U.S. patent application number 11/240589 was filed with the patent office on 2006-02-09 for apparatuses and methods for heart valve repair.
Invention is credited to Gregory Mathew Hyde.
Application Number | 20060030885 11/240589 |
Document ID | / |
Family ID | 35758405 |
Filed Date | 2006-02-09 |
United States Patent
Application |
20060030885 |
Kind Code |
A1 |
Hyde; Gregory Mathew |
February 9, 2006 |
Apparatuses and methods for heart valve repair
Abstract
A medical device for treating a heart having a faulty heart
valve is disclosed. The medical device comprises a ligature
including a first anchoring member and a second anchoring member is
used. The ligature is percutaneously deployable into a patient with
a faulty heart valve wherein the first anchoring member to anchor
to a first tissue area of the heart and the second anchoring member
to anchor to a second tissue area of the heart.
Inventors: |
Hyde; Gregory Mathew; (Menlo
Park, CA) |
Correspondence
Address: |
James C. Scheller, Jr.;BLAKELY, SOKOLOFF, TAYLOR & ZAFMAN LLP
Seventh Floor
12400 Wilshire Boulevard
Los Angeles
CA
90025
US
|
Family ID: |
35758405 |
Appl. No.: |
11/240589 |
Filed: |
September 29, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10272060 |
Oct 15, 2002 |
|
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11240589 |
Sep 29, 2005 |
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Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0409 20130101;
A61B 2017/00243 20130101; A61B 17/0483 20130101; A61B 2017/0441
20130101; A61B 2017/06057 20130101; A61F 2/2487 20130101; A61B
17/0401 20130101; A61B 2017/0472 20130101; A61B 2017/0475 20130101;
A61B 17/068 20130101; A61F 2/2445 20130101; A61F 2/2454 20130101;
A61B 17/06061 20130101; A61B 2017/0496 20130101; A61B 2017/00783
20130101; A61B 17/00234 20130101; A61B 2017/0649 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1-8. (canceled)
9. A medical device comprising: a delivery shaft having a delivery
lumen, a proximal end, and a distal end; a first deployment shaft
disposed within said delivery lumen and extending from said
proximal end to said distal end; a second deployment shaft disposed
within said delivery lumen and extending from said proximal end to
said distal end; a ligature having a first anchoring member and a
second anchoring member is releasably coupled to said delivery
shaft; said delivery shaft to deploy said ligature into a patient
wherein said first deployment shaft to deploy said first anchoring
member to a first tissue area of said patient and said second
deployment shaft to deploy said second anchoring member to a second
tissue area of said patient.
10. The medical device as in claim 9 further comprises a delivery
handle coupling to said delivery shaft at said proximal end, said
delivery handle further comprises a first deployment mechanism and
a second deployment mechanism wherein said first deployment
mechanism deploys said first anchoring member to said first tissue
area and said second deployment mechanism deploys said second
anchoring member to said second tissue area.
11. The medical device as in claim 10 wherein said delivery handle
further comprises a first rotating mechanism and a second rotating
mechanism wherein said first rotating mechanism deploys rotates
said first anchoring member to pierce said first anchoring member
into said first tissue area and said second rotating mechanism
rotates said second anchoring member to pierce said second
anchoring member into said second tissue area.
12. The medical device as in claim 9 wherein said delivery shaft is
pre-shaped to allow said delivery shaft to be maneuvered to an area
within said patient.
13. The medical device as in claim 9 further comprises a guidewire
disposed within said delivery shaft to guide said delivery shaft to
an area within said patient.
14. The medical device as in claim 9 further wherein said delivery
shaft further comprises a first deployment lumen, a second
deployment lumen, and a guidewire lumen wherein said first
deployment shaft is disposed within said first deployment lumen,
said second deployment shaft is disposed within said second
deployment lumen, and said guidewire is disposed within said
guidewire lumen.
15. The medical device as in claim 9 wherein said delivery shaft
further comprises a lumen that is to be pressurized to facilitate
maneuvering of said delivery shaft.
16. The medical device as in claim 9 further comprises a support
member disposed within said delivery shaft extending from said
distal end to said proximal end, said support member having a shape
that curves said delivery shaft to facilitate maneuvering of said
delivery shaft.
17. The medical device as in claim 9 wherein said first anchoring
member and said second anchoring member have configurations of one
of a barbed end, a helical end, and a hooked end.
18. The medical device as in claim 9 wherein said ligature is made
from one of an elastomeric material, a superelastic material, a
flexible material, a shape memory material, and a rigid
material.
19. The medical device as in claim 9 wherein said ligature is made
out of a stretchable material.
20. The medical device as in claim 19 wherein during deployment,
said ligature is stretched and after said deployment, said ligature
is returned to an unstretched length.
21. The medical device as in claim 9 wherein said ligature has a
cross section size sufficiently small to not significantly impede a
blood flow through an area where said ligature is anchored
across.
22. The medical device as in claim 9 wherein said ligature is
placed across a heart valve to constrict said heart valve, said
ligature to have a cross section size sufficiently small to not
significantly impede a blood flow through said heart valve.
23. The medical device as in claim 22 wherein said heart valve is a
mitral valve.
24. A method of constricting a heart valve of a patient comprising:
providing a medical device comprising a delivery shaft having a
delivery lumen, a proximal end, and a distal end, said delivery
shaft further comprises a first deployment shaft and a second
deployment shaft disposed within said delivery lumen, said delivery
shaft further comprises a ligature releasably coupled thereto, said
ligature having a first anchoring member and a second anchoring
member; and deploying said ligature into said patient wherein said
first deployment shaft deploys said first anchoring member to a
first tissue area around said heart valve and said second
deployment shaft deploys said second anchoring member to a second
tissue area of said heart valve, and wherein said deploying anchors
said first anchoring member to said first tissue area and said
second anchoring member to said second tissue area.
25. The method of claim 24 wherein said first tissue area and said
second tissue area are substantially opposite from each other.
26. The method as in claim 24 said delivery shaft is further
coupled to a delivery handle having a first deployment mechanism
and a second deployment mechanism wherein said first deployment
mechanism deploys said first anchoring member and said second
deployment mechanism deploys said second anchoring member.
27. The method as in claim 26 wherein said delivery handle further
comprises a first rotating mechanism and a second rotating
mechanism wherein said first rotating mechanism deploys rotates
said first anchoring member to pierce said first anchoring member
into said first tissue area and said second rotating mechanism
rotates said second anchoring member to pierce said second
anchoring member into said second tissue area.
28. The method as in claim 24 wherein said first anchoring member
and said second anchoring member have configurations of one of a
barbed end, a helical end, and a hooked end.
29. The method as in claim 24 wherein said ligature is made from
one of an elastomeric material, a superelastic material, a flexible
material, a shape memory material, and a rigid material.
30. The method as in claim 24 wherein said ligature is made out of
a stretchable material.
31. The method as in claim 30 wherein said ligature is returnable
to said first length after said first anchoring member is anchored
to said first tissue area and said second anchoring member is
anchored to said second tissue area.
32. The method as in claim 24 wherein said ligature has a cross
section size sufficiently small to not significantly impede a blood
flow through said heart valve when said ligature is anchored across
said heart valve.
33. The method as in claim 24 wherein said heart valve is a mitral
valve.
34. The method as in claim 24 wherein said ligature is deployed
percutaneously into said patient wherein said ligature is deployed
though a blood vessel.
35. A method of constricting a heart valve of a patient comprising:
providing a medical device comprising a delivery shaft having a
delivery lumen, a proximal end, and a distal end, said delivery
shaft further comprises a first deployment shaft and a second
deployment shaft disposed within said delivery lumen; coupling a
first ligature to said delivery shaft and deploying said first
ligature to a heart valve area of said patient; coupling a second
ligature to said delivery shaft and deploying said second ligature
to said heart valve area of said patient; wherein each ligature of
said first ligature and second ligature has a first anchoring
member and a second anchoring member; wherein said first deployment
shaft deploys said first anchoring member to anchor said first
anchoring member to said heart valve area to constrict said heart
valve, said second deployment shaft deploys said second anchoring
member to anchor said second anchoring member to said heart valve
area to constrict said heart valve.
36. The method of claim 35 wherein said delivery shaft deploys said
first ligature and said second ligature sequentially.
