U.S. patent application number 11/058957 was filed with the patent office on 2005-07-07 for cardiac valve leaflet attachment device and methods thereof.
This patent application is currently assigned to Quantumcor, Inc.. Invention is credited to Hauck, Wallace N., Lichtenstein, Samuel Victor.
Application Number | 20050149014 11/058957 |
Document ID | / |
Family ID | 21693869 |
Filed Date | 2005-07-07 |
United States Patent
Application |
20050149014 |
Kind Code |
A1 |
Hauck, Wallace N. ; et
al. |
July 7, 2005 |
Cardiac valve leaflet attachment device and methods thereof
Abstract
A medical device system comprising a guide catheter and a
leaflet fastening applicator, the guide catheter having suitable
dimensions for deployment and insertion percutaneously into a human
heart in a vicinity of a heart valve, the leaflet fastening
applicator having a size allowing insertion through the guide
catheter and being capable of holding portions of opposing heart
valve leaflets, wherein the fastening applicator comprises a pair
of grasping-electrodes adapted for holding and engaging the
portions of opposing heart valve leaflets together and for applying
energy to fasten the portions, in which heart valve leaflets can be
captured and securely fastened, thereby improving coaptation of the
leaflets and improving competence of the valve.
Inventors: |
Hauck, Wallace N.; (Irvine,
CA) ; Lichtenstein, Samuel Victor; (Vancouver,
CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
Quantumcor, Inc.
Mento Park
CA
Evalve, Inc.
|
Family ID: |
21693869 |
Appl. No.: |
11/058957 |
Filed: |
February 15, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11058957 |
Feb 15, 2005 |
|
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|
10457757 |
Jun 9, 2003 |
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|
10457757 |
Jun 9, 2003 |
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10000992 |
Nov 15, 2001 |
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6575971 |
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Current U.S.
Class: |
606/41 ;
128/898 |
Current CPC
Class: |
A61B 2017/00566
20130101; A61B 18/1442 20130101; A61B 2018/00357 20130101; A61B
2017/306 20130101; A61B 18/1492 20130101; A61B 2017/00243 20130101;
A61B 2018/00619 20130101 |
Class at
Publication: |
606/041 ;
128/898 |
International
Class: |
A61B 018/18 |
Claims
What is claimed is:
1. A method for fastening a portion of a first valve leaflet with a
portion of a second valve leaflet in a patient, said method
comprising: holding said portion of the first valve leaflet in
contact with said portion of the second valve leaflet; and applying
energy to securely fasten said two portions together.
2. The method of claim 1, wherein the energy comprises an energy
source selected from the group consisting of radiofrequency energy,
ultrasound energy, laser energy, microwave energy, and
electromagnetic energy.
3. The method of claim 1, wherein holding comprises applying
suction to hold said portion of the first valve leaflet in contact
with said portion of the second valve leaflet.
4. The method of claim 1, wherein holding comprises grasping the
leaflets with a grasper.
5. The method of claim 1, wherein holding comprises portions of
opposing valve leaflets with a leaflet fastening applicator.
6. A method for treating a valvular annulus, said method
comprising: fastening portions of two opposite leaflets; and
applying energy to the valvular annulus to shrink at least a
portion of the annulus tissue.
7. The method of claim 6, wherein fastening comprises: holding a
portion of the first valve leaflet in contact with a portion of the
second valve leaflet; and applying energy to securely fasten said
portions of two opposite leaflets together.
8. The method of claim 7, wherein the energy comprises an energy
source selected from the group consisting of radiofrequency energy,
ultrasound energy, laser energy, microwave energy, and
electromagnetic energy.
9. The method of claim 7, wherein holding comprises applying
suction to hold said portion of the first valve leaflet in contact
with said portion of the second valve leaflet.
10. The method of claim 6, wherein fastening portions of two
opposite leaflets and applying energy are carried out
percutaneously.
11. The method of claim 6, wherein the applied energy comprises
radiofrequency energy.
12. The method of claim 6, wherein the applied energy comprises
ultrasound energy.
13. The method of claim 6, wherein the applied energy comprises
microwave energy.
14. The method of claim 6, wherein the applied energy comprises
laser energy.
15. The method of claim 7, wherein holding comprises grasping the
leaflets with a grasper.
16. The method of claim 7, wherein holding comprises portions of
opposing valve leaflets with a leaflet fastening applicator.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This patent application is a divisional of application Ser.
No. 10/457,757 (Attorney Docket No. 020489-001830US), filed on Jun.
9, 2003, which was a continuation-in-part application of
application Ser. No. 10/000,992 filed Nov. 15, 2001, entitled
"Cardiac Valve Leaflet Stapler Device and Methods Thereof", now
U.S. Pat. No. 6,575,971, the full disclosures of which are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] Field of the Invention
[0003] The present invention generally relates to new coupling
devices and methods for use. More particularly, this invention
relates to a percutaneous device, which grasps, secures, and then
attaches two adjacent heart valve leaflets with staples or an RF
coupling element causing a shortening of the leaflet in the desired
direction or orientation. The invention also relates to a method
for treating a valvular annulus comprising steps of fastening
portions of two opposite leaflets and applying energy to the
valvular annulus adapted for shrinking at least a portion of the
annulus tissue.
