U.S. patent application number 11/743343 was filed with the patent office on 2007-09-06 for apparatus and methods for treating tissue.
Invention is credited to Russell A. HOUSER, Stephen R. Ramee, Vahid Sadaat.
Application Number | 20070208357 11/743343 |
Document ID | / |
Family ID | 25409955 |
Filed Date | 2007-09-06 |
United States Patent
Application |
20070208357 |
Kind Code |
A1 |
HOUSER; Russell A. ; et
al. |
September 6, 2007 |
APPARATUS AND METHODS FOR TREATING TISSUE
Abstract
Apparatus and methods are provided for thermally and/or
mechanically treating tissue, such as valvular structures, to
reconfigure or shrink the tissue in a controlled manner. The
apparatus comprises a catheter in communication with an end
effector which induces a temperature rise in an annulus of tissue
surrounding the leaflets of a valve or in the chordae tendineae
sufficient to cause shrinkage, thereby causing the valves to close
more tightly. Mechanical clips can also be implanted over the valve
either alone or after the thermal treatment. The clips are
delivered by a catheter and may be configured to traverse directly
over the valve itself or to lie partially over the periphery of the
valve to prevent obstruction of the valve channel. The clips can be
coated with drugs or a radiopaque coating. The catheter can also
incorporate sensors or energy delivery devices, e.g., transducers,
on its distal end.
Inventors: |
HOUSER; Russell A.;
(Livermore, CA) ; Sadaat; Vahid; (Saratoga,
CA) ; Ramee; Stephen R.; (New Orleans, LA) |
Correspondence
Address: |
LEVINE BAGADE HAN LLP
2483 EAST BAYSHORE ROAD, SUITE 100
PALO ALTO
CA
94303
US
|
Family ID: |
25409955 |
Appl. No.: |
11/743343 |
Filed: |
May 2, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10669204 |
Sep 23, 2003 |
7217284 |
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11743343 |
May 2, 2007 |
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09898726 |
Jul 3, 2001 |
6626899 |
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10669204 |
Sep 23, 2003 |
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09602436 |
Jun 23, 2000 |
6669687 |
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09898726 |
Jul 3, 2001 |
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60141077 |
Jun 25, 1999 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 2018/1432 20130101; A61B 2018/00232 20130101; A61F
2/2445 20130101; A61B 2018/1253 20130101; A61B 2017/044 20130101;
A61B 17/1285 20130101; A61B 2017/0461 20130101; A61B 17/122
20130101; A61B 2017/0458 20130101; A61B 2017/0496 20130101; A61B
2018/0022 20130101; A61B 2018/00797 20130101; A61B 2017/0451
20130101; A61B 18/1492 20130101; A61B 17/0469 20130101; A61B
18/1477 20130101; A61B 90/39 20160201; A61N 7/00 20130101; A61B
18/24 20130101; A61B 18/1442 20130101; A61B 2017/0437 20130101;
A61B 2018/00273 20130101; A61B 2018/00791 20130101; A61B 2017/00867
20130101; A61B 2017/00084 20130101; A61B 17/0401 20130101; A61B
2017/0427 20130101; A61B 2017/0464 20130101; A61B 2018/00083
20130101; A61B 2018/126 20130101; A61B 2018/00214 20130101; A61B
2090/064 20160201; A61F 2/2454 20130101; A61B 2018/00023 20130101;
A61B 2017/0409 20130101; A61B 2018/00369 20130101; A61F 2/2451
20130101; A61N 7/02 20130101; A61B 2017/0412 20130101; A61B 17/0487
20130101; A61B 18/00 20130101; A61B 2018/1435 20130101; A61B
2017/0454 20130101; A61B 17/29 20130101; A61B 2017/2945 20130101;
A61B 2017/0414 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. An apparatus for treating tissue near a valve to modify flow
through the valve, comprising: a cinching member having a central
region and at least two anchoring regions on opposing ends of the
central region, the cinching member being configured for delivery
through a catheter to the tissue whereby the cinching member has a
first shape during the delivery and a second shape after the
delivery.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 09/898,726 filed Jul. 3, 2001, which is a
continuation-in-part of U.S. patent application Ser. No. 09/602,436
filed Jun. 23, 2000, which in turn claims benefit from U.S.
Provisional Patent Application Ser. No. 60/141,077 filed Jun. 25,
1999, each being incorporated herein by reference in its
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to treatment of tissue. More
particularly, the present invention provides methods and apparatus
for treating valvular disease with a catheter inserted into a
patient's cardiac chambers, the catheter having an end effector for
modifying cardiac structures, including valve leaflets and support
structure.
BACKGROUND OF THE INVENTION
[0003] Degenerative valvular disease is the most common cause of
valvular regurgitation in human beings. Regurgitation is typically
characterized by an expanded valve annulus or by lengthened chordae
tendineae. In either case, an increase in the geometry of a valve
or its supporting structure causes the valve to become less
effective, as it no longer fully closes when required.
[0004] Loose chordae tendineae may result, for example, from
ischemic heart disease affecting the papillary muscles. The
papillary muscles attach to the chordae tendineae and keep the
leaflets of a valve shut. Some forms of ischemic cardiac disease
cause the papillary muscles to lose their muscle tone, resulting in
a loosening of the chordae tendineae. This loosening, in turn,
allows the leaflets of the affected valve to prolapse, causing
regurgitation.
[0005] It therefore would be desirable to provide methods and
apparatus for treatment of tissue that modify the geometry and
operation of a heart valve.
[0006] It would also be desirable to provide methods and apparatus
that are configured to thermally treat chordae tendineae, the
annulus of a valve, or valve leaflets.
[0007] It would also be desirable to further provide methods and
apparatus that are configured to mechanically modify the geometry
and operation of a heart valve and annulus of a valve either alone
or in addition to thermal treatment.
SUMMARY OF THE INVENTION
[0008] In view of the foregoing, it is an object of the present
invention to provide methods and apparatus for the treatment of
tissue that modify the geometry and operation of a heart valve.
[0009] It is another object of the present invention to provide
methods and apparatus that are configured to thermally treat
chordae tendineae, the annulus of a valve, or valve leaflets.
[0010] It is another object of the present invention to further
provide methods and apparatus that are configured to mechanically
modify the geometry and operation of a heart valve and annulus of a
valve either alone or in addition to thermal treatment.
[0011] These and other objects of the present invention are
accomplished by providing apparatus and methods for thermally or
mechanically treating tissue, such as valvular structures, to
reconfigure or shrink the tissue in a controlled manner, thereby
improving or restoring tissue function. Embodiments of the present
invention advantageously may be employed to modify flow regulation
characteristics of a cardiac valve or its component parts, as well
as to modify flow regulation in other lumens of the body,
including, for example, the urinary sphincter, digestive system
valves, leg vein valves, etc., where thermal shrinkage or
mechanical reconfiguration of tissue may provide therapeutic
benefit.
[0012] In a first family of embodiments of the present invention,
apparatus is provided having an end effector that induces a
temperature rise in an annulus of tissue surrounding the leaflets
of a valve sufficient to cause shrinkage of the tissue, thereby
reducing a diameter of the annulus and causing the valves to close
more tightly. In a second family of embodiments, apparatus is
provided having an end effector that selectively induces a
temperature rise in the chordae tendineae sufficient to cause a
controlled degree of shortening of the chordae tendineae, thereby
enabling the valve leaflets to be properly aligned. In yet a third
family of embodiments, apparatus is provided having an end effector
comprising a mechanical reconfigurer configured to attach to a
longitudinal member, such as the chordae tendineae. The
reconfigurer forces the longitudinal member into a tortuous path
and, as a result, reduces the member's effective overall or
straight length.
[0013] Any of these embodiments may employ one or more expanding
members that serve to stabilize the end effector in contact with
the tissue or structure to be treated. In addition, where it is
desired to preserve the interior surface of a lumen or structure,
the instrument may include means for flushing the surface of the
tissue with cooled saline. Where it is desired to achieve a
predetermined degree of heating at a depth within a tissue or
structure, the end effector may comprise a laser having a
wavelength selected to penetrate tissue to the desired depth, or
the end effector may comprise a plurality of electrically
conductive needles energized by an RF power source, as is known in
the electrosurgical arts. The end effector may alternatively
comprise an acoustic heating element, such as an ultrasonic
transducer.
[0014] In another aspect of the present invention, mechanical clips
may be provided preferably made from shape memory alloys or
superelastic alloys, e.g., Nickel-Titanium alloy (nitinol). Such
clips may be delivered to the valve and annulus of tissue
surrounding the valve in a variety of ways, e.g., intravascularly,
endoscopically, or laparoscopically, either after the thermal
treatment described above, or without the thermal treatment. During
delivery by, e.g., a catheter, the clips may be compressed into a
smaller configuration to facilitate transport. Upon exiting the
catheter, the clips preferably expand to a second configuration for
attachment to the valve tissue. The clips may be attached to the
annulus of tissue surrounding the valve upon being urged out of the
catheter distal end; they may be attached to opposing sides of the
valve and preferably have a compressive spring force to draw or
cinch the sides of the valve towards one another. The clips may be
configured to traverse directly over the valve itself, but they are
preferably configured to lie partially over the periphery of the
valve to prevent obstruction of the valve channel. A central region
of the clips may be formed in a variety of geometric shapes, e.g.,
semi-circles, arcs, half-ellipses, triangles, rectangles, and
loops. Aside from clips, expandable meshes and grids may also be
used to draw or cinch the valve edges together.
