiment of a system of the invention, the
function is a transseptal procedure.
[0063] In another embodiment of a system of the invention, the
function is an ablation procedure.
[0064] In another embodiment of a system of the invention, two
units can be configured such that one unit can slide into the other
and the larger unit can cross the septum and provide access through
its inner lumen to the other side of the heart.
[0065] In another embodiment of a system of the invention, a
steerable catheter with an inner deployable and retractable inner
transseptal element is delivered via an arterial approach via the
retrograde aortic approach (male component) and the tip is placed
in the left atrium; wherein a right-sided, larger inner diameter
female mating guide catheter is positioned from the venous approach
and placed in the right atrium; wherein the two catheters are
guided towards one another to identify the inter-atrial septum;
wherein, once identified, the steerable left-sided catheter's
transseptal member is deployed across the septum and within the
right-sided guide catheter; wherein the steerable catheter is then
advanced, without advancing the inner element, into the guide
catheter and then the guide catheter is advanced across the septum
into the left atrium; and wherein the left-sided catheter is then
removed, and an ablation catheter is then placed into the
right-sided guide catheter and delivered into the left atrium. Or
vice versa.
[0066] In another embodiment of a system of the invention, securing
the distal ends of two catheters together provides additional
functionality selected from the group consisting of strength,
maneuverability, and stability within the heart.
[0067] In another embodiment of the invention, a method for safely
transversing an inter-atrial septum, comprises: [0068] advancing a
distal end of a catheter having a lumen into the left atrium of a
patient so that the distal end contacts the inter-atrial septum;
[0069] advancing a distal end of a guide wire through the distal
end of the catheter across the inter-atrial septum into the
patient's right atrium; [0070] advancing the distal end of the
guide wire distally to a point where a sheath having a distal end
can be engaged; [0071] advancing the sheath over the guide wire so
that the distal end of the sheath enters the left atrium.
[0072] In another embodiment of a method of the invention, magnetic
navigation is used to position the distal end of the catheter in
the left atrium.
[0073] In another embodiment of a method of the invention, the
catheter is advanced across the inter-atrial septum and the sheath
is advanced over the catheter.
[0074] In another embodiment of a method of the invention, the
guide wire and/or catheter are withdrawn.
[0075] In another embodiment of a catheter system of the invention,
the sheath is a long, right-sided transseptal sheath.
[0076] In another embodiment of a catheter system of the invention,
a guide wire, needle, stylet, or RF (or other energy) modality
punctures the inter-atrial septum.
[0077] In another embodiment of a catheter system of the invention,
a method for safely transversing an inter-atrial septum, comprises:
[0078] advancing a distal end of a first catheter having magnetic
coils and having a lumen into the left atrium of a patient so that
the distal end contacts the inter-atrial septum; [0079] advancing a
distal end of second catheter having magnetic coils and a lumen
into the right atrium of a patient so that the distal end of the
catheter contacts the inter-atrial septum; [0080] advancing a guide
wire through the distal end of the first catheter across the
inter-atrial septum into the lumen of the second catheter; [0081]
advancing the distal end of the guide wire distally to a point
where a sheath or dilator having a distal end can be engaged; and
[0082] advancing the sheath or dilator over the guide wire so that
the distal end of the sheath or dilator enters the left atrium.
[0083] In another embodiment of a catheter system of the invention,
magnetic navigation is used to position the distal ends of the
catheters.
[0084] In another embodiment of a catheter system of the invention,
the first catheter is advanced across the inter-atrial septum and
the sheath or dilator is advanced over the catheter.
[0085] In another embodiment of a catheter system of the invention,
the guide wire and/or first catheter are withdrawn.
[0086] In another embodiment of a catheter system of the invention,
the sheath is a long, right-sided transseptal sheath.
[0087] In another embodiment of the invention, a steerable catheter
system to perform a transseptal puncture, mapping, and ablation
procedure, comprises: [0088] a steerable catheter shaft having a
proximal portion, a distal portion, and at least one inner lumen,
[0089] an optional control handle integral with the proximal
portion, and [0090] an inner element slidably positioned within a
shaft lumen, [0091] wherein the distal tip of the shaft can he
deflected, counter-deflected, rotated, and counter-rotated and
wherein the inner element can be deployed or retracted.
[0092] In another embodiment of a catheter system of the invention,
deployment or retraction of the inner element is controlled via a
knob, button, lever, or switch on the catheter handle.
