U.S. patent application number 12/885183 was filed with the patent office on 2011-03-17 for annuloplasty system and surgical method.
Invention is credited to Tigran Khalapyan.
Application Number | 20110066236 12/885183 |
Document ID | / |
Family ID | 38924185 |
Filed Date | 2011-03-17 |
United States Patent
Application |
20110066236 |
Kind Code |
A1 |
Khalapyan; Tigran |
March 17, 2011 |
ANNULOPLASTY SYSTEM AND SURGICAL METHOD
Abstract
An annuloplasty system for repairing incompetent heart valves is
provided. This system includes a substantially circular valve
reinforcing device adapted to be surgically implanted into around a
heart valve annulus; anchoring means for attaching the
substantially circular valve reinforcing device to the heart valve,
wherein attaching the substantially circular valve reinforcing
device to the heart valve annulus reduces the circumference of the
heart valve annulus by plicating annular tissue underneath the
valve reinforcing device; and constricting means for, if necessary,
reducing the circumference of the substantially circular valve
reinforcing device, wherein reducing the circumference of the
substantially circular valve reinforcing device further reduces the
circumference of the heart valve annulus.
Inventors: |
Khalapyan; Tigran; (Hershey,
PA) |
Family ID: |
38924185 |
Appl. No.: |
12/885183 |
Filed: |
September 17, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11776915 |
Jul 12, 2007 |
7799073 |
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12885183 |
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Current U.S.
Class: |
623/2.37 |
Current CPC
Class: |
A61B 17/0401 20130101;
A61B 2017/0496 20130101; A61B 2017/00783 20130101; A61B 2017/0464
20130101; A61B 2017/0456 20130101; A61B 17/0467 20130101; A61B
2017/0472 20130101; A61B 2017/048 20130101; A61B 2017/0406
20130101; A61F 2/2445 20130101; A61B 2017/0458 20130101 |
Class at
Publication: |
623/2.37 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An annuloplasty system for repairing incompetent heart valves,
comprising: (a) a valve reinforcing device adapted to be surgically
implanted around a heart valve annulus, wherein the valve
reinforcing device further includes: (i) a plurality of individual
suture support components, wherein the plurality of suture support
components further includes: a) at least one anchor component
covered with a sewing cuff, wherein the at least one anchor
component further includes a channel passing lengthwise
therethrough; b) at least one terminal component covered with a
sewing cuff, wherein the at least one terminal component further
includes a channel passing lengthwise therethrough and wherein the
terminal component further includes a suture attached to the distal
end of the terminal segment; c) a plurality of intermediate
components disposed between the at least one anchor component and
the at least one terminal component, wherein each intermediate
component is covered with a sewing cuff, and wherein each
intermediate component further includes a channel passing
lengthwise therethrough; and (b) anchoring means for attaching the
valve reinforcing device to the heart valve annulus, wherein
attaching the valve reinforcing device to the heart valve annulus
reduces the circumference of the annulus by plicating annular
tissue underneath the valve reinforcing device, and wherein the
anchoring means further includes: (i) a dual-armed suture, wherein
at least one end of the suture is attached to a surgical needle,
and; (c) constricting means for reducing the circumference of the
valve reinforcing device, wherein reducing the circumference of the
valve reinforcing device further reduces the circumference of the
annulus, and wherein the constricting means further includes: (i) a
supportive drawstring, wherein one end of the drawstring is secured
to one end of the anchor component, wherein the supportive
drawstring passes through the channel in each intermediate
component and the channel in the terminal component.
2. The annuloplasty system of claim 1, wherein each individual
suture support components has a length of approximately 4.2
millimeters.
3. The annuloplasty system of claim 1, wherein the supportive
drawstring further includes suture material, biodegradable suture
material, a Teflon strip, a band, a filament, a wire, a strap or
combinations thereof.
4. The annuloplasty system of claim 1, wherein the individual
suture support segments are rigid or semi-rigid and are
cylindrical, tubular, square, round, oval, or combinations
thereof.
5. The annuloplasty system of claim 1, wherein the individual
suture support segments have rigid or semi-rigid core and resist
bucking when the anchoring means are tied and reduce the potential
of over-plication of annular tissue underneath the suture support
segments when the anchoring means are tied.
6. The annuloplasty system of claim 1, wherein the individual
suture support segments further include a textured surface or
coating for promoting tissue in-growth and reducing
thromboembolism.
7. A method for surgically implanting the annuloplasty system of
claim 1, comprising: (a) utilizing the anchoring means for securing
the valve reinforcing device to the heart valve annulus, wherein
securing the valve reinforcing device to the heart valve annulus
reduces the circumference of the heart valve annulus by plicating
annular tissue underneath the valve reinforcing device, and wherein
utilizing the anchoring means further includes: (i) affixing the
suture to the heart valve annulus as a horizontal mattress stitch
by passing one of the surgical needles attached to the sutures
through the heart valve annulus; (ii) threading the surgical
needles attached to the suture through the sewing cuff of the
anchor component; (iii) pushing the anchor component down over the
strands of the suture until the anchor component is aligned with
the heart valve annulus; (iv) securing the anchor component to the
heart valve annulus by tying the ends of the sutures together; (v)
affixing another suture to a incompetent heart valve annulus as a
horizontal mattress stitch by passing one of the surgical needles
attached to the sutures through the heart valve annulus; (vi)
threading the surgical needles attached to the suture through the
sewing cuff on the intermediate component; (vii) using the
supportive drawstring and the strands of the suture to guide the
intermediate component to a position above the heart valve annulus;
(viii) pushing the intermediate component down the suture strands
until the intermediate component is aligned with the heart valve
annulus; (ix) securing the intermediate component to the heart
valve annulus by tying the ends of the sutures together; (x)
repeating steps (v)-(ix) until the desired circumference around the
heart valve annulus is covered by a plurality of intermediate
suture support components; (xi) threading the supportive drawstring
through the channel which passes through the length of the terminal
component; (xii) affixing the suture to a heart valve annulus by
passing one of the surgical needles attached to the sutures through
the heart valve annulus; (xiii) threading the surgical needles
attached to the suture through the sewing cuff on the terminal
component; (xiv) using the supportive drawstring and the strands of
the suture to guide the terminal component to the position above
the heart valve annulus; (xv) pushing the terminal component down
over the strands of the sutures until the terminal component is
aligned with the heart valve annulus; (xvi) securing the terminal
component to the heart valve annulus by tying the ends of the
sutures together; and (xvii) testing the repaired heart valve to
verify that appropriate constriction has been achieved; and (b)
utilizing the constricting means to reduce the circumference of the
valve reinforcing device, wherein reducing the circumference of the
valve reinforcing device further reduces the circumference of the
heart valve annulus by plicating the annular tissue between
adjacent components of the valve reinforcing device, and wherein
utilizing the constricting means further includes: (i) pulling the
supportive drawstring to the desired tension to decrease the
circumference of the heart valve annulus; and (ii) tying the
supportive drawstring that runs through the terminal component to
the suture attached to the distal end of the terminal
component.
