U.S. patent application number 11/403859 was filed with the patent office on 2006-08-31 for valve to myocardium tension members device and method.
This patent application is currently assigned to Myocor, Inc.. Invention is credited to Todd J. Mortier, Cyril J. JR. Schweich.
Application Number | 20060195012 11/403859 |
Document ID | / |
Family ID | 25538181 |
Filed Date | 2006-08-31 |
United States Patent
Application |
20060195012 |
Kind Code |
A1 |
Mortier; Todd J. ; et
al. |
August 31, 2006 |
Valve to myocardium tension members device and method
Abstract
A device for heart valve repair including at least one tension
member having a first end and second end. A basal anchor is
disposed at the first end of the tension member and a secondary
anchor at the second end. The method includes the steps of
anchoring the basal anchor proximate a heart valve and anchoring
the secondary anchor at a location spaced from the valve such that
the chamber geometry is altered to reduce heart wall tension and/or
stress on the valve leaflets.
Inventors: |
Mortier; Todd J.;
(Minneapolis, MN) ; Schweich; Cyril J. JR.; (St.
Paul, MN) |
Correspondence
Address: |
MIN, HSIEH & HACK LLP
8270 GREENSBORO DRIVE
SUITE 630
MCLEAN
VA
22102
US
|
Assignee: |
Myocor, Inc.
|
Family ID: |
25538181 |
Appl. No.: |
11/403859 |
Filed: |
April 14, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11172437 |
Jul 1, 2005 |
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11403859 |
Apr 14, 2006 |
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09981790 |
Oct 19, 2001 |
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11172437 |
Jul 1, 2005 |
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08992316 |
Dec 17, 1997 |
6332893 |
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09981790 |
Oct 19, 2001 |
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Current U.S.
Class: |
600/37 ;
623/2.16; 623/2.36 |
Current CPC
Class: |
A61F 2/2457 20130101;
A61F 2/2445 20130101; A61F 2/2454 20130101; A61F 2/2463 20130101;
A61B 2017/048 20130101; Y10S 623/90 20130101; A61F 2/2487
20130101 |
Class at
Publication: |
600/037 ;
623/002.16; 623/002.36 |
International
Class: |
A61F 2/02 20060101
A61F002/02; A61F 2/24 20060101 A61F002/24 |
Claims
1-17. (canceled)
18. A method of treating mitral valvular regurgitation in a human
heart, the method comprising: providing a self-anchoring mechanical
device; identifying a target region of a myocardium of the heart;
and positioning the self-anchoring mechanical device within a
portion of the identified target region so as to adjust a position
of a base of at least one papillary muscle coupled to a mitral
valve.
19. The method of claim 18, wherein the position is adjusted by
decreasing distension of the base.
20. The method of claim 18, wherein the self-anchoring mechanical
device comprises a longitudinal axis, the method further
comprising: positioning the longitudinal axis substantially
parallel to the endocardial surface in an apex-to-base
direction.
21. The method of claim 18, wherein the target region comprises the
apical base region of the heart.
22. The method of claim 18, wherein the target region comprises a
wall of the left ventricle.
23. The method of claim 18, wherein: the identified target region
comprises at least one of normal tissue, infarcted tissue,
peri-infarcted tissue and ischemic tissue.
24. The method of claim 23, wherein the self-anchoring mechanical
device restricts or limits motion in the identified target
region.
25. The method of claim 18, wherein the mechanical device comprises
a flexible member.
26. The method of claim 25, wherein the mechanical device is placed
in one of: a relaxed condition; and a pre-stretched condition.
27. A method of treating mitral valvular regurgitation, the method
comprising: providing a restraining device having a distal anchor
and a proximal anchor; embedding the distal anchor of the device in
heart tissue; and embedding the proximal anchor in the heart
tissue, wherein the restraining device is substantially positioned
in a mid-wall of the heart and oriented approximately parallel to
an endocardial surface in an apex-to-base direction to adjust a
position of a base of at least one papillary muscle coupled to a
mitral valve.