[0015] Moreover, the clips may be coated with therapeutic drugs,
which may be time-released, or they may also be coated at least
partially with a radiopaque coating to aid in visualization during
implantation.
[0016] Delivery catheters which may be used to deliver the clips
may also incorporate sensors or energy delivery devices, e.g.,
transducers, on the distal ends. For example, they may be
configured as a sensor to measure properties, e.g., ultrasound,
Doppler, electrode, pressure sensor or transducer, etc., of the
tissue prior to catheter withdrawal. Such sensors may also be used
to measure properties such as flow rates, pressure, etc. for
measurement pretreatment and post-treatment. Alternatively, they
may also be used as a transducer to deliver energy, e.g., RF,
electrical, heat, etc., to the affected tissue or the surrounding
area by, e.g., either as a separate device or directly through the
clip itself.
[0017] Methods of using apparatus according to the present
invention are also provided.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The above and other objects and advantages of the present
invention will be apparent upon consideration of the following
detailed description, taken in conjunction with the accompanying
drawings, in which like reference numerals refer to like parts
throughout, and in which:
[0019] FIG. 1 is a side-sectional view of a human heart showing
major structures of the heart, including those pertaining to
valvular degeneration;
[0020] FIG. 2 is a side view of apparatus of a first family of
embodiments constructed in accordance with the present
invention;
[0021] FIGS. 3A-3C are, respectively, a side view of an end
effector for use with the apparatus of FIG. 2 and a sectional view
through its catheter along sectional view line A-A, a side view of
an alternative end effector and a sectional view of its catheter
along view line B-B, and a side view of a still further alternative
end effector;
[0022] FIG. 4 is a sectional view through the human heart,
depicting a method of using the apparatus of FIG. 2 to shrink
tissue in an annulus surrounding the leaflets of a regurgitating
valve;
[0023] FIGS. 5A and 5B are schematic views of alternative
embodiments of the apparatus of FIG. 2;
[0024] FIGS. 6A-6D are views of a still further alternative
embodiment of the apparatus of FIG. 2 having barbs, and
illustrating a method of use;
[0025] FIGS. 7A-7C are schematic views showing, respectively, an
alternative embodiment of the end effector of FIG. 6 having
electrically insulated barbs, a method of using the end effector to
thermally treat tissue, and a temperature profile within the tissue
during treatment;
[0026] FIGS. 8A and 8B are side views of another alternative
embodiment of the apparatus of FIG. 6 having multipolar, individual
electrodes;
[0027] FIG. 9 is a side view of an alternative embodiment of the
apparatus of FIG. 8 having individual ultrasonic transducers;
[0028] FIG. 10 is a side-sectional view of another alternative
embodiment of the apparatus of FIG. 8 having individual laser
fibers;
[0029] FIG. 11 is a side-sectional view of an alternative
embodiment of the apparatus of FIGS. 8-10 having individual barb
members that may comprise multipolar electrodes, ultrasonic
transducers, or laser fibers;
[0030] FIG. 12 is a sectional view through the human heart,
illustrating an alternative method of introducing apparatus of the
first family of embodiments to a treatment site;
[0031] FIGS. 13A and 13B are views of an alternative embodiment of
the apparatus of FIG. 2 shown, respectively, in schematic side view
and in use shrinking an annulus of tissue;
[0032] FIGS. 14A and 14B are, respectively, a side view of an
alternative embodiment of the apparatus of FIG. 2, and a method of
using the embodiment via the introduction technique of FIG. 12;
[0033] FIGS. 15A and 15B are isometric views of an alternative end
effector for use with the apparatus of FIG. 14;
[0034] FIG. 16 is a top view of apparatus of a second family of
embodiments constructed in accordance with the present
invention;
[0035] FIG. 17A-17C are views of end effectors for use with the
apparatus of FIG. 16;
[0036] FIG. 18 is a sectional view of the human heart, illustrating
a method of using the apparatus of FIG. 16 to selectively induce a
temperature rise in the chordae tendineae sufficient to cause a
controlled degree of shortening of the tendineae;
[0037] FIGS. 19A-19C show a section of chordae tendineae and
illustrate a method of shrinking the tendineae in a zig-zag fashion
using the end effector of FIG. 17C with the apparatus of FIG.
16;
[0038] FIGS. 20A-20C show, respectively, a side view of an intact
tendineae, a side view of the tendineae after treatment by a
shrinkage technique, and a cross section through the tendineae
along sectional view line C-C of FIG. 20A after treatment by an
alternative shrinkage technique;
[0039] FIGS. 21A and 21B are side views of apparatus of a third
family of embodiments, constructed in accordance with the present
invention, shown in a collapsed delivery configuration and in an
expanded deployed configuration;
[0040] FIGS. 22A and 22B are schematic views depicting a method of
using the apparatus of FIG. 21 to mechanically shorten an effective
length of chordae tendineae; and
[0041] FIG. 23 is a side view, partially in section, illustrating a
method and apparatus for non-invasive coagulation and shrinkage of
scar tissue in the heart, or shrinkage of the valve structures of
the heart.
[0042] FIG. 24A is an isometric view of a variation on a valve
resizing device as an expandable grid with anchoring ends.
[0043] FIG. 24B is a top view of another variation on the valve
resizing device as an expandable mesh.
[0044] FIGS. 25A and 25B are side views of exemplary anchors which
may be used with a valve resizing device.
[0045] FIG. 26 is a cross-sectional superior view of a heart
section with the atrial chambers removed for clarity with the
device of FIG. 24A implanted over a valve.
[0046] FIGS. 27A and 27B are a top view showing variations on a
circumferential clip.
[0047] FIG. 28 is a cross-sectional superior view of a heart
section with the atrial chambers removed for clarity with the
device of FIG. 27A implanted around a valve.
[0048] FIGS. 29A and 29B show a side view and an end view,
respectively, of a variation on a clip.
[0049] FIGS. 30A and 30B show a side view and an end view,
respectively, of another variation on a clip.
[0050] FIGS. 31A-31D show a top, side, end, and isometric view,
respectively, of a further variation on the clip.
[0051] FIGS. 32A-36B show top and side views of alternative
variations on the clip.
[0052] FIG. 37 shows a cross-sectional view of a variation on the
distal section of a delivery catheter.
[0053] FIG. 38 shows a cross-sectional view of another variation on
the distal section of a delivery catheter where the clip is held in
a different configuration.
[0054] FIG. 39 shows a cross-sectional view of yet another
variation on the distal section of a delivery catheter.
[0055] FIGS. 40A and 40B are top and side views of a variation on a
handle for controlling the advancement of the clip.
[0056] FIGS. 41A and 41B illustrate a cross-sectional view of a
heart and a possible method of delivering and implanting a clip
over the heart valve.
[0057] FIG. 41C is a cross-sectional view of a heart and a
variation on the delivery catheter having a sensing device or a
transducer integrated on the distal end.
[0058] FIGS. 42A-42D are cross-sectional superior views of a heart
section with the atrial chambers removed showing an alternative
method of delivering and implanting clips through the coronary
sinus.
[0059] FIGS. 43A and 43B are a superior view and a side view of a
valve, respectively, showing an alternative clip configuration
implanted on the valve.
DETAILED DESCRIPTION OF THE INVENTION
[0060] With reference to FIG. 1, a sectional view through human
heart H is presented. Major structures labeled include the right
atrium RA, left atrium LA, right ventricle RV, left ventricle LV,
superior vena cava SVC, inferior vena cava IVC, and ascending aorta
AA. Structures that may be involved in valvular degeneration and
regurgitation are also labeled, including the papillary muscles PM,
chordae tendineae CT, valve leaflets L, and annuluses of tissue
surrounding the leaflets A, as well as the tricuspid valve TV, the
bicuspid or mitral valve MV, and the aortic valve AV. The pulmonary
valve PV is not seen in the cross section of FIG. 1, but may also
experience valvular degeneration. As discussed previously,
degenerative valvular disease often leads to valvular
regurgitation, which is typically characterized by an expanded
valve annulus A or by lengthened chordae tendineae CT. Loose
chordae tendineae may result from ischemic heart disease affecting
the papillary muscles PM, which attach to the chordae tendineae and
act to regulate flow through leaflets L.