8. An annuloplasty system for repairing incompetent heart valves
without traditional knotting, comprising: (a) a flexible valve
reinforcing device adapted to be surgically implanted into a heart
valve annulus, wherein the valve reinforcing device further
includes a core formed of a plurality of thin fibers which are held
together by a tubular polyester velour cloth; and (b) anchoring
means for attaching the flexible valve reinforcing device to the
heart valve annulus and for pleating the annulus to reduce its
circumference to substantially that of the flexible valve
reinforcing device, wherein the anchoring means further includes:
(i) a plurality of suture apparatuses containing a surgical suture
and at least one surgical needle at each proximal end of the
surgical suture; and (ii) a plurality of barbed structures formed
at a medial point on each of the plurality of suture apparatuses
with a first barb structure being placed a distance away from a
second barb structure to create a bridge area, wherein the first
barbed structure is oriented to permit passage of the suture
through the heart valve annulus in a forward direction and prevent
movement in a reverse direction, and wherein the second barbed
structure is oriented to prevent passage of the suture through the
heart valve annulus in a forward direction.
9. A method for surgically implanting the annuloplasty system of
claim 8, comprising: (a) utilizing the anchoring means to secure
the valve reinforcing device to the heart valve annulus, wherein
utilizing the anchoring means further includes: (i) providing the
plurality of suture apparatuses; (ii) inserting one of the surgical
needles of the suture apparatus into the heart valve annulus and
pulling the surgical needle which draws a first portion of the
suture apparatus through the heart valve annulus until the second
barbed structure engages the surface of the annulus at the
insertion point preventing further advancement of the suture
apparatus into the heart valve annulus; (iii) inserting another
suture apparatus into the heart valve annulus approximately 2
millimeters apart from the previous suture apparatus and pulling
the surgical needle which draws the first portion of the suture
apparatus through the heart valve annulus until the second barbed
structure engages the surface of the heart valve annulus at the
insertion point preventing further advancement of the suture
apparatus into the heart valve annulus; (iv) repeating step (ii)
until the entire circumference of the posterior annulus of the
heart valve is sutured; (v) using both surgical needles of each of
the plurality of suture apparatuses to pierce the annuloplasty ring
(vi) sliding the annuloplasty ring over the surgical sutures of
each of the plurality of suture apparatuses into position above the
heart valve annulus; (vii) pushing the annuloplasty ring onto the
first and second barbed structures, wherein the first and second
barbed structures catch the thin fibers in the annuloplasty ring;
(viii) using the first and second barbed structures of each of the
plurality of suture apparatuses to hold the annuloplasty ring into
place; and (ix) cutting off any excess portion of the surgical
sutures of the plurality of the suture apparatuses at a point
beyond the annuloplasty ring.
10. A flexible annuloplasty system adapted to be surgically
implanted around a heart valve annulus without traditional
knotting, wherein the flexible annuloplasty system further
includes: (a) a plurality of substantially identical suture support
components, wherein each suture support component has a proximal
end and a distal end, and wherein the plurality of suture support
components further includes: (i) at least one anchor component,
wherein the at least one anchor component further includes an
opening at its distal end having a one-way suture retaining device
for engaging a suture threaded therethrough; (ii) a plurality of
intermediate components, wherein each intermediate component
further includes at least two channels passing lengthwise
therethrough, and wherein each intermediate component further
includes an opening at its distal end having a one-way suture
retaining device for engaging a suture threaded therethrough; and
(b) a surgical suture pre-attached at the proximal end of each
suture support component, and; (c) at least two supportive
drawstrings, wherein one end of each drawstring is attached to one
end of the at least one anchor component, wherein the drawstrings
pass through the two channels in each intermediate component, and
wherein the ends of the drawstrings are tied together over a final
individual suture support component after the heart valve repair is
completed.
11. The annuloplasty system of claim 10, wherein each of the
individual suture support components has a length of approximately
4.3 millimeters.
12. The annuloplasty system of claim 10, wherein the center of the
opening of each individual suture support component is
approximately 4 millimeters in distance from the suture attached to
the proximal end of each of the individual suture support
components.
13. The annuloplasty system of claim 10, wherein the surgical
suture has a core formed of a plurality of fibers which are held
together by tubular braided cover and wherein the fibers are
thermally bonded together to form a plurality of rigid bridges at
selected short intervals along the longitudinal axis of the
suture.
14. The annuloplasty system of claim 10, wherein the one-way suture
retaining device comprises a plurality of flexible fingers, barbs,
or series of sheets configured to engage the suture threaded
therethrough.
15. The annuloplasty system of claim 10, wherein the plurality of
flexible fingers, barbs or series of sheets of the one-way suture
retaining device include a plurality of sharp points in a common
axial direction adapted to prevent the suture from sliding in a
direction opposite to a direction of an inclination of the
plurality of flexible fingers, barbs or series of sheets.
16. The annuloplasty system according to claim 10, wherein the
one-way suture retaining device includes a passage having a
sufficient diameter to allow the suture to pass through the
opening, wherein the passage allows the plurality of sharp points
on the plurality of flexible barbs or fingers to engage the suture
when the suture is moved in the direction opposite to the direction
of inclination of the plurality of barbs, and wherein the sharp
points of the flexible fingers, barbs or series of sheets penetrate
the core of the suture between the rigid bridges.
17. The annuloplasty system of claim 10, wherein the opening in
each of the individual suture support components contains a
meltable polymeric material, wherein the suture is threaded through
the opening, and wherein the polymeric material and suture are
melted together to form a seal for the purpose of tying.
18. The annuloplasty system of claim 10, wherein the suture
includes a needle attached thereto.
19. The annuloplasty system of claim 10, wherein the suture is
stored within each of the individual suture support components.