[0004] The heart is a four-chambered organ located in the thoracic
space. The heart is responsible for pumping blood through the body,
through two distinct circuits. One circuit takes blood low in
oxygen from the systemic venous system, which collects in the right
atrium (one chamber). The atrium pumps the blood into the
immediately lower chamber, the right ventricle. In passing from the
atrial chamber to the ventricular chamber, the blood passes through
the "tricuspid" valve opening, so named because of the three
leaflets (cusps) of the valve. The right ventricle contracts to
pump the blood into the lungs (second circuit) and in so
contracting, forces the tricuspid valve leaflets closed, thus
preventing backflow of blood into the right atrium.
[0005] The oxygenated blood flowing back to the heart from the
lungs enters the left atrium (third chamber) and collects there
until the atrium contracts and pumps the blood through the mitral
valve into the immediately lower chamber, the left ventricle,
during diastole. When the left ventricle contracts to pump the
blood into the systemic circulation (back to the first circuit)
during systole, the mitral valve leaflets are closed, preventing
backflow of blood into the left atrium and the pulmonary
circulation. The mitral valve is comprised of two valve leaflets.
The atria contract simultaneously, as do the ventricles.
[0006] Another set of valves is present in the main artery of the
left ventricle, the aorta and the main artery of the right
ventricle, the pulmonary artery. These valves are called the aortic
and pulmonary valves, respectively and they are similar in
appearance.
[0007] The anatomy of the mitral and tricuspid valves is similar,
but quite distinctly different from the anatomy of the aortic and
pulmonary valves. These valves are comprised of the following six
different components: the left (or right) atrial wall, the left (or
right) ventricular wall, the annulus, the leaflets, the chordae
tendinae and the papillary muscles. The annulus is a zone of
junction that serves as the attachment of the muscular fibers of
the atrium and the ventricle and as the attachment of the mitral
(or tricuspid) valve. Annular tissue is pliable permitting
contraction of the annular ring when the ventricles contract and
thus narrowing the aperture.
[0008] The annulus forms the foundation for the leaflets, which are
secured to the ventricular wall by way of the chordae tendinae,
thin fibrous cords attaching the free edges of the leaflets to the
papillary muscles, which are elevations or extensions of the
ventricular wall. All structures are covered by endothelial cell
lining but the contractile elements (muscles) of the atria and
ventricles are capable of independent movement. The other
structures are largely fibrous in nature, composed of dense fibrous
connective tissue and collagen.
[0009] When the ventricles contract during systole, the pressure
within the ventricles forces the leaflets upward until the free
edges contact. This is called coaptation. The free edges of the
leaflets are inhibited by the chordae tendinae from prolapsing
beyond the plane of the annulus and into the atrial chambers. When
the normal mitral or tricuspid valves close, the valve becomes
competent and no blood escapes through the annulus. The operation
of these valves (plus the normal closure of the aortic and
pulmonary valves) ensures that the heart functions as a one-way
pump.
[0010] As one understands the complex operation of the mitral or
tricuspid valves, one can begin to appreciate the number of
possible causes for failure of proper function of these valves.
Some of these are: loss of pliability of the annulus leading to
decreased contractibility; widening of the annulus; thickening,
shortening or swelling of the leaflets; dilation of the ventricle;
elongation or breaking of the chordae tendinae; and elongation of
the attachment of the chordae tendinae with the papillary muscles
or ventricular wall.
[0011] Individual or combinations of these causes for failure
eventually lead to loss of coaptation of the leaflets, loss of
competence of the valve and decreased efficiency of the heart as a
one-way pumping mechanism. When the latter occurs, various symptoms
are seen in the patients, including breathlessness or lack of
stamina and heart murmurs.
[0012] Repair of the incompetent valves is designed to address two
functional conditions of the leaflets, either the opening or
closing of the leaflets is increased or restricted. The former
condition, called leaflet prolapse, exists when the free edge of
one leaflet overrides the annulus when the ventricles contract. The
latter condition occurs when the restricted leaflet motion prevents
the leaflets from opening. The other possible functional condition
is where the valve leaflets may be functionally normal, but the
annulus does not contract or is too enlarged. When this occurs the
leaflets will not close effectively.
[0013] The current accepted modes of treatment of these conditions
described for the mitral and tricuspid valves include the
following: valvuloplasty, in which the affected leaflets are
remodeled to perform normally; repair of the chordae tendinae
and/or papillary muscle attachments; and surgical insertion of an
"annuloplasty" ring. This requires suturing a flexible support ring
over the annulus and tucking the annulus to constrict the radial
dimension.
[0014] Each of these procedures requires open-heart surgery and
cardiopulmonary bypass procedure, in which the heart is removed
from the blood circuits as the circuits have been described above
and a pumping system circulates the blood through the patient
during the surgical procedure. The heartbeat is stopped and the
heart is usually cooled and infused with a cold nutrient solution
during the procedure. Open-heart surgery with cardiopulmonary
bypass is a very expensive procedure, requiring considerable time,
multiple surgeons and a host of assisting personnel to operate the
equipment, monitor the patient and proceed with caution but quickly
for the patient's benefit. These procedures are also associated
with serious risks, including death and adverse events for the
patient and the patient has a long painful course of recovery,
first in the hospital, then at home.
