U.S. patent application number 13/486632 was filed with the patent office on 2013-02-07 for minimally invasive repair of heart valve leaflets.
The applicant listed for this patent is David Joseph Parins, Arun Saini, John Zentgraf. Invention is credited to David Joseph Parins, Arun Saini, John Zentgraf.
Application Number | 20130035757 13/486632 |
Document ID | / |
Family ID | 47260394 |
Filed Date | 2013-02-07 |
United States Patent
Application |
20130035757 |
Kind Code |
A1 |
Zentgraf; John ; et
al. |
February 7, 2013 |
MINIMALLY INVASIVE REPAIR OF HEART VALVE LEAFLETS
Abstract
A method of repairing a heart valve provides intravascular
access for repair of a heart valve through a ventricular
trans-septal approach. An external guide catheter can be inserted
through a vein of a patient into the right ventricle via the right
atrium. An internal guide catheter can be inserted through the
external guide and can provide access to the septum for a puncture
tool to create an opening through the septum to the left ventricle.
The internal guide can then be advanced into the left ventricle and
used to guide a deployment catheter that deploys a repair device
onto the heart valve.
Inventors: |
Zentgraf; John;
(Minneapolis, MN) ; Parins; David Joseph;
(Corcoran, MN) ; Saini; Arun; (Burnsville,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Zentgraf; John
Parins; David Joseph
Saini; Arun |
Minneapolis
Corcoran
Burnsville |
MN
MN
MN |
US
US
US |
|
|
Family ID: |
47260394 |
Appl. No.: |
13/486632 |
Filed: |
June 1, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61492135 |
Jun 1, 2011 |
|
|
|
Current U.S.
Class: |
623/2.1 |
Current CPC
Class: |
A61B 17/0482 20130101;
A61B 17/0057 20130101; A61B 17/0469 20130101; A61B 17/0487
20130101; A61F 2250/0012 20130101; A61B 2017/06042 20130101; A61B
17/0467 20130101; A61B 2017/00606 20130101; A61B 2017/0496
20130101; A61B 2017/0456 20130101; A61F 2/2457 20130101; A61B
2017/00243 20130101 |
Class at
Publication: |
623/2.1 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A method of repairing a heart valve in a beating heart of a
patient, comprising: inserting an external guide catheter through a
vein of a patient and into a right atrium of a heart of a patient;
advancing the external guide catheter into a right ventricle of the
patient's heart; inserting an internal guide catheter into the
external guide catheter and advancing the internal guide catheter
into the right ventricle; puncturing a septum in the patient's
heart to create an opening between the right ventricle and a left
ventricle; advancing the internal guide catheter through the
opening in the septum and into the left ventricle; inserting a
deployment catheter through the internal guide catheter and
advancing the deployment catheter adjacent a heart valve in the
left ventricle; and deploying a repair device onto the heart valve
with the deployment catheter.
2. The method of claim 1, further comprising: advancing a sealing
device through the internal guide catheter to the septum; and
positioning the sealing device within the opening in the septum to
seal the opening.
3. The method of claim 1, wherein the repair device is a
suture.
4. The method of claim 3, wherein deploying a repair device onto
the heart valve with the deployment catheter includes: capturing a
heart valve leaflet with a clamping mechanism of the deployment
catheter; and inserting the suture through the heart valve leaflet
with a needle of the deployment catheter.
5. The method of claim 3, further comprising: advancing a sealing
device through the internal guide catheter to the septum; extending
the suture through a lumen extending through the sealing device;
and positioning the sealing device within the opening in the septum
to seal the opening, such that a proximal end of the suture extends
from the heart valve through the septum.
6. The method of claim 5, further comprising: threading the suture
through an anchoring device; advancing the anchoring device through
the internal guide catheter to the septum; interfacing the
anchoring device with the sealing device to lock a position of the
suture with respect to the sealing device; advancing a cutting
catheter having a cutting tool through the internal guide catheter
to the septum; and cutting the suture in the right ventricle
adjacent the sealing device.
7. The method of claim 5, further comprising selectively tensioning
the suture to have a desired tension through the septum.
8. The method of claim 7, wherein the suture tension is maintained
by a seal within the sealing element that engages the suture, and
further comprising: releasing the tension on the suture by engaging
the seal to cause the seal to release the suture; and retensioning
the suture.
9. The method of claim 3, wherein the deployment catheter deploys a
plurality of sutures on the valve.