20. A method for surgically implanting the flexible annuloplasty
system of claim 10, comprising: (a) utilizing the anchoring means
for securing the annuloplasty system to the heart valve annulus,
wherein securing the annuloplasty system to the heart valve annulus
reduces the circumference of the heart valve annulus by plicating
annular tissue underneath the suture support components, and
wherein utilizing the anchoring means further includes: (i)
affixing the suture of the anchor component to the heart valve
annulus by passing a needle attached to the suture through the
heart valve annulus; (ii) passing the needle attached to the suture
through the opening and pulling the needle and the suture through
the opening; (iii) pushing the anchor component down over the
suture until the anchor component is aligned with the heart valve
annulus; (iv) cutting off the excess portion of the suture of the
anchor component; (v) passing a needle attached to the suture on
the intermediate suture support component through the heart valve
annulus at approximately 2 millimeters apart from the anchor
component; (vi) threading the needle through the opening on the
intermediate suture support component; (vii) pulling the suture
through the opening on the intermediate suture component and
pushing the intermediate suture support component down over the
suture and the supportive drawstring until the intermediate
component is aligned with the heart valve annulus; (viii) cutting
off the excess portion of the of the suture of the intermediate
suture component; (ix) repeating steps (v)-(viii) until the desired
circumference around the heart valve annulus is covered by the
plurality of intermediate suture support components; and (x) tying
the ends of the supportive drawstrings around the final suture
support component.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a divisional of U.S. patent
application Ser. No. 11/776,915, now allowed, filed on Jul. 12,
2007.
BACKGROUND OF THE INVENTION
[0002] The described invention relates in general to surgical
systems, devices, and methods and more specifically to an
annuloplasty system for damaged heart valve repair. This invention
is useful for humans and may be used for the surgical correction of
a deformed heart valve, and in particular a heart valve that has
become dilated.
[0003] Diseases of the mitral valve affect the annulus, altering
annular geometry and function. Dilation and/or deformation of the
valve annulus result in the displacement of the cusps away from the
center of the valve. This results in an ineffective closure of the
valve during ventricular contraction, which results in the
regurgitation or leakage of blood during ventricle contraction.
[0004] Two known surgical methods or techniques, generally referred
to as annuloplasty, are typically used to reshape the distended
and/or deformed valve annulus. In the technique known as
"plication", the circumference of the valve annulus is reduced by
implanting a prosthetic ring of reduced circumference about the
base of the annulus while the annulus is pleated to reduce its
circumference to that of the ring. In the technique known as
"reconstruction", the circumference of the annulus is not reduced,
but the annulus is restructured into an elongate shape. To
accomplish this goal, a rigid or semi-rigid ring (e.g., the
Carpentier ring) having the same circumference as the annulus but
in an elliptical shape is surgically implanted about the base of
the valve. Both plication and restructuring are intended to
eliminate the gap in the closure of the distended valve by bringing
back together the tips of the valve cusps, reinforce suture lines,
and prevent further annular dilatation.
[0005] Interrupted sutures of 2/0 braided synthetic material with
double-end needles are typically used for the described surgical
methods. The stitches are placed into the fibrous tissue of the
annulus. Large bites of the heart annulus are taken, and the
needles are passed close together through the ring prosthesis. The
annuloplasty ring is slid down over the sutures into position above
the mitral valve and the sutures are tied firmly, attaching the
device to the annulus. As the sutures are tied down to approximate
the prosthetic ring to the mitral valve annulus, the annular
diameter is reduced and the contour is improved.
[0006] A hypothetically "ideal" annuloplasty would correct the
dilatation of the posterior annulus in a measured fashion while
allowing a full range of motion of the mitral annulus. Initially
the prostheses were designed as rigid and flat frame members, to
correct the dilation and reshape the valve annulus to the natural
state. However, rigidity impedes the beneficial flexing movements
and displacements of the native annulus during the cardiac cycle.
Another disadvantage with highly rigid ring prosthesis is the
tendency of the sutures to tear during the normal movement of the
valve annulus.
[0007] Recognizing that the annulus is a dynamic structure that
changes dramatically with the cardiac cycle, thereby facilitating a
reduction in mitral orifice size to allow leaflet apposition,
flexible annuloplasty rings have been developed. Flexible
annuloplasty rings (e.g., the Duran ring) have been shown to
minimize risk of dehiscence because there is reduced tension on
sutures and reduced negative consequences of inaccurate placement
of ring sutures. However, one disadvantage of the completely
flexible ring prostheses is that during the implantation process
the drawstring effect of the sutures tends to bunch the material
covering the flexible ring at localized areas. The rigidity of the
Carpentier ring prevents deformity, whereas when the Duran flexible
ring is sutured to the annulus by interrupted U-stitches multiple
plications of the Dacron polyester fabric occur. This bunching of
the prosthesis resulted in the phenomenon known as multiple
plications of the ring prosthesis. One result of this phenomenon is
variability of the ability of the ring to control the shape of the
valve annulus. Each plication of the posterior annulus is dependent
on the tension placed on the sutures at the time of tying.
Therefore, it is possible to have too small a plication resulting
in insufficiency or too large a plication resulting in valve
stenosis. Plication of the annuloplasty ring determines a reduction
of at least one or two sizes in the selected flexible ring. The
residual stenotic effect without early homodynamic repercussion,
together with progression of the underlying disease, may be a
predisposing factor toward valve stenosis necessitating late
reoperation. Some patients in whom the Duran flexible ring had been
inserted required valve-related operations as a result of hemolysis
with or without prosthetic dehiscence. Patients who underwent
reoperation for mitral restenosis showed absence of endothelium in
the areas in which the ring was folded. In series of 85 patients
reviewed after 10 to 12 years, Duran and coauthors (Duran C G, J L
Pomar and J M Revuelta et al., Conservative operation for mitral
insufficiency, J Thorac Cardiovasc Surg 79 (1980), pp. 326-337)
found a 20.1% incidence of thromboembolic complications. The over
narrowing and purse-string effects with irregular contour of the
totally flexible ring were the main causes of high rate of
thromboembolism.
[0008] While rigid and semi-rigid annuloplasty rings eliminate the
bunching caused by flexible rings, the restrictive nature of such
rings is generally detrimental to the valve's ability to open and
close normally. On the other hand, because of their flexibility,
flexible rings can be difficult to handle during surgical
manipulations and generally must be supported during implantation
by a holder, which is subsequently removed before tying off the
implanting sutures. The Cosgrove Band is totally flexible; however,
bunching of the Cosgrove Band is prevented by the suturing of the
device on a rigid template subsequently removed after the
implanting sutures are tied off. The approach of tying down over a
rigid template eliminates the potential of plication of an
inappropriate amount of the posterior annulus of the heart.
[0009] The rigid template is in turn releasably secured to a
bendable handle to facilitate positioning of the template and ring
in the heart adjacent to the annulus of the valve to be repaired.
