U.S. patent application number 11/120470 was filed with the patent office on 2005-09-08 for systems for heart treatment.
This patent application is currently assigned to Extensia Medical, Inc.. Invention is credited to Domingo, Nicanor, Pai, Suresh, Whayne, James G..
Application Number | 20050197692 11/120470 |
Document ID | / |
Family ID | 27402229 |
Filed Date | 2005-09-08 |
United States Patent
Application |
20050197692 |
Kind Code |
A1 |
Pai, Suresh ; et
al. |
September 8, 2005 |
Systems for heart treatment
Abstract
Described are devices and methods for treating degenerative,
congestive heart disease and related valvular dysfunction.
Percutaneous and minimally invasive surgical tensioning structures
offer devices that mitigate changes in the ventricular structure
(i.e., remodeling) and deterioration of global left ventricular
performance related to tissue damage precipitating from ischemia,
acute myocardial infarction (AMI) or other abnormalities. These
tensioning structures can be implanted within various major
coronary blood-carrying conduit structures (arteries, veins and
branching vessels), into or through myocardium, or into engagement
with other anatomic structures that impact cardiac output to
provide tensile support to the heart muscle wall which resists
diastolic filling pressure while simultaneously providing a
compressive force to the muscle wall to limit, compensate or
provide therapeutic treatment for congestive heart failure and/or
to reverse the remodeling that produces an enlarged heart.
Inventors: |
Pai, Suresh; (Mountain View,
CA) ; Domingo, Nicanor; (Santa Clara, CA) ;
Whayne, James G.; (Chapel Hill, NC) |
Correspondence
Address: |
THE PATENT LAW OFFICE OF FRANK P. BECKING
P. O. BOX 800
PALO ALTO
CA
94302
US
|
Assignee: |
Extensia Medical, Inc.
156 Holly Court
Mountain View
CA
94043
|
Family ID: |
27402229 |
Appl. No.: |
11/120470 |
Filed: |
May 2, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11120470 |
May 2, 2005 |
|
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10269844 |
Oct 11, 2002 |
|
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60329694 |
Oct 16, 2001 |
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60368918 |
Mar 29, 2002 |
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Current U.S.
Class: |
623/2.1 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 17/064 20130101; A61B 17/0487 20130101; A61B
2017/0461 20130101; A61F 2/2478 20130101; A61B 2017/0412 20130101;
A61F 2/2451 20130101; A61B 2017/0462 20130101; A61B 17/00234
20130101; A61B 2017/048 20130101; A61B 2017/0496 20130101; A61B
17/0401 20130101; A61F 2002/249 20130101 |
Class at
Publication: |
623/002.1 |
International
Class: |
A61F 002/24; A61N
001/18 |
Claims
We claim:
1-50. (canceled)
51. An intravascular mitral valve support system comprising: a
proximal anchor, a distal anchor and an elongate member secured
between the proximal and distal anchors, the elongate member
including a spring section, at least the distal anchor being
adapted for receipt within a coronary sinus vessel, the system
being adapted to exert force on the mitral valve when the elongate
member is tensioned against the anchors.
52. The system of claim 51, wherein the elongate member comprises a
wire.
53. The system of claim 51, wherein the wire is selected from
stainless steel, NiTi and titanium alloy.
54. The system of claim 51, wherein at least one of said anchors
comprises a structure selected from a single hook, multiple hooks,
a stent, a helix, a loop and a disk.
55. The system of claim 51, wherein at least the distal anchor is
adapted to hold against the coronary sinus lumen.
56. The system of claim 54, wherein the proximal anchor is adapted
to hold against the coronary sinus lumen.
57. The system of claim 51, wherein the proximal anchor is adapted
to hold at an ostium of the coronary sinus.
58. The system of claim 51, wherein the spring section includes a
plurality of switchbacks.
59. The system of claim 51, comprising a detent mechanism to
selectively alter spring performance.
60. The system of claim 51, wherein the spring section is shaped in
waves.
61. The system of claim 60, comprising a ratchet member interfacing
with the spring waves to alter spring performance.
62. The system of claim 51, wherein the spring section is spiral or
helical shaped.
63. The system of claim 62, further comprising a plurality of loops
to engage portions of the spring section.
64. The system of claim 51, further comprising a plurality of loops
to engage portions of the spring section.
65. The system of claim 64, wherein the loop comprises suture
material, ribbon or wire.
66. The system of claim 65, wherein release of the loops relaxes
the spring section.
67. The system of claim 51, wherein the system is adapted for
intraoperative tension adjustment.
68. The device of claim 51, wherein the system is adapted for
postoperative tension adjustment.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of Provisional
Application Ser. No. 60/329,694 entitled "Percutaneous Cardiac
Support Structures and Deployment Means" filed Oct. 16, 2001 and
Provisional Application Ser. No. 60/368,918 entitled "Percutaneous
Vascular Tensioning Devices and Methods" filed Mar. 29, 2002, each
of which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to minimally
invasive medical devices for treating or preventing congestive
heart failure and related or concomitant valvular dysfunction. More
specifically, the invention relates to tensioning structures and
related deployment devices to mitigate changes in the ventricular
structure and geometry and deterioration of global left and right
ventricular performance related to tissue damage from myocardial
ischemia, acute myocardial infarction (AMI), valve related disease
or dysfunction, or other instigators of deterioration of cardiac
function.
BACKGROUND
[0003] Congestive heart failure (CHF) is a progressive and lethal
disease if left untreated. CHF syndrome often evolves as a
continuum of clinical adaptations, from the subtle loss of normal
function to the presence of symptoms refractory to medical therapy.
While the exact etiology of the syndrome that causes heart failure
is not fully understood, the primary cause of CHF is left
ventricular dysfunction (i.e., the inability of the heart to
properly and adequately fill or empty blood from the left ventricle
with adequate efficiency to meet the metabolic needs of the
body).
[0004] In addition, non-cardiac factors can also be activated due
the overall degenerative cycle that ensues. These include
neuro-hormonal stimulation, endothelial dysfunction,
vasoconstriction, and renal sodium retention-all of which can cause
dyspnea, fatigue and edema rendering patients unable to perform the
simplest everyday tasks. These types of non-cardiac factors are
secondary to the negative, functional adaptations of the
ventricles, cardiac valves and/or load conditions applied to or
resisted by these structures. With existing pharmacological,
surgical and device-based therapies symptoms can be alleviated, but
the quality of a patient's life remains significantly impaired.
Further morbidity and mortality associated with the disease is
exceptionally high.
[0005] Ischemic heart disease is currently the leading cause of CHF
in the western world, accounting for greater than 70% of cases
worldwide. In these cases, CHF can precipitate from ischemic
conditions or from muscle damage (i.e., due to obstruction of a
coronary artery) which can weaken the heart muscle, thereby
initiating a process known as remodeling in which changes in
cardiac anatomy and physiology include ventricular dilatation,
regional wall motion abnormalities, decreases in the left
ventricular ejection fraction and impairment of other critical
parameters of ventricular function. Such left ventricular
dysfunction may be further aggravated by hypertension and valvular
disease in which a chronic volume or pressure overload can alter
the structure and function of the ventricle. Decreases in systolic
contraction can lead to cardiomyopathy, which further exacerbates
the localized, ischemia damaged tissue or AMI insult into a global
impairment, thereby leading to episodes of arrhythmia, progressive
pump failure and death.
[0006] Ischemia-damaged and/or infarct damaged heart muscle tissue
results in progressive softening or degeneration of cardiac tissue.
These ischemic and infarcted zones of the heart muscle wall have
limited, if not complete loss of tissue contractile functionality
and overall physical integrity and present an analogous situation
to those presented by vascular aneurysms.
[0007] CHF is usually associated with a progressive enlargement of
the heart as it increases contractility and heart rate in a
compensatory response to the decreasing cardiac output. With this
enlargement, the heart's burden is increased to pump more blood
with each pump cycle. A phenomenon known as myocardial stretch is
implicated in a degenerative cycle/ feedback loop that causes areas
of compromised heart muscle tissue to bulge further outward. When
the bulging is related to AMI, this behavior is characterized as
infarct expansion. With this bulging, the heart's natural
contraction mechanism is dissipated and attenuated, resulting in a
marked and progressing decrease in cardiac output.
[0008] Normal cardiac valve closure (especially that of the mitral
valve) is dependent upon the integrity of the myocardium, as well
as that of the valve apparatus itself. The normal mitral valve is a
complex structure consisting of leaflets, an annulus, chordae
tendineae, and papillary muscles. Any damage or impairment in
function of any of these key components can render the valve
structure incompetent. Impairment of valve function, due to
independent factors (i.e., a concomitant valve pathology) or
dependent factors (i.e.,valve dilation related to dilated
cardiomyopathy), can result in valvular insufficiency further
exacerbating the degenerative CHF cycle.
[0009] The major objectives of heart failure therapy are to
decrease symptoms and prolong life. The American Heart Association
guidelines suggest that optimal treatment objectives include means
to increase survival and exercise capacity, and to improve quality
of life, while decreasing symptoms, morbidity and the continued
progression of the cardiac degeneration. Various pharmacological
and surgical methods have been applied both with palliative and
therapeutic outcome goals. However, there still remains no
definitive cure for CHF.
[0010] Modern pharmacological approaches such as diuretics,
vasodilators, and digoxin dramatically lessen CHF symptoms and
prolong life by mitigating the non-cardiac factors implicated in
the syndrome. Furosemide (more commonly known as Lasix.TM.) is also
a valuable diuretic drug which eliminates excess water and salt
from the body by altering kidney function and thereby increasing
urine output, thus relieving circulatory congestion and the
accompanying pulmonary and peripheral edema.
[0011] Vasodilators, like angiotensin-converting-enzyme (ACE)
inhibitors have become cornerstones in treatment of heart failure.
These kinds of vasodilators relax both arterial and venous smooth
muscle, thereby reducing the resistance to left ventricular
ejection. In patients with enlarged ventricles, the drug increases
stroke volume with a reduction in ventricular filling pressure.
Administering digoxin has also been found to be positively
inotropic (i.e., strengthening to the heart's contractile
capability).
[0012] On the surgical front, cardiomyoplasty is a recently
developed treatment of CHF. In such a procedure, the latissimus
dorsi muscle is removed from the patient's shoulder, wrapped around
the heart and chronically paced in synchrony with ventricular
systole in an effort to assist the heart to pump during systole.
The procedure is known to provide some symptomatic improvement, but
is controversial with regard to its ability to enable active
improvement of cardiac performance. It is hypothesized that the
symptomatic improvement is primarily generated by passive
constraint and mitigation of the degenerative, remodeling process.
In spite of the positive outcome on relieving some of the symptoms,
the procedure is highly invasive, requiring access to the heart via
a sternotomy, expensive, complex and of unknown durability (due to
the muscle wrap blood flow requirements and fibrosis issues).
[0013] Another surgical procedure of interest has been developed by
R. Bautista, MD. In this procedure, the overall mass, volume and
diameter of the heart are physically reduced by dissection and
removal of left ventricular tissue. While innovative, the procedure
is highly invasive, traumatic and costly. Further, the actual
volume reduction results in a reduction in valve competence and
elicits the associated regurgitation.
[0014] Surgical treatment of valvular dysfunction includes a wide
range of open procedure options ranging from mitral ring
annuloplasty to complete valve replacement using mechanical or
tissue-based valve prosthesis. While being generally successful and
routine in surgical practice today, these procedures are also
costly, highly invasive and are still have significant associated
morbidity and mortality.
[0015] More recently, mechanical assist devices which act as a
bridge to transplant such as the left ventricular assist device
(LVAD) or the total artificial heart (TAH) implant have become
available. LVAD's are implantable, mechanical pumps that facilitate
the flow of blood from the left ventricle into the aorta. The
latest TAH technologies feature many improved design and material
enhancements that increase their durability and reliability. Still,
the use of such devices is limited by high costs and a lack of
substantial, clinical evidence warranting their use.
[0016] Other device-based options for CHF patients include
approaches for reshaping, reinforcement and/or reduction of the
heart's anatomical structure using polymeric and metallic bands,
cuffs, jackets, balloon/balloon-like structures or socks to provide
external stress relief to the heart and to reduce the
propensity/capability of the cardiac tissue to distend or become
continually stretched and progressively damaged with pump cycles.
Examples of such devices are United States Patent No. 2002/0045799
and U.S. Pat. No. 5,702,343. In addition, devices are being studied
that attempt to prevent the tissue remodeling using tethers and
growth limiting struts or structures described in various patents
(i.e., U.S. Pat. No. 6,406,420).
[0017] Generally, all of these concepts support the cardiac muscle
and restrict growth externally and globally via surgical placement
about the epicardium and in some instances are positioned across
the cardiac muscle tissue. As a result, these types of approaches
require unnecessary positioning of the devices over healthy (non
local, undamaged) areas or zones of the heart affecting the entire
organ when the primary treatment is usually focused is on the left
ventricle or the mitral valve annulus. Such non-localized treatment
can elicit iatrogenic conditions such as undesired valvular
dysfunction and/or constrictive physiology due to over restriction
of the heart by such restraints.
[0018] Recently, several-device based options have been introduced
where implants are positioned by minimally invasive means in the
coronary sinus in one configuration and then assume a post
deployment configuration that constricts around the heart annulus
to improve valve competence in dilated cardiomyopathy (see, United
States Patent Application Publication No. 2002/016628.) While
appealing, the clinical efficacy of this approach is unknown at
this time.
[0019] The ultimate treatment for people suffering end stage CHF is
a heart transplant. Transplants represent a massive challenge with
donor hearts generally in short supply and with the transplant
surgery itself presenting a high risk, traumatic and costly
procedure. In spite of this, transplants present a valuable, albeit
limited, upside, increasing life expectancy of end stage congestive
heart failure patient from less than one year up to a potential
five years.
[0020] In view of the above, it should be evident that there is
currently no ideal treatment among the various surgical,
pharmacological, and device-based approaches to treat the multiple
cardiac and non-cardiac factors implicated with the syndrome of
CHF. Accordingly, there is a clear, unmet clinical need for
technology that is minimally invasive (especially, percutaneous)
that can prevent, treat or reduce the structural remodeling to the
heart and its sub-structures across the continuum of the CHF
syndrome beginning acutely with the ischemia or ischemic infarct
through the end stages where there is often left ventricular and
valvular dysfunction refractory to conventional treatments.
[0021] Still, patients suffering from CHF, who are unresponsive to
medication, generally precluded to open surgical approaches and
potentially awaiting transplant could derive massive and direct
benefit from a minimally invasive device as provided by the present
invention to limit further degeneration of their condition. In
addition, implant embodiments of the present invention can also
facilitate positive or reverse remodeling (i.e., provide a mild
compressive force both during systole and diastole to improve
cardiac output and efficiency).
SUMMARY OF THE INVENTION
[0022] The present invention meets these needs with tensioning
structures that can be utilized locally (e.g., left ventricular
anterior wall only versus about the entire heart) to reduce wall
stresses, reinforce the walls, and reduce/limit volume of the heart
muscle as required using percutaneous, minimally invasive surgical
(MIS), and open surgical means or a combination thereof. Devices
according to the present invention may be used to facilitate
operator controlled "tailoring" of localized treatment using
various embodiments of the invention at various chosen target zones
(i.e., left ventricle, mitral valve annulus, or sub-valvular
apparati). Custom tailoring of each tensioning structure enables
application of compression against specific regions of tissue in
one, two or three dimensions relative to the heart's surface and
patient specific adjustability of the amount of compression applied
to the tissue to optimize the heart's overall hemodynamic
performance.
[0023] Tensioning structures according to the invention can be
individually placed within or about the heart (intravascularly or
extravascularly) working in concert to provide reinforcement
against myocardial stretch (or infarct expansion) and additionally
to facilitate contraction of tissue previously subject to such
myocardial degeneration. In doing so, the contractile and expansion
energies of the heart can be transferred to and across the weakened
sections of the heart from the more viable sections of the heart
muscle. Such devices provide localized dynamic support or
reinforcement and are active throughout the cardiac cycle unlike
previous device approaches that generally only reduce the stress in
the heart wall during diastole. Diastolic compliance can also be
regulated or controlled with structures according to the invention.
