U.S. patent application number 16/011207 was filed with the patent office on 2018-10-18 for papillary muscle position control devices, systems, and methods.
The applicant listed for this patent is Georgia Tech Research Corporation. Invention is credited to Jorge Hernan Jimenez, Ajit P. Yoganathan.
Application Number | 20180296340 16/011207 |
Document ID | / |
Family ID | 38459485 |
Filed Date | 2018-10-18 |
United States Patent
Application |
20180296340 |
Kind Code |
A1 |
Yoganathan; Ajit P. ; et
al. |
October 18, 2018 |
Papillary Muscle Position Control Devices, Systems, And Methods
Abstract
Papillary muscle position control devices, systems, and methods
are provided. A papillary muscle position control device generally
includes a first anchor, a second anchor, and a support structure.
The first anchor can be configured to fixedly connect to an in-situ
valve of a heart ventricle. The second anchor can be configured to
fixedly connect to a muscle wall of the valve. The support
structure can be configured to have an adjustable length and be
coupled to the first anchor and second anchor such that adjusting
the length of the support structure varies a distance between the
first anchor and the second anchor.
Inventors: |
Yoganathan; Ajit P.;
(Atlanta, GA) ; Jimenez; Jorge Hernan; (Atlanta,
GA) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Georgia Tech Research Corporation |
Atlanta |
GA |
US |
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|
Family ID: |
38459485 |
Appl. No.: |
16/011207 |
Filed: |
June 18, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14846932 |
Sep 7, 2015 |
10010419 |
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16011207 |
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12096948 |
Oct 24, 2008 |
9125742 |
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PCT/US2006/062185 |
Dec 15, 2006 |
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14846932 |
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60750561 |
Dec 15, 2005 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2445 20130101;
A61F 2250/0004 20130101; A61F 2/2457 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Goverment Interests
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] This invention was made with Government support under
Contract No. HL052009, awarded by awarded the National Institutes
of Health. The Government has certain rights in the invention.
Claims
1. A papillary muscle system comprising: an exterior pad
positionable exterior a heart valve wall; a papillary muscle
support structure extending from the exterior pad to a control
portion of a papillary muscle of the heart; and a papillary muscle
adjustment mechanism proximate the exterior pad for lockably
adjusting, while the heart is beating, a distance between the
exterior pad and the control portion of the papillary muscle.
2. The system of claim 1, wherein the papillary muscle adjustment
mechanism comprises: a tension control member; and a tension member
located between the exterior pad and the tension control member;
wherein the papillary muscle support structure extends from the
tension control member to the control portion of the papillary
muscle of the heart; and wherein the distance between the exterior
pad and the control portion of the papillary muscle is adjustable
via the tension control member.
3. The system of claim 2, wherein the papillary muscle support
structure further extends through the exterior pad and the tension
member; and wherein tension in the tension member is adjustable by
the tension control member.
4. The system of claim 1 further comprising an interior papillary
muscle pad proximate the control portion of the papillary muscle;
wherein the papillary muscle support structure extends from the
exterior pad to the interior papillary muscle pad; and wherein the
papillary muscle adjustment mechanism adjusts a distance between
the exterior pad and the interior papillary muscle pad.
5. The system of claim 4, wherein the papillary muscle support
structure extends through a portion of the papillary muscle between
the heart valve wall and the control portion.
6. The system of claim 1, wherein the papillary muscle support
structure has an exterior pad end and a papillary muscle end,
wherein the papillary muscle end is cooperatively shaped to engage
the control portion of the papillary muscle.
7. The system of claim 1 further comprising a first anchor
configured to fixedly connect to an in-situ heart valve situated in
the heart between a heart ventricle and atrium; wherein the
papillary muscle support structure extends from the exterior pad to
the first anchor; and wherein the adjustment mechanism additionally
lockably adjusts a distance between the first anchor and the
control portion of the papillary muscle.
8. The system of claim 7, wherein the distance between the exterior
pad and the control portion of the papillary muscle, and the
distance between the first anchor and the control portion of the
papillary muscle, are interpedently adjustable one from the
another.
9. The system of claim 7, wherein the papillary muscle adjustment
mechanism comprises: a tension control member; and a tension member
located between the exterior pad and the tension control member;
wherein the papillary muscle support structure extends from the
tension control member to the control portion of the papillary
muscle of the heart; and wherein the distance between the exterior
pad and the control portion of the papillary muscle is adjustable
via the tension control member.
10. The system of claim 9, wherein the papillary muscle support
structure further extends through the exterior pad and the tension
member; and wherein tension in the tension member is adjustable by
the tension control member.
11. The system of claim 7 further comprising an interior papillary
muscle pad proximate the control portion of the papillary muscle;
wherein the papillary muscle support structure extends from the
exterior pad to the interior papillary muscle pad; and wherein the
papillary muscle adjustment mechanism adjusts a distance between
the exterior pad and the interior papillary muscle pad.
12. The system of claim 7, wherein the papillary muscle support
structure extends through a portion of the papillary muscle between
the heart valve wall and the control portion.
13. The system of claim 1 further comprising: a first anchor
configured to fixedly connect to an in-situ heart valve situated in
the heart between a heart ventricle and atrium; and an anchor
adjustment mechanism proximate the first anchor configured to
lockably adjust a distance between the first anchor and the control
portion of the papillary muscle; wherein the papillary muscle
support structure extends from the exterior pad to the first
anchor.
14. The system of claim 13, wherein the distance between the
exterior pad and the control portion of the papillary muscle, and
the distance between the first anchor and the control portion of
the papillary muscle, are interpedently adjustable one from the
another.
15. The system of claim 13, wherein the papillary muscle adjustment
mechanism comprises: a tension control member; and a tension member
located between the exterior pad and the tension control member;
wherein the papillary muscle support structure extends from the
tension control member to the control portion of the papillary
muscle of the heart; and wherein the distance between the exterior
pad and the control portion of the papillary muscle is adjustable
via the tension control member.
16. The system of claim 15, wherein the papillary muscle support
structure further extends through the exterior pad and the tension
member; and wherein tension in the tension member is adjustable by
the tension control member.
17. The system of claim 13 further comprising an interior papillary
muscle pad proximate the control portion of the papillary muscle;
wherein the papillary muscle support structure extends from the
exterior pad to the interior papillary muscle pad; and wherein the
papillary muscle adjustment mechanism adjusts a distance between
the exterior pad and the interior papillary muscle pad.
18. The system of claim 13, wherein the papillary muscle support
structure extends through a portion of the papillary muscle between
the heart valve wall and the control portion.
19. The system of claim 1 further comprising: a first anchor
configured to fixedly connect to an in-situ heart valve situated in
the heart between a heart ventricle and atrium; an anchor support
structure coupled between the first anchor and the control portion
of the papillary muscle; and an anchor adjustment mechanism
proximate the first anchor configured to lockably adjust via the
anchor support structure a distance between the first anchor and
the control portion of the papillary muscle.
20. The system of claim 11, wherein the distance between the
exterior pad and the control portion of the papillary muscle, and
the distance between the first anchor and the control portion of
the papillary muscle, are interpedently adjustable one from the
another.
21. The system of claim 19, wherein the papillary muscle adjustment
mechanism comprises: a tension control member; and a tension member
located between the exterior pad and the tension control member;
wherein the papillary muscle support structure extends from the
tension control member to the control portion of the papillary
muscle of the heart; and wherein the distance between the exterior
pad and the control portion of the papillary muscle is adjustable
via the tension control member.
22. The system of claim 21, wherein the papillary muscle support
structure further extends through the exterior pad and the tension
member; and wherein tension in the tension member is adjustable by
the tension control member.
23. The system of claim 19 further comprising an interior papillary
muscle pad proximate the control portion of the papillary muscle;
wherein the papillary muscle support structure extends from the
exterior pad to the interior papillary muscle pad; and wherein the
papillary muscle adjustment mechanism adjusts a distance between
the exterior pad and the interior papillary muscle pad.
24. The system of claim 19, wherein the papillary muscle support
structure extends through a portion of the papillary muscle between
the heart valve wall and the control portion.
25. A papillary muscle system comprising: a first anchor configured
to fixedly connect to an in-situ heart valve situated in a heart
between a heart ventricle and atrium; a second anchor configured to
fixedly connect to at least one of a ventricular wall and a
papillary muscle of the heart; a support structure extending from
the first anchor to a control portion of a papillary muscle of the
heart, and from the control portion of the papillary muscle to the
second anchor; an anchor adjustment mechanism proximate the first
anchor configured to lockably adjust, while the heart is beating, a
distance between the first anchor and the control portion of the
papillary muscle; and a papillary muscle adjustment mechanism
proximate the second anchor to lockably adjust, while the heart is
beating, a distance between the second anchor and the control
portion of the papillary muscle.
26. The system of claim 25, wherein the support structure
comprises: an anchor support structure coupled between the first
anchor and the control portion of the papillary muscle; and a
papillary muscle support structure extending from the second anchor
to the control portion of the papillary muscle of the heart;
wherein the anchor support structure is independent from the
papillary muscle support structure.
27. A method for treating a diseased heart comprising: positioning
a first anchor in proximity to a diseased portion of a heart;
positioning a second anchor in proximity to a second portion of the
heart; adjusting the distance between the first anchor and the
second anchor while the heart is beating; monitoring an effect of
adjusting the distance between the first anchor and the second
anchor on the beating heart; and locking the distance between first
anchor and the second anchor.
28. The method of claim 27, wherein the diseased portion of the
heart is a heart valve; and wherein the second portion of the heart
is an exterior of the ventricular wall.
29. The method of claim 28, wherein monitoring an effect of
adjusting the distance between the first anchor and the second
anchor comprises monitoring valve regurgitation.
30. The method of claim 28 further comprising extending a support
structure between the first anchor and the second anchor; wherein
adjusting the distance between the first anchor and the second
anchor comprises adjusting the length of the support structure
between the first anchor and the second anchor.
31. The method of claim 28 further comprising: extending a support
structure from the first anchor before positioning the second
anchor; and extending the support structure to the second anchor
before adjusting the distance between the first anchor and the
second anchor; wherein adjusting the distance between the first
anchor and the second anchor comprises adjusting the length of the
support structure between the first anchor and the second
anchor.
32. The method of claim 31 further comprising fixing a first end of
the support structure to the first anchor before positioning the
second anchor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This Application is a continuation of U.S. patent
application Ser. No. 14/846,932 filed 7 Sep. 2015 (and issued as
U.S. patent Ser. No. 10/010/419 on 3 Jul. 2018), which is a
continuation of U.S. patent application Ser. No. 12/096,948 filed
24 Oct. 2008 (and issued as U.S. Pat. No. 9,125,742 on 8 Sep.
2015), which is a 35 USC .sctn. 371 US National Stage of
International Application No. PCT/US2006/062185 filed 15 Dec. 2006,
which claims priority to and the benefit of U.S. Provisional
Application No. 60/750,561 filed 15 Dec. 2005, all of which are
hereby incorporated by reference in their entirety as if fully set
forth below.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0003] The various embodiments of the present invention relate
generally to heart valve repair devices and methods, and more
particularly, to devices and methods capable of positioning and
controlling papillary muscles of an atrioventricular valve.