[0015] Oz et al. in U.S. Pat. No. 6,269,819 discloses an apparatus
for repairing valve leaflets comprising a grasper capable of
grabbing and co-apting the leaflets of valve to cure mitral
regurgitation. The principles of the "grasper" arrangement and its
mechanism as disclosed are incorporated herein by reference. Oz et
al. does not disclose a medical system having a fastening
applicator that comprises a pair of grasping-electrodes means
adapted for holding and engaging portions of opposing heart valve
leaflets together and for applying suitable energy to fasten the
portions.
[0016] Robertson et al. in U.S. Pat. No. 6,203,553 discloses a
surgical stapler for securing a prosthetic heart valve within a
patient by driving a first leg of the stapler assembly through a
peripheral cuff of the prosthetic heart valve and crimping a second
leg of the stapler assembly in a direction toward the first leg
such that the second leg pierces a portion of heart tissue
surrounding the prosthetic valve for securing purposes. The
principles of "stapler" arrangement and its securing mechanism as
disclosed are incorporated herein by reference. Robertson et al.
does not disclose a medical system having a fastening applicator
that comprises a pair of grasping-electrodes means adapted for
holding and engaging portions of opposing heart valve leaflets
together and for applying suitable energy to fasten the
portions.
[0017] This invention discloses a series of devices to be used to
repair leaking valves with normal leaflets (that is, abnormal
annulus) or leaflet prolapse, without the disadvantages associated
with open-heart surgery, because the device is inserted into the
heart via the blood vessels, through the skin in the groin or neck
area percutaneously. During the procedure, the patient may be
awake, sedated or anesthetized and the device and progress of the
procedures are monitored and guided using fluoroscopy and
echocardiography, both non-invasive methods, in the continuously
beating heart. Obviously fewer personnel are required to assist
with the procedure. When the procedure is completed the patient may
be discharged within hours to days. All of these contrasting
features to open-heart procedures make the use of the stapling
device a potentially valuable resource for the interventional
cardiologist. These specialists will be able to add yet another
"minimally invasive" procedure for treatment of their patients.
BRIEF SUMMARY OF THE INVENTION
[0018] In general, it is an object of the present invention to
provide a method and an improved medical device for attaching
adjacent leaflet edges or foreshortening individual leaflets. The
leaflets referred to herein include mitral and tricuspid leaflets,
and may also include aortic and pulmonary valve leaflets, venous
valve leaflets, defects within the heart in the atria or ventricles
and any other intravascular structure(s) which may need to be
stapled together or foreshortened as described for the mitral and
tricuspid valves.
[0019] It is another object of the present invention to provide a
method and device for approaching the desired location on a leaflet
and attaching the device to the desired location on the leaflet
through various means, including suction or metallic hooks. For
example, using suction, the end of the leaflet holder device is
placed upon the leaflet and a negative pressure (suction) is
applied wherein the leaflet tissue is sucked for a short distance
into the end of the leaflet holder device.
[0020] It is another object of the present invention to provide a
method and device for approaching an adjacent leaflet edge and
securing the leaflet by one of various means, such that when the
two leaflet holding devices containing the secured leaflets are
withdrawn into the distal end of the tubular gripper, the two
leaflet edges are in close apposition, possibly touching each
other. The device system may apply suction to grip at least two of
the heart valve leaflets to enter the lumen of the tubular gripper
adapted for fastening the portions of opposing heart valve leaflets
together.
[0021] It is still another object of the present invention to
provide a method and device for attaching two leaflets or for
foreshortening one leaflet by insertion of a metal or plastic
staple, which when crimped physically or electronically,
permanently attaches the staple to the one or two leaflets. The
configuration of the staple may be linear, curved, kinked, spiral
or any other configuration that would permanently secure the
leaflet(s).
[0022] It is further another object of the present invention to
provide a method and device for transporting the staple to the
desired site of attachment, in the proper position to accomplish
the attachment, without the possibility of releasing the free
staple into the heart chamber. Following the attachment the staple
must be released from its holder and then the secured leaflet(s)
will then be released from the leaflet holding device(s). The
method and device of securing the staple prior to its insertion
into the leaflet(s) may be through use of a breakable fiber or a
metallic link. For example, the metallic link may be one that is
broken at a specified temperature. When electrical energy, such as
radiofrequency voltage is applied to the metallic line, the
temperature rises to a level wherein the link is broken and the
previously attached staple becomes free from its metallic line
tether.
[0023] In one preferred embodiment, it is provided a device system
for treating a valvular annulus comprising a guide catheter and a
leaflet fastening applicator, the guide catheter having suitable
dimensions for deployment and insertion into a human heart in a
vicinity of a heart valve and comprising a non-ablative energy
means for shrinking at least a portion of the valvular annulus, the
leaflet fastening applicator having a size allowing insertion
through the guide catheter and being capable of holding portions of
opposing heart valve leaflets, wherein the fastening applicator
comprises a pair of grasping-electrodes adapted for holding and
engaging the portions of opposing heart valve leaflets together and
for applying radiofrequency energy to fasten the portions, wherein
a first of the grasping-electrodes comprises a plurality of spikes
and a second of the grasping-electrodes comprises a plurality of
recesses configured to receivably match and engage the spikes of
the first grasping-electrode, wherein the catheter comprises at
least a gripper inside the catheter, the gripper having a suitable
opening sized and configured for applying vacuum suction to
releasably grip one of the heart valve leaflets.