10. A method comprising: providing a heart valve repair system, the
system including an external guide catheter, an internal guide
catheter adapted to be slidably inserted through the external guide
catheter, a septal puncture tool and a deployment catheter; and
providing instructions for deploying a repair device onto a heart
valve of a beating heart of a patient with the heart valve repair
system, the instructions comprising: inserting the external guide
catheter through a vein of the patient and into a right atrium of a
heart of the patient; advancing the external guide catheter into a
right ventricle of the patient's heart; inserting the internal
guide catheter into the external guide catheter and advancing the
internal guide catheter into the right ventricle; inserting the
septal puncture tool through the internal guide catheter and
puncturing a septum of the patient with the septal puncture tool to
create an opening through the septum between the right ventricle
and a left ventricle; advancing the internal guide catheter through
the opening in the system and into the left ventricle; inserting
the deployment catheter through the internal guide catheter and
advancing the deployment catheter adjacent the heart valve; and
deploying a repair device onto the heart valve with the deployment
catheter.
11. The method of claim 10, wherein providing a heart valve repair
system includes providing a sealing device, and the instructions
further comprise: advancing the sealing device through the internal
guide catheter to the septum; and positioning the sealing device
within the opening in the septum to seal the opening.
12. The method of claim 10, wherein providing a heart valve repair
system includes providing a suture as the repair device, wherein
deploying a repair device onto the heart valve with the deployment
catheter includes: capturing a heart valve leaflet with a clamping
mechanism of the deployment catheter; and inserting the suture
through the heart valve leaflet with a needle of the deployment
catheter.
13. The method of claim 10, wherein providing a heart valve repair
system includes providing a sealing device and providing a suture
as the repair device and wherein the instructions further comprise:
advancing the sealing device through the internal guide catheter to
the septum; extending the suture through a lumen extending through
the sealing device; and positioning the sealing device within the
opening in the septum to seal the opening, such that a proximal end
of the suture extends from the heart valve through the septum.
14. The method of claim 13, wherein providing a heart valve repair
system includes providing an anchoring device and a cutting
catheter having a cutting tool, and the instructions further
comprise: threading the suture through the anchoring device;
advancing the anchoring device through the internal guide catheter
to the septum; interfacing the anchoring device with the sealing
device to lock a position of the suture with respect to the sealing
device; advancing the cutting catheter through the internal guide
catheter to the septum; and cutting the suture in the right
ventricle adjacent the sealing device with the cutting tool.
15. The method of claim 14, wherein the instructions further
comprise selectively tensioning the suture to have a desired
tension through the septum.
16. A system comprising: means for intravenously accessing a right
ventricle of a beating heart of a patient; means for creating an
opening through a septum of the patient's heart between the right
ventricle and a left ventricle; means for deploying a repair device
onto a heart valve; means for positioning the means for deploying
in the left ventricle; and means for sealing the opening in the
septum.
17. The system of claim 16, wherein the means for deploying a
repair device includes a means for grasping a heart valve leaflet
and a means for inserting a suture through the leaflet.
18. The system of claim 17, further comprising means for
selectively tensioning the suture through the sealing device.
19. The system of claim 17, further comprising means for anchoring
the suture at the sealing device.
20. The system of claim 18, further comprising means for
selectively retensioning the suture.
Description
RELATED APPLICATION
[0001] The present application claims the benefit of U.S.
Provisional Application No. 61/492,135 filed Jun. 1, 2011, which is
incorporated herein in its entirety by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to minimally invasive delivery
of a suture. More particularly, the present invention relates to
attaching the suture as an artificial chordae tendineae to a
flailing or prolapsing leaflet in a beating heart via an
intravascular ventricular septal approach.
BACKGROUND OF THE INVENTION
[0003] Various types of surgical procedures are currently performed
to investigate, diagnose, and treat diseases of the heart and the
great vessels of the thorax. Such procedures include repair and
replacement of mitral, aortic, and other heart valves, repair of
atrial and ventricular septal defects, pulmonary thrombectomy,
treatment of aneurysms, electrophysiological mapping and ablation
of the myocardium, and other procedures in which interventional
devices are introduced into the interior of the heart or a great
vessel.
[0004] Using current techniques, many of these procedures require a
gross thoracotomy, usually in the form of a median sternotomy, to
gain access into the patient's thoracic cavity. A saw or other
cutting instrument is used to cut the sternum longitudinally,
allowing two opposing halves of the anterior or ventral portion of
the rib cage to be spread apart. A large opening into the thoracic
cavity is thus created, through which the surgical team may
directly visualize and operate upon the heart and other thoracic
contents.
[0005] Surgical intervention within the heart by a thoracotomy
generally requires isolation of the heart and coronary blood
vessels from the remainder of the arterial system, and arrest of
cardiac function (an "open heart" procedure). Usually, the heart is
isolated from the arterial system by introducing an external aortic
cross-clamp through a sternotomy and applying it to the aorta
between the brachiocephalic artery and the coronary ostia.
