U.S. patent application number 13/049499 was filed with the patent office on 2011-07-07 for compliant cardiac support device.
This patent application is currently assigned to Mardil, Inc.. Invention is credited to Clifton A. ALFERNESS, James E. COX, Michael J. GIRARD, Donald F. PALME, II, Donald G. ROHRBAUGH, James Edward SHAPLAND.
Application Number | 20110166413 13/049499 |
Document ID | / |
Family ID | 24374006 |
Filed Date | 2011-07-07 |
United States Patent
Application |
20110166413 |
Kind Code |
A1 |
ALFERNESS; Clifton A. ; et
al. |
July 7, 2011 |
COMPLIANT CARDIAC SUPPORT DEVICE
Abstract
A jacket of biological compatible material has an internal
volume dimensioned for an apex of the heart to be inserted into the
volume and for the jacket to be slipped over the heart. The jacket
has a longitudinal dimension between upper and lower ends
sufficient for the jacket to surround a lower portion of the heart
with the jacket surrounding a valvular annulus of the heart and
further surrounding the lower portion to cover at least the
ventricular lower extremities of the heart. The jacket is adapted
to be secured to the heart with the jacket surrounding at least the
valvular annulus and the ventricular lower extremities. The jacket
is adjustable on the heart to snugly conform to an external
geometry of the heart and assume a maximum adjusted volume for the
jacket to constrain circumferential expansion of the heart beyond
the maximum adjusted volume during diastole and to permit unimpeded
contraction of the heart during systole.
Inventors: |
ALFERNESS; Clifton A.; (Port
Orchard, WA) ; ROHRBAUGH; Donald G.; (Minnetonka,
MN) ; SHAPLAND; James Edward; (Vadnais Heights,
MN) ; GIRARD; Michael J.; (Lino Lakes, MN) ;
PALME, II; Donald F.; (Princeton, MN) ; COX; James
E.; (Corcoran, MN) |
Assignee: |
Mardil, Inc.
Orono
MN
|
Family ID: |
24374006 |
Appl. No.: |
13/049499 |
Filed: |
March 16, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12752614 |
Apr 1, 2010 |
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13049499 |
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11144353 |
Jun 3, 2005 |
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12752614 |
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10716020 |
Nov 17, 2003 |
6902524 |
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11144353 |
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10279176 |
Oct 23, 2002 |
6682476 |
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10716020 |
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09593251 |
Jun 13, 2000 |
6482146 |
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10279176 |
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Current U.S.
Class: |
600/37 |
Current CPC
Class: |
A61F 2/2481 20130101;
Y10S 623/904 20130101 |
Class at
Publication: |
600/37 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. A device for treating a disease of a heart, the device
comprising: a jacket of flexible material formed with a base end
and an apex end and having an interior, said base end sized to be
placed over an apex of said heart and moved toward a base of said
heart for at least a portion of said heart to be received within
said interior; said material compliant for said jacket to conform
to an external geometry of said portion of said heart; said
material adapted for said jacket to exert a maximum pressure on
said heart less than 40 mm Hg.
2. A device according to claim 1 wherein said maximum pressure is a
pressure on said heart at end diastole.
3. A device according to claim 1 wherein said maximum pressure is
less than 20 mm Hg.
4. A device according to claim 3 wherein said maximum pressure is a
pressure on said heart at end diastole.
5. A device according to claim 1 wherein said material is adapted
for said jacket to exert a range of pressure on said heart of 2 mm
Hg to 40 mm Hg.
6. A device according to claim 1 wherein said jacket is sized for
said interior of said jacket to be smaller than an external
geometry of said heart prior to application of said device.
7. A device according to claim 1 wherein said material has a
compliance for said jacket to conform with an external shape of
said portion of said heart without application of forces on said
heart which would otherwise impair cardiac function.
8. A device according to claim 1 wherein said jacket is open at
said apex end.
9. A device according to claim 1 wherein said jacket is closed at
said apex end.
10. A device according to claim 1 wherein said material constructed
of a plurality of flexible elongated members interconnected to form
a jacket material.
11. A device according to claim 10 wherein said elongated members
are fibers formed of multiple filaments.
12. A device according to claim 10 wherein said elongated members
have a plurality of bends which straighten for said jacket to
expand.
13. A device according to claim 10 wherein said elongated members
are metal.
14. A device according to claim 13 wherein said metal is stainless
steel.
15. A device according to claim 13 wherein said metal is
titanium.
16. A device according to claim 10 wherein said elongated members
are coated.
17. The device according to claim 1 wherein said jacket is adapted
to constrain said heart from expanding beyond a maximum volume.
18. The device according to claim 1 wherein said jacket is
collapsible for placement through a minimally invasive surgical
instrument.
19. A method for treating a disease of a heart, the method
comprising: a. selecting a device including: i. a jacket of
flexible material formed with a base end and an apex end and having
an interior, said base end sized to be placed over an apex of said
heart and moved toward a base of said heart for at least a portion
of said heart to be received within said interior; ii. said
material compliant for said jacket to conform to an external
geometry of said portion of said heart; iii. said material adapted
for said jacket to exert a maximum pressure on said heart less than
40 mm Hg. b. placing said jacket on said heart with said material
surrounding at least the ventricles of said heart with said jacket
exerting no more than said maximum pressure.
20. A method according to claim 19 wherein said step of placing a
jacket includes covering a lower end of said heart.
21. A method according to claim 19 wherein said step of placing
said jacket includes leaving a lower end of said heart exposed.
22. A method according to claim 19 wherein said maximum pressure is
a pressure on said heart at end diastole.
23. A method according to claim 19 wherein said maximum pressure is
less than 20 mm Hg.
24. A method according to claim 23 wherein said maximum pressure is
a pressure on said heart at end diastole.
25. A method according to claim 19 wherein said placing includes
placing said jacket on said heart for said jacket to exert a range
of pressure on said heart of 2 mm Hg to 40 mm Hg.
26. A method according to claim 19 including sizing said jacket for
said interior of said jacket to be smaller than an external
geometry of said heart prior to application of said device.
27. A method according to claim 19 wherein said material has a
compliance for said jacket to conform with an external shape of
said portion of said heart without application of forces on said
heart which would otherwise impair cardiac function.
28. A method according to claim 19 wherein said material
constructed of a plurality of flexible elongated members
interconnected to form a jacket material.
29. A method according to claim 28 wherein said elongated members
are fibers formed of multiple filaments.
30. A method according to claim 28 wherein said elongated members
have a plurality of bends which straighten for said jacket to
expand.
31. A method according to claim 28 wherein said elongated members
are metal.
32. A method according to claim 31 wherein said metal is stainless
steel.
33. A method according to claim 31 wherein said metal is
titanium.
34. A method according to claim 28 wherein said elongated members
are coated.
35. The method according to claim 19 wherein said placing includes
placing said jacket on said heart for said jacket to constrain said
heart from expanding beyond a maximum volume.
36. A method according to claim 19 wherein said jacket is delivered
minimally invasively to said heart by collapsing said jacket into a
hollow minimally invasive surgical tool.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
12/752,614, filed Apr. 1, 2010, pending, which is a continuation of
application Ser. No. 11/144,353, filed Jun. 3, 2005, now abandoned,
which is a continuation of application Ser. No. 10/716,020, filed
Nov. 17, 2003, now U.S. Pat. No. 6,902,524, issued Jun. 7, 2005,
which is a continuation of application Ser. No. 10/279,176, filed
Oct. 23, 2002, now U.S. Pat. No. 6,682,476, issued Jan. 27, 2004,
which is a continuation of application Ser. No. 09/593,251, filed
Jun. 13, 2000, now U.S. Pat. No. 6,482,146, issued Nov. 19, 2002,
all of which are incorporated herein by reference in their entirety
and for all purposes.
FIELD OF THE INVENTION
[0002] The present invention pertains to a device and method for
treating heart disease. More particularly, the present invention is
directed to a method and device for treating congestive heart
disease and related valvular dysfunction.
BACKGROUND OF THE INVENTION
[0003] Congestive heart disease is a progressive and debilitating
illness. The disease is characterized by a progressive enlargement
of the heart.
[0004] As the heart enlarges, the heart is performing an increasing
amount of work in order to pump blood each heart beat. In time, the
heart becomes so enlarged the heart cannot adequately supply blood.
An afflicted patient is fatigued, unable to perform even simple
exerting tasks and experiences pain and discomfort. Further, as the
heart enlarges, the internal heart valves cannot adequately close.
This impairs the function of the valves and further reduces the
heart's ability to supply blood.
[0005] Causes of congestive heart disease are not fully known. In
certain instances, congestive heart disease may result from viral
infections. In such cases, the heart may enlarge to such an extent
that the adverse consequences of heart enlargement continue after
the viral infection has passed and the disease continues its
progressively debilitating course.