2. Description of Related Art
BACKGROUND
[0004] Cardiovascular disease accounts for nearly fifty percent of
deaths in both the developed world and in developing countries. The
risk of dying from heart disease is greater than the risk from AIDS
and all forms of cancer combined. Cardiovascular diseases cause
approximately 12 million deaths in the world each year. It is the
leading cause of death in the US, killing approximately 950,000
people each year. It also accounts for a significant amount of
disability and diminished quality of life. Indeed, approximately 60
million people in the US alone have some form of heart disease. A
great need, therefore, exists for the advancement of devices,
methods, systems, and procedures to cure, treat, and correct a wide
variety of forms of heart disease.
[0005] Normal heart function primarily relies upon the proper
function of each of the four valves of the heart, which allow blood
to pass through the four chambers of the heart. These four valves
have cusps or leaflets, comprised of fibrous tissue, which attach
to the walls of the heart. The four chambers of the heart include
the right atrium and left atrium, the upper chambers, and the right
ventricle and left ventricle, the lower chambers. The four valves,
controlling blood flow in and between the chambers, include the
tricuspid, mitral, pulmonary, and aortic valves. Heart valves are
complex structures that comprise moveable leaflets that open and
close the valve. For example, the mitral valve has two leaflets and
the tricuspid valve has three leaflets. The aortic and pulmonary
valves have three leaflets that are more aptly termed "cusps," as
they have a half moon shape.
[0006] The cardiac cycle involves the pumping and distribution of
both oxygenated and deoxygenated blood within the four chambers.
Oxygenated blood, enriched by the lungs, reenters the heart into
the left atrium or left upper chamber. The mitral valve, a one-way
inflow valve, then directs the oxygenated blood into the left
ventricle. The contraction of the left ventricle pumps the
oxygenated blood through the aortic valve, into the aorta, and into
the blood stream. When the left ventricle contracts the mitral
valve closes such that the oxygenated blood passes into the aorta.
Deoxygenated blood returns from the body via the right atrium. This
deoxygenated blood flows through the tricuspid valve into the right
ventricle. When the right ventricle contracts, the tricuspid valve
closes, and the deoxygenated blood is pumped through the pulmonary
valve. Deoxygenated blood is directed to the pulmonary vascular bed
for oxygenation, and the cardiac cycle repeats itself.
[0007] Mitral valve regurgitation is one the most prevalent heart
disease conditions, which has many levels of severity. After 55
years of age, some degree of mitral regurgitation is found in
almost 20% of men and women who have an echocardiogram. Mitral
valve regurgitation, or mitral regurgitation, is a condition in
which the mitral valve doesn't close tightly. It results from the
failure of the mitral valve leaflets to completely close when the
left ventricle contracts, resulting in the flow of blood back into
the left atrium due to an overworked left atrium. This allows blood
to flow backward in the heart which in turn can lead to serious
heart conditions such as congestive heart failure and serious heart
rhythm irregularities (arrhythmias). Mitral valve regurgitation is
also a progressive condition that, if not corrected, can be
fatal.
[0008] Also, approximately 40% of patients having some form of
surgery in an attempt to correct mitral valve regurgitation end up
with either 1+ or 2+ regurgitation measurements. While this may
result in improved regurgitation characteristics, the future for
these patients can involve additional surgery as their improved
regurgitation characteristics will typically degrade over time as
1+ or 2+ regurgitation can negatively affect heart valve
functionality.
[0009] The function of an atrioventricular valve, like the mitral
valve, involves the complex interaction of numerous components,
including the leaflets, chordae tendineae, and papillary muscles.
If one of the components or functions of the complicated
interaction fails, then mitral valve regurgitation can result. For
example, excess leaflet tissue, inadequate leaflet tissue, or
restricted motion of the leaflets can lead to mitral
regurgitation.
[0010] Techniques currently exist to assist in correcting the shape
of a mitral valve to control the geometries of mitral valve shape.
For example, one conventional technique includes surgically
reshaping the ventricle with extensive surgical manipulation.
Another conventional technique involves reshaping the geometry of
the annulus of the ventricle with a ring or other annuloplasty
device. Another conventional device is the Coapsys Device
manufactured by Myocor, Inc. (Maple Grove, Minn. USA) and described
in U.S. Pat. Nos. 6,332,893 and 7,077,862.
[0011] These conventional techniques, while serving their
respective purposes, do possess drawbacks. For example, certain of
these conventional techniques, can at times, require extensive
surgery which can increase possible associated risks to patients.
Also, these techniques do not utilize an atrioventricular valve's
papillary muscles to assist in reshaping valve geometry by apically
adjusting a papillary muscle to control valve regurgitation.
Further, these conventional devices do not enable fine tuning
adjustments to be made on a beating heart to control, reduce, and
eliminate blood regurgitation in atrioventricular valves.
[0012] Accordingly, there is a need for devices and methods to
control the position of papillary muscles relative to an annulus of
an atrioventricular valve. In addition, there is a need for devices
and methods to reposition a papillary muscle using a positioning
device to assist in controlling, reducing, and eliminating blood
regurgitation. Still yet, there is a need for devices and processes
enabling apical adjustability of positions between papillary
muscles and an annulus of an associated atrioventricular valve.
There is still yet a further need for devices and methods enabling
fine tuning adjustments to be made on a beating heart to control,
reduce, and eliminate blood regurgitation in atrioventricular
valves. It is to the provision of such papillary muscle positioning
devices, systems, processes, and methods that the various
embodiments of the present invention are directed.
BRIEF SUMMARY OF THE INVENTION
[0013] Embodiments of the present invention provide devices and
methods capable of controlling positioning of papillary muscles and
an annulus of an atrioventricular valve. According to some
embodiments, the present invention comprises methods, implants, and
tools enabling control of a relative position between papillary
muscles of an atrioventricular valve and an associated annulus to
aid in reshaping the geometry of the annulus to control, reduce,
and eliminate blood flow regurgitation. Some embodiments can be
used with an annuloplasty device, and other embodiments may not use
an annuloplasty device.
[0014] In an exemplary embodiment of the present invention a
papillary muscle system can comprise an exterior pad positionable
exterior a heart valve wall, a papillary muscle support structure
extending from the exterior pad to a control portion of a papillary
muscle of the heart, and a papillary muscle adjustment mechanism
proximate the exterior pad for lockably adjusting, while the heart
is beating, a distance between the exterior pad and the control
portion of the papillary muscle.
[0015] The system can further comprise an interior papillary muscle
pad proximate the control portion of the papillary muscle, wherein
the papillary muscle support structure extends from the exterior
pad to the interior papillary muscle pad, and wherein the papillary
muscle adjustment mechanism adjusts a distance between the exterior
pad and the interior papillary muscle pad.
[0016] The system can further comprise a first anchor configured to
fixedly connect to an in-situ heart valve situated in the heart
between a heart ventricle and atrium, wherein the papillary muscle
support structure extends from the exterior pad to the first
anchor, and wherein the adjustment mechanism additionally lockably
adjusts a distance between the first anchor and the control portion
of the papillary muscle.
[0017] The system can further comprise a first anchor configured to
fixedly connect to an in-situ heart valve situated in the heart
between a heart ventricle and atrium, and an anchor adjustment
mechanism proximate the first anchor configured to lockably adjust
a distance between the first anchor and the control portion of the
papillary muscle, wherein the papillary muscle support structure
extends from the exterior pad to the first anchor.
[0018] The system can further comprise a first anchor configured to
fixedly connect to an in-situ heart valve situated in the heart
between a heart ventricle and atrium, an anchor support structure
coupled between the first anchor and the control portion of the
papillary muscle, and an anchor adjustment mechanism proximate the
first anchor configured to lockably adjust via the anchor support
structure a distance between the first anchor and the control
portion of the papillary muscle.
[0019] The papillary muscle adjustment mechanism can comprise a
tension control member, and a tension member located between the
exterior pad and the tension control member, wherein the papillary
muscle support structure extends from the tension control member to
the control portion of the papillary muscle of the heart, and
wherein the distance between the exterior pad and the control
portion of the papillary muscle is adjustable via the tension
control member.
[0020] The papillary muscle support structure can further extend
through the exterior pad and the tension member, and tension in the
tension member is adjustable by the tension control member.
[0021] The papillary muscle support structure can extend through a
portion of the papillary muscle between the heart valve wall and
the control portion.
[0022] The papillary muscle support structure can have an exterior
pad end and a papillary muscle end, wherein the papillary muscle
end is cooperatively shaped to engage the control portion of the
papillary muscle.
[0023] The distance between the exterior pad and the control
portion of the papillary muscle, and the distance between the first
anchor and the control portion of the papillary muscle, can be
interpedently adjustable one from the another.
[0024] In another exemplary embodiment of the present invention a
papillary muscle system can comprise a first anchor configured to
fixedly connect to an in-situ heart valve situated in a heart
between a heart ventricle and atrium, a second anchor configured to
fixedly connect to at least one of a ventricular wall and a
papillary muscle of the heart, a support structure extending from
the first anchor to a control portion of a papillary muscle of the
heart, and from the control portion of the papillary muscle to the
second anchor, an anchor adjustment mechanism proximate the first
anchor configured to lockably adjust, while the heart is beating, a
distance between the first anchor and the control portion of the
papillary muscle, and a papillary muscle adjustment mechanism
proximate the second anchor to lockably adjust, while the heart is
beating, a distance between the second anchor and the control
portion of the papillary muscle.
[0025] The support structure can comprise an anchor support
structure coupled between the first anchor and the control portion
of the papillary muscle, and a papillary muscle support structure
extending from the second anchor to the control portion of the
papillary muscle of the heart, wherein the anchor support structure
is independent from the papillary muscle support structure.
[0026] In another exemplary embodiment of the present invention a
method for treating a diseased heart can comprise positioning a
first anchor in proximity to a diseased portion of a heart,
positioning a second anchor in proximity to a second portion of the
heart, adjusting the distance between the first anchor and the
second anchor while the heart is beating, monitoring an effect of
adjusting the distance between the first anchor and the second
anchor on the beating heart, and locking the distance between first
anchor and the second anchor.
[0027] The diseased portion of the heart can be a heart valve, and
wherein the second portion of the heart is an exterior of the
ventricular wall.
[0028] Monitoring an effect of adjusting the distance between the
first anchor and the second anchor can comprise monitoring valve
regurgitation.
[0029] The method can further comprise extending a support
structure between the first anchor and the second anchor, wherein
adjusting the distance between the first anchor and the second
anchor comprises adjusting the length of the support structure
between the first anchor and the second anchor.
[0030] The method can further comprise extending a support
structure from the first anchor before positioning the second
anchor, and extending the support structure to the second anchor
before adjusting the distance between the first anchor and the
second anchor, wherein adjusting the distance between the first
anchor and the second anchor comprises adjusting the length of the
support structure between the first anchor and the second
anchor.