[0024] Further, a method for fastening portions of opposing heart
valve leaflets in a patient, the method comprising means for
holding the portions of opposing heart valve leaflets close to each
other and applying energy to jointly fasten the portions together.
Some aspects of the invention relate to a method for fastening a
portion of a first valve leaflet with a portion of a second valve
leaflet in a patient, comprising steps of holding the portion of
the first valve leaflet in contact with the portion of the second
valve leaflet and applying a plurality of energy sources to
securely fasten the two portions together, wherein the plurality of
energy sources is selected from a group consisting of
radiofrequency energy, ultrasound energy, laser energy, microwave
energy, and electromagnetic energy.
[0025] It is another preferred object to provide a method for
fastening a first edge of a first valve leaflet to a second edge of
an opposite second valve leaflet in a patient, the method
comprising: first, introducing a medical device into a vicinity of
a valve needed for repairing, the medical device comprising a
catheter and a leaflet fastening applicator, the catheter having
suitable dimensions for deployment and insertion into the patient
in the vicinity of the valve, the leaflet fastening applicator
having a size allowing insertion through the catheter and being
capable of holding the first edge of the first valve leaflet to the
second edge of the opposite second valve leaflet, wherein the
fastening applicator comprises a pair of fastening elements adapted
for holding and engaging the first edge and second edge of valve
leaflets close to each other; and applying energy to the fastening
elements to securely fasten the first edge of the first valve
leaflet to the second edge of the second valve leaflet.
[0026] Briefly, access to the blood vascular system is obtained
through a skin puncture over a peripheral vein or artery. An
introducer device is used to secure the vascular access and a
guidewire is passed down the introducer into the vessel and
advanced into the heart. A guide catheter is placed over the
guidewire and advanced over the guidewire to the desired position
in the heart. The guidewire is withdrawn from the guide catheter
and the leaflet holder device is inserted and advanced into the
guide catheter to the desired location in the heart. The leaflet
holder device is then manipulated into position and the leaflet(s)
is/are secured and the tips of the leaflet holder device are
withdrawn slightly into the end of the guide catheter. When the
interventional cardiologist is confident that the proper position
on the leaflet(s) is secured, the staple(s) located in the end of
the guide catheter is/are attached to the leaflet(s). The staple is
then released from the guide catheter attachment via breakable
fiber or breakable metallic link. Finally, the leaflet(s) is/are
released from the leaflet holding device and the leaflet(s) is/are
free to function with the restrictions imposed by the staple.
Multiple sites may be stapled in the same procedure.
[0027] In one embodiment, the leaflet holding device consists of a
tube used to attach and secure one leaflet. Use of two such leaflet
holder devices enables the user to grasp and secure two leaflets.
In the embodiment, the guide catheter, a separate tube-shaped
device, contains the staples and the staple securing system.
[0028] In another embodiment, the leaflet holder device and the
guide catheter/staple holding device are one and the same device.
In this device, the staple holding device may be stationary or may
be moveable for some part of the length of the guide catheter.
[0029] Some aspects of the invention relate to a method for
treating a valvular annulus, comprising: fastening portions of two
opposite leaflets; and applying energy to the valvular annulus
adapted for shrinking at least a portion of the annulus tissue. In
one embodiment, the steps of fastening portions of two opposite
leaflets and applying energy are carried out percutaneously. In
another embodiment, it is provided a method for fastening a portion
of a first valve leaflet with a portion of a second valve leaflet
in a patient, comprising steps of holding the portion of the first
valve leaflet in contact with the portion of the second valve
leaflet and applying a plurality of energy sources to securely
fasten the two portions together.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] Additional objects and features of the present invention
will become more apparent and the invention itself will be best
understood from the following Detailed Description of the Exemplary
Embodiments, when read with reference to the accompanying
drawings.
[0031] FIG. 1 is a cutaway schematic of the heart showing the
chambers and the spatial relationships of the various anatomical
features discussed in the invention.
[0032] FIG. 2 is a cutaway schematic of the heart showing the
relationships of the annulus to the leaflets and the relationship
of the mitral valve to the aortic valve.
[0033] FIG. 3 is a top-down view of the mitral valve showing the
annulus and the FIG. 4 is a top-down view of the tricuspid valve
showing the annulus and the three leaflet tops.
[0034] FIG. 5A-5D is a four-part schematic drawing showing the
steps in performing annuloplasty of the posterior leaflet and
attaching an annuloplasty ring to the valve (prior art).
[0035] FIG. 6 is a schematic diagram of a guide catheter of the
medical device according to the principles of the present
invention.
[0036] FIG. 7 is a schematic diagram of a leaflet fastening
applicator within the guide catheter according to one embodiment of
the present invention.
[0037] FIG. 8 is a schematic diagram of the leaflet fastening
applicator inserted inside the guide catheter as the device system
of the present invention.
[0038] FIG. 9 is a schematic diagram of the leaflet fastening
applicator retracted back inside the guide catheter as the device
system of the present invention.