[0006] Patients suffering from congestive heart disease are
commonly grouped into four classes (i.e., Classes I, II, III and
IV). In the early stages (e.g., Classes I and II), drug therapy is
the commonly proscribed treatment. Drug therapy treats the symptoms
of the disease and may slow the progression of the disease.
Importantly, there is no cure for congestive heart disease. Even
with drug therapy, the disease will progress. Further, the drugs
may have adverse side effects.
[0007] Presently, the only permanent treatment for congestive heart
disease is heart transplant. To qualify, a patient must be in the
later stage of the disease (e.g., Classes III and IV with Class IV
patients given priority for transplant). Such patients are
extremely sick individuals. Class III patients have marked physical
activity limitations and Class IV patients are symptomatic even at
rest.
[0008] Due to the absence of effective intermediate treatment
between drug therapy and heart transplant, Class III and IV
patients will have suffered terribly before qualifying for heart
transplant. Further, after such suffering, the available treatment
is unsatisfactory. Heart transplant procedures are very risky,
extremely invasive and expensive and only shortly extend a
patient's life. For example, prior to transplant, a Class IV
patient may have a life expectancy of 6 months to one-year. Heart
transplant may improve the expectancy to about five years.
[0009] Unfortunately, not enough hearts are available for
transplant to meet the needs of congestive heart disease patients.
In the United States, in excess of 35,000 transplant candidates
compete for only about 2,000 transplants per year. A transplant
waiting list is about 8-12 months long on average and frequently a
patient may have to wait about 1-2 years for a donor heart. While
the availability of donor hearts has historically increased, the
rate of increase is slowing dramatically. Even if the risks and
expense of heart transplant could be tolerated, this treatment
option is becoming increasingly unavailable. Further, many patients
do not qualify for heart transplant for failure to meet any one of
a number of qualifying criteria.
[0010] Congestive heart failure has an enormous societal impact. In
the United States alone, about five million people suffer from the
disease (Classes I through IV combined). Alarmingly, congestive
heart failure is one of the most rapidly accelerating diseases
(about 400,000 new patients in the United States each year).
Economic costs of the disease have been estimated at $38 billion
annually.
[0011] Not surprising, substantial effort has been made to find
alternative treatments for congestive heart disease. Recently, a
new surgical procedure has been developed. Referred to as the
Batista procedure, the surgical technique includes dissecting and
removing portions of the heart in order to reduce heart volume.
This is a radical, new and experimental procedure subject to
substantial controversy. Furthermore, the procedure is highly
invasive, risky and expensive and commonly includes other expensive
procedures (such as a concurrent heart valve replacement). Also,
the treatment is limited to Class IV patients and, accordingly,
provides no hope to patients facing ineffective drug treatment
prior to Class IV. Finally, if the procedure fails, emergency heart
transplant is the only available option.
[0012] Clearly, there is a need for alternative treatments
applicable to both early and later stages of the disease to either
stop the progressive nature of the disease or more drastically slow
the progressive nature of congestive heart disease. Unfortunately,
currently developed options are experimental, costly and
problematic.
[0013] Cardiomyoplasty is a recently developed treatment for
earlier stage congestive heart disease (e.g., as early as Class III
dilated cardiomyopathy). In this procedure, the latissimus dorsi
muscle (taken from the patient's shoulder) is wrapped around the
heart and chronically paced synchronously with ventricular systole.
Pacing of the muscle results in muscle contraction to assist the
contraction of the heart during systole.
[0014] While cardiomyoplasty has resulted in symptomatic
improvement, the nature of the improvement is not understood. For
example, one study has suggested the benefits of cardiomyoplasty
are derived less from active systolic assist than from remodeling,
perhaps because of an external elastic constraint. The study
suggests an elastic constraint (i.e., a non-stimulated muscle wrap
or an artificial elastic sock placed around the heart) could
provide similar benefits. Kass et al., Reverse Remodeling From
Cardiomyoplasty In Human Heart Failure: External Constraint Versus
Active Assist, 91 Circulation 2314-2318 (1995).
[0015] Even though cardiomyoplasty has demonstrated symptomatic
improvement, studies suggest the procedure only minimally improves
cardiac performance. The procedure is highly invasive requiring
harvesting a patient's muscle and an open chest approach (i.e.,
stemotomy) to access the heart. Furthermore, the procedure is
expensive--especially those using a paced muscle. Such procedures
require costly pacemakers. The cardiomyoplasty procedure is
complicated. For example, it is difficult to adequately wrap the
muscle around the heart with a satisfactory fit. Also, if adequate
blood flow is not maintained to the wrapped muscle, the muscle may
necrose. The muscle may stretch after wrapping reducing its
constraining benefits and is generally not susceptible to
post-operative adjustment. Finally, the muscle may fibrose and
adhere to the heart causing undesirable constraint on the
contraction of the heart during systole.
[0016] German Utility Model Patent Application DE 295 17 393 U1
describes a pericardium prosthesis made from a biocompatible,
non-expansible material, or at least hardly expansible material
which surrounds the heart. While the pericardium prosthesis
prevents overexpansion of the wall of the heart, the action is
deployed suddenly when the volume of the heart reaches the volume
enclosed by the prosthesis. The sudden deployment may adversely
affect the heart.
[0017] PCT application WO 98/58598 describes an elastic pouch for
at least partially enveloping a heart. The elastic pouch always
exerts the same force, substantially irrespective of its expansion,
on the heart, so that the heart is always relieved of substantially
the same tension irrespective of its volume. The volume of the
pouch in the unexpanded state is smaller than the volume of the
heart at the stage of minimum filling, thereby ensuring that the
pouch is in contact with the heart in all stages of expansion.
While such a force may help eject blood during systole, such a
force could interfere with ventricle filling during diastole.
[0018] Commonly assigned U.S. Pat. No. 5,702,343 to Alferness dated
Dec. 30, 1997 (corresponding to PCT Published Application No. WO
98/14136) teaches a jacket to constrain cardiac expansion during
diastole. The present invention pertains to improvements to the
invention disclosed in the '343 patent.
SUMMARY OF THE INVENTION
[0019] According to a preferred embodiment of the present
invention, a method and device are disclosed for treating
congestive heart disease and related cardiac complications such as
valvular disorders. The invention includes a jacket of biologically
compatible material. The jacket defines an internal volume
dimensioned for an apex of the heart to be inserted into the volume
and for the jacket to be slipped over the heart. The jacket has a
longitudinal dimension between upper and lower ends sufficient for
the jacket to surround a lower portion of the heart preferably
between, or even including the valvular annulus of the heart and
the ventricular lower extremities. The jacket is adjustable on the
heart to snugly conform to an external geometry of the heart and
assume a maximum adjusted volume for the jacket to constrain
circumferential expansion of the heart beyond the maximum adjusted
volume during diastole and to permit unimpeded contraction of the
heart during systole.