Once the template is placed and sutures initiated, the handle is
withdrawn to give the surgeon room to work and properly see the
annulus. When the procedure is completed, valve closure is tested
by injecting saline solution. The sutures attaching the ring to the
template are then cut, and the template is removed, leaving the
ring in place. Such templates, however, do not prevent the ring
from bunching or pleating when the implant sutures are tied off, if
the sutures are not precisely placed. The removal of the sutures,
which attach the annuloplasty ring to the holder, can be cumbersome
and time consuming. Cutting the sutures can also cause damage to
the annuloplasty ring. Care must be taken to ensure that pieces of
the suture remain attached to the holder and are not left in the
patient. The drag from the suture can make it difficult to remove
the ring from the holder. Further, the retention sutures can be
captured by the sutures used to implant the ring, thereby creating
great difficulty in removing the ring from the holder.
[0010] Using conventional techniques, most valve repair procedures
require a gross thoracotomy, usually in the form of a median
sternotomy or right thoracotomy, to gain access into the patient's
thoracic cavity. Using such open-chest techniques enables the
surgeon to see the affected valve directly, and to position his or
her hands within the thoracic cavity in close proximity to the
exterior of the heart for manipulation of surgical instruments and
introduction of an annuloplasty ring through the atriotomy for
attachment within the heart. However, these invasive, open-chest
procedures produce a high degree of trauma, a significant risk of
complications, an extended hospital stay, and a painful recovery
period for the patient.
[0011] Minimally invasive surgery (MIS) enables valve repair
without opening the chest cavity. Such minimally invasive heart
valve repair surgeries still require bypass, but the procedures are
accomplished by means of elongated tubes or cannulas introduced
through one or more small access incisions in the thorax, with the
help of endoscopes and other such visualization techniques. Such
minimally invasive procedures usually provide speedier recovery for
the patient with less pain and bodily trauma, thereby reducing the
medical costs and the overall disruption to the life of the
patient. The use of a minimally invasive approach, however,
introduces new complexities to surgery thus placing a greater
burden on the operating surgeon. Most notably, minimally invasive
approaches drastically reduce the size of the surgical field
available to the surgeon for the manipulation of tissue and for the
introduction of necessary surgical instruments. These complexities
are especially acute in connection with heart surgery. Unlike
common heart surgeries performed using a full medial sternotomy,
minimally invasive heart surgery offers a surgical field that may
be only as large as a resected intercostal space or a transversely
cut and retracted sternum. Consequently, the introduction and
proper positioning of tools, such as annuloplasty ring holders, and
other such devices, becomes a great deal more complicated.
[0012] The primary barriers to widespread adoption of minimally
invasive, robot assisted (MIRA) cardiac procedures are associated
with increased cardiopulmonary bypass (CPB) times and increased
surgical skill requirements. Current MIRA technology does not
reduce the need for CPB during cardiac procedure. To the contrary
bypass times associated with some MIRA cardiac procedures are
actually increased. For many MIRA cardiac procedures, the increased
time on CPB limits the potential benefits and leads to the
exclusion of high-risk patients.
[0013] Suture management is a primary contributor to increased CPB
times in MIRA cardiac procedures. Typical mitral valve repairs
involve 15-20 sutures, each requiring 5-6 knots, causing suturing
to consume the majority of operating time. Surgeons are typically
very experienced and comfortable tying knots with their hands, but
robotic technology adds another level of complexity to this task.
Knot tying with surgical robots, particularly using the smaller 2-0
sutures required for mitral valve prosthesis fixation, takes
considerably longer than with minimally invasive surgical
instruments. The large number of required knots in annuloplasty
fixation, coupled with the increased difficulty in tying the knots
robotically, cause MIRA mitral valve repair to take longer than
minimally invasive surgical approaches. Operating within limited
space and with limited vision, it is not surprising that surgeons
require more time to tie knots in MIRA surgery, despite the
assistance of tele-robotic system. Furthermore, current commercial
robotic surgery systems provide no force feedback from the
instruments and dexterity with current minimally invasive
instruments, manual or robotic, is less than optimal. Because there
is no tactile sensation, the knot tying depends on visual clues as
to appropriate tension and tightness.
[0014] An improved method of suture-based knotless fixation for
MIRA mitral valve repair could allow surgeons all of the
flexibility and precision of current techniques, while requiring
less time and training to perform. Such an improvement could allow
more patients to benefit more fully from the potential of MIRA
cardiac surgery through increased access and reduced cost. By
reducing CPB time, more patients will be candidates for MIRA
cardiac procedures. Reduced CPB time will also help reduce direct
surgical cost and indirect cost associated with post-surgical
recovery.
[0015] One final problem associated with the annuloplasty rings of
the prior art is that when such annuloplasty rings are implanted
into children or adolescents the subsequent growth of the patient
may render the annuloplasty ring too small, thus abnormally
constricting the annulus. Follow-up surgery would be necessary to
replace the originally implanted annuloplasty ring with a larger
ring suitable for the current size of the patient. However, the
tissue of the heart valve annulus grows into the fabric of the ring
making such surgery problematic. Therefore the preservation of
growth potential in the native annulus is an important issue in
terms of long-term stability of valve repair procedures in children
and adolescents.
[0016] What is needed, therefore, are devices and methods for
carrying out heart valve repair that reduce the trauma, risks,
recovery time and pain that accompany current techniques. The
devices and methods should facilitate surgical intervention without
the need for a gross thoracotomy. In particular, the devices and
methods should enable the implantation of annuloplasty repair
segments without the need for excessive additional implements.
SUMMARY OF THE INVENTION
[0017] The following provides a summary of exemplary embodiments of
the annuloplasty system according to the present invention. This
summary is not an extensive overview and is not intended to
identify key or critical aspects or elements of the present
invention or to delineate its scope.
[0018] In accordance with one aspect of the present invention, and
in general terms, an annuloplasty system for repairing incompetent
heart valves or other tissues is provided. This system includes a
substantially circular valve reinforcing device adapted to be
surgically implanted around a heart valve annulus; anchoring means
for attaching the substantially circular valve reinforcing device
to the heart valve annulus, wherein attaching the substantially
circular valve reinforcing device to the heart valve annulus
reduces the circumference of the annulus by plicating annular
tissue underneath the valve reinforcing device; and constricting
means for reducing the circumference of the substantially circular
valve reinforcing device, wherein reducing the circumference of the
substantially circular valve reinforcing device further reduces the
circumference of the heart valve annulus. The structural (e.g.,
valve) reinforcing device of this invention is generally flexible
in nature; however, the basic component parts thereof (i.e.,
individual segments), do not typically deform when sutured into the
areas of the body that the device is intended to reinforce.
