U.S. patent application number 16/024439 was filed with the patent office on 2018-11-08 for mitral leaflet tethering.
The applicant listed for this patent is Pipeline Medical Technologies, Inc.. Invention is credited to Steven F. Bolling, Randall T. Lashinski.
Application Number | 20180318083 16/024439 |
Document ID | / |
Family ID | 59225835 |
Filed Date | 2018-11-08 |
United States Patent
Application |
20180318083 |
Kind Code |
A1 |
Bolling; Steven F. ; et
al. |
November 8, 2018 |
MITRAL LEAFLET TETHERING
Abstract
This disclosure includes apparatuses and techniques to access
the right ventricle via trans-femoral vein threading a catheter or
catheters to the apex or bottom of the right ventricle. Piercing
through the venous or right side of the heart in the
interventricular septal wall to access the left ventricle a
catheter can be passed to turn upward pointing to the mitral valve.
From this access point in the left ventricle the flail mitral
leaflet can be sutured and tethered pulling it back into position
and reattached with a grounding anchor in the right ventricle or
imbedding the anchor into the septal wall. The interventricular
septal wall crossing technique could include the passing of a
coaxial catheter through the first access catheter where the first
access catheter could act as a guide to direct the internal or
second coaxial catheter toward the flail mitral leaflet.
Inventors: |
Bolling; Steven F.; (Ann
Arbor, MI) ; Lashinski; Randall T.; (Windsor,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Pipeline Medical Technologies, Inc. |
Wilmington |
DE |
US |
|
|
Family ID: |
59225835 |
Appl. No.: |
16/024439 |
Filed: |
June 29, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2016/069567 |
Dec 30, 2016 |
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16024439 |
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62273300 |
Dec 30, 2015 |
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62383338 |
Sep 2, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2230/0091 20130101;
A61M 25/0147 20130101; A61F 2/2457 20130101; A61B 2017/00876
20130101; A61B 2017/0427 20130101; A61B 2017/048 20130101; A61F
2220/0008 20130101; A61B 2017/0419 20130101; A61M 25/0054 20130101;
A61F 2/2466 20130101; A61B 17/0401 20130101; A61B 17/0469 20130101;
A61F 2220/0016 20130101; A61B 2017/0409 20130101; A61B 2017/00292
20130101; A61B 2017/0441 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61M 25/01 20060101 A61M025/01; A61B 17/04 20060101
A61B017/04; A61M 25/00 20060101 A61M025/00 |
Claims
1-11. (canceled)
12. A catheter-based system for mitral chordal repair, the
catheter-based system comprising: a steerable catheter configured
to extend through a septal wall to access a mitral valve, the
steerable catheter including wires extending from a handle at a
proximal portion of the steerable catheter to a distal portion of
the steerable catheter, the wires configured to actively deflect
the steerable catheter through a predetermined curve to position a
distal tip of the steerable catheter adjacent a mitral leaflet; a
ventricular anchor coupled to a first suture, the ventricular
anchor configured for delivery through the septal wall and through
the mitral valve in order to attach to tissue in a left ventricle;
a piercing tool configured to thread a second suture through the
mitral leaflet at a leaflet attachment site, the second suture
extending from a first side of the mitral leaflet; a strain
relieving pledget configured to distribute local forces at the
leaflet attachment site, the pledget being configured for placement
on a second side of the mitral leaflet opposite the first side of
the mitral leaflet; and a securement member for adjustably coupling
the first and second sutures in order to tether the mitral leaflet
to the tissue of the left ventricle.
13. The catheter-based system of claim 12, wherein the steerable
catheter includes slots configured to collapse as tension is
applied to the wires to curve the steerable catheter through the
predetermined curve.
14. The catheter-based system of claim 12, wherein the steerable
catheter is a first catheter, the catheter-based system further
comprising a second catheter configured to guide the first catheter
through the septal wall and toward the mitral leaflet.
15. The catheter-based system of claim 14, wherein the piercing
tool is configured to pass through the second catheter.
16. The catheter-based system of claim 14, wherein the first
catheter and the second catheter are coaxial.
17. The catheter-based system of claim 14, wherein the second
catheter is a steerable catheter.
18. The catheter-based system of claim 12, further comprising
rotational screws configured to translate rotational motion into
longitudinal forces on the wires.