[0020] The jacket is preferably constructed from a flexible
material having a multi-axial expansion less than about 30% when
said material is exposed to a load up to about 5 pounds per inch (9
Newtons per centimeter). More preferably, the expansion of the
material along a first axis is between about 30% and 40% when
exposed to a uniaxial load between about 0.1 pounds per inch (0.2
Newtons per centimeter) to about 0.5 pounds per inch (0.9 Newtons
per centimeter) with no lateral constraint and the expansion of the
material along a second axis perpendicular to the first axis of
said material is between about 20% and 30% when exposed to a
uniaxial load between about 0.1 pounds per inch (0.2 Newtons per
centimeter) to about 0.5 pounds per inch (0.9 Newtons per
centimeter) with no lateral constraint. Most preferably, the jacket
material is oriented such a that the first axis (i.e., the more
compliant direction) extends parallel to the longitudinal axis
(AA-BB) of the heart.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a schematic cross-sectional view of a normal,
healthy human heart shown during systole;
[0022] FIG. 1A is the view of FIG. 1 showing the heart during
diastole;
[0023] FIG. 1B is a view of a left ventricle of a healthy heart as
viewed from a septum and showing a mitral valve;
[0024] FIG. 2 is a schematic cross-sectional view of a diseased
human heart shown during systole;
[0025] FIG. 2A is the view of FIG. 2 showing the heart during
diastole;
[0026] FIG. 2B is the view of FIG. 1B showing a diseased heart;
[0027] FIG. 3 is a perspective view of a first embodiment of a
cardiac constraint device according to the present invention;
[0028] FIG. 3A is a side elevation view of a diseased heart in
diastole with the device of FIG. 3 in place;
[0029] FIG. 4 is a perspective view of a second embodiment of a
cardiac constraint device according to the present invention;
[0030] FIG. 4A is a side elevation view of a diseased heart in
diastole with the device of FIG. 4 in place;
[0031] FIG. 5 is a cross-sectional view of a device of the present
invention overlying a myocardium and with the material of the
device gathered for a snug fit;
[0032] FIG. 6 is an enlarged view of a knit construction of the
device of the present invention in a rest state;
[0033] FIG. 7 is a schematic view of the material of FIG. 6;
[0034] FIG. 8 shows a Force-Displacement plot of a material
suitable for use in the jacket of the invention;
[0035] FIG. 9 shows comparative Force-Displacement plots for
material suitable for use in the jacket of the invention, an
elastic material and a non-elastic material;
[0036] FIG. 10 is a Force-Strain plot of material suitable for use
in the jacket of the invention in which the load is exerted
uniaxially, along both a first axis and second axis of the fabric
and multiaxially;
[0037] FIG. 11 is a photograph of the material from FIG. 10. loaded
along the second axis of the material at points AC, BC, CC and
Dc;
[0038] FIG. 12 is a photograph of the material from FIG. 10 loaded
along the first axis of the material at points A.sub.L, B.sub.L,
C.sub.L and D.sub.L;
[0039] FIG. 13 is a photograph of a variety of materials;
[0040] FIG. 14 is a Force-Strain plot of the uniaxial compliance
for the materials shown in FIG. 13'
[0041] FIG. 15 is a Force-Strain plot of the multiaxial compliance
for the materials shown in FIG. 13'
[0042] FIG. 16 is an illustrative Stress-Strain plot showing a
linear elastic slope according to Hooke's Law;
[0043] FIG. 17 is an illustrative Stress-Strain plot showing the
area of resilience and the elastic limit of a material;
[0044] FIG. 18 is an illustration of a fiber in which the
overlapping filaments are substantially aligned with the fiber axis
F-F;
[0045] FIG. 19 is an illustration of a fiber in which the
overlapping filaments are not substantially aligned with the fiber
axis F-F;
[0046] FIG. 20 is an illustration of a fiber which is composed of
continuous filaments;
[0047] FIG. 21 is an example of a Force-Strain plot for a spherical
shaped heart with multiaxial loading of material suitable for use
in the jacket of the invention; and
[0048] FIG. 22 is an example of a Force-Strain plot for a
cylindrical shaped heart with uniaxial loading of material suitable
for use in the jacket of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0049] Congestive Heart Disease
[0050] With initial reference to FIGS. 1 and 1A, a normal, healthy
human heart H' is schematically shown in cross-section and will now
be described in order to facilitate an understanding of the present
invention. In FIG. 1, the heart H' is shown during systole (i.e.,
high left ventricular pressure). In FIG. 1A, the heart H' is shown
during diastole (i.e., low left ventricular pressure).
[0051] The heart H' is a muscle having an outer wall or myocardium
MYO' and an internal wall or septum S'. The myocardium MYO' and
septum S' define four internal heart chambers including a right
atrium RA', a left atrium LA', a right ventricle RV' and a left
ventricle LV'. The heart H' has a length measured along a
longitudinal axis AA'-BB' from an upper end or base B' to a lower
end or apex A'.
[0052] The right and left atria RA', LA' reside in an upper portion
UP' of the heart H' adjacent the base B'. The right and left
ventricles RV', LV' reside in a lower portion LP' of the heart H'
adjacent the apex A'. The ventricles RV', LV' terminate at
ventricular lower extremities LE' adjacent the apex A' and spaced
therefrom by the thickness of the myocardium MYO'.
[0053] Due to the compound curves of the upper and lower portions
UP', LP', the upper and lower portions UP', LP' meet at a
circumferential groove commonly referred to as the A-V groove AVG'.
Extending away from the upper portion UP' are a plurality of major
blood vessels communicating with the chambers RA', RV', LA', LV'.
For ease of illustration, only the superior vena cava SVC' and a
left pulmonary vein LPV' are shown as being representative.
[0054] The heart H' contains valves to regulate blood flow between
the chambers RA', RV', LA', LV' and between the chambers and the
major vessels (e.g., the superior vena cava SVC' and a left
pulmonary vein LPV'). For ease of illustration, not all of such
valves are shown. Instead, only the tricuspid valve TV' between the
right atrium RA' and right ventricle RV' and the mitral valve MV'
between the left atrium LA' and left ventricle LV' are shown as
being representative.
[0055] The valves are secured, in part, to the myocardium MYO' in a
region of the lower portion LP' adjacent the A-V groove AVG' and
referred to as the valvular annulus VA'. The valves TV' and MV'
open and close through the beating cycle of the heart H'.
[0056] FIGS. 1 and 1A show a normal, healthy heart H' during
systole and diastole, respectively. During systole (FIG. 1), the
myocardium MYO' is contracting and the heart assumes a shape
including a generally conical lower portion LP'. During diastole
(FIG. 1A), the heart H' is expanding and the conical shape of the
lower portion LP' bulges radially outwardly (relative to axis
AA'-BB').
[0057] The motion of the heart H' and the variation in the shape of
the heart H' during contraction and expansion is complex. The
amount of motion varies considerably throughout the heart Ht,
although the external dimension of the heart H' generally reduces
from about 4% to about 10% from end diastole to end systole. The
motion includes a component which is parallel to the axis AA'-BB'
(conveniently referred to as longitudinal expansion or
contraction). The motion also includes a component perpendicular to
the axis AA'-BB' (conveniently referred to as circumferential
expansion or contraction).
[0058] Having described a healthy heart H' during systole (FIG. 1)
and diastole (FIG. 1A), comparison can now be made with a heart
deformed by congestive heart disease. Such a heart H is shown in
systole in FIG. 2 and in diastole in FIG. 2A. All elements of
diseased heart H are labeled identically with similar elements of
healthy heart H' except only for the omission of the apostrophe in
order to distinguish diseased heart H from healthy heart H'.
[0059] Comparing FIGS. 1 and 2 (showing hearts H' and H during
systole), the lower portion LP of the diseased heart H has lost the
tapered conical shape of the lower portion LP' of the healthy heart
H'. Instead, the lower portion LP of the diseased heart H bulges
outwardly between the apex A and the A-V groove AVG. So deformed,
the diseased heart H during systole (FIG. 2) resembles the healthy
heart H' during diastole (FIG. 1A). During diastole (FIG. 2A), the
deformation is even more extreme.
[0060] As a diseased heart H enlarges from the representation of
FIGS. 1 and 1A to that of FIGS. 2 and 2A, the heart H becomes a
progressively inefficient pump. Therefore, the heart H requires
more energy to pump the same amount of blood. Continued progression
of the disease results in the heart H being unable to supply
adequate blood to the patient's body and the patient becomes
symptomatic insufficiency. In contrast to a healthy heart H', the
external dimension of the diseased heart H generally reduces from
about 4% to about 6% from end diastole to end systole.
[0061] For ease of illustration, the progression of congestive
heart disease has been illustrated and described with reference to
a progressive enlargement of the lower portion LP of the heart H.
While such enlargement of the lower portion LP is most common and
troublesome, enlargement of the upper portion UP may also
occur.
[0062] In addition to cardiac insufficiency, the enlargement of the
heart H can lead to valvular disorders. As the circumference of the
valvular annulus VA increases, the leaflets of the valves TV and MV
may spread apart. After a certain amount of enlargement, the
spreading may be so severe the leaflets cannot completely close (as
illustrated by the mitral valve MV in FIG. 2A). Incomplete closure
results in valvular regurgitation contributing to an additional
degradation in cardiac performance. While circumferential
enlargement of the valvular annulus VA may contribute to valvular
dysfunction as described, the separation of the valve leaflets is
most commonly attributed to deformation of the geometry of the
heart H. This is best described with reference to FIGS. 1B and
2B.
[0063] FIGS. 1B and 2B show a healthy and diseased heart,
respectively, left ventricle LV', LV during systole as viewed from
the septum (not shown in FIGS. 1B and 2B). In a healthy heart H',
the leaflets MVL' of the mitral valve MV' are urged closed by left
ventricular pressure. The papillary muscles PM', PM are connected
to the heart wall MYO', MYO, near the lower ventricular extremities
LE', LE. The papillary muscles PM', PM pull on the leaflets MVL',
MVL via connecting chordae tendineae CT, CT. Pull of the leaflets
by the papillary muscles functions to prevent valve leakage in the
normal heart by holding the valve leaflets in a closed position
during systole. In the significantly diseased heart H, the leaflets
of the mitral valve may not close sufficiently to prevent
regurgitation of blood from the ventricle LV to the atrium during
systole.