[0019] In accordance with another aspect of the present invention,
and also in general terms, a method for surgically implanting the
annuloplasty system described in the previous paragraph is
provided. This method includes utilizing the anchoring means to
secure the substantially circular valve reinforcing device to the
heart valve annulus, wherein securing the substantially circular
valve reinforcing device to the heart valve annulus reduces the
circumference of the heart valve annulus by plicating annular
tissue underneath the valve reinforcing device; testing the
implanted annuloplasty system to verify that appropriate and/or
desired constriction has been achieved; and utilizing the
constricting means to reduce the circumference of the substantially
circular valve reinforcing device if appropriate and/or desired
constriction has not been achieved, wherein reducing the
circumference of the substantially circular valve reinforcing
device further reduces the circumference of the heart valve
annulus.
[0020] Additional features and aspects of the present invention
will become apparent to those of ordinary skill in the art upon
reading and understanding the following detailed description of the
exemplary embodiments. As will be appreciated by the skilled
artisan, further embodiments of the invention are possible without
departing from the scope and spirit of the invention. Accordingly,
the drawings and associated descriptions are to be regarded as
illustrative and not restrictive in nature.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The accompanying drawings, which are incorporated into and
form a part of the specification, schematically illustrate one or
more exemplary embodiments of the invention and, together with the
general description given above and detailed description given
below, serve to explain the principles of the invention, and
wherein:
[0022] FIG. 1A is top view of a first exemplary embodiment of the
annuloplasty system of the present invention wherein the system
includes flexible dual-supportive drawstrings.
[0023] FIGS. 1B-E are various views of the suture support segments
that are included in the annuloplasty system of FIG. 1A.
[0024] FIGS. 1F-R illustrate an exemplary method for surgically
implanting the annuloplasty system of FIG. 1A in a dilated heart
valve.
[0025] FIG. 2A is a top view of a second exemplary embodiment of
the annuloplasty system of the present invention wherein the system
includes a flexible single supportive drawstring.
[0026] FIGS. 2B-F are various views of the suture support segments
that are included in the annuloplasty system of FIG. 2A.
[0027] FIGS. 2G-O illustrate an exemplary method for surgically
implanting the annuloplasty system of FIG. 2A in a dilated heart
valve.
[0028] FIGS. 2P-2Z illustrate an exemplary method for surgically
implanting the annuloplasty systems of FIGS. 1A and 2A in a dilated
heart valve using robotic assisted surgery.
[0029] FIGS. 2AA-2AC illustrate a method for surgically implanting
the annuloplasty system of FIG. 2A in an infant or child.
[0030] FIGS. 3A-3E illustrate a third exemplary embodiment of the
annuloplasty system and surgical implantation method of the present
invention wherein a dual-armed suture that is not attached to a
suture support segment and a single supportive drawstring are
utilized.
[0031] FIGS. 4A-4H illustrate a fourth exemplary embodiment of the
annuloplasty system and surgical implantation method of the present
invention wherein a dual-armed suture with barbs and an
annuloplasty ring or band are utilized.
[0032] FIGS. 5-7 illustrate an annuloplasty system that utilizes a
suture material stored within a suture support segment which is
pulled out of the support segment once the suture is needed, as
well as single or multiple supportive drawstrings.
[0033] FIG. 8 illustrates a method of attaching suture support
segments using an intracardiac ultra sonic welder.
[0034] FIGS. 9-11 illustrate a method of attaching suture support
segments having an eye-like opening using a one-way suture that
includes barbs.
[0035] FIGS. 12-13 illustrate a method of attaching suture support
segments having a one-way suture retaining device embedded therein
for attaching the suture without tying.
[0036] FIGS. 14-15 illustrate a method of attaching suture support
segments using a braided suture and a suture support segment with a
locking device.
[0037] FIG. 16 depicts a suture support segment having a locking
device that allows for lateral insertion of the suture material
into the suture segment body.
[0038] FIGS. 17-18 illustrate a method of using a suture support
segment having a lumen for use in attachment.
[0039] FIGS. 19-20 illustrate a method of attachment using a
self-closing clip assembly.
[0040] FIGS. 21-23 illustrate various methods of tightening the
supportive drawstring.
[0041] FIG. 24 illustrates a method of implanting suture support
segments from opposite ends.
[0042] FIG. 25-26 show a method of using the supportive drawstrings
to achieve a selective reduction of the inferior limb of the
posterior annulus.
DETAILED DESCRIPTION OF THE INVENTION
[0043] Exemplary embodiments of the present invention are now
described with reference to the Figures. Reference numerals are
used throughout the detailed description to refer to the various
elements and structures. In other instances, well-known structures
and devices are shown in block diagram form for purposes of
simplifying the description. Although the following detailed
description contains many specifics for the purposes of
illustration, a person of ordinary skill in the art will appreciate
that many variations and alterations to the following details are
within the scope of the invention. Accordingly, the following
embodiments of the invention are set forth without any loss of
generality to, and without imposing limitations upon, the claimed
invention.
[0044] The present invention relates to an annuloplasty system for
repairing incompetent heart valves. A first general embodiment of
this invention provides an annuloplasty system that utilizes
various suture support segments and two supportive drawstrings; a
second general embodiment of this invention provides an
annuloplasty system that utilizes various suture support segments
and one supportive drawstring; a third general embodiment of this
invention provides an annuloplasty system that utilizes segments
having a sewing cuff, a plurality of sutures, and a supportive
drawstring; a fourth general embodiment of this invention provides
an annuloplasty system that utilizes suture apparatus having barbed
structures and an annuloplasty band or ring; and a fifth general
embodiment of this invention provides an annuloplasty system that
utilizes only suture support segments. With reference now to the
Figures, various specific embodiments of this invention shall be
described in greater detail.