19. The catheter-based system of claim 12, wherein the
predetermined curve positions a distal tip of the steerable
catheter upwards to point towards the ventricle side of the mitral
valve.
20. The catheter-based system of claim 12, wherein the steerable
catheter is configured to hold the mitral leaflet for suture
piercing and tethering.
21. The catheter-based system of claim 12, wherein the
predetermined curve is a curve of about 180 degrees.
22. The catheter-based system of claim 12, wherein the steerable
catheter includes slots configured to collapse as tension is
applied to the wires to curve the steerable catheter through the
predetermined curve, and wherein the slots are laser-cut into one
side of the steerable catheter.
23. The catheter-based system of claim 12, wherein the steerable
catheter includes slots configured to collapse as tension is
applied to the wires to curve the steerable catheter through the
predetermined curve, and wherein the slots are formed into one or
more of the following: chevron, angled, and radiused shapes.
24. The catheter-based system of claim 12, wherein the ventricular
anchor includes a strain relief at an anchor exit, the strain
relief configured to reduce fretting of the first suture.
25. The catheter-based system of claim 12, wherein the ventricular
anchor includes a main body and barbs extending at an acute angle
from an outer surface of the main body.
26. The catheter-based system of claim 12, wherein the ventricular
anchor is a coiled anchor.
27. The catheter-based system of claim 12, wherein the securement
member is configured to adjustably secure proper positioning of the
mitral leaflet.
28. The catheter-based system of claim 27, wherein the securement
member is a sliding one-way stopper.
29. The multi-catheter system of claim 12, wherein the ventricular
anchor is configured to couple to tissue directly below the
attachment point of the mitral leaflet.
30. A multi-catheter system for mitral chordal repair, the
multi-catheter system comprising: a first catheter configured to
traverse a septal wall to provide access to a mitral valve; a
second catheter including means for steering the second catheter to
locate a piercing tool through a mitral leaflet; the second
catheter securing a pledget and a suture to the mitral leaflet; a
ventricular anchor configured for delivery through the septal wall
and through the mitral valve in order to attach to tissue in a left
ventricle; and means for adjustably joining the suture to the
ventricular anchor to tether the mitral leaflet to the ventricular
anchor.
31. The multi-catheter system of claim 30, wherein the ventricular
anchor includes a strain relief at an anchor exit, the strain
relief configured to reduce fretting of a suture attached to the
ventricular anchor.
32. The multi-catheter system of claim 30, wherein the ventricular
anchor is configured for delivery via the first catheter and is
configured to attach to tissue in a left ventricle directly below
the mitral leaflet.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] This application claims a priority benefit to U.S.
Provisional Application No. 62/383,338, filed Sep. 2, 2016 and U.S.
Provisional Application No. 62/273,300, filed Dec. 30, 2015, the
entire disclosure of these provisional applications are hereby
incorporated by reference herein for all purposes in their
entireties and should be considered a part of this
specification.
BACKGROUND
Field
[0002] The disclosure relates generally to cardiac treatment
devices and techniques, and in particular, to methods and devices
for mitral valve repair.
Description of the Related Art
[0003] The heart includes four heart valves, which allow blood to
pass through the four chambers of the heart in one direction. The
four valves are the tricuspid, mitral, pulmonary and aortic valves.
The four chambers are the right and left atria (upper chambers) and
right and left ventricle (lower chambers).
[0004] The mitral valve is formed by two leaflets, which are known
as the anterior leaflet and the posterior leaflet, which open and
close in response to pressure placed on the leaflets by the pumping
of the heart. There are several problems that can develop or occur
with respect to the mitral valve. Such problems include mitral
valve regurgitation (MR), in which the mitral valve leaflets do not
close properly, which can cause leakage of the mitral valve. Severe
mitral regurgitation can adversely affect cardiac function and
compromise a patient's quality of life and life-span. There are
several techniques directed to correcting mitral valve
regurgitation, which include valve replacement, chordae tendinea
shortening or replacement and mitral annular repair also known as
annuloplasty.
[0005] Current techniques to correct mitral regurgitation include
repairing the mitral valve via open heart surgery while a patient's
heart is stopped and the patient is on cardiopulmonary bypass. Such
techniques are highly invasive that have inherent risks. It would
be desirable to provide a less invasive procedure for repairing a
mitral valve.