Cardioplegic fluid is then injected into the coronary arteries,
either directly into the coronary ostia or through a puncture in
the aortic root, so as to arrest cardiac function. In some cases,
cardioplegic fluid is injected into the coronary sinus for
retrograde perfusion of the myocardium. The patient is placed on
cardiopulmonary bypass to maintain peripheral circulation of
oxygenated blood.
[0006] Of particular interest to the present invention are open
heart procedures for surgical treatment of heart valves, especially
the mitral and aortic valves. According to recent estimates, more
than 79,000 patients are diagnosed with aortic and mitral valve
disease in U.S. hospitals each year. More than 49,000 mitral valve
or aortic valve replacement procedures are performed annually in
the U.S., along with a significant number of heart valve repair
procedures.
[0007] Various surgical techniques may be used during an open heart
procedure to repair a diseased or damaged valve, including
annuloplasty (contracting the valve annulus), quadrangular
resection (narrowing the valve leaflets), commissurotomy (cutting
the valve commissures to separate the valve leaflets), shortening
mitral or tricuspid valve chordae tendonae, reattachment of severed
mitral or tricuspid valve chordae tendonae or papillary muscle
tissue, and decalcification of valve and annulus tissue.
Alternatively, the valve may be replaced by excising the valve
leaflets of the natural valve and securing a replacement valve in
the valve position, usually by suturing the replacement valve to
the natural valve annulus. Various types of replacement valves are
in current use, including mechanical and biological prostheses,
homografts, and allografts.
[0008] The mitral valve, located between the left atrium and left
ventricle of the heart, is most easily reached through the wall of
the left atrium, which normally resides on the posterior side of
the heart, opposite the side of the heart that is exposed by a
median sternotomy. Therefore, to access the mitral valve via a
sternotomy, the heart is rotated to bring the left atrium into a
position accessible through the sternotomy. An opening, or
atriotomy, is then made in the left atrium, anterior to the right
pulmonary veins. The atriotomy is retracted by means of sutures or
a retraction device, exposing the mitral valve directly posterior
to the atriotomy. One of the aforementioned techniques may then be
used to repair or replace the valve.
[0009] An alternative technique for mitral valve access during an
open heart procedure may be used when a median sternotomy and/or
rotational manipulation of the heart are/is undesirable. In this
technique, a large incision is made in the right lateral side of
the chest, usually in the region of the fifth intercostal space.
One or more ribs may be removed from the patient, and other ribs
near the incision are retracted outward to create a large opening
onto the thoracic cavity. The left atrium is then exposed on the
posterior side of the heart, and an atriotomy is formed in the wall
of the left atrium, through which the mitral valve may be accessed
for repair or replacement.
[0010] The mitral and tricuspid valves inside the human heart
include an orifice (annulus), two (for the mitral) or three (for
the tricuspid) leaflets and a subvalvular apparatus. The
subvalvular apparatus includes multiple chordae tendineae, which
connect the mobile valve leaflets to muscular structures (papillary
muscles) inside the ventricles. Rupture or elongation of the
chordae tendineae results in partial or generalized leaflet
prolapse, which causes mitral (or tricuspid) valve regurgitation. A
commonly used technique to surgically correct mitral valve
regurgitation is the implantation of artificial chordae (usually
4-0 or 5-0 Gore-Tex sutures) between the prolapsing segment of the
valve and the papillary muscle. This open heart operation is
generally carried out through a median sternotomy and requires
cardiopulmonary bypass with aortic cross-clamp and cardioplegic
arrest of the heart.
[0011] Using such open heart techniques, the large opening provided
by a median sternotomy or right thoracotomy enables the surgeon to
see the mitral valve directly through the left atriotomy, and to
position his or her hands within the thoracic cavity in close
proximity to the exterior of the heart for manipulation of surgical
instruments, removal of excised tissue, and/or introduction of a
replacement valve through the atriotomy for attachment within the
heart. However, these invasive open heart procedures produce a high
degree of trauma, a significant risk of complications, an extended
hospital stay, and a painful recovery period for the patient.
Moreover, while heart valve surgery produces beneficial results for
many patients, numerous others who might benefit from such surgery
are unable or unwilling to undergo the trauma and risks of current
techniques.
[0012] One alternative to open heart surgery is a robotically
guided, thoracoscopically assisted cardiotomy procedure marketed
under the tradename of the DaVinci.RTM. system. Instead of
requiring a sternotomy, the DaVinci.RTM. system uses a minimally
invasive approach guided by camera visualization and robotic
techniques. Unfortunately, the DaVinci.RTM. system is not approved
for mitral valve repair procedures on a beating heart. Thus, the
use of the DaVinci.RTM. system for mitral valve repair still
requires a cardiopulmonary bypass with aortic cross-clamp and
cardioplegic arrest of the heart.