[0093] In another embodiment of a catheter system of the invention,
deployment or retraction of the inner element is controlled without
a switch.
[0094] In another embodiment of a catheter system of the invention,
the catheter contains at least one distal electrode
[0095] In another embodiment of a catheter system of the invention,
the catheter contains at least two recording electrodes
[0096] In another embodiment of a catheter system of the invention,
the distal electrode permits the passage of an inner element for
the purpose of crossing the inter-atrial septum.
[0097] In another embodiment of a catheter system of the invention,
at least one of the electrodes could be used to perform a catheter
ablation procedure.
[0098] In another embodiment of a catheter system of the invention,
the distal electrode is enlarged and/or irrigated to perform
radiofrequency catheter ablation.
[0099] In another embodiment of a catheter system of the invention,
an inner element which is designed to safely engage and traverse
the inter-atrial septum.
[0100] In another embodiment of a catheter system of the invention,
the distal electrode has a central lumen for passage of the inner
element.
[0101] In another embodiment of a catheter system of the invention,
the inner element is designed for easy and safe passage across the
inter-atrial septum.
[0102] In another embodiment of a catheter system of the invention,
the inner element has sensors to determine the appropriate location
of the tip of the inner element.
[0103] In another embodiment of a catheter system of the invention,
the inner element employs feedback from said sensors to guide the
positioning of the inner element and the delivery of the ablation
catheter.
[0104] In another embodiment of a catheter system of the invention,
the inner element could record and help display essential
information to assure appropriate placement.
[0105] In another embodiment of a catheter system of the invention,
the inner element would be radio-opaque and trackable on
fluoroscopy.
[0106] In another embodiment of a catheter system of the invention,
the inner element is a needle consisting of a tapered end.
[0107] In another embodiment of a catheter system of the invention,
the inner element is conicaland/or cylindrical.
[0108] In another embodiment of a catheter system of the invention,
the inner element contains electrodes for recording contact with
heart tissue.
[0109] In another embodiment of the invention, a single steerable
catheter is intended to perform catheter ablation and the
transseptal procedure all in one, wherein the ablation catheter
comprises an outer steerable catheter with a controllable handle
and an inner element which can be deployed to perform a transseptal
puncture, and wherein, once the inner element crosses the atrial
septum, the catheter itself can slide forward without advancement
of the inner element.
[0110] In another embodiment of a catheter system of the invention,
control on the handle can deploy an inner element to cross the
atrial septum and then allow advancement over the inner element via
said catheter.
[0111] In another embodiment of a catheter system of the invention,
a system to safely perform transseptal puncture comprises an
apparatus is capable of being employed from the left-atrium across
the atrial septum into the right atrium, or vice versa.
[0112] In another embodiment of a catheter system of the invention,
the system comprises: [0113] a steerable catheter with an inner
deployable and retractable transseptal element, and [0114] a
right-sided, larger inner diameter female mating guide catheter.
[0115] wherein the two catheters are capable of being are guided
towards one another to identify the inter-atrial septum, the
steerable left-sided catheter's transseptal member being deployed
across the septum and within the right-sided guide catheter, the
steerable catheter then being advanced, without advancing the inner
element, into the guide catheter, and then the guide catheter is
advanced across the septum into the left atrium.
[0116] In another embodiment of the invention, an apparatus
comprises a steerable catheter specifically designed to deploy a
barrier or shield to provide a target for a transseptal needle or
element crossing from one side of the heart to the other and to
protect cardiac tissue from damage.
[0117] In another embodiment of a catheter system of the invention,
the system comprises a steerable catheter with a shaft and handle
and an inner element which when deployed creates a target and
protective shield larger than the tip of the catheter and which is
intended to guide another device on the other side of the heart
across the inter-atrial septum.
[0118] In another embodiment of a catheter system of the invention,
the catheter contains one or more electrodes to electrically locate
structures via a myriad of imaging means (electrically,
fluoroscopically, nonfluoroscopically, 3-D mapping, and/or via
intracardiac echocardiography).
[0119] In another embodiment, of a catheter system of the
invention, once the distal tip of the catheter is positioned
adjacent the inter-atrial septum, is capable of deploying the inner
element and of deploying a large protective shield and target is
deployed.
