U.S. patent application number 14/283818 was filed with the patent office on 2014-11-13 for steerable ablation device.
This patent application is currently assigned to St. Jude Medical, Atrial Fibrillation Division, Inc.. The applicant listed for this patent is St. Jude Medical, Atrial Fibrillation Division, Inc.. Invention is credited to Gregory J. Kampa, Jonathan L. Podmore, Andrew Radin.
Application Number | 20140336685 14/283818 |
Document ID | / |
Family ID | 39585043 |
Filed Date | 2014-11-13 |
United States Patent
Application |
20140336685 |
Kind Code |
A1 |
Podmore; Jonathan L. ; et
al. |
November 13, 2014 |
Steerable ablation device
Abstract
The invention relates to a flexible assembly for use in a region
of a medical or surgical device. In preferred embodiments, the
flexible region comprises a set of pull wires for controllably
moving a treatment end of the device, and elements to separate the
pull wires and maintain the integrity of the shaft of the flexible
region in order to improve the operating aspects of the device. The
devices and methods can be especially useful in ablation
treatments, such as ablation at cardiac or epicardial tissues.
Inventors: |
Podmore; Jonathan L.; (San
Carlos, CA) ; Kampa; Gregory J.; (Laguna Nigel,
CA) ; Radin; Andrew; (Mountain View, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
St. Jude Medical, Atrial Fibrillation Division, Inc. |
St. Paul |
MN |
US |
|
|
Assignee: |
St. Jude Medical, Atrial
Fibrillation Division, Inc.
St. Paul
MN
|
Family ID: |
39585043 |
Appl. No.: |
14/283818 |
Filed: |
May 21, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13873348 |
Apr 30, 2013 |
8764746 |
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14283818 |
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11647315 |
Dec 29, 2006 |
8444637 |
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13873348 |
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Current U.S.
Class: |
606/169 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 2017/320069 20170801; A61B 17/2202 20130101; A61B
2017/003 20130101; A61B 17/00234 20130101 |
Class at
Publication: |
606/169 |
International
Class: |
A61B 17/32 20060101
A61B017/32; A61B 17/00 20060101 A61B017/00 |
Claims
1. (canceled)
2. A medical catheter component, comprising: a cylindrical body
including a circumferential wall defining an inner lumen; and a
plurality of cuts through the circumferential wall of the
cylindrical body, wherein the plurality of cuts define a ribbed
structure comprising a first continuous spine extending from a
first point on the cylindrical body just proximal of a most
proximal of the plurality of cuts to a second point on the
cylindrical body just distal of a most distal of the plurality of
cuts.
3. The medical device component according to claim 2, wherein the
ribbed structure further comprises a second continuous spine
extending from a third point on the cylindrical body just proximal
of the most proximal of the plurality of cuts to a fourth point on
the cylindrical body just distal of the most distal of the
plurality of cuts.
4. The medical device component according to claim 2, wherein the
second continuous spine is located diametrically opposite the first
continuous spine.
5. The medical device component according to claim 2, wherein the
first continuous spine has a switchback arrangement.
6. The medical device component according to claim 2, wherein the
first continuous spine comprises an uncut portion of the
circumferential wall extending longitudinally along a length of the
cylindrical body.
7. The medical device component according to claim 2, further
comprising a tri-lumenal insert positioned within the inner lumen
of the cylindrical body.
8. The medical device component according to claim 7, wherein the
tri-lumenal insert comprises an anchor member secured to a distal
section of the cylindrical body.
9. The medical device component according to claim 7, wherein the
tri-lumenal insert comprises an hourglass-shaped central lumen and
a pair of pull wire lumens positioned peripheral to the
hourglass-shaped central lumen.
10. The medical device component according to claim 9, wherein the
pair of peripheral lumens are positioned opposite each other
adjacent a neck of the hourglass-shaped central lumen.
11. The medical device component according to claim 2, wherein the
cylindrical body comprises a shape memory material.
12. A medical catheter component, comprising: a cylindrical body
including a wall that defines a plurality of lumens, the plurality
of lumens comprising: an hourglass-shaped central lumen; and at
least two additional lumens positioned peripheral of the
hourglass-shaped central lumen.