[0039] FIG. 10 is an enlarged schematic diagram of the distal end
of a preferred embodiment of the leaflet fastening applicator.
[0040] FIG. 11 is a schematic illustration of the leaflet fastening
applicator with grasping-electrodes grasping two valve
leaflets.
[0041] FIG. 12 is a schematic illustration of the leaflet fastening
applicator with grasping-electrodes grasping and holding the two
valve leaflets together.
[0042] FIG. 13 is a detailed perspective view of the
grasping-electrodes with a first hole on the first
grasping-electrode and a second hole that is aligned with the first
hole.
[0043] FIG. 14 is a detailed perspective view of the
grasping-electrodes with a plurality of spikes on a first
grasping-electrode and a plurality of recesses on a second
grasping-electrode configured to engage the spikes of the first
grasping-electrode.
[0044] FIG. 15 is a detailed perspective view of the
grasping-electrodes with one clip button set having a notch on the
first grasping-electrode and a lip on the second
grasping-electrode.
[0045] FIG. 16 is an enlarged view of one embodiment of the
invention, wherein the guide catheter is configured such that the
distal opening provides access for securing a pair of the valve
leaflets adapted for fastening the edges of leaflets with an energy
welding method or a mechanical coupling method.
DETAILED DESCRIPTION OF THE INVENTION
[0046] Referring to FIG. 1 through FIG. 16, what is shown is
various views of the heart structures discussed and one embodiment
of the present invention.
[0047] FIG. 1 shows a cut away schematic of the heart depicting the
right atrium 74, left atrium 71, right ventricle 73, and left
ventricle 72. The aorta 75 of the heart 70 connects with the left
ventricle 72 and contains an aortic valve 76. Pulmonary artery 77
connects with the right ventricle 73 through a pulmonary valve.
Left atrium 71 communicates with the left ventricle 72 through a
mitral valve 79. The right atrium 74 communicates with the right
ventricle 73 through a tricuspid valve. Oxygenated blood is
returned to the heat 70 via pulmonary veins 88. In a perspective
illustration, a device or catheter is inserted into the right
atrium 74 and is positioned through the inner wall 51 and the
annular structure 52 of the tricuspid valve leaflets 80. The
leaflets 80 of the tricuspid valve open toward the ventricle side.
Blood returned from the superior vena cava 84 and the inferior vena
cava flows into the right atrium 74. Subsequently, blood flows from
the right atrium 74 to the right ventricle 73 through the tricuspid
valve. Therefore, the grasping-electrodes 12 of the catheter shaft
1 does not interfere with the leaflet movement during the proposed
less invasive thermal fastening for the leaflets of the invention.
The term "grasping-electrode" is meant to indicate herein an
electrode having means for grasping/fastening an object and
providing energy for intended use.
[0048] FIG. 2 shows a cutaway diagram of part of the heart,
containing the mitral valve 79 and aortic valve 76 and showing the
relationships between the annulus 91 and the leaflets 92 of the
mitral valve 79. The circumflex artery 93 is located adjacent the
mitral annulus 91.
[0049] FIG. 3 shows a top-down view of the mitral valve 91, looking
through the left atrium 71. The relative positions of the anterior
valve leaflet 94 and posterior valve leaflet 95 are shown, as are
the antero-lateral commissure 96 and postero-medial commissure
97.
[0050] FIG. 4 shows a top-down view of the tricuspid valve 98,
looking through the right atrium 74. The anterior valve leaflet 61,
posterior valve leaflet 62 and septal valve leaflet 63 are shown,
as are the three associated commissures.
[0051] For illustration purposes, FIG. 5A-5D shows a top-down view
of a mitral valve 79 in various stages of repair, according to the
current practices of open-heart surgery under cardiopulmonary
bypass (prior art). View FIG. 5A shows the area AA of the posterior
leaflet 95 to be resected in the valvuloplasty. View FIG. 5B shows
the resected posterior leaflet 95B and placement of stay-sutures 99
in the annulus 91, drawing and tightening the annulus. View FIG. 5C
shows the closed valvuloplasty and the tightening of the annulus 91
along a suture line 64 above the posterior leaflet. View FIG. 5D
shows the placement of an annuloplasty ring 65, which secures the
mitral valve annulus 91 in the desired shape and size. Note the
difference between the shape and size achieved by the surgery in
view FIG. 5D, compared to that in view FIG. 5A.
[0052] Williamson, IV et al. in U.S. Pat. No. 5,891,160 and No.
6,162,233 discloses wire fasteners having legs and lengths for use
in minimally invasive surgery, entire contents of which are
incorporated herein by reference. More particularly, it is
disclosed that the fasteners are manipulated into position and then
immobilized by the legs thereof for tensioning, cutting and forming
in situ so as to secure the prosthesis to the patient. However,
Williamson, IV et al. does not disclose a medical system having a
fastening applicator that comprises a pair of grasping-electrodes
means adapted for holding and engaging portions of opposing heart
valve leaflets together and for applying suitable energy to fasten
the portions.