37. The method of claim 35 wherein said first anchoring member of
each of said first ligature and said second ligature is anchored to
a tissue area around said heart valve that is opposite from another
tissue area around said heart valve where said second anchoring
member of each of said first ligature and said second ligature is
anchored to.
38. The method of claim 37 wherein said first ligature and said
second ligature are parallel to one another after said first
ligature and said second ligature are deployed and anchored to said
heart valve.
39. The method of claim 37 wherein said first ligature and said
second ligature are intersect one another after said first ligature
and said second ligature are deployed and anchored to said heart
valve.
40. The method as in claim 35 wherein said first ligature and said
second ligature are deployed percutaneously into said patient
wherein said first ligature and said second ligature are deployed
though blood vessels.
41. A method of constricting a ventricle of a patient comprising:
providing a medical device comprising a delivery shaft having a
delivery lumen, a proximal end, and a distal end, said delivery
shaft further comprises a first deployment shaft and a second
deployment shaft disposed within said delivery lumen, said delivery
shaft further comprises a ligature releasably coupled thereto, said
ligature having a first anchoring member and a second anchoring
member; and deploying said ligature into the heart of said patient
wherein said first deployment shaft deploys said first anchoring
member to a first tissue area of said ventricle and said second
deployment shaft deploys said second anchoring member to a second
tissue area of said ventricle, wherein said deploying anchors said
first anchoring member to said first tissue area and said second
anchoring member to said second tissue area.
42. The method of claim 41 wherein said first tissue area is a
papillary muscle of said ventricle and wherein said second tissue
area is another papillary muscle of said ventricle that is
substantially opposite said first tissue area.
43. The method as in claim 41 wherein said ligature is deployed
percutaneously into said patient wherein said ligature is deployed
though blood vessels.
44. A method of constricting a mitral valve of a patient
comprising: providing a medical device comprising a delivery shaft
having a delivery lumen, a proximal end, and a distal end, said
delivery shaft further comprises a first deployment shaft and a
second deployment shaft disposed within said delivery lumen, said
delivery shaft further comprises a ligature releasably coupled
thereto, said ligature having a first anchoring member and a second
anchoring member; and deploying said ligature is within a coronary
sinus that substantially encircles said mitral valve; deploying
said first anchoring member to a first tissue area around said
mitral valve; deploying said second anchoring member to a second
tissue area around said mitral valve; wherein said first deployment
shaft deploys and anchors said first anchoring member to said first
tissue area and said second deployment shaft deploys and anchors
said second anchoring member to said second tissue area.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention involves a medical device that is used
for treating a defective heart valve.
[0003] 2. Discussion of Related Art
[0004] FIG. 1A illustrates a heart 10. There are four valves in the
heart 10 that serve to direct the flow of blood through the two
sides of the heart 10 in a forward direction. The four valves are a
mitral valve 20, an aortic valve 18, a tricuspid valve 60, and a
pulmonary valve 62 as illustrated in FIG. 1A. The mitral valve 20
is located between the left atrium 12 and the left ventricle 14.
The aortic valve 18 is located between the left ventricle 14 and
the aorta 16. These two valves direct oxygenated blood coming from
the lungs, through the left side of the heart, into the aorta 16
for distribution to the body. The tricuspid valve 60 is located
between the right atrium 22 and the right ventricle 24. The
pulmonary valve 62 is located between the right ventricle 24 and
the pulmonary artery 26. These two valves direct de-oxygenated
blood coming from the body, through the right side of the heart,
into the pulmonary artery 26 for distribution to the lungs, where
it again becomes re-oxygenated and distributed to the mitral valve
20 and the aortic valve 18. All of the heart valves are complex
structures. Each valve consists of moveable "leaflets" that are
designed to open and close. The mitral valve has two leaflets and
the tricuspid valve has three. The aortic and pulmonary valves have
leaflets that are more aptly termed "cusps" and are shaped somewhat
like a half-moon. The aortic and pulmonary valves each have three
cusps.
[0005] Blood flows into the left ventricle 14 through the mitral
valve 20 opens during diastole. Once the left ventricular cavity
has filled, the left ventricle 14 contracts during systole. The
mitral valve 20 closes (the leaflets of the mitral valve 20
re-approximate) while the aortic valve 18 opens during systole
allowing the oxygenated blood to be ejected from the left ventricle
14 into the aorta 16. A normal mitral valve allows blood to flow
into the left ventricle and does not allow leaking or regurgitating
back into the left atrium and then into the lungs. The aortic valve
allows blood to flow into the aorta and does not allow leaking (or
regurgitating) back into the left ventricle. The tricuspid valve 60
functions similarly to the mitral valve to allow deoxygenated blood
to flow into the right ventricle 24. The pulmonary valve 62
functions in the same manner as the aortic valve 18 in response to
relaxation and contraction of the right ventricle 24 in moving
de-oxygenated blood into the pulmonary artery and thence to the
lungs for re-oxygenation.
[0006] With relaxation and expansion of the ventricles (diastole),
the mitral and tricuspid valves open, while the aortic and
pulmonary valves close. When the ventricles contract (systole), the
mitral and tricuspid valves close and the aortic and pulmonary
valves open. In this manner, blood is propelled through both sides
of the heart.
[0007] The anatomy of the heart and the structure and terminology
of heart valves are described and illustrated in detail in numerous
reference works on anatomy and cardiac surgery, including standard
texts such as Surgery of the Chest (Sabiston and Spencer, eds.,
Saunders Publ., Philadelphia) and Cardiac Surgery by Kirklin and
Barrett-Boyes.
[0008] Regurgitation is a condition when leaflets of a heart valve
do not completely close causing backflow of blood. For instance, in
a condition typically called mitral valve prolapse, the leaflets of
the mitral valve do not close properly and thus, there is backflow,
or regurgitation, of blood into the left atrium and then into
lungs. The heart then has to work harder to pump enough blood for
the body, which can lead to heart damage. Regurgitation is common,
and is occurring in about 7% of the population. Mitral valve
regurgitation is caused by a number of conditions, including
genetic defects, infections, coronary artery disease (CAD),
myocardial infarction (MI) or congestive heart failure (CHF). Most
cases are mild and if the symptoms are bothersome, they can usually
be controlled with drugs.
[0009] In more serious cases, the faulty or defective valve can be
repaired with a surgical procedure such as an annuloplasty. As
illustrated in FIG. 1B, an annuloplasty 30 is a surgical procedure
in which a synthetic ring 32 is placed around the valve rim
(annulus) 34. Sutures 38 are put into the valve annulus 34 and the
synthetic ring 32. This causes proper closing by shrinking the size
of the valve opening 36. FIG. 1C illustrates another surgical
procedure in which a heart valve such as the mitral valve 20 is
repaired by reconstruction. First, at step A, a section P2 from the
posterior leaflet 40 of the mitral valve 20 is excised. Then,
sequentially at steps B, C, D, and E, sections P1 and P3 of the
posterior leaflet 40 are sutured together. The reconstruction
shrinks the size of the valve opening 36. In some instances, a
faulty or defective valve must be surgically replaced with a new
valve. Examples of new valves include homograft valves (valves
harvested from human cadavers), artificial mitral valves, and
mechanical valves.
[0010] All of the procedures above are typically major surgical
procedures that require the opening of the chest by sternotomy or
at best through small incisions in the chest wall, heart lung
bypass and stopping the heart beat. These procedures are extremely
invasive subjecting patients to a lot of pain and discomfort and
these procedures require long recovery time and hospitalization
time. In some instances, some patients may not tolerate surgery,
for example, due to them having congestive heart failures. Thus,
having alternative procedures as options to surgery is helpful.
SUMMARY OF THE INVENTION
[0011] The present invention discloses apparatuses and methods for
treating a defective heart valve.
[0012] In one exemplary embodiment of the present invention, a
medical device comprises a ligature, including a first anchoring
member and a second anchoring member. The ligature is used to treat
a hear having a faulty heart valve (e.g., a faulty mitral valve).
The ligature is percutaneously deployable into a patient with a
faulty heart valve, wherein the first anchoring member anchors to a
first tissue area of the faulty heart valve and the second
anchoring member anchors to a second tissue area of the faulty
heart valve. The ligature constricts or reduces the size of the
faulty heart valve.