13. The medical device component according to claim 12, wherein the
at least two peripheral lumens comprise a first peripheral lumen
and a second peripheral lumen, and wherein the first and second
peripheral lumens are positioned on opposite sides of a neck of the
hourglass-shaped central lumen.
14. A medical catheter, comprising: a cylindrical body including a
plurality of lumens, the plurality of lumens comprising: an
hourglass-shaped central lumen including a central portion and a
peripheral portion; and at least two peripheral lumens each
configured to slidably receive a pull wire therein, wherein the at
least two peripheral lumens are each coextensive with the
peripheral portion of the hourglass-shaped central lumen.
15. The medical catheter according to claim 14, wherein the at
least two peripheral lumens comprise a first peripheral lumen and a
second peripheral lumen, and wherein the first and second
peripheral lumens are positioned on opposite sides of a neck of the
hourglass-shaped central lumen.
16. The medical catheter according to claim 14, wherein the
cylindrical body comprises a plurality of cuts through a
circumferential wall of the cylindrical body, the plurality of cuts
defining a ribbed structure comprising a first continuous spine
extending from a first point on the cylindrical body just proximal
of a most proximal of the plurality of cuts to a second point on
the cylindrical body just distal of a most distal of the plurality
of cuts.
17. The medical catheter according to claim 16, wherein the ribbed
structure further comprises a second continuous spine extending
from a third point on the cylindrical body just proximal of the
most proximal of the plurality of cuts to a fourth point on the
cylindrical body just distal of the most distal of the plurality of
cuts.
18. The medical catheter according to claim 17, wherein the second
continuous spine is located diametrically opposite the first
continuous spine.
19. The medical catheter according to claim 17, wherein the first
continuous spine has a switchback arrangement.
20. The medical catheter according to claim 16, wherein the first
continuous spine comprises an uncut portion of the circumferential
wall extending longitudinally along a length of the cylindrical
body.
21. The medical catheter according to claim 14, wherein the
cylindrical body comprises a shape memory material.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/873,348, filed 30 Apr. 2013 (the '348 application), now
______; which is a continuation of U.S. application Ser. No.
11/647,315, filed 29 Dec. 2006 (the '315 application), now U.S.
Pat. No. 8,444,637. The '348 application and '315 application are
each incorporated by reference as fully set forth herein.
BACKGROUND OF THE INVENTION
[0002] a. Field of the Invention
[0003] The instant invention relates to ablation devices, methods
of using them, and steerable devices for use in medical treatments.
In particular, the invention relates to devices used in conjunction
with atrial fibrillation procedures and improvements related to the
introduction of devices around the heart or at epicardial
surfaces.
[0004] b. Background Art
[0005] A number of surgical procedures employ the use of steerable
devices, such as catheters. In an atrial fibrillation treatment for
ablating cardiac tissues, an alternative to the surgical incisions
of the heart is the maze procedure, where transmural ablations of
the heart are made within an ablation device. Such ablations may be
performed either from within the chambers of the heart (endocardial
ablation) using endovascular devices (e.g., catheters) introduced
through arteries or veins, or from outside the heart (epicardial
ablation) using devices introduced into the chest. Various ablation
techniques have been used, including cryogenic, radiofrequency
(RF), laser and microwave, to create elongated transmural lesions
and block electrical conduction in the atrial myocardium. An
advantageous use of transmural ablation rather than surgical
incisions is the ability to perform the procedure on the beating
heart without the use of cardiopulmonary bypass. Maintaining the
proper positioning against the wall of a beating heart can also be
difficult. Visualization of endocardial anatomy and endovascular
devices is often inadequate and knowing the precise position of
such devices in the heart can be difficult, resulting in misplaced
lesions.