[0053] Kuehn et al. in U.S. Pat. No. 6,165,183 discloses a method
for performing an edge-to-edge fastening/securing of opposing heart
valve leaflets through a catheter percutaneously. The catheter
includes a leaflet fastener applicator with a gripper to hold the
heart valve leaflets while they are fastened. The principles of
"gripping/securing/fastening" arrangement and the mechanism as
disclosed are incorporated herein by reference. However, Kuehn et
al. does not disclose a medical system having a fastening
applicator that comprises a pair of grasping-electrodes means
adapted for holding and engaging portions of opposing heart valve
leaflets together and for applying suitable energy to fasten the
portions.
[0054] FIG. 6 shows a schematic of a guide catheter 11 comprising a
catheter sheath 1 and at least a lumen 2. The catheter 11 further
comprises a cap 3 on the handle 25 of the guide catheter 11 for
closing the lumen 2 of the catheter during placement, a sideport 4
for injection of solutions into the catheter (e.g., radiographic
contrast medium), a radiopaque band 6 at about the distal end 5 to
locate the end during placement on fluoroscopy. The solution for
injection through the sideport 4 or the lumen 2 may be selected
from a group consisting of heparin, aspirin, saline, antibiotic
solution, anti-inflammatory solution, anti-septic solution or the
like.
[0055] FIG. 7 shows a schematic of a leaflet fastening applicator
7, which may contain a locking port 8 on the proximal end 9 and
splits 15A, 15B in the applicator lumen 10 on the applicator distal
end 13. The splits 15A, 15B can be configured in different shape,
size and functional structures adapted for gripping, securing,
fastening and/or coupling two pieces of tissue together. The
proximal end 9 can be attached to a vacuum source for the
applicator 7 to capture and secure the leaflets by way of vacuum.
If the leaflets are to be secured by way of small hooks, individual
cables attached to respective hooks are installed in the lumens of
the leaflet holders. In another embodiment with energy
transmission, the energy transmission route, such as electrical
conductors 29, may be provided within the lumen 10 of the
applicator 7. One end of the electrical conductor 29 is usually
connected to an external energy generator or source.
[0056] FIG. 8 depicts the guide catheter in place, with the leaflet
fastening applicator 7 contained within the guide catheter 11,
wherein the splits 15A, 15B of the leaflet fastening applicator 7
extend out the distal end 5 of the guide catheter 11, such as these
two splits may appear when attempting to capture and secure the
leaflet(s) or other tissue. In one embodiment, the splits 15A, 15B
may comprise a suction arrangement or other means for capturing the
flexible leaflet and contain at their end portion a pair of
grasping-electrodes for applying radiofrequency energy. The suction
arrangement of the splits 15A, 15B may be accomplished by
configuring the splits with an inner lumen connecting with an
external suction source. In another embodiment, at least one of the
splits 15A, 15B may contain at its end portion an ultrasound
transducer, an optic fiber for laser or infrared transmission, or
an element for electromagnetic energy transmission.
[0057] FIG. 9 depicts the guide catheter in place, with the leaflet
fastening applicator 7 retracted within the guide catheter 11 and
the ends of the leaflet fastening applicator 7 drawn slightly into
the lumen 2 of the guide catheter 11.
[0058] In one embodiment, a device system of the present invention
as shown in FIG. 10 comprises a guide catheter and a leaflet
fastening applicator 7. As illustrated in FIGS. 8 and 9, the guide
catheter has suitable dimensions for deployment and insertion into
a human heart in a vicinity of a heart valve, wherein the leaflet
fastening applicator 7 has a size allowing insertion through the
guide catheter 11 and is capable of holding portions of opposing
heart valve leaflets (as illustrated in FIG. 11 and FIG. 12). A
typical guide catheter may range from about 1 mm in diameter to
about 15 mm or larger in diameter. And the guide catheter can be
made of any convenient biocompatible material, such as plastic or
the like.
[0059] As shown in FIG. 10, the device system may further comprise
at least a gripper 35 or 36 inside the applicator 7, the gripper
having a suitable opening 29 for applying suction to one of the
heart valve leaflets or tissue.
[0060] As shown in FIGS. 11 and 12, the fastening applicator 7 may
optionally comprise a pair of grasping-electrodes 42A, 42B that is
mounted at the distal end of the splits 15A, 15B, wherein the
grasping-electrodes are configured and adapted for holding and
engaging the portions 31, 32 of opposing heart valve leaflets 33,
34 together and for applying radiofrequency energy or other
suitable energy to fasten the portions 31, 32. The radiofrequency
energy may be introduced from an external radiofrequency source and
passes from the first grasping-electrode 15A through the portions
of opposing heart valve leaflets 31, 32 to the second
grasping-electrode 15B. The device is equally applicable to a
venous valve. The bi-polar radiofrequency arrangement and
principles for tissue welding or fastening are well known to an
ordinary artisan who is skilled in the art.
[0061] For illustration purposes as shown in FIG. 12, it is
provided a non-ablative energy means 50 for shrinking at least a
portion of the valvular annulus 52. One example of the non-ablative
energy means is a deployable spiral wire electrode at a distal end
of an elongate shaft 53 adapted to contact the tissue of the
valvular annulus to be treated and to apply high frequency energy
to the tissue for therapeutic purposes. A deployable spiral wire
electrode is well known to one ordinary skill in the art and is
disclosed in U.S. Pat. No. 6,267,781 that is co-invented by one of
the current applicants. The energy for treating annulus tissue may
be selected from a group consisting of radiofrequency, ultrasound,
laser, microwave, electromagnetic, and combination thereof. The
term "non-ablative" energy is herein intended to mean the energy
sufficiently suitable to shrink or tighten collagen or tissue;
however, the non-ablative energy is below the tissue ablation
threshold that causes tissue injury or necrosis irreversibly.