Also, the tensioning structures facilitate and maintain a more
efficient and perhaps optimal wall motion through the cardiac cycle
thereby aiding in diastolic filling and systolic contraction at the
tissue area that has been compromised by ischemia, infarct or other
abnormalities. The tensioning structures are implanted in target
heart regions using standard cardiovascular, interventional
techniques using guiding catheters and introducing sheaths or less
invasive surgical techniques involving port access or small
incisions into the thoracic cavity to eliminate the need for more
radical surgery (e.g., median sternotomy) to provide a potential,
palliative or therapeutic response to the disease.
[0024] Furthermore, the tensioning structures of the invention may
provide a complete, comprehensive solution for treatment of
congestive heart failure addressing deficiencies to the wall motion
of the heart (e.g., akinesis, hypokinesis or dyskinesis), and/or
valve insufficiencies. The present invention comprises such
device-based technology as summarized above, that is further
described below with associated methodology, including deployment,
production, development and use of the same. Still further, as part
of a system, kit or otherwise, the invention shown herein may be
provided or used in connection with the invention described in U.S.
Provisional Patent Application Atty. Docket No. EXMA-002PRV,
entitled "Minimally Invasive Cardiac Force Transfer Structures," to
the inventors hereof and filed on even date herewith, the same
being incorporated by reference in its entirely as part of the
present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIGS. 1A and 1B show perspective views of a healthy heart in
systole and diastole, respectively.
[0026] FIGS. 2A and 2B show perspective views of a diseased
(enlarged) heart in systole and diastole, respectively.
[0027] FIGS. 3A and 3B show perspective views of a diseased heart
reinforced with an intravascular, tensioning structure of the
invention in systole and diastole respectively.
[0028] FIGS. 4A and 4B show perspective views dramatizing the
progression of myocardial stretch (or infarct expansion) in a
diseased, enlarged heart with the infarcted/ischemic zone shown as
highlighted; FIG. 4C shows a perspective view of the heart of FIG.
4B reinforced with an intravascular, tensioning structure of the
invention.
[0029] FIGS. 5A and 5B show anterior views of a heart with
intravascular, tensioning structures of the invention being
percutaneously deployed into various target vessels.
[0030] FIGS. 6A and 6B show posterior views of a heart with
intravascular, tensioning structures of the invention being
percutaneously deployed into various target vessels.
[0031] FIGS. 7A and 7B show exploded cut-away views of vessels in
which a tensioning structure is placed, with each of the structures
anchored transmyocardially.
[0032] FIGS. 8A to 8F show various tensioning structures of the
invention.
[0033] FIGS. 9A and 9B show side views of various tensioning
structures adapted for anchoring in branch vessels.
[0034] FIGS. 10A to 10C show side views of various tensioning
structures that incorporate tensioning springs.
[0035] FIG. 11 shows a side view of a tensioning structure
embodiment incorporating independent wire components interlaced
with one another.
[0036] FIG. 12 shows a side view of a tensioning structure
embodiment incorporating a tubular body with radial anchor
members.
[0037] FIGS. 13A and 13C show side views of a ratcheting mechanism
of an adjustable tensioning structure.
[0038] FIGS. 14A to 14D show side-sectional views highlighting the
process of positioning a tensioning structure in a delivery
catheter.
[0039] FIGS. 15A to 15D, 16A, 16B, 17A to 17E, 18A to 18D show side
views of various tensioning structure anchor members in compressed
and expanded orientations, variously.
[0040] FIG. 19 shows a perspective view of a heart with sectional
view of the coronary sinus and right atrium.
[0041] FIG. 20 shows a perspective view of a heart with sectional
view of the right atrium and right ventricle.
[0042] FIG. 21 shows a perspective-sectional view of a heart
incorporating an intravascular, tensioning structure secured by
anchor members at the coronary sinus and the right ventricular
outflow tract.
[0043] FIG. 22A shows a perspective-sectional view of a heart
incorporating an intravascular, tensioning structure secured inside
the coronary sinus and at the ostium of the coronary sinus in the
right atrium; FIGS. 22B to 22F show perspective views of a heart
dramatizing highlighting the process of inserting and anchoring the
distal end of a tensioning structure into the coronary sinus and
anchoring the proximal end along the epicardial surface of the
heart.
[0044] FIG. 23 shows a side-sectional view of an intravascular,
tensioning structure secured within a vessel in which another
vessel is located below or underneath the target/treated
vessel.
[0045] FIG. 24 shows a perspective view of a heart with sectional
view of the right ventricle and right atrium showing an
intravascular, tensioning structure deployed in the coronary sinus
and secured on one end to the right ventricular outflow tract.
[0046] FIG. 25 shows a perspective view of a heart with sectional
views of the coronary sinus and right atrium broken showing an
intravascular, tensioning structure deployed in the coronary sinus
and anchored on one end to the ostium of the coronary sinus in the
right atrium.
[0047] FIGS. 26A to 26D show side-sectional views of
intravascularly deployed tensioning structures indicating various
attachment points between tensile member and anchor components of
the tensioning structure.
[0048] FIGS. 27A to 27C show close-up views of various anchor
structures in connection with various tensile member attachment
points.
[0049] FIGS. 28A to 28M show side views of various anchor
structures and attached tensile member configurations for
tensioning structures according to the invention.
[0050] FIG. 29 shows a side-sectional view of a ratcheting
mechanism of an adjustable tensioning structure.
[0051] FIG. 30 shows a cross-sectional view of the distal tip of a
delivery catheter system used to place tensioning structures.
[0052] FIGS. 31A to 31C show side-sectional views of a vessel
dramatizing the process of intravascularly deploying a tensioning
structure comprising a deformable anchor using a balloon
expandable, delivery system.
[0053] FIGS. 32A to 32C show side-sectional views of an ostium to a
vessel highlighting the process of deploying a self-expanding
anchor member of a tensioning structure using a retractable sheath
delivery system.
[0054] FIGS. 33A and 33B show cross-sectional views of tensile
members in a vessel illustrating variance in force
distributions.
[0055] FIGS. 34A and 34B, respectively, show a perspective view and
a close-up view along line B-B of a tensioning structure anchor
with a locking mechanism adapted for manually tightening the
tensile member.
[0056] FIGS. 34C to 34E show side views highlighting fabrication
steps of the locking mechanism used in FIGS. 34A and 34B.
[0057] FIGS. 35A to 35D show a side, perspective, and two-sided
sectional views, respectively, of another anchor structure adapted
for manual adjustment and locking of the tensile member.
[0058] FIGS. 36A to 36D show top and perspective views,
respectively, of a deployment system used to insert tensioning
structures into or through myocardium.
[0059] FIGS. 36E to 36H show perspective and side views,
respectively, of two tensioning structures deployed into or through
myocardium with delivery systems such as that shown in FIGS. 36A to
36D.
[0060] FIGS. 37A to 37C show cross-sectional views of the heart
broken in sections with the deployment system of FIGS. 36A to 36D
inserting the tensioning structures of FIGS. 36E to 36H
into/through the myocardium.
[0061] 38A to 38C show cross-sectional views of the heart broken in
sections with an alternative deployment system used to insert the
tensioning structures of FIGS. 36E to 36H into/through the
myocardium.
[0062] FIG. 39A shows a cross-sectional view of the heart broken in
sections with the tensioning structures of FIGS. 36E to 36H
deployed and secured into/through the myocardium in the right
ventricle and the left ventricle; FIG. 39B shows a cross-sectional
view of the heart with the tensioning structures embodiments of
FIGS. 36E to 36H deployed and secured along the valve annulus.
[0063] FIGS. 40A to 40F show perspective views of a heart
indicating various placement configurations of the tensioning
structures of FIGS. 36E to 36H.
[0064] FIGS. 41A to 41D show a cross-sectional view of the heart, a
perspective view and two top views, respectively, illustrating
alternative tensioning structure approaches; FIG. 41E shows a
side-sectional view taken along A-A of the anchor of the tensioning
structure embodiment in FIG. 41D; FIGS. 41F and 41G show a
myocardial tensioning structure with an anchor that is adapted for
manual adjustment and locking of the tensile member; FIG. 41H show
a close-up view of the anchor formations shown in FIGS. 41F and
41G; FIG. 41I shows a close-up, cross-sectional view of a proximal
anchor from a cardiac valve annulus tensioning structure adapted
for manual adjustment and locking of the tensile member.
[0065] FIG. 42 shows an alternative, puncturing device used to
deploy a tensioning structure.
[0066] FIGS. 43A to 43D show two side-sectional views and two side
views, respectively, illustrating the components of an alternative
coaxially arranged delivery system used to deploy tensioning
structures.
[0067] FIGS. 44A to 44C show cross-sectional views of the heart
broken in sections dramatizing an extravascular deployment and
securing process for a tensioning structure that incorporates
anchors at each end.
[0068] FIGS. 45A to 45B show cross-sectional views of the heart
dramatizing a catheter-based delivery and securing process for a
tensioning structure that incorporates anchors at each end; FIGS.
45C to 45E show side views with components of the delivery system
and process used to deploy and secure the anchor of the tensioning
structure in FIGS. 44A to 44C and 45A and 45B within the myocardium
or to a tissue surface; FIG. 45F to 45H show perspective views of
an anchor member for a tensioning structure highlighting the
expansion (e.g., plastic deformation via balloon expansion or
self-expansion upon release from an external compression force) for
the variation of the invention in FIGS. 45C to 45E; FIGS. 45I to
45L show three perspective views and one side view, respectively,
of an alternative anchor member indicating the fabrication process
for a tensioning structure.
[0069] FIGS. 46A to 46K show side-sectional views of an integrated
tensioning structure that functions as a puncturing device for a
deployment system, an anchor member, and the tensile member; FIGS.
46L to 46M show a perspective view of the heart with a deployed and
secured integrated tensioning structure shown as in FIGS. 46A to
46K; FIGS. 46N to 46P show a side view and two perspective views,
respectively, of alternative delivery systems used to deploy
integrated tensioning structures into or/through the myocardium;
FIGS. 46Q and 46R show perspective views of additional integrated
tensioning structures according to the present invention; FIGS. 46S
to 46T show a perspective view and a side view, respectively, of
another integrated tensioning structure; FIGS. 46U to 46Y show a
perspective view, a side view, and side and top close-up views,
respectively, of the integrated tensioning structure of FIGS. 46N
to 46O with a separate anchor attached.
[0070] FIGS. 47A to 47D show a cross-sectional view of the heart
dramatizing the process of deploying and securing a tensioning
structure around and/or to a chordae tendineae or papillary
muscle.
[0071] FIG. 48A shows a side-sectional view of another tensioning
structure compressed into a low profile within a deployment device
for placement inside the heart cavity and attachment to the chordae
tendineae and/or papillary muscle; FIG. 48B shows a side-sectional
view of the deployed and secured tensioning structure of FIG.
48A.
[0072] FIGS. 49A and 49B show perspective views of a heart with
parts cut-out highlighting the process of deploying and securing a
tensioning structure to the chordae tendineae.
[0073] FIGS. 50A and 50B show cut-away perspective views of the
heart showing the process of deploying and securing the tensioning
structure embodiment of FIGS. 48A and 48B to the chordae
tendineae.
[0074] FIGS. 51A and 51B show close-up, side views of the end of a
mechanism used to directly grasp, engage and reposition valve
leaflets.
DETAILED DESCRIPTION
[0075] Having described the characteristics and problems of
congestive heart failure in the background and summarized hereto,
the treatment method and apparatus of the present invention will
now be described in detail below. The variations of the invention
described below may be used to provide a complete, comprehensive
solution to treating congestive heart disease, and the contributing
or associated co-morbid, anatomical, and physiological
deficiencies. Addressing the multiple factors that affect or cause
congestive heart disease can retard or reverse the implicated
remodeling thereby treating or mitigating the congestive heart
disease and associated symptoms.
[0076] Before the present invention is described in such detail,
however, it is to be understood that this invention is not limited
to particular variations set forth and may, of course, vary.
Various changes may be made to the invention described and
equivalents may be substituted without departing from the true
spirit and scope of the invention. In addition, many modifications
may be made to adapt a particular situation, material, composition
of matter, process, process act(s) or step(s), to the objective(s),
spirit or scope of the present invention. All such modifications
are intended to be within the scope of the claims made herein.
[0077] Methods recited herein may be carried out in any order of
the recited events which is logically possible, as well as the
recited order of events. Furthermore, where a range of values is
provided, it is understood that every intervening value, between
the upper and lower limit of that range and any other stated or
intervening value in that stated range is encompassed within the
invention. Also, it is contemplated that any optional feature of
the inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein.
[0078] All existing subject matter mentioned herein (e.g.,
publications, patents, patent applications and hardware) is
incorporated by reference herein in its entirety except insofar as
the subject matter may conflict with that of the present invention
(in which case what is present herein shall prevail). The
referenced items are provided solely for their disclosure prior to
the filing date of the present application. Nothing herein is to be
construed as an admission that the present invention is not
entitled to antedate such material by virtue of prior
invention.
[0079] Reference to a singular item, includes the possibility that
there are plural of the same items present. More specifically, as
used herein and in the appended claims, the singular forms "a",
"and," "said" and "the" include plural referents unless the context
clearly dictates otherwise. It is further noted that the claims may
be drafted to exclude any optional element. As such, this statement
is intended to serve as antecedent basis for use of such exclusive
terminology as "solely," "only" and the like in connection with the
recitation of claim elements, or use of a "negative" limitation.
Unless defined otherwise herein, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs.
[0080] With initial reference to FIGS. 1A and 1B, an anterior view
of a healthy heart in systole and diastole, respectively, is shown
with directional arrows indicating motion of the heart in each
phase. The great cardiac vein 16 is shown on the surface of the
ventricle 18 of the heart. The great cardiac vein 16 resides
adjacent to the left anterior descending artery (not shown).
[0081] In FIGS. 2A and 2B, perspective views are shown of a
diseased (enlarged) heart in systole and diastole, respectively. An
infarcted or ischemic region 20 is shown to stretch from systole to
diastole consistent with the progressive remodeling that occurs due
to increased diastolic filling pressures exerted on the diseased
tissue. A radial and axial expansion that is experienced by the
heart leads to stretching or degenerative remodeling and
concomitant organ enlargement. This enlargement can be localized
along the anterior wall of the left ventricle, can be located or
extend septally, can include the right ventricle, and/or can
involve the mitral valve annulus.
[0082] Fundamentally, all tensioning structure aspects of the
present invention comprise individually or in combination of
several, components or devices including tensile member(s), anchor
member(s) and deployment device(s). These components or devices are
designed to be able to work in concert in order to facilitate and
provide palliative or therapeutic cardiac reinforcement in the
following critical target areas of the heart: 1) intravascular
conduits, 2) cardiac valve annulus, 3) myocardium, 4) chordae
tendineae and valve leaflets. The sub-sections broken-out below
will further describe these specific aspects of the invention.
[0083] Intravascular Conduit Tensioning Structures
[0084] A number of embodiments of the present invention are
provided mainly in the context of tensioning structures positioned
and anchored within intravascular conduits to provide cardiac
muscle support and reinforcement. Such intravascular conduit
tensioning structures can be designed to be interchangeably
deployed within various vascular conduits (arteries, veins, and
branching vessels associated with these structures); or through
these conduit walls directly into or through myocardium tissue, as
described below. The primary vascular targets for intravascular
conduit tensioning structure embodiments of the invention are in
the venous tree (i.e., great cardiac vein, middle cardiac vein,
small cardiac vein, anterior cardiac veins, oblique veins, and the
coronary sinus). These venous structures generally run in symmetric
apposition to their arterial equivalents, albeit at spaced
intervals, where most myocardial infarcts originate. As such, in
anatomical areas clinically known to have a significant prevalence
of coronary artery disease, such as the left anterior descending,
right coronary and circumflex arteries, the associated venous
structures provide ideal target locations for catheter-based,
percutaneous implantation of intravascular conduit tensioning
structures to provide palliation and/or therapy.