[0061] The present invention therefore provides apparatus and
methods for shrinking or reconfiguring tissue, such as annulus A or
chordae tendineae CT. The present invention also encompasses
optionally altering a shape of the valve through mechanical
attachments. The mechanical attachments, as discussed in detail
below, may be done either after the shrinking or reconfiguring of
the tissue, or it may be done as a stand-alone procedure.
Embodiments of the present invention advantageously may be employed
to modify flow regulation characteristics of a cardiac valve or its
component parts, as well as to modify flow regulation in other
lumens of the body, including, for example, the urinary sphincter,
digestive system valves, leg vein valves, etc., where thermal
shrinkage or mechanical reconfiguration of tissue may provide
therapeutic benefit.
[0062] FIGS. 2-15 illustrate apparatus of a first family of
embodiments of the present invention. The first family of
embodiments have an end effector that induces a temperature rise in
an annulus of tissue surrounding the leaflets of a valve sufficient
to cause shrinkage of the tissue, thereby reducing a diameter of
the annulus and causing the valve to close more tightly.
[0063] Referring to FIG. 2, apparatus 30 comprises catheter 32
having end effector 34 in a distal region of the catheter. End
effector 34 may be collapsible within and extendable beyond the
distal end of catheter 30 to permit percutaneous delivery to a
treatment site. End effector 34 has an annular shape to facilitate
treatment of an annulus of tissue, as well as stabilization against
the walls of a treatment site.
[0064] With reference to FIGS. 3A-3C, alternative embodiments of
end effector 34 and catheter 32 are described. In FIG. 3A, end
effector 34 comprises expandable balloon 40. Balloon 40 comprises
bipolar electrodes 42a and 42b that may be attached to a
radiofrequency ("RF") voltage or current source (not shown).
Balloon 40 further comprises lumen 44 to facilitate unimpeded blood
flow or fluid transport therethrough, and temperature sensors 46 to
monitor shrinkage of tissue caused by current flow between bipolar
electrodes 42a and 42b. Sensors 46 may comprise, for example,
standard thermocouples, or any other temperature sensor known in
the art.
[0065] The end effector of FIG. 3A is thus capable of achieving
controlled luminal shrinkage while allowing blood to pass through
the center of balloon 40. Electrodes 42a and 42b are disposed as
bands on the periphery of balloon 40 and may inject an RF
electrical current into the wall of a treatment site, such as an
annulus or lumen, to shrink collagen contained therein.
Furthermore, balloon 40 may be inflated with a circulating coolant
C, such as water, to cool the surface of balloon 40 and thereby
minimize thermal damage at the surface of the treatment site.
Thermally damaged tissue may be thrombogenic and may form thrombus
on its surface, leading to potentially lethal complications.
[0066] FIG. 3A also provides a cross section through an embodiment
of catheter 32, along sectional view line A-A, for use in
conjunction with the balloon embodiment of end effector 34.
Catheter 32 comprises coolant lumens 48a and 48b that may circulate
coolant C into and out of balloon 40, respectively. It further
comprises wires 49a-49c, electrically coupled to electrode 42a,
electrode 42b, and temperature sensors 46, respectively.
[0067] In FIG. 3B, an alternative embodiment of end effector 34 and
catheter 32 is presented. Instead of RF energy, the heating element
in this embodiment is a laser source (not shown) coupled to fiber
optic cable 50 having side firing tip 51. The laser source injects
light energy into the wall of a treatment site via fiber optic
cable 50, thereby thermally shrinking the tissue. The wavelength of
the laser may be selected to penetrate tissue to a desired depth.
Furthermore, a plurality of fiber optic cables 50, coupled to the
laser source and disposed about the circumference of balloon 40,
may be provided.
[0068] Balloon 40 is substantially transparent to the laser energy,
and coolant C may again serve to cool the surface of balloon 40,
thereby minimizing damage at the surface of the treatment site. The
circulating stream of coolant C maintains the temperature of
surface tissue layers at a sufficiently low level to prevent
thermal damage, and thus, to prevent formation of thrombus.
Temperature sensor 46 optionally may also be provided.
[0069] As seen in FIG. 3C, end effector 34 may alternatively
comprise wrapped sheet 52 incorporating one or more electrodes on
its surface. Sheet 52 may be advanced to a treatment site in a
collapsed delivery configuration within a lumen of catheter 32, and
may then be unfurled to an expanded deployed configuration wherein
it contacts the interior wall of the treatment site and may be
energized to shrink tissue.
[0070] Referring now to FIG. 4, a method of using apparatus 30 to
thermally shrink an annulus of tissue is described. End effector 34
is placed in intimate contact with the inner wall of a blood vessel
or other body lumen. In the valvular regurgitation treatment
technique of FIG. 4, end effector 34 is percutaneously delivered
just proximal of aortic valve AV within ascending aorta AA at
annulus of tissue A supporting leaflets L, using well-known
techniques. Aortic valve AV suffers from valvular degeneration,
leading to regurgitation. End effector 34 delivers energy to
annulus A sufficient to heat and shrink the annulus, thus enhancing
function of the degenerative valve.
[0071] Collagen within annulus A shrinks and reduces a diameter of
the annulus. Leaflets L are approximated towards one another, as
seen in dashed profile in FIG. 4, and valvular regurgitation is
reduced or eliminated. In addition to valvular regurgitation, the
technique is expected to effectively treat aortic
insufficiency.
[0072] End effector 34 stabilizes apparatus 30 against the wall of
a body passageway. Once stabilized, a source of energy may be
applied to the wall to thermally shrink the tissue contained in the
wall. In addition to the application of FIG. 4, treatment may be
provided, for example, to the annulus of mitral valve MV, to the
urinary sphincter for treatment of incontinence, to digestive
system valves for treatment of acid reflux, to leg vein valves, and
to any other annulus of tissue where treatment is deemed
beneficial.
[0073] With reference to FIGS. 5A and 5B, alternative embodiments
of the apparatus of FIG. 2 are described. In FIG. 5A, apparatus 60
comprises catheter 62 having a lumen, in which end effector 64 is
advanceably disposed. End effector 64 comprises monopolar electrode
66, which is fabricated in an arc from a shape memory alloy, such
as spring steel or nitinol, to approximate the shape of an annulus
of tissue at a treatment site within a patient. Electrode 66 may be
retracted within the lumen of catheter 62 to facilitate
transluminal, percutaneous delivery to the treatment site. Once in
position, electrode 66 may be advanced out of a distal region of
catheter 62. The electrode resumes its arc shape and approximates
the wall of the treatment site.
[0074] Monopolar electrode 66 is electrically coupled to RF source
68, which is positioned outside of the patient. RF source 68 is, in
turn, coupled to reference electrode 69. When RF source 68 is
activated, current flows between monopolar electrode 66 and
reference electrode 69, which may, for example, be attached to the
exterior of the patient in the region of the treatment site. RF
current flows into the wall of the treatment site, thereby
effecting annular tissue shrinkage, as described previously.
[0075] In FIG. 5B, a bipolar embodiment is provided. Apparatus 70
comprises catheter 72 and end effector 74. End effector 74
comprises a plurality of atraumatic tipped legs 76 that are
electrically coupled by a plurality of current carrying wires 78 to
an RF source (not shown). The plurality of legs contact the wall of
a treatment site and inject current into the wall. The current
flows between the tips of the legs. Alternatively, the plurality of
legs may comprise a monopolar electrode coupled by a single wire to
the RF source, and current may flow between the plurality of legs
and a reference electrode, as in FIG. 5A.
[0076] Referring to FIGS. 6A-6D, another alternative embodiment of
the apparatus of FIG. 2 is described. FIG. 6A shows apparatus 80 in
side-sectional view in a retracted delivery configuration.
Apparatus 80 comprises catheter 82 and end effector 84. Catheter 82
further comprises central bore 86, a plurality of side bores 88,
and optional temperature sensors 90. End effector 84 may, for
example, be fabricated from nitinol or spring steel, and comprises
conductive shaft 92 having a plurality of radially extending
electrodes 94 with optional barbs 96. Conductive shaft 92 is
electrically coupled to RF source 98, which is electrically coupled
to reference electrode 99. Conductive shaft 92 is disposed within
central bore 86, while electrodes 94 are disposed within side bores
88.
[0077] End effector 84 is advanceable with respect to catheter 82.
When advanced distally, apparatus 80 assumes the expanded deployed
configuration of FIG. 6B, wherein electrodes 94 extend through side
bores 88 beyond the surface of catheter 82. Apparatus 80 is also
configured such that its distal region may approximate the shape of
an annulus of tissue, as described hereinbelow with respect to FIG.
6D, and is thus suited for both linear and circular subsurface
tissue coagulation and shrinkage.
[0078] FIGS. 6C and 6D provide a method of using apparatus 80 to
treat annulus of tissue A surrounding a heart valve. Apparatus 80
is percutaneously advanced to the surface of a heart valve in the
delivery configuration of FIG. 6C. Once positioned at annulus A,
the distal region of apparatus 80 approximates the shape of the
annulus, as seen in FIG. 6D. This may be accomplished, for example,
with a steering mechanism comprising two purchase points or a
pre-shaped tip that is retracted within a straight guiding catheter
to allow insertion into the vascular system, as described in U.S.