[0013] In another exemplary embodiment of the present invention, a
medical device comprises a delivery shaft having a delivery lumen,
a proximal end, and a distal end. A first deployment shaft,
extending from the proximal end to the distal end, is disposed
within the delivery lumen. A second deployment shaft, extending
from the proximal end to the distal end, is disposed within the
delivery lumen. A ligature is releasably coupled to the delivery
shaft. The ligature includes a first anchoring member and a second
anchoring member. The delivery shaft deploys the ligature into a
patient, wherein the first deployment shaft deploys the first
anchoring member to a first tissue area of the patient, and the
second deployment shaft deploys the second anchoring member to a
second tissue area of the patient.
[0014] In another exemplary embodiment of the present invention, a
method of constricting a heart valve of a patient comprises
providing a medical device comprising a delivery shaft having a
delivery lumen, a proximal end, and a distal end. The delivery
shaft comprises a first deployment shaft and a second deployment
shaft disposed within the delivery lumen. A ligature including a
first anchoring member and a second anchoring member is releasably
coupled to the delivery shaft wherein the first anchoring member is
releasably coupled to the first deployment shaft and the second
anchoring member is releasably coupled to the second deployment
shaft. The method further comprises deploying the ligature into the
patient wherein the first deployment shaft deploys the first
anchoring member to a first tissue area around the heart valve, and
the second deployment shaft deploys the second anchoring member to
a second tissue area of the heart valve. Once deployed, the
ligature anchors the first anchoring member to the first tissue
area and the second anchoring member to the second tissue area.
[0015] In another exemplary embodiment of the present invention, a
method of constricting a heart valve of a patient comprises
providing a medical device comprising a delivery shaft having a
delivery lumen, a proximal end, and a distal end. The delivery
shaft comprises a first deployment shaft and a second deployment
shaft disposed within the delivery lumen. The method further
comprises coupling a first ligature to the delivery shaft and
deploying the first ligature to a heart valve area of the patient
and coupling a second ligature to the delivery shaft and deploying
the second ligature to the heart valve area of the patient. Each of
the ligatures includes a first anchoring member and a second
anchoring member wherein the first anchoring member is releasably
coupled to the first deployment shaft and the second anchoring
member is releasably coupled to the second deployment shaft. The
first deployment shaft deploys the first anchoring member to anchor
the first anchoring member to the heart valve area to constrict the
heart valve. The second deployment shaft deploys the second
anchoring member to anchor the second anchoring member to the heart
valve area to constrict the heart valve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The present invention is illustrated by way of example and
not limitation in the figures of the accompanying drawings, in
which like references indicate similar elements and in which:
[0017] FIG. 1A is an illustration of a heart;
[0018] FIG. 1B is an illustration of an annuloplasty procedure to
constrict a defective valve;
[0019] FIG. 1C is an illustration of a reconstruction procedure to
reduce the size of a defective valve;
[0020] FIG. 2A is an illustration of an exemplary embodiment of a
ligature in accordance with the present invention;
[0021] FIG. 2B is an illustration of another exemplary embodiment
of a ligature in accordance with the present invention;
[0022] FIG. 3 is an illustration of another exemplary embodiment of
a ligature in accordance with the present invention;
[0023] FIG. 4 is an illustration of an exemplary embodiment of two
ligatures being placed across a mitral valve in a parallel pattern
to constrict the mitral valve in accordance with the present
invention;
[0024] FIG. 5 is an illustration of another exemplary embodiment of
two ligatures being placed across a mitral valve in an intersecting
pattern to constrict the mitral valve in accordance with the
present invention;
[0025] FIG. 6 is an illustration of an exemplary embodiment of a
medical device that includes a delivery device which is used to
percutaneously deploy a ligature into a patient to constrict a
heart valve;
[0026] FIG. 7 is an illustration of a distal end of the medical
device shown in FIG. 6 having a ligature disposed therein;
[0027] FIG. 8 is an illustration of a mid-section of the medical
device shown in FIG. 6;
[0028] FIGS. 9-10 are illustrations of a perspective view of the
medical device shown in FIG. 6 wherein a ligature is being deployed
from the delivery shaft;
[0029] FIGS. 11A-11B illustrate another exemplary embodiment of a
medical device that includes a delivery device which is used to
percutaneously deploy a ligature into a patient to constrict a
heart valve;
[0030] FIG. 12A is an illustration of an exemplary embodiment of a
deployment shaft that can be used to deploy a ligature made in
accordance with the present invention;
[0031] FIG. 12B is an illustration of an exemplary embodiment of
the deployment shaft shown in FIG. 12A being disposed within a
deployment lumen of a delivery device;
[0032] FIG. 12C is an illustration of an exemplary embodiment of a
ligature with helix ends as anchoring members made in accordance
with the present invention;
[0033] FIG. 12D is an illustration of an exemplary embodiment of
the ligature shown in FIG. 12C being disposed within the deployment
shaft shown in FIG. 12B;
[0034] FIG. 12E is an illustration of an exemplary embodiment of
the ligature shown in FIG. 12C being disposed within the deployment
shaft shown in FIG. 12B which is disposed within a deployment lumen
of a delivery device;
[0035] FIGS. 12F-12G are illustrations of a distal end of the
medical device shown in FIG. 6 with a ligature having helix ends as
anchoring members;
[0036] FIGS. 13A-13H are illustrations of an exemplary embodiment
of a method to deploy a ligature or ligatures in accordance with
the present invention;
[0037] FIG. 14A is an illustration of an exemplary embodiment where
a medical device made in accordance with the present invention can
be inserted percutaneously into a patient to deploy a ligature to a
heart valve area;
[0038] FIG. 14B is an illustration of another exemplary embodiment
where a medical device made in accordance with the present
invention can be inserted percutaneously into a patient to deploy a
ligature to a heart valve area;
[0039] FIG. 14C is an illustration of an exemplary embodiment where
a medical device made in accordance with the present invention can
be inserted percutaneously into a patient to deploy a ligature to a
ventricle area;
[0040] FIGS. 15A-15D are illustrations of an exemplary embodiment
where a medical device made in accordance with the present
invention can be inserted percutaneously into a coronary sinus;
and
[0041] FIG. 16 is an illustration of an exemplary method of
treating heart valve using medical devices made in according with
the present invention.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0042] The present invention pertains to novel medical devices and
methods of using these medical devices to treat defective or faulty
heart valves. In the following description, for purposes of
explanation, numerous specific details are set forth in order to
provide a thorough understanding of the present invention. It will
be evident, however, to one skilled in the art, that the present
invention may be practiced without these specific details. In other
instances, specific apparatus structures and methods have not been
described so as not to obscure the present invention. The following
description and drawings are illustrative of the invention and are
not to be construed as limiting the invention.
[0043] FIG. 2A illustrates an exemplary embodiment of a medical
device that comprises a ligature 100. The ligature 100 can be a
strap, string, cord, wire, bond, thread, suture, or other
connector. The ligature 100 includes a first anchoring member 102A
and a second anchoring member 102B. The ligature 100 serves to link
together the first anchoring member 102A and the second anchoring
member 102B. The ligature 100 can be percutaneously deployed into a
patient with a faulty heart valve. By percutaneous deployment, the
ligature 100 is deployed through blood vessels, veins, or arteries
into a patient. In one embodiment, the ligature 100 is deployed
through the blood vessels, veins, or arteries and into the heart
area of a patient. The first anchoring member 102A and the second
anchoring member 102B are then attached or anchored to a cardiac
tissue (e.g., tissue around the heart valve). In one embodiment,
the first anchoring member 102A and the second anchoring member
102B are not attached or anchored to a blood vessel, vein, or
artery, and only attached or anchored to a cardiac tissue.
[0044] A faulty heart valve includes a heart valve that will not
properly close causing backflow or regurgitation of blood. Such a
faulty heart valve can be seen in a patient with a condition called
regurgitation. In treating the faulty heart valve, the first
anchoring member 102A anchors to a first tissue area of the faulty
heart valve and the second anchoring member 102B anchors to a
second tissue area of the faulty heart valve. The ligature 100 has
a length that is sufficient to constrict or reduce the size of the
heart valve once the anchoring members 102A and 102B are anchored
into the tissue areas of the heart valve. Examples of a heart valve
that can be treated with the ligature 100 include a mitral valve,
an aortic valve, a tricuspid valve, and a pulmonary valve.