28. The method as recited in claim 27, further comprising:
adjusting an amount of tension between the distal anchor and the
proximal anchor on the restraining device, the tension urging the
anchors toward one another.
29. The method as recited in claim 28, further comprising:
embedding the proximal anchor in the heart tissue while the device
is under tension.
30. The method as recited in claim 27, wherein: tension of the
restraining device causes a decrease in a distance from a base of
the papillary muscle to the mitral valve plane.
31. The method as recited in claim 27, wherein the heart tissue in
which the restraining device is positioned comprises at least one
of: peri-infarcted heart tissue; infarcted heart tissue; ischemic
heart tissue; and non-ischemic heart tissue.
32. The method of claim 28, wherein the restraining device
comprises a flexible member and adjusting the amount of tension of
the restraining device comprises at least one of: placing the
restraining member in a relaxed condition; and placing the
restraining member in a pre-stretched condition.
33. A method of treating a heart, the method comprising: providing
a restraining device having a distal anchor and a proximal anchor;
embedding the distal anchor of the device in heart tissue; and
embedding the proximal anchor in the heart tissue, wherein the
restraining device is substantially positioned in a mid-wall of the
heart.
34. The method as recited in claim 33, further comprising:
orienting the restraining device to adjust a position of a base of
at least one papillary muscle coupled to a mitral valve.
35. The method as recited in claim 33, further comprising:
orienting the restraining device approximately parallel to an
endocardial surface in an apex-to-base direction.
36. The method as recited in claim 35, further comprising:
adjusting a tension of the restraining device to decrease a
distance from a base of a papillary muscle to a mitral valve
plane.
37. The method as recited in claim 33, further comprising:
orienting the restraining device approximately parallel to a
circumferential plane of the heart.
38. A method of treating a heart with mitral valvular regurgitation
as recited in claim 33.
39. A method of treating a heart in which a myocardial infarction
has occurred as recited in claim 33.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention pertains generally to the field of
heart valve repair. More specifically, the present invention
pertains to a device and method for the reduction of myocardial
wall tension and the repair of mitral valve insufficiency.
[0002] Dilated cardiomyopathy is often accompanied by mitral valve
insufficiency. There are several reasons for the presence of mitral
valve insufficiency associated with a dilated heart. First, chamber
dilation and associated high wall stresses increase the diameter of
the mitral valve annulus. Additionally, as the heart dilates, the
positioning of the papillary muscles is altered. Papillary muscles
and chordae in a dilated heart will have moved both radially away
and down from the mitral valve. This rearrangement of the vascular
apparatus and enlargement of the annulus prevent the valve from
closing properly.
[0003] Currently mitral valve insufficiency is treated by either
repairing or replacing the valve. Surgical procedures used to
repair the valve including ring posterior annuloplasty which
consists of sewing a C or D-shaped ring around the posterior leaf
let of the mitral valve and drawing in the annulus, reducing its
previously enlarged diameter. Another method is to approximate the
anterior and posterior mitral leaflets (Alfieri repair) by placing
one suture through the center of both leaflets. This gives the
valve a figure 8-shaped appearance when the valve is opened. When
the mitral valve is replaced, the original leaflets are removed and
the chordae are cut. An artificial valve consists of mechanical or
tissue leaflets suspended on struts attached to a metal stent, and
is sutured into place on the mitral annulus.
[0004] It has been argued that valve repair is preferable to valve
replacement if the leaflet-chordae-papillary connections can be
maintained. Heart wall stress will increase if the chordae are cut
during valve replacement. It has been shown that by severing the
chordae there can be 30 percent (30%) reduction in chamber
function. Mitral valve replacement has high morality in very sick,
chronic heart failure patients.
SUMMARY OF THE INVENTION
[0005] The present invention pertains to a device and method for
mitral valve repair. The mitral-valve is generally defined as its
leaflets or cusps, but in reality, it actually consists of the
entire left ventricle chamber. By creating an improved chamber
geometry, both chamber and valve function will be improved. The
device of the present invention and method for valve
repair/replacement can include treatment for chronic heart failure
by reducing left ventricular wall tension.