Pat. No. 5,275,162, which is incorporated herein by reference. Once
inserted, the pre-shaped tip is advanced out of the guide catheter
and recovers its preformed shape.
[0079] With apparatus 80 approximating annulus A, end effector 84
is distally advanced with respect to catheter 82, thereby
selectively advancing electrodes 94 into the annulus. RF source 98
then provides RF current, which flows between electrodes 94 and
reference electrode 99. The annulus of tissue shrinks; bringing
valve leaflets into proper position and minimizing or eliminating
regurgitation through the valve.
[0080] Catheter 82 insulates conductive shaft 92 from annulus A,
thereby protecting surface tissue and only allowing coagulation at
depth in treatment zones surrounding electrodes 94. To further
ensure that coagulation only occurs at depth, a coolant, such as
saline, may be introduced through central bore 86 and side bores 88
of catheter 82 to the surface of annulus A, thereby cooling and
flushing the area where electrodes 94 penetrate the tissue. It is
expected that such liquid infusion will keep the surface of the
annulus clean and will prevent thrombus formation in response to
thermal damage.
[0081] Referring now to FIG. 7A-7C, an alternative embodiment of
end effector 84 of FIG. 6 is described. The end effector of FIG. 7
is equivalent to the end effector of FIG. 6 except that it is
coated with electrically insulating layer I. Insulation layer I
covers the entire exterior of end effector 84, except at the distal
ends of the plurality of electrodes 94. The layer is preferably
sufficiently thin to allow insertion of electrodes 94 into tissue T
without impediment. The exposed distal ends of the electrodes are
configured to deliver energy into subsurface tissue at treatment
zones Z. The zones may be ideally modeled as spheres of subsurface
tissue. Tissue shrinks within treatment zones Z without damaging
surface tissue, as seen in FIG. 7B.
[0082] The size of treatment zones Z may be controlled to ensure
that tissue remodeling only occurs at depth. Assuming a temperature
T.sub.1, at which tissue damage is negligible, the magnitude of
current passed through tissue T may be selected (based on the
material properties of the tissue and the depth of insertion of
electrodes 94 within the tissue) such that the temperature decays
from a temperature T.sub.0 at a position D.sub.0 at the surface of
an electrode 94 to the benign temperature T.sub.1 at a distance
D.sub.1 from the surface of the electrode. The distance D.sub.1 may
be optimized such that it is below the surface of tissue T. An
illustrative temperature profile across a treatment zone Z is
provided in FIG. 7C.
[0083] With reference to FIGS. 8A and 8B, another alternative
embodiment of the apparatus of FIG. 6 is described. Apparatus 100
comprises catheter 102 and end effector 104. End effector 104
further comprises a plurality of individual, multipolar electrodes
106, which are electrically coupled to an RF or other current
source (not shown) by a plurality of current carrying wires 108. As
with the embodiments of FIGS. 6 and 7, apparatus 100 is configured
such that end effector 104 may approximate an annulus, as seen in
FIG. 8B.
[0084] Referring to FIGS. 9-11, alternative embodiments of the
apparatus of FIG. 8 are described. In FIG. 9, apparatus 110
comprises catheter 112 and end effector 114. End effector 114
comprises a plurality of acoustic heating elements 116. Acoustic
elements 116 may, for example, comprise ultrasonic transducers. The
acoustic energy may further be focused by appropriate means, for
example, by lenses, such that a tissue damage threshold sufficient
to cause shrinkage is only attained at a specified depth within
treatment site tissue, thereby mitigating surface tissue damage and
thrombus formation. Acoustic elements 116 are connected to
appropriate controls (not shown). Apparatus 110, and any other
apparatus described herein, may optionally comprise temperature
sensors 118.
[0085] In FIG. 10, apparatus 120 comprises catheter 122 and end
effector 124. Catheter 122 comprises a plurality of central bores
126 and a plurality of side bores 128, as well as a plurality of
optional temperature sensors 130. End effector 124 comprises a
plurality of side-firing fiber optic laser fibers 132 disposed
within central bores 126 of catheter 122. The fibers are aligned
such that they may deliver energy through side bores 128 to heat
and induce shrinkage in target tissue. Fibers 132 are coupled to a
laser source (not shown), as discussed with respect to FIG. 3B.
Suitable wavelengths for the laser source preferably range from
visible (488-514 nm) to infrared (0.9-10.6 microns), wherein each
wavelength has an ability to heat tissue to a predetermined depth.
As an example, a preferred laser source comprises a continuous wave
laser having a 2.1 micron wavelength, which will shrink and heat
tissue to a depth of 1-2 mm.
[0086] In FIG. 11, apparatus 140 comprises catheter 142 and end
effector 144. Catheter 132 comprises central bores 146 and side
bores 148. Catheter 132 further comprises temperature sensors 150
that are configured to penetrate superficial tissue layers to
measure temperature at depth. Temperature sensors 150 may be
retractable and extendable to facilitate percutaneous delivery of
apparatus 140. End effector 144 comprises fibers 152 disposed
within central bores 146. Fibers 152 are retractable within and
extendable beyond side bores 148. Fibers 152 are preferably
sharpened to facilitate tissue penetration and energy delivery to
subsurface tissue, thereby inducing shrinkage of the tissue.
[0087] Fibers 152 may comprise any of a number of energy delivery
elements. For example, fibers 152 may comprise a plurality of
optical fibers coupled to a laser (not shown). The wavelength of
the laser may be selected as described hereinabove, while the
energy deposited by the fibers may be controlled responsive to the
temperature recorded by sensors 150. Thus, for example, a
controller (not shown) may be provided to switch off the laser once
a preset temperature, for example, 45.degree. C.-75.degree. C., is
attained, thereby ensuring that a sufficiently high temperature is
achieved to cause tissue shrinkage without inadvertently damaging
surrounding tissues.
[0088] Fibers 152 may alternatively comprise a plurality of
multipolar electrodes. Each electrode may be capable of injecting
RF energy into tissue independently. Alternatively, current may be
passed between a pair of adjacent or non-adjacent electrodes to
heat intervening tissue.
[0089] Referring now to FIG. 12, an alternative method of
introducing apparatus of the first family of embodiments to a
treatment site is described. Apparatus 30 of FIG. 2 is been
introduced to the annulus of tissue A surrounding mitral valve MV
via the venous circulatory system. Catheter 32 is transluminally
inserted via the jugular vein and superior vena cava SVC. The
distal end of the catheter or a separate instrument then penetrates
atrial septum AS using a procedure known as septostomy. Once the
septum is perforated, end effector 34 may be inserted into left
atrium LA and positioned over mitral valve annulus A to effect the
thermal treatment described hereinabove. The tricuspid valve in the
right ventricle, and the pulmonic valve, may also be treated in the
same manner using a venous approach.
[0090] Referring to FIGS. 13A and 13B, a further alternative
embodiment of the apparatus of FIG. 2 is described that may be
introduced using the technique of FIG. 4, the technique of FIG. 12,
or by another suitable technique. Apparatus 160 comprises catheter
162 and end effector 164. End effector 164 comprises adjustable,
heatable loop 166, which is configured for dynamic sizing to
facilitate positioning next to tissue at a treatment site. The size
of loop 166 is adjusted so as to lie contiguous with annulus of
tissue A at a treatment site, as seen in FIG. 13B. The loop may be
collapsible within catheter 162 to facilitate percutaneous delivery
and is electrically coupled to RF source 168, which is electrically
coupled to reference electrode 170. Loop 166 may be fabricated from
nitinol, copper, or any other suitably conductive and ductile
material.
[0091] Referring to FIGS. 14A and 14B, a still further alternative
embodiment of the apparatus of FIG. 2, and a method of using the
embodiment with the introduction technique of FIG. 12, is
described. Apparatus 170 comprises catheter 172 and end effector
174. End effector 174 is capable of grabbing and penetrating
tissue, as well as delivering RF energy into tissue. End effector
174 comprises jaws 176a and 176b, which are spring-biased against
one another to a closed position. By pushing a knob on the
handpiece (not shown), the jaws may be actuated to an open position
configured to grab tissue at a treatment site. RF energy may then
be deposited in the tissue in a monopolar or bipolar mode. Jaws 176
may optionally be coated with electrically insulating layer I
everywhere except in a distal region, such that tissue is only
treated at depth, as described hereinabove. End effector 174 has
temperature sensor 178 to control power delivered to the tissue,
again as described hereinabove.
[0092] With reference to FIG. 14B, a method of using apparatus 170
via a septostomy introduction technique to treat mitral valve
regurgitation is described. In particular, jaws 176 of end effector
174 are actuated to engage individual sections of valve annulus A
so as to penetrate into the collagenous sublayers and to thermally
shrink those sublayers. The procedure may be repeated at multiple
locations around the perimeter of annulus A until regurgitation is
minimized or eliminated.