[0031] The method can further comprise fixing a first end of the
support structure to the first anchor before positioning the second
anchor.
[0032] More generally, the present invention can be described as a
papillary muscle positioning device can comprise a first anchor, a
second anchor, and a support structure. The term anchor is at times
used synonymously with the term pad herein. The first anchor can be
configured to fixedly connect to an in-situ valve of a heart
ventricle, and the second anchor can be configured to fixedly
connect to a muscle wall of the valve. The support structure can be
configured to have an adjustable length and coupled to the first
anchor and second anchor. In this configuration, the length of
support structure can be adjusted to vary a distance between the
first anchor and the second anchor, which in turn can vary the
distance between the in-situ valve and the muscle wall.
[0033] A device embodiment of the present invention can also
include additional features. For example, the first anchor can be
an annuloplasty ring secured to an annulus of the valve. The second
anchor can penetrate the muscle wall at a papillary muscle to
enable the adjustable length support structure to vary a distance
between the papillary muscle and the first anchor. Still yet, a
device can further comprise one of an internal restraint disposed
within the valve or an external restraint disposed about an
exterior of the valve. These restraints can alter a lateral
position of the papillary muscle.
[0034] Still yet other features are also contemplated for devices
according to the present invention. For example, the support
structure can have a generally circular or generally square
cross-sectional shape. The first anchor and the second anchor can
comprise a lock to engage the support structure. The support
structure can comprise an internal locking region to enable the
length of the support structure to be locked of fixed. The first
anchor can be an annulus anchor comprising flexible arms that
extend at least partially around a perimeter of the annulus. The
first anchor can comprise a connection mechanism adapted to connect
to an annuloplasty device. And the support structure can comprise
interior corresponding threaded regions enabling the length of the
support structure to be adjusted.
[0035] Embodiments of the present invention also include methods to
position a papillary muscle. Broadly described, a method to control
a distance between a valve muscle and a valve annulus in a human
heart can comprise providing a device configured to be positioned
between a valve muscle and a valve annulus; disposing the device
between the valve muscle and the valve annulus; and adjusting a
length of the device to alter the distance between the valve muscle
and the valve annulus. A positioning method can also comprise
attaching the device to at least one of an annulus ring or a
papillary muscle. Another feature of a positioning method can
include rotating one end of the device relative to another end of
the device to adjust the length of the device.
[0036] Other method embodiments of the present invention can
include additional steps. For example, a method can comprise
flexing one end of the device relative to another end of the device
to adjust the length of the device. Also, a method can comprise
attaching the device to at least one exterior area proximate a
papillary muscle of the valve muscle or providing a tension member
to tension the valve muscle to change the shape of the valve
muscle. The valve muscle can be a papillary muscle having a tip,
and one end of the device can be attached to the tip of the
papillary muscle. Also, one end of the device can be attached
proximate the base of the papillary muscle and one end of the
device can be secured to at least a portion of the exterior of the
papillary muscle. The device can be provided with corresponding
internal locking members adapted to adjust the length of the device
according to some methods. And according to some methods, the
device can comprise multiple support structures each connected to a
separate papillary muscle. The multiple support structures can have
adjustable lengths to alter the distance between the valve muscle
and the valve annulus.
[0037] According to another embodiment of the present invention, a
papillary muscle position system can comprise a first support
structure and a first adjustment mechanism. The first support
structure can be coupled to a first papillary muscle and the first
adjustment mechanism can be coupled to the first support structure
to adjust the length of the first support structure to position the
first papillary muscle. A system can also comprise a second support
structure coupled to a second papillary muscle, and a second
adjustment mechanism coupled to the second support structure to
adjust the length of the second support structure to position the
second papillary muscle. A system can also include an annuloplasty
device coupled to an annulus of an atrioventricular valve and
coupled to the first and second adjustment mechanisms. In this
configuration, the first and second adjustment mechanisms can be
positioned proximate the annulus. Also, a system can comprise an
anchor disposed proximate the first papillary muscle. The anchor
can receive the first support structure so that the first support
structure is coupled to the first papillary muscle.
[0038] Other features are also contemplated according to additional
system embodiments. For example, an anchor can be attached to one
of the exterior of the first papillary muscle or beneath the first
papillary muscle on an exterior surface of an associated valve
wall. Also, the support structure can be a suture that is looped
about the first papillary muscle. In another configuration, the
first adjustment mechanism can comprise threaded components that
interact with each other to adjust a length of the first support
structure. One of the treaded components can be coupled to the
first support structure. Alternatively, the first adjustment
mechanism can comprise a pin to lockably engage the first support
structure to fix the length of the first support structure. The
first support structure can be a semi-rigid elongated rod that
flexes in a substantially unidirectional manner. And the first
support structure can house an internal security wire to secure the
first support structure according to some embodiments.
[0039] Still yet, other embodiments of the present invention
include additional method embodiments. According to other method
embodiments, a method to position a papillary muscle can comprise
coupling a first end of a support structure to a papillary muscle;
coupling a second end of the support structure proximate an annulus
of a valve; and adjusting the position of the papillary muscle in a
substantially apical direction with an adjustment device so that
the papillary muscle is positioned closer to the annulus. A method
can also comprise providing an anchor proximate the papillary
muscle, the anchor to receive the first end of the support
structure. A method can also include coupling the adjustment device
to an annuloplasty device coupled to the annulus. Another method
embodiment can comprise positioning the adjustment device proximate
at least one of the papillary muscle or the annulus. Compressing a
papillary muscle to alter at least one of the shape, position, or
length of the papillary muscle can also be included in a method
embodiment.
[0040] In yet another embodiment of the present invention, a
papillary muscle positioning device generally comprises a support
structure and an adjustment mechanism. The support structure can be
disposed between a papillary muscle and an annulus. The adjustment
device can lockably engage the support structure to alter the
length of the support structure and to fix the length of the
support structure at an altered length. The adjustment device can
be attached proximate to at least one of the annulus, an
annuloplasty device coupled to the annulus, the papillary muscle,
or disposed partially within the papillary muscle. Also, at least
one of the support structure or the adjustment device can comprise
threaded components. In this configuration, the threaded components
can interact with each other in response to an applied mechanical
force such that one of the threaded components can move relative to
and lockably engage the other threaded component.
[0041] Accordingly, it is an aspect of some embodiments of the
present invention to provide a cardiovascular implant to control
the geometry, size, and area of an annulus of an atrioventricular
valve and the relative position between papillary muscles and an
annulus of an atrioventricular valve.
[0042] Another aspect of some embodiments of the present invention
is to control the relative position between papillary muscles and
an annulus of an atrioventricular valve.
[0043] Another aspect of some embodiments of the present invention
is to provide a cardiovascular implant to control the apical
position between papillary muscles and an annulus of an
atrioventricular valve.
[0044] Other aspects according to some embodiments of the present
invention include providing a cardiovascular implant to control the
chordal force distribution of an atrioventricular valve or to
reduce the length of a papillary muscle.
[0045] Still yet other aspects according to some embodiments of the
present invention include providing a cardiovascular implant which
may be delivered percutaneously or thoracoscopically to control a
relative position between papillary muscles and an annulus of an
atrioventricular valve.
[0046] Still yet another aspect according to some embodiments of
the present invention includes providing a cardiovascular implant
that can be fine-tuned and adjusted on a beating heart to control,
reduce, and eliminate blood flow regurgitation.
[0047] These and other objects, features and advantages of the
present invention will become more apparent upon reading the
following specification in conjunction with the accompanying
drawing figures.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0048] FIG. 1 illustrates a perspective view of a mitral valve and
certain other components associated with a mitral valve.
[0049] FIG. 2 illustrates a spatial reference system based on
normal papillary muscle position that the inventors used during a
study of papillary muscle position.
[0050] FIG. 3 illustrates a device to control the position of
multiple papillary muscle including an annular ring according to
some embodiments of the present invention.
[0051] FIG. 4 illustrates a device to control the position of a
papillary muscle including an annulus support anchor according to
some embodiments of the present invention.
[0052] FIG. 5 illustrates a device to control the position of a
papillary muscle including an annular ring and an external
restraint according to some embodiments of the present
invention.
[0053] FIG. 6 illustrates a device to control a position of a
papillary muscle including a support that does not penetrate a
papillary muscle according to some embodiments of the present
invention.
[0054] FIG. 7 illustrates a device to control a position of a
papillary muscle including support structures having variable
lengths according to some embodiments of the present invention.
[0055] FIG. 8 illustrates a device to control a position of a
papillary muscle including internally threaded support structures
according to some embodiments of the present invention.
[0056] FIG. 9 illustrates yet another device to control a position
of a papillary muscle according to some embodiments of the present
invention.
[0057] FIG. 10 illustrates a device to control a position of a
papillary muscle including a compression force system according to
some embodiments of the present invention.
[0058] FIG. 11 illustrates a device to control a position of a
papillary muscle including another compression force system
according to some embodiments of the present invention.
[0059] FIG. 12 illustrates a logical flow diagram depicting a
method embodiment of the present invention capable of reforming an
atrioventricular valve by controlling position of an associated
papillary muscle.
DETAILED DESCRIPTION OF THE INVENTION
[0060] To facilitate an understanding of the principles and
features of the various embodiments of the invention, various
illustrative embodiments are explained below. Although exemplary
embodiments of the invention are explained in detail, it is to be
understood that other embodiments are contemplated. Accordingly, it
is not intended that the invention is limited in its scope to the
details of construction and arrangement of components set forth in
the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced or
carried out in various ways. Also, in describing the exemplary
embodiments, specific terminology will be resorted to for the sake
of clarity.
[0061] It must also be noted that, as used in the specification and
the appended claims, the singular forms "a," "an" and "the" include
plural references unless the context clearly dictates otherwise.
For example, reference to a component is intended also to include
composition of a plurality of components. References to a
composition containing "a" constituent is intended to include other
constituents in addition to the one named.
[0062] Also, in describing the exemplary embodiments, terminology
will be resorted to for the sake of clarity. It is intended that
each term contemplates its broadest meaning as understood by those
skilled in the art and includes all technical equivalents which
operate in a similar manner to accomplish a similar purpose.
[0063] Ranges may be expressed herein as from "about" or
"approximately" or "substantially" one particular value and/or to
"about" or "approximately" or "substantially" another particular
value. When such a range is expressed, other exemplary embodiments
include from the one particular value and/or to the other
particular value.
[0064] Similarly, as used herein, "substantially free" of
something, or "substantially pure", and like characterizations, can
include both being "at least substantially free" of something, or
"at least substantially pure", and being "completely free" of
something, or "completely pure".
[0065] By "comprising" or "containing" or "including" is meant that
at least the named compound, element, particle, or method step is
present in the composition or article or method, but does not
exclude the presence of other compounds, materials, particles,
method steps, even if the other such compounds, material,
particles, method steps have the same function as what is
named.