[0062] For illustration purposes, another example of non-ablative
energy means is a rotational electrode with sweeping force at the
distal section of the tubular element to effect the heat treatment
and the rotational sweeping massage therapy for target annulus
tissues. A rotatable electrode is well known to one ordinary skill
in the art and is disclosed in U.S. Pat. No. 6,283,962 that is
co-invented by one of the current applicants. The energy for
treating annulus tissue may be selected from a group consisting of
radiofrequency, ultrasound, laser, microwave, electromagnetic, and
combination thereof.
[0063] For illustration purposes, still another example of
non-ablative energy means is an apparatus capable of sandwiching
and compressing the annulus and applying heat sufficient to shrink
or tighten tissue surrounding the annulus tissue. A sandwichable
electrode is well known to one ordinary skill in the art and is
disclosed in U.S. Pat. No. 6,485,489 that is co-invented by two of
the current applicants. The energy for treating annulus tissue may
be selected from a group consisting of radiofrequency, ultrasound,
laser, microwave, electromagnetic, and combination thereof.
[0064] As shown in FIG. 13, the first grasping-electrode 42A of the
present invention may comprise a first hole 44A and the second
grasping-electrode 42B comprises a second hole 44B that is aligned
with the first hole 44A, the first and second holes being adapted
suitable for inserting a suture, a staple, a hook or other
attachment device to fasten the portions of the opposing heart
valve leaflets. The aligned holes are particularly suitable for any
conventional types of tissue coupling and fastening. The exterior
surfaces 43A, 43B of the non-contacting sides of the
grasping-electrodes 42A, 42B in FIGS. 13 to 15 can be smooth
surfaces or other appropriate arrangement.
[0065] In another embodiment as shown in FIG. 14, a first
grasping-electrode 42A of the grasping-electrodes arrangement may
comprise a plurality of spikes 45A and a second grasping-electrode
42B of the grasping-electrodes comprises a plurality of recesses
45B configured to engage the spikes 45A of the first
grasping-electrode 42A, wherein the spikes' sharp ends of the first
grasping-electrode pushes the body tissue into the recesses of the
second grasping-electrode with enhanced grasping capability.
[0066] Scott et al. in U.S. Pat. No. 5,527,313 discloses a device
wherein a first grasping-electrode has a plurality of spikes and a
second grasping-electrode has a plurality of spikes configured to
engage the spikes of the first grasping-electrode. Both jaws have a
plurality of spikes and valleys in between the spikes. U.S. Pat.
No. 5,527,313 further shows the two grasping-electrodes at an open
position with the spikes' sharp ends of the first jaw facing the
spikes' sharp ends of the second jaw whereas the two grasping
electrodes at a closed position with the spikes' sharp ends of the
first jaw falling into the valleys of the opposite spikes of the
second jaw in a manner that does not push the body tissue into the
recesses of the second grasping-electrode. And therefore, the prior
art device does not have enhanced grasping capability.
[0067] In a further embodiment of FIG. 15, the pair of
grasping-electrodes of the device system is configured to comprise
at least one clip button set, wherein each of the at least one clip
button set has a notch 46A on the first grasping-electrode 42A and
a lip 46B on the second grasping-electrode 42B in which the notch
46A engages the lip 46B when the grasping-electrodes 42A, 42B are
held close to each other for tissue fastening purposes.
[0068] In a preferred embodiment as shown in FIG. 16, the device
system of the present invention may further comprise a tubular
gripper 27 having a distal end 38 and a lumen 39, the tubular
gripper 37 having a suitable opening 40 at its distal end 38 for
applying suction to grip at least two of the target heart valve
leaflets 33, 34 to enter the lumen 39 adapted for fastening the
portions of opposing heart valve leaflets together using a
mechanical fastening method or energy fastening method. In an
alternate embodiment, a plurality of suction tubular elements 47,
48 is positioned within the lumen 39 of the tubular gripper 37. The
adjacent leaflet edges are held in place within elements 47, 48
with constant vacuum. In this position, the cardiologist can
evaluate the effects of attaching the leaflets, by examining the
flow of contrast medium or examining flow with ultrasound, during
the beating of the heart and the flow and ebb of blood at the
valve. An ultrasonic imaging system may be incorporated during the
procedure to assist the cardiologist. The fastening means may
comprise energy welding or mechanical fastening.