[0006] Epicardial ablation devices and methods useful for creating
transmural lesions for the treatment of atrial fibrillation have
been described in U.S. Pat. No. 7,052,493 to Vaska et al. ("Vaska")
and U.S. Pat. No. 6,971,394 to Sliwa et al. ("Sliwa"), both of
which are hereby expressly incorporated by reference. Sliwa
describes a method of forming a transmural lesion in a wall of the
heart adjacent to the pulmonary veins by placing an ablation device
through a thoracic incision and then through a pericardial
penetration so that the ablation device is disposed in contact with
an epicardial surface of the heart. Vaska describes an ablation
device and system which may be used to wrap an ablation device
around the pulmonary veins at an epicardial location.
[0007] Execution of a contiguous pulmonary vein (PV) isolation
procedure can occasionally present considerable challenges to the
physician. Difficulties in maneuvering the devices and passing them
around anatomical structures, maintaining accurate placement on a
beating heart, and avoiding unintended contact with other tissues
mean that a high degree of physician skill and experience may be
required in some circumstances. What are needed, therefore, are
devices and methods which allow for precise introduction and
placement of the ablation elements in PV isolation and linear left
atrial ablations. More particularly, devices and methods which
insure that ablation devices are properly placed or introduced for
a PV isolation or mitral isthmus ablation procedure are
desired.
BRIEF SUMMARY OF THE INVENTION
[0008] It is desirable to be able to maneuver or steer an ablation
cell or device near epicardial surfaces and other areas in surgical
procedures without concern for the unintended movement or reaction
of the device while in the body. The invention relates to a
flexible assembly for use in a region of a medical or surgical
device. In preferred embodiments, the flexible region comprises a
set of pull wires for controllably moving a treatment end of the
device, and elements to separate the pull wires and maintain the
integrity of the shaft of the flexible region in order to improve
the operating aspects of the device. The devices and methods can be
especially useful in ablation treatments, such as ablation at
cardiac or epicardial tissues.
[0009] The present invention meets these and other objectives by
providing devices, assemblies, and methods for placing and
controlling the movement of medical devices. For example, some
steerable devices may crimp or twist if deflected too far or
deflected suddenly or forcefully. In addition, some flexible device
may break if deflected too far. The invention provides a medical
device, such as a catheter or shaft for introduction into the body
or an assembly therefor, having improved structural properties and
steerable characteristics that, in part, addresses these
shortcomings in some existing devices. In particular and in one
aspect, the invention provides a steerable wand or shaft-type
device, or assembly therefor, for controllably introducing and/or
positioning an ablation element on a cardiac or epicardial surface.
However, the invention is not limited to use in cardiac procedures
or with ablation treatments or devices. Instead, the invention
relates more generally to deflectable or steerable medical devices
that contain a flexible support region that allows a desired degree
of deflection and prevents crimping, breaking, twisting or other
movements that may effect the controllability of the device.
[0010] Thus, in one aspect, the invention includes an assembly for
a steerable device for use in surgical or ablation therapy wherein
the device typically has an elongated shaft with a flexible distal
region and a generally straight proximal region. In the example of
an ablating device, one or more ablation elements or cells are
disposed along the distal end of the device, but which need not be
part of the assembly itself. A steerable deflection area is defined
within the flexible region, and it includes a first anchor member,
preferably a ring-shaped or other shape to accommodate the profile
associated with the shaft of the device, attached to a distal
portion of the flexible distal region. The anchor member has one or
more passageways for one or more pull wires extending from the
proximal region and one or more actuators to the distal region. The
steerable deflection region comprises a coiled or interlocking flex
support member designed to permit deflection to a desired angle of
deflection and maintain the integrity of the interior and exterior
of the device during its use in a procedure. Typically, the
proximal region of the elongated shaft contains one or more
actuators to control the movement of the steerable deflection
region, such that, for example, the distal region and distal end of
the device move in response to actuation of the one or more pull
wires.
[0011] The invention also includes methods to design and produce
flexible assemblies to allow a desired range of controlled motion
for a distal end of a device. For example, if the desired range of
deflection of the distal end is from a straight to a 60 degree
angle, the flexible support member, its structure and composition,
can be selected to substantially prevent the flexible region from
crimping, yielding, cracking, on its interior or exterior surfaces,
and/or substantially prevent blocking or interfering with the
movement of pull wires, or twisting or moving in unintended
directions or degrees. Thus, the distal end comprising a treatment
or diagnostic element can be steered or moved more controllably by
a physician using the medical device.