[0093] FIGS. 15A and 15B show an alternative end effector for use
with apparatus 170 of FIG. 14. End effector 180 is shown in an open
position and in a closed position, respectively, and comprises jaws
182a and 182b. End effector 180 is similar to end effector 174,
except that jaws 182 are configured to engage tissue with a forceps
grasping motion wherein bent tips 184a and 184b of the jaws are
disposed parallel to one another and contact one another when
closed.
[0094] With reference now to FIGS. 16-20, apparatus of a second
family of embodiments of the present invention are described. These
embodiments are provided with an end effector that selectively
induces a temperature rise in the chordae tendineae sufficient to
cause a controlled degree of shortening of the chordae tendineae,
thereby enabling valve leaflets to be properly aligned.
[0095] A preferred use for apparatus of the second family is in
treatment of mitral valve regurgitation. Mitral valve regurgitation
has many causes, ranging from inherited disorders, such as
Marphan's syndrome, to infections and ischemic disease. These
conditions affect the macromechanical condition of the mitral valve
and prevent the valve from closing completely. The resulting gap in
the leaflets of the valve permit blood to regurgitate from the left
ventricular chamber into the left atrium.
[0096] Mechanically, the structural defects characterizing mitral
valve regurgitation include: (1) the chordae tendineae are too long
due to a given disease state; (2) papillary muscle ischemia changes
the shape of the papillary muscle, so that attached chordae
tendineae no longer pull the leaflets of the mitral valve
completely shut; (3) the annulus of the mitral valve becomes
enlarged, resulting in the formation of a gap between the leaflets
when closed; and (4) there is an inherent weakness in the leaflets,
leaving the leaflets floppy and dysfunctional.
[0097] In accordance with the principles of the present invention,
a temperature rise is induced in the support structure of the
mitral valve to cause shrinkage that modifies the geometry of the
valve to restore proper stopping of blood backflow and thereby
regurgitation. This process is depicted in FIGS. 18-20 using the
apparatus of FIGS. 16 and 17 to selectively shrink portions of the
chordae tendineae, thereby bringing leaflets of the mitral valve
leaflets into alignment. Apparatus of the second family may also be
used in treatment of aortic valve regurgitation, and in treatment
of a variety of other ailments that will be apparent to those of
skill in the art.
[0098] Referring to FIG. 16, apparatus 200 comprises catheter 202
and end effector 204. Catheter 204 optionally comprises collapsible
and expandable stabilizer 206, configured to stabilize apparatus
200 in a body lumen. Stabilizer 206 may comprise, for example,
struts or an inflatable balloon.
[0099] End effector 204 may be collapsible to a delivery
configuration within catheter 202, and may expand to a delivery
configuration beyond a distal end of the catheter. End effector 204
is configured to engage, heat, and shrink chordae tendineae.
Various sources of energy may be used to impart heat to the
collagenous tissue and thereby shrink it, including RF energy,
focused ultrasound, laser energy, and microwave energy. In
addition, chemical modifiers, such as aldehydes, may be used. For
laser embodiments, a preferred laser is a continuous wave
Holmium:Yag laser, with application of visible or infrared laser
energy in the wavelength range of 400 nanometers to 10.6
micrometers.
[0100] With reference to FIGS. 17A-17C, embodiments of end effector
204 are described. In FIG. 17A, the end effector comprises a
gripping mechanism that carries the heating element. Arms 210a and
210b are opposing and spring-biased against each other. The arms
may be actuated to an open position using a handpiece (not shown)
coupled thereto. Arms 210a and 210b may alternatively be vertically
displaced with respect to one another to allow the arms to
cross-cross and tightly grasp tissue. Heating elements 212 and
temperature sensors 214 are attached to the arms. Heating elements
212 may comprise electrodes, acoustic transducers, side-firing
laser fibers, radioactive elements, etc. It may be desirable to
employ a saline flush with heating elements 212 to prevent
coagulation of blood caught between arms 210.
[0101] FIG. 17B shows an embodiment of end effector 204 with fixed,
straight arms 220a and 220b. The arms are configured to engage and
disengage chordae tendineae simply by being positioned against the
tendineae. FIG. 17C shows an embodiment of the end effector having
arms 230a and 230b. Multiple heating elements 212 are disposed on
arm 230a. When heating elements 212 comprise bipolar electrodes,
current flow through the tendineae using the embodiment of FIG. 17C
may be achieved primarily along a longitudinal axis of the
tendineae, as opposed to along a radial axis of the tendineae, as
will be achieved with the embodiment of FIG. 17A. These alternative
heating techniques are described in greater detail hereinbelow with
respect to FIGS. 19 and 20.
[0102] Referring to FIG. 18, a method of using apparatus of the
second family of embodiments to induce shrinkage of chordae
tendineae CT is described. Catheter 202 of apparatus 200 is
advanced percutaneously, using well-known techniques, through the
ascending aorta AA and aortic valve AV into the left ventricle LV,
with end effector 204 positioned within the catheter in the
collapsed delivery configuration. Stabilizer 206 is then deployed
to fix catheter 202 in ascending aorta AA, thereby providing a
stationary leverage point.
[0103] End effector 204 is expanded to the deployed configuration
distal of catheter 202. The end effector is steerable within left
ventricle LV to facilitate engagement of chordae tendineae CT. End
effector 204, as well as any of the other end effectors or
catheters described herein, may optionally comprise one or more
radiopaque features to ensure proper positioning at a treatment
site. End effector 204 is capable of moving up and down the chordae
tendineae to grab and selectively singe certain sections thereof,
as illustrated in dotted profile in FIG. 18, to selectively shorten
chordae tendineae CT, thereby treating valvular regurgitation.
[0104] When energy is transmitted through tissue utilizing one of
the embodiments of this invention, the tissue absorbs the energy
and heats up. It may therefore be advantageous to equip the end
effector with temperature or impedance sensors, as seen in the
embodiments of FIG. 17, to output a signal that is used to control
the maximum temperature attained by the tissue and ensure that the
collagen or other tissues intended to be shrunk are heated only to
a temperature sufficient for shrinkage, for example, a temperature
in the range of 45.degree. C.-75.degree. C., and even more
preferably in the range of 55.degree. C.-65.degree. C. Temperatures
outside this range may be so hot as to turn the tissue into a
gelatinous mass and weaken it to the point that it loses structural
integrity. A closed loop feedback system advantageously may be
employed to control the quantity of energy deposited into the
tissue responsive to the output of the one or more sensors. In
addition, the sensors may permit the clinician to determine the
extent to which the cross-section of a chordae has been treated,
thereby enabling the clinician to heat treat only a portion of the
cross-section.
[0105] This technique is illustrated in FIGS. 19 and 20, in which
alternating bands, only a single side, or only a single depth of
the chordae is shrunk to leave a "longitudinal intact fiber
bundle." This method may be advantageous in that, by avoiding heat
treatment of the entire cross section of the chordae, there is less
risk of creating mechanical weakness.
[0106] FIGS. 19A-19C depict a method of shrinking a section of
chordae tendineae CT in a zig-zag fashion using the embodiment of
end effector 204 seen in FIG. 17C. In FIG. 19A, the tendineae has
an initial effective or straight length L.sub.1. Arms 230 engage
chordae tendineae CT, and heating elements 212 are both disposed on
the same side of the tendineae on arm 230a. The heating elements
may comprise bipolar electrodes, in which case the path of current
flow through tendineae CT is illustrated by arrows in FIG. 19A.
[0107] Collagen within the tendineae shrinks, and chordae tendineae
CT assumes the configuration seen in FIG. 19B. Treatment zone Z
shrinks, and the tendineae assumes a shorter effective length
L.sub.2. Treatment may be repeated on the opposite side of the
tendineae, as seen in FIG. 19C, so that the tendineae assumes a
zig-zag configuration of still shorter effective length L.sub.3. In
this manner, successive bands of treatment zones Z and intact
longitudinal fiber bundles may be established.
[0108] An additional pair of bipolar electrodes optionally may be
disposed on arm 230b of the end effector to facilitate treatment in
bands on opposite sides of chordae tendineae CT. The depth of
shrinkage attained with apparatus 200 is a function of the distance
between the electrodes, the power, and the duration of RF energy
application. If, laser energy is applied, the wavelengths of energy
application may be selected to provide only partial penetration of
the thickness of the tissue. For example, continuous wave
Holmium:YAG laser energy having a wavelength of 2.1 microns
penetrates a mere fraction of a millimeter and may be a suitable
energy source.
[0109] FIGS. 20A-20C illustrate additional shrinkage techniques.
Intact chordae tendineae CT is seen in FIG. 20A. FIG. 20B
demonstrates shrinkage with apparatus 200 only on one side of the
chordae, using the technique described with respect to FIG. 19.