[0006] In one embodiment of the present invention, the valve repair
device includes an elongate tension member having a first end and
second end. The basal anchor is disposed at the first end and the
secondary anchor is disposed at the second end.
[0007] The basal anchor could include a pad and annuloplasty ring
or the like. Alternately an artificial heart valve could serve as
the basal anchor.
[0008] Tension members can be substantially rigid or substantially
flexible. The secondary anchor can include a hook-shaped papillary
muscle tissue loop, screw-shaped tissue anchor or transmural anchor
pad.
[0009] The method of the present invention providing a tension
member having a first end and a second end. The tension member has
a basal anchor at the first end and a secondary anchor at the
second end. The basal anchor is anchored proximate to the valve
such that the tension member is disposed in the chamber. The
secondary anchor is anchored to a portion of the heart spaced from
the basal anchor such that the tension member is under tension and
the geometry of the chamber has been altered by placement of the
tension member.
[0010] The basal anchor can include an artificial heart valve,
annuloplasty ring or the like. The secondary anchor can be anchored
to a papillary muscle or transmurally anchored.
[0011] More than one tension member can be used. Additionally, a
transverse tension member can be placed across the chamber
generally perpendicular to the other tension members to further
alter the geometry of the heart, reducing wall stress and improving
chamber performance.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a transverse cross section of the left ventricle
of a human heart taken from FIG. 2;
[0013] FIG. 2 is a vertical cross section of the left ventricle of
a human heart;
[0014] FIG. 3 is a modified, transverse, cross section of the left
ventricle of a human heart taken from FIG. 4;
[0015] FIG. 4 is modified, vertical cross section of a human heart,
modified by a device in accordance with the present invention;
[0016] FIG. 5 is a cross section of an insufficient mitral valve of
a left ventricle of a human heart;
[0017] FIG. 6 is a cross section of a repaired valve and device in
accordance with the present invention;
[0018] FIG. 7 is an embodiment of the device of the present
invention;
[0019] FIG. 8 is an alternate embodiment of a device in accordance
with the present invention;
[0020] FIG. 9 is yet another alternate embodiment of a device in
accordance with the present invention;
[0021] FIG. 10 is yet another alternate embodiment of the device in
accordance with the present invention;
[0022] FIG. 11 is yet another alternate embodiment of a device in
accordance with the present invention;
[0023] FIG. 12 is a view of a basal anchor for the device of the
present invention;
[0024] FIG. 13 is a suture ring serving as a basal anchor for the
device of the present invention;
[0025] FIG. 14 is a replacement valve serving as a anchor for the
device of the present invention;
[0026] FIG. 15 is a top view of an alternate embodiment of a suture
ring acting as an anchor for the device of the present
invention;
[0027] FIG. 16 is a side view of the suture ring of FIG. 15;
[0028] FIG. 17 is a view of an alternate embodiment of a suture
ring which can act as basal anchor for the device of the present
invention;
[0029] FIG. 18 is a view of yet another alternate embodiment of a
suture ring which can act as a basal anchor for the present
invention;
[0030] FIG. 19 is a embodiment of a secondary anchor for the device
of the present invention;
[0031] FIG. 20 is a view of an alternate embodiment of a secondary
anchor for the device of the present invention; and
[0032] FIG. 21 is yet another embodiment of a secondary anchor for
the device of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0033] Referring now the drawings wherein like reference numerals
refer to like elements throughout the several views, FIG. 1 shows a
transverse cross section of the left ventricle 10 of a failing
heart taken from FIG. 2. The papillary muscles 12 are shown in
cross section. FIG. 2 is a vertical cross section of human heart
10. A mitral valve is disposed near the top of left ventricle 10.
Mitral valve 14 includes two leaflets or cusps 16. Chordae 18
extend between leaflets 16 and papillary muscles 12.
[0034] FIG. 3 is a cross section of heart 10 modified from that
shown in FIG. 1 by placement of valve repair device 20 in
accordance with the present invention as shown in FIG. 4. FIG. 4 is
a vertical cross section of left ventricle 10 with geometry
modified by device 20. In this embodiment of the invention, device
20 includes a basal anchor 22 such as an annuloplasty or suture
ring sewn proximate the annulus of valve 14. Extending from basal
anchor 22 are elongate tension members 24. Each have a first end
connected to basal anchor 22 and a second end anchored to papillary
muscles 12 or the heart wall.