[0012] A particularly preferred embodiment of the invention
includes steerable ablation devices having a shaft with a flexible
distal region and a generally straight proximal region. One or more
ablation cells are disposed along the distal end, which has a
steerable deflection degree defined be a region of the device
assembly within a designed flexible region. The steerable
deflection region has at least one anchor member attached to a
distal portion of the flexible distal region, the anchor member
having passageways for one or more pull wires extending from the
proximal region to the distal region. The steerable deflection
region comprises a coiled or interlocking flex support member
designed to permit deflection to a desired angle of deflection or
range of deflection angles, and at the same time maintain the
integrity of the interior and/or exterior of the steerable
deflection region to prevent unintended movement, or prevent during
multiple maximum deflections and relaxations of the device
cracking, breaking, crimping, or yielding in the flexible region.
Thus, in particularly preferred embodiments, the interlocking flex
support member can be a laser cut metal or polymer formed into a
ribbed-like coil, such as those shown in the figures, which
maintains the integrity of the flexible region by substantially
preventing breaking, cracking, yielding, or crimping of the
flexible region over the course of 10 or 20 or 50 maximum
deflection and relaxation cycles of the flexible region, for
example. The steerable device can have two or more pull wires for
deflection of the distal end in at least two directions. In
preferred embodiments, the flexible region includes a flexible
separating member within the steerable deflection region, where the
flexible separating member is disposed in the flexible distal
region to maintain the pull wires on separate sides of the interior
of the flexible distal region. As described herein, the coiled or
interlocking flex support member can be comprised of one or more of
a polymer, metal, nitinol, or combination of two or more of these
materials. The selection of the material and shape of the coiled or
interlocking support member can include pre-formed linear, curved,
or curvilinear shapes, for example. The steerable device typically
has one or more pull wires actuated by a handle at the proximal end
of the device.
[0013] The invention also includes methods of using a steerable
device of the invention, such as introducing the flexible distal
region and distal end of the device into a body during a surgical
treatment and moving the distal end through actuating at least one
pull wire. Preferred methods include those where the surgical
procedure comprises ablation of cardiac or pericardial tissue, or
where the ablation comprises the use of at least one ultrasound
ablation element.
[0014] The foregoing and other aspects, features, details,
utilities, and advantages of the present invention will be apparent
from reading the following description and claims, and from
reviewing the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 depicts the flexible distal region of a device of the
invention.
[0016] FIG. 2 depicts an embodiment of the coiled or interlocking
support member of the flexible distal region.
[0017] FIG. 3 depicts an alternate embodiment of the coiled or
interlocking support member of the flexible distal region.
[0018] FIG. 4 depicts an exploded view of exemplary components in a
flexible distal region of a device of the invention.
[0019] FIGS. 5 and 6 depict two views of an exemplary anchor member
for use in the invention.
[0020] FIG. 7 depicts an exemplary connection area for the anchor
member.
[0021] FIGS. 8 and 9 depict two additional embodiments of the
coiled or interlocking support member of the flexible distal
region.
[0022] FIGS. 10 A-C schematically depict the profile shapes of some
designs for laser cut embodiments of an interlocking support
member.
DETAILED DESCRIPTION OF THE INVENTION
[0023] The headings (such as "Brief Summary") used are intended
only for general organization of topics within the disclosure of
the invention and are not intended to limit the disclosure of the
invention or any aspect of it. In particular, subject matter
disclosed in the "Background Art" may include aspects of technology
within the scope of the invention and thus may not constitute
solely background to the invention. Subject matter disclosed in the
"Brief Summary" is not an exhaustive or complete disclosure of the
entire scope of the invention or any particular embodiment.