[0064] As shown in FIG. 1B, the geometry of the healthy heart H' is
such that the myocardium MYO', papillary muscles PM' and chordae
tendineae CT' cooperate to permit the mitral valve MV' to fully
close. However, when the myocardium MYO bulges outwardly in the
diseased heart H (FIG. 2B), the bulging results in displacement of
the papillary muscles PM. This displacement acts to pull the
leaflets MVL to a displaced position such that the mitral valve
cannot fully close.
[0065] Having described the characteristics and problems of
congestive heart disease, the treatment method and apparatus of the
present invention will now be described.
[0066] Jacket
[0067] In general, the device of the invention comprises a jacket
configured to surround the myocardium MYO. As used herein,
"surround" means that the jacket provides reduced expansion of the
heart wall during diastole by applying constraining surfaces at
least at diametrically opposing aspects of the heart. In some
preferred embodiments disclosed herein, the diametrically opposed
surfaces are interconnected, for example, by a continuous material
that can substantially encircle the external surface of the
heart.
[0068] With reference now to FIGS. 3, 3A, 4 and 4A, the device of
the present invention is shown as a jacket 10 of flexible,
biologically compatible material. As used herein, the term
"biologically compatible material" refers to material that is
biologically inert such that the material does not adversely affect
the surrounding tissue, for example, by eliciting excessive or
injurious rejection responses, inflammation, infarction, necrosis,
etc.
[0069] The jacket 10 is an enclosed material having upper and lower
ends 12, 14. The jacket 10, 10' defines an internal volume 16, 16'
which is completely enclosed but for the open ends 12, 12' and 14'.
In the embodiment of FIG. 3, lower end 14 is closed. In the
embodiment of FIG. 4, lower end 14' is open. In both embodiments,
upper ends 12, 12' are open. Throughout this description, the
embodiment of FIG. 3 will be discussed. Elements in common between
the embodiments of FIGS. 3 and 4 are numbered identically with the
addition of an apostrophe to distinguish the second embodiment and
such elements need not be separately discussed.
[0070] The jacket 10 is dimensioned with respect to a heart H to be
treated. Specifically, the jacket 10 is sized for the heart H to be
constrained within the volume 16. The jacket 10 can be slipped
around the heart H. The jacket 10 has a length L between the upper
and lower ends 12, 14 sufficient for the jacket 10 to constrain the
lower portion LP. The upper end 12 of the jacket 10 extends at
least to the valvular annulus VA and further extends to the lower
portion LP to constrain at least the lower ventricular extremities
LE.
[0071] The volume 16 defined by the jacket 10 is preferably
substantially the same size as or larger than the volume of the
heart H, in particular the lower portion LP of the heart, at the
completion of systolic contraction such that the jacket 10 exerts
no or only a slight pressure on the heart at end systole.
Preferably, the pressure on the heart at end systole is no more
than 10 mm Hg (1.3 kPa), more preferably no more than 5 mm Hg (0.66
kPa), most preferably no more than 2 mm Hg (0.27 kPa).
[0072] Generally, the jacket 10 is adjusted to a snug fit
encompassing the external volume of the heart H during diastole
such that the jacket 10 constrains enlargement of the heart H
during diastole without significantly assisting contraction during
systole. The amount of assistance during systole can be
characterized by the pressure exerted by the jacket 10 on the heart
H during systole. A jacket 10 that does not significantly assist
contraction during systole will not exert significant pressure on
the heart H at completion of systolic contraction.
[0073] If the enlargement of the external dimension of the heart H
is considered to be zero percent (0%) at completion of systole (end
systole) and one hundred percent (100%) at completion of diastole
(end diastole), the jacket 10 preferably exerts pressure between
about 4 mm Hg (0.53 kPa) and 40 mm Hg (5.3 kPa), more typically
between about 4 mm Hg (0.53 kPa) and 20 mm Hg (2.7 kPa) when the
enlargement of the external dimension of the heart is between 50%
and 100%. In contrast, when the enlargement of the external
dimension of the heart H is below 50%, it is preferred that the
jacket 10 exert a pressure between about 2 mmHg (0.27 kPa) and
about 20 mmHg (2.7 kPa), preferably no more than 10 mm Hg (1.3 kPa)
on the heart H. It is noted that a jacket 10 that exerts a higher
pressure (e.g., closer to 40 mm Hg (5.3 kPa)) at end diastole is
likely to exert a higher pressure (e.g., closer to 10 mm Hg (1.3
kPa)) at end systole than a jacket that exerts a lower pressure
(e.g., closer to 5 mm Hg (0.66 kPa)) at end diastole.
[0074] Since enlargement of the lower portion LP is most
troublesome, in a preferred embodiment, the jacket 10 may be sized
so that the upper end 12 can reside in the A-V groove AVG. Where it
is desired to constrain enlargement of the upper portion UP, the
jacket 10 may be extended to cover the upper portion UP.
[0075] Sizing the jacket 10 for the upper end 12 to terminate at
the A-V groove AVG is desirable for a number of reasons. First, the
groove AVG is a readily identifiable anatomical feature to assist a
surgeon in placing the jacket 10. By placing the upper end 12 in
the A-V groove AVG, the surgeon is assured the jacket 10 will
provide sufficient constraint at the valvular annulus VA. The A-V
groove AVG and the major vessels act as natural stops for placement
of the jacket 10 while assuring coverage of the valvular annulus
VA. Using such features as natural stops is particularly beneficial
in minimally invasive surgeries where a surgeon's vision may be
obscured or limited.
[0076] When the parietal pericardium is opened, the lower portion
LP is free of obstructions for applying the jacket 10 over the apex
A. If, however, the parietal pericardium is intact, the
diaphragmatic attachment to the parietal pericardium inhibits
application of the jacket over the apex A of the heart. In this
situation, the jacket can be opened along a line extending from the
upper end 12' to the lower end 14' of jacket 10'. The jacket can
then be applied around the pericardial surface of the heart and the
opposing edges of the opened line secured together after placed on
the heart. Systems for securing the opposing edges are disclosed
in, for example, U.S. Pat. No. 5,702,343, the entire disclosure of
which is incorporated herein by reference. The lower end 14' can
then be secured to the diaphragm or associated tissues using, for
example, sutures, staples, etc.
[0077] In the embodiment of FIGS. 3 and 3A, the lower end 14 is
closed and the length L is sized for the apex A of the heart H to
be received within the lower end 14 when the upper end 12 is placed
at the A-V groove AVG. In the embodiment of FIGS. 4 and 4A, the
lower end 14' is open and the length L' is sized for the apex A of
the heart H to protrude beyond the lower end 14' when the upper end
12' is placed at the A-V groove AVG. The length L' is sized so that
the lower end 14' extends beyond the lower ventricular extremities
LE such that in both of jackets 10, 10', the myocardium MYO
surrounding the ventricles RV, LV is in direct opposition to
material of the jacket 10, 10'. Such placement is desirable for the
jacket 10, 10' to present a constraint against enlargement of the
ventricular walls of the heart H.
[0078] After the jacket 10 is positioned on the heart H as
described above, the jacket 10 is secured to the heart. Preferably,
the jacket 10 is secured to the heart H through sutures. The jacket
10 is sutured to the heart H at suture locations S
circumferentially spaced along the upper end 12. While a surgeon
may elect to add additional suture locations to prevent shifting of
the jacket 10 after placement, the number of such locations S is
preferably limited so that the jacket 10 does not restrict
contraction of the heart H during systole.
[0079] To permit the jacket 10 to be easily placed on the heart H,
the volume and shape of the jacket 10 are larger than the lower
portion LP during diastole. So sized, the jacket 10 may be easily
slipped around the heart H. Once placed, the jacket's volume and
shape are adjusted for the jacket 10 to snugly conform to the
external geometry of the heart H during diastole. Such sizing is
easily accomplished due to the construction of the jacket 10. For
example, excess material of the jacket 10 can be gathered and
sutured S'' (FIG. 5) to reduce the volume of the jacket 10 and
conform the jacket 10 to the shape of the heart H during diastole.
Such shape represents a maximum adjusted volume. The jacket 10
constrains enlargement of the heart H beyond the maximum adjusted
volume while preventing restricted contraction of the heart H
during systole. As an alternative to gathering of FIG. 5, the
jacket 10 can be provided with other ways of adjusting volume. For
example, as disclosed in U.S. Pat. No. 5,702,343, the jacket can be
provided with a slot. The edges of the slot can be drawn together
to reduce the volume of the jacket.
[0080] The volume of the jacket can be adjusted prior to, during,
or after application of the device to the heart. In one embodiment,
the heart is treated with a therapeutic agent, such as a drug to
decrease the size of the heart, prior to application of the jacket.