[0013] While there are other laparoscopic and minimally invasive
surgical techniques and tools that have been developed, none of
these devices are useable for the unique requirements of mitral
valve repair on a beating heart. Suturing devices like the
Superstich.TM. vascular suturing device or the Gore.RTM. suture
passer are designed to permit manual placement of sutures as part
of a surgical procedure, but are not designed for use on a beating
heart. While certain annuloplasty techniques and instruments that
can suture an annuloplasty ring as part of vascular repair or heart
bypass surgery may be used in conjunction with a beating heart,
these annuloplasty procedures do not involve the capture or
retention of a constantly moving leaflet. Consequently, the design
and use of annuloplasty techniques and instruments are of little
help in solving the problems of developing instruments and
techniques for minimally invasive thoracoscopic repair of heart
valves during a beating heart procedure.
[0014] Recently, a technique has been developed for minimally
invasive thoracoscopic repair of heart valves while the heart is
still beating. Int'l Pub. No. WO 2006/078694 A2 to Speziali, which
is incorporated by reference herein, discloses a thoracoscopic
heart valve repair method and apparatus. Instead of requiring open
heart surgery on a stopped heart, the thorascopic heart valve
repair methods and apparatus taught by Speziali utilize fiber optic
technology in conjunction with transesophageal echocardiography
(TEE) as a visualization technique during a minimally invasive
surgical procedure that can be utilized on a beating heart. U.S.
Publication No. 2008/0228223 to Alkhatib also discloses a similar
apparatus for attaching a prosthetic tether between a leaflet of a
patient's heart valve and another portion of the patient's heart to
help prevent prolapse of the leaflet and/or to otherwise improve
leaflet function.
[0015] More recent versions of these techniques are disclosed in
U.S. Patent Application Publication Nos. 2009/0105751 and
2009/0105729 to Zentgraf, which disclose an integrated device that
can enter the heart chamber, navigate to the leaflet, capture the
leaflet, confirm proper capture, and deliver a suture as part of a
mitral valve regurgitation (MR) repair.
[0016] These references disclose suturing valve leaflets by
accessing the heart through an open surgical approach that requires
an artificial opening in the heart wall be made, for example at the
apex of the ventricle, during the open surgical approach. It would
be advantageous for a minimally invasive suture delivery system to
be able to suture valve leaflets in a beating heart procedure
without requiring an open surgical approach or an incision into the
exterior ventricular wall in order to minimize blood loss.
SUMMARY OF THE INVENTION
[0017] Embodiments of the present invention allow for repair of
heart valve regurgitation during a beating heart procedure
including various steps and apparatuses for entering the heart
chamber, navigating to a heart valve leaflet, capturing the
leaflet, confirming proper capture, and delivering a suture. The
devices and procedures of these embodiments can be used with an
intravascular catheter based approach for delivery of sutures for
the treatment of heart valve regurgitation.
[0018] In one embodiment, the system provides venous access into a
heart chamber (venous access via the femoral or jugular vein) while
minimizing the loss of blood within and without the system. The
device can be inserted through the right atrium and into the right
ventricle, with the position within the ventricular apex visualized
via ultrasound or fluoroscopy. Once access into the heart chamber
is achieved, the system is positioned via a non-invasive imaging
modality. The system allows capture of intra-cardiac tissue
structure. Once captured, the system allows control to be
maintained over said tissue structure. Imaging modalities allow
confirmation of proper capture position of the system relative to
the tissue structure. The system then accommodates the delivery of
the deployment catheter to said tissue structure once proper
position has been confirmed.
[0019] In one embodiment, a guide-in-guide catheter system provides
venous access to the ventricular septal wall for a trans-septal
puncture tool to provide the access to the left ventricular cavity.
Once the left ventricle is accessed, an internal guide catheter can
be advanced within the external guide across the septal wall into
the left ventricle. The external guide catheter can have a side
exiting lumen to facilitate the positioning of the internal guide,
or alternatively a septal puncture catheter with a septal puncture
device therein, to the selected area for crossing the ventricular
septum. A curve in the guide can angle the tip of the catheter to
the desired location for trans-septal puncture. A guide wire may be
used to maintain position. After the septal puncture is completed
the device can be removed and a dilator inserted into the internal
guide to aid the passage of the guide through the septal wall. The
dilator can be removed after the internal guide has crossed the
septal wall. The internal guide can also have a pre-shaped
curvature to the distal tip. This curve can provide the direction
support to guide the deployment catheter toward the mitral
valve.
[0020] The deployment catheter can have a central lumen to accept a
guide wire used in positioning the deployment catheter to
effectively engage the mitral valve. The central lumen can also be
used for an intravascular ultrasound device or a direct
visualization device. The suture is deployed by the deployment
catheter at the selected site. The deployment catheter can be
withdrawn from the guide catheter and re-loaded or replaced for
successive suture deployments.