[0120] In another embodiment of a catheter system of the invention,
wherein as on one side of the heart a transseptal procedural system
is delivered towards the target and shield, the intent is to mate
the two and at the same time protect the inner element (including a
transseptal needle/stylet) from going beyond the shield and
puncturing the wall of the left atrium.
[0121] In another embodiment of a system of the invention, a
cardiac transseptal system comprises: [0122] a catheter for
deploying a transseptal element and crossing the inter-atrial
septum, and [0123] a catheter for providing protection and covering
the element, [0124] wherein each catheter has one or more coils at
its distal end and the magnetic fields of the two catheters are
configured to draw both catheters together at or near the
inter-atrial septum.
[0125] In another embodiment of a system of the invention, one
catheter is an ablation catheter and the other catheter is an
introducer sheath.
[0126] In another embodiment of a system of the invention, the
catheters are configured such that one catheter can slide into the
other and the larger catheter can cross the septum and provide
access through its inner lumen to the other side of the heart.
[0127] In another embodiment of the invention, a system and method
safely perform transseptal puncture in which an apparatus is
designed and employed from the left-atrium across the atrial septum
into the right atrium.
[0128] In another embodiment of a catheter system of the invention,
a system comprises a pair of right and left heart catheters
designed to mechanically mate, wherein the two catheters are
configured to draw both catheters together at or near the
inter-atrial septum, wherein a mechanical element from a catheter
on one side of the heart can grab and pull a second element from
the other side of the heart to enhance the performance of a
specific function, and wherein once the task is performed the
pulling catheter can release the second catheter and both catheters
can perform independent tasks or be withdrawn from the heart and
circulatory system.
[0129] In another embodiment of a catheter system of the invention,
the function is a transseptal procedure.
[0130] In another embodiment of a catheter system of the invention,
the function is an ablation procedure.
[0131] In another embodiment of a catheter system of the invention,
two units can be configured such that one unit can slide into the
other and the larger unit can cross the septum and provide access
through its inner lumen to the other side of the heart.
[0132] In another embodiment of a catheter system of the invention,
a steerable catheter with inner deployable and retractable inner
transseptal element is delivered via an arterial approach via the
retrograde aortic approach (male component) and the tip is placed
in the left atrium; wherein a right-sided, larger inner diameter
female mating guide catheter is positioned from the venous approach
and placed in the right atrium; wherein the two catheters are
guided towards one another to identify the inter-atrial septum;
wherein, once identified, the steerable left-sided catheter's
transseptal member is deployed across the septum and within the
right-sided guide catheter; wherein the steerable catheter is then
advanced (without advancing the inner element) into the guide
catheter and then the guide catheter is advanced across the septum
into the left atrium; and wherein the left-sided catheter is then
removed, and an ablation catheter is then placed into the
right-sided guide catheter and delivered into the left atrium.
[0133] In another embodiment of a catheter system of the invention,
securing the distal ends of two catheters together provides
additional functionality selected from the group consisting of
strength, maneuverability, and stability within the heart.
BRIEF DESCRIPTION OF THE DRAWINGS
[0134] FIG. 1 is a schematic representation of an embodiment of a
catheter system useful according to the invention;
[0135] FIG. 2 is a schematic representation of a detail
representing another embodiment of the invention;
[0136] FIGS. 3A to 3C are schematic representations of the distal
tip of a catheter useful according to the invention;
[0137] FIG. 4 is a schematic representation of a further embodiment
of the Invention;
[0138] FIG. 5 is a schematic representation of yet another
embodiment of the invention;
[0139] FIGS. 6A to 6E are schematic representations of a yet
further embodiment of the invention; and
[0140] FIGS. 7 to 7D are schematic representations of a yet further
embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0141] The invention can perhaps be better appreciated by referring
to the Drawings. In FIG. 1, an ablation catheter 2 comprises a
steerable catheter shaft 4, a proximal portion 6, and a distal
portion 8. Proximal portion 6 comprises a control handle 12, to
provide deflection, rotation, and articulation to distal portion 8.
Control handle 12 has a deflection knob 14 and a counter-deflection
knob 16. Distal portion 8 comprises at least two electrodes 20 and
the distal portion of a retractable inner element 22. Inner element
22 is controlled by a lever 24 in or on control handle 12. When
lever 24 is slid in the distal direction, inner element 22
advances, and when lever 24 is slid proximally, inner element 22
retracts. Preferably, when lever 24 is moved to the right, inner
element is disengaged so that ablation catheter 2 can be
advanced.