[0085] FIGS. 3A and 3B show perspective views of a diseased heart
reinforced with intravascular conduit tensioning structure 4 of the
invention. Tensioning structure 4 limits myocardial stretch or
infarct expansion by locally reinforcing the infarcted/ischemic
regions 20 or other diseased sections of tissue, and limiting the
tension applied to the tissue regions 20 in conjunction with
diastolic filling pressure exerted directly against this diseased
section. In this example, an intravascular conduit tensioning
structure 4 is shown deployed in the great cardiac vein 16 such
that it targets ischemic or infarcted tissue 20 associated with an
occluded or stenosed left anterior descending artery or its
emanating branches. Tensioning structure 4 can also be placed
directly into the artery; however, it is preferred to anchor the
structure in immediately apposed veins to eliminate concerns of
thrombogenicity and adverse sequelae associated with placing
foreign objects into arterial structures. Alternatively, the
tensioning structures can also be positioned intravascularly, but
anchored to the heart by extension into or through the
myocardium.
[0086] All of the intravascular conduit tensioning structure
embodiments are preferably positioned and deployed such that they
extend from within the infarcted/ischemic region to tissue residing
within or beyond the border region of this zone, or between spaced
apart, border zone regions extending through, over, or under the
infarct/ischemic zones. Tensioning structure 4 are capable of
applying a continuous or strain limiting tensile force to resist
diastolic filling pressure while simultaneously providing a
commensurate compressive force to the muscle wall to additionally
or alternatively limit, compensate or provide therapeutic treatment
for congestive heart failure and/or to reverse the remodeling that
produces an enlarged heart.
[0087] FIGS. 4A and 4B show perspective views of hearts
highlighting the remodeling that occurs over time due to the
inability of the ischemic/infarcted area 20 to withstand pumping
pressures. FIG. 4A shows the heart with diseased tissue 20 at the
onset of remodeling. Further FIG. 4B also shows the result of
remodeling with an aneurysmal-like bulging of tissue outward from
the ischemic/infarcted area 20. This remodeling disrupts cardiac
output by producing zones of hypokinesis, dyskinesis and/or
akinesis, which further exacerbates the burden on the heart. The
heart tries to compensate for this remodeling to maintain cardiac
output by altering the compliance, contractility, and/or heart
rate; in doing so the response only accelerates or perpetuates the
degeneration.
[0088] As shown in FIG. 4C, intravascular conduit tensioning
structures 4 can be secured such that they effectively cover the
ischemic/infarcted area 20 and also extend across the diseased
section 20 at both ends where they are anchored. Accordingly, the
tensioning structure in FIG. 4C is shown anchored in the great
cardiac vein 16 providing reinforcement and treatment to the
weakened region 20 This provides sufficient reinforcement of the
heart to regulate and withstand the internal forces that would
otherwise perpetuate the remodeling process. In doing so, the
tensioning structures 4 facilitate and maintain a more efficient
and perhaps optimal, or at least-more optimal, wall motion
throughout the cardiac cycle, thereby aiding in diastolic filling
and systolic contraction at the diseased sections of the heart 20.
As such, the precursors to remodeling (such as excess strain in the
weakened, diseased sections of the heart 20 during systolic and
diastolic cycles) are reduced, removed and even reversed.
[0089] FIGS. 5A and 5B show an anterior view of a heart with
tensioning structure 4 of the invention being percutaneously
deployed from a catheter delivery system 6 into the great cardiac
vein 16 and the small cardiac vein 22. FIG. 5A also shows
tensioning structure 4 being deployed within the great cardiac vein
16 and in 5B in the small cardiac vein 22. These figures again
illustrate the use of the tensioning structures to provide local
reinforcement to the cardiac muscle.
[0090] The tensioning structures according to the present invention
can be deployed within these venous structures as a stand-alone
therapy for congestive heart disease or in combination with
adjunctive treatment of the valve annulus. As such, it is noted
that a multitude of such tensioning structures can be deployed
about the heart in various, venous conduit structures, and as
required anchored at various myocardial tissue positions to provide
the reinforcement required to regulate and withstand the stresses
and strains that would otherwise perpetuate the remodeling process.
More than one tensioning structure 4 can be deployed into a single
coronary vein (or other vascular conduit), into or through the
myocardium associated with or adjacent to the infarcted/ischemic
zone(s) of the heart, or a combination of vascular and direct
myocardial approaches (described below) to vary the reinforcement
pattern and effect throughout the coronary bed.
[0091] FIGS. 6A and 6B show a posterior view of the heart depicting
deployment of an intravascular conduit tensioning structure 4 into
the middle cardiac vein 28 and into the coronary sinus 26 to
provide additional reinforcement. In FIGS. 5B, 6A and 6B, the
tensioning structures 4 are shown deployed in the great cardiac
vein 16, middle cardiac vein 28 and branches 30 and 38 emanating
from such veins. Preferably, the tensioning structures are
positioned and anchored distally prior to securing tensioning
structures directly in the coronary sinus 26 because the distal
most target vessel should be accessed first. However, anchoring in
the coronary sinus could be deployed first if desired or required
by the operator. FIGS. 6A and 6B illustrate various proximal and
distal anchor configurations that are preferred for the invention.
FIG. 6A depicts the distal deployment of an intravascular conduit
tensioning structure 4 into the middle cardiac vein 28 and FIG. 6B
illustrates deployment of the tensioning structure and proximal
anchoring in the coronary sinus 26 with the distal anchoring in the
left marginal vein 30.
[0092] The tensioning structures can also be positioned
intravascularly, but anchored to the heart into or through the
myocardium. As an example, FIGS. 7A and 7B show a detailed, cut
away anterior view of two tensioning structures 4 anchored to the
great cardiac vein 16 at the ventricle 24. Tensioning structure 4
in FIG. 7A is shown deployed within the vein with both
ends/termination secured to the vessel using anchors 32 placed
transmyocardially (into or through the myocardial wall 34). The
tensioning structure shown in FIG. 7A incorporates a tensile member
84 featuring an undulating sine wave section 44, which provides an
elastic or spring like loading to regulate or moderate expansion of
the heart during diastole. In addition, this tensioning structure 4
incorporates radiopaque marker bands 36 which facilitate evaluation
of cardiac performance by allowing measurement of the distance
between marker bands 36 during the cardiac cycle under fluoroscopic
guidance. Alternatively, the marker bands 36 could be fashioned
from an echogenic material that can be located and visualized with
ultrasonic imaging guidance, or otherwise similar means.
[0093] Tensioning structure 4 in FIG. 7B is shown deployed within
the great cardiac vein 16. In this illustration, anchoring is
achieved by positioning within a branch vessel 38 emanating from
the great cardiac vein 16 by locating anchor 32 in the said branch
vessel 38. This tensioning structure also features a tapered
section 40 to properly engage and deploy within a tapering vein
section 42. The tensioning structure design shown in FIG. 7
radially supports a portion of the vein vessel at spaced apart
intervals. This embodiment incorporates reduced diameter sections
defining flexible tensile members 84 associated with radially,
curved extensions designed to lock the tensioning structure to the
vasculature. In an alternate embodiment (not shown) the tensioning
structure could fully support the lumen of the vein, especially at
spaced apart intervals. Either sort of design could be fashioned
from materials or processed by various means to have sections or
regions of varying stiffness customized or tailored to provide
optimal performance characteristics.
[0094] FIGS. 8A to 8E show a variety of alternate tensioning
structures that can limit ischemia related myocardial stretch and
infarct expansion. FIG. 8A shows an embodiment where the body of
the tensioning structure 4 is a tensile member body 84 (e.g., tube,
ribbon, strand, or wire, which can limit elongation with
satisfactory elasticity based upon the selection of material
properties and cross sectional area) incorporating at least one
stress distribution feature such that the tensioning structure can
apply tension against tissue without damaging the contacted tissue
regions. A variety of materials can be used as the tensile member
84 of the tensioning structure, including PTFE, expanded PTFE,
nylon, silicone, urethane derivatives, polyurethane, polypropylene,
PET, polyester, superelastic materials (e.g., nickel titanium
alloy), other alloys (e.g., stainless steel, titanium alloy etc.),
metal (e.g., titanium), biological materials (e.g., strips of
pericardium, collagen, elastin, vascular tissue such as a saphenous
vein or radial artery, tendons, ligaments, skeletal muscle,
submucosal tissue etc.) other alternate materials having the
desired properties, or a combination of these and other
materials.
[0095] The performance of the tensioning structure depends upon and
can be tailored to the desired features. For example, when column
strength is required, superelastic materials or other alloys or
metals are preferred tensile member bodies 84 of the tensioning
structure. When pure tension is required and the tensioning
structure is to be deployed through tortuous access points, more
flexible materials such as expanded PTFE, polyester, or other
suture type materials may be preferred as tensile members. When
absorption or biological integration is desired over a period of
time, biological materials such as strips of pericardium or
collagen, or absorbable materials are preferred.
[0096] FIGS. 8A to 8F show a variety of alternative tensioning
structures of the invention. FIG. 8A also shows anchor members 32
secured to a tensile member 84 at both ends of tensioning structure
4 to anchor the device to and within a conduit vessel. These anchor
formations. 32 can alternatively be used to anchor the device
directly into or through myocardial tissue for embodiments where
the tensioning structures are placed or deployed extravascularly
using surgical access to the epicardium, or using a catheter-based
approach into the left ventricular cavity to target the
endocardium. Anchors 32 are preferably fabricated from
biocompatible materials commonly used in medical implants including
nickel titanium (especially, for self-expanding or
thermally-actuated anchors), deformable stainless steel (especially
for balloon-expanded anchors), spring stainless steel, or other
metals and alloys capable of being deformed using balloon catheters
or other expansive means, or self-expanded to secure the tensioning
structure to the vasculature, myocardium, or other tissue.
Alternatively, the anchors 32 can be fabricated from superelastic
polymers, flexible or deformable polymers such as urethane,
expanded PTFE, or stiff materials such as FEP, polycarbonate,
etc.
[0097] FIG. 8B illustrates a tensioning structure 4 that can at
least impart partial radial support and be anchored to a vessel
with anchors 32. In this variation of the invention, spaced apart
anchor members are shown interconnected by tensile members 84. The
multiple anchor members aid with cinching/compression of the local
tissue region(s) to reduce wall stress while mitigating
over-expansion of the tissue. Also, the multiple anchors can import
or help to exert an elastic recoil effect during wall motion of the
heart. That is, the tensioning structure would be fixed within the
vascular conduit by frictional forces imposed upon the wall to
maintain position of the structure in spite of cardiac wall motion.
Therefore, the frictional fit provided by the multiple anchors
along with the tensile member 84 mitigates over expansion of the
heart.
[0098] FIG. 8C shows a three-dimensional view of another embodiment
of a tensioning structure 4 deployed in a vessel where the tensile
member 84 geometry features an undulating pattern (e.g., a sine
wave pattern). Such a pattern may be provided in order to offer
partial radial support to a vessel by conforming to and following
the shape of the vessel lumen. FIG. 8D shows another tensioning
structure 4 that incorporates a tensile member 84 featuring a
three-dimensional undulation or switchback (e.g., a sinusoidal
pattern) that fully supports the vessel lumen. FIG. 8E shows a
variation of FIG. 8C embodiment with the addition of anchor
formations 32.
[0099] FIG. 8F shows an embodiment of the tensioning structure 4
configured in a specific geometry suitable for use in or about the
valve annulus 108. The design in FIG. 8F features switchbacks or a
waveform at its center which when deployed about a valve annulus
108 can provide additional compressive radial force to the area
opposite of anchors 32.
[0100] FIGS. 9A and 9B show various tensioning structures 4,
adapted for anchoring in branch vessels 30. Anchor members 32
provided therewith can be of various geometric configurations to
enable stabilization of the support structure 4 within the vessel
to provide reinforcement to the heart, especially by leveraging the
complex three-dimensional tortuosity of the vessel anatomy to
facilitate or achieve fixation or anchoring.
[0101] The tensioning structure embodiments shown in FIGS. 10A to
10C feature a sine wave spring section 44 within the tensile member
84 of the structure. Thereby, the tensile member embodiments in
FIGS. 10A to 10C provide an additional elastic section over
straight members and provide another method to optimize cardiac
wall motion to improve cardiac output. In FIG. 10A, the tensile
member 84 spring 44 is an undulating spiral-shape, (e.g., in the
form of a sine wave). In FIG. 10B, the tensile member 84 spring 44
is a helix. In FIG. 10C, tensile member 84 spring 44 features a
geometric pattern, which enables a lower profile
compression/confinement to enabling enable more efficient delivery
via percutaneous or MIS means.
[0102] In FIG. 11, an embodiment of the tensioning structure
variation 4 is shown, wherein the tensile member 84 incorporates
individual wire, ribbon, suture, tube, or other raw material
segments 48 formed so as to interlace to and with each other. The
segment terminations 46 are formed about the adjacent segment
members creating overlap and are curled to interfere with the
curled termination of the adjacent members. At the same time, the
interlaced segments 48 can expand and contract with the cardiac
cycle, with the interfering terminations 46 placing a limit on the
overall elongation.
[0103] FIG. 12 illustrates an embodiment of thea tensioning
structure variation 4 featuring a tensile member 84 with an
undulating sine wave pattern (e.g., a sine wave pattern) formed
along a cylindrical body. The cylindrical body shown in FIG. 12
provides complete radial support within the vessel where it is
implanted. The shape also facilitates flexibility to for deployment
in complex three-dimensional tortuous anatomies. Anchor formations
32 on both ends of tensile member 84 may be provided, in which case
they will be oriented in a direction so as to resist the expansion
of the heart when deployed within the vessel lumen.
[0104] FIGS. 13A to 13C show various, adjustable, tensioning
structures 4 to provide modification or adjustability of
stiffness/resistance or force outputs by incorporating means to
increase or decrease flexibility of the structure. The device of
FIG. 13A achieves the such adjustability utilizing removable loop
structures 50 strategically positioned along the tensile member 84
that can communicate with the hub of the deployment system 6
enabling a physician operator to selectively disengage or remove
the same to increase the flexibility of the structure. The device
of FIG. 13B employs a ratchet mechanism 176 with spring loaded ball
detents 52 along the tensile member 84 to achieve the same effect
as described in 13A. The (ball) detents 52 are either resilient or
spring loaded so as to selectively lock within a cut out section 54
at the distal end of the catheter deployment system 6 by engaging a
push/pull mechanism moving the ball detents in a relative motion to
a stationary deployment system 6 sheath. FIG. 13C, shows an
embodiment similar to that in 13B, wherein the a ratchet mechanism
176 is provided that employs a sine wave-like structure instead of
spring loaded ball detents to similarly facilitate
adjustability.
[0105] FIGS. 14A to 14D illustrate the process of constraining a
tensioning structure 4 into a deployment catheter system 6 sheath.
FIG. 14A illustrates a generic embodiment of a tensioning structure
4 containing self-expanding (e.g., superelastic) components (anchor
32 and/or tensile member 84) in an unconstrained, resting geometry.
FIG. 14B illustrates the initial loading of thea tensioning
structure 4 within or into the inner lumen of the deployment system
6 sheath using a hooked wire or stylet 8 to pull the structure
within the lumen space. FIG. 14C continues the depiction of the
loading of tensioning structure 4 into the deployment system 6
sheath. Finally, FIG. 14D shows the deployment system 6 sheath with
the tensioning structure fully constrained therein. For deployment
within a target vessel, the process shown in FIGS. 14B to 14D can
generally be followed in reverse order with the exception that the
stylet 8 pushes the tensioning structure out of the sheath once it
is advanced to the desired location. Alternatively, the stylet 8
can maintain the position of the tensioning structure as the
deployment system 6 sheath is retracted. It should be noted that
deployment of tensioning structures incorporating deformable
components will be modified in that a balloon or other expandable
mechanism can be used to deform pertinent components after placing
at the desired implantable location. Details of deployment of at
least some of the tensioning members, given the particulars of the
device, may be apparent at least to skilled surgeons,
interventionalists and technicians.
[0106] Deployment of these and other tensioning structures
described below can be achieved 1) using a catheter-based approach
to access the endocardium, vasculature, or epicardium; 2)
surgically accessing the target site along the epicardium to insert
and secure the tensioning structures, as described in later
sections; or 3) using a combined surgical and catheter-based
approach. Described below is the method and process of deploying
tensioning structures into, within, or through the vasculature to
reinforce the left ventricle about an infarcted/ischemic region,
the mitral valve annulus to address mitral regurgitation or other
insufficiencies, or other anatomy. It should be noted that this
deployment process can be modified to enable positioning these
tensioning structures intravascularly and then anchoring directly
into or through the myocardium (or other tissue) to reinforce the
anatomy without being confined to the vasculature. In addition, the
deployment process can also be modified to enable positioning of
these tensioning structures extravascularly with anchoring directly
into or through myocardium (or other tissue) to reinforce the
anatomy without being confined to the vasculature.