[0021] In one embodiment, a medical repair device may be added to
the procedure, such as a leaflet extension, a passive valve
occlusion device or a pledget. The deployed sutures exit the
internal guide catheter and can be temporarily fixed outside the
body. Once the desired amount of sutures is positioned, they can be
loaded through a central lumen of a septal seal device. The septal
seal device is advanced through the external guide catheter and
guided, via the sutures and external guide catheter, through the
ventricular puncture site. The right ventricular side of the seal
device is deployed and then the left side of the seal device is
deployed. The internal catheter is then detached from the septal
seal element and withdrawn from the external guide catheter. The
sutures remain in the internal lumen of the septal closure device
attached to the mitral valve and exit through the external
guide.
[0022] In one embodiment, the sutures can have the tension
individually adjusted to evaluate the physiological effect. The
evaluation can be done using transesophageal echocardiography or
other non-invasive methods. If the suture is overly tightened, a
catheter can be delivered through the external guide to the lumen
seal inside of the septal seal device. Advancing the catheter
through the seal will release suture tension and allow for
re-tensioning. When the tensioning task is complete, the sutures
can be fixed at the septal seal element.
[0023] In one embodiment, an anchor catheter with a distally
mounted cam lock element or other mechanical lock permanently fixes
to the septal seal element and fixes the position of the sutures
while maintaining the adjusted tension. This step completes the
septal seal and suture tensioning. The anchor catheter can then be
withdrawn with the proximal ends of the sutures. The sutures can
then be threaded through the lumen or opening of a cutting
catheter. A cutting catheter can be advanced over the sutures until
it contacts the septal seal device. The cutting catheter then cuts
the sutures at the seal to complete the implant procedure. The
entire catheter system is then removed from the patient and the
access site closed.
[0024] In another embodiment, a deployment catheter is capable of
multiple suture deployments in a single activation. This would
reduce the number of instrument exchanges and provide increased
control of the position of the sutures relative to each other.
[0025] A further embodiment uses the sutures to deliver a biomatrix
patch to enhance closure. The patch can be attached to the valve
with the sutures. The patch could be delivered to either the
ventricular or atrial side of the mitral valve leaflet. This patch
can improve leaflet coaptation and reduce/eliminate mitral valve
regurgitation by augmenting the native leaflet tissue structure
supported by the delivery of a biomatrix material that can support
the mitral valve annular ring or subvalvular apparatus.
[0026] Another embodiment includes the deployment of a passive
occlusive device intended to improve valve closure, the device
would be delivered, positioned and anchored via the ventricular
septal approach described herein.
[0027] The above summary of the various embodiments of the
invention is not intended to describe each illustrated embodiment
or every implementation of the invention. This summary represents a
simplified overview of certain aspects of the invention to
facilitate a basic understanding of the invention and is not
intended to identify key or critical elements of the invention or
delineate the scope of the invention.
BRIEF DESCRIPTION OF DRAWINGS
[0028] The embodiments of the present invention may be more
completely understood in consideration of the following detailed
description of various embodiments in connection with the
accompanying drawings, in which:
[0029] FIG. 1 is a view of a device for venous access into a heart
chamber via the femoral vein to facilitate repair of a heart valve
leaflet according to an embodiment of the present invention;
[0030] FIG. 2A is a view of a valve leaflet repair device according
to an embodiment of the present invention with an internal guide
and puncture tool passed into the left ventricle;
[0031] FIG. 2B is a partial view of the valve leaflet repair device
depicted in FIG. 2A;
[0032] FIG. 3 is a view of a valve leaflet repair device according
to an embodiment of the present invention with an internal guide
exiting a side exit guide catheter;
[0033] FIG. 4 is a view of a valve leaflet repair device according
to an embodiment of the present invention with a deployment
catheter exiting an internal guide and positioned at the mitral
valve;
[0034] FIG. 5A is a view of a deployment catheter tip according to
an embodiment of the present invention with a moveable catheter jaw
and a suture capture needle, with the catheter jaw in the closed
position;
[0035] FIG. 5B is a view of the deployment catheter tip of FIG. 5A
with the moveable catheter in the open position;
[0036] FIG. 6 is a cross-sectional view of the deployment catheter
tip of FIGS. 5A and 5B;
[0037] FIG. 7 is a view of a valve leaflet repair device according
to an embodiment of the present invention with several sutures
attached to the mitral valve and exiting through an internal
guide;
[0038] FIG. 8 is a view of a valve leaflet repair device according
to an embodiment of the present invention with ventricular septal
seal devices deployed in the septal wall with sutures extending
through a center lumen;
[0039] FIG. 9 is a schematic representation of the septal seal
device of FIG. 8 in place in the heart;
[0040] FIG. 10 is a perspective view of septal seal types according
to embodiments of the present invention;
[0041] FIG. 11 is a partial view of a septal seal device lumen with
a seal element for holding a suture in tension showing the suture
freed from tension by a catheter that releases the seal
element;
[0042] FIG. 12 is a view of a valve leaflet repair device according
to an embodiment of the present invention with an anchor device
fixing the position of the sutures;
[0043] FIG. 13 is a side cut-away view of the anchor device of FIG.