[0066] It is also to be understood that the mention of one or more
method steps does not preclude the presence of additional method
steps or intervening method steps between those steps expressly
identified. Similarly, it is also to be understood that the mention
of one or more components in a composition does not preclude the
presence of additional components than those expressly
identified.
[0067] The materials described as making up the various elements of
the invention are intended to be illustrative and not restrictive.
Many suitable materials that would perform the same or a similar
function as the materials described herein are intended to be
embraced within the scope of the invention. Such other materials
not described herein can include, but are not limited to, for
example, materials that are developed after the time of the
development of the invention.
[0068] FIG. 1 illustrates a mitral valve 100. As shown, the mitral
valve 100 includes a mitral annulus 105, an anterior mitral leaflet
110, a posterior mitral leaflet 115, chordae tendineae 120, and
medial and lateral papillary muscles 135, 140. Mitral annulus
refers to the elliptical region of the valve leaflet attachment
contiguous with the base of the left atrium. The mitral annulus 105
is composed of anterior mitral annulus 125 and a posterior mitral
annulus 130. The mitral annulus 105 is saddle shaped with the basal
portions of the saddle located medially and laterally. Attached to
the anterior mitral annulus 125 is the anterior mitral leaflet 110
and attached to the posterior mitral annulus 130 is the posterior
mitral leaflet 115. The regions where the anterior mitral leaflet
110 and the posterior mitral leaflet 115 meet are termed the
lateral commissure 145 and the medial commissure 150.
[0069] The various components of the mitral valve 100 depicted in
FIG. 1 control blood flow within a heart between the left atrium
and left ventricle of the heart. In a normal mitral valve, when the
atrial pressure exceeds the ventricular pressure, the valve
leaflets 110, 115 open in to the ventricle. When the ventricle
pressure increases, the leaflets meet and close, covering the area
of the valve annulus 105. Therefore, as shown in FIG. 1, the
anterior mitral leaflet 110 and the posterior mitral leaflet 115
will open during systole to allow blood to flow through the mitral
valve 100. Conversely, the anterior mitral leaflet 110 and the
posterior mitral leaflet 115 will overlap and close the mitral
valve 100 to prevent regurgitation, into the left atrium. As people
age and due to other factors, the mitral valve 100 and its
components can stop functioning correctly thereby allowing
regurgitation of blood.
[0070] As part of their discovery of the various embodiments of the
invention discussed herein, the inventors performed several
studies. These studies led the inventors to conclude that
controlling the position of papillary muscles of an
atrioventricular valve can enable an abnormal atrioventricular
valve to have normal functional characteristics. With respect to a
mitral valve, such normal functional characteristics include
improved closure between valve leaflets 110, 115 (or leaflet
malcoaptation) to help control, reduce, and eliminate regurgitation
between the left atrium and left ventricle of the heart. In
addition to discussing various embodiments of the present invention
below, certain of the inventor's study results and methodologies
are also provided to further explain concepts and details
associated with various embodiments of the present invention.
Discussion of Study Methodologies and Study Results
[0071] The inventors studied seven human and four porcine valves
using a left heart simulator with a standard atrial model.
Variations in chordal force and mitral regurgitation due to
papillary muscle displacement utilize a normal papillary muscle
position as a reference for the study. The papillary muscles were
displaced to eight different papillary muscle positions. FIG. 2
illustrates a spatial reference system based on normal papillary
muscle position that the inventors used during a study of papillary
muscle.
[0072] The reference for the displacements illustrated in FIG. 2 is
the normal papillary muscle position. All papillary muscle
displacements were symmetrical in the study; therefore, both
papillary muscles were displaced equally to reach each position.
All papillary muscle positions were constructed from 5 mm vectoral
displacements from the normal position in the apical, lateral, and
posterior directions in the study. Illustrated in FIG. 2 is a
displacement reference system 205 that shows the various
displacement positions used by the inventors in their studies. The
below table (TABLE I) summarizes the vectoral compositions of the
papillary muscles that the inventors used with the displacement
reference system 205 illustrated in FIG. 2.
TABLE-US-00001 TABLE I Papillary Muscle Displacement (millimeters)
Position Apical Lateral Posterior 000 0 0 0 005 0 0 5 050 0 5 0 055
0 5 5 500 5 0 0 505 5 0 5 550 5 5 0 555 5 5 5
[0073] During the cardiac cycle, the mitral valve is held within a
very dynamic environment which is described by annulus
displacement, ventricular motion, and papillary muscle contraction.
Within this environment, the basal chords maintain a relatively
constant distance from the tips of the papillary muscles to the
annulus, aiming to maintain overall valve geometry and isolating
the motion of the leaflets from the surrounding environment
movement. The geometrical and anatomical construct of the mitral
valve must ensure that the chords controlling coaptation and
especially those involved in the appropriate sealing of the valve
are less sensitive to the changing environment. Therefore, the
intermediate chords are less sensitive to changes in papillary
muscle position than the basal chords, whereas the marginal chords
are the least sensitive of all chordal types to papillary muscle
position variations.
[0074] These characteristics were clearly shown by the standard
deviations of the forces of the chords when different papillary
muscle positions were compared. In addition, the direction of
displacement of the papillary muscles was directly related to which
chord type presented altered tensions. For example, apical
displacement affected tension on the secondary chords of both
leaflets, whereas posterior displacement tended to reduce the force
on chords which inserted into the posterior leaflet. The tensions
on chords which inserted near the annulus were affected by
displacement of the papillary muscles in all directions. Apical
displacement significantly increased the tension present on the
anterior strut chord. When the papillary muscles are displaced
apically, the coaptation geometry of the mitral valve changes.
Thus, apical displacement generates tented leaflet geometries, and
under a tented geometry, the intermediate chords restrict leaflet
motion.
[0075] The study results for the anterior strut chord showed that
as apical displacement of the papillary muscles tented the leaflets
and significantly increased the load the anterior strut chord. The
decrease in force when repositioning the papillary muscles from
position 500 to position 505 was probably related to a
redistribution of the load between chords. Posterior papillary
muscle displacement decreased the tension on the posterior
intermediate chord by approximately 37%. This papillary muscle
relocation shifted the coaptation line posteriorly, reducing the
area of the orifice covered by this leaflet and decreasing the
insertion angle of this chord. Both changes reduced the resultant
force vector. The increase in tension associated with position 500
is explained by the same tenting described for the anterior strut
chord.
[0076] Combined apical-lateral displacement induced a significant
increase in tension due to tenting of the leaflet and the
stretching and redirection of the posterior intermediate chord.
This effect was reduced in position 555 because of the posterior
motion associated with this position. The force on the anterior
marginal chord and posterior marginal chord was relatively
homogeneous for the different papillary muscle positions. As the
marginal chords control coaptation in the tip of the leaflet,
tension in them may be less sensitive to changes in papillary
muscle position as the mitral valve is designed to operate in a
highly dynamic environment. The tension on the posterior basal
chord was highly sensitive to papillary muscle displacement.
Posterior displacement reduced the tension on the posterior basal
chord as it redirected the angle of the chord. This motion reduced
the septal lateral component of force, and thus reduced the overall
resultant force. As chordae tendineae have a non-linear mechanical
response to elongation, apical displacement increased peak systolic
tension on the basal posterior chord because of pre-straining. A
pre-strained chord will be subjected to a higher tension for a
similar strain during coaptation. Lateral displacement of the
papillary muscles reduced the force on the basal posterior chord.
This reduction was probably due to a redistribution of the load
with other chords.
[0077] The commissural chord selected experiments inserted near the
annulus and below the septa lateral midpoint of the valve
(posterior section of the valve); therefore, trends in force
variation due to papillary muscle displacement were like those
present in the basal posterior chord. Similarly, pre-straining
increased the force on the basal posterior chord during apical
motion of the papillary muscles. In addition, both posterior and
lateral relocation of the papillary muscles decreased the force on
these chords. The relative contributions of these motions (lateral,
posterior) to the force on the commissural chord should be
different than the contributions to the force of the basal
posterior chord because of their different angle and location of
insertion on the valve.
[0078] Finally, positions associated with apical displacement (500,
505, 550, 555), showed clinically significant levels of mitral
regurgitation (>20%). Other positions associated with lateral or
posterior displacement of the papillary muscle did not induce
clinically relevant mitral regurgitation. Only position 505
associated with both lateral and posterior displacement showed an
increase in regurgitation.
[0079] The study results revealed the effects of papillary muscle
displacement on the peak systolic tension present on different
types of chordae tendineae. Apical motion increased peak systolic
tension on the secondary chords, whereas chords on the posterior
side of the valve were subject to a reduction in peak systolic
tension after posterior motion of the papillary muscles. Chords
which insert near the annulus were affected by lateral, posterior,
and apical displacement of the papillary muscles. The study results
also showed that variation in tension due to papillary muscle
relocation decreased with increasing distance of chordal insertion
from the mitral annulus. Chords which insert near the annulus are
the most sensitive to variations in papillary muscle position,
whereas chords which insert into the tip leaflet are the least
sensitive to papillary muscle relocation. Additionally, mitral
regurgitation was associated with apical displacement of the
papillary muscles, and therefore may also be associated with
increased tension of the intermediate or basal chords.
[0080] A second study on papillary muscle displacement was designed
to elucidate the interaction between annular dilation and both
symmetrical and asymmetrical papillary muscle displacement. The
porcine mitral valves mounted in a normal sized annulus and in a
normal papillary muscle position closed efficiently, with a central
coaptation length of approximately 15.8.+-.2.1 mm, and without
echodetectable mitral regurgitation. With dilated mitral annuli
and/or displaced papillary muscles, regurgitation occurred. The
measured central coaptation lengths decreased with annular dilation
and papillary muscles displacement. Coaptation length reached its
minimum value of approximately 0.4.+-.0.5 mm while using the large
annulus and under symmetrical papillary muscle displacement.
[0081] Mitral regurgitation volume increased with annular dilation
and papillary muscle displacement. The volume reached approximately
18.5.+-.10.2 ml with the large annulus under symmetrical papillary
muscle displacement. Regurgitation volume correlated with central
coaptation length (r=approximately 0.71). Asymmetric tethering of
the posterior papillary muscle led to mitral regurgitation volumes
of approximately 4.1.+-.1.9; 12.4.+-.4.3; and 20.1.+-.12.5 ml for
the normal, medium, and large annuli, respectively. Asymmetric
anterior papillary muscle tethering led to regurgitation volumes of
approximately 3.6.+-.1.8; 10.5.+-.3.5; and 19.6.+-.9.9 ml for the
normal, medium, and large annuli, respectively.
[0082] Increased distance between the anterior and posterior annuli
in the dilated mitral annular model decreased leaflet coaptation
length, shifting the coaptation line towards the edges of the
leaflets. This describes how a larger orifice must be covered by
the same amount of tissue; therefore, the overlapping of the
leaflets is reduced. Clinical observations of extensive left
ventricular infarction, or left ventricular dilation, have shown
that both papillary muscles move in the radial direction away from
the center of the left ventricle. The apical posterior lateral
papillary muscle displacement performed in the inventor's study
simulated this condition. Indeed, apical displacement was
restricted by the chordae tendineae because of their stiffness.