[0107] The percutaneous approach to deliver and deploy a tensioning
structure is illustrated in FIGS. 6A and 6B. In these figures, an
introducing sheath or guiding catheter 5, as described above, is
percutaneously inserted into the right atrium 58 such that the
distal end of the delivery device enters the coronary sinus 26. The
delivery system catheter 6 can then be inserted through this
introducing sheath such that it enters the venous system of the
heart, and facilitates access to the target vessel at which
tensioning/support structure 4 selected is to be deployed. The
tensioning structure can take various forms such as shown in FIGS.
8A to 8E, 9A, 9B, 10A to 10C, 11, and 12 all of which can be
preloaded in the deployment catheter 6 prior to insertion into the
vasculature. Once the delivery system catheter 6 is positioned, the
stylet 8 is held in position while the catheter is retracted. As
shown in FIGS. 14A, 14B and 14D (viewed in reverse order),
retraction of the catheter 6 relative to the stylet 8 causes the
tensioning structure 4 to extend beyond the end of the deployment
catheter 6 deploying in the target vessel as shown in FIGS. 5A, 5B,
6A and 6B. FIGS. 7A and 7B show proper securing of a tensioning
structure according to the invention into a coronary vein after
withdrawal of the delivery system catheter.
[0108] Various visualization features can be used to aid in proper
deployment of a tensioning structure within the vasculature. A
fluoroscopic marker and/or ultrasonic markers can be used to
designate the side of the delivery system catheter in which the
inner surface of the tensioning structure resides, thereby
demarking the surface in which the tensioning structure curves.
[0109] Additional Tensioning Structure Anchor Formations
[0110] FIGS. 15A, 15B, 16A, 16B, 17A, 17B, 17C, 18A and 18B provide
alternative anchor types that can be deployed into the myocardium
34 itself, or though the myocardium and against the endocardium or
epicardium of the proximate ventricle or atrium to provide
interference with surrounding tissues to achieve the desired
attachment. FIGS. 15C, 15D, 17D, 17E, 18C, and 18D provide
additional anchor designs that can be deployed within the vessel
lumen, through the vessel wall, into the myocardium, or through the
myocardium and against the endocardium or epicardium or
combinations thereof. In circumstances where anchor formation 32
penetrates the vessel wall in venous structures, it is anticipated
that slow flow hemodynamics will cause expedient closure and
clotting of the pierced area. For myocardial placements, hemostasis
is maintained by the musculature tending to close around the
implant anchor preventing back-bleed. Common to each type of anchor
is that their effect is achieved through interference with or
engagement to surrounding tissues, though use of other anchoring
approaches such as adhesive joints, tissue welding, and the like
are within the scope of the present invention.
[0111] FIGS. 15A to 15D, 16A, 16B, 17A to 17E, and 18A to 18D show
various embodiments of anchors in constrained and expanded forms or
states. FIG. 15A and 15C show a constrained anchor 32 which when
expanded takes the form of a helix spiral or screw as shown in FIG.
15B and 15D respectively. FIGS. 16A and 16B show an anchor
formation 32 that features an expandable disc configuration. FIG.
16A shows a view of the disc in a constrained configuration and 16B
show the expanded form of the same. The disc structure of the
anchor formation in this embodiment may employ polymeric or
metallic coverings attached to the anchor formation 32. FIG. 17A
shows a collapsed/constrained view of a hook like wire structure
that can engage tissue. Upon expansion, the anchor can take the
form in FIG. 17B or 17C, the difference between the configurations
of FIG. 17B and 17C being the anchor formation 32 angle. FIG. 17D
shows a hook-like structure similar to that in 17A in a constrained
state with an expanded state subsequently shown in FIG. 17E. In
FIGS. 18A to 18D, yet another variation of a hook-like anchor 32 is
shown, in which a plurality of hooks is employment to increase the
anchoring strength by distributing load among the hooks. As above
these, anchor formations can be fabricated from superelastic
materials to self-expand into contact with tissue structures or
otherwise such as with deformable materials that require a balloon
or other expanding device to deform the anchor formations into an
enlarged, deployed state causing the anchor features of the anchor
formations to expand into engagement with tissue structures capable
of securing the tensioning structure at each end. Alternatively,
the anchors 32 can be fabricated from superelastic polymers,
deformable polymers, or rigid materials, depending on the anchor
design and required dimensions.
[0112] Cardiac Valve Annulus Tensioning Structures
[0113] An enlarged heart can also be associated with valvular
dysfunction and disorders. As myocardial hypertrophy progresses and
the circumference of the heart increases, valvular leaflets can
begin to separate and result in incomplete closure, incompetence
and blood regurgitation further exacerbating the degenerative cycle
of failure of the heart. The present invention offers a solution
for this disorder by the use of the tensioning structures in
vascular conduits about the annulus of the valve to apply radial,
tightening forces to restore valvular function by decreasing the
annulus diameter and the related stress.
[0114] The variations of the invention described in the section are
well suited for use in annulus reinforcement at the primary
vascular targets in the venous tree (i.e., coronary sinus 26, great
cardiac vein 16, and middle cardiac vein 28) especially since the
coronary sinus anatomically navigates the atrioventricular groove
178 defining the mitral valve annulus 108 as seen in FIG. 22A. This
particular target location provides an ideal location for
implantation of tensioning structures to provide palliation and/or
therapy. The tensioning structures described in this section are
capable of applying continuous or strain limiting tensile force to
resist diastolic filling pressure at the cardiac valve annulus to
provide therapeutic treatment for valve incompetency, its
associated detrimental role in the congestive heart failure
syndrome and/or to reduce the rate of or reverse the remodeling
that produces an enlarged annulus or heart chamber.
[0115] With initial reference to FIG. 19, a perspective view of a
heart is shown with the coronary sinus 26 and right atrium 58,
adjacent the inferior vena cava 78, broken in sections. The
coronary sinus 26 is shown along the atrioventricular groove 178 of
the heart. The coronary sinus 26 partially negotiates the mitral
valve and enters the right atrium at an ostium 76 located between
the inferior vena cava 78 and the tricuspid valve 180. Access to
the coronary sinus 26 during percutaneous catheterization involves
inserting an introducer sheath into a vein (e.g., femoral vein,
subclavian, etc.) and feeding a catheter, under fluoroscopy or
other imaging means, into the right atrium. An abrupt curve in the
catheter, or steerability incorporated in the catheter or other
separate guiding device, allows for feeding the end of the catheter
through the ostium 76 and into the coronary sinus 26. From here,
the tensioning structure 4 is advanced through the catheter or
another guiding device, or positioned into the coronary sinus over
the catheter (e.g., balloon catheter) into the desired positions
within the coronary sinus (or other target vessel), and
secured.
[0116] In FIG. 20, a perspective view is shown of a heart with the
right atrium 58 and right ventricle 58 shown broken in sections
exposed. The right ventricular outflow tract 72 (RVOT) is shown as
a potential securing location for the a tensioning structure 4.
Other proximal anchoring locations include the fossa ovalis 182,
the ostium 76 of the coronary sinus 26, the inferior vena cava 78,
the superior vena cava 80, the right atrial appendage (not shown),
the left atrial appendage (not shown), and the trabeculated tissue
of the right ventricle 58. Alternatively, the tensioning structure
4 can be anchored into or through the right atrial free wall 184 or
the right ventricle 24 by attaching the proximal end of the
tensioning structure to the myocardium or along the epicardial
surface.
[0117] Alternatively, the tensioning structure 4 can be passed
through the right atrium or right ventricle, and anchored to the
left ventricle or left atrium to provide further, more complete
coverage of the tensioning structure around or about the mitral
valve annulus. Of course, a similar approach can be used to cinch,
reinforce, or repair the tricuspid valve annulus 108.
[0118] FIG. 21 shows a perspective view of a heart 186 whose mitral
valve annulus 108 is reinforced with a tensioning structure 4
embodiment of the invention, with the device positioned and
anchored to limit expansion of the mitral valve and also to tighten
the mitral valve. The tensioning structures 4 reduce radially,
stiffen, and/or support the mitral valve by cinching the annulus
similar to tightening as a purse-string; the tensioning structures
also limit the localized forces exerted directly against the valve
annulus.
[0119] In this example, the tensioning structure 4 is again shown
deployed in the coronary sinus 26 such that it navigates the mitral
valve annulus. The distal end 188 of the tensioning structure 4 is
secured in the coronary sinus, great cardiac vein, or other
branching vessel by an anchor 32, adapted for engagement to or
through venous tissue, to which the tensile member 84 is secured
(or integrated). The proximal end 190 of tensioning structure 4 is
secured at the right ventricular outflow tract 72 (RVOT) with
another anchor 32 adapted for attachment to this specific
attachment site. For example, a stent anchor having a significantly
larger expanded diameter can be inserted into the RVOT and expanded
(using a balloon or via self-expansion) to lock the proximal end
190 of the tensile member 84.
[0120] In contrast, other annulus supports that do not extend the
reinforcement device into engagement with or beyond the ostium may
provide insufficient coverage around the mitral valve annulus
because the attachment position and the length of the anchoring
modality within the coronary sinus dramatically reduces the angular
coverage around the mitral valve annulus. Instead, securing the
proximal end of tensioning structure 4 to the RVOT 72 allows for
reinforcing a larger amount of the mitral valve annulus since the
tensioning structure is able to reinforce the valve annulus 108
from the great cardiac vein 16, along the coronary sinus 26, past
the ostium 76 into the right atrium 58, along the interatrial
septum 192, past the tricuspid valve 180, into the right ventricle
24, and terminating at the RVOT 72, as illustrated in solid and
broken line
[0121] When securing a tensioning structure to the right atrial
free wall, the right ventricle, the left atrium, or the left
ventricle, the guiding catheter or introducing sheath used to
position the tensioning structure into the coronary sinus can be
placed through the right atrium or right ventricle during surgical
access to the interior of the right atrium. Alternatively, the
catheter can be percutaneously placed and be advanced through the
right atrial appendage (not shown) or right ventricle 24 from the
inside of the chest cavity. Once the distal end of the tensioning
structure is positioned and the corresponding anchoring mechanism
secured, the introducing sheath can be retracted, thereby allowing
the proximal end of the tensioning structure to expand into the
myocardium or against the epicardium of the right atrium or right
ventricle. Alternatively the proximal anchor mechanism can be
manually set by deforming the same using a balloon or other
expansion mechanism, as described below. Still further, the
proximal anchoring mechanism can be manipulated into contact with
the left atrium or left ventricle and secured, also to provide
increased coverage of the tensioning structure around the annulus.
Similarly, the guiding catheter or introducing sheath used to
position the tensioning structure into the coronary sinus can be
used to position the proximal anchoring mechanism into or through
the myocardium of the right atrium or right ventricle. Additional
features can be required for this approach including a puncturing
mechanism to penetrate into or through the myocardium, as will be
described below.
[0122] FIG. 22A shows a side view of the heart open in sections,
with a tensioning structure 4 secured within the coronary sinus 26
with a distal anchor (not shown) and a proximal anchor 32 attached
at the ostium 76 into the coronary sinus 26. The distal anchor can
comprise one of the various anchor formations described in the
preceding sections of the detailed description. As shown in FIGS.
21, 22A to 22F, 24, and 25, the tensioning structures 4 of the
invention generally extend into engagement with or beyond the
ostium 76 of the coronary sinus, thereby covering the mitral valve
annulus from the great cardiac vein 16 past the coronary sinus
ostium 76. This significant amount of coverage provides sufficient
reinforcement to the annulus to regulate and withstand the internal
forces that would otherwise perpetuate the remodeling process
and/or adversely affect valve competency.
[0123] Securing the tensioning structure 4 proximal end at the
ostium of the coronary sinus is facilitated by a device design
including a stop feature integrated with the proximal anchor 32 to
prevent migration of the tensile member 84 back into the coronary
sinus. This can be accomplished by a myriad of anchor member
embodiments described below. These proximal anchors 32 can be, for
example, plastically deformable from a small diameter to an
enlarged profile (using a balloon expandable catheter) to allow
positioning part of the anchor in the right atrium outside the
periphery of the orifice 76 thereby acting as a stop which
interferes with the atrial wall to prevent the anchor from
dislodging into the lumen of the coronary sinus. Alternatively, the
proximal anchors 32 can be fabricated from superelastic material
capable of elastically deflecting into a low profile for deployment
and returning towards a preformed shape once external compressive
force is removed. This preformed shape could provide the required
interference at the ostium as well.
[0124] A minimally invasive surgical approach for deployment of the
present embodiment is provided in FIGS. 22B to 22F. These figures
show a tensioning structure 4 that has its proximal end 190 secured
through the right atrium and against the right ventricular
epicardium. The tensioning structure can be deployed using a
catheter delivery system capable of puncturing through the right
atrium 58 from inside the heart to deploy and secure the proximal
anchor after positioning the distal anchor. Alternatively, as shown
in FIGS. 22B to 22F, a surgical approach may be to puncture the
right atrium from the epicardial surface and then place a delivery
system catheter 6 into the coronary sinus. After deploying and
securing the distal anchor 32, the delivery system catheter is
retracted past the insertion site leaving the tensioning member 84
behind in the coronary sinus 16 and right atrium 58. A purse-string
can be used to ensure hemostasis at the insertion site, around the
delivery catheter during deployment of the distal anchor or around
the tensile member 84 after removing the delivery catheter. The
proximal anchor 32 is then engaged and secured against the
insertion site 194, the right atrium 58, the right ventricle 24 (as
shown in FIG. 22F), the left atrium 74, the left ventricle 18, or
other anatomic structure capable of maintaining tension to the
tensioning member 84. It should be noted that the same approach can
be used to deploy the tensioning structure through the right
ventricle 24, the inferior vena cava 78, the superior vena cava 80,
or other anatomy.
[0125] FIG. 23 shows a side-sectional view of a coronary sinus 26
(or other vessel) that overlays or is otherwise in close proximity
to a coronary artery (or other vessel) with a tensioning structure
4 positioned and secured within the coronary sinus. As shown in
FIG. 23, the spaced apart distal anchors 32 of the tensioning
structure are short relative to the length of the coronary sinus
(or other target vessel) and are interconnected by the more
flexible tensile member 84, so they can be positioned and secured
away from the overlaying vessel 82. That way, the tensioning
structure does not occlude the overlaying vessel. More than two
anchors 32 can be used to further distribute the forces along the
coronary sinus (or other vessel) and ensure overlaying vessels are
not compromised once the tensioning structure is secured. By
placing anchors on each side of the overlaying vessel 82, the
coronary sinus is supported throughout this region to ensure the
tightening, or compressive forces exerted by the tensile member 84
do not constrict the overlaying vessel 82.
[0126] FIG. 24 shows a perspective view of a heart 2 cut away
broken along the right atrium 58 and right ventricle 24 with
another tensioning structure embodiment 4 deployed within the
coronary sinus 26 and having the proximal anchor 32 secured to the
RVOT 72. As opposed to the embodiment in FIG. 21, in which the
proximal anchor 32 is fabricated as a tubular member or spiral
component configured to contact the RVOT 72 throughout a
cross-sectional region of tissue, the embodiment in FIG. 24 shows a
proximal anchor 32 defining a hook or pigtail capable of taking
advantage of the tortuosity of the RVOT 72 relative to the coronary
sinus which grapples or engages onto or within the RVOT 72.
[0127] FIG. 25 shows a perspective view of a cut-away heart with a
tensioning structure positioned within the coronary sinus 26 and
secured to the ostium 76 with the use of a balloon expandable stent
(or self-expanding stent) as the proximal anchor 32. The fully
expanded diameter of the stent (anchor 32) is larger than the inner
diameter of the coronary sinus 26 to ensure that the stent does not
migrate back into the coronary sinus 26 upon deployment. This
ensures that the forces, which are applied when deploying the
tensioning structure, are maintained continuously.