12 having a fixation catheter with a locking element for mating
with seal internal lock features;
[0044] FIG. 14 is a view of a valve leaflet repair device according
to an embodiment of the present invention with a cutting device for
cutting sutures at the right ventricular side of a septal seal;
[0045] FIG. 15 is a side cross-sectional view of the suture cutting
device of FIG. 14;
[0046] FIG. 16 is a view of a completed implant procedure using a
valve leaflet repair device according to an embodiment of the
present invention;
[0047] FIG. 17 is a flow chart of surgical procedural steps for
repair of heart valve leaflets according to an embodiment of the
present invention.
[0048] While the present invention is amenable to various
modifications and alternative forms, specifics thereof have been
shown by way of example in the drawings and will be described in
detail. It should be understood, however, that the intention is not
to limit the present invention to the particular embodiments
described. On the contrary, the invention is to cover all
modifications, equivalents, and alternatives falling within the
spirit and scope of the present invention.
DESCRIPTION OF EMBODIMENTS
[0049] In the following detailed description of the present
invention, numerous specific details are set forth in order to
provide a thorough understanding of the present invention. However,
one skilled in the art will recognize that various embodiments of
the present invention may be practiced without these specific
details. In other instances, well-known methods, procedures, and
components have not been described in detail so as to not
unnecessarily obscure aspects of the present invention.
[0050] One embodiment of the heart valve repair and delivery system
will be examined to demonstrate the multiple catheter access steps
required to enter the target heart chamber and deliver the repair
device. This embodiment performs the repair of mitral valve
regurgitation by delivering sutures to repair the defective valve
with a deployment catheter that acts to reduce/eliminate mitral
valve regurgitation (MR). In other embodiments, the access approach
described herein can be used to access the heart for any other type
of procedure, such as, for example, a heart valve replacement,
repair of another heart structure or delivery of repair devices
other than sutures to valve leaflets.
[0051] Embodiments of the present invention can be used as a
vascular access system. It can include a standard vascular
introducer that 1) eliminates the need for multiple passes of the
instrument against the vein wall, 2) minimizes blood loss due to
instrument leakage (circular components are more amenable to closer
tolerances and sealing capability), and 3) reduces push/pull forces
on the vein wall. The introducer contains seals to maintain
hemostasis during instrument exchanges. A side exiting external
guide catheter 102 can provide access into the right ventricle 10
as shown in FIG. 1. In one embodiment, a distal end of the external
guide 102 can include a suction element to ensure that it holds its
position in the right ventricle at, for example, the right
ventricular apex. The system can include an internal guide catheter
104 disposed in the side exiting external guide catheter 102 design
that facilitates the access through the right ventricle 10 to the
right ventricular wall. The introducer and/or external guide
catheter 102 can therefore function as means for accessing the
right ventricle. A standard septal puncture tool 106 with a needle
like end can serve as a means for creating an opening in the septum
to create the hole in the ventricular septal wall 12 to provide the
passageway for the guide catheter 104 through the wall as depicted
in FIG. 2A. As used herein, the term catheter can refer to an
elongate, generally flexible and tubular medical device that
extends along a longitudinal axis and defines a diameter around the
longitudinal axis.
[0052] The pre-shaped internal guide catheter 104 is then advanced
into the left ventricle 14, as shown in FIG. 3, and positioned to
deliver a deployment catheter 108 to properly capture a leaflet 16
of the mitral valve 18 for repair as shown in FIG. 4. The internal
guide catheter 104 can therefore function as a means for
positioning the deployment catheter 108 in the left ventricle. The
deployment catheter 108, as shown in FIGS. 5A-5B and 6, can provide
a means for deploying a repair device and can include a clamping
mechanism 110 or other means for grasping for capturing the leaflet
and a suture deployment mechanism including a suture capture needle
112 or other means for inserting the suture into the leaflet. The
deployment catheter 108 can be exchangeable within the guide
catheter 104 to permit multiple suture 114 deployments on the valve
leaflet as shown in FIG. 7. Alternatively, the deployment catheter
108 can deliver several sutures 114 at one deployment. Note that in
some Figures, such as FIG. 7, the external guide catheter 102 is
not shown for sake of clarity.