This is consistent with measurements by others, who observed that
the distance between the tips of the papillary muscle and the
mitral annulus is relatively constant. Both the anterior and
posterior mitral leaflets were restricted during systole with
symmetrical papillary muscle displacement.
[0083] Symmetrical papillary muscle displacement induced the
coaptation line to shift towards the ventricle parallel to the
annulus plane and produced leakage gaps and regurgitation in the
central region of the valve. This is like the phenomenon observed
in patients with extensive myocardial infarction, where the area of
the roots of both papillary muscles may be affected, leading to
subsequent relocation. Regional myocardial infarction produces
local effects which may result in uneven papillary muscle
displacement, especially if the area affected involves only one of
the papillary muscles. Asymmetric papillary muscle displacement
restricted leaflet motion on the tethered side of the valve.
Commissural leaflets appeared to be more affected by papillary
muscle displacement, because they are shorter than the posterior
and anterior leaflets and are therefore characterized by a smaller
coaptation area. With a dilated annulus and under papillary muscle
tethering, the commissural leaflets decreased their coaptation area
and developed leakage gaps. Furthermore, tethering only one
papillary muscle (i.e., asymmetric tethering) led the commissural
leaflet on the opposite side of the valve to bulge towards the
atrium during systole, because of relative slackness in the chordae
tendineae in this area of the valve.
[0084] These observations, which describe irregular tenting and
bulging of the leaflets, are consistent with observations in
experiments using an in-vivo ovine model of acute infarction of the
posterior left ventricular wall. Increased tension on one
commissural side leads to an uneven coaptation with off-centered
gaps and consequently significant mitral regurgitation on the
tethered side of the valve, which is also consistent with clinical
observations, where the regurgitation Jets were found on the side
of the infarction. Ischemic myocardial infarction may also restrict
anterior leaflet motion and generated posterior leaflet
prolapse.
[0085] Leaflet geometry during valve closure was affected by
annular dilation and papillary muscle position. Symmetrical
papillary muscle displacement caused leakage gaps in the central
region of the coaptation line and subsequent regurgitation.
Asymmetric papillary muscle tethering caused tethered side leakage
gaps and moderate to severe regurgitation. Tenting and bulging of
the commissural leaflets generated vulnerable points for mitral
regurgitation under these conditions. In general, under similar
conditions of annular dilation asymmetric papillary muscle
displacement induced larger regurgitation volumes than symmetric
papillary muscle displacement.
[0086] In summary, the inventor's studies showed that papillary
muscle displacement are associated with mitral regurgitation.
Increased annular area reduces leaflet coaptation resulting in
regurgitation. In addition, papillary muscle displacement can
produce leaflet malcoaptaion and subsequent regurgitation. The
inventors also found that the regurgitation due to papillary muscle
displacement was more severe when the papillary muscles are
displaced asymmetrically. The inventors also discovered that apical
displacement is an important determinant of regurgitation due to
papillary muscle displacement.
[0087] Apical displacement affects the tension on the intermediate
chords restriction leaflet motion. Thus, controlling papillary
muscle position was found to be a factor to correct mitral
regurgitation. Considering that there is a constant distance
between the commissural areas of the annulus and papillary muscles,
this distance can be controlled by the below discussed various
embodiments of the present invention to restore normal valve
functions to an abnormal functioning atrioventricular valve.
[0088] Turning now specifically to the other figures, FIG. 3
illustrates a device 300 that includes papillary muscle support
structures to control papillary muscle position according to some
embodiments of the present invention. The device 300 is configured
to enable control of a distance along line L between the annulus
and the tip of the papillary muscles. The distance along line L is
at times referred to herein as the apical distance between
papillary muscles and an associated atrioventricular valve.
[0089] As shown in FIG. 3, the device 300 has various components.
These components can include an annuloplasty device 305, a first
support structure 310, a second support structure 315, a first
papillary muscle pad 320, a second papillary muscle pad 325, a
first ventricle wall pad 330, and a second ventricle wall pad 335.
As shown, the two support structures 310, 315 are disposed and
coupled between the annuloplasty device 305 and a respective
papillary muscle pad and ventricle pad. More specifically, the
first support structure 310 is coupled between the annuloplasty
device 305, and the first papillary muscle pad 320 and the first
ventricle wall pad 330. Similarly, the second support structure 315
is coupled between the annuloplasty device 305, and the first
papillary muscle pad 325 and the first ventricle wall pad 335. As
discussed below in greater detail, other embodiments may utilize a
single support structure, may not include an annuloplasty device,
or may utilize different mechanisms to attach to an annuloplasty
device and a papillary muscle.
[0090] Preferably the device 300 enables the support structures
310, 315 to move so that the length of line L can vary. For
example, the papillary muscle pads 320, 325 and the ventricle wall
pads 330, 335 can be adapted to enable movement of the support
structures 310, 315 such that the length of the support structures
can be adjusted or varied. According to some embodiments, one or
both papillary muscle pads 320, 325 and ventricle wall pads 330,
335 can include locking mechanisms or other pressure mechanisms to
enable the distance between a papillary muscle and an annulus to be
adjusted and fixed at a certain length. For example, the pads can
comprise a clamping or pin mechanism that will fix the support
structures 310, 315 in a static position. The movement of the
papillary muscle relative to the annulus can alter or change the
geometric shape of valve leaflets to control, reduce, and eliminate
regurgitation.
[0091] The annuloplasty device 305 can have various
characteristics. Indeed, according to some embodiments, the
annuloplasty device 305 can have a proximal ring 307. The proximal
ring 307 may be rigid, flexible, complete, partial, or comprise
multiple links. The proximal ring 307 may also be constructed of a
biocompatible material or of a non-biocompatible material covered
by a biocompatible layer. For example, the proximal ring 307 may be
constructed of a biocompatible metal or biocompatible polymer. The
proximal ring 307 may be covered by a suturing layer which will
allow it to be attached using sutures to the annulus. The proximal
ring 307 may be attached on or to the annulus of an
atrioventricular valve using clamps, hooks, sutures, or other
anchoring mechanisms.
[0092] As mentioned above, the support structures 310, 315 can be
coupled to the annuloplasty device 305 according to some
embodiments. The annuloplasty device 305 may permanently or
temporarily be coupled to or engage the support structure 310, 315.
For example, the support structures 310, 315 can be manufactured
integrally with the annuloplasty device 305 to form a unitary
device or the supports structures 310, 315 can be manufactured
separately from the annuloplasty device 305. For embodiments where
the support structures 310, 315 are not permanently coupled to the
annuloplasty device 305, the support structures 310, 315 can
include attachment members that enable the support structures 310,
315 to connect to any annuloplasty device. This advantageous
feature of certain embodiments of the present invention enables use
with an annuloplasty device already deployed or implanted within a
patient, or an annuloplasty device manufactured by a different
manufacturer. Alternatively, the support structures 310, 315 can
comprise clamps to enable the support structures 310, 315 to clamp
onto an annuloplasty device 305. Other techniques for coupling
support structures to an atrioventricular valve annulus or
annuloplasty device are discussed below.
[0093] The support structures 310, 315 of the device 300 can also
have various characteristics. As mentioned above, and as shown in
FIG. 3, the support structures 310, 315 can be connected to a
papillary muscle and the annuloplasty device 305. Alternatively,
the support structures 310, 315 may be connected between a
papillary muscle and an annulus of an atrioventricular valve or a
wall of an atrioventricular valve. The support structures 310, 315
may be an elongated rod, wire, suture, or many other similar
tension members. The support structures 310, 315 may be constructed
of numerous materials, including but not limited to, a
biocompatible metal, biocompatible polymer, biocompatible silk,
other biocompatible materials, collagen, bio-engineered chords, or
other bio-engineered materials. The support structures 310, 315 can
also be slidably coupled to or otherwise interact with the pads
320, 325, 330, 335 enabling the apical distance L to be adjusted
and fine-tuned after implantation of the device 300.
[0094] The pads 320, 325, 330, 335 of device 300 can have various
characteristics. More specifically, the papillary muscle pads 320,
325 preferably enable the support structures 310, 315 to pass
through (or penetrate) a papillary muscle so that the papillary
muscle is not damaged and so that the support structures 310, 315
do not entangle among the several chords associated with a
papillary muscle. As shown, the papillary muscle pads 320, 325 can
be attached or secured to a tip of a papillary muscle. In other
embodiments, the papillary muscle pads 320, 325 may have other
configurations that allow the papillary muscle pads 320, 325 to be
attached or secured along the exterior of or proximate the base of
a papillary muscle. An exemplary configuration can include a donut
shaped papillary muscle connection device. The ventricle wall pads
330, 335 preferably provide a support on the exterior of a
ventricle wall so that a support structure can be securedly affixed
to the ventricle wall pads 330, 335. The ventricle wall pads 330,
335 can have various lengths.
[0095] The pads 320, 325, 330, 335 of device 300 can connect to the
support structures 310, 315 in numerous configurations. According
to some embodiments, the attachment pads 320, 325, 330, 335 can
include an aperture for receiving the support structures 310, 315.
Such a configuration enables the support structures 310, 315 to
move relative to the attachment pads 320, 325, 330, 335 to enable
the apical distance L to be adjusted thereby controlling the
position of a papillary muscle relative to an associated
annuloplasty device or annulus.
[0096] FIG. 4 illustrates a device 400 to control the position of a
papillary muscle including an annulus support anchor according to
some embodiments of the present invention. As shown, device 400
generally includes an annulus anchor 405, a support structure 410,
and a papillary muscle attachment system 415. As shown, the annulus
anchor 405 is coupled to an annulus 420 of an atrioventricular
valve 425, and the papillary muscle attachment system 415 is
coupled to a papillary muscle 430 of the atrioventricular valve
420. The device 400 can enable the apical distance L between the
annulus 420 and the papillary muscle 430 to be adjusted thereby
controlling the geometrical shape of the annulus 420 and its
associated leaflets (not shown).
[0097] As shown, the support structure 410 is disposed between the
annulus 420 and the papillary muscle 430. In some embodiments, the
support structure 410 may directly anchor to the annulus 420 of the
atrioventricular valve 420 (without the need for an annuloplasty
ring) and in other embodiments, the support structure 410 can be
coupled to an annuloplasty ring. The annulus anchor 405 can be many
attachment mechanisms that enable the support structure 410 to be
fixedly secured to the annulus 405. For example, such attachment
mechanisms can include, but are not limited to, a single or a
plurality of hooks, clamping surfaces, or an umbrella type device.
Still yet, the annulus anchor 405 can have divergently extending
arm members, such as arm members 406, 407, that can extend at least
partially around the perimeter of the annulus 420. The arm members
406, 407 can have variable flexibilities to enable the support
structure 410 to attach at various places along the annulus 405 or
attach to various types of annuloplasty devices. The annulus anchor
405 may be permanently connected to the support structure 410 in
some embodiments or may be detachably affixed such that the annulus
anchor 405 and the support structure 410 can be detached and
reattached numerous times.