SUMMARY
[0006] One embodiment disclosed herein includes a method of
repairing a mitral valve of a patient's heart that comprises
accessing a right ventricle of the patient's heart with a catheter
extending through a venous or right side of the heart to access the
left ventricle and and with the catheter securing a mitral valve
leaflet.
[0007] Another embodiment disclosed herein is a chordae replacement
system that can include a catheter and a chordae replacement
implant. The catheter can have an elongate, flexible tubular body
with a proximal end and a distal end. The catheter can be
configured for transvascular access into the right ventricle,
through the intraventricular septum and into the left ventricle.
The chordae replacement implant can be deployably carried by the
catheter. The chordae replacement implant can comprise an elongate
body having a proximal end with a proximal tissue anchor and a
distal end with a mitral valve leaflet attachment anchor.
[0008] Another embodiment disclosed herein is method of repairing a
mitral valve, the method comprising with a catheter transvascularly
accessing the right ventricle and extending the catheter through
the intraventricular septum and into the left ventricle and
deploying a chordae replacement implant with the catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1AA illustrates the normal mitral leaflet connections
in the left ventricle include chordal attachments from the free
margin of the mitral leaflet to the papillary muscles.
[0010] FIG. 1A illustrates a ruptured chordal attachment.
[0011] FIG. 1 illustrates a technique to access the right ventricle
via trans-femoral vein threading a catheter or catheters to the
apex or bottom of the right ventricle.
[0012] FIG. 2 illustrates a catheter piercing through the venous or
right side of the heart in the interventricular septal wall to
access the left ventricle.
[0013] FIG. 3 illustrates first and second catheters that could be
steered to position the distal tip to capture the margin of the
mitral leaflet.
[0014] FIG. 4 illustrates magnets that can be used to position the
tips of two catheters relative to one another.
[0015] FIG. 4A illustrates passing a suture loop through the mitral
leaflet and tethered back through a lower catheter and attached to
the anchor at the apex or intraventricular septal wall.
[0016] FIG. 5 illustrates a grounding plug.
[0017] FIG. 5A illustrates an internal anchor within the tissue
wall separating the left and right ventricle or interventricular
septal wall tissue.
[0018] FIG. 5AA illustrates a septal anchor
[0019] FIG. 5B illustrate embodiments of an internal anchor and
apex anchor.
[0020] FIG. 6 illustrates a grounding anchor positioned within the
heart.
[0021] FIG. 7 illustrates a coiled anchor.
[0022] FIG. 8 illustrates access from the jugular vein would also
provide access into the vena cava and right ventricle and or access
into the left atrium via trans-septal puncture.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] Normal mitral leaflet 10 connections in the left ventricle
include chordal attachments 12 from the free margin of the mitral
leaflet 10 to the papillary muscles 14, which are shown in FIG.
1AA
[0024] The repair and reconnection of a flail leaflet (a ruptured
chord 7 being shown in FIG. 1A) surgically can be completed with a
suture by reattaching the leaflet to a papillary muscle. Another
technique would be a trans-apical reconnection of the flail leaflet
similar to a technology developed by a company named NeoChord.
[0025] A different technique would be to access the right ventricle
16 via trans-femoral vein 18 threading a catheter 20 or catheters
to the apex or bottom of the right ventricle 16 as shown in FIG. 1.
The entry would start in the femoral vein 18 in the groin
proceeding up through the inferior vena cava into the right atrium
24 through the tricuspid valve 22 to the bottom of the right
ventricle 16. Piercing through the venous or right side of the
heart in the interventricular septal wall 19 to access the left
ventricle 26 a catheter 20 can be passed to turn upward pointing to
the mitral valve 28 as shown in FIG. 2. From this access point in
the left ventricle 26 the flail mitral leaflet can be sutured and
tethered pulling it back into position and reattached with a
grounding anchor in the right ventricle 16 or imbedding the anchor
into the septal wall. The interventricular septal wall crossing
technique could include the passing of a coaxial catheter 30
through the first access catheter 20 where the first access
catheter 20 could act as a guide to direct the internal or second
coaxial catheter 30 toward the flail mitral leaflet. Both first and
second catheters 20, 30 could be steerable to position the distal
tip direction to capture the margin of the mitral leaflet as shown
in FIG. 3. A piercing needle could be passed to thread a suture
through the mitral leaflet for reattachment or the leaflet to the
lower chamber of the heart, into the septal wall or transvers the
septal wall and anchor in the right ventricle. Threaded a tether
through the mitral leaflet and back through the second internal
catheter 30 and attached to the grounding anchor, the leaflet would
be pulled into proper position replicating a chordal attachment
that may have failed or broken. The attachment of the new suture to
the grounding anchor could be achieved through a knot, sliding
one-way stopper or other means to join the anchor and suture
together. A single line attachment or a plurality of lines would
allow the load to be shared or pulled in different force vectors
moving the grounding point of the mitral leaflet in different
directions. As shown in FIG. 3, a secondary atrial access could be
achieved through the venous system superiorly to the mitral valve
via trans-septal puncture to pass an additional catheter 32 into
the left atrium for positioning above the flail leaflet. Achieving
a second securement of the leaflet from above along with below
would allow for positive positioning and suture attachment within
the leaflet margin as viewed under echo and fluoroscopy. At the tip
of each catheter could be a magnet 36, 34 to position the tips of
each catheter 30, 32 relative to one another as shown in FIG. 4.