[0035] As can be seen in FIGS. 3 and 4, both the transverse radius
and vertical dimension of left ventricle 10 has been reduced in
comparison to that of FIGS. 1 and 2 by drawing papillary muscles 12
toward valve 14 with tension members 24. This change in geometry
reduces heart wall stress and consequently increasing chamber
function. Valve function is also improved as explained in more
detail by reference to FIGS. 5 and 6.
[0036] FIG. 5 is a generally vertical cross section of an
insufficient mitral valve of a heart suffering from chronic heart
failure. In this case as the failing heart has dilated, papillary
muscle 12 has been drawn away from mitral valve 14. The chordae
connections between papillary muscles 12 and valve 14 in turn draws
leaflets 16 apart such that during the normal cardiac cycle,
leaflets 16 may not completely close. Thus, an opening 26 is left
between leaflets 16 throughout the cardiac cycle. Opening 26 will
allow blood to leak, reducing chamber efficiency.
[0037] FIG. 6 is a view of the mitral valve 14 of FIG. 5 which has
been modified by placement of valve repair device 20 as shown.
Suture ring 22 is sewn proximate the annulus of valve 14, as known
to those skilled in the use of suture rings. The annulus of valve
14 can be decreased in size by drawing the annulus toward the
suture ring by the sutures used to connect ring 22 to the valve.
Drawing the annulus of valve 14 toward suture ring 22 will help to
eliminate opening 26. Tension member 24 is then anchored to
papillary muscle 12 such that papillary muscle 12 is drawn toward
valve 14. Whether or not the suture ring alone is sufficient to
eliminate opening 26, drawing papillary muscle 12 toward valve 14
will provide additional stress relief on leaflet 16 promoting
complete closure of valve 14. Drawing papillary muscle 12 toward 14
also reduces heart wall stress and increases chamber efficiency as
discussed previously.
[0038] FIG. 7 is a highly simplified view of left ventricle 10 and
valve repair device 20 as shown in FIG. 4. It can be noted that
tension members 24 extend from basal anchor 22 to an adjacent
papillary muscle 12. In contrast, FIG. 8 is a similar cross
sectional view of left ventricle 10, but a valve repair device 120
is placed such that its tension members 124 extend between a basal
anchor 122 and a papillary muscle 12 transversely opposite the
point at which tension member 124 is connected to basal anchor 122.
This arrangement, as opposed to that shown in FIG. 7, can increase
the transverse component of the tension force in tension members
124 relative to the vertical component of that tensile force.
[0039] FIG. 9 shows yet another embodiment of the valve repair
device in accordance with the present invention referred to by
numeral 220. In this embodiment, device 220 is disposed in left
ventricle 10 in a manner similar to that of device 20 shown in FIG.
7 in that tension members 224 of device 220 extend from a basal
anchor 222 to an adjacent secondary anchor point. The secondary
anchor point is established by transverse extension of a tension
member 225 across left ventricle 10. Tension member 225 is anchored
transmurally to the heart wall at its opposite ends by pads 227. In
turn, tension members 224 are anchored or connected to tension
member 225.
[0040] Tension member 225 can be used to further alter the geometry
of left ventricle 10 in a manner disclosed in U.S. patent
application Ser. No. 08/933,456, entitled "HEART WALL TENSION
REDUCTION APPARATUS AND METHOD", which was filed on Sep. 18, 1997
and is incorporated herein by reference.
[0041] FIG. 10 shows yet another embodiment of a valve repair
device in accordance with the present invention referred to by
numeral 320. This embodiment includes a basal anchor 322 and
tension members 324 and a transverse tension member 325 having
anchor pads 327 similar to those of device 220. With respect to
device 320, however, tension members 324 are crossed similar to
those of device 120 of FIG. 8 to increase the horizontal component
relative to the vertical component of the tensile force in tension
member 324.