In this embodiment, the therapeutic agent acts to reduce the
overall size of the heart prior to surgery, and the jacket is
thereafter applied to the reduced heart. Alternatively, the present
invention can be used to reduce heart size at the time of placement
in addition to preventing further enlargement. For example, the
device can be placed on the heart and sized snugly to urge the
heart to a reduced size. More preferably, the heart size can be
reduced at the time of jacket placement through drugs, for example
dobutamine, dopamine or epinephrine or any other positive inotropic
agents, or surgical procedure to reduce the heart size. The jacket
of the present invention is then snugly placed on the reduced sized
heart and constrains enlargement beyond the reduced size.
[0081] The jacket 10 is adjusted to a snug fit on the heart H
during diastole. Care is taken to avoid tightening the jacket 10
too much such that cardiac function is impaired. During diastole,
the left ventricle LV fills with blood. If the jacket 10 is too
tight, the left ventricle LV may not adequately expand and left
ventricular pressure will rise. During the fitting of the jacket
10, the surgeon can monitor left ventricular pressure. For example,
a well-known technique for monitoring so-called pulmonary wedge
pressure uses a catheter placed in the pulmonary artery. The wedge
pressure provides an indication of filling pressure in the left
atrium LA and left ventricle LV. While minor increases in pressure
(e.g., 1 mm Hg (0.13 kPa) to 3 mm Hg (0.40 kPa) can be tolerated,
the jacket 10 is snugly fit on the heart H but not so tight as to
cause a significant increase in left ventricular pressure during
diastole.
[0082] Furthermore, because the wall of the right ventricle RV
tends to be thinner than the wall of the left ventricle LV and the
pressure in the right ventricle RV tends to be lower than the
pressure in the left ventricle LV, the pressure exerted by the
jacket 10 on the heart H is preferably not greater than the end
diastolic pressure of the right ventricle RV. If the pressure
exerted by the jacket 10 is greater than the pressure of the right
ventricle RV, expansion and/or filling of the right ventricle RV
may be compromised. Generally, a jacket 10 that imposes between
about a 5% to about a 10% reduction in maximum diastolic volume
serves to reduce cardiac volume without compromising cardiac
function. Generally, excessive pressure exerted by the jacket 10 on
the heart H results in decreased cardiac output, increased central
venous pressure, and/or decreased systolic pressure.
[0083] The jacket 10 can be used in early stages of congestive
heart disease. For patients facing heart enlargement due to viral
infection, the jacket 10 permits constraint of the heart H for a
sufficient time to permit the viral infection to pass. In addition
to preventing further heart enlargement, the jacket 10 treats
valvular disorders by constraining circumferential enlargement of
the valvular annulus and deformation of the ventricular walls,
causing displacement of the papillary muscles PM and chordae
tendineae CT. Preventing displacement of these heart elements is
important for allowing the leaflets MVL to fully close.
[0084] The fabric 18 of the jacket 10 is preferably tear and run
resistant. In the event of a material defect or inadvertent tear,
such a defect or tear is restricted from propagation by reason of
the knit construction.
[0085] Material
[0086] Preferably the jacket 10 is constructed from a compliant,
biocompatible material. As used herein, the term "compliant" refers
to a material that can expand in response to a force. "Compliance"
refers to the displacement (in inches or centimeters) or strain
(inches/inch or cm/cm) per a unit load (in pounds or kilograms) or
load per unit width (in pounds per inch or kilograms per
centimeter) for a material. "Elasticity" refers to the ability of
the deformed material to return to its initial state after the
deforming load is removed.
[0087] The compliance of the device is influenced by the fabric
stitch and fabrication processing as well as interaction with the
tissue after implantation. The multiaxial expansion of the material
is generally less than about 30%, more typically less than about
25%, most typically between about 10% and 20% as the material is
exposed to a load up to about 5 pounds per inch (9 N/cm) more
typically between about 1 pound per inch (1.8 N/cm) and 3 pounds
per inch (5 N/cm). As used herein, the term "uniaxial expansion"
refers to the expansion of a material along only one axis. The term
"biaxial expansion" refers to the expansion of a material along a
first axis and a second axis, typically the second axis is
perpendicular to the first axis. The term "multiaxial expansion"
refers expansion of a material along at least a first and a second
axis and includes expansion along more than two axes.
[0088] The compliance of the material allows the jacket to be
implanted without gaps and an insignificant load at end diastole.
The compliance of the device along with the compliance of the heart
allows the device to conform nicely to the irregular and unique
shape of each heart.
[0089] FIG. 8 is a graph generated from data of a ball burst test
using a 1.75 inch diameter test area of sample material from the
jacket of the invention. The test was performed according to ASTM
D3787-89. According to this test, a ball is pressed against the
center of the material with a measured force. As the load on the
material is increased from 0 pounds (0 Newtons) to 36 pounds (160
Newtons), the material expands multiaxially. The initial part of
the curve, up to about 5 pounds (22 Newtons) and 0.30 in (0.76 cm)
deformation, has a shallow (somewhat horizontal) slope. As the load
is increased above 5 pounds (22 Newtons), the slope becomes more
steep (i.e., more vertical). At a load of just over 36 pounds (160
Newtons), the fabric reaches its load capacity and fails.
[0090] The force exerted by the heart during diastolic filling is
small, e.g., less than 5 pounds (22 Newtons) of equivalent burst
load. The normal diastolic load is more typically equivalent to a 1
to 3 pound (4 to 13 Newtons) ball burst load. Therefore, in use,
the multiaxial expansion of the jacket 10 material remains within
the shallow part of the curve. At maximum diastole, further
expansion of the heart is resisted by the increasing slope of the
compliance curve.
[0091] FIG. 9 compares the compliance of the jacket of the
invention with a pouch constructed from a non-compliant material,
such as described in DE 295 17 393 (Hohmann), and a pouch
constructed from an elastic material, such as described in PCT WO
98/58598 (Haindl).
[0092] Hohmann describes a pouch which is non-expansible. The pouch
described by Hohmann does not materially present a resisting force
during diastole nor does the pouch materially provide an assisting
force during systole. In FIG. 9, the Hohmann material is shown in
an idealized form where the pouch has no force on the heart ("zero
force region") until maximum diastolic filling, where the pouch
does not expand ("expansion limit").
[0093] Haindl describes a pouch that is smaller than the smallest
volume of the heart and exerts a constant force on the heart which
increases as the heart volume increases. As shown in FIG. 9, the
material of Haindl has a progressively increasing force on the
heart ("elastic region") until maximum diastolic filling, when the
pouch becomes inelastic ("inelastic region") preventing further
expansion.
[0094] In contrast to the pouch described by Hohmann, the material
used in the jacket of the invention is compliant rather than
elastic. In contrast to the pouch described by Haindl, the jacket
of the invention does not apply a significant or constant force on
the heart H throughout the cardiac cycle. Instead, the jacket 10 of
the invention generally applies a greater pressure (e.g., about 6
mm Hg (0.8 kPa) to about 36 mm Hg (4.8 kPa) more pressure) on the
heart at end diastole than at end systole.
[0095] Compliance
[0096] Generally, the jacket 10 material is formed from intertwined
fibers 20 which are made up of a plurality of filaments 30 (See,
e.g., FIGS. 6, 11 and 12). The compliance of the material may be
due to a variety of factors, including, but not limited to, the
compliance of the individual filaments 30 that make up the fibers
20, the relative movement of the filaments 30 within a fiber 20,
and/or the relative movement of the intertwined fibers 20 when
subjected to load.
[0097] Additionally, the compliance of the material may be affected
by the shape of the heart, the manner in which the jacket 10 is
fitted on the heart H and tissue fibrosis. Fibrosis tends to reduce
the acute compliance of the material by preventing the openings of
the fabric from geometrically changing shape.
[0098] The compliant nature of the jacket material can be easily
contrasted with elastomeric material. Whereas the compliant
material of the jacket preferably expands linearly up to about 30%
to 50%, and elastically up to 70% without undergoing significant
plastic deformation or failure, elastomeric material can be
stretched repeatedly to at least twice its original length (200%),
and upon release of the load, will return without force to its
approximate original length. Rubber and spandex are examples of
elastomeric materials. The force of the recoil depends upon the
density of the elastomeric fibers within the material.
[0099] Compliance due to the relative movement (e.g., geometric
deformation of the fabric openings) of the intertwined fibers 20
may be affected by the manner in which the fibers 20 are entwined.
For example, a knit material will tend to be more compliant than a
woven material because the loops of the knit are capable of
deforming (e.g., widening or lengthening) to accommodate applied
stress. In comparison, woven materials tend to have less elongation
unless elastomeric fibers are used. Knit material also tends to
recover well from deformation because the loops attempt to return
to their original positions. The looped configuration of the fibers
accommodates this recovery more readily than does the interwoven
configuration found in woven materials. The ease and quickness with
which elastic recovery takes place is also dependent on the fiber
composition. The fibers 20 of the jacket 10 material may be
entwined as a knit (for example, a warp knit) or as a weave.