[0045] Although the ligature 100 is discussed in relation to
treating a faulty heart valve, the ligature 100 may be used to
treat other areas of a patient. For example, the ligature 100 can
be used in ventricular remodeling to constrict, reshape, or reduce,
the size of a left ventricle that has been enlarged due to some
heart conditions. Alternatively, the ligature 100 can be used to
close a vein or an artery of a patient.
[0046] The ligature 100 can be flexible or rigid. In one
embodiment, the ligature 100 is made out of an elastic/resilient
material, an elastomeric material, or a superelastic material. In
one embodiment, the ligature 100 is made out of a superelastic
nickel titanium, Nitinol, or stainless steel. In another
embodiment, the ligature 100 is made out of a suture material
suitable for suturing a tissue of a patient. The ligature 100 can
be made out of existing suture materials such as polymers like
PTFE, Polyethylene or similar polymers, and resorbable polymers.
The ligature 100 can also be made out of an allograph material such
as treated porcine, bovine or human tissue.
[0047] In one embodiment, a delivery device, described below, is
used to deploy the ligature 100 to a heart to treat a faulty heart
valve. Such a delivery device is able to attach the two anchoring
members 102A and 102B of the ligature 100 to two different
attachment sites (e.g., cardiac tissues or tissue areas within or
proximate the heart). The anchoring member 102A is attached to one
attachment site and the anchoring member 102B is attached to the
other attachment site. During the attachment step, the ligature 100
may be stretched so as to reach both attachment sites. In some
cases, the ligature 100 does not need to be stretchable for the
anchoring members 102A and 102B of the ligature 100 to anchor into
the two different attachment sites. After the attachment step, the
ligature 100 is able to constrict or reduce the size of the heart
valve. In the embodiment where the ligature 100 is flexible, the
ligature 100 is stretched during the attachment step and is
returned to its unstretched length after the attachment step thus,
constricting (or reducing) the size of the heart valve. In the
embodiment where the ligature 100 is rigid, the length of the
ligature 100 is smaller than the size or the diameter of the heart
valve thus, after the attachment step, the valve can be constricted
or reduced.
[0048] In one embodiment, multiple ligatures 100 are placed across
the faulty heart valve annulus to reshape or reduce the
circumference or perimeter of the heart valve annulus. The ligature
100 may have cross section size that is sufficiently small to not
significantly impede the flow of blood (or other fluid) through the
heart valve or produce thrombus. The ligature 100 may be of a
dimension that is similar to surgical sutures known in the field.
The ligature 100 may have a cross section size between 0.001 mm and
5.0 mm. The ligature 100 may have a length between 10 mm and 600
mm. The ligature 100 may have an unstretched length between 10 mm
and 600 mm that can be stretched to an appropriate length for
deployment purposes and that can be returned to the unstretched
length after the deployment of the ligature 100.
[0049] In some cases, the ligatures 100 are placed across a faulty
heart valve and left in place for a specific period of time to
improve the heart valve function. In other cases, the ligatures 100
aid in positive remodeling of the left ventricle by constricting
(or reducing) the size of the faulty heart valve annulus so as to
relieve the left ventricle from working extra hard to pump blood
out of the left ventricle to other areas of the body. After this
remodeling/recovery time a removal system could be employed at a
later date to excise the ligatures 100.
[0050] In one embodiment, the ligature 100 has two ends wherein the
first anchoring member 102A is attached to one end of the ligature
100 and the second anchoring member 102B is attached to the other
end of the ligature 100. The anchoring members 102A and 102B are
elements that can enter a tissue of a patient body (e.g., a cardiac
tissue) and be anchored and retained therein. FIG. 2A illustrates
an exemplary configuration of the anchoring members 102A and 102B,
which are referred to as "barbed end" configurations. The anchoring
members 102A and 102B have pointy ends 106A and 106B. The anchoring
members 102A and 102B may also have a plurality of prongs 108A and
108B. The pointy ends 106A and 106B allow the anchoring members
102A and 102B to easily pierce through a tissue wall to begin the
anchoring process. The prongs 108A and 108B prevent the anchoring
members 102A and 102B from being detached or released from the
tissue thus anchoring the anchoring members 102A and 102B to the
tissue wall. Each of the anchoring members 102A and 102B has a
predetermined length 126A and length 126B, which is dependent upon
on the tissue depth that the each of the anchoring members 102A and
102B needs to pierce through to be anchored to the tissue.
[0051] The anchoring members of the ligature 100 need not have the
configurations shown in FIG. 2A. Another possible configurations
includes a hook-end configuration as shown in FIG. 2B. The ligature
100 shown in FIG. 2B includes a first hook-end anchoring member
103A and a second hook-end anchoring member 103B. The first
hook-end anchoring member 103A and the second hook-end anchoring
member 103B can anchor the ends of the ligature 100 to a cardiac
tissue similar to the anchoring members 102A and 102B shown in FIG.
2A.
[0052] In one embodiment, the anchoring members have a helix end
configuration as illustrated in FIG. 3. In this embodiment, the
ligature 100 includes helix ends 104A and 104B. The helix ends 104A
and 104B have ends 105A and 105B that may be pointy, sharp, or
blunt depending on the type of tissue that the helix ends are to be
anchored to. The helix ends 104A and 104B may be continuous helixes
made of shape memory material that can maintains the helix ends
104A and 104B in their helical configuration. The helix ends 104A
and 104B enter the tissue by threading and rotating through the
tissue similar to action of a screw. Each of the anchoring members
104A and 104B has a predetermined length 127A and length 127B,
which is dependent upon on the tissue depth that the each of the
helix ends 104A and 104B needs to pierce through to be anchored to
the tissue. In another embodiment, the ligature 100 includes double
helix ends (not shown) to increase retentive or anchoring
strength.
[0053] The anchoring members (e.g., the anchoring members 102A,
102B, 103A, 103B, 104A, and 104B) of the ligature 100 can be made
out of metals, plastic, or any other hard materials that are
biocompatible or implantable and are suitable for use in a
patient's body. The anchoring members can also be made out of a
semi stiff implantable material. The anchoring members can be made
out of stainless steel, titanium, titanium alloy, nickel, nickel
titanium alloy, chroma alloy or other suitable metal alloys. The
anchoring members can also be made out of polymers, high density
polyethylene (HDPE), polyglycolic acid, and polyglycolid
hydroxyacetic acid. In one embodiment, the anchoring members or at
least portions of the anchoring members are coated with a
biocompatible lubricious material that provides for easier delivery
and entrance into the tissue.
[0054] FIG. 4 illustrates an exemplary embodiment where two of the
ligatures 100 are placed across a heart valve such as a mitral
valve. In FIG. 4, a heart 202 includes a mitral valve 204, a mitral
valve annulus 206, a left fibrous ring 220, a right fibrous trigone
200 and a left fibrous trigone 210. The mitral valve 204 may be a
faulty mitral valve such as those seen in patients having
regurgitation. In one embodiment, the ligatures 100 (each including
anchoring members 102A and 102B) are placed across the mitral valve
204 in a semi-parallel pattern. In one embodiment, an anchoring
member 102A of a ligature 100 is placed in the left fibrous trigone
210 and an anchoring member 102B is placed in a location on the
opposite side of the mitral valve annulus 206 in the left fibrous
ring 220. Another anchoring member 102A of another ligature 100 is
placed in the right fibrous trigone 200 and the other end of
another ligature is placed in a location on the opposite side of
the mitral valve annulus 206 in the left fibrous ring 220. If
necessary, multiple ligatures 100 may be placed across the mitral
valve annulus 206 in a semi-parallel pattern.
[0055] FIG. 5 illustrates another exemplary embodiment where two of
the ligatures 100 are placed across a heart valve such as a mitral
valve. The placement of the ligatures 100 in FIG. 5 is similar to
the placement shown in FIG. 4 except that the ligatures 100
intersect or cross each other. In FIG. 5, a heart 202 includes a
mitral valve 204, a mitral valve annulus 206, a left fibrous ring
220, a right fibrous trigone 200 and a left fibrous trigone 210. In
one embodiment, the ligatures 100 (each including anchoring members
102A and 102B) are placed across the mitral valve 204 in an
intersecting or cross pattern. In one embodiment, an anchoring
member 102A of a ligature 100 is placed in the left fibrous trigone
210 and an anchoring member 102B is placed in a location on the
opposite side of the mitral valve annulus 206 in the left fibrous
ring 220. Another anchoring member 102A of another ligature 100 is
placed in the right fibrous trigone 200 and the other end of this
ligature 100 is placed in a location on the opposite side of the
mitral valve annulus 206 in the left fibrous ring 220. If
necessary, multiple ligatures 100 may be placed across the mitral
valve annulus 206 in the intersecting or cross pattern.