[0128] Such proximal anchor configurations are easy to deploy
since, after securing the distal anchor, tension is applied to the
tensile member 84 by retracting the proximal anchor until the
appropriate tightening or cinching of the valve annulus is
achieved; at this position, a balloon can be used (for balloon
expandable proximal anchors) to over-expand the proximal anchor
such that the region outside the coronary sinus orifice has a
substantially larger outer diameter than the inner diameter at the
orifice. This configuration permanently locks the tensioning
structure in the plastically-deformed position. Self-expanding
proximal anchors can be released from an external, compressive
sheath that maintains the anchors in a compressed, low profile
state during positioning pre-deployment. It should be noted that
such proximal anchors can be configured to be used at any vessel
ostium that is to be reinforced. It should also be noted that other
expandable (balloon deformable or self expanding) anchor
configurations can be used at the orifice with or without barbs
that actively engage the interior surface of the tissue (i.e.,
right atrial wall).
[0129] FIGS. 26A to 26D show side-sectional views of vessels 56
containing the distal anchor region of a tensioning structure
illustrating various attachment points between the tensile member
84 and anchor 32. FIG. 26A shows an embodiment where the tensile
member 84 is bonded to the near, inside edge 196 of the anchor 32.
FIG. 26B shows an embodiment where the tensile member 84 is bonded
to the far, inside edge 197 of the anchor 32. FIG. 26C shows an
embodiment where the tensile member 84 is bonded to the near,
outside edge 198 of the anchor 32. Finally, FIG. 26D shows an
embodiment where the tensile member 84 is bonded to the far,
outside edge 199 of the anchor 32. Indeed, the tensile member can
be bonded to any region of the anchor 32 as required or desired.
Suitable fixation methods to join the tensile member 84 to the
anchor 32 include chemical bonding, tying, welding, adhesive
bonding, mechanical crimping, combinations thereof or any other
suitable fixation means.
[0130] When the anchor provided used is a stent like anchor
formation (balloon expandable or self-expanding), as shown in FIGS.
26A to 26D, the anchor preferably has a length that is preferably
more than 1.5 times the inner diameter of the target vessel (e.g,
coronary sinus). Stent-like anchors are most suitable for small and
medium diameter vessels, such as the coronary sinus; other anchors
may be better suited for other attachment points, such as the RVOT
72. The location of the bond/attachment between tensile member 84
and anchor 32, as shown in FIGS. 26A to 26D, ensures stability of
the anchor as tension is applied because tension causes the anchor
to slightly rotate in the target vessel increasing the engagement
of the anchor to the target vessel and preventing axial
dislodgement. If the tensile forces are applied in a purely axial
manner, instead of providing some torque, then the risk of
dislodgment increases, but since a slight rotation is caused by
tension and the length of the anchor is greater than the inner
diameter, the anchor pull-out forces increases as applied tension
to the anchor increases.
[0131] It should be noted that the tensile member 84 can be
integrated to the anchor as opposed to being bonded or joined as
separate components. For the integrated configuration, these
anchors can be fabricated from one or more strands of material that
form a helix, mesh, open cell, or other anchor geometry and emanate
into one or more strands that produce the tensile member. For the
non-integrated condition, any anchor configuration can be
bonded/attached to a tensile member to form these two components of
the tensioning structure.
[0132] It will often be preferred to maximize flexibility of the
tensile member 84 to aid in the traversal of tortuous anatomy in
order facilitate percutaneous and/or minimally invasive surgical
approaches structure of deployment. Accordingly, materials that are
most suited to fabricate tensile member 84 will have a high degree
of flexibility in the bending direction or, otherwise stated, have
zero or minimal buckling resistance. In addition, this preferred
material should have resistance to tensile elongation unless
elasticity is a desired component for the tensile members, in which
case, the tensile member enables temporary elongation with
corresponding recoil. Materials that creep are not preferred since
they might prompt the need for undesired, post-surgical tensioning
structure adjustment.
[0133] FIGS. 27A to 27C show close-up views of three anchor
configurations 32 and the attachment of non-integrated tensile
members 84 to the anchors. FIG. 27A shows an anchor 32 formed from
a mesh or braid of raw material strands and a tensile member tied
to the intersection of the strands. Alternatively, as alluded to
above, tensile member 84 can be glued, ultrasonically welded, spot
welded, soldered, or bonded with other means, depending on the
types of materials used. It should be noted that the anchor(s) 32
and/or tensile member(s) 84 can be fabricated from metallic
materials such as stainless steel, nickel titanium, titanium, or
other metal or alloy; superelastic polymers; biological materials
such as pericardium, collagen, submucosal tissue, skeletal muscle,
and vascular tissue (e.g., saphenous vein, radial artery, or other
artery or vein), genetically engineered tissues; or other materials
such as nylon, polyester, polypropylene, expanded PTFE, polyimide,
silicone, PET, polyurethane, urethane composites, thermoplastic
materials, thermoset plastics, composites of such materials, or
other biocompatible material. FIG. 27B shows an anchor 32
fabricated from a tube or other raw material geometry laser cut
into the desired pattern of cells and other features with a tensile
member 84 bonded thereto. It should be noted that laser cutting,
chemical etching, water-jet cutting, or other cutting mechanism can
be used to create the anchor and the tensile member as an
integrated unit from a single piece of raw material (tube stock,
sheet stock, or other geometry).
[0134] FIGS. 28A to 28M illustrate various anchor 32 embodiments
with attached or integrated tensile members 84. FIG. 28A shows an
anchor 32 with radial protrusions to further embed the anchor into
the target vessel wall and increase the pull-out forces as tension
is applied through the tensile member 84. FIGS. 28B to 28F show
alternative anchor embodiments with bonded or integrated tensile
members 84 that incorporate radially extending elements ideally
suited for the proximal anchor configured to be secured to the
ostium of the coronary sinus (or other target vessel), the
trabeculae of the right ventricle, the interatrial septum, the
inferior vena cava, the superior vena cava, or the RVOT 72. The
anchor embodiments in FIGS. 28A to 28F can also be used to secure
tensioning structures 4 within the myocardium or against the
epicardial or endocardial surface during surgical or catheter based
reinforcement procedures where the tensioning structures 4 are
positioned into or through myocardium.
[0135] FIGS. 28G and 28H show alternative anchor embodiments with
attached or integrated tensile members ideally suited for attaching
to any size vessel (e.g., coronary sinus 26, RVOT 72, inferior vena
cava 78, superior vena cava 80, etc.), the ostium to the target
vessel, the fossa ovalis, or other anatomic structure. The anchor
embodiments in FIGS. 28G and 28H can also be used for tensioning
structures 4 that are inserted through myocardial tissue where the
anchor members abut the endocardial or epicardial surface,
depending on placement location of the tensioning structures, and
do not further penetrate into or through the endocardial or
epicardial surface engaged to secure the anchor. FIGS. 28I to 28M
show additional anchor embodiments with secured or integrated
tensile member(s) suited for any size vessel. These embodiments
directly engage the vessel and partially or completely penetrate
into the vessel wall to secure the tensioning structure. Again, all
of these anchor embodiments can be used to secure tensioning
structures 4 into or through myocardial tissue for indications
where the tensioning structures are used to reinforce an
infarcted/ischemic zone by passing tensioning structures along or
through the zone from outside the border of the zone into the
region of the zone, or from opposing sides of the zone passing
through the infarcted/ischemic zone.
[0136] Post placement and anchoring of tensioning structures it
would be desirable to adjust the tension in the structure
intraoperatively and post operatively as needed. For example, FIG.
29 shows an embodiment of the proximal anchor that incorporates a
mechanism to variably tighten the tensile member 84 relative to an
anchor. A ratcheting mechanism is shown with elastic balls or other
teeth-like mechanisms able to retract in one-direction to increase
tension applied to the tensile member 84 and prevent release of the
tension applied. Such a mechanism enables variably adjustment and
tightening of the annulus, or other tissue region, intraoperatively
and postoperatively as the tissue heals and recovers.
[0137] When deploying tensioning structures to reinforce or tighten
a mitral or tricuspid valve annulus via catheter-based approach, an
introducing sheath or guiding catheter can be percutaneously
inserted into the right atrium 58 such that the distal end enters
the coronary sinus 26. Alternatively, the delivery system can be
inserted directly through the right atrium. (e.g., at the right
atrial appendage) or the right ventricle to access the coronary
sinus during surgical procedures. A catheter-based delivery system
approach would involve insertion through an introducing sheath
positioned in the femoral vein into the venous system of the heart
such that it facilitates access to the target vessel into which the
tensioning structure 4 is to be deployed. The tensioning structure
can take various forms as described above all of which can be
preloaded in the deployment catheter prior to insertion into the
vasculature.
[0138] In the preferred embodiment, the delivery system catheter is
a balloon catheter capable of expanding with pressure to an
enlarged diameter forcing the tensioning structure anchor
(especially those with stent-like characteristics) radially outward
into engagement with the interior surface of the vessel or other
associated anatomy. After securing the first anchor, other anchors
can be sequentially (or simultaneously) deployed with the same or
other balloons. Alternatively, the anchors can be self-expanding
and constrained within a guide catheter used for deployment. A
stylet or multiple stylets can be used to sequentially or
simultaneously deploy the anchors as tension is applied. It should
be noted that balloon expandable and self-expanding anchors can be
utilized on the same tensioning structure and the deployment
catheter can incorporate balloon catheters and guiding catheters
collaborating to deploy the anchors at targets. Various
visualization features can be used to aid in proper deployment of
tensioning structures within the vasculature. For example, a
fluoroscopic marker and/or ultrasonic markers can be used to
designate the side of the deployment catheter in which the inner
surface of the tensioning device resides; this demarks the surface
in which the tensioning structure curves.
[0139] An important benefit of percutaneous approach to place and
anchor tensioning structures is the ease of deployment and the
rapid healing post procedure. The endovascular approach to remotely
access the target sites eliminates the need for traumatic or more
invasive surgical methods to access the target structures. The
incision to facilitate positioning and subsequent delivery and
deployment of the support structures is minimal, most likely with
only local anesthesia, and accordingly the procedure can be
conducted on an outpatient basis. The technique typically involves
navigating the distal end of a catheter along a tortuous path
extending along the lumens defined by the patient's vasculature
between a point of entry into the patient's body and the remote
target site.
[0140] It would be advantageous if the cross-sectional dimensions
of such catheter or less invasive deployment system, and
constrained tensioning structures could be reduced. This would ease
the task of navigating such deployment systems along tortuous paths
through body lumens, especially lumens having relatively small
internal diameters. Minimizing the profile of the tensioning
structures and deployment systems also facilitates insertion of
tensioning structures described in this specification through heart
tissue (myocardium) or other tissue without compromising integrity
of the tissue or causing excess bleeding through the tissue.
[0141] The delivery system and process for placement of the anchors
32 can also feature means to facilitate adequate fluoroscopic
visualization of vessel structures where the structure is to be
positioned to ensure optimal performance. The ideal design for such
a delivery system (catheter) is to include a lumen at the distal
tip of such means having sufficient cross-sectional area to
facilitate suitable flow rates for injections of conventional
contrast media used in standard interventional catheterization
procedures. The lumen exit at the distal tip can be arranged so as
to communicate along the length of the catheter body such that the
proximal end can be connected to manual or automatic injection
means, allowing the operator to hydraulically force the contrast
media through the luminal space within the catheter. The contrast
can then exit at the distal end of the catheter at the luminal
opening or port and flow into the blood stream. The injected
contrasted would then enable kinetic visualization and mapping of
the vasculature as it flows with the blood when monitored under a
fluoroscope.
[0142] The ability to image at the distal tip of the deployment
means is also ideal since the apposition of the anchor 32 relative
to the vessel wall can be well characterized prior to application
of tension. Also, the anchor 32 and the surrounding vessel wall can
be assessed for damage to the wall due to catheter manipulations,
deployment of the anchor 32, or damage at the anchor 32 itself.
[0143] FIG. 30 shows a cross-sectional view of a representative
distal tip 86 of a delivery system catheter capable of deploying
the tensioning structure, illustrating the expandable balloon 92, a
balloon expandable anchor formation 32, a lumen for contrast
injection 88, and a guide wire lumen 90. The lumens can be
configured in various geometries using standard plastic processing
techniques such as extrusion. Ideally, the guide wire lumen 90 is
located at the center of the catheter to facilitate coaxial
delivery of the delivery catheter over standard guide wires in the
preferred embodiment. The contrast lumen 88, can be positioned to
exit at the tip or cut out of the sidewall of the lumen. The
contrast lumen 88 diameter should be ideally sized to allow
sufficient flow rates to inject radiopaque contrast media using
standard interventional technique.
[0144] FIG. 31A shows the distal segment 86 of the delivery system
catheter in a vessel prior to deployment of a distal anchor 32. The
unexpanded balloon 92 with an anchor 32 crimped over its outer
surface is shown traveling over a guide wire 94 to the distal
vessel segment deployment target. FIG. 31B displays the expansion
of the expandable balloon 92 inflated preferably with saline to
deploy (i.e.,plastically deform) the anchor 32 against the inner
lumen of the vessel. FIG. 31C exhibits the retraction of the
delivery catheter (in the direction of the arrow shown in the
illustration) leaving the deployed anchor 32 behind at the vessel
target location with tensile member 84 attached and extending
proximal to the anchor. The tensile member 84 can be housed within
the guide wire lumen 90, contrast lumen 88, a lumen of it's own
(not shown), or outside the catheter to facilitate smooth,
untangled delivery of the tensile member 84.
[0145] FIGS. 32A, 32B, and 32C shows the deployment of a proximal
anchor 32 into the ostium of the coronary sinus located within the
right atrium 76. In this embodiment, the anchor 32 is of the
self-expanding variety and is shown with a retractable sheath
system at the distal tip of the delivery system catheter 86. This
system facilitates deployment and constraining of the anchor by the
operator. In FIG. 32A, the delivery system catheter tip is shown
with the tensile member 84 extending beyond the distal tip of the
catheter. The termination of the tensile member is configured for
attachment to a balloon expandable anchor 32 as shown in FIG. 31C
or alternatively to a self-expanding anchor structure 32 as shown
in FIG. 32C. FIG. 32B displays the self-expanding anchor 32
structure partially deployed in the coronary sinus 26. FIG. 32C
displays the self expanding anchor structure 32 fully deployed
within the ostium 76 with a flared or trumpeted end to enable
mechanical lock up to fully secure the tensioning structure at the
ostium.
[0146] FIG. 33A and FIG. 33B show cross-sectional areas of a
coronary sinus 26 (or similar conduit) and the tensile member 84.
FIG. 33A shows a smaller contact surface area 164 of the tensile
member 84 to the inside wall of the coronary sinus 26 than that of
FIG. 33B. A larger contact surface area 164 provides a means to
reduce the stress from the loading of the tensile member 84 to the
coronary sinus 26 and other adjacent venous structures to minimize
the propensity for abrasion/trauma to or through the vessel wall.
As such, the tensioning member 84 of the tensioning structure 4
described above can be fabricated from a rectangular or ovalized
strip of flexible tensioning material such as expanded PTFE, FEP,
polypropylene, PET, polyester, nylon-based materials, silicone,
urethane derivatives, absorbable materials, cellulose acetate,
regenerated cellulose, biological materials (e.g., pericardium,
submucosal, saphenous vein, other vein or artery, skin, tendon,
other collagen based material, strips of skeletal muscle, etc.).
When metals or alloys are used as the tensioning member 84, they
can be fabricated into a mesh, helix, sinusoid, elliptical bar,
rectangular bar, or other geometry designed to distribute the
stress applied to the vessel wall or other tissue structure when
tension is applied to tighten the annulus or otherwise apply forces
to the vessel or other tissue. Alternatively, a jacket of these
same materials can be coaxially arranged over an inner tensile
member component to achieve the same effect.
[0147] FIGS. 34A to 34E and 35A to 35D show additional proximal
anchor embodiments capable of securing the tensioning structure to
the coronary sinus orifice. These embodiments show tightening
capabilities described in FIG. 29 above. FIG. 34A and 34B show a
split wall anchor 166 designed to plastically deform into an
expanded orientation partially within the coronary sinus and
partially expanded beyond the outer diameter of the coronary sinus
orifice to prevent movement or relaxation of the tensioning
structure. A ratcheting or ball locking mechanism is incorporated
in the side of the anchor such that as the tensioning member 84 is
retracted relative to the anchor, the tensioning member becomes
incrementally tighter as the locking balls or teeth are pulled into
the mating latch of the anchor. This embodiment can alternatively
be fabricated as a self-expanding anchor by utilizing superelastic
components that transform into or maintain their austenite phase
during deployment.