FIG. 20C demonstrates shrinkage with, for example the end effector
of FIG. 17A or 17B, wherein, for example, bipolar current flows
across the tendineae and treats the tendineae radially to a certain
preselected depth. When viewed in cross-section along sectional
view line C-C of FIG. 20A, chordae tendineae CT has an intact
longitudinal fiber bundle core C surrounded by treatment zone
Z.
[0110] With reference to FIGS. 21-22, apparatus of a third family
of embodiments of the present invention are described. These
embodiments are provided with an end effector comprising a
mechanical reconfigurer configured to engage a longitudinal member,
such as the chordae tendineae. The reconfigurer forces the
longitudinal member into a tortuous path and, as a result, reduces
the member's effective overall or straight length.
[0111] Referring to FIGS. 21A and 21B, apparatus 300 comprises
catheter 302 and end effector 304. End effector 304 comprises
mechanical reconfigurer 306, adapted to mechanically alter the
length of a longitudinal member, for example, chordae tendineae.
Reconfigurer 306 comprises a preshaped spring fabricated from a
shape memory alloy, for example, nitinol, spring steel, or any
other suitably elastic and strong material. Reconfigurer 306 is
preshaped such that there is no straight path through its loops.
Overlap between adjacent loops is preferably minimized. The shape
of reconfigurer 306 causes longitudinal members, such as chordae
tendineae, passed therethrough to assume a zig-zag configuration
and thereby be reduced in effective length. Reconfigurer 306 is
collapsible to a delivery configuration within catheter 302, as
seen in FIG. 21A, and is expandable to a deployed configuration, as
seen in FIG. 21B. The reconfigurer optionally may be selectively
detachable from catheter 302.
[0112] With reference to FIGS. 22A and 22B, a method of using
apparatus 300 to mechanically shorten chordae tendineae CT is
described. Apparatus 300 is advanced to the chordae tendineae, for
example, using the technique described hereinabove with respect to
FIG. 18. End effector 304 is then expanded from the delivery
configuration seen in FIG. 22A to the deployed configuration of
FIG. 22B. Mechanical reconfigurer 306 regains its preformed shape,
and chordae tendineae CT is passed through a tortuous path that
reduces its effective length, thereby treating valvular
regurgitation. Reconfigurer 306 may then be detached from apparatus
300 and permanently implanted in the patient, or the reconfigurer
may be left in place for a limited period of time to facilitate
complementary regurgitation treatment techniques.
[0113] Other embodiments of the third family in accordance with the
present invention will be apparent to those of skill in the art in
light of this disclosure.
[0114] Referring now to FIG. 23, apparatus in accordance with the
present invention is described that may be used as either an
embodiment of the first family or of the second family. Apparatus
and methods are provided for noninvasively coagulating and
shrinking scar tissue around the heart, or valve structures inside
the heart, using energy delivered via high intensity, focused
ultrasound. Apparatus 350 comprises catheter 352 and end effector
354. End effector 354 comprises ultrasonic transducer 356 and
focusing means 358, for example, a lens. Focused ultrasound is
propagated and directed with a high level of accuracy at the
chordae CT, the annuluses A of the valves or at a section of
bulging wall of the heart, using, for example, echocardiography or
MRI for guidance. As with the previous embodiments, the shrinkage
induced by energy deposition is expected to reduce valvular
regurgitation. Apparatus 350 may also be used to reduce ventricular
volume and shape, in cases where there is bulging scar tissue on
the wall of the left ventricle LV secondary to acute myocardial
infarction.
[0115] Alternatively, various mechanical valve resizing systems and
methods may be used in conjunction with the apparatus and methods
discussed above. Optionally, the various mechanical valve resizing
systems and methods, as discussed below, may be used as a
stand-alone system. These mechanical resizing systems may generally
entail the positioning, deployment, and securing of one or more
clips to bring the annular edges of a valve, e.g., a heart valve,
or opening together to correct for valvular regurgitation. This
would typically result in the reduction of the effective diameter
of the valve or opening. The clip is preferably made of
superelastic or shape memory materials, e.g., Nickel-Titanium
alloys, because of the ability of these types of materials to be
easily formed, e.g., by annealing, into desirable geometries. Such
materials are very strong and have the ability to be constrained
into a reduced diameter size for deployment as well as being
capable of providing a permanent compressive spring force.
[0116] The variations of clip geometries described herein may be
manufactured in several ways. One method involves securing a wire,
band, or other cross-sectioned length, preferably made of a
superelastic or shape memory material, to a custom forming fixture
(not shown). The fixture preferably has a geometry similar to the
valve or opening where the completed clip is to be placed and the
fixture preferably has a diameter which is smaller than the
diameter of the valve or opening. The fixture diameter may be
determined by the amount of closure by which the valve or opening
may need to be closed or approximated to reduce or eliminate
valvular regurgitation. The fixture, with a constrained clip placed
thereon, may be subjected to a temperature of about 500.degree. to
700.degree. F. preferably for a period of about 1 to 15 minutes.
Additional details about the processing and performance of
superelastic and shape memory materials may be seen in U.S. Pat.
No. 5,171,252 to Friedland, which is incorporated herein by
reference in its entirety. The fixture and clip may then be removed
and subjected to rapid cooling, e.g., quenching in cold water. The
clip may then be removed from the fixture and the ends of the clip
may be trimmed to a desired length. The trimmed ends may also be
formed into a sharpened point by, e.g., grounding, to facilitate
piercing of the tissue.
[0117] FIG. 24A shows a variation of a valve resizing device in
expandable grid 360. Grid 360 is shown as having alternating member
362 formed of a continuous alternating length while forming several
anchoring regions 364, which may be radiused. The number of
alternating members (and number of resultant anchoring regions 364)
formed may be determined by a variety of factors, e.g., the
geometry of the valve to be resized or the amount of spring
compression required. Grid 360 is preferably made of a shape memory
alloy, as discussed above. The terminal ends of alternating member
362 preferably end in anchoring ends 366. Anchoring ends 366 may
define a range of angles with the plane formed by alternating
member 362, e.g., 45.degree., but is preferably formed
perpendicular to the plane. Ends 366 may be formed integrally from
alternating member 362, which may first be cut to length, by
reducing a diameter of ends 366 to form, e.g., a barbed end or
double-barbed end as shown in the figure and in the detail view.
Alternatively, anchoring ends 366 may be formed separately and
attached to the ends of alternating member 362 by, e.g., adhesives,
welding, or scarf joints. The ends 366 are shown in this example as
a double-barbed anchoring fastener, but generally any type of
fastening geometry may be used, e.g., single-barbs, semi-circular
or triangular ends, screws, expandable locks, hooks, clips, and
tags, or generally any type of end geometry that would facilitate
tissue insertion yet resist being pulled or lodged out. Also,
sutures and adhesives, as well as the barbs, may be used to fasten
grid 360 to the tissue.
[0118] Another variation on a grid-type device is shown in FIG. 24B
as expandable mesh 368. In this variation, several individual
interwoven members 370 may be woven together to form a continuous
mesh. Members 370 may be either welded together or loosely
interwoven to form expandable mesh 368. In either case, the
geometries of both expandable grid 360 and mesh 368 are formed to
preferably allow a compressive spring force yet allow a relative
degree of expansion once situated on the valve or opening.
[0119] To maintain grid 360 or mesh 368 over the valve or opening,
fasteners located around the valve or opening are preferably used
for anchoring grid 360 or mesh 368. Fasteners are preferably made
of a biocompatible material with relatively high strength, e.g.,
stainless steel or Nickel-Titanium. Biocompatible adhesives may
also be used. A variation of such a fastener is shown in FIG. 25A.
Anchor 372 is shown having a barbed distal end 374 for piercing
tissue and for preventing anchor 372 from being pulled out. Shown
with a double-barb, it may also be single-barbed as well. Stop 376,
which is optional, may be located proximally of distal end 374 to
help prevent anchor 372 from being pushed too far into the tissue.
A protrusion, shown here as eyelet 378, is preferably located at
the proximal end of anchor 372 and may extend above the tissue
surface to provide an attachment point. Grid 360 or mesh 368 may be
looped through eyelet 378 or they may be held to eyelet 378 by
sutures or any other conventional fastening methods, e.g.,
adhesives.
[0120] Another variation on fasteners is shown in FIG. 25B. Here,
locking anchor 380 is shown with distal end 382 having pivoting or
butterfly-type lock 384. Stop 386 is preferably located proximally
of distal end 382 and protrusion (or eyelet) 388 is preferably
located at the proximal end of locking anchor 380. In use, pivoting
lock 384 may be retracted against the shank of anchor 380 while
being pushed into the tissue. When anchor 380 is pulled back,
pivoting lock 384 may extend outwardly to help prevent anchor 380
from being pulled out of the tissue.