[0069] Some aspects of the invention relate to a device system for
treating a valvular annulus comprising a guide catheter and a
leaflet fastening applicator, the guide catheter having suitable
dimensions for deployment and insertion into a human heart in a
vicinity of a heart valve and comprising a non-ablative energy
means for shrinking at least a portion of the valvular annulus, the
leaflet fastening applicator having a size allowing insertion
through the guide catheter and being capable of holding portions of
opposing heart valve leaflets, wherein the fastening applicator
comprises a pair of grasping-electrodes adapted for holding and
engaging the portions of opposing heart valve leaflets together and
for applying radiofrequency energy to fasten the portions, wherein
a first of the grasping-electrodes comprises a plurality of spikes
and a second of the grasping-electrodes comprises a plurality of
recesses configured to receivably match and engage the spikes of
the first grasping-electrode, wherein the catheter comprises at
least a gripper inside the catheter, the gripper having a suitable
opening sized and configured for applying vacuum suction to
releasably grip one of the heart valve leaflets. The non-ablative
energy means may be selected from a group consisting of
radiofrequency energy, ultrasound energy, laser energy,
electromagnetic energy, microwave energy and the like.
[0070] One mode of performing the method of the present invention
is to have a catheter introduced via aortic valve or more commonly
across atrial septum as in balloon valvuloplasty of the mitral
valve. After entrapment of leaflets, a stapling device is pushed to
site where anterior and posterior leaflets approximate each other.
The staple, suture or other attachment device is guided to
approximate leaflets and pulled back to ensure both leaflets are
caught and then released. This stapling step may optionally be
added to the energy-assisted leaflets welding/fastening disclosure
of the present invention with at least one energy source, wherein
the energy source is selected from a group consisting of
radiofrequency energy, ultrasound energy, laser energy,
electromagnetic energy, cryogenic energy, microwave energy and the
like.
[0071] In some preferred aspects, it is provided a method for
treating a valvular annulus, comprising: (a) fastening portions of
two opposite leaflets; and (b) applying energy to the valvular
annulus adapted for shrinking at least a portion of the annulus
tissue. In one embodiment, the steps of fastening portions of two
opposite leaflets and applying energy are carried out
percutaneously. In another embodiment, the steps of fastening
portions of two opposite leaflets and applying energy are carried
out through an open chest procedure. In still another embodiment,
the energy for shrinking at least a portion of the annulus tissue
is selected from a group consisting of radiofrequency energy,
ultrasound energy, electromagnetic energy, microwave energy, laser
energy, and cryogenic energy.
[0072] Although the explanations and illustration herein have used
the mitral valve as an example, the devices in either embodiment
can be used on mitral, tricuspid, aortic or pulmonary valves as
indicated for the improvement in leaflet coaptation and valve
competence, during normal heart/blood cycling, without the need for
costly, risky and painful open-heart surgery and cardiopulmonary
bypass. This invention is not a complete replacement for the repair
offered by cardiothoracic surgeons in repair of these heart valves.
Practically, there are certain cases, which can be aided only
through open-heart procedures. However, this invention should serve
a significant segment of the population, who will be assisted with
the type of repairs offered by these methods and devices.
[0073] U.S. Pat. No. 6,267,781, co-invented by one of the current
applicants, teaches anon-ablative energy treating device for
treating valvular annulus or valvular organ structure of a patient,
comprising a flexible elongate tubular shaft having a deployable
spiral wire electrode at its distal end adapted to
contact/penetrate the tissue to be treated and to apply high
frequency energy to the tissue for therapeutic purposes. U.S. Pat.
No. 6,283,962, co-invented by one of the current applicants,
discloses a medical energy device system for treating valvular
annulus wherein an elongate tubular element comprises an electrode
disposed at its distal section that is extendible from an opening
at one side of the tubular element, the energy generator, and means
for generating rotational sweeping force at the distal section of
the tubular element to effect the heat treatment and the rotational
sweeping massage therapy for target tissues. Both patents, entire
contents of which are incorporated herein by reference, teach the
local tissue shrinkage, not for simultaneously fastening portions
of two opposite valve leaflets together to enhance annulus
repairing and function.
[0074] U.S. Pat. No. 6,306,133, co-invented by one applicant of the
present invention, entire contents of which are incorporated herein
by reference, discloses a non-ablative energy catheter system and
methods for repairing an annular organ structure comprising high
frequency non-ablative energy for the purposes of tightening and
stabilizing a tissue. A catheter suitable for high frequency energy
delivery comprises a flexible tissue-contactor means located at the
distal tip section of a catheter shaft for contacting an inner wall
of the annular organ structure, and a needle electrode means
located at or within the flexible tissue-contactor means for
penetrating into the tissue, wherein the needle electrode means is
deployable out of the tissue-contactor means in a manner
essentially perpendicular to a longitudinal axis of the catheter
shaft.
[0075] U.S. Pat. No. 6,485,489, co-invented by two applicants of
the present invention, entire contents of which are incorporated
herein by reference, discloses a catheter system and methods for
repairing a valvular annulus of a patient comprising sandwiching
and compressing the annulus and applying heat sufficient to shrink
or tighten tissue surrounding the annulus defect. Some aspects of
the invention relate to simultaneously fastening the leaflets
together and applying energy effective to shrink or tighten annulus
tissue for annulus repairing.
[0076] From the foregoing description, it should now be appreciated
that an energy-assisted tissue fastening approach percutaneously
for valve leaflets fastening has been disclosed. While the
invention has been described with reference to a specific
embodiment, the description is illustrative of the invention and is
not to be construed as limiting the invention. Various
modifications and applications may occur to those who are skilled
in the art, without departing from the true spirit and scope of the
invention, as described by the appended claims.
* * * * *