[0148] FIGS. 34C and 34D show a laser cut anchor locking mechanism
pre- and post-forming. The anchor embodiment in FIG. 34E
incorporates the formed locking mechanism 168 in FIG. 34D attached
to the anchor mechanism, in this case a balloon expandable (or
self-expanding) stent. The locking mechanism 168 in FIGS. 34D and
34E consists of radial extensions cut into the raw material as
shown in FIG. 34C defining a one-way deflectable lock allows that a
tensile member containing ratcheting teeth, balls, or other
mechanism to move one way while inhibiting movement in the opposite
direction. FIG. 34E shows the completed anchor assembly 32 which
defines a mesh or open cell stent-like anchor (plastically
deformable or self-expanding) capable of anchoring the tensioning
structure to the coronary sinus orifice and orienting the mesh or
open cell structure to produce a locking mechanism capable of
engaging and restraining the ratchet teeth, balls, or other locking
mechanism of the tensile members.
[0149] FIGS. 35A to 35D show another anchor embodiment capable of
securing the tensioning structure to the coronary sinus orifice and
incorporating a latching mechanism capable of engaging and locking
mating components (teeth, balls, or other feature) of the tensile
member 84 to enable manual tightening or adjustment of the
tensioning structure once deployed. FIGS. 35A and 35B show a side
view and a perspective view of an anchor containing a
self-expanding (or plastically deformable) anchoring loop or loops
156 capable of engaging the right atrial, endocardial surface
immediately adjacent to the coronary sinus orifice to prevent
migration of the anchor into the coronary sinus once deployed and
tension is applied. The housing that holds the anchoring loop 156
preferably constructed from a material that provides spring-like
properties. The groove and slot shown in FIGS. 35A and FIG. 35B
would act in combination as a living hinge 154 facilitating passage
of the ball detents 52 or knots 102. The inner conical lead-in 170
in combination with the living hinge 154 allows unidirectional
ratcheting. FIG. 35C shows the tensile member 84 with locking
features (in this case, balls 52 that engage the mating locking
mechanism 168 of the anchor) being pulled through a channel to move
toward the orifice thereby applying tension to the tensioning
structure while preventing movement of the tensioning element in
the opposite direction. FIG. 35D shows additional features of the
deployment system. In this embodiment, the guiding catheter
contains a channel through its side wall for the tensile member to
pass such that tension can be applied through the guiding catheter
whereby the distal segment of the guiding catheter can stabilize
the anchor while applying the desired tension to ensure the
tensioning member locking mechanism engage the mating components of
the anchor. This channel through the sidewall can also incorporate
a blade (movable or stationary) capable of cutting the excess
tensile member after the tensioning structure is deployed and
tightened in place.
[0150] The deployment systems and tensioning structures described
above for reinforcing a mitral or tricuspid valve annulus can
alternatively be used to reinforce infarcted and ischemic zones by
positioning and securing tensioning structures intravascularly, as
described previously, or directly into or through myocardium, as
described below.
[0151] Myocardial Tensioning Structures
[0152] The tensioning structures 4 described above can additionally
be positioned through or into myocardium to locally reinforce
infarcted/ischemic zones and maintain wall motion adjacent to and
throughout those zones. This aids cardiac output by increasing the
left ventricular ejection fraction and wall motion throughout the
heart thereby improving efficiency and reducing the effects of
congestive heart failure aiding the process of reverse
remodeling.
[0153] The delivery systems described above can additionally be
used to insert the anchors of the tensioning structures into or
through myocardium where they engage the myocardium, the
epicardium, or the endocardium and attach the tensioning structures
to the heart. These delivery systems can percutaneously access the
desired attachment site through a catheter-based approach where a
guiding catheter is passed retrograde through the aorta and into
the left ventricle, transeptally through the interatrial septum
from the right atrium and past the mitral valve into the left
ventricle, or through the right atrium past the tricuspid annulus
and into the right ventricle. With this catheter-based approach the
tensioning structures are individually deployed into engagement
with trabeculae or other endocardially located anatomic structures,
through the endocardial surface into the myocardium, or through the
myocardium where they engage the epicardial surface.
[0154] Alternatively the catheter-based or minimally invasive
surgical approaches can access the epicardial surface by puncturing
the right or left atrial appendage (which can be closed after the
procedures), the inferior or superior vena cava, or other venous
structures that can be closed readily after performing the
procedure. In these cases, the tensioning structures are deployed
through the epicardial surface into the myocardium or through the
myocardium into engagement with the endocardium.
[0155] The delivery systems described above can also be used to
deploy the tensioning structures through a thoracotomy,
thoracostomy, subxiphoid access, median sternotomy or other
surgical access. This way the deployment system can access the
heart along the epicardium or endocardium and position the
tensioning structures at the desired locations in the heart.
[0156] Many of the embodiments described previously incorporate a
tensile member 84 terminating at anchor mechanisms 32 at each end.
The embodiments described below are specially configured to be
positioned into or through the myocardium and define anchor
mechanisms augmented by the inherent structure and deployment
process and/or can incorporate one or more anchors to aid in
positioning and securing the tensioning structures 4 in place.
[0157] FIGS. 36A to 36D show a delivery system capable of
simultaneously and/or independently inserting opposite ends or
terminals of a tensioning structure through or into myocardium via
a catheter-based or surgical approach. The discussion for this
embodiment is described from a surgical approach initially
inserting the tensioning structures through the epicardium to
access the myocardium; although it should be noted that a
catheter-based approach can be utilized with these embodiments if
modified for percutaneous access and fluoroscopic visualization
requirements facilitating insertion of the tensioning structures
either through the endocardial surface to access to or through the
myocardium. The delivery system embodiment shown in FIGS. 36A to
36D involves a pair of puncturing devices fabricated from
superelastic materials (e.g., nickel titanium), metals (e.g.,
titanium) or other alloys (e.g., spring stainless steel) exhibiting
sufficient elasticity and spring characteristics to compress into a
low profile for insertion through a tissue surface and controllably
expand as the puncturing devices are extended beyond the confines
of the sheath used to apply the external force to compress the
puncturing devices. The delivery system embodiment in FIGS. 36A and
36B show the puncturing devices compressed into a low profile
inside a sheath (single lumen or multi-lumen with a dedicated lumen
per puncturing device) having sufficient radial strength and column
strength to straighten the puncturing devices. Each puncturing
device incorporates a holder that engages a free end of the tensile
member 84 of the tensioning structure, and advances or retracts the
tensile member 84 as the puncturing device is advanced or
retracted. This delivery system enables placing an independent
tensile member 84 (without anchors) into or through myocardium and
securing it to apply tension along an infarcted/ischemic zone to
reinforce the zone. As implanted, the tensile member can contract
and expand in conjunction with the wall motion about the border of
the infarcted/ischemic zone.
[0158] FIGS. 36E to 36H show perspective and side views of two,
3-dimensional, cinching, tensioning structure embodiments that
inherently define anchors at each end of the tensioning structure.
These embodiments comprise at least one tensile member 84 (in these
embodiments, only one tensile member is shown) supporting at least
one stress distributing tube either secured 146 or movable 148 in
relation to the tensile member 84.
[0159] As FIGS. 36E to 36H show, the stress distributing tubes,
secured 146 to the tensile member 84, are located at the proximal
end naturally forming a loop when opposite sides of the tensile
member 84 are positioned at spaced apart insertion sites. This loop
forms an anchor 96 and the secured 146 stress distributing tubes
prevent highly localized stress from being applied against the
tissue surface at the insertion or exit points of the tensile
member 84.
[0160] In the embodiment shown in FIGS. 36E and 36F, the secured
146 stress distributing tubes are located at the insertion sites
for the proximal anchor 96 and the exit sites for the sides 98 and
100 of the tensile member 84. As such, the stress distributing
tubes locally increase the stiffness of the tensioning structure at
the insertion and exit sites to direct the tension applied to the
tissue region between the stress distributing tubes. In addition,
the secured 146 stress distributing tubes increase the surface area
of the tensile member at the insertion and exit sides to distribute
the force applied against the tissue along a larger surface
area.
[0161] In the embodiment shown in FIGS. 36G and 36H, the secured
146 stress distributing tubes are located along the proximal anchor
96 and between the insertion and exit sites to regulate the amount
of cinching, upon applying tension to the tensile member 84, along
the plane defined by the length of the proximal anchor 96 loop and
the plane defined by the space between the insertion and exit
sites; two of the three planes defined by the 3-dimensional
cinching tensioning structure. The third plane is defined by the
relationship between the secured 146 and movable 148 stress
distributing tubes. In this embodiment, the secured 146 stress
distributing tubes limit the cinching and can vary the ratios of
cinching along each plane by changing the cross-section thickness,
the material type, the length of the tubes, or other parameter
capable of making the tubes more flexible or rigid.
[0162] The secured tubes 146 can be fabricated by injection
molding, extruding, ultrasonic welding, adhesive bonding, or by
mechanically securing a covering over the tensile member 84 at
defined locations. The secured tubes 146 can comprise a tubular,
elliptical, rectangular, or other cross-sectional geometry. The
secured tubes 146 can consist of materials such as expanded PTFE,
silicone, cellulose acetate, regenerated cellulose, polyester,
polypropylene, nylon-based materials, urethane or its derivatives,
biological tissues (e.g., vessels, collagen based tissue
structures, etc.), metals, alloys, other material capable of
distributing stress over a length of the tensile member, or a
composite of such materials.
[0163] The movable 148 stress distributing tubes can be fabricated
with the same processes, parameters, and materials as the secured
146 tubes described above provided the tensile member 84 can be
pulled through the movable 148 stress distributing tubes. After
placing the free ends of the tensile member 84 through myocardial
tissue and pulling the free ends beyond the tissue surface, the
movable (148) stress distributing tubes can be advanced over the
tensile member 84 and positioned into the myocardial tissue. Once
the stress distributing tubes are positioned, the tensile member
can be tied into a knot 102 to compress the tissue region
throughout the defined 3-dimensional region. The movable 146 stress
distributing tubes can also comprise additional features such as
flared proximal ends to abut the tissue surface to ensure
hemostasis at the insertion and/or exit sites, and internal gaskets
also to ensure hemostasis once a tensile member is advanced through
a tube.
[0164] In the embodiments shown in FIGS. 36E to 36H and described
above, the secured 146 and movable 148 stress distributing tubes
prevent excess reduction or compression in the myocardial wall
thickness upon application of tension to the tensioning structure.
As such, the three-dimensional cinching tensioning structure is
capable of compressing the region of myocardium along the tissue
surface to reverse the remodeling effect and support the tissue
region without applying excess force along the plane defined by the
thickness of myocardium.
[0165] The three-dimensional, cinching, tensioning structures
described above also exhibit required features to ensure the
appropriate amount of compression against the tissue region is
applied without tearing or damaging the tissue. A simple suture
defines a highly localized stress concentration; especially at the
insertion and exit puncture sites capable of cutting and severely
traumatizing the tissue. In addition, a simple suture does not
regulate the amount of compression applied along each of the three
planes defined by the three-dimensional, cinching, tensioning
structures; as such the myocardial wall thickness can be
dramatically and undesirably reduced upon tightening without
applying the desired compressive forces.
[0166] FIGS. 37A to 37C show the steps of placing a tensioning
structure 4, such as shown in FIGS. 36E to 36H, through myocardium
using the delivery system shown in FIGS. 36A to 36D. Each free end
of the tensile member is placed through a holder 64 of a puncturing
device and the puncturing devices are compressed inside the
deployment sheath. In the minimally invasive surgical approach, it
is preferred that the two puncturing devices are placed in contact
with the epicardial surface as shown in FIG. 37A (or alternatively
can be placed into contact with the endocardial 70 surface for
catheter-based or open surgical procedures). The puncturing devices
are designed to penetrate the epicardium with sharpened or beveled
tips 66 at spaced apart intervals. Prior to inserting the
puncturing devices, the tensile member 84 can be placed through a
pledget 118 or other atraumatic surface (e.g., an ePTFE patch,
polyester patch, other synthetic patch, a piece of pericardium,
muscle or other tissue) to add additional support at the anchor and
provide additional strain relief to the underlying tissue once the
tensile member is tightened, not shown. As FIG. 37B shows, the
puncturing devices 62 are advanced through the deployment sheath 60
at which time they expand toward their preformed configuration
channeling through myocardium to define a space for the tensile
member to pass. Alternatively, the puncturing devices 62 can pass
the tensile member 84 from the epicardial surface through the
myocardium, past the endocardium, along the endocardium, and back
to the epicardium. Once the puncturing devices have advanced the
ends of the tensile member through the heart wall and back past the
epicardium, the ends of the tensile member are removed from the
holder and the puncturing device is subsequently removed from the
heart. The free ends of the tensile member are then tied together
thereby tightening and compressing a region of the heart wall.
Again, prior to tightening the free ends of the tensile member,
they can also be inserted through pledgets 118 or other atraumatic
structure to provide additional support and strain relief at the
tissue puncture sites. FIG. 37C shows a heart with sections cut-out
and a tensioning structure 4 placed through the myocardium. The
solid line demarcates the tensioning structure on the surface of
the heart wall or along the cut-out section of the heart wall and
the dotted line demarcates the tensioning structure section
positioned through a spaced away section of myocardium. The
tensioning structure passes through the myocardium along two spaced
apart lines thereby producing a 3-dimensional cinching mechanism
capable of tightening the heart wall in three planes, (a) along the
insertion line through the myocardium, (b) between the insertion
points defined by the spacing between insertion points through the
epicardial 68 surface and into the myocardium and between the exit
points the tensioning structure traverses prior to tightening into
a knot, and (c) along the myocardial wall thickness. The ratio
between these tension parameters (i.e., a, b, and c above), in
terms of the length of the insertion line and the spacing
respectively, the stress distribution ratios defined by the secured
146 and movable 148 stress distributing tubes, and the magnitude of
the tightening force applied to the tensioning structure defines
the applied load to the heart tissue. This applied tensile load
thereby also defines the degree of tightening of the heart wall in
the axial (from the annulus to the apex), lateral, and vertical
directions respectively and can be adjusted to custom tailor the
reduction in volume of the infarcted/ischemic zone. Furthermore,
the tension can be adjusted as required to alter the wall motion of
this zone to better match that of adjacent myocardium. Also, it is
noted that these tensioning structures can be oriented at other
angles relative to the heart thereby defining different tensioning
planes, and the tensioning planes do not have to extend
perpendicular to one another.
[0167] The tensile members 84, and secured 146 and movable 148
stress distributing tubes of tensioning structure embodiments
deployed into the 3-dimensional, cinching pattern, as shown in
FIGS. 36E to 36H, 37A to 37C and described above, can consist of
expanded PTFE, polypropylene, urethane derivatives, silicone,
nylon, polyester, biological materials (e.g., pericardial tissue
formed into strips, vascular tissue such as saphenous veins
maintained in tubular form or cut into strips, submucosal tissue
formed into strips, or other collagen or elastin based tissue
structure), genetically engineered tissue formed into strips,
metals (e.g., titanium), alloys (e.g., stainless steel, nickel
titanium, etc.), polymers, or other material formed into a line,
strip, tube, rod, bar, or other geometry.
[0168] FIGS. 38A to 38C show the deployment of a tensioning
structure through myocardium utilizing an alternative deployment
system of the invention, which is shown in FIGS. 43A to 43D. In
this embodiment, a single tensile member 84 is shown deployed
through the myocardium. Afterwards, anchors can be placed over the
free ends of the tensile member 84 to secure both ends of said
member to the tissue surface. The opposite ends of the tensile
member can then be tied producing an axially oriented tightening of
the tensioning structure; or one free end of the tensile member can
be subsequently inserted through myocardium at a spaced apart
location to produce a three-dimensional, cinching effect; or a
second tensile member can be inserted at a spaced apart location
with the deployment system and the free ends of the tensile member
pair can be tied together in some pattern to tighten the tensioning
structure and reinforce the infarcted/ischemic zone. Again, secured
146 and movable 148 stress distributing tubes can be oriented to
define the ratios of compression, regulate the amount of myocardial
wall thickness reduction/compression, and distribute the stress at
the insertion and exit sites of the tensile member.