Preferably, the fibers 20 of the jacket 10 material are entwined as
a knit.
[0100] Compliance due to the relative movement of the intertwined
fibers 20 can be observed by the deformation of the structure of
the fibers 20 within the material. Compliance can also be
characterized using MTS Sintech test equipment. At a given load,
the strain refers to the percentage increase in length of the
fabric in that direction with the load applied. Preferably, the
internal volume 16 of the jacket 10 is capable of multiaxial
expansion up to about 30%, more typically between about 10% and
20%, in response to a load or stress up to about 5 pounds per inch
(9 N/cm) without significant plastic deformation or failure.
[0101] FIG. 10 is a plot showing the uniaxial compliance along a
first axis and along a second axis perpendicular to the first axis
and the multiaxial compliance of a material suitable for use in the
jacket 10. The compliance parallel to the first axis of the fabric
is slightly greater than the compliance perpendicular to the first
axis (parallel to the second axis) of the fabric and the multiaxial
compliance is significantly lower than either uniaxial compliance.
Preferably, the first axis (with slightly greater compliance) is
oriented longitudinally round the heart and the second axis (with
slightly less compliance) is oriented circumferentially around the
heart.
[0102] As shown in FIG. 10, between 20% and 40% strain, the slope
of the compliance curve for the multiaxial case is 3 to 4 times
greater than either uniaxial compliance curve. However, between 70%
and 100% strain, the extrapolated multiaxial compliance curve slope
is only 1.3 to 1.4 times greater than either uniaxial compliance
curve. This indicates that the limiting stiffness of the fabric in
multiaxial or uniaxial loading is similar. However, strain to reach
that constraint is dependent upon loading direction.
[0103] Compliance due to the relative movement of the intertwined
fibers 20 under uniaxial tension with no lateral constraint is
depicted in FIGS. 11 and 12. FIG. 12 shows a knit exposed to a load
in the first uniaxial direction, again with no lateral constraint
(load is applied vertical with reference to the photograph). FIG.
11 shows the same knit exposed to a load in a second uniaxial
direction (perpendicular to the load in FIG. 12) with no lateral
constraint (load is applied horizontal with reference to the
photograph). A comparison of FIGS. 11 and 12 shows that the fabric
compliance along one axis (vertical with reference to the
photograph) of the fabric is greater than the compliance
perpendicular to that axis (horizontal with reference to the
photograph). Preferably, the uniaxial compliance along a first axis
(with no lateral constraint) is between about 30% and 40% when
exposed to a load between about 0.1 pounds per inch (0.2 N/cm) to
about 0.5 pounds per inch (0.9 N/cm); between about 40% and 50%
when exposed to a load between about 0.5 pounds per inch (0.9 N/cm)
to 1.0 pounds per inch (1.8 N/cm); and between about 50% and 60%
when exposed to a load between about 1.0 pounds per inch (1.8 N/cm)
and 1.5 pounds per inch (2.6 N/cm). Preferably, the uniaxial strain
along a second axis of the fabric (perpendicular to the first axis,
with no lateral constraint) is about 20% to about 30% when exposed
to a load between about 0.1 pounds per inch (0.2 N/cm) to about 0.5
pounds per inch (0.9 N/cm); about 30% and 40% when exposed to a
load between about 0.5 pounds per inch (0.9 N/cm) to about 1.0
pounds per inch (1.8 N/cm); and between about 40% and 50% when
exposed to a load between about 1.0 pounds per inch (1.8 N/cm) and
1.5 pounds per inch (2.6 N/cm).
[0104] Four locations (A, B, C and D) are identified on both
uniaxial curves in FIG. 10. These locations correspond
approximately to the loads applied to the fabric in the photos of
FIGS. 11 and 12. For both uniaxial directions, as the fabric load
increases from A.sub.C to D.sub.C and from A.sub.L to D.sub.L the
compliance curve is fairly flat. The load is predominantly
accommodated by linearization of filament 30 and fiber 20 crimp and
geometric distortion of the knit pattern. The photos in FIGS. 11
and 12 illustrate the distortion of the knit fabric as the openings
in the fabric collapse. For example, the looping configuration of a
warp knit allows the openings to collapse more along a first axis
(e.g., along the warp direction) as compared to a second axis,
perpendicular to the first axis (e.g., along the weft direction).
This is the reason for the slightly greater compliance in the warp
direction. Beyond points D.sub.C and D.sub.L, the fabric becomes
less compliant due to little remaining geometric distortion. The
compliance curves become linear and nearly parallel to each other
beyond about 80% strain. The compliance in this portion of each
curve is primarily due to the elongation of the poly(ethylene
terephthalate) (e.g., polyester) filaments in the fibers after the
filament crimp has been removed.
[0105] As shown in FIG. 10, multiaxial loading of the fabric causes
the fabric to be generally less compliant due to the inability of
the fabric to geometrically deform. The multiaxial compliance of
the jacket 10 material up to 12% strain is essentially linear. The
slight nonlinear portion of the curve is primarily due to yarn
crimp and tightening of the loops that form the geometric
structure. Beyond about 12% strain, the curve is linear and is
controlled by the elongation of the filaments within the fiber.
Generally, the slope of the compliance curve is 30% to 40% less
compliant than either of the uniaxial compliance curves.
[0106] Preferably, the knit is a so-called "Atlas knit" well known
in the fabric industry. The Atlas knit is described in Paling, Warp
Knitting Technology, p. 111, Columbine Press (Publishers) Ltd.,
Buxton, Great Britain (1970). The Atlas knit is a knit of fibers 20
having directional expansion properties. As shown in FIGS. 6, 11
and 12, the intertwined fibers 20 include a plurality of
longitudinally extending filaments 30, wherein opposing surfaces of
said multi-filament fibers 20 define a cell structure. The fibers
20 of the fabric 18 are woven into two sets of fiber strands 21a,
21b having longitudinal axes X.sub.a and X.sub.b. The strands 21a,
21b are interlaced to form the fabric 18 with strands 21a generally
parallel and spaced apart and with strands 21b generally parallel
and spaced apart.
[0107] For ease of illustration, fabric 18 is schematically shown
in FIG. 7 with the axis of the strands 21a, 21b only being shown.
The strands 21a, 21b are interlaced with the axes X.sub.a and
X.sub.b defining a diamond-shaped open cell 23 having diagonal axes
A.sub.m. In a preferred embodiment, the axes A.sub.m are 5 mm in
length when the fabric 18 is at rest and not stretched. The fabric
18 can stretch in response to a force. For any given force, the
fabric 18 stretches most when the force is applied parallel to the
diagonal axes A.sub.m. The fabric 18 stretches least when the force
is applied parallel to the strand axes X.sub.a and X.sub.b. The
jacket 10 is constructed for the material of the knit to be
directionally aligned for a diagonal axis A.sub.m to be parallel to
the heart's longitudinal axis AA-BB.
[0108] FIG. 6 illustrates the knit 18 in a rest state. FIGS. 11 and
12 illustrate a knit exposed to a variety of loads in a first
uniaxial direction (FIG. 12), or a second uniaxial direction (FIG.
11), perpendicular to the first uniaxial direction. The directional
compliance of the knit material is apparent from a comparison of
FIG. 11 and FIG. 12 (e.g., a load in one direction does not produce
the same strain as a load in the perpendicular direction).
[0109] FIG. 13 displays photographs of a variety of fabrics: (A) a
knit fabric (thickness: 0.018 in.) suitable for use in the jacket
of the invention; (B) a monofilament polypropylene mesh fabric
(thickness: 0.026 in.), commercially available under the name
Marlex (C. R. Bard, Inc., New Jersey); (C) a polyester mesh
(thickness: 0.008 in.), commercially available under the name Lars
Mesh (Meadox of Boston Scientific); (D) a stretch polyester fabric
(thickness: 0.027 in.), commercially available as Meadox from
Boston Scientific; and (E) a double velour material (thickness:
0.048 in.), commercially available under the name Cooley Double
Velour (Meadox of Boston Scientific). The results of uniaxial and
multiaxial compliance testing of these materials are shown in FIGS.
14 and 15, respectively.
[0110] In FIG. 14, the Marlex, Lars and double velour are less
compliant under uniaxial tension while the fabric with a uniaxial
compliance most similar to the material used in the jacket 10 of
the invention is the Meadox stretch polyester. It is slightly more
compliant than either uniaxial strains of the material used in the
jacket 10 at low stress. At high stress, the stretch polyester has
a compliance slope nearly parallel and offset by about 5% to the
right of the second axis uniaxial curve of the fabric used in the
jacket 10 of the invention.