[0045] A first exemplary embodiment of this invention (shown in
FIGS. 1A-N) provides an annuloplasty system for repairing
incompetent heart valves. This system includes: a substantially
circular valve reinforcing device adapted to be surgically
implanted around a heart valve annulus; anchoring means for
attaching the substantially circular valve reinforcing device to
the heart valve annulus, wherein attaching the substantially
circular valve reinforcing device to the heart valve annulus
reduces the circumference of the annulus by plicating annular
tissue underneath the valve reinforcing device; and constricting
means for reducing the circumference of the substantially circular
valve reinforcing device, wherein reducing the circumference of the
substantially circular valve reinforcing device further reduces the
circumference of the annulus. The valve reinforcing device further
includes: (i) a plurality of individual suture support segments,
wherein the plurality of suture support segments further includes:
a) at least one anchor segment, wherein the anchor segment further
includes at least two channels passing lengthwise therethrough; and
b) a plurality of intermediate segments adapted to be implanted
into the heart valve annulus after the anchor segment, wherein each
intermediate segment further includes at least two channels passing
lengthwise therethrough. The anchoring means further includes: (i)
at least two sutures attached to the anchor segment, wherein at
least one of the sutures includes a surgical needle attached
thereto; and (ii) at least two sutures attached to the intermediate
segment wherein at least one of the sutures includes a surgical
needle attached thereto. The constricting means further includes:
at least two supportive drawstrings, wherein one end of each
drawstring is attached to one end of the anchor segment, wherein
each of the drawstrings passes through the channels in each
intermediate segment, and wherein the ends of the drawstrings are
tied together over the last intermediate segment after the heart
valve repair is completed.
[0046] A method for surgically implanting this annuloplasty system
includes: (a) utilizing the anchoring means for securing the
substantially circular valve reinforcing device to the heart valve
annulus, wherein securing the substantially circular valve
reinforcing device to the heart valve annulus reduces the
circumference of the heart valve annulus by plicating annular
tissue underneath the valve reinforcing device; and (b) utilizing
the constricting means to reduce the circumference of the
substantially circular valve reinforcing device if appropriate
constriction has not been achieved, wherein reducing the
circumference of the valve reinforcing device further reduces the
circumference of the heart valve annulus by plicating the annular
tissue between adjacent segments of the substantially circular
valve reinforcing device. Utilizing the anchoring means further
includes: (i) affixing the anchor segment to a dilated heart valve
annulus by passing one of the surgical needles attached to the
sutures on the anchor segment through the heart valve annulus; (ii)
pulling the needle and suture which has passed through the heart
annulus until the anchor segment aligns with the heart valve
annulus; (iii) securing the anchor segment to the heart valve
annulus by tying the ends of the sutures on the anchor segment
together; (iv) using the supportive drawstrings to guide the
intermediate segment through a minimally-invasive tube or small
incision to the position above the heart valve annulus adjacent to
the anchor segment; (v) affixing the intermediate segment to the
heart valve annulus by passing one of the surgical needles attached
to the sutures on the intermediate segment through the heart valve
annulus; (vii) pulling the surgical needle and suture which has
passed through the heart annulus until the intermediate segment
aligns with the heart valve annulus; (viii) securing the
intermediate segment to the heart valve annulus by tying the ends
of the sutures on the intermediate segment together; (ix) repeating
steps (iv)-(vii) until the desired circumference around the heart
valve annulus is covered by intermediate suture support segments;
and (ix) testing the repaired heart valve to verify that
appropriate constriction has been achieved. Utilizing the
constricting means further includes: (i) pulling both ends of the
supportive drawstrings to the desired tension to further decrease
the circumference of the heart valve annulus; and (ii) tying the
ends of the supportive drawstrings around the last intermediate
segment.
[0047] FIG. 1A illustrates a dual-supportive drawstring
annuloplasty system 100 having an anchor suture support segment 102
with supportive drawstrings 106 attached, and a plurality of
intermediate suture support segments 104 threaded through the
supportive drawstrings 106. The supportive drawstrings 106 have a
free end 108 wherein approximately 10-14 intermediate suture
support segments (not shown) 104 are added after the anchor suture
support segment 102 to the supportive drawstring to form a flexible
dual-supportive drawstring annuloplasty system 100.
[0048] FIGS. 1B-1E provide various views of the elements that
comprise the flexible dual-supportive drawstring annuloplasty
system 100. FIG. 1B depicts the detail of an anchor suture support
segment 102. The anchor suture support segment 102 is made up of an
anchor suture support segment body 170, at least one surgical
needle 172, and at least one suture 174. The anchor suture support
segment body 170 may be made from any material that is
radio-opaque, preferably inert, non-corrosive, non-thormbogenic and
bio-compatible with blood and tissue. By way of example, but not
limitation, such material might be a barium sulfate impregnated
acetal resin Delrin. The anchor suture support segment body 170 can
be cylindrical, tubular, square, round, oval, elongated oval or
combinations thereof shaped as necessary to achieve the desired
configuration. The anchor suture support segment body 170 may have
a textured blood-contacting surface or may be coated, in whole or
in part, by a material designed to promote tissue in-growth and
reduce thromboemblosim. By way of example, but not limitation, such
material might be Dacron, polyester velour or some other suitable
material. A preferred size of the anchor suture support segment
body 170 is 1 mm to 4 mm in length but more preferably 2 mm to 6 mm
in length, with a circumference of 1 mm to 4 mm, although other
sizes and dimensions are possible. Attached to the anchor suture
support segment body 170 is at least one suture 174, but more
preferably two sutures 174. The anchor suture support segment body
170 must be rigid or semi-rigid in the longitudinal direction, and
must not be deformable, such that when the sutures 174 are tied
against the anchor suture support segment body 170, to secure the
anchor suture support segment 102 to the mitral valve annulus 50,
the anchor suture support segment body 170 does not buckle.
[0049] The material for the suture 174 may be of any conventional
type used in surgical procedures such as 2/0 braided suture,
mono-filament suture, or polyfilament suture. The length of each of
the sutures 174 may range between 1 centimeter to 25 centimeters,
and more preferably between 2 centimeters to 10 centimeters. The
sutures 174 are attached to the side of the anchor suture support
segment body 170 in such a way as to create a dual-armed suture
structure 176. Attached to the free ends of each suture 174 is a
surgical needle 172. The surgical needle 172 is attached to the
suture 174 by a conventional swedging process. The surgical needle
172 is a conventional curved surgical needle. Such surgical needles
or suture needles are generally known and are normally made from a
corrosion-resistant metal, preferably chrome-nickel steel.
[0050] FIG. 1B also shows an alternative embodiment where the
anchor suture support segment 102' has an anchor suture support
segment body 170' with attached suture 174'. Only one of the
sutures 174' has attached to the free end a surgical needle 172'
and the second suture 174' has a free end 178' without a surgical
needle 172'.