[0056] It is to be appreciated that the semi parallel and the
intersecting patterns can be combined together for the placements
of the ligatures 100 if necessary. Additionally, the anchoring
members of the ligatures shown in FIGS. 4 and 5 can have barbed end
configurations as those shown for the anchoring members 102A or
102A, helix ends 104A or 104B, as those shown in FIG. 3 or hook
ends 103A and 103B as those shown in FIG. 2B, or other types of
ends that will anchor the ends of the ligature 100 to a tissue or a
cardiac tissue. Also, a ligature 100 may include more than one
anchoring member at each end of the ligature 100.
[0057] FIG. 6 illustrates a perspective view of one exemplary
embodiment of a medical device 301 that includes a ligature 100
which can be used to percutaneously deploy a ligature 100 to a
heart to treat a faulty heart valve. FIG. 7 illustrates a cross
section "A" of the distal end 324 of the medical device 301. FIG. 8
illustrates a cross section "B" of the mid-section of the medical
device 301.
[0058] In one embodiment, the medical device 301 comprises a
delivery shaft 300 having a delivery lumen 305 (FIGS. 7-8), a
proximal end 322, and a distal end 324. In one embodiment, the
delivery shaft 300 is a catheter, which is sized and shaped as
generally known in the art to travel within and along the vascular
tree to the heart of a patient. A first deployment shaft 310A and a
second deployment shaft 310B are disposed within the delivery lumen
305 and extend from the distal end 324 to the proximal end 322. A
ligature 100 is releasably coupled to the delivery shaft 300 at the
distal end 324 such that the ligature 100 is coupled to the
delivery shaft 300 for deployment, and after deployment, the
ligature 100 is released from the delivery shaft 300. The ligature
100 includes a first anchoring member 102A and a second anchoring
member 102B and the ligature 100 links them as previously
described. The medical device 301 can deploy the ligature 100 into
a patient wherein the first deployment shaft 310A deploys the first
anchoring member 102A to a first tissue area of the patient (e.g.,
a cardiac tissue, a tissue proximate a mitral valve, or a portion
of the mitral valve) and the second deployment shaft 310B deploys
the second anchoring member 102B to a second tissue area of the
patient (e.g., another cardiac tissue, another tissue proximate a
mitral valve, or another portion of the mitral valve).
[0059] In one embodiment, the ligature 100 is contained in the
distal end 324 of the delivery shaft 300 near the cross section
"A." The delivery lumen 305 may be a dumbbell shaped lumen 305. The
dumb bell shaped lumen 305 provides a compartment in the distal end
of the delivery shaft 300 where the ligature 100 can reside
undisturbed as the medical device 301 is advanced to an area of the
heart to be treated.
[0060] In one embodiment, the ligature 100 is housed inside the
delivery lumen 305 on the distal end 324. The anchoring member 102A
of the ligature 100 is mounted on the distal end of the deployment
shaft 310A; and, the anchoring member 102B is mounted on the distal
end of the deployment shaft 310B. In one embodiment, the deployment
shaft 310A is housed in its own deployment lumen 306 and the
deployment shaft 3101B is housed in its own deployment lumen 308.
The deployment lumens 306 and 308 may combine together to form the
dumb bell shape lumen 305 or may be two separate lumens comprised
within the delivery shaft 300. The delivery lumen 305 does not need
to (but may) maintain its dumb bell shape for the entire length of
the delivery shaft 300 or may only have the dumb bell shape at the
distal end 324 of the delivery shaft 300. The delivery shaft 300
may include additional lumens such as additional lumens for the
delivery of additional ligatures or for sensing endoscopy or to
allow a pull wire to be used to deflect the distal end 324 (in
order to control the positions where the anchoring members are
anchored).
[0061] In one embodiment, the delivery shaft 300 is further coupled
to a handle member 340, which is used in deploying the ligature or
ligatures 100 as shown in FIG. 6. The handle member 340 includes a
deployment mechanism 350A and a deployment mechanism 350B, which
can advance or retract the deployment shafts 310A and 3101B,
respectively, to deploy the ligature 100. In one embodiment, the
proximal end of the deployment shaft 310A is connected to the
deployment mechanism 350A. The proximal end of the deployment shaft
3101B is connected to the deployment mechanism 350B.
[0062] In one embodiment, the delivery shaft 300 also includes a
guide wire lumen 320 as shown in FIGS. 7-8. The guide wire lumen
320 extends from the distal end 324 of the delivery shaft 300 to
the proximal end 322 of the delivery shaft 300, through the handle
member 340, and is connected to a guide wire port 360 in the
proximal end of the handle member 340. The guide wire lumen 320 is
sufficiently sized and shaped to allow for the insertion of a guide
wire (not shown). The guide wire may be disposed through the guide
wire lumen 320 to guide or maneuver the delivery shaft 300 from the
entrance of the patient's body through the body of the patient to
reach the area of the heart where the ligature 100 will be
deployed, e.g., a mitral valve. In one embodiment, the guide wire
port 360 is used to control the advancement, movement, or steering
of the guide wire through the patient's body.
[0063] In one embodiment, the delivery shaft 300 may include
reinforcement member such as a plurality of strands disposed in
braided pattern, a plurality of fibers kitted together, or a coiled
wire (not shown). In another embodiment, the delivery shaft 300 may
comprise other lumens or supporting member (not shown) that can be
used to steer or aim the distal end 324 of the medical device 301
in a desired direction. These supporting members may be of a
pre-shaped nature curving the delivery shaft 300 as the supporting
members are advanced within a lumen to the distal end 324 of the
delivery shaft 300. One or more of these steering lumen and
supporting member may be present in the delivery shaft 300.
[0064] In another embodiment, a supporting member may consist of a
member (not shown) that is coupled to the distal end 324 of a
steering lumen included within the delivery shaft 300. The steering
lumen can be the guidewire lumen 320 shown in FIGS. 7-8. The
supporting member may extend from the distal end 324 to the
proximal end 322 of the delivery shaft 300. In one embodiment,
pulling on this supporting member at the proximal end 322 causes
the distal end 324 of the delivery shaft to become curved. In
another embodiment, the steering lumen is pressurized causing the
distal end 324 of the delivery system to bend in a desired
direction.
[0065] In one embodiment, the guide wire lumen 320 may only be
present in the distal end 322 of the delivery shaft 300 as in
common rapid exchange catheter design known in the art. A common
rapid exchange catheter is well known in the art. In another
embodiment, the guide wire lumen 320 may absent from the delivery
shaft 300 and may be replaced by one or more tendons to produce a
bendable tip delivery shaft 300.
[0066] The delivery shaft 300 may be made out of numerous different
types of materials. In one embodiment, the delivery shaft 300 is
made out of materials that are suitable for inserting into a
patient's body. For example, the delivery shaft 300 may be made out
of materials suitable for making a catheter. The delivery shaft 300
may be made out of polyether block amid (PEBA), polyethylene (PE),
polyproplylene (PP), polyvinylchloride (PVC),
polytetrafluoroethylene (PTFE), or polyurethane, or other types of
biocompatible material.
[0067] In one embodiment, the delivery shaft 300 comprises at least
one radiopaque marker to aid the operator (e.g., a physician) in
the monitoring, placing, or inserting of the delivery shaft 300
into a patient. The radiopaque marker can be a band of radiopaque
material disposed proximate the distal end 324 of the delivery
shaft 300. The radiopaque material aids the operator in determining
the location of the distal end 324 of the delivery shaft 300.
Examples of a radiopaque material include gold, platinum, tungsten,
iron, silver, and thermoplastic material loaded with a radiopaque
filler such as barium sulfate, bismuth subcarbonate, bismuth
trioxide, bismuth oxychloride, tungsten power, and depleted
uranium, etc. In another embodiment, the delivery shaft 300
comprises at least one Magnetic Resonance Imaging (MRI) marker to
aid the operator in the monitoring, placing, or inserting of the
delivery shaft 300 into a patient. An example of an MRI marker
materials include platinum, tungsten, iridium, barium sulfate,
plastic, or other particles suitable for a MRI process.