[0111] The five fabrics were also tested under multiaxial loading
and the compliance is plotted in FIG. 15. Under multiaxial loading
the Meadox stretch polyester shows the greatest compliance. The
slope of the curve at about 12% strain is nearly four times greater
for the fabric used in the jacket 10 of the invention than the
slope for the stretch polyester. The multiaxial compliance of the
other three commercial fabrics are again much stiffer and nearly
indistinguishable from one another. They all have compliance curves
that are more than double the stiffness of the fabric used in the
jacket 10 of the invention at low strain. None of the commercial
fabrics tested provide desirable levels of compliance for both
uniaxial and multiaxial loading, yet provide the constraining
support required at higher strains to prevent continued heart
dilation for this application. Only the stretch polyester appears
to have compliance that is similar to the jacket 10 fabric,
allowing conformance to the heart. However, at larger strains the
stretch polyester does not stiffen under multiaxial loads like the
fabric used in the jacket 10, resulting in less constraining
support.
[0112] The knit material has numerous advantages. Such a material
is flexible to permit unrestricted movement of the heart H (other
than the desired constraint on circumferential expansion). The
material is open defining a plurality of interstitial spaces for
fluid permeability as well as minimizing the amount of surface area
of direct contact between the heart H and the material of the
jacket 10 (thereby minimizing areas of irritation or abrasion) to
minimize fibrosis and scar tissue.
[0113] The open areas of the knit construction also allows for
electrical connection between the heart and surrounding tissue for
passage of electrical current to and from the heart. For example,
although the knit material is an electrical insulator, the open
knit construction is sufficiently electrically permeable to permit
the use of trans-chest defibrillation of the heart. Also, the open,
flexible construction permits passage of electrical elements (e.g.,
pacer leads) through the jacket. Additionally, the open
construction permits other procedures, e.g., coronary bypass, to be
performed without removal of the jacket.
[0114] A large open area for cells 23 is desirable to minimize the
amount of surface area of the heart H in contact with the material
of the jacket 10 (thereby reducing fibrosis). However, if the cell
area 23 is too large, localized aneurysm can form. Also, a strand
21a, 21b can overly a coronary vessel with sufficient force to
partially block the vessel. A smaller cell size increases the
number of strands thereby decreasing the restricting force per
strand. In a preferred embodiment, the cell area CA of cells in a
particular row directly correlates with a cross-sectional
circumferential dimension of the heart that the row of cells
surrounds relative to other cross-sectional circumferential
dimensions. That is, the greater the cross-sectional
circumferential dimension, the greater the area of the cells in the
row of cells directly overlying that cross-sectional
circumferential dimension. By "correlating" cell area with
cross-sectional circumferential dimension of the heart, the cell
area is determined as a function of the cross-sectional
circumferential dimension of the heart. The cell area is determined
so that when the weave material is applied to the heart or is
shaped into a jacket and applied to the heart, each cell can widen
sufficiently to provide desirable cardiac constraint. Thus, the
cell area will be smaller for cells in a row applied over a region
of the heart that has a smaller cross-sectional circumferential
dimension than the cell area of cells in a row applied over a
region of the heart having a larger cross-sectional circumferential
dimension. The appropriate maximum cell area may be, for example, 1
to 100 mm.sup.2, typically 16 to 85 mm.sup.2. The maximum cell area
is the area of a cell 23 after the material of the jacket 10 is
fully stretched and adjusted to the maximum adjusted volume on the
heart H as previously described.
[0115] Young's Modulus
[0116] Prior to discussing the contribution of filament elasticity
and fiber structure to the compliance of the jacket material, an
overview of Young's Modulus will be provided.
[0117] Stress refers to the force (F) normalized by the cross
sectional area (A) of an object. Stress can be represented by the
following formula: F/A. For fabrics, unit load is commonly used in
lieu of stress. The unit load is force (F) normalized by the width
of a unit measure of fabric. Strain is defined as the change in
length of the object normalized by the initial length. Strain can
be represented by the following formula: (1.sub.1-1.sub.0/1.sub.0.
Thus, if stress (or unit load) is plotted versus strain, the slope
of the line in the elastic/linear range of the material gives the
elastic modulus or Young's modulus (E) of the object. (FIG.
16).
[0118] The stress-strain curve begins at zero stress and stops at
the amount of force which ruptures the fiber. The shape, length and
height of a stress-strain curve indicates how well a fiber resists
elongation, how far it will elongate before rupturing and how
strong it is. The curve also establishes the point at which a fiber
will not recover fully from an applied stress.
[0119] According to Hooke's law, (at relatively low stress) the
strain is proportional to stress and therefore the ratio of the two
is a constant that may be used to indicate the elasticity of the
object. Young's Modulus may be loosely defined as the force
required to elongate an object. The elastic modulus can be
calculated from measurements obtained by pulling a sample of the
object in a tensile testing machine. Young's Modulus for some
polymers is provided in Table 1, below.
TABLE-US-00001 TABLE 1 Young's Modulus for Some Polymers Modulus
Modulus Material (Kpsi) (GPa) Polyimides 400-700 3-5 Polyesters
150-700 1-5 Nylon 300-600 2-4 Polystryene 400-500 .sup. 3-3.4
Polyethylene 30-100 0.2-0.7
[0120] The linear portion of the curve generally indicates the
elastic behavior of the material. Strains induced in the material
due to a stress within the linear portion are totally recoverable
once the stress is removed. The strain is thus referred to as
elastic. When the initial linear segment of the stress-strain curve
rises steeply, a relatively large increase in stress produces a
relatively small increase in strain (e.g., the fiber has a high
initial modulus). If the lines slopes at 45.degree., then there is
a unit increase in strain for each unit increase in stress and the
initial modulus of the fiber is average. As the slope decreases or
the line become more horizontal, the initial modulus of the fiber
becomes lower. Fibers with low initial modulus are relatively easy
to elongate. A slight force results in considerable fiber
lengthening. In contrast, a large force must be applied to fibers
with high initial modulus for small amounts of extension to
occur.
[0121] In this initial segment of the stress-strain curve, the
lengthening of the fiber is (1) the result of the degree to which
polymers lying at angles to the fiber axis can be moved into
alignment with the axis and (2) polymers with a nonlinear
configuration can be straightened. Polymers that are spiraled and
folded tend to act like springs; once stress is released they
attempt to return to their original configuration. Thus, low
modulus fibers tend to be less oriented than high modulus fibers.
Polymer slippage does not occur within the fiber during the initial
modulus segment of the stress strain curve.
[0122] As the stress on an object is increased, the plot of stress
versus strain becomes non-linear (FIG. 17). The elastic limit
generally refers to the point where the curve begins to deviate
from linearity. Beyond the elastic limit, the material undergoes
plastic deformation. Unlike elastic deformation, plastic
deformation is not recoverable, i.e., the change is permanent. When
a load is applied to an object and the object deforms and does not
return to its original length when the load is removed, the object
is said to have undergone a plastic deformation. At the elastic
limit, the polymers of the object begin to slip by one another as
the stress becomes larger than the force of attraction between the
polymers. However, when polymers are covalently cross-linked, the
crosslinks work to pull the polymers back their original
positions.
[0123] Fibers
[0124] The compliance of the jacket 10 may also be affected by the
relative movement of the filaments 30 within the fibers 20. The
relative movement of the filaments 30, in turn, may be affected by
the structure of the fiber 20. A fiber 20 may be composed of
overlapping filaments 30 that are twisted about one another and
held together by a binding mechanism (FIGS. 18 and 19) or the fiber
20 may be composed of continuous filaments 30 (or a single
filament) that extend longitudinally along the length of the fiber
20 (FIG. 20), assembled with or without a twist. The fiber 20 may
be composed of filaments 30 that are substantially aligned with the
fiber axis F-F (FIG. 18) or the filaments 30 may lie more obliquely
with respect to the fiber 20 axis (FIG. 19).
[0125] Preferably, the fiber 20 is composed of continuous filaments
30. Because continuous filaments 30 have less protruding ends,
continuous filaments 30 are less likely to abrade the surface of
the heart H during systole and diastole. In a fiber made of
continuous filaments 30, the lengthening of the fiber 20 is
generally the result of the degree to which filaments 30 lying at
angles to the fiber axis F-F can be moved into alignment with the
axis F-F and filaments 30 with a nonlinear configuration can be
straightened. Filaments 30 that are spiraled and folded tend to act
like springs; once stress is released they attempt to return to
their original configuration. Overlapping filaments 30 in a fiber
20 may slip when exposed to stress, thus permanently altering or
"stretching" the fiber 20.