[0121] FIG. 26 shows a cross-sectional superior view of, e.g.,
human heart section 390, with the atrial chambers removed for
clarity. Heart tissue 392 is seen surrounding tricuspid valve 400
and bicuspid or mitral valve 402. Sectioned ascending aorta 394 and
pulmonary trunk 396 are also seen as well as coronary sinus 398
partially around the periphery of heart section 390. An example of
expandable grid 360 in a deployed configuration is shown over
tricuspid valve 400. Grid 360 may be placed entirely over valve 400
and anchored into heart tissue 392 by anchors 404, which may be of
a type shown in FIG. 25A or 25B, at anchoring regions 364. Once
grid 360 is in place, it may impart a spring force which may draw
the opposing sides of valve 400 towards one another, thereby
reducing or eliminating valvular regurgitation.
[0122] Another variation on a biasing clip device is shown in FIGS.
27A and 27B. FIG. 27A shows circumferential clip 406 having
opposing members 408. This clip variation, preferably made of a
shape memory alloy, e.g., Nickel-Titanium alloy, may be inserted
into the tissue surrounding a valve. This clip may surround the
periphery of the valve and provide an inwardly biased spring force
provided by opposing members 408 to at least partially cinch the
valve. The variation in FIG. 27A preferably surrounds about 50% to
75% of the valve circumference. The variation of clip 410 is shown
in FIG. 27B with opposing members 412. Here, the clip may be made
to surround at least about 50% of the valve circumference. FIG. 28
again shows the cross-sectional superior view of heart section 390
except with circumferential clip 406 placed in the tissue 392
around valve 400. As shown, opposing members 408 preferably provide
the inwardly biased spring force to at least partially cinch valve
400.
[0123] A further variation of the clip is shown generally in FIGS.
29A and 29B. A side view of valve clip 414 is shown in FIG. 29A
having anchoring members 416 on either end of clip 414. FIG. 29B is
an end view of valve clip 414. FIGS. 30A and 30B likewise show
another variation of valve clip 418 with curved anchoring members
420 on either end of the clip. This variation of valve clip 418
shows the addition of curved central region 422 which may be
located near or at the center of clip 418. Region 422 may be
incorporated to act as a stress-relieving mechanism by allowing
clip 418 to bend or pivot to a greater degree about region 422 than
clip 418 normally would. This may also allow for greater
adjustability when placing clip 418 over a valve. FIG. 30B shows an
end view of the clip.
[0124] Another variation is seen in FIGS. 31A to 31D. FIG. 31A
shows a top view of arcuate valve clip 424. Clip 424 preferably has
an arcuate central member 426, which is shown as a semicircle
having a radius, R. Central member 426 may serve to act as a
stress-relieving member, as described above, and it may also be
designed to prevent any blockage of the valve by clip 424 itself.
Thus, radius, R, is preferably large enough so that once clip 424
is placed over the valve, central member 426 lies over the valve
periphery. FIG. 31B shows a side view of the clip. This view shows
anchoring members 430 attached by bridging members 428 on either
end to central member 426. FIG. 31C shows an end view of the clip
where the anchoring members 430 and central member 426 are clearly
shown to lie in two different planes defining an angle, .alpha.,
therebetween. The angle, .alpha., may vary greatly and may range
from about 60.degree. to 120.degree., but is preferably about
90.degree. for this variation. Finally, FIG. 31D shows an isometric
view of clip 424 where the biplanar relationship between anchoring
members 430 and central member 426 can be seen.
[0125] The curved anchoring members above are shown as being curved
in a semi-circle such that they face in apposition to one other.
But any geometry may be used, e.g., arcs, half-ellipses, hooks,
V-shapes or triangles, and generally any type of end geometry that
would facilitate tissue insertion yet resist being pulled or lodged
out.
[0126] The shape of the clip itself may range from a wide variety
of geometries. Such geometries may include circles, semi-circles,
rectangles, triangles, or any combinations thereof. FIGS. 32A and
32B show a top and side view, respectively, of valve clip 432a and
anchoring members 434a where the entire clip 432a preferably curves
in an arcuate manner. FIGS. 33A and 33B show a top and side view,
respectively, of clip 432b with anchoring members 434b where clip
432b is in a triangular shape. FIGS. 34A and 34B show a top and
side view, respectively, of clip 432c with anchoring members 434c
where clip 432c is in a rectangular shape. FIGS. 35A and 35B show a
top and side view, respectively, of clip 432d with anchoring
members 434d where clip 432d is a looped section. Likewise in FIGS.
36A and 36B show a top and side view, respectively, of clip 432e
with anchoring members 434e where clip 432e has a curved section,
which may act as a stress-relieving member. These various clip
geometries are presented as examples and in no way limit the scope
of the invention.
[0127] Any of the above-described clips or any other clip geometry
in the spirit of this invention may be coated with a variety of
substances. For example, a clip may be coated with a hydrophilic
(which may be used, e.g., for surface lubricity), anti-thrombosis
agent, therapeutic agent, or any other drug coating to prevent,
e.g., thrombosis, or to act as a drug delivery mechanism. Such drug
coatings may be applied during the clip manufacture or just prior
to deployment. Also, the clips may be made to become more
radiopaque by coating them with, e.g., Nickel-Titanium alloy,
Platinum, Palladium, Gold, Tantalum, or any other biocompatible
radiopaque substance. Such a coating could be applied, e.g., by
sputter coating or ion deposition. Moreover, the coating is
preferably applied in a thin enough layer such that it would not
affect the physical properties of the clip material.
[0128] The clip may be delivered and placed over or around the
valve using a variety of different methods, e.g., endoscopically,
laparoscopically, or through other conventional methods such as
open-heart surgery. A preferable method and apparatus is to deliver
the clip through the vasculature using a delivery catheter and/or
guidewire. FIG. 37 shows a variation of such a catheter in the
cross-sectioned view of a distal section of delivery catheter 436.
Catheter body 438, which may comprise an outer layer of catheter
section 436, may be comprised of a variety of materials, e.g.,
polyimide, polymeric polyolefins such as polyethylene and
polypropylene, high density polyethylene (HDPE), etc. and is
preferably lubricious to allow easy traversal of the vasculature.
Catheter body 438 preferably has delivery lumen 440 defined
throughout the length of catheter section 436 and may terminate at
the distal tip in delivery port 442. Delivery port 442 may be an
open port and it may be sealable during delivery when catheter
section 436 traverses the vasculature. At the distal most end of
section 436, distal tip 443 may be placed with delivery port 442
defined therethrough. Distal tip 443 may be metallic, e.g.,
Nickel-Titanium alloy, Platinum, Palladium, Gold, Tantalum, etc. to
provide radiopacity for visualization by, e.g., a fluoroscope, CT,
or PET, and is preferably rounded to be atraumatic to the
vasculature. Catheter section 436 may alternatively use a
radiopaque marker band (not shown) either alone or in addition to
tip 443 to further aid in visualization.
[0129] Clip 444 may be disposed in lumen 440 within catheter
section 436; as seen, clip 444 is preferably in a compressed
configuration to fit within lumen 440 during delivery. The clip 444
may be loaded into catheter section 436 through delivery port 442,
or alternatively, through the proximal end of delivery lumen 440
and advanced towards the distal end of catheter section 436.
Reinforced liner 446 may surround the area where clip 444 is loaded
to allow structural reinforcement to catheter body 438. Liner 446
may also allow constrainment of clip 444 while allowing forward
movement of the clip 444 during deployment. Liner 446 may be made
from a thin-walled superelastic or shape memory tube and may also
have a lubricious coating to reduce the amount of force required
for deployment of clip 444. Catheter section 436 may be guided
within the vasculature via a conventional guidewire (not shown), or
it may be steered through the vasculature via steering lumen 452
which may contain steerable components, e.g., wire 453, disposed
within to steer catheter section 436. Wire 453 may be a pull-wire,
leaf spring, or other steering-type device.
[0130] Once catheter section 436 has reached the target site, clip
444 may be advanced through delivery port 442 by plunger 448.
Plunger 448 is preferably attached to a distal end of stylet 450,
which may run through the full length of catheter body 438 to allow
manipulation from the proximal end. Plunger 448 may be advanced
towards the distal end of catheter section 436 to urge clip 444 out
of delivery port 442 by manipulating the proximal end of stylet
450. Stylet 450 may be advanced manually like a guidewire, or by
attaching it to an advancement mechanism, e.g., a thumb-slide.
Stylet 450 may also be passed through a hemostatic valve located
within catheter body 438, either at a distal or proximal end, to
prevent backflow into lumen 440 during insertion and delivery
through the vasculature. The advancement mechanism, discussed
further below, may be controlled by an indexed linear movement
mechanism, e.g., a screw, ratchet, etc., located on a handle at the
proximal end of catheter body 438. Once plunger 448 and stylet 450
is advanced completely, clip 444 may be urged completely through
delivery port 442, where it may then expand or form its deployed
configuration.