[0142] The distal portion 8 of catheter 2 is shown adjacent to or
abutting the transseptal septum 28 between right atrium 30 and left
atrium 32. Inner element 22 is shown to have perforated transseptal
septum 28 at perforation 36.
[0143] Ablation catheter 2 can essentially he a standard
radiofrequency ablation catheter. However, the catheter encompasses
an inner element which can be deployed and retracted to perform a
transseptal procedure within a single system. Catheter 2 is
positioned in the right atrium near the foramen, and good atrial
contract is confirmed via an atrial electrogram as well as
fluoroscopic position. Intracardiac echocardiography can also
assure the location. Once the distal portion 8 of ablation catheter
2 is advanced against septum 28 so that the foramen is tented,
lever 24 is slid forward to advance inner element 22 to puncture
septum 28 in a controlled fashion. Once septum 28 has been
perforated, catheter 2 can be advanced without advancing inner
element 22. Preferable inner element 22 is withdrawn distally to
allow safe manipulation of ablation catheter 2.
[0144] In another embodiment of the invention, a left-side catheter
guides, shields, and protects left-sided heart structures during a
standard transseptal needle puncture (performed from the right side
of the heart). FIG. 2 shows the design of such a system. In
essence, a left-sided catheter 40 with a deployable protective
shield 42 can help with imaging and location of left atrium 44 and
serve as a protective shield to "catch" needle 46 as it is
delivered from right atrium 48 across the inter-atrial septum 52.
Needle 46 could be viewed as a ball thrown by a pitcher, and
catheter/shield 40/42 could be viewed as a deployable catcher's
mitt. Protective catheter 40 can he steered from the femoral artery
(or another artery) up the aorta via the retrograde aortic approach
using fluoroscopic guidance across the aortic valve, and into the
left ventricle. Protective catheter 40 would then be positioned
across the mitral valve into left atrium 44 and steered towards
inter-atrial septum 52 on the left side.
[0145] The protective shield would be deployed and the location
used to guide and protect the delivery of the transseptal needle 46
from the right to left atrium 44. Once needle 46 crosses septum 52,
it could safely hit deployed shield 42. The guidewire/sheath could
be safely placed and thereby minimize left atrial and aortic
perforation.
[0146] The distal tip 54 of catheter 40 is shown in three stages in
FIGS. 3A to 3B, where protective shield 42 is not deployed at all
(FIG. 3A), partially deployed (FIG. 3B), and then totally deployed
(FIG. 3C). Protective shield 42 may comprise a flexible or rigid
deployable material that can function to protect tissue from an
inadvertent needle puncture. A nitinol or stainless steel mesh is
an an example of useful material.
[0147] An alternative, entirely different approach to performing a
transseptal approach is shown in FIG. 4. A steerable ablation
catheter 60 with a retractable inner element 62 lumen and a
retractable right atrial access system could be placed via standard
steerable means (via the retrograde aortic approach) through the
aorta 64 into the left atrium 66 and positioned towards the
inter-atrial septum 68. Catheter 60 could record from a tip
electrode 70 and confirm the electrical position. Fluoroscopy or an
internal imaging system (such as intracardiac echocardiography)
could record the catheter's location. Once in position, and pointed
towards right atrium 74, retractable needle 62 is deployed and the
distal portion 76 of the transseptal access system can safely enter
and potentially confirm entry to right atrium 74. Once this occurs,
a long introducer sheath 80 can be engaged, and catheter/wire 60/42
can slide into sheath 80, and sheath 80 can be advanced into left
atrium 66.
[0148] An essential aspect of certain embodiments of the invention
is the need for tight and left-sided apparatuses to "mate." It is
even conceivable that the left sided system could cross over to the
right atrium and secure a right-sided element and pull it across
into the left atrium. Once across, the sheath can than be advanced
across the septum over the apparatus which served as a guide.
[0149] FIG. 5 shows two magnetically coupled right and left sided
devices which could be used to draw the male and female elements in
close proximity to facilitate a transseptal procedure. The distal
tip 84 of a long sheath 86 (with or without steerability) is placed
adjacent the inter-atrial septum 88 from the right atrium 90, and
the distal tip 92 of a catheter 94 for performing the transeptal is
positioned in the left atrium 96. Sheath distal tip 84 and catheter
distal tip 92 each have magnetic coils, and the magnetic fields
created by the magnetic coils can pull the respective distal tips
84 and 92 together at inter-atrial septum 88. The transseptal
procedure could then be performed, sheath 86 and catheter 94 can be
coupled, and introducer slid 86 can be slid over catheter 94 to
provide an entry access point for an ablation catheter into left
atrium 96.