[0098] As shown, the support structure 410 is also connected to the
papillary muscle 430 via the papillary muscle attachment system
415. The papillary muscle attachment system 415 can comprise
multiple pads, such as a first pad 435 and a second pad 440,
enabling the papillary muscle attachment system 415 to be fixedly
secured to or encompass the papillary muscle 430. For example, the
first pad 435 and the second pad 440 can be sutured proximate the
papillary muscle 430. Alternatively, the pads 435, 440 may not be
secured directly to the papillary muscle 430 and may be slidably
coupled to the support structure 410. Still yet, one or more of the
pads can lockably engage the support structure 410 to a certain
length to adjust the apical distance between the annulus 420 and
the papillary muscle 430. This configuration can also enable the
pads 435, 440 to be axially moved along the axis of support
structure 410 to encompass the papillary muscle 430 to alter the
shape of the papillary muscle 430.
[0099] The papillary muscle system 415 preferably enables movement
of the papillary muscle 430 relative to the annulus 420. This
movement can adjust the apical distance L and enables the geometry
of the annulus to be altered in a manner to control, reduce, or
eliminate regurgitation that may be associated with
atrioventricular valve 425. The apical movement can occur in
various manners according to the various embodiments of the present
invention. For example, the section of the support structure 410
disposed between the annulus 420 and the papillary muscle 430 can
be adjusted by moving the first pad 435 and the second pad 440
along the axis of the support structure. The first pad 435 and the
second pad 440 can have interior apertures located within the first
pad 435 and the second pad 440 that allow the support structure 410
to slidably pass through the first pad 435 and the second pad 440.
Once the length of the support structure 410 has been adjusted to
an appropriate amount that corresponds to an optimal apical
distance modification, the pads 435, 440 can be used to fix the
support structure the appropriate amount. Although the movement of
the support structure 410 is discussed as movement based from the
papillary muscle 430 other embodiments may utilize movement based
from one or more of the annulus 420 and the annulus anchor 405.
[0100] One or both first pad 435 and the second pad 440 can also
have locking mechanisms. A locking mechanism enable the pads 435,
440 to lock at a certain point along the axis of the support
structure 410. Sample locking mechanisms can include, but are not
limited to, threaded screw devices, pin locking devices, detent
mechanisms, or many other mechanisms capable of applying pressure
to the support structure 410. Advantageously, the locking feature
enables the device 400 to be adjusted to fix the apical distance L
to provide an optimal change to the morphology of the annulus 420
thereby enabling specific control and position of the papillary
muscle 430 with respect to the annulus 420.
[0101] FIG. 5 illustrates a device 500 to control the position of a
papillary muscle according to some embodiments of the present
invention. The device 500 generally includes an annular ring 505, a
support structure 510, a papillary muscle attachment system 515,
and a restraint 520. While the restraint 520 is illustrated as an
external restraint (positioned outside a valve), the restraint 520
may also be an internal restraint positioned within a valve. For
brevity, certain details of the annular ring 505, the support
structure 510, and the papillary muscle attachment system 515 are
not discussed in detail with device 500 as these items can have
characteristics and details like the corresponding named components
discussed herein. As shown in FIG. 5, the annular ring 505 is
coupled to an annulus of a valve and the papillary muscle
attachment system 515 enables a support structure 510 extending
from the annular ring 505 to be fixedly attached to a papillary
muscle. The restraint 520 partially blocks from view the papillary
muscle attachment system 515 since the restraint 520 is an external
restraint.
[0102] The annular ring 505 can have various characteristics. For
example, the annular ring 505 may be a flexible ring, a rigid ring,
or a multilink ring. The annular ring 505 may be complete or
partial. Also, the ring 505 may have a saddle height to commissural
ratio between approximately 0% and approximately 30%. In one
preferred embodiment, the annular ring 505 can be composed of
titanium wire, stainless steel, Nitnol, other biocompatible metals,
or combinations thereof. In yet other embodiments, the annular ring
505 may be constructed of a biocompatible polymer. The annular ring
505 may be covered by a suturing cuff when coupled to an annulus of
a valve. The cuff material may be Dacron or other biocompatible
suture support polymers. The annular ring 505 may be attached to a
valve annulus through suture, clamps, titanium clips, hooks, or
many other anchoring mechanisms.
[0103] The annular ring 505, like rings of other embodiments, can
be deployed using a variety of methods. For example, the annular
ring 505 may be collapsed and delivered through a catheter
endovascularly or through a long arm thoracoscopically. The annular
ring 505, if partial, may be extended within a lumen of a catheter
during delivery. If the annular ring 505 is composed of a series of
links, it may be reversibly opened to deliver it using less
invasive (or minimally invasive) methods according to some
embodiments of the present invention.
[0104] The support structure 510 can also have a variety of
characteristics. For example, the support structure 510 can be
permanently attached to the annular ring 505. The support structure
510 can also be retractable and anchored onto the annular ring 505
through a latching, locking, or screw mechanism. Other mechanisms
to attach or couple the support structure 510 to the annular ring
505 include screws, clamping, knots, and clips. In one preferred
embodiment, the support structure 510 can be a single or a
plurality of elongated rods. The support structure 510 may be
rigid, flexible, straight, or curved. Additionally, the support
structure 510 may be formed of a single or plurality of component
materials. For example, the support structure 510 can be formed of
a plurality of thin metal wires. The support structure 510 can be
constructed using various materials, included but not limited to,
titanium, stainless steel, biocompatible alloys, biocompatible
polymers, GORE-TEX, silk, or other biocompatible materials.
[0105] As shown in FIG. 5, the device 500 includes a single support
structure 510 and use of an annular ring 505. It should be
understood, however, that other embodiments of the present
invention encompass using multiple support structures 510 and not
using an annular ring 505. For example, some embodiments comprise a
single or a plurality of biocompatible support structures 510 which
extend between a valve annulus and a papillary muscle or a
ventricular wall. Thus, one end a support structure 510 can
comprise an anchoring mechanism that can couple the support
structure 510 to a valve annulus. The anchoring mechanism may
comprise a series of hooks, clamps, expanding umbrella, or a memory
alloy mesh.
[0106] FIG. 5 also illustrates how the restraint 520 can be
provided around the exterior of an atrioventricular valve. The
restraint 520 can be used to help control the lateral distance
between papillary muscles (e.g., medial and lateral papillary
muscles) and in reshaping the exterior of a valve as it might grow
or expand. This lateral distance is labeled as line D.sub.PM in
FIG. 5. Controlling the lateral distance can assist in controlling
the apical distance between papillary muscles and an associate
valve annulus. A lateral distance control mechanism can also be
used in accordance with other embodiments of the present invention.
Other features of the restraint 520 can include restricting lateral
growth of a valve wall by applying a radially inward force to the
valve wall.
[0107] The restraint 520 can have additional characteristics. For
example, the restraint 520 can be attached at multiple points along
the exterior of a valve wall to control the distance between medial
and lateral papillary muscles. As mentioned above, the restraint
520 can also be provided internally within a valve such that it can
be disposed between medial and lateral papillary muscles. For
example, in one configuration, an internal restraint can be a
suture or other tension member that is coupled to the medial and
lateral papillary muscles or at positions along the valve wall
proximate the medial and lateral papillary muscles. The restraint
520 can be made from many materials, and can comprise one or more
materials, including but not limited to, polymer materials, a
metallic mesh, and cloth materials.
[0108] The restraint 520 can also have an adjustable length. For
example, the ends of the restraint 520 may be fixedly secured to
the papillary muscle attachment system 515. Adjustment of the
length of the restraint 520 can occur when one or both ends of the
restraint 520 are moved relative to the papillary muscle attachment
system 515 thereby having a cinching effect to decrease the lateral
distance DPM. Also, in some embodiments, the papillary muscle
attachment system 515 can comprise a locking or securing mechanism
enabling the length of the restraint 520 to be fixed after an
optimal length has been obtained. For example, a device can be at
least partially located within a papillary muscle to enable the
length of the restraint 520 to be adjusted and then clamped or
pinned to have a certain length.
[0109] FIG. 6 illustrates a device 600 to control a position of a
papillary muscle including a support structure that does not
penetrate a papillary muscle according to some embodiments of the
present invention. Generally, the device 600 comprises an annular
ring 605, a support structure 610, and a ventricle wall pad 615. In
this embodiment, the support structure 610 and the ventricle wall
pad 615 are adapted so that the papillary muscle 620 is not
penetrated by the support structure 610. Such a configuration may
be advantageous when penetration of a papillary muscle may not be
beneficial for a patient or when movement of a papillary muscle
with respect to the support structure 610 may cause the device 600
to function improperly.
[0110] Because of the placement of the support structure 610 around
the exterior of the papillary muscle 620, the shape of the
ventricle wall pad 615 can be modified. As shown in FIG. 6, the
ventricle wall pad 615 is shown to extend below the papillary
muscle 620 such that it cups the exterior valve wall proximate the
papillary muscle 620. Also, as shown, the ventricle wall pad 615
has a bottom end 625 that is curved to cup the exterior valve wall.
Such configuration of the ventricle wall pad 615 ensures that
pressure applied to the valve wall does not harm the valve wall or
papillary muscle 620 and sufficiently controls the position of the
papillary muscle 620.
[0111] As with other embodiments of the present invention, device
600 is preferably adapted so that the apical distance L between the
annular ring 605 and the papillary muscle 620 can be adjusted.
Adjusting this distance can occur by moving or sliding the
ventricle wall pad 615 along the axis of the support structure 610.
The ventricle wall pad 615, therefore, preferably includes a
locking mechanism that enables the ventricle wall pad 615 to lock
onto a certain point along the axis of the support structure 610.
This advantageous feature enables an optimal apical distance L to
be obtained after deployment of device 600. For example, after
device 600 is surgically deployed within a patient, the apical
distance L can be modified such that regurgitation can be reduced
or eliminated.
[0112] FIG. 7 illustrates a device 700 to control a position of a
papillary muscle using support structures having variable lengths
according to some embodiments of the present invention. Generally,
the device 700 comprises an annular ring 705, two support
structures 710, 711 and an attachment system 715. The support
structures 710, 711 are disposed between and coupled to the annular
ring 705 and the attachment system 715. As shown, the attachment
system is attached to papillary muscles 720. In other embodiments
the attachment system 715 can be coupled to a ventricular wall.
Also, the attachment system 715 may anchor to a ventricular wall by
being coupled to inner or outer surfaces of a ventricular wall. The
attachment system 715 may move axially along the length of the
support structures 710, 711 to control the apical distance L
between the papillary muscles 720 and the annulus ring 705.
[0113] The attachment system 715 can also comprise other
components. These components can include a tension member 725
disposed between opposing end members 730, 735. The end members
730, 735 can each comprise apertures to receive the support
structures 710, 711. This configuration enables the end members
730, 735 to compress the tension member 725 as the end members 730,
735 are moved along the axis of the support structures 710, 711.