Alternatively, the MRI marker can be an active component such as a
small circuit that can generate a radio frequency (RF) that an MRI
scanner can detect.
[0068] FIG. 9 illustrates a perspective view of the medical device
301 wherein the delivery shaft 300 is deploying the ligature 100
that is releasably coupled to the delivery shaft 300. In one
embodiment, the medical device 301 is used to deploy the ligature
100 to place the ligature 100 across the mitral valve as
illustrated in FIG. 4-5. The medical device 301 can be used to
deploy the ligature 100 to other area of the heart, for example,
within a coronary sinus (see FIG. 15A) or over the left ventricle
of the heart (see FIGS. 14B and 14C).
[0069] In one embodiment, advancing the deployment shaft 310A
advances the anchoring member 102A of the ligature 100 out of the
delivery shaft 300 as illustrated in FIG. 9. As the deployment
shaft 310A is advanced, the anchoring member 102A is advanced from
the lumen 305 at the distal end 324 of the delivery shaft 300 to a
tissue area 326. Once the anchoring member 102A is anchored to the
tissue area 326, the deployment shaft 310A can be retracted into
the delivery shaft 300 leaving the anchoring member 102A embedded
in the tissue area 326. In one embodiment, the deployment shaft
310A is retracted as illustrated in FIG. 10 wherein the anchoring
member 102A is left attached or anchored to the tissue area 326.
This process can be repeated for the anchoring member 102B of the
ligature 100. The deployment shaft 310B is advanced out of the
delivery shaft 300 thus advancing the anchoring member 102B. In one
embodiment, the anchoring member 102B is anchored to a tissue area
328 which can be substantially opposite the tissue area 326 where
the anchoring member 102A is anchored. Once the anchoring member
102B is anchored into the tissue area 328, the deployment shaft
310B is retracted into the delivery shaft 300.
[0070] In the embodiment where the ligature 100 is flexible, once
both of the anchoring members 102A and 102B of the ligature 100 are
anchored, the ligature 100 is allowed to return to its original
length (unstretched length) or its original shape, thus, bringing
the tissue areas 326 and 328 closer to each other. When the tissue
areas 326 and 328 are brought closer to each other, the heart
structure that the ligature 100 is placed across, e.g., the mitral
valve, is narrowed, reduced, or constricted. In the embodiment
where the ligature 100 is made of a rigid material, once the
anchoring members 102A and 102B of the ligature 100 are anchored,
the ligature 100 pull the tissue areas 326 and 328 are closer to
each other. Again, when the tissue areas 326 and 328 are brought
closer to each other, the heart structure that the ligature 100 is
placed across, e.g., the mitral valve, is narrowed, reduced, or
constricted.
[0071] The medical devices 301 shown in FIGS. 6-8 and 9-10 include
the ligature 100 that has barbed end configurations for the
anchoring members 102A and 102B. It is to be appreciated that the
anchoring members 102A and 102B may have other configurations, for
examples, helixes, or hooks as shown in FIGS. 2B and 3.
[0072] FIGS. 11A-11B illustrate an exemplary medical device 302.
The medical device 302 is similar to the medical device 301 except
that the device 302 is more preferred for delivering a ligature 100
that has helix ends as the anchoring members. As illustrated in
FIGS. 11A-11B, the medical device 302 comprises a delivery shaft
303 having a delivery lumen 318, a proximal end 332, and a distal
end 334. In one embodiment, the delivery shaft 303 is a catheter,
which is sized and shaped as generally known in the art to travel
within and along the vascular tree to the heart of a patient. In
another embodiment, the delivery shaft 303 is the same as the
delivery shaft 300.
[0073] In one embodiment, a first deployment shaft 307 and a second
deployment shaft 309 are disposed within the delivery lumen 318 and
extended from the distal end 334 to the proximal end 332. A
ligature 100 is releasably coupled to the delivery shaft 303 at the
distal end 334 such that the ligature 100 is coupled to the
delivery shaft 303 for deployment, and after deployment, the
ligature 100 is released from the delivery shaft 303. The ligature
100 includes a first anchoring member 104A and a second anchoring
member 104B which are of helix ends. The medical device 302 can
deploy the ligature 100 into a patient wherein the first deployment
shaft 307 deploys the first anchoring member 104A to a first tissue
area of the patient (e.g., a cardiac tissue, a tissue proximate a
mitral valve, or a portion of the mitral valve) and the second
deployment shaft 309 deploys the second anchoring member 104B to a
second tissue area of the patient (e.g., a cardiac tissue, a tissue
proximate a mitral valve, or a portion of the mitral valve).
[0074] In one embodiment, the ligature 100 is contained in the
distal end 334 of the delivery shaft 303. The delivery lumen 318
may be a dumbbell shaped lumen 318. The dumb bell shaped lumen 318
provides a compartment in the distal end of the delivery shaft 303
where the ligature 100 can reside undisturbed as the medical device
302 is advanced through the patient's vasculature to an area of the
heart to be treated.
[0075] In one embodiment, the ligature 100 is housed inside the
delivery lumen 318 on the distal end 334. The anchoring member 104A
of the ligature 100 is mounted on the distal end of the deployment
shaft 307; and, the anchoring member 104B is mounted on the distal
end of the deployment shaft 309. In one embodiment, the deployment
shaft 307 is housed in its own deployment tube 336 and the
deployment shaft 308 is housed in its own deployment tube 338 as
illustrated in FIG. 1I B. The deployment tubes 336 and 338 may
combine together to form the dumb bell shape lumen 318 or may be
two separate tubes disposed within the delivery shaft 303. The
delivery lumen 318 does not need (but may) maintain its dumb bell
shape for the entire length of the delivery shaft 303 or may only
have the dumb bell shape at the distal end 334 of the delivery
shaft 303.
[0076] In one embodiment, the delivery shaft 303 is further coupled
to a handle member 304, which is used to deploy the ligature or
ligatures 100. The handle member 304 includes a deployment
mechanism 350A and a deployment mechanism 350B, which can advance
or retract the deployment shafts 307 and 309, respectively, to
bring the ligature 100 closer to the anchoring sites. In one
embodiment, at least a section near the proximal end of the
deployment shaft 307 is connected to the deployment mechanism 350A.
A section near the proximal end of the deployment shaft 309 is
connected to the deployment mechanism 350B. In one embodiment, as
the deployment shafts 309 and 309 are advanced or retraced, the
anchoring members 104A and 104B of the ligature 100 are advanced or
retracted.
[0077] The handle member 304 also includes a rotating mechanism 314
and a rotating mechanism 316, which can rotate the deployment
shafts 307 and 309 as the deployment shafts 307 and 309 are
advanced or retracted. In one embodiment, the proximal end of the
deployment shaft 307 is connected to the rotating mechanism 314.
The proximal end of the deployment shaft 309 is connected to the
rotating mechanism 316. In one embodiment, rotating the rotating
mechanism 314 rotates the deployment shaft 307 thus rotating the
anchoring member 104A. Similarly, rotating the rotating mechanism
316 rotates the deployment shaft 309 thus rotating the anchoring
member 104B.
[0078] In one embodiment, the deployment tubes 336 and 338 are
connected to the deployment mechanisms 350A and 350B, respectively.
In this embodiment, the deployment tubes 336 and 338 are advanced
or retracted by the deployment mechanisms 350A and 350B. As the
deployment tube 336 and 338 are advanced or retracted, the
deployment shafts 307 and 309 are also advanced or retracted. Thus,
in this case, to deploy the anchoring members 104A and 104B, the
deployment mechanisms 350A and 350B advance the deployment tubes
336 and 338, respectively. The deployment tubes 336 and 338 may be
advanced completely out of the delivery shaft 303 or may only be
partially advanced. Then, the deployment shafts 307 and 309 are
then rotated by the rotating mechanisms 314 and 316, respectively
to deploy the anchoring members 104A and 104B.