[0169] As shown in FIGS. 43A to 43D this delivery system embodiment
incorporates two sheaths defining different curves and a puncturing
device 62. The outer sheath 104 incorporates a beveled tip to
define the initial penetration through the tissue surface. The
middle sheath 106 incorporates a curved region and a beveled tip to
tunnel through the myocardium (either partially or completely
through the other tissue surface). The curved region of the middle
sheath 106 straightens as the middle sheath is retracted into the
outer sheath in a coaxial arrangement. The inner puncturing device
62 incorporates a curve to orient the distal end of the puncturing
device back out of the myocardium and past the initial tissue
surface at a defined distance from the initial penetration or
insertion site defined by the curve of the middle sheath and the
curve of the puncturing device as shown in FIG. 43D. The puncturing
device 62 also incorporates a needle tip 66 (e.g., beveled tip,
cutting tip, pointed tip, diamond tip, or other configuration) and
a holder 64. The holder 64 in this configuration is a slotted
region from one side that includes a small inward protrusion to
prevent the tensile member from migrating out of the slotted region
once positioned. The tensile member 84 is positioned into the
holder by advancing a side of the tensile member through the slot
until it is advanced past the protrusion. Removal of the tensile
member can be done manually by pulling the member laterally from
the slot or axially past the protrusion with forceps, needle
drivers, or other surgical instrument. It should also be noted that
two inner puncturing devices can alternatively be utilized with a
larger middle sheath (single or dual-lumen) and a larger outer
sheath to simultaneously deploy two ends of a single tensile member
through tissue at spaced apart intervals or two individual tensile
members through tissue at spaced apart intervals. Alternatively,
three or more inner puncturing devices can be utilized with
appropriately configured middle and outer sheaths to deploy more
than two individual tensile members through tissue
simultaneously.
[0170] FIG. 42 illustrates an alternative, puncturing device that
incorporates the holder 64 as a separate component inserted through
a hole or slot in the body of the puncturing device 62 just
proximal to the needle tip 66. The holder 64 component of this
embodiment consists of a wire wound into a shepherd's hook type or
other similar geometry that can be fed through the hole or slot of
the puncturing device such that it enables insertion or retraction
of tensioning structures through tissue.
[0171] FIG. 39A shows the placement of a three-dimensional,
cinching, tensioning structure placed through myocardium of the
left ventricle, extending from the epicardium, through myocardium,
past the endocardium and back to the epicardium at a distance from
the initial puncture site. It also depicts the placement of a
three-dimensional, cinching pattern using tensioning structures
through the myocardium of the right ventricle and extending along
the endocardium of the right ventricle for a significant distance.
The tensioning structures can be deployed with the systems
described above to reinforce the left or right ventricle along an
infarcted/ischemic zone or other weak or remodeling zones.
[0172] FIGS. 39B and 40E show three-dimensional cinching,
tensioning structures placed along the mitral valve annulus 108
with one section of the tensile member (or one discrete tensile
member as discussed above) placed on the left atrial side 74 and
one section (or another discrete tensile member) placed on the left
ventricular side. FIG. 40E also shows a three-dimensional,
cinching, tensioning structure similarly placed along the tricuspid
annulus. Once tied, the tensioning structure can cinch and tighten
the mitral (or tricuspid) annulus similar to the tensioning
structure embodiments discussed previously. This embodiment also
enables further tightening of the tensioning structure
intraoperatively, during follow-up procedures, or with mechanisms
remotely actuated by directly tying the knot(s) tighter or
providing a mechanism to twist, retract over a spacer, or otherwise
manipulate the knot or insertion end of the tensioning structure,
post procedure as desired. Alternatively, the tensioning structure
can also reinforce the aortic valve by deploying one or more
tensioning structures and tightening, until valve insufficiencies
are resolved.
[0173] FIGS. 40A to 40D show representative three-dimensional,
cinching, tensioning structure patterns capable of reinforcing
infarcted and ischemic zones of the heart. Any pattern of
tensioning structures can be capable of providing the desired
recovery or reverse remodeling response where the tensioning
structures extend between border regions of the infarcted/ischemic
zones passing through the zone or extending from inside the
infarcted/ischemic zone to just beyond the border regions. Also, an
individual tensioning structure can pass through multiple
infarcted/ischemic zones to reinforce a larger region of
ventricular tissue. The flexibility of these tensioning structure
and deployment system embodiments enable the physician to custom
tailor the treatment options to the patient after careful analysis
of the valve competency, ventricular wall motion, ejection
fraction, and other diagnostic parameters. FIG. 40F shows a group
of three-dimensional, cinching, tensioning structures extending
around an infarcted/ischemic zone and passing from a border zone
into or beyond the infarcted/ischemic zone. The free ends of this
flower-shaped pattern of three-dimensional, cinching, tensioning
structures can be tied together permanently or secured to a
mechanism capable of twisting the knotted regions or otherwise
manipulating the free ends to adjust or tighten the tensioning
structures intraoperatively, during a follow-up procedure, or
remotely post procedure. Again, these adjustments can facilitate
chronic maintenance of positive hemodynamic conditions.
[0174] FIG. 41A shows a three-dimensional, cinching, tensioning
structure incorporating two insertion and exit points along the
axial plane. Again, secured 146 and movable 148 stress distributing
tubes can be oriented along the tensile member, especially
proximate to the various insertion and exit sites. In these
tensioning structure embodiments, the tightening force is
distributed at more than two locations (i.e.,the insertion and
knotted sites) thereby ensuring that a long, tightening structure
will be capable of reinforcing tissue midway between the ends of
the three-dimensional, cinching, tensioning structure. It is also
noted that more than two, inline loops (as shown in FIG. 41A) can
be utilized for the three-dimensional cinching tensioning
structures.
[0175] In FIG. 41B, a three-dimensional, cinching, tensioning
structure oriented in a dual-loop shaped configuration surrounded
by a similar tensioning structure oriented in a shield-shaped
configuration. The tensile member passes through and above the
tissue 112 at the center of the configuration. Together, the two
patterns apply tightening forces laterally and apically to the
heart to reinforce the infarcted/ischemic zone and restore a more
desirable wall motion to the heart.
[0176] FIG. 41C shows an alternative tensioning structure pattern
that spirals around the infarcted/ischemic zone from the border
region to the center of the zone. The free ends of this structure
can be tightened to compress the zone inward towards the middle.
The spiral pattern can be also be adjusted to take into account the
different degrees of motion laterally versus apically by altering
the length versus width ratio of the spiral pattern, the spacing
between entry and exit points, and the spacing between each
concentric ring of the pattern.
[0177] FIGS. 41D and 41E show a top view and a side-sectional,
close-up view of another tensioning structure 4 embodiment that
comprises tensile members 84 attached to radially extensible
anchors 32 at each end. The tensioning structures 4 extend from
within the infarct/ischemic region 20 to outside the border zone
and also incorporate anchors 32 placed into or through myocardium.
The proximal ends of each of the various tensile members are
attached to a central hub 158 positioned on the external surface of
the heart configured so that it can be tightened at or about this
hub 158. The close up view of the anchor in FIG. 41E illustrates
the outwardly expanded extensions placed against the endocardial
(or epicardial) surface to lock the attached tensile member 84 to
the heart. It is also noted that these tensioning structures can
also comprise secured 146 and movable 148 stress distributing tubes
as described above.
[0178] FIGS. 41F and 41G show a perspective view of a heart with a
three-dimensional, cinching, myocardial tensioning structure
embodiment incorporating an automatic, knot-locking anchor
mechanism to variably tighten the free ends of the tensile member
84. FIG. 41F shows the tensioning structure 4 with the knot anchor
150 engaging the tensile members 84, but not completely tightened.
FIG. 41G shows the myocardial tensioning structure 4 with the knot
anchor 150 tightened over the free ends of the tensile member 84.
FIG. 41H shows a close-up, cross-sectional view of the knot anchor
150 in FIGS. 41F and 41G. A ratcheting extension or jaw 152 allows
movement of the tensile member 84 in one direction, but prevents
movement or migration of the tensile member in the opposite
direction. FIG. 41I also depicts a close-up, cross-sectional view
of an alternative, knot anchor embodiment with one end of the
tensile member 84 attached and the other end movable relative to
the ratcheting extension or jaw 152. In this embodiment and as with
FIGS. 41F and 41G, the knot anchor also incorporates a ratchet
mechanism jaw 152 that enables the tensile member 84 to pass in one
direction through a sidewall exit hole 172, but prevents migration
in the opposite direction allowing it to act as a locking mechanism
168. These knot anchor embodiments permit remote tightening and
adjustment of the tensioning structure 4 once positioned to enable
gradual tightening over a period of time to maximize and maintain
the reverse remodeling effects.
[0179] Also seen in FIG. 41I is the anchoring loop 156. A formed
tube 160 captures the anchoring loop 156. This tube is formed
around the anchoring loop 156 such that an interference is created
resulting in a mechanical joint between the components. This along
with the ratcheting mechanism or jaw 152 is encapsulated by another
tube to create a proximal anchor with a ratcheting capability. This
embodiment is ideally suited for constriction of the valve
annulus.
[0180] FIGS. 44A and 44B show a tensioning structure embodiment
that incorporates a tensile member secured to a self-expanding (or
plastically deformable) anchor as described above in the
Intravascular Conduit Tensioning Structures and Cardiac Valve
Annulus Tensioning Structures sections of this specification. Both
anchor ends of a tensioning structure are compressed into a low
profile within the lumen of a delivery sheath, similar to FIG. 43A,
incorporating a beveled tip to puncture through tissue. A single
sheath can be used to insert both anchors of the tensioning
structure into or through myocardium, or each anchor can be
compressed into individual sheaths. FIG. 44A shows a heart with
sections cut away containing a deployed anchor extending through
the myocardium and incorporating radial extensions engaging the
endocardial surface. In this figure, a tensioning member is shown
attached to the deployed anchor formation with the opposite end of
the same tensioning member shown secured to an anchor compressed
inside a sheath for deployment through the myocardium and into the
left ventricular cavity. Once the sheath accesses the anchoring
site, a stylet is used to advance the anchor beyond the confines of
the constraining sheath where the anchor is allowed to expand into
its preformed or radially expanded configuration. Then, the anchor
can be retracted into engagement with the endocardial surface as
shown in FIG. 44B with application of tension to the tensile
member. At this point, the tensile member can be further tightened
by creating a knot or by twisting to increase the applied force as
required. It should be noted that the anchors can be placed into
the myocardium such that the extensions lock to myocardial tissue
without extending beyond the endocardial surface. The sheath used
to deploy the anchors of the tensioning structure can incorporate a
slot for the tensioning member to pass thereby preventing slack
along the tensile member that is tightened by forming a knot or
other tying mechanism. It is therefore noted that individual
tensioning structures containing an anchor only at one end while
the opposite end remains free can be deployed and secured using the
deployment system previously described and the free ends can be
tied together to tighten the tensioning structures to produce the
desired volume reduction, reinforcement or other compressive
response.
[0181] FIG. 44C shows additional features to the tensioning
structure described above where pledgets 118 or other similar
atraumatic interfaces mentioned elsewhere in this specification are
positioned at each insertion point of the anchor through the
epicardial surface to provide strain relief and to prevent abrasion
or other unwanted effect of tightening of the tensile member
against tissue. A pledget 118 or other atraumatic interface can
also be placed under the knot used to tighten the tensioning
structure. In addition, it is also noted that the tensioning
structures can comprise secured 146 and movable 148 stress
distributing tubes, as described above, at the insertion or exit
sites, along the myocardial wall, or elsewhere along the tensile
member(s).
[0182] The tensioning structures and incorporated anchors can
alternatively be inserted from the endocardial surface into
myocardium or through myocardium such that the anchors contact the
epicardial surface during surgical or catheter-based approaches, as
shown in FIGS. 45A and 45B. One or more sheaths can be used to
deploy the two anchors and the tensile member into the heart. The
base 114 of such endocardial anchors can be configured with marker
bands 36 in this approach.
[0183] A guiding catheter, as shown in FIG. 45C, covers the beveled
deployment sheath and is used to cross the aorta during a
retrograde procedure, or the mitral valve during a trans-septal
procedure or a surgical procedure accessing the left ventricular
cavity from the left atrial appendage or atrial free wall. The
deployment sheath is then advanced relative to the guiding sheath,
as shown in FIG. 45D, and is used to puncture the endocardial
surface to access the myocardium. The anchor can then be expelled
by advancing a stylet or retracting the deployment sheath while
maintaining the position of the stylet, as shown in FIG. 45E. The
anchor is inserted within the myocardium or further manipulated
through the myocardium, past the epicardial surface, and into the
pericardial space where it expands towards its preformed
configuration and is engaged against the epicardial surface, as
shown in FIG. 45A.
[0184] FIGS. 45F to 45H show this anchor embodiment expanding
towards its preformed enlarged, radially expanded configuration.
Alternatively, a balloon or other expansion mechanism can be used
to plastically deform the anchor into an enlarged orientation. The
engagement pins 130 are biased outward to contact myocardium or the
epicardial surface (or endocardial surface for surgical approaches
described above) and prevent retraction of the anchor once
positioned. As shown in FIGS. 45F to 45H, the tensile member 84 is
secured to the base 114 of the anchor preferably such that maximum
outer diameter of the tensile member 84 is greater than the
cross-sectional diameter of the base 114 of the anchor to ensure
hemostasis through the channel created through the myocardium once
the anchor is inserted and secured in place. In this embodiment,
the tensile member 84 covers the entire cross-section of the base
114 of the anchor 32. Alternatively, the tensile member can be
secured to one side of the base and have a diameter smaller than
the outside diameter of the base 114. It should be noted that the
deployment system and anchor embodiments shown in FIGS. 45C to 45H
are directly applicable to the surgical process described for FIGS.
44A to 44C above.
[0185] FIGS. 45I to 45L show an alternative anchor member 32 well
suited for use as a myocardial tensioning structure embodiment.
FIG. 45I shows a tube of anchor material (e.g., nickel titanium,
titanium, stainless steel, superelastic polymer, or other such
anchor material previously described) cut into a pattern of
extensions 132 emanating from the distal end 132 of the anchor, and
a base 114 to which the tensile member 84 is attached. The base 114
(and distal end 132) can be fabricated as expandable/compressible
to enable expansion or compressing the anchor during or after
deployment. FIG. 45J shows the process of thermal forming the
anchor extensions 116 into a radially expanded orientation. FIGS.
45K and 45L show a perspective view and a side view of the anchor
32 with a tensile member 84 attached to the interior surface of the
anchor from the distal end 132 to the base 114. As described in
FIGS. 45F to 45H above, the tensile member 84 can alternatively be
attached beyond the exterior surface of the base 114.
[0186] In addition, the anchor embodiments shown in FIGS. 45F to
45L can be utilized as an anchor that engages the coronary sinus
orifice when inserting the tensioning structure intravascularly
within the coronary sinus for tightening and reinforcing the valve
annulus as described in the Cardiac Valve Annulus Tensioning
Structures section above. These anchor embodiments can also be
inserted through valve leaflets to reposition the valves upon
applying tension via the tensioning structure, as described in the
Chordae Tendineae and Valve Leaflet Tensioning Structures section
below.
[0187] A single sheath incorporating two stylets having different
profiles to accommodate different diameter anchors or anchors
incorporating features enabling sequential deployment of the first
anchor prior to actuation of the second anchor can be used to
deploy the tensioning structure during catheter-based procedures.
Once the first anchor is positioned and engaged into tissue, the
second can be positioned and deployed. The final result of such an
approach is illustrated in FIG. 45B.