The magnet 36, 34 could have a through-hole or central lumen to
pass wires, suture 43 or other items longitudinally from one tip to
another. A suture loop 41 would be passed through the mitral
leaflet 27 and tethered back through the lower catheter 30 and
attached to the anchor at the apex or intraventricular septal wall
as shown in FIG. 4A.
[0026] The grounding plug or anchor 40 could be similar to an
Amplatz device used for closing an ASD or another device to
distribute forces to a larger area distributing the load throughout
a larger surface area in the right ventricle or within the
interventricular septal wall as shown in FIG. 5 Another means to
secure the sutures within the right ventricle would be attach them
to a pledget 73 or other pad to spread the load within the right
ventricle. One alternative technique would be to imbed an internal
anchor 42 within the tissue wall separating the left and right
ventricle or interventricular septal wall tissue as shown in FIG.
5A. This internal anchors 50 of FIGS. 5B and 5AA could be delivered
from above, or from the left atrium, through the septal access and
passing through the mitral leaflet to connect the mitral leaflet to
the suture 43 and into the septal wall between the right and left
ventricle securing it to an internal structure such as an anchor to
resist movement during the tensioning of the suture line. As shown
in FIG. 5A, the intertal anchor can include barbs 80 and a suture
hold 82. It may also be advantageous to extend a section of the
anchor into the left atrium away from the septal wall to position
the tangent point directly below the attachment point of the mitral
leaflet. This would provide a direct line to the attachment points
above and below without a torque or moment about the entry to the
septal wall and not interfere with any other chordal structures or
papillary muscles. A strain relief at the anchor exit may also
prohibit fretting of the suture line as its cyclical loading may be
an area of stress concentration. Also a coiled anchor 52 (see FIG.
5B) could be delivered from above with a trans-septal access
through the mitral valve and into the apex of the heart or into the
myocardial tissue as shown in FIG. 7. The coil 55 would allow a
contact point connected to the suture line which is farther
connected to the mitral leaflet. A plurality of connection points
could also be added for additional support or to tether additional
ruptured chords. A secondary adjustment could also occur by
re-tethering the connection lines by winding, re-knotting or
pulling the suture lines post implant procedure.
[0027] Access into the femoral vein could occur with a guidewire 70
measuring about 0.035 inches in diameter and about 180 centimeters
in length. An introducer sheath could follow to provide a conduit
to pass additional catheters in and out of the femoral access site
as shown in FIG. 8. The catheter 72 could measuring about 10 to 24
French in diameter the introducer could be advanced into the
femoral vein with a dilator to guide the tip without vessel trauma.
The length of the catheter 72 could be about 100 centimeters in
length. Advancing the device delivery catheter through this
introducer sheath over the guidewire 72 could provide a radiopaque
means for tracking the guidewire, introducer sheath and delivery
catheter via live x-ray or fluoroscopy. Passed into the inferior
vena cava and turning into the right atrium through the tricuspid
valve, the catheter can follow the guidewire or be actively shaped
or bent through a deflectable catheter at the handle via pull-wire
or shaping system. Contrast dye injected into the heart can provide
a road map to structural items within the heart. Aiming or steering
the catheter and guidewire to the apex of the right ventricle and
passing a needle or piercing tool to pass from the right ventricle
to the left ventricle will provide access from the femoral vein to
the left ventricle accessing the mitral valve.