[0079] In one embodiment, the delivery shaft 303 also includes a
guide wire lumen 312 as illustrated in FIGS. 11A-11B. The guide
wire lumen 312 extends from the distal end 334 of the delivery
shaft 303 to the proximal end 332 of the delivery shaft 303, and
through the handle member 304 and is connected to a guide wire port
330 located at the proximal end of the handle member 304. The guide
wire lumen is sufficiently sized and shaped to allow for the
insertion of a guide wire (not shown). The guide wire may be
disposed through the guide wire lumen 312 to guide or maneuver the
delivery shaft 303 through the body of the patient to reach the
area of the heart where the ligature 100 is to be deployed, e.g., a
mitral valve. In one embodiment, the guide wire port is used to
control the advancement, movement, or steering of the guide wire
through the patient's body.
[0080] In one embodiment, the delivery shaft 303 may include
reinforcement member similar to the delivery shaft 300 described
above. In another embodiment, the delivery shaft 303 may comprise
other lumens or supporting member that can be used to steer or aim
the distal end 334 of the medical device 302 in a desired
direction. These supporting members may be of a pre-shape nature
curving the delivery shaft 303 as the supporting members are
advanced within a lumen to the distal end 334 of the delivery shaft
303. One or more of these steering lumen and supporting member may
be present in the delivery shaft 303.
[0081] In another embodiment, a supporting member may consist of a
member (not shown) that is coupled to the distal end 334 of a
steering lumen included within the delivery shaft 303. The steering
lumen can be the guidewire lumen 312 shown in FIGS. 11A-11B. The
supporting member may extend from the distal end 334 to the
proximal end 332 of the delivery shaft 303. In one embodiment,
pulling on this supporting member at the proximal end 332 causes
the distal end 334 of the delivery shaft to become curved. In
another embodiment, the steering lumen is pressurized causing the
distal end of the delivery system to bend in a desired
direction.
[0082] In one embodiment, the guide wire lumen 312 may only be
present in the distal end 332 of the delivery shaft 303 as in
common rapid exchange catheter design as is known in the art. In
another embodiment, the guide wire lumen 312 may absent from the
delivery shaft 303 and may be replaced by one or more tendons to
produce a bendable tip delivery shaft 303.
[0083] The delivery shaft 303 may made out of numerous different
types of materials similar to the material used to make the
delivery shaft 300 described above. Also, similar to the delivery
shaft 300, the delivery shaft 303 may also comprise at least one
radiopaque marker or an MRI marker to aid the operator (e.g., a
physician) in the monitoring, placing, or inserting of the delivery
shaft 303 into a patient.
[0084] FIGS. 12A-12G illustrate an exemplary deployment shaft that
can be used with the medical device 302 to deploy the ligature 100.
The deployment shaft can be the deployment shaft 307 or 309 shown
in FIGS. 11A-11B. In one embodiment, the deployment shaft 307 shown
in FIG. 12A is disposed within the deployment tube 336 as shown in
FIG. 12B. In one embodiment, the deployment shaft 307 includes a
slot 342 wherein a portion of the ligature 100 can reside until
deployment. The slot 342 is useful in that it helps keep the
ligature 100 from being entangled between two deployment shafts 307
and 309. The slot 342 is not necessary for the deployment shaft 307
or 309 to function properly in deploying the ligature 100.
[0085] In one embodiment, a portion of the ligature 100 proximate
the anchoring member 104A is spiraled around the deployment shaft
307 (as shown in FIG. 12D); and, the other portion of the ligature
100 proximate the anchoring member 104B would be spiraled around
the deployment shaft 309 in a similar manner (not shown). In the
embodiment where the deployment shafts 307 and 309 each includes a
slot 342, the portion of the ligature 100 that is not wound around
the deployment shafts 307 and 309 extends through the slot 342. The
ligature 100 extending from one slot 342 of one deployment shaft
(e.g., deployment shaft 307) can be inserted into another slot 342
on another deployment shaft (e.g., deployment shaft 309).
[0086] In one embodiment, the distal end of the deployment shaft
307 further comprises an axis 344 such that the helix anchoring
member 104A can be kept there or releasably coupled thereto until
the deployment of the ligature 100. The deployment shaft 307 with
the ligature 100 releasably coupled thereto can be disposed within
the deployment tube 336 as illustrated in FIG. 12E. FIGS. 12F-G
further illustrates the distal end 334 of the delivery shaft 302
wherein the deployment shafts 307 and 309 are disposed within the
deployment tube 336 and 338, respectively.
[0087] It is to be appreciated that a similar construction to the
deployment shaft 307 can used for the ligature 100 with the barbed
end configurations for the anchoring member 102A and 102B described
above. In this embodiment, the barbed end will be kept at the axis
344 until after deployment.
[0088] FIGS. 13A-13H illustrate an exemplary process of deploying
the ligature 100 that includes helix ends anchoring members. At
FIGS. 13A-13B, the deployment tube 336 is advanced in order to
advance the deployment shaft 307 (not visible in these figures)
toward a tissue area 344. Advancing the deployment shaft 307 would
advance the helix ends 104A toward the tissue area 344. In one
embodiment, the deployment tube 336 is advanced toward the tissue
area 344 by a deployment mechanism, such as the deployment
mechanism 350A shown in FIG. 11. After the advancement, the
deployment shaft 307 is then rotated by a rotating mechanism such
as the rotating mechanism 314 shown in FIG. 11. In this case, the
linkage portion of the ligature 100 which joins the two anchoring
members, the helix ends 104A and 104B, is flexible and twistable so
that one helix end can be rotated while the other helix end is not.
As the deployment shaft 307 is rotated, the helix end 104A is also
rotated allowing it to pierce through the tissue area 344 as
illustrated in FIG. 13C. In one embodiment, upon advancing, the
helix end 104A is rotated in a direction that would enhance the
advancement of the helix end 104A into the tissue area 344. The
rotation of the deployment shaft 307 is initiated by a rotation of
the rotating mechanism. Once the helix end 104A is anchored to the
tissue area 344, the deployment tube 336 together with the shaft
307 is retracted into the delivery shaft 303 leaving the helix end
104A embedded (or anchored) in the tissue area 344 as illustrated
in FIG. 13D. This process can be repeated for the helix end 104B of
the ligature 100.
[0089] As shown in FIGS. 13D-13E, the deployment tube 338 is
advanced out of the delivery shaft 303 to advance the deployment
shaft 309 to a tissue area 346. Advancing the deployment shaft 309
would advance the helix end 104B toward the tissue area 346. After
the advancement, the deployment shaft 309 is rotated by a rotating
mechanism such as the rotating mechanism 316 shown in FIG. 11. As
the deployment shaft 309 is rotated, the helix end 104B is also
rotated allowing it to pierce through the tissue area 346 as
illustrated in FIGS. 13E-F. In one embodiment, upon advancing, the
helix end 104B is rotated in a direction that would enhance the
advancement of the helix end 104B into the tissue area 346. Once
the helix end 104B is anchored to the tissue area 346 as shown in
FIG. 13F, the deployment shaft 309 is retracted into the delivery
shaft 303 leaving the helix end 104B embedded in the tissue area
346 as illustrated in FIGS. 3G-H.
[0090] After the helix ends 104A and 104B are anchored to the
tissue area 344 and 346, respectively, the delivery shaft 303 may
then be retracted from the tissue area 344 and 346. The process
described in FIGS. 13A-13H may be repeated as needed to deploy as
many ligatures 100 as necessary. In one embodiment, the process is
used to constrict a heart valve such as a mitral valve by placing
multiple ligatures 100 across the mitral valve's annulus. In one
embodiment, the tissue area 344 and 346 are the fibrous tissue
around the annulus of the mitral valve. The anchoring of the helix
ends 104A and 104B thus places the ligature 100 across the heart
valve to reduce or constrict the size of the heart valve. The
ligatures 100 with the helix ends can be placed across the mitral
valve using this process to place the ligatures 100 similarly to
what is depicted in FIGS. 4 and 5.
[0091] FIG. 14A illustrates an exemplary route of percutaneously
inserting the ligatures 100 into a patient's heart 110. As
previously mentioned, by percutaneous deployment, the ligature 100
is deployed through blood vessels, veins, or arteries into a
patient. In one embodiment, the ligature 100 is deployed through
the blood vessels, veins, or arteries and into the heart area of a
patient.