[0051] FIG. 1C shows a cross sectional view of an anchor suture
support segment body 170 with dual-channels 180. One end of the
supportive drawstring 106 is treaded through one of the
dual-channels 180 in the anchor suture support segment body 170 to
a desired length and then that same end of the supportive
drawstring 106 is looped around the channel opening and treaded
back through the other channel 180 of the anchor suture support
segment body 170 to create a dual supportive drawstring 106. The
supportive drawstring 106 may be comprised of suture material,
Teflon strip, a band, a filament, a wire or a strap.
[0052] FIG. 1D depicts the detail of an intermediate suture support
segment 104. The intermediate suture support segment 104 is made up
of an intermediate suture support segment body 120, at least one
surgical needle 122, and at least one suture 124. The intermediate
suture support segment body 120 may be made from any material that
is radio-opaque, preferably inert, non-corrosive, non-thormbogenic
and bio-compatible with blood and tissue. By way of example, but
not limitation, such material might be a barium sulfate impregnated
acetal resin Delrin. The intermediate suture support segment body
120 can be a cylindrical, a tubular, a square, a round, an oval, an
elongated oval or the like shaped as necessary to achieve the
desired configuration. The intermediate suture support segment body
120 may have a textured blood-contacting surface or may be coated,
in whole or in part, by a material designed to promote tissue
in-growth and reduce thromboemblosim. By way of example, but not
limitation, such material might be Dacron, polyester velour or some
other suitable material. A preferred size of the intermediate
suture support segment body 120 is 1 mm to 4 mm in length but more
preferably 2 mm to 6 mm in length, with a circumference of 1 mm to
4 mm, although other sizes and dimensions are possible. Attached to
the intermediate suture support segment body 120 is at least one
suture 124, but more preferably two sutures 124. The intermediate
suture support segment body 120 must be rigid or semi-rigid in the
longitudinal direction, and must not be deformable, such that when
the sutures 124 are tied against the intermediate suture support
segment body 120, to secure the intermediate suture support segment
body 120 to the mitral valve annulus 50, the intermediate suture
support segment body 120 does not buckle.
[0053] The material for the suture 124 may be of any conventional
type used in surgical procedures such as 2/0 braided suture,
mono-filament suture, or polyfilament suture. The length of the
suture 124 may range between 1 centimeter to 25 centimeters, and
more preferably between 2 centimeters to 10 centimeters. The
sutures 124 are attached to the side of the intermediate suture
support segment body 120 in such a way as to create a dual-armed
suture structure 126. Attached to the free ends of each suture 124
is a surgical needle 122. The surgical needle 122 is attached to
the suture 124 by a conventional swedging process. The surgical
needle 122 is a conventional curved surgical needle. Such surgical
needles or suture needles are generally known and are normally made
from a corrosion-resistant metal, preferably chrome-nickel
steel.
[0054] FIG. 1D also shows an alternative embodiment where the
intermediate suture support segment 104' has an intermediate suture
support segment body 120' with attached suture 124'. Only one of
the sutures 124' has attached to the free end a surgical needle
122' and the second suture 124' has a free end 128' without a
surgical needle 122'.
[0055] FIG. 1E shows a cross sectional view of an intermediate
suture support segment body 120 with dual-channels 130. Both free
ends 108 of the supportive drawstrings 106 are threaded through the
dual-channels 130 in the intermediate suture support segment body
120. The supportive drawstrings 106 prevent against inadvertently
dropping the intermediate support segments into the heart cavity
and facilitate the delivery of the intermediate support segments
104 to the remote implantation site during surgery. The
intermediate suture support segments can be slid down over the
supportive drawstrings into position above the mitral valve from
outside of the chest cavity through a small incision or port.
[0056] FIGS. 1F-1N depict a method of implantation of the
dual-supportive drawstring annuloplasty system 100 described in
FIGS. 1A-1E. The surgical methods used to implant the annuloplasty
system 100 may be conventional open heart surgery techniques or
minimally invasive heart surgery techniques. FIGS. 1F-1N provide an
illustration of the superior view of the mitral valve of a human
heart. The mitral valve includes a fibrous annulus 50 and anterior
and posterior leaflets 42, 40. In a healthy heart the leaflets
close tightly during systole and do not allow any of the blood to
flow backwards through the mitral valve into the left atrium.
However, one consequence of a number of cardiac diseases is that
mitral valve annulus 50 becomes dilated so that the anterior and
posterior leaflets 42 and 40 cannot close tightly during systole,
thereby creating gap 46 between the anterior and posterior leaflets
42 and 40. As a result, mitral valve regurgitation occurs,
resulting in some of the blood flowing backwards through the
incompletely closed mitral valve leaflets into the left atrium.
[0057] FIG. 1F depicts the first step of the method of implantation
which is to guide the surgical needle 172 of the anchor suture
support segment 102 into the surgical site 44 on the mitral valve
annulus 50. The surgical needle 172 and suture 174 will be passed
through the mitral valve annulus 50 in a conventional surgical
technique so as to make a horizontal mattress stitch. As shown in
FIG. 1A the anchor suture support segment 102 has attached to the
distal end supportive drawstrings 106 that have a free end 108.
[0058] FIG. 1G shows the next step in the method of implantation.
The surgeon will continue to pull the surgical needle 172 and
suture material 174, which has passed through surgical site 44,
away from the mitral valve annulus 50 which will bring the anchor
suture support segment 102 flush with the mitral valve annulus
50.
[0059] FIG. 1H depicts the anchor suture support segment 102
aligned with the mitral valve annulus 50. To secure the anchor
suture support segment 102 the surgeon will first cut off the
surgical needles 172 from each of the sutures 174 (not shown).
Next, as depicted in FIG. 1I the surgeon will tie the two free ends
of the sutures 174 together with sufficient tension thereby
securing the anchor suture support segment 102 in place on the
mitral valve annulus 50. After five or six knots have been made the
free tails of the sutures 174 are cut by any suitable means (not
shown). The suture 174 traverses a longer distance along the mitral
valve annulus 50 than the distance between two suture attachments
in the side of the anchor suture support segment body 170. Sutures
174, when tightened and tied, create an imbrication in the mitral
valve annulus 50 underneath the segment thereby reducing the
circumference of the mitral valve annulus 50 by an amount equal to
the difference between the length each suture travels in the tissue
of the heart annulus and the distance between the suture
attachments in the support segment (not shown).
[0060] FIG. 1J depicts the method of implantation of the first
intermediate suture support segment 104. First, the surgeon will
guide a surgical needle 122 to the surgical site 48 and then will
pass the surgical needle 122 through the surgical site 48 on the
mitral valve annulus 50 about 2-4 mm away from the first surgical
site 44. The surgical needle 122 and suture 124 will be passed
through the mitral valve annulus 50 in a conventional surgical
technique so as to make a horizontal mattress stitch.