[0024] As used herein, the words "preferred," "preferentially," and
"preferably" refer to embodiments of the invention that afford
certain benefits, under certain circumstances. However, other
embodiments may also be preferred, under the same or other
circumstances. Furthermore, the recitation of one or more preferred
embodiments does not imply that other embodiments are not useful
and is not intended to exclude other embodiments from the scope of
the invention and no disclaimer of other embodiments should be
inferred from the discussion of a preferred embodiment or a figure
showing a preferred embodiment.
[0025] FIGS. 1 and 4 depict different views of a preferred
embodiment of the invention comprising a flexible distal region 5
of a medical device. This assembly can be incorporated into a
catheter, ablation device, or other diagnostic or treatment device
and function to more controllably allow the movement of the distal
end of the device in response to the physician's actions on a
proximal control or actuating end or handle (not shown). Various
deflectable medical devices are known and can be made available for
adaptation with the present invention, including those of U.S.
published patent applications 20050187455 and 20040034348, and U.S.
Pat. Nos. 7,052,493 and 6,971,394, each specifically incorporated
herein by reference. The device can have a pre-formed curve or
curvilinear distal region or distal end for use in particular
surgical procedures.
[0026] FIG. 1 shows an exemplary assembly with flexible region 5
composed in interlocking ribbed structure in a flexible support
member 3, which can be any of a number of biocompatible metals,
polymers, nitinol, shape-memory polymers or metals, or combinations
thereof. In practice, the design of the interlocking ribbed
structure should account for desired degree of deflection for a
particular use. For example, interlocking pointed ends in the
coiled or interlocking member 3, as shown in FIGS. 1 and 2, allow
for a certain degree of movement before they become prone to
crimping or separating. Similar interlocking ribbed structures with
balled tips, flattened tips, or alternating tips may allow a
greater degree of bending and may be desired for certain uses.
FIGS. 10A-C show exemplary laser-cut designs for interlocking
ribbed structures that can provide structural support and maintain
the integrity of the flexible region during maximum deflection. The
designs shown in FIGS. 10A-C correspond to a junction point similar
to that shown in FIG. 3, where the points of each of the ribbed
coils meet or come together. These structures can be formed by
methods known in the art for laser cutting or other computer
numerical control milling machines, for example. Alternatively, the
interlocking area can be designed so that the two sides interlock
when bent to a certain degree, and then can be held in place at
that angle or substantially that angle until the area is bent
further to release the interlocking A number of geometrical shapes
and designs can be incorporated into the interlocking area or
ribbed area of the flexible support member. As shown in FIGS. 8 and
9, the assembly can include a designed orientation of the ribbed
structure in relation to the direction of deflection allowed in the
medical device.
[0027] FIG. 3 depicts an alternative coiled structure for this
member 3, which can similarly be made or comprised of metals,
polymers, nitinol shape-memory materials. A variety of spring-like
structures, braided structures, or coil structures can similarly be
used to add structural integrity to the flexible distal region of a
device according to the invention.
[0028] FIG. 1 further depicts the arrangement of elements in an
exemplary assembly 5. Anchor member 1, here in shape of an anchor
ring of the same diameter as the shaft of the device, fits into the
distal end 6 of the distal flexible region of assembly. In this
embodiment, a single anchor ring is used. The proximal end of the
assembly 4 connects to an elongated shaft and optionally terminates
in a proximal end handle and actuating elements (not shown). The
exterior of the assembly and device can be coated or covered in a
number of biocompatible compositions or polymers, as known in the
art.
[0029] FIGS. 2 and 3 depict two of the many optional embodiments of
the flexible support member 3 and its optional coiled, ribbed, or
interlocking structure. The characteristics of this member can be
determined by the desired flexibility, desired freedom of movement
over a range of deflection angles, and/or desired strength or
stress limits or Young's modulus of the material and structure
selected. As noted, a number of polymeric, metal, and other
material can be selected, and a preferred material is a
shape-memory composition such as nitinol. Similarly and as noted
above, the designs of FIGS. 10A-C can be used to produce the
interlocking structure of a flex support as shown in FIG. 2 or 3,
especially if laser cutting productions techniques are
employed.