[0092] In one embodiment, FIG. 14A illustrates an exemplary route
of percutaneously inserting the ligatures 100 into the heart 110
and placing the ligatures 100 across the mitral valve 120 of the
heart 110. In one embodiment, a medical device containing the
ligature 100 is introduced into the patient's body percutaneously
using a modified Seldinger technique in which the medical device is
inserted into the venous vascular tree through the femoral vein. In
one embodiment, the medical device enters or reaches the annulus of
the mitral valve 120 from the atrial side of the heart 110. A
medical device 130 is first provided. The medical device 130 can be
the medial device 301 or the medical device 302 described above.
The medical device 130 can also be a catheter capable of delivering
and deploying a ligature 100 to the heart. The medical device 130
is advanced up the inferior vena cava (IVC) 122 and into the right
atrium (RA) 112 of the heart 110. The medical device 130 then
enters then left atrium (LA) 114 of the heart 110. In one
embodiment, the medical device 130 crosses the atrial septum 124
through a small atrial septostomy (created by cardiological
techniques known in the art) to enter the left atrium 114 of the
heart 110. In one embodiment, a guidewire (not shown) is placed
across the atrial septostomy and the medical device 130 is threaded
along the guidewire and into the left atrium 114. The medical
device 130 is stopped at a predetermined point in, at, or in
proximity to the mitral valve 120. In one embodiment, the medical
device 130 may have a preformed or deflectable short hook
configuration at its tip region to facilitate the insertion of the
medical device 130 into the mitral valve area. Once the medical
device 130 reaches the area in, at, or in proximity to mitral valve
120, the ligature 100 can be deployed as previous described and be
placed across the mitral valve in similar manners as those shown in
FIGS. 4-5.
[0093] FIG. 14B illustrates an exemplary route of percutaneously
inserting the ligatures 100 into a patient's heart 110 to perform a
ventricular remodeling of the heart. In ventricular remodeling, the
ligature (or ligatures) 100 can be used to reduce the size of the
ventricle by placing these ligatures around the left ventricle
(which is typically the ventricle that is enlarged due to a faulty
mechanism in the heart such as regurgitation). With the ligatures
100 placed around the left ventricle, the size of the left
ventricle can be reduced, hence, remodeled.
[0094] Continuing with FIG. 14B, in one embodiment, a medical
device 130 is first provided. In one embodiment, the medical device
130 can be the medial device 301 or the medical device 302
described above. In another embodiment, the medical device 130 can
be a catheter capable of delivering and deploying a ligature 100 to
the heart. The medical device 130 is advanced up the inferior vena
cava (IVC) 122 and into the right atrium (RA) 112 of the heart 110.
The medical device 130 then enters then left atrium (LA) 114 of the
heart 110. In one embodiment, the medical device 130 crosses the
atrial septum 124 through a small atrial septostomy (created by
cardiological techniques known in the art) to enter the left atrium
114 of the heart 110. In one embodiment, a guidewire (not shown) is
placed across the atrial septostomy and the medical device 130 is
threaded along the guidewire and into the left atrium 114. The
medical device 130 is advanced through the mitral valve 120 to
enter the left ventricle 118. In one embodiment, the medical device
130 may have a preformed or deflectable short hook configuration at
its tip region to facilitate the insertion of the medical device
130 into the mitral valve area. Once the medical device 130 is
inserted through the mitral valve 120, the ligature 100 can be
deployed as previous described to anchor one of the anchoring
members into the papillary muscles in the left ventricle 118 and
the other anchoring member into a cardiac tissue opposite the heart
muscles. This process is repeated to deploy several ligatures 100
as it may be necessary to employ more than one ligature to reduce
the size of an enlarged left ventricle. In one embodiment, after
several ligatures 100 have been deployed, the ligatures surround
the left ventricle 118 as shown in FIG. 14B.
[0095] FIG. 14C illustrates another exemplary route of
percutaneously inserting the ligatures 100 into a patient's heart
110 to perform a ventricular remodeling of the heart. A medical
device 130 is first provided. In one embodiment, the medical device
130 can be the medial device 301 or the medical device 302
described above. In another embodiment, the medical device 130 can
be a catheter capable of delivering and deploying a ligature 100 to
the heart. The medical device 130 is advanced up the aorta 119 and
directly into the left ventricle 118. In one embodiment, the
medical device 130 may have a preformed or deflectable short hook
configuration at its tip region to facilitate the insertion of the
medical device 130 into the left ventricle 118. Once the medical
device 130 reaches the left ventricle 118, the ligature 100 is
deployed as previous described to place the ligature 100 into the
tissues of the left ventricle 118. One such tissue is the heart
muscles in the left ventricle 118. This process is repeated to
deploy several ligatures 100 as it may be necessary to employ more
than one ligature to reduce the size of an enlarged left ventricle.
In one embodiment, after several ligatures 100 have been deployed,
the ligatures span the interior of the left ventricle 118 as shown
in FIG. 14C.
[0096] FIG. 15A illustrates an alternative embodiment of placing
the ligature 100 around a mitral valve. In this embodiment, the
ligature 100 described previously is placed within the coronary
sinus 212 of the heart 202. The coronary sinus 212 substantially
encircles the mitral valve annulus 206 of the mitral valve 204. A
first anchoring member of the ligature 100 (e.g., the first
anchoring member 102A) extends outside one end of the coronary
sinus 218 and anchors into the left fibrous trigone 210. A second
anchoring member of the ligature 100 (e.g., the second anchoring
member 102B) extends outside the coronary sinus 218 and anchors
into the right fibrous trigone 200. In one embodiment, the ligature
100 has a preformed shape such that once the ligature 100 is
deployed and that the first and the second anchoring members are
anchored, the ligature 100 bends and reduces the radius of
curvature of the coronary sinus 218. In this embodiment, the
ligature 100 can be made of a shape memory material and may be
flexible or rigid. The ligature 100 may be made of a shape memory
material such as Nitinol or other material that has a memory of an
original shape as shown in FIG. 15B and can be temporarily
stretched or forced into another shape during deployment as shown
in FIG. 15C and FIG. 15D. Since the coronary sinus 218
substantially encircles the mitral valve annulus 206, the reduction
of the radius of curvature of the bent coronary sinus 218 will
result in a diameter and circumference reduction of the mitral
valve annulus 206. In one embodiment the ligature 100 is surrounded
or encapsulated by a jacket so as to prevent the ligature 100, once
deployed within the coronary sinus 218, from cutting through the
coronary sinus 218.
[0097] FIG. 16 illustrates an exemplary method 150 of treating a
faulty heart valve by constricting or reducing the size of the
heart valve. At operation 152, a medical device such as the medical
device 301 or 302 described above is provided. At operation 154,
the ligature 100 is deployed into the patient wherein the first
deployment shaft (e.g., the deployment shaft 310A, or 307) deploys
the first anchoring member (e.g., the anchoring member 102A or
104A) to a first tissue area around the heart valve and the second
deployment shaft (e.g., the deployment shaft 3101B, or 309) deploys
the second anchoring member (e.g., the anchoring member 102B or
104B) to a second tissue area of the heart valve. The ligature 100
can be deployed using the embodiments previously described.
Deploying the ligature 100 anchors the first anchoring member to
the first tissue area and the second anchoring member to the second
tissue area as described above. The method 150 can be repeated in
embodiments where multiple ligatures 100 are to be placed across
the heart valve. The number of ligatures 100 sufficient to treat a
faulty heart valve depends on how much of the size of the faulty
heart valve needs to be constricted or reduced. The cross section
size of each of the ligatures 100 is sufficiently small so as to
not cause thrombus or to not significantly impede the blood flow
through the heart valve. The length of each of the ligatures 100
can be varied depending on the area the ligature 100 needs to
constrict or reduce.
[0098] The percutaneous methods described above can be used to
place the ligature(s) 100 across the mitral valve to constrict (or
reduce) the size of a faulty or defective heart valve. In one
embodiment, the ligatures 100 are placed across the mitral valve in
order to prevent back flow of blood that a patient with a
regurgitation condition caused by a faulty mitral valve would
experience. The described medical devices including the ligatures
100 that enable percutaneous introduction of the ligatures 100 into
patients can replace those cases that require surgical procedures
to reduce or constrict the mitral valve. Such a percutaneous method
also reduces patient discomfort, improves recovery time, and
reduces hospitalization time relatives to a surgical procedure in
which the chest is opened.
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