[0188] FIGS. 46A to 46M show an alternative, integrated tensioning
structure embodiment where the tensile member 84 incorporates
features to enable anchoring and a preformed geometry having
sufficient column strength to be directed through myocardium
without the need for the deployment sheath to puncture tissue to
insert the tensile member and/or anchor. As shown in FIGS. 46A and
46B, the tensioning structure is constrained into a low profile
inside a blunt tip deployment sheath. This tensioning structure
embodiment is preferably fabricated from a superelastic alloy
(e.g., nickel titanium), other alloy (e.g., stainless steel), or
metal (e.g., titanium) incorporating an elastic component and a
preformed geometry. As shown in FIGS. 46E through 46F, the
tensioning structure itself is used to puncture the epicardial
surface (or endocardial surface for catheter-based approaches) and
channel through the myocardium. As the tensioning structure is
further advanced beyond the confines of the blunt deployment
sheath, as shown in FIG. 46G, the tensioning structure returns
towards it preformed or expanded shape directing the free end of
the tensioning structure back up towards and past the epicardial
(or endocardial) surface. This tensioning structure embodiment
consists of a stiff tensile member formed into a "U" shape with
sharp free ends 120 to penetrate tissue. Each of the free ends 120
is inserted through the tissue surface at spaced apart intervals
such that once positioned the looped or flat end of the "U" shape
can be used to anchor the tensioning structure at one end. As
described previously, secured 146 or movable 148 stress
distributing tubes can be used as required at this end to dampen
the trauma and regulate application of the compressive forces by
the tensioning structure against the tissue surface. As shown in
FIGS. 46H through 46K, a separate locking anchor 124 can be secured
to the free ends of the tensioning structure into notches 122 or
other mating features in the tensioning structure 4 to define and
maintain the applied tension and to prevent migration. The anchor
can consist of a tube, bar, or sheet containing openings and a
ratchet mechanism that allows the sharp ends of the tensioning
structure to enter while preventing separation once placed, as
shown in FIG. 46K. FIGS. 46L and 46M show an illustrated placement
of this tensioning structure embodiment after deployment and after
locking with the anchor component, respectively. As with all of the
3-dimensional, cinching, tensioning structures described
previously, this clip-like tensioning structure embodiment can
traverse in any direction around the infarcted/ischemic zone and
multiple clip-like tensioning structures can be inserted and
secured throughout the infarcted/ischemic zones to custom tailor
the reinforcement profile to the patients needs.
[0189] FIGS. 46N to 46P show additional delivery system features
for deploying these integrated 3-dimensional, cinching, tensioning
structures. FIG. 46N shows the deployment sheath with a flared,
distal end 134 to provide strain relief during puncture, and FIGS.
46O and 46P show expandable/compressible extensions associated with
the deployment sheath to enable low profile entry into the body, to
stabilize and provide a surface to leverage the deployment sheath
during puncture preventing inadvertent insertion of the sheath
through the heart's surface. An outer constraining tube 138 is used
to compress the extensions 136 during deployment through ports into
the chest cavity or other less invasive access. Alternatively, the
extensions can be fabricated rigid, especially for invasive
surgical approaches such as a median sternotomy.
[0190] FIGS. 46Q to 46Y show alternative integrated, 3-dimensional,
cinching, tensioning structures 4 of the invention. These
tensioning structures 4 incorporate spring mechanisms at the loop
anchors 96 and anchor lock springs 144 to further custom tailor the
cinching forces applied by the tensioning structure to the heart
tissue. These spring mechanisms can comprise a helix, a sinusoid,
open cells, or other expandable and compressible mechanisms. As
shown in FIG. 46X, anchor lock holes 142 can be incorporated in the
distal end of the tensile member 84 to enable locking the anchor
lock springs 144 to the tensile member 84 to define the attached
tensioning structure 4.
[0191] The three-dimensional, cinching, tensioning structure in
FIGS. 46S to 46Y further incorporates a straightening lumen 140
through which a stylet can be inserted to orient the tensile member
84 for deployment into or through myocardium. As the stylet (not
shown) is advanced through the straightening lumen 140, the tensile
member straightens for insertion into or through myocardium. As the
stylet is retracted or the tensile member is advanced beyond the
end of the stylet, the tensile member reverts back towards its
preformed, curved shape channeling through tissue and defining the
deployed configuration. Once deployed, the stylet is removed
leaving the tensile member to be locked with the anchor spring
144.
[0192] Chordae Tendineae & Valve Leaflet Tensioning
Structures
[0193] As mentioned before, the tensioning structures of the
invention by also be used to apply tension to papillary muscles
and/or chordae tendineae to reposition the valve leaflets to
reduce/eliminate regurgitation, to limit the motion of the leaflets
to improve/restore the function of cardiac valves; and to directly
reposition the valve leaflets to prevent prolapse or other
abnormalities of the leaflets and to prevent associated
deficiencies. In this spirit, FIGS. 47A to 47D show a tensioning
structure embodiment and delivery system used to place the
tensioning structure from the epicardium through the myocardium,
around one or more chordae tendineae or through a papillary muscle,
and back through the myocardium where the tensioning structure is
anchored such that it applies tension to these sub-valvular
structures to reorient the valve leaflets and restrict valve
prolapse. FIGS. 47A to 47C show the three-component delivery system
from FIGS. 43A to 43D passing one or more tensioning structures
through or around the chordae tendineae 110, or through or around a
papillary muscle. The delivery system locates the free ends of the
tensioning structures through myocardium and external to the
endocardium where they can be tied to tighten the tensioning
structures. As shown in FIG. 47A, the outer sheath is inserted
through the heart wall. The outer sheath can incorporate a beveled
tip as shown in FIG. 43A or can be inserted over a trocar, needle,
or other penetrating mechanism. The middle sheath is then advanced
through the outer sheath as shown in FIG. 47B. In this version, the
middle sheath does not require a beveled or sharpened tip and it is
preferred that the distal end is atraumatic so the middle sheath
does not damage the chordae tendineae as it is advanced through the
outer sheath where it is allowed to expand towards its preformed,
curved configuration passing around chordae tendineae. If the
middle sheath needs to pass through papillary muscles then it would
require a beveled or sharpened tip to puncture the papillary
muscle. Alternatively, the sheath can incorporate a steering
mechanism to manually curve the sheath around the papillary muscle
or chordae tendineae instead of relying upon a self-expanding
preformed shape. Once positioned, as shown in FIG. 47C, the
puncturing device is inserted through the middle sheath and is used
to pass the tensioning structure 4 through the middle sheath and
back through the endocardium, through the myocardium and past the
epicardium where it can be removed from the holder with forceps or
other similar instrument. Then as shown in FIG. 47D, the deployment
system is removed and the tensioning structure is tightened. The
degree of tightening can be guided or adjusted based on
Transesophageal Echocardiography, Intracardiac Echocardiography,
MRI, Fluoroscopy, CT, or other imaging or visualization modality
capable of determining the apposition and movement of the valve
leaflets.
[0194] FIGS. 48A and 48B show an alternative tensioning structure
and associated delivery system used to engage a chordae tendineae
or papillary muscle with one end while the opposite end produces an
anchor that is capable of tightening to apply tension to the
chordae tendineae or papillary muscles 128. As shown in FIGS. 49A,
49B, 50A and 50B, the distal anchor 32 of the tensioning structure
is advanced through the myocardium and is entangled to the chordae
tendineae 110 or papillary muscle 128, and the proximal end is then
pulled through the epicardial surface and expanded (plastically
deformable) or allowed to expand (superelastic) into a preformed,
enlarged shape preventing migration of the proximal anchor 32 into
the heart cavity. At this point the amount of tension applied to
the chordae tendineae or papillary muscle depends on the placement
of the proximal anchor and the length of the tensile member 84
between these anchors. The tension can then be altered utilizing a
variably tightening mechanism as described above or by relocating
the proximal anchor 32 to increase or decrease tension as
required.
[0195] The tensioning structures, such as those shown in FIGS. 45F
to 45L, can alternatively be inserted through the valve leaflets as
opposed to around or through the papillary muscle or chordae
tendineae to directly reposition the valve leaflets by tightening
the tensioning structures from the epicardial surface of the heart.
In this configuration, a grasping instrument containing a lumen
providing passage for the puncturing device can be used to
temporarily engage the valve leaflet and provide a path to advance
the tensioning structure past the epicardial surface, through the
myocardium, up to and through the valve leaflet. Then the anchor is
deployed (by balloon expansion or release of a self-expanding
anchor) against the valve leaflet thereby attaching the tensile
member 84. The proximal end of the tensile member is then retracted
past the epicardial surface and the desired amount of tension to
reposition or stabilize the valve leaflet is applied based upon
real-time assessment/visualization of hemodynamics and anatomic
motion. Finally, the proximal end of the tensile member 84 is
anchored to the epicardial surface at a suitable location.
Alternatively, the delivery system used to engage the valve leaflet
can provide a mechanism to grasp the tensile member 84 after
insertion of the tensile member through the valve leaflet. Such a
mechanism would enable retraction back past the myocardium and
epicardium so that the opposite free ends of the tensile member 84
can be tied, tightened and used to manipulate the position of the
valve leaflets, thereby defining the tensioning structure.
Alternatively, the leaflets may be directly manipulated and
repositioned using the mechanism in FIGS. 51A and 51B. This
mechanism facilitates grasping and then locking onto the leaflet
tissue by engaging the jaw 152 with an anchor cincher tube 150.
Furthermore, the mechanism could be attached to a tensile member
and anchor to facilitate locating and securing the structure at the
desired position to urge valve competency.
[0196] Tensioning Structure Materials and General Fabrication
Methods
[0197] The embodiments of the entire invention described herein can
be fabricated from various biological, metallic, and polymeric
materials. For self-expanding components of the embodiments, those
components are preferably fabricated from a superelastic, shape
memory material like nitinol (nickel titanium alloy). These types
of materials elastically deform upon exposure to an external force
and return to their preformed shape upon reduction or removal of
the external force. This elasticity property renders the material
as ideal for deployment with vascular conduit target about
eccentric, three-dimensional tortuous geometries with limited
concern toward fatigue failure and difficulty in placement.
Superelastic shape memory alloys also enable straining of the
material numerous times without plastic deformation. The repetitive
strain capability facilitates a limited systolic stretch to enable
adequate cardiac output while limiting or restricting the
possibility of over stretch and continuation of the cyclic
damage.
[0198] Various components of the tensioning structures can be
fabricated from shape memory alloys (e.g., nickel titanium)
demonstrating stress-induced martensite at ambient temperature.
Other shape memory alloys can be used and the superelastic material
can alternatively exhibit austenite properties at ambient
temperature. The composition of the shape memory alloy is
preferably chosen to produce the finish and start martensite
transformation temperatures (Mf and Ms) and the start and finish
austenite transformation temperatures (As and Af) depending on the
desired material response. When fabricating shape memory alloys
that exhibit stress induced martensite the material composition is
chosen such that the maximum temperature that the material exhibits
stress-induced martensite properties (Md) is greater than Af and
the range of temperatures between Af and Md covers the range of
ambient temperatures to which the support members are exposed. When
fabricating shape memory alloys that exhibit austenite properties
and do not transform to martensite in response to stress, the
material composition is chosen such that both Af and Md are less
than the range of temperatures to which the supports are exposed.
Of course, Af and Md can be chosen at any temperatures provided the
shape memory alloy exhibits superelastic properties throughout the
temperature range to which they are exposed. Nickel titanium having
an atomic ratio of 51.2% Ni to 48.8% Ti exhibits an Af of
approximately -20.degree. C.; nickel titanium having an atomic
ratio of 50% Ni to 50% Ti exhibits an Af of approximately
100.degree. C. [Melzer A, Pelton A. Superelastic Shape-Memory
Technology of Nitinol in Medicine. Min Invas Ther & Allied
Technol. 2000: 9(2) 59-60].
[0199] Such superelastic components are able to withstand strain as
high as 10% without plastically deforming. Materials other than
superelastic shape memory alloys can replace superelastic materials
in appropriate tensioning structure components provided they can be
elastically deformed within the temperature, stress, and strain
parameters required to maximize the elastic restoring force,
thereby enabling the tensioning structures to exert a directional
force in response to an induced deflection. Such materials include
other shape memory alloys, bulk metallic glasses, amorphous
Beryllium, suitable ceramic compositions, spring stainless steel
17-7, Elgiloy.TM., superelastic polymers, etc.
[0200] The tensioning structures are expected to be of limited
thrombogenicity and with percutaneous deployment especially in
venous structures of the heart, the risk of infarct, adverse
cerebral embolic events and other similar ischemic events/injury is
severely limited if not avoided. Also, administration of commonly
used anti-clotting and anti-platelet pharmacological agents is
generally restricted to the implant procedure and not required in
an ongoing basis.
[0201] The tensioning structures can be fabricated from at least
one rod, wire, suture, strand, strip, band, bar, tube, sheet,
ribbon or other such raw material having the desired pattern, cross
sectional profile, dimensions, or a combination of cross-sections.
These raw materials can be formed from various standard means
including but not limited to: extrusion, injection molding,
press-forging, rotary forging, bar rolling, sheet rolling, cold
drawing, cold rolling, using multiple cold working and annealing
steps, or casting. When using superelastic materials or other
alloys as the tensioning structures, they can be cut into the
desired pattern and thermally formed into the desired
three-dimensional geometric form. The tensioning structures can
then be cut into the desired length, pattern or other geometric
form using various means including, but not limited to,
conventional abrasive sawing, water jet cutting, laser cutting, EDM
machining, photochemical etching or other etching techniques. The
addition of holes, slots, notches and other cut away areas on the
support structure body facilitates the capability to tailor the
stiffness of the implant.
[0202] The tensioning structure components, especially those that
employ the use of tubular or wire raw materials, can also be
further modified via centerless grinding means to enable tensioning
structures that are tapered (i.e.,have a cross-sectional diameter
on the proximal end of the structure that progressively ramps down
to a smaller cross-section on the opposite or distal end).
Tensioning structure components of this type of geometry are
ideally suited for placement in the vascular conduits since said
anatomical conduits tend to taper in a similar fashion from the
proximal ostia down to distal locations.
[0203] The tensioning structure components can be fabricated from a
multitude of these individually processed or unprocessed components
(rods, wires, bands, bars, tubes, sheets, ribbons, etc.) and joined
together using various means including but not limited to the
following: laser welding, adhesive bonding, soldering, spot
welding, mechanical crimping, swaging and other attachment means to
produce composite tensioning structures.
[0204] When fabricating superelastic tensioning structure
components from tubing, the raw material can have an oval,
circular, rectangular, square, trapezoidal, or other
cross-sectional geometry capable of being cut into the desired
pattern. After cutting the desired pattern, the tensioning
structure components are formed into the desired shape, heated, for
example, between 300.degree. C. and 600.degree. C., and allowed to
cool in the preformed geometry to set the shape of the support
members.
[0205] When fabricating superelastic tensioning structure
components from flat sheets of raw material, the raw material can
be configured with at least one width, W, and at least one wall
thickness, T, throughout the raw material. As such, the raw sheet
material can have a consistent wall thickness, a tapered thickness,
or sections of varying thickness. The raw material is then cut into
the desired pattern, and thermally shaped into the desired
three-dimensional geometry. Opposite ends or intersections of
thermally formed tensioning structure components can be secured by
using shrink tubing, applying adhesives, welding, soldering,
mechanically engaging, utilizing another bonding means or a
combination of these bonding methods. Opposite ends of the
thermally formed tensioning structure components can alternatively
be free-floating to permit increased flexibility.
[0206] Once superelastic tensioning structure components are
fabricated and formed into the desired three-dimensional geometry,
the supports can be electropolished, tumbled, sand blasted,
chemically etched, ground, or otherwise treated to remove any edges
and/or produce a smooth surface.
[0207] The previous discussions provide description of minimally
invasive and percutaneous tensioning structures and delivery
devices used to treat degenerative heart disease in patients
suffering any stage of congestive heart failure. In addition, the
described inventions provide a methods and devices to provide
restriction of continued enlargement of the heart, potentially
progressively reduce heart size via reverse remodeling
(i.e.,application of compressive force during both systole and
diastole) and finally decrease valvular regurgitation associated
with said enlargement.
[0208] It will be obvious to those skilled in the art that the
support structures described herein can be applied across a broad
spectrum of organ structures to provide reinforcement and to limit
enlargement facilitated by compensatory physiologic mechanisms.
[0209] Though the invention has been described in reference to
certain examples, optionally incorporating various features, the
invention is not to be limited to the set-ups described. The
invention is not limited to the uses noted or by way of the
exemplary description provided herein. Numerous modifications
and/or additions to the above-described embodiments would be
readily apparent to one skilled in the art; it is intended that the
scope of the present inventions extend to all such modifications
and/or additions. It is to be understood that the breadth of the
present invention is to be limited only by the literal or equitable
scope of the following claims. That being said,
* * * * *