[0028] An access pathway to the left atrium through a trans-septaL
puncture can be completed by also via the femoral artery at the
groin to advance a guidewire and catheter system in a similar manor
as described above. This would allow for an above and below
intimate contact of the mitral valve leaflets to secure and suture
them back into proper positioning. The above-catheter from the left
atrium and below-catheter from the left ventricle, via right
ventricle, can locate and hold the position of the flail leaflet
for suture piercing and tethering back into its proper position to
coapt with the adjacent leaflet eliminating the mitral regurgitated
blood flow. Piercing needles and strain relieving pledgets 75 could
be used to pass suture 75 and distribute the local forces at the
leaflet attachment site as shown in FIG. 6. Single or multiple
passes through the leaflet will provide a duplication of the normal
chorde providing normal leaflet motion. The suture material can be
#4 or #5 pTFE, Silk or other common materials used in normal valve
repair. The position of the suture would allow for normal left
ventricle and mitral valve motion and freedom as the suture would
pass in between the papillary muscles and connect to the flail
leaflet at one end and into the right ventricle at the other end
held by a strain relief in the right ventricle. Access from the
jugular vein would also provide access into the vena cava and right
ventricle and or access into the left atrium via trans-septal
puncture as shown in FIG. 8. This jugular access would eliminate
the first 180 degree turn up the femoral vein and into the right
ventricle but is not a conventional access for most interventional
cardiologist.
[0029] Catheters would be constructed of common polymers including
nylon, Teflon, urethanes, and other commonly used materials having
a proximal and distal end with a guidewire port through s The
catheter curves needed would be pre-set, fixed or actively curved
through differential forces transmitted via pull wires or tubes to
bias one direction or another providing a column compression on one
side of the catheter relative to the other. Column and tubular
strength could be provided by imbedded coiled wires, braided with
ribbon or round wire, laser cut tubes or skeletal structures to
form a defined structure and or curve needed to gain access.
Variable durometers, construction techniques are well known in the
industry to allow for specific pushability, stiffness and curves
needed to deliver. Coatings and surface treatments both internally
and externally could aid in relative movement between vessel walls
and between wires and other catheters. The tensioning means could
be provided by a pull-wire extending from the distal end of the
catheter to the handle of the proximal section. This pull wire
could be activated by rotational screws translated into
longitudinal forces pulling a connection to the distal end of the
catheter. The overall length of the femoral catheter access would
be about 100 cm in length and have a through lumen to accept a
guidewire for positioning within the bodies vasculature. The
overall length of the internal jugular catheter would be about 60
cm in length. Both catheters would be about 6-20 French in diameter
with at least one lumen from the proximal distal end of the
delivery system.
[0030] Access from the femoral vein will allow for catheterization
through the tricuspid valve and into the right ventricle. At the
apex of the right ventricle an access will be attained by advancing
a needle or catheter in through the septal wall gaining access to
the left ventricle. Use of a needle, ultrasonic or coring tool to
pass a guidewire from right ventricle to left ventricle is the
pathway and access route to repair the mitral valve. Once a needle
and or guidewire can be advanced additional tools such as catheters
can be utilized to repair the mitral valve. The septal wall can be
over 1 centimeter in thickness so maintaining an access port may be
achieved by a balloon dilatation, guide catheter or access conduit
to pass tools and catheters through during the repair. A steerable
sheath, catheter or conduit may allow an easier access direction to
the specific area of the mitral valve for repair. Adjustments made
rotationally and or angularly can be fixed or locked into position
once optimal positioning is obtained. This can be achieved by a
pre-shaped curve configuration whereas the catheter is curved down
through the tricuspid valve and across the ventricular septal wall
then pointing upward toward the mitral valve. This shape can be
fixed or variable based upon patient needs and anatomy. Guidewires
measuring about 0.035 inches in diameter and about 180 to 300
centimeters in length will allow for catheters to be advanced over
and allow exchange of additional tools to be interchanged.
Expandable dilators can be used expand areas where tight access is
required or larger bore catheters are required. Catheter sizing may
start from about 6 French to about 24 French in diameter and range
from lengths including 90 centimeters to 160 centimeters.
Construction of these catheters can be of normal polymers including
nylon, polyurethane, polyethylene or other similar polymers.
Braids, coils or laser cut tubes can be used within the catheter
construction to better support inner diameters, shapes or curves
required. These materials can also include stainless steel,
Nitinol, Platinum or MP35N metallic suitable for catheter
construction.