[0053] As can be seen in FIG. 4, embodiments of the present
invention provide a tri-catheter approach for accessing a heart
valve to deploy a repair device onto a portion of the valve, such
as a valve leaflet. The tri-catheter approach can include the
external guide catheter 102, internal guide catheter 104 received
within the external guide catheter 102 and deployment catheter 108
received within the internal guide catheter 104. In some
embodiments, as depicted in FIG. 4, the tri-catheter arrangement
can define a generally S-shaped access configuration to the valve
with the catheters defining a first curve in the right atrium to
access the right ventricle and a second curve where the internal
guide 104 exits the external guide 102 to cross the septum and
access the heart valve in the left ventricle. In one embodiment,
the external guide 102 defines a curvature of about 130 degrees and
the internal guide 104 has a generally U-shaped distal end that
angles towards the valve to define the generally S-shaped
configuration. Both external guide 102 and internal guide 104 may
be given various curvatures to match the anatomy of a given
patient. In one embodiment, the external guide 102 has a diameter
of between 12 and 16 French and the inner guide 104 has
approximately 2 French sizes smaller than the external guide 102.
The delivery catheter 108 and other catheters inserted into the
internal guide 104 can have a diameter that is approximately 2
French sizes smaller than the internal guide 104.
[0054] The deployment catheter 108 can alternatively or
additionally deliver an additional medical repair device such as a
leaflet extension or a passive valve occlusion device. A medical
repair device is a device that is permanently implanted for the
repair treatment or a device that supports the primary repair
treatment. Such medical repair devices can be suture materials,
biomatrix materials used to support or augment a tissue structure,
or devices that would provide repair treatment by device assisted
coaptation of one of the cardiac valves. In one embodiment,
deployment catheter 108 can deliver a pledget, such as described in
commonly owned, copending U.S. patent application Ser. No.
13/339,865, which is incorporated by reference herein. In another
embodiment, deployment catheter 108 can deliver a replacement valve
or a device that seats in the valve annulus and has a portion
extending down between the valve leaflets that is anchored to the
heart.
[0055] After the desired number of sutures 114 is deployed, the
sutures 114 are threaded through a lumen of a septal seal device
117. The septal sealing device 117 is then advanced down the guide
catheter 104 with a seal catheter and into the right ventricle 10.
The device 117 is positioned to have right side and left side seal
elements 116, depicted in FIG. 9, positioned on opposite sides of
the septal wall 12. The sealing elements 116 are deployed to
provide a means for sealing the opening in the septum with the
sealing device 117 and the catheter withdrawn as shown in FIG. 8.
In one embodiment, seal device 117 comprise a pre-shaped wire frame
having tensioned flanges on opposing sides that abut the opposing
sides of the septal wall 12 to hold the seal elements 116 in place
and an internal lumen 118 extending through the device. In one
embodiment, the wire frame is comprised of Nitinol.
[0056] The sutures 114 can now be tensioned from a location
external of the heart to have a desired tension that provides for
proper valve function. The internal lumen 118 of the septal sealing
device 117 can have one or more seals 126 that provide pressure on
the sutures to prevent them from easily moving to maintain the set
tension on the sutures 114 and provide a means for setting the
tension. Seals 126 can also serve to maintain the integrity of the
lumen 118. The seal can be similar to a silicone slit seal 122 or a
flap seal 120, as shown in FIG. 10, both of which facilitate
release of the suture 114 position using a catheter 128 or other
means for re-tensioning if desired to allow for re-tensioning, as
shown in FIG. 11.
[0057] After tension of the sutures 114 is confirmed via
trans-esophageal echo cardiography, for example, the sutures 114
can be fixed to the sealing device 117 for permanent anchoring of
the sutures 114. The sutures 114 are threaded through a lumen in an
anchoring catheter 130 to provide coaxial positioning of a locking
element 132 or anchoring device that can function as a means for
anchoring the sutures at the sealing device 117. Fixation can be
accomplished with the anchoring catheter 130 with the releasable
locking element 132 that interfaces with internal lock features 134
in the right side sealing element 116 of the sealing device 117 and
locks the sutures 114 in position and permanently fixes to the
sealing device 117 as shown in FIGS. 12 and 13. The locking
mechanism 132 can be a rotational cam lock or a screw in
element.
[0058] Once the sutures 114 are permanently fixed to the sealing
element 116, the sutures 114 can be threaded through the end of a
cutting catheter 136 which is advanced until it contacts the
sealing element 116 as shown in FIG. 14. The sutures 114 can then
be cut at the sealing element 116 with a cutting device or tool 138
in the cutting catheter 136, also shown in FIG. 15, which is then
withdrawn. The intervention is then complete and the guide
catheters and introducers can be withdrawn leaving behind the
anchored sutures 114 as shown in FIG. 16. The access site can then
be closed.