Advantageously, this configuration can also restrict axial movement
of the papillary muscles 720 and/or can enable the length of the
papillary muscles 720 to be controlled. Such a configuration may be
desired if one of the papillary muscles 720 is damaged or does not
properly function. According to some embodiments, the position of
the attachment system 715 along the axis of the support structure
may also be controlled externally, or outside of the heart. For
example, a surgeon could insert an adjustment tool via minimally
invasive process into a patient (with a beating heart) and use the
tool to adjust, or fine tune, the length of the support structures
710, 711 to control and eliminate regurgitation.
[0114] In other embodiments, the attachment system 715 can be
controlled remotely via a remote adjuster outside of a patient's
body. Such a remote adjuster may transmit radio frequency signals,
microwave signals, or other non-visible energy to activate or
instruct the attachment system to adjust the length of one or more
of the support structures 710. Thus, the attachment system 715 may
comprise a signal receiver or transmitter to receive such
instructions or transmit status information to a remote adjuster
about the attachment system 715 or the patient. The attachment
system 715 can also be used to decrease or increase via remotes
means the length of the papillary muscles 720 by compressing the
tissue between the tip of the papillary muscle 720 and a
corresponding ventricular wall.
[0115] As mentioned above, the attachment system 715 may move
axially along the length of the support structures 710, 711. To
enable this advantageous feature, the attachment system 715 may
comprise adjustable and lockable mechanisms, such as a first
exterior pad 740 and a second exterior pad 742. As shown, the first
exterior pad 740 is disposed on the exterior wall of the
illustrated valve. The second exterior pad 742 has a first portion
that is disposed on the exterior wall of the illustrated valve and
a second portion that is partially disposed within the papillary
muscle.
[0116] As shown in the close-up illustrations of the pads 740, 742,
they have features enabling the pads 740, 742 to lockably engage
the support structures 710, 711. For example, the first pad 740 can
have a notched interior aperture to receive a detent member formed
on the support structure 710. An axial force applied to the support
structure 710 can move detent member of the support structure 710
along the notched interior aperture. Also, the second pad 742 can
have a pin clamp that lockably engages the support structure 711.
The pin clamp can have a shaft to receive the support structure and
a pin 743 that can be pushed toward and clamp the support
structure. As the pads 740, 742 illustrate, some embodiments of the
present invention can have support structure length adjustment
mechanisms proximate papillary muscles.
[0117] FIG. 8 illustrates a device 800 to control a position of a
papillary muscle using internally threaded support structures
according to some embodiments of the present invention. Device 800
generally comprises a first support structure 810, and a second
support structure 815. The device 800 may also comprise annular
saddle ring 805 in accordance with some embodiments of the
invention. The device 800 can be deployed in an atrioventricular
valve to control, reduce, and eliminate mitral regurgitation
associated with the atrioventricular valve by reducing the apical
distance between the atrioventricular valve's annulus and papillary
muscles. The annular saddle ring 805 can be sutured or otherwise
attached to the annulus, and the support structures 810, 815 can be
extended in a valve to the valve's papillary muscles. The support
structures 810, 815 can be coupled to the annular saddle ring 805
via clamps 815, 835 or many other anchoring or coupling mechanisms.
The support structures 810, 815 may be covered with a biocompatible
material (such as GORE-TEX) and pierce or penetrate through the
valve's papillary muscles and connect to exterior pads 820, 840
located outside of the valve's muscle wall.
[0118] The support structures 810, 815 can be adapted such their
lengths can be adjusted. Adjustment of the lengths of the support
structures 810, 815 can be utilized to vary the distance between
the annular saddle ring 805 and the exterior pads 820, 840.
Variation of this distance between the annular saddle ring 805 and
the exterior pads 820, 840 in turn modifies the apical distance
between the valve's annulus and papillary muscles. Apical distance
modification can result in reshaping the morphology and geometry of
the valve's annulus thereby enabling the leaflets of the annulus to
move closer together.
[0119] The support structures 810, 815 can have interiors that
enable the length of the support structures to be modified. For
example, support structure 810 can have an interior 830 with detent
members that enable movement and locking of the interior with
corresponding apertures when a force is applied to an axial force
interface member 825. For example, the axial force interface member
can be a suture or a wire and when subjected to an axial force, the
length of the support structure 810 can be reduced so that the
annulus saddle ring 805 and the exterior pad 820 are moved closer
together.
[0120] Similarly, support structure 815 can have a threaded
interior that enables rotation of one end of the support structure
815 to be rotated to adjust the length of the support structure
815. This threaded interior configuration 830 can enable the length
of the support structure 815 to be increased and decreased.
According to some embodiments, support structure 830 may have a
lever 845 at one end corresponding to pad 840 and rotation of the
lever 845 may cause the length of the support structure 815 to
change. In other embodiments, a screw can be used in the place of
the lever 845 and rotation of the screw can cause the length of
support structure 815 to be modified.
[0121] The support structures 810, 815 can also have certain
internal flexibility characteristics. For example, the support
structures 810, 815, as illustrated, can have internal spinal
structures that enable the support structures to flex inward toward
each other. Also, the support structures 810, 815 can have internal
spinal structures that do not permit the support structures to flex
away from each other. In other embodiments, the support structures
810, 815 can restrict lateral motion from one or more of the atrial
or ventricular sides within a heart's mitral valve. Such an
advantageous feature can, for example, aid in preventing growth of
a heart's ventricle valve wall thus enabling the support structures
810, 815 to assist in controlling the position of one or more
papillary muscles.
[0122] Exemplary internal spinal structures can comprise a
unidirectional bending structure. This type of bending structure
can comprise a plurality of internal components that taper away
from the non-flexing direction. By tapering in the direction of the
flexing direction, the internal spinal structures enable the
support structure 810, 815 to compress. In one configuration, the
plurality of internal components can generally have a triangular
shape. In another configuration, the internal components can have a
cross-section shaped as a "T". Advantageously, restricting the
support structure from flexing can aid in shaping a valve wall and
implanting the device 800 within a patient.
[0123] The support structures 810, 815 may also comprise internal
security characteristics. As the support structures 810, 815 may
fracture or break, a security wire may be disposed within the
support structures 810, 815. The security wire may transverse the
entire interior length of the support structures 810, 815.
Advantageously, a security wire can hold together or collocate any
fracture support structure 810, 815 pieces because they will be
disposed generally around the security wire.
[0124] FIG. 9 illustrates yet another device 900 to control a
position of a papillary muscle according to some embodiments of the
present invention. The device 900 enables adjustment of the
position of two papillary muscles of the mitral valve through the
atrium 901 with an adjustment tool 902. Generally, the device 900
comprises an annular ring 905 coupled to papillary muscles A, B via
sutures 915, 916 as shown in FIG. 9. The device 900 also comprises
adjustment mechanisms 909, 910, papillary muscle pad 920, and
ventricle wall pad 925. The adjustment mechanisms 909, 910 can be
used to adjust the length of the sutures 915, 916. Adjusting the
length of the sutures 915, 916 can change the position of the
papillary muscles A, B such that they are closer to the annular
ring 905 and the annulus of the mitral valve. The adjustment
mechanisms 909, 910 may be situated proximate the annulus, the
papillary muscles A, B, or both such that adjustment to the length
of the sutures 915, 916 can be performed in multiple locations.
[0125] In some embodiments, adjustment mechanisms 909, 910 may be
remotely adjusted from outside of the body. For example, a remote
adjuster (not shown) can be used to activate the adjustment
mechanisms 909, 910. The remote adjuster may transmit radio
frequency signals, microwave signals, heat energy, or other
invisible energy to the adjustment mechanisms 909, 910. The
adjustment mechanisms 909, 910 can receive such items and, in
response, automatically activate the adjustment mechanisms 909, 910
to adjust the length of the sutures 915, 916. Also, the adjustment
mechanisms 909, 910 may transmit status information outside of the
body to inform about the status of the patient, device 900,
adjustment mechanisms 909, 910, and/or the sutures 915, 916.
[0126] The components of device 900 can be implanted within a
mitral valve to reduce, control, and eliminate mitral valve
regurgitation. The annular ring 905 can be sutured to the annulus
of the mitral valve. The annular ring 905 can be used to change the
shape of the annulus and may not be used in all embodiments. The
adjustment mechanisms 909, 910 can be securedly coupled to the
annular ring 905. In this embodiment, the adjustment mechanisms are
clamped to the annular ring 905. The adjustment mechanism 909, 910
preferably include internal devices that enable the length of the
sutures 915, 916 to be altered. Also, as shown, both adjustment
mechanisms are located proximate the atrium of the illustrated
mitral valve so that they can be adjusted through the atrium. For
example, an adjustment tool 902 can be inserted through the atrium
901, as shown, to adjust the length of sutures 915, 916. Having the
adjustment mechanisms 909, 910 located proximate the atrium 901
advantageously enables access to the adjustment mechanisms 909, 910
during surgery or post-operative procedures. In other embodiments,
the adjustment mechanisms can be located proximate to one or both
papillary muscles A, B.
[0127] As shown in the close-up view of adjustment mechanism 910,
an adjustment mechanism according to certain embodiments of the
present can comprise various components. As shown, the adjustment
mechanism 910 can generally include a clamp 911, a housing 912, an
internal threaded bolt 913, and an internal thread nut 914. The
internal thread nut 914 can include attachment points so that the
suture 916 can be securedly attached to the adjustment mechanism
910. The clamp 911 enables the adjustment mechanism 910 to be
securedly attached to an annulus or annuloplasty device.
[0128] As shown, the housing 912 houses the internal threaded bolt
913 and the internal thread nut 914. The internal thread bolt 913
can be countersunk into the housing 912. The internal thread bolt
912 can also be rotatably affixed to the housing 912 so that the
internal thread bolt 919 can rotate within the housing 912. In this
exemplary embodiment, the internal threaded bolt 913 can have a
head to communicate with or that corresponds to adjustment tool
902. This enables the adjustment tool 902 to transfer a mechanical
torque force to the threaded bolt 913 for rotation of the threaded
bolt 913. The internal thread nut 914 can be disposed within the
housing. The internal thread nut 914 can be interlocked or in
communication with the internal thread bolt 913. As shown, the
internal thread nut can be situated proximate and between opposing
inner walls of the housing 912. Rotation of the internal thread
bolt 913 causes the internal thread nut 914 to move along the
length of the internal thread bolt 913. In some embodiments, the
internal thread nut 914 may be adapted to between approximately 0.1
centimeters to approximately 5 centimeters. Also, the internal the
internal thread bolt 913 and the internal thread nut 914 may have
very fine thread pitch counts to enable precise specific movements
thereby translating into very precise changes in the length of the
suture 916.
[0129] FIG. 9 also illustrates a specific placement of the
papillary muscle pad 920 which can be utilized in accordance with
some embodiments of the present invention. The papillary muscle pad
920 can be used to attach the suture 915 to papillary muscle A. The
papillary muscle pad 920, as shown, can be a collar-type device
situated proximately around the exterior of the base of papillary
muscle A. Alternatively, the papillary muscle pad 920 may be
located at other positions along the exterior of or at the tip of
papillary muscle A. In this embodiment, the papillary muscle pad
920 is in the interior of the mitral valve so that surrounding
areas of the heart are not affected, but in other embodiments, the
papillary muscle pad 920 may be located outside of the mitral valve
proximate papillary muscle A.