[0042] FIG. 11 is a yet another embodiment 420 of the valve repair
device of the present method. Valve repair device 420 includes a
basal anchor 422 and tension members 424. Tension members 424 are
disposed in an arrangement similar to tension members 24 of device
20 shown in FIG. 7 except that tension members 424 are anchored
transmurally by pads 427 rather than into papillary muscles 12. The
relatively greater thickness of tension members 424 shown in FIG.
11, as compared to tension members 24 shown in FIG. 7, merely
illustrates that the tension members can be substantially rigid or
in the case of tension members 24, substantially flexible. It
should be understood, however, that in any of the embodiments shown
herein, the tension members could be advantageously formed to be
substantially flexible or substantially rigid.
[0043] FIG. 12 is a top or posterior view of valve 14. In this
embodiment, the basal anchor for the valve repair device is shown
as discrete pads 28 which can be sewn to the posterior side of
valve 14. Tension members 24 are shown extending from respective
pads 28 into the left ventricle.
[0044] FIG. 13 is the same view of valve 14 as FIG. 12. In FIG. 13,
however, the basal anchor 22 is shown as a crescent-shaped suture
ring. Tension members 24 extends from basal anchor 22 through valve
14 into the left ventricle.
[0045] FIG. 14 is a side view of an artificial heart valve 30. If
it is necessary to replace the valve rather than merely repair it,
artificial valve 30 can be used as a basal anchor for tension
members 24.
[0046] FIG. 15 is a top view of an alternate embodiment of a suture
ring basal anchor 32. Ring 32 has a crescent shape and a pylon 34
extending through the mitral valve. FIG. 16 is a side view of
suture ring 32 showing tension members 24 attached to pylon 34.
[0047] Tension members 24 preferably extend through the tissue of
valve 14 rather than through the valve opening. It can be
appreciated, however, that tension members 24 could be disposed
through the valve opening. In the case of the embodiment of FIGS.
15 and 16, however, pylon 34 would be disposed through the valve
opening. Tension members 24 associated with pylon 34 would be
disposed on the opposite side of valve 14 from suture ring 32.
Pylon 34 would preferably be disposed through the valve opening
rather than the tissue forming valve 14.
[0048] FIGS. 17 and 18 are yet additional alternate embodiments of
suture rings which can be used as basal anchors in accordance with
the present invention. The shape of the rings is selected such that
as they are sewn into place on valve 14, the sutures can be used to
draw tissue toward the inside of the ring, thus reducing the
transverse and/or vertical cross sectional area of the associated
heart chamber. This will advantageously reduce heart wall stress
which is of particular benefit if the patient has a failing
heart.
[0049] It can be appreciated that tension members 24 can be fixably
or releasably attached to the basal anchor. Preferably, the tension
members are fixably attached to the basal anchor during the valve
repair procedure.
[0050] FIGS. 19-21 show various configurations of anchoring devices
shown at the second end of tension member 24. It can be appreciated
that these anchoring devices could be used with each of the tension
members described above. In FIG. 19, the second end of tension
member 24 includes a secondary anchor 40 formed as screw which is
shown augured into papillary muscle 12. FIG. 20 shows a secondary
anchor 42 including a loop sewn through papillary muscle 12. FIG.
21 shows a tension member 24 extending transmurally to an exterior
pad 44 to which it is connected. Tension member 24 could be sewn to
pad 44 or otherwise mechanically connected thereto.
[0051] It can be appreciated that various biocompatible materials
can be advantageously used to form the various components of the
device of the present invention. It is anticipated that the present
device will usually be chronically implanted. Thus, when selecting
materials to form each of the components consideration should be
given to the consequences of long term exposure of the device to
tissue and tissue to the device.
[0052] Numerous characteristics and advantages of the invention
covered by this document have been set forth in the foregoing
description. It will be understood, however, that this disclosure
is, in many respects, only illustrative. Charges may be made in
details, particularly in matters of shape, size, and arrangement of
parts without exceeding the scope of the invention. The
inventions's scope is, of course, defined in the language in which
the appended claims are expressed.
* * * * *