[0059] FIG. 17 depicts a flowchart of surgical steps 200 that can
be taken to repair a heart valve leaflet according to an embodiment
of the present invention. At step 202, the femoral or jugular vein
is accessed via a cut down or Seldinger technique and an introducer
with a hemostasis valve is inserted into the vein. In one
embodiment, the outer diameter of the introducer is a maximum of 24
french. At step 202, access is gained to the right atrium 20 using
a guide wire and an external guide catheter 102 is advanced over
the guide wire to the ventricular apex. In one embodiment, the
external guide catheter 102 is a side-exiting catheter. An internal
guide catheter 104 is inserted into the external guide catheter
following removal of the guide wire until it exits the external
guide. At step 206, proper positioning of the internal guide
catheter for puncture of the ventricular septal wall 12 is
confirmed and a septal puncture device 106 is inserted into the
internal guide 104 and advanced to the desired position at the
septal wall 12 to puncture the septal wall 12. A guide wire can
then be advanced through the internal guide 104 to maintain
position in the left ventricle 14. The puncture tool 106 can be
withdrawn and a dilator can be used to facilitate passage of the
internal guide catheter 104 into the left ventricle 14 and then
withdrawn.
[0060] At step 208, a suture deployment catheter 108 can be
inserted into the internal guide catheter 104 and advanced in the
left ventricle 14. The deployment catheter 108 can be positioned
near the leaflet 16, capture the leaflet 16 with a moveable jaw
110, advance a suture needle 112 through the leaflet 16, withdraw
the needle 112 back through the leaflet 16 and into the catheter
108, release the leaflet 16 and be withdrawn. In one embodiment,
proper capture of the valve leaflet 16 is confirmed prior to
advancing the needle 112 through the leaflet 16. In one embodiment,
this can be done with a fiber optic visualization system. In one
embodiment, deployment catheter 108 can be reinserted to deploy
additional sutures 114 onto leaflet 16. In another embodiment,
leaflet capture and suture deployment can be aided with an
augmented reality navigation system utilizing magnetic tracking
such as is disclosed in commonly owned, copending U.S. Provisional
Application No. 61/565,795, which is hereby incorporated by
reference. In some embodiments, deployment catheter 108 can deploy
multiple sutures 114 onto leaflet 16 in a single insertion.
[0061] At step 210, the sutures 114 are threaded through a lumen
118 of a ventricular septal sealing device 117, which is then
advanced to the ventricular septal wall 12 puncture site with a
septal sealing catheter. The septal seal device 117 can have seal
elements 116 deployed to seal the puncture and the septal sealing
catheter is withdrawn, leaving the sutures 114 in the sealing
device 117 and extending outward through the body. At step 212, the
sutures 114 can be tensioned to a desired level for proper valve
leaflet function. In one embodiment, proper tensioning of sutures
114 and valve leaflet function can be confirmed via transesophogeal
echo. In one embodiment, tension of the sutures 114 can be released
using a catheter 128 and readjusted.
[0062] At step 214, the sutures 114 are inserted into a lumen of an
anchoring catheter 130, which is advanced through the internal
guide 104 to the septal sealing device 117. An anchoring element
132 can then be deployed into the sealing device 117 to fix the
sutures 114 in position in the sealing device 117 and the anchoring
catheter 130 can be withdrawn. At step 216, a suture cutting
catheter 136 is inserted into the guide catheter and used to cut
the sutures adjacent the septal sealing device 117 with a cutting
element 138. The cutting catheter 136, guide catheters 102, 104 and
introducers can then all be withdrawn and the access site can be
closed to complete the procedure.
[0063] Although the system and method described herein are
primarily described in connection with intravenous access for a
ventricular septal approach, it should be understood that the
devices and methods described can be adapted for use with various
other approaches. For example, the system can also provide venous
access to the atrial septal wall for a trans-septal puncture that
provides access to the left atrium. In addition, the system can be
used to provide venous access to the left ventricle through the
aortic valve.
[0064] It should further be noted that although the system and
method described herein are primarily described with reference to
repairing a heart valve leaflet, other tissue structures can be
targeted for repair as well. For example, the papillary muscle,
heart wall or any other intra-cardiac structure can be targeted for
repair or anchoring.
[0065] In various embodiments, a heart valve repair system as
described herein can be provided as a kit including the various
catheters and devices described herein and instructions for
repairing a heart valve of a patient as described herein. In one
embodiment, the present application comprises the instructions. In
another embodiment, an FDA required Instructions for Use can
comprise the instructions.
[0066] Various embodiments of systems, devices and methods have
been described herein. These embodiments are given only by way of
example and are not intended to limit the scope of the present
invention. It should be appreciated, moreover, that the various
features of the embodiments that have been described may be
combined in various ways to produce numerous additional
embodiments. Moreover, while various materials, dimensions, shapes,
implantation locations, etc. have been described for use with
disclosed embodiments, others besides those disclosed may be
utilized without exceeding the scope of the invention.
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