[0130] Device 900 also illustrates how a ventricle pad (ventricle
wall pad 925) may be disposed or positioned on the exterior of the
mitral valve according to some embodiments of the present
invention. Indeed, as shown, the ventricle wall pad 925 is along
the exterior of the mitral valve proximate papillary muscle B. The
ventricle wall pad 925 can be sutured or otherwise attached to the
exterior wall of the mitral valve at this position. Alternatively,
the ventricle wall pad 925 may be affixed in place via the suture
916. The ventricle wall pad 925 can have multiple apertures to
receive suture 916. Adjustment of the length of the suture 916 by
reduction can result in cinching effect on papillary muscle B by a
force applied to the ventricle wall pad 925. This cinching effect
along with a reduction in the length of the suture 916 can control
the apical position of the papillary muscle B and move the
papillary muscle B closer to the annulus of the mitral valve.
[0131] As shown in FIG. 9, the sutures 915, 916 generally couple
the annulus of the mitral valve to the papillary muscles A, B. More
specifically, the sutures 915, 916 connect the adjustment
mechanisms 909, 910 (which are coupled to the annulus) to the pads
920, 925 (which are coupled to the papillary muscles A, B). The
sutures 915, 916 are shown in a looped configuration, wherein the
sutures 915, 916 are looped around or through the pads 920, 925 and
the ends of the sutures 915, 916 are connected to the adjustment
mechanisms 909, 910. In other embodiments, the sutures 915, 916 may
not be looped. Alternatively, other support members can be used in
the place of or in concert with the sutures 915, 916, including,
but not limited, to wires, elongated rods, biocompatible metal,
biocompatible polymer, biocompatible silk, other biocompatible
materials, collagen, bio-engineered chords, or other bio-engineered
materials.
[0132] FIG. 10 illustrates a device 1000 to control a position of a
papillary muscle using a compression force according to some
embodiments of the present invention. The device 1000 generally
comprises an interior pad 1005, a support structure 1010, an
exterior pad 1015, a tension member 1020, and a tension control
member 1025. As shown, the interior pad 1005 can be proximate a tip
1030 of the papillary muscle 1035. The support structure 1010 can
extend from the interior pad 1005 through the papillary muscle 1035
to the exterior of a valve wall 1040. The exterior pad 1015 can be
positioned proximate the exterior of the valve wall 1040 and the
tension member 1025 can be disposed between the exterior pad 1015
and the tension control member 1025. The support structure 1010 can
be coupled to one surface of the interior pad 1005 and be placed
within apertures located within the exterior pad 1015 and the
tension control member 1025.
[0133] The length of papillary muscle 1035 can be controlled using
the device 1000. For example, tension control member 1025 can be
adjusted to move closer to the interior pad 1005 and such movement
can decrease the length of the support structure 1010 between
interior and exterior pads 1005, 1015. This decreased length in
turn can compress the papillary muscle 1035 in a manner that can
control the tip 1030 of the papillary muscle 1035 relative to an
associated annulus.
[0134] The device 1000 can have various applications according to
embodiments of the present invention. The device 1000 can be used
as a stand-alone device or in conjunction with a device such as
that illustrated in FIG. 4 with a single support structure. In such
a configuration, the devices 400, 1000 can form a system which can
compress a first papillary muscle to control the position of a
valve annulus in addition to apically adjusting a second papillary
muscle. The device 1000 can also be used to control the length or
shape of a papillary muscle in some embodiments.
[0135] FIG. 11 illustrates a device 1100 to control a position of a
papillary muscle using a compression force according to some
embodiments of the present invention. The device 1100 is similar in
operation to the device 1000 illustrated in FIG. 10, so for brevity
the same reference numerals are used in FIG. 11 for corresponding
features shown and described above with reference to FIG. 10. One
difference between FIG. 10 and FIG. 11 is that the support
structure 1010 in FIG. 10 penetrates the papillary muscle 1035 and
the support structure 1010 in FIG. 9 does not penetrate the
papillary muscle 1035. Rather, the support structure 1110 of device
1100 illustrated in FIG. 11 is positioned along the exterior of the
papillary muscle 1035. This configuration is beneficial and
advantageous because it may be desired when penetrating a papillary
muscle is not required. Also, this configuration may be desired to
assist in controlling a papillary muscle having reduced
functionality. The support structure 1110 of device 1100 can also
be different in that it can have an interior pad 1105 that curves
around the tip 1030 of the papillary muscle 1035 as shown in FIG.
11.
[0136] FIG. 12 illustrates a logical flow diagram depicting a
method 1200 embodiment of the present invention capable of
reforming a mitral valve by controlling position of an associated
papillary muscle. According to some method embodiments the complete
implant or partial sections may be delivered percutaneously, and in
other embodiments, the complete implant or partial sections may be
delivered thoracoscopically in a beating heart. Those skilled in
the art will understand that the method 1200 is only one method
embodiment of the present invention and that the method 1200 can
have various steps or be performed in various orders.
[0137] The method 1200 can initiate at 1205 during a surgical
operation being performed on a patient. The surgical operation may
be an open-heart surgery to fix or repair a patient's heart or to
correct regurgitation associated with an atrioventricular valve,
such as a mitral valve. In other embodiments, the surgical
operation may be performed utilizing minimally invasive techniques
in which surgical implants are inserted into a patient using
lumens. The method 1200 can continue at 1210 where a patient's
heart may be stopped and bypassed by a surgeon so that a papillary
muscle control device can be deployed or implanted within the
patient's heart. The method 1200 may also be performed on a beating
heart and in such an instance and bypass of the heart may not
occur.
[0138] Next, the papillary muscle control device can be deployed
within a patient's heart to control, reduce, and eliminate
regurgitation. The papillary muscle control device can be one of
the exemplary embodiments discussed above, such as those
illustrated in FIGS. 2-11. The papillary muscle control device may
be implanted in a variety of manners and the implantation may
depend on the utilized surgical procedure, health of the patient,
or other factors. For example, and according to the method 1200,
that papillary muscle control device may be attached (or anchored)
to at least one of a valve annulus or an annuloplasty device at
1215.
[0139] That is, in some embodiments, the papillary muscle control
device may be directly attached to a valve annulus, attached
directly to an annuloplasty device, or both. The papillary muscle
control device can be anchored using clamps, sutures, hooks,
crimps, or other coupling mechanisms. If attached to an
annuloplasty device, the papillary muscle control device may be
permanently coupled to the annuloplasty device or capable of being
attached and reattached to the annuloplasty device. Also, the
annuloplasty device may be pre-implanted within a patient or
implanted during the method 1200.
[0140] After the papillary muscle control device is connected to at
least one of a valve annulus or an annuloplasty device, the
papillary muscle control device can then be connected to at least
one papillary muscle at 1220. Connecting the papillary muscle
control device in this manner in turn couples at least one
papillary muscle to at least one of a valve annulus or annuloplasty
device at 1225. Advantageously, connecting the papillary muscle
control device in this manner can adjust or move a papillary muscle
to rectify abnormal movement of the papillary muscle. Indeed,
connecting the papillary muscle control device to a papillary
muscle enables the position of the papillary muscle to be
controlled and moved apically toward a valve annulus so that an
initial apical adjustment occurs at 1230. The inventors have
discovered that controlling the movement of a papillary muscle in
an apical direction can alter leaflet geometry.
[0141] The papillary muscle control device can have various
connection and functional characteristics. For example, the
papillary muscle control device can have multiple connection
structures. These multiple connection structures can enable
connection or coupling between a valve annulus and to two papillary
muscles. Also, the papillary muscle control device preferably
comprises connection structures capable of having adjustable
lengths. For example, the connection structures themselves can
incorporate multiple parts that interact to alter the length of the
connections structures (e.g., an interior threaded configuration).
Alternatively, the papillary muscle control device can have length
adjustment mechanism that adjust the apical distance between a
papillary muscle and valve annulus by movement along the length of
a support structure.
[0142] The length adjustment mechanism can interact with (e.g.,
slidably engage) a support structure so that the apical distance
can be varied to an optimal length. The optimal length may be the
length that eliminates regurgitation or controls regurgitation to a
sufficient amount. The length adjustment mechanism can also have a
locking mechanism (e.g., pin lock, detent member, or clamp) that
can fix the length of the support structure at the optimal length.
The length adjustment mechanism can be located proximate a valve
annulus, proximate a papillary muscle, or both according to the
various embodiments of the present invention. Thus, the length
adjustment mechanism can be utilized to adjust the length of a
support structure so that the apical distance between a papillary
muscle and valve annulus is modified to reduce regurgitation.
[0143] After implantation of the papillary muscle control device,
the surgical operation can be completed at 1235. If the surgical
operation required stopping of a patient's heart, then the
patient's heart can be restarted at this time. Preferably, the
patient's heart will then be allowed to operate for approximately
five minutes so that the function of the heart at this time can be
close to normal operation. After waiting, further adjustments can
be made to the papillary muscle control device at 1240. These
adjustments, for example, can be made as a surgeon analyzes Doppler
regurgitation results. Advantageously, this feature enables fine
tuning of the papillary muscle control device on a beating heart.
Also, this feature enables apical adjustment of a papillary muscle
in real time while monitoring regurgitation data to control,
reduce, or eliminate regurgitation.
[0144] These further adjustments can be made at any time
post-operation. For example, after waiting several minutes, a
surgeon can perform the adjustments. Alternatively, the adjustments
to the papillary muscle control device may occur days, months, or
years after successful conclusion of a surgery and after a patient
has healed. This would enable a surgeon to use minimally invasive
procedures to access the papillary muscle control device to alter
the length of a support structure thereby altering the apical
distance of a papillary muscle relative to a valve annulus. Thus,
adjustments to the papillary muscle control device can be repeated
at 1245 as needed to control heart valve regurgitation at 1245 to
complete method 1200 at 1250.
[0145] The embodiments of the present invention are not limited to
the particular exemplary embodiments, process steps, and materials
disclosed herein as such embodiments, process steps, and materials
may vary somewhat. Moreover, the terminology employed herein is
used for the purpose of describing exemplary embodiments only and
the terminology is not intended to be limiting since the scope of
the various embodiments of the present invention will be limited
only by the appended claims and equivalents thereof.
[0146] Numerous characteristics and advantages have been set forth
in the foregoing description, together with details of structure
and function. While the invention has been disclosed in several
forms, it will be apparent to those skilled in the art that many
modifications, additions, and deletions, especially in matters of
shape, size, and arrangement of parts, can be made therein without
departing from the spirit and scope of the invention and its
equivalents as set forth in the following claims. Therefore, other
modifications or embodiments as may be suggested by the teachings
herein are particularly reserved as they fall within the breadth
and scope of the claims here appended.
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