[0030] FIG. 4 depicts an embodiment with two pull wires 10 running
through the flexible distal region assembly and the elements of the
assembly. While pull wires 10 are shown to extend beyond anchor
member or anchor ring 1, the pull wires can terminate at the holes
or connection points in the ring in optional embodiments. A central
separating member 11 fits into anchor member 1 in slits to
effectively separate the interior of the flexible region so that
pull wires 10 are held away from each other. The flat, plate shape
of separating member 11 is one embodiment, and several other
designs are possible especially when more than two pull wires are
used. The separating member is typically a flexible element
designed to flex and deflect with the assembly. The interlocking
ribbed flex support member 12 adds structural stability and
integrity to the assembly. The flex support member 12 fits onto,
inside, or is integrally formed into the flexible region 3, which
fits into the proximal end 1 of the shaft. The proximal end of the
flexible region can also contain an anchor member or additional
anchor member (not shown) to support or control movement of pull
wires 10.
[0031] FIGS. 5 and 6 depict views of each side of the anchor member
1 and its optional features. Slots 21 are designed to hold or fix
in a separating position the separating member 11, as shown in FIG.
4. Holes 23 are designed to allow pull wires to pass through and
can be contoured to fit a terminating ball or other fixed point at
the end of a pull wire. The differing diameters shown on the
profile of anchor member 1 allow for the insertion into the
flexible region of assembly. The anchor member can optionally be
placed at more than one position in a flexible region assembly,
such as at each of the proximal and distal end, and at the distal
end, the center or intermediate point of, and the proximal end of
the flexible region.
[0032] FIG. 7 depicts a proximal end 13 connection point for the
flexible assembly, where slots 20 fix the separating member in
position, and inserting diameter 16 region fits into the flexible
region of assembly. FIGS. 8 and 9 depict the deflection of the
flexible distal region to a desired angle.
[0033] The assemblies and devices of the invention can be used in
methods to ablate cardiac or epicardial tissue, or other tissue.
The flexible region assembly can be designed to allow, for example,
about 90 degrees of deflection, or from about 60 to about 100
degrees of deflection, to a distal end and maintain the integrity
of the flexible region and control over the movement of the
ablating element at distal end. By maintaining the integrity, the
interior and/or exterior walls of the flexible region do not crimp,
yield, crack, or break at maximum deflection. Alternatively, the
interior and/or exterior walls can withstand multiple rounds of
maximum deflection and release, such as 10 rounds, 20 rounds, or 50
rounds, without substantially effecting the integrity of the
interior or exterior walls by showing signs of crimping, cracking,
yielding or breaking. Thus, for example, the pull wires can be
actuated at a handle at the proximal end of the device to fully
deflect the distal end to 90 degrees. The materials used in
construction of the flexible region can be shape-memory materials
that allow the flexible region to return to a desired position or
move a desired angle to ablate tissue as controlled by pull wires.
The deflection can be in one, two, or multiple directions with the
use of a number of pull wires and connection points of the pull
wires to the device or within the flexible region. The angle of
deflection in each direction desired, or range of angles, can be
selected from any number between, for example, 45 to 90
degrees.
[0034] Although several embodiments of this invention have been
described above with a certain degree of particularity, those
skilled in the art could make numerous alterations to the disclosed
embodiments without departing from the spirit or scope of this
invention.
[0035] All directional references (e.g., upper, lower, upward,
downward, left, right, leftward, rightward, top, bottom, above,
below, vertical, horizontal, clockwise, and counterclockwise) are
only used for identification purposes to aid the reader's
understanding of the present invention, and do not create
limitations, particularly as to the position, orientation, or use
of the invention. Joinder references (e.g., attached, coupled,
fixed, connected, and the like) are to be construed broadly and may
include intermediate members between a connection of elements and
relative movement between elements. As such, joinder references do
not necessarily infer that two elements are directly connected and
in fixed relation to each other.
[0036] It is intended that all matter contained in the above
description or shown in the accompanying drawings shall be
interpreted as illustrative only and not limiting. Changes in
detail or structure may be made without departing from the spirit
of the invention as defined in the appended claims.
* * * * *