[0031] Nesting multiple catheters inside one another will provide
for additional curves, movement, and translational freedoms. In one
embodiment a larger catheter (24 French inner diameter) to access
the apex of the right ventricle could be used to position a stable
base from which to advance an inner catheter (18 French inner
diameter) through the ventricular septal wall and a third catheter
could be advanced through this catheter measuring about 14 French
inner diameter to advance into the left ventricle directing toward
the mitral valve. These catheters would allow for multiple
adjustments and angles for various anatomies. The ability to
translate, rotate and lock position of each of these catheters
together or independently will provide a stable platform to deliver
repair tools to the valve. Locking means for each of these
catheters nested inside one another can be achieved by an expansion
via diameter change using a hydraulic pressure, a mechanical
expansion via rotational means creating an eccentric lock or a
longitudinal pull to create a differential diameter between the
catheters. This push-pull translation could force the catheter to
accordion creating a larger bump within one catheter.
[0032] Additionally, push pull wires could force the catheters into
predetermined shapes and curves in single or multiple plains. By
laser cutting a specific pattern into the catheter inner frame a
shape can be forced by a pull wire reducing one side of the
catheter length while collapsing the round column shape of the
catheter creating a shape as determined by the laser cut element
internal to the catheter. As an example, a slot could be cut into
one side of the tube and a tension wire attached at the distal end
of the tube. As tension is applied to the wire, a collapsing of the
slotted side of the tube would result in curve or bias to the
tubular element. These slots could also be complex shapes to lock
the rotational angle into a pre-determined shape. This complex
shape could be a chevron, angled cut, radiused shape or another
detailed pattern to stop the collapsing of the tube at a
predetermined radius. This pattern could also be rotated about the
tube to create three-dimensional shapes and curves out of a single
plane.
[0033] This patterning would be laser cut into the inner tube of
the catheter and be constructed from a metallic or polymer and
embedded into the wall of the catheter wall.
[0034] The first angular curve would be about 180 degrees changing
the direction of the catheter from the femoral access through the
tricuspid valve and directing toward the apex of the right
ventricle. The second curve in this catheter would be about a 90
degree turn toward the ventricular septal wall making a "Shepard's
Crook" shape. This 90 degree direction could be also attained with
a second inner catheter passed through the first larger diameter
catheter to direct the access through the ventricular septal wall.
This would require a 90 degree curve to redirect the tip toward the
septal wall. Once a penetration of the septal wall is achieved
another 90 degree curve would be required to direct the catheter
toward the mitral valve. Between these two 90 degree curves and
separation of about 1 to 2 centimeters is required to traverse the
septal wall tissue. This straight section could be preshaped into
the curve configuration and be actuated with a single pull wire or
multiple pull wires. The preferred embodiment would utilize the
first catheter to attain the 90 degree curve toward the ventricular
septal wall.
[0035] The next inner catheter directed toward the mitral valve
could be advanced toward the valve leaflets in the left ventricle.
Directed and placed below the leaflet the catheter tip could locate
the free margin of the mitral valve leaflet to secure a tether for
a ruptured chord or flail leaflet repair. Single or multiple chords
can emanate from a single access point or from separate locations
along the valve leaflet. From above through a trans-septal access a
second catheter could located the top side of the leaflet along the
same free margin of the leaflet. Locating these two catheters
coaxially could be achieved through a magnetic tip that is built
into the catheter or advanced through each central lumen of the
catheters.
[0036] Locating these two catheters above and below the leaflet
pinching one another with the leaflet sandwiched in between would
allow for an access through the leaflet for chordal repair or
tethering to secure through the lower access point originating from
the right ventricle. The chordal repair could be a PTFE suture or
another material suitable for permanent implantation. With the
lower access point extending into the right ventricle an anchor
could be located completely in the right ventricle or within the
ventricular septal wall exposing only the replacement suture
material in the left ventricle. Anchor designs can be similar to a
barbed anchor with a single or plurality of barbs to engage the
tissue, a plug to hold from the right ventricle side of the septal
wall or a screw means to engage the tissue in the right or left
ventricle. The attachment of the tissue anchor to the chordal
leaflet attachment can be adjusted while monitoring the tension of
the chord or the echo results live during or after the implantation
of the chords and anchor system.
* * * * *