[0126] Fibers 20 with multifilaments that are not substantially
aligned are preferred, such that fabric compliance from the fiber
straightening can help to accommodate expansion of the ventricles
during diastole. Generally, preferred fibers include 70 Denier
textured polyester.
[0127] Filaments
[0128] The elasticity of the filaments 30 which make up the fibers
20 may also affect the compliance of the jacket 10. The filaments
30 are preferably formed of a non-elastomeric material (i.e., the
filament 30 does not return to its approximate original length with
force), preferably the filament is constructed from a material with
a moderate modulus of elasticity, more preferably between 1.0 GPa
(150 Kpsi) and 5 GPa (700 Kpsi). In a preferred embodiment, the
filaments 30 include 34 strands to construct the 70 Denier
poly(ethylene terephthalate) (e.g., polyester) fibers 20. While
poly(ethylene terephthalate) is presently preferred, other suitable
materials may include polytetrafluoroethylene (PTFE), expanded PTFE
(ePTFE), polypropylene, titanium and stainless steel.
[0129] With the foregoing, a device and method have been taught to
treat cardiac disease. The jacket 10 constrains further undesirable
circumferential enlargement of the heart while not impeding other
motion of the heart H. With the benefits of the present teachings,
numerous modifications are possible. For example, the jacket 10
need not be directly applied to the epicardium (i.e., outer surface
of the myocardium) but could be placed over the parietal
pericardium. Further, an anti-fibrosis lining (such as a PTFE
coating on the fibers of the knit) could be placed between the
heart H and the jacket 10. Alternatively, the fibers 20 can be
coated with PTFE.
[0130] The jacket 10 is low-cost, easy to place and secure, and is
convenient for use in minimally invasive procedures. The thin,
flexible fabric 18 permits the jacket 10 to be collapsed and passed
through a small diameter tube in a minimally invasive
procedure.
[0131] The jacket 10, including the knit construction, freely
permits longitudinal and circumferential contraction of the heart H
(necessary for heart function). Unlike a solid wrap (such as a
muscle wrap in a cardiomyoplasty procedure), the fabric 18 does not
impede cardiac contraction. After fitting, the jacket 10 is
inelastic to prevent further heart enlargement while permitting
unrestricted inward movement of the ventricular walls. Because the
jacket 10 is not constructed from an elastomeric material, it does
not substantially assist the heart during systolic contraction.
[0132] The open cell structure permits access to coronary vessels
for bypass procedures subsequent to placement of the jacket 10.
Also, in cardiomyoplasty, the latissimus dorsi muscle has a
variable and large thickness (ranging from about 1 mm to 1 cm). The
material of the jacket 10 is uniformly thin (less than 1 mm thick).
The thin wall construction is less susceptible to fibrosis and
minimizes interference with cardiac contractile function.
[0133] Animal test studies on the device show the efficacy of the
invention. Test animals were provided with the device 10 of FIG. 3.
The animals' hearts were rapidly paced to induce enlargement. After
six weeks, animals without the device experienced significant heart
enlargement while those with the device experienced no significant
enlargement. Further, animals with the device had significantly
reduced mitral valve regurgitation.
[0134] In addition to the foregoing, the present invention can be
used to reduce heart size at the time of placement in addition to
preventing further enlargement. For example, the device can be
placed on the heart and sized snugly to urge the heart to a reduced
size. More preferably, the heart size can be reduced at the time of
jacket placement through drugs (e.g., dobutamine, dopamine or
epinephrine or any other positive inotropic agents) to reduce the
heart size. The jacket of the present invention is then snugly
placed on the reduced sized heart and prevents enlargement beyond
the reduced size.
[0135] From the foregoing, a low cost, reduced risk method and
device are taught to treat cardiac disease. The invention is
adapted for use with both early and later stage congestive heart
disease patients. The invention reduces the enlargement rate of the
heart as well as reducing cardiac valve regurgitation.
EXAMPLES OF IMPLANT SCENARIOS
Example 1
[0136] In this example, the heart is assumed to be spherical in
shape and 46 cm (18 in.) in diameter at end diastole. The device is
installed around the heart and adjusted to create a uniform loading
of the fabric. Because the heart is spherical in shape, the
pressure is uniformly applied to the heart and resisted by the
device like a spherical pressure vessel, where the load per unit
width is pd/4 (Note: p=pressure, d=diameter). Since the load is
uniform the multiaxial compliance curve of the fabric would be most
applicable. FIG. 21 illustrates the installed condition for an end
diastolic device pressure of 20 mm Hg (2.7 kPa). This corresponds
to 0.6 lbs/in. fabric load for this size heart.
[0137] During systole the heart muscle contracts and the external
dimension is reduced. On average, the heart reduces
circumferentially by approximately 6% and longitudinally by 4% from
end diastole to end systole. Thus, for the case of a 4% to 5%
change in circumference and diameter is assumed. This linear
dimensional change relates to a 12% to 15% external ventricular
volume change for a spherical heart. At end systole, FIG. 21 shows
that the circumference reduces to 44 cm (17.3 in.) and the applied
pressure drops from 20 mm Hg (2.7 kPa) to 4 mm Hg (0.53 kPa). For
this condition the fabric load is only 0.1 lbs/in and the device is
nearly unloaded.
[0138] The pressure applied by the device is helping to offload
heart wall stress throughout the cardiac cycle. This support is
greatest at end diastole when the heart volume is greatest
(relaxing between systolic contractions). Although the diastolic
phase is considered relaxing, the myocardium may never actually
completely relax. Some slight loading during diastole may not
significantly restrict filling but rather serve to off load the
wall stress throughout the cardiac cycle.
[0139] If the heart becomes improved and reduces in size, the
device will become unloaded at end systole. Only a 16% volume
reduction will result in the device being completely unloaded. If
the heart continues to dilate due to continued disease progression,
load support from the jacket increases dramatically. With less than
4% increase dilation, the applied pressure would double to a load
of 40 mm Hg (5.3 kPa). The biaxial compliance curve of the fabric
results in very significant pressure changes for relatively small
volume changes.
Example 2
[0140] In this example, the heart is assumed to be cylindrical in
shape and again 46 cm (18 in.) in circumference at end diastole.
The device is installed around the heart and adjusted to create a
primarily circumferential loading of the fabric with the end
effects and longitudinal loading assumed to be negligible. Because
the heart is cylindrical in shape, the circumferential load per
unit width is pd/2. Note that based on the pressure vessel theory,
this is twice the load resisted in the spherical shape of Example 1
for the same pressure. Since the load is only circumferential, the
uniaxial compliance curve of the fabric would be most applicable.
FIG. 22 illustrates the installed condition for an end diastolic
device pressure of 10 mm Hg (1.3 kPa). This corresponds to 0.6
pounds per inch (1.1 N/cm) fabric load for this size heart.
[0141] Similar to Example 1, during systole the heart muscle
contracts and the external dimensions of the heart are reduced. If
a 6% change in circumference and diameter is assumed, along with a
4% longitudinal length change, the external ventricular volume
change would be approximately 17%. At end systole, FIG. 22 shows
that the circumference reduces to 44 cm (17.3 in.) and the applied
pressure only drops from 10 mm Hg (1.3 kPa) to 8 mm Hg (1.1 kPa).
For this condition, the fabric load is nearly unchanged from 0.6 to
0.5 pounds per inch (1.1 N/cm to 0.88 N/cm). This small load change
is due to a flat compliance curve.
[0142] Similar to Example 1, the pressure applied by the device is
helping to offload heart wall stress throughout the cardiac cycle.
However, in this case the support from the jacket is nearly
constant throughout the cardiac cycle.
[0143] For the case shown in FIG. 22, if the heart becomes improved
and reduces in size, the device will continue to be supported for a
volume reduction of up to 70%. This compliance/load scenario would
result in longer term support than in Example 1. As the heart
diameter reduces and progresses to the left on the compliance
curve, the loading is gradually lowered. This will continue until a
very significant 70% external volume reduction occurs. If the heart
continues to dilate due to continued disease progression or
exercise overload, the load support from the jacket increases
dramatically with a significant increase in dilation. A 30-mm Hg (4
kPa) increase in pressure to the 40 mm Hg (5.3 kPa) design load
will allow a 30% increase diametrical dilation. The uniaxial
compliance curve of the fabric allows very large changes in size
with relative small load changes, assuming the load remains
unidirectional.
[0144] The therapy provided by the device may be a combination of
Examples 1 and 2. When installed the jacked behaves as in Example 1
if it is adjusted to provide a nearly uniform load. Then as the
heart improves and reduces in size, the loading may become more
unidirectional if either the longitudinal or circumferential
directions do not change at the same rate. This would change the
compliance curve to behave more like Example 2. The actual fabric
compliance curve may transition from multiaxial to uniaxial as the
heart shape changes.
* * * * *