[0131] FIG. 38 shows catheter section 436 with another compressed
variation of clip 454. Here, clip 454 may be compressed into a "U"
or "V" shape for delivery and deployed in the same manner by
plunger 448 and stylet 450 through delivery port 442, as discussed
above. This variation enables the ends of clip 454 to be deployed
simultaneously; however, this variation may also require a larger
delivery port 442 than the variation shown in FIG. 37.
[0132] FIG. 39 shows a further variation of the distal end of
deployment catheter section 456. This variation shows catheter body
458 with delivery lumen 460 terminating in distal tip 461, much
like the variations shown above. But here, distal tip 461 does not
have a delivery port defined through it, rather delivery port 462
is preferably defined along a distal length of catheter body 458
proximally of distal tip 461. Clip 464 may be any of the
variational shapes described above but is shown here in a
compressed arcuate shape. Clip 464 may be held within catheter
section 456 by an external constraining sheath or it may be held
simply by friction fitting clip 464 within delivery port 462.
Catheter section may be steered to the desired target site via
steering lumen 468 and once in position, deployment stylet 466 may
be urged towards the distal end of section 456 in much the same
manner as described above. However, stylet 466 is preferably angled
at its distal tip to facilitate pushing clip 464 out through
delivery port 462.
[0133] FIGS. 40A and 40B show a top and side view, respectively, of
an example of catheter handle 470 which may be used to advance the
clip into position over a valve or opening. This variation shows
handle 470 with distal end 472, where the catheter is preferably
attached, and the linear advancement mechanism, shown here as
thumb-slide 474. Thumb-slide 474 may be advanced in advancement
slot 476 towards distal end 472 to urge the plunger and stylet.
Within handle 470, the advancement of thumb-slide 474 may be
controlled by an indexing mechanism, e.g., a screw, ratchet, or
some type of gear, which may allow the proximal and distal movement
of the thumb-slide 474 through slot 476.
[0134] Delivering and placing the clip over the desired tissue,
valve, or opening may be accomplished by several different methods.
As shown in FIG. 41A, one exemplary method is to introduce
deployment catheter 478 into the coronary vasculature through,
e.g., the jugular vein, and into the superior vena cava SVC. From
there, tricuspid valve TV may be treated or the mitral valve MV may
be treated by having catheter 478 penetrate the atrial septum AS
using a septostomy procedure, as discussed above. Once septum AS is
perforated, catheter distal end 480 may be inserted into the left
atrium LA and brought into position over the mitral valve MV.
Catheter distal end 480 may be positioned over mitral valve MV by
tracking its position visually through a fluoroscope or other
device by using the radiopaque distal tip (as described above) or
via a radiopaque marker band or half-marker band 486. As shown,
distal end 480 may be brought into contact against or adjacent to
one side of the annulus of tissue A. The plunger may be advanced
(as described above) to then urge a first end of clip 484 out
through delivery port 482 and into the annulus of tissue A.
[0135] Then, as shown in FIG. 41B, distal end 480 may be moved or
steered to the opposite side of the annulus of tissue A after or
while the rest of clip 484 is advanced through delivery port 482.
The distal end 480 is preferably moved to the opposite side of the
mitral valve MV at about 180.degree., if possible, from the initial
contact point to allow for optimal reduction of the diameter of the
valve. Once distal end 480 is positioned on the opposing side of
the valve, the plunger may then be finally advanced so that the
remaining second end of clip 484 exits delivery port 482 and
engages the annulus of tissue A.
[0136] The variations described above may incorporate a variety of
sensors or transducers in the delivery catheter to ensure adherence
or optimal clip performance. For instance, as seen in FIG. 41C
sensor/transducer 485, e.g., ultrasound, Doppler, electrode,
pressure sensor or transducer, etc., may be incorporated into the
distal end 480 of the catheter 478. Sensor/transducer 485 may be
connected, electrically or otherwise, to a sensor monitor 487,
which is preferably located outside the body of the patient and
which may be used to record and/or monitor a variety of signals
generated from sensor/transducer 485. For example, a pressure
sensor may be used as sensor/transducer 485. This pressure sensor
may then be used to quantify the treatment effectiveness before
catheter 478 is withdrawn. In another variation, sensor/transducer
485 (in this case, used as, e.g., a transducer) may be used to
deliver energy, e.g., RF, electrical, heat, etc., to enhance the
treatment effectiveness, in which case monitor 487 may be an
electrical or RF power source.
[0137] Distal end 480 may also incorporate a grasping and/or
releasing mechanism (not shown) to aid in clip release and
implantation. Such a mechanism may be incorporated on the plunger
or stylet, or a separate catheter may be inserted in conjunction
with catheter 478. The grasping and/or releasing mechanism may also
be used to temporarily provide an electrical connection to the
clip.
[0138] In a further variation for delivering and placing the clip,
it may be deployed through one or more delivery ports located in
the side of the catheter rather than from the distal end.
Delivering from the catheter side may be accomplished in much the
same manner as described for FIGS. 41A-41C above. Alternatively, a
catheter may be inserted into the coronary vasculature,
particularly the coronary sinus, via the aorta to deliver the clip.
A cross-sectional superior view of mitral valve opening 488 of
mitral valve 402 of a patient's heart is seen in FIG. 42A. Delivery
catheter 490 may be inserted into the coronary sinus 398 and
positioned adjacent to mitral valve 402 such that delivery ports
492a, 492b, 492c are preferably facing in apposition to mitral
valve 402. Although three delivery ports are shown in this example,
one to any number of desired delivery ports may be used. Delivery
ports 492a, 492b, 492c are preferably located proximally of distal
end 494 and the orientation of the ports may be maintained against
mitral valve 402 by the use of an orientation marker 496, which may
be, e.g., a half-marker.
[0139] Once proper orientation has been determined, a first clip
498a, which may be compressed in catheter 490 may be urged out of
delivery port 492a by a plunger and stylet, as described above or
twisted out, and pushed through a wall of the coronary sinus 398
and through the adjacent heart tissue 392, as shown in FIG. 42B.
The clips are preferably made of a superelastic or shape memory
alloy, e.g., Nickel-Titanium alloy (e.g., nitinol), and are
preferably made to expand as it exits catheter 490. Accordingly,
clip 498a may be pushed until the farthest anchoring member of clip
498a is in contact with and enters the edge of valve 402 farthest
from catheter 490. As clip 498a finally exits delivery port 492a,
the anchoring member may exit and then engage the edge of valve 402
closest to catheter 490. This procedure may be repeated for several
clips, as seen in FIG. 42C, where first and second clip 498a, 498b,
respectively, are shown to have already exited and engaged the
tissue surrounding valve 402. FIG. 42D shows the final engagement
of third clip 498c having exited delivery port 492c and engaged the
tissue surrounding valve 402. Once the clips are in place, the
compressive spring force of the clips may aid in drawing the
opposing sides of valve 402 together, thereby drawing or cinching
opening 488 close and reducing or eliminating the occurrence of
valvular regurgitation through the valve. The use of three clips is
merely exemplary and any number of desired or necessary clips may
be used.
[0140] FIGS. 43A and 43B show the valve of FIGS. 42A-42D and a side
view of the valve, respectively. FIG. 43A shows another example of
arcuate clips 500a, 500b, as described in FIGS. 31A-31D, engaged to
mitral valve 402. Arcuate clips 500a, 500b are designed such that
the curved region of each clip is preferably opposite to each other
in order to keep opening 488 unobstructed. FIG. 43B shows a side
view of valve 402 in annulus 502. Clips 500a, 500b are preferably
engaged to the tissue surrounding annulus 502, e.g., to annulus
walls 504.
[0141] All of the above mentioned methods and apparatus may be
delivered not only intravascularly through catheters, but also
through conventional procedures such as open-heart surgery.
Moreover, all of the above mentioned methods and apparatus may also
be used in conjunction with flow-indicating systems, including, for
example, color Doppler flow echocardiography, MRI flow imaging
systems, or laser Doppler flow meters. Application of energy from
the end effector may be selected such that regurgitation stops
before the procedure is completed, as verified by the
flow-indicating system. Alternatively, the procedure may be
"overdone" to compensate for expected tissue relapse, without
compromising the ultimate outcome of the procedure.
[0142] Additionally, all of the foregoing apparatus and methods
optionally may be used in conjunction with ECG gating, thereby
ensuring that tissue is at a specified point in the cardiac cycle
before energy is deposited into the tissue. ECG gating is expected
to make treatment more reproducible and safer for the patient.
[0143] Although preferred illustrative embodiments of the present
invention are described above, it will be evident to one skilled in
the art that various changes and modifications may be made without
departing from the invention. For instance, variations of the
present invention may be used as permanent or temporary localized
tissue retracting devices. Moreover, modified variations may also
be used to mechanically expand or dilate tissue, e.g., for use in
maintaining open nasal passages. It is intended in the appended
claims to cover all such changes and modifications that fall within
the true spirit and scope of the invention.
* * * * *