[0150] FIGS. 6A to 7D should be self-explanatory. FIGS. 6A to 6E
show a safe transseptal puncture system using magnetic navigation.
The heart's anatomy is shown in FIG. 6A, and FIG. 6B shows the
magnetic navigation placing the distal tip 102 of a soft, flexible,
magnetically driven catheter 100 using non-fluoroscopic 3D mapping
at an inter-atrial septum 104 (technology available from
Stereotaxis, St Louis, Mo.) Tip 102 is positioned at inter-atrial
septum 104 (preferably the foramen ovale) via retrograde aortic
approach. A specifically designed inner punctive stylet, wire,
needle, or combination thereof 108 is advanced in a controlled
fashion into the right atrium 106 (FIG. 6C). In FIG. 6D, the distal
portion of a long, right-sided transseptal sheath 110 has been
advanced into right atrium 106, and wire 108 and/or catheter 100
are advanced across inter-atrial septum 104 to engage transseptal
sheath 110, which could be coupled to and/or provide protection or
a target for puncture. Sheath 110 is then advanced (with or without
a dilator) over wire 108 and/or catheter 100 into left atrium 112,
as shown in FIG. 6E. The distal portion of sheath 110 is in left
atrium 112, and catheter 100 and/or wire 108 can be withdrawn.
Sheath 110 is flushed and ready now for any left atrial
procedure.
[0151] FIGS. 7A to 7D show an approach similar to that of FIGS. 6A
to 6E using magnetic navigation and mating. The heart's anatomy is
shown in FIG. 7A, and FIG. 7B shows magnetic navigation placing a
distal tip 120 of a soft, flexible, magnetically driven catheter
122 using non-fluoroscopic 3D mapping at an inter-atrial septum
124. Tip 120 is positioned at inter-atrial septum 124 (preferably
the foramen ovale) from the femoral artery or some other arterial
system via the retrograde aortic approach across the aortic valve
and mitral valve. In FIG. 7C, distal tip 120 is held in place by a
magnetic field, and the distal portion of a right-sided sheath or
dilator/sheath system 130 is advanced into right atrium 132. Sheath
130 (introducer or even a catheter) with a marker, tracer, unipolar
or bipolar electrode, transducer, magnetic coil or component or
component with ferromagnetic properties 136 (which can be built-in
to the tip of sheath 130 or turned on via coil activation) can mate
(via either the magnetic field alone, fluoroscopy imaging, or 3D or
other imaging) with distal tip 120. A guide wire, needle, or stiff
angioplasty wire 128 can perform the transseptal procedure (going
left to fight) through a lumen of catheter 122. This could advance
into right-sided sheath 130 on the right side of the heart which
would slide over wire 128 and eventually across septum 124
(transseptal). This mating process can then allow guidance of a
guide wire/needle/stylet/etc. through the left-sided catheter 122
into sheath 130. Wire 128 could be short or long; the simplest
approach would be a very long wire which is now transseptal and
extends the length of the right-sided sheath. A dilator could then
slide over the wire and follow it up the right side into the right
atrium and across inter-atrial septum 124. Sheath 130 could then
follow, and the dilator/wire can be removed as well as the
left-sided lumened catheter. The sheath would then be flushed and
ready for an ablation catheter to be advanced into this long
right-sided sheath into the left atrium for a left-sided procedure
such as a valve repair, replacement, or atrial fibrillation
ablation procedure.
[0152] FIG. 7 shows a similar approach as that of FIG. 6 using
magnetic navigation and mating. FIGS. 7A and 7B are the same as in
FIGS. 6A and 6B.
[0153] An advantage of the training or exercising device described
herein is that a user can easily exercise certain lower body
muscles to include the core, legs, hips and/or thighs leg or thigh
muscles as well as the cardio vascular system with a low impact,
dynamic, relatively simple device.
[0154] While certain embodiments of the present invention have been
illustrated and described, it will be clear that the present
invention is not limited to these embodiments only. Numerous
modifications, changes, variations, substitutions and equivalents
will be apparent to those skilled in the art, without departing
from the spirit and scope of the present invention, as described in
the following claims.
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