[0061] FIG. 1K shows how the intermediate suture support segment
104 is guided onto the mitral valve annulus 50. The surgeon will
use the supportive drawstrings 106 which run through the channels
130 in the intermediate support segment 104 to guide the
intermediate support segment down toward the mitral valve while
pulling on the surgical needle 122 and the suture 124 to shuttle
the intermediate suture support segment 104 next to the anchor
suture support segment 102.
[0062] FIG. 1L depicts the first intermediate suture support
segment 104 aligned with the mitral valve annulus 50 and adjacent
to the anchor suture support segment 102. To secure the
intermediate suture support segment 104 the surgeon will first cut
off the surgical needles 122 from each of the sutures 124 (not
shown). Next, as depicted in FIG. 1M the surgeon will tie the two
free ends of the sutures 124 together with sufficient tension
thereby securing the intermediate suture support segment 104 in
place on the mitral valve annulus 50 next to the anchor suture
support segment 102. After five or six knots have been made the
free tails of the sutures 124 are cut by any suitable means (not
shown).
[0063] The above described steps shown in FIGS. 1J-1M are repeated
until the desired circumference around the mitral valve annulus 50
is covered by intermediate suture support segments 104. The number
of support segments placed into the mitral valve annulus 50
determines the overall reduction in the circumference of the
annulus. FIG. 1N depicts the repaired mitral valve 52 surrounded by
an anchor suture support segment 102 and intermediate suture
support segments 104 that make up the flexible dual supportive
drawstring annuloplasty system 100. When the desired circumference
of the valve annulus has been covered the mitral valve is tested
for competence by distending the left ventricle with isotonic
solution infused through rubber-bulbed syringe. If needed the
annuloplasty system 100 is further adjusted and the suture support
segments 102 and 104 are further aligned by pulling the supportive
drawstrings 106 that is found at the distal end of the last
intermediate suture support segment 104. Since the support segments
102 and 104 are slidably coupled with the supportive drawstring 106
the annular tissue between adjacent suture support segments will
plicate and the circumference of the valve annulus will reduce
further. To complete the valve repair the free ends 108 of the
supportive drawstring 106 are tied together at the distal end of
the last intermediate suture support segment 104. After seven or
eight knots are made the free ends 108 of the supportive drawstring
106 are cut at the point beyond the last intermediate suture
support segment 104 by any suitable means.
[0064] FIG. 1O depicts an alternate embodiment of the
dual-supportive drawstring annuloplasty system 100 which only
partially surrounds the mitral valve annulus 50. The anchor suture
support segment 102 is attached to the mitral valve annulus 50
using the process described in FIGS. 1F-1H. The intermediate suture
support segments 104 are attached to the mitral valve annulus using
the process described in FIGS. 1J-1M. The intermediate suture
support segments 104 only partially surround the mitral valve
annulus 50 and the annuloplasty system 100 is ended by tying the
free ends 108 of the supportive drawstrings 106 around the distal
end of the last intermediate suture support segment 104. As an
alternate embodiment, this method of implantation can also be done
with a single-supportive drawstring annuloplasty system 200,
although it is not depicted.
[0065] FIG. 1P depicts a repaired mitral valve annulus 52 and shows
how a completed annuloplasty system 100 should look once implanted
in the mitral valve annulus 50.
[0066] FIG. 1Q depicts that the anchor suture support segment 102
may be attached to the surgical site 44 using the surgical needle
172 to place the sutures 174 in a counter-clockwise fashion. This
also applies to placement of the intermediate suture support
segments 104 of the dual-supportive drawstring system 100 and this
also applies to all segments (202, 204, and 210) of the single
supportive drawstring system 200.
[0067] FIG. 1R depicts that the anchor suture support segment 102
may be attached to the surgical site 44 using the surgical needle
172 to place the sutures 174 in a clockwise fashion. This method
also applies to placement of the intermediate suture support
segments 104 of the dual-supportive drawstring system 100 and this
also applies to all segments (202, 204, and 210) of the single
supportive drawstring system 200.
[0068] A second exemplary embodiment of this invention (shown in
FIGS. 2A-AC) also provides an annuloplasty system for repairing
incompetent heart valves. This system includes: a substantially
circular valve reinforcing device adapted to be surgically
implanted around a heart valve annulus; anchoring means for
attaching the substantially circular valve reinforcing device to
the heart valve annulus, wherein attaching the substantially
circular valve reinforcing device to the heart valve annulus
reduces the circumference of the annulus by plicating annular
tissue underneath the valve reinforcing device; and constricting
means for reducing the circumference of the substantially circular
valve reinforcing device, wherein reducing the circumference of the
substantially circular valve reinforcing device further reduces the
circumference of the annulus. The valve reinforcing device further
includes: (i) a plurality of individual suture support segments,
wherein the plurality of suture support segments further includes:
a) at least one anchor segment, wherein the at least one anchor
segment further includes a channel passing lengthwise therethrough;
b) at least one terminal segment, wherein the at least one terminal
segment further includes a channel passing lengthwise therethrough;
and c) a plurality of intermediate segments disposed between the at
least one anchor segment and the at least one terminal segment,
wherein each intermediate segment further includes a channel
passing lengthwise therethrough. The anchoring means further
includes: (i) at least two sutures attached to the anchor segment,
wherein at least one of the sutures includes a surgical needle
attached thereto; (ii) at least two sutures attached to the
intermediate segment, wherein at least one of the sutures includes
a surgical needle attached thereto; and (iii) at least two sutures
attached to the body portion of the terminal segment wherein at
least one of the sutures includes a surgical needle attached
thereto and a third suture attached to the end portion of the
terminal segment for tying off the supportive drawstring following
implantation. The constricting means for reducing the circumference
of the substantially circular valve reinforcing device, wherein
reducing the circumference of the valve reinforcing device further
reduces the circumference of the heart valve annulus, and wherein
the constricting means further includes: (i) a supportive
drawstring, wherein one end of the drawstring is attached to one
end of the anchor segment, and wherein the supportive drawstring
passes through the channel in each intermediate segment and the
channel in the terminal segment.
[0069] A method for surgically implanting this annuloplasty system
includes (a) utilizing the anchoring means for securing the
substantially circular valve reinforcing device to the heart valve
annulus, wherein securing the substantially circular valve
reinforcing device to the heart valve annulus reduces the
circumference of the annulus by plicating annular tissue underneath
the valve reinforcing device; and (b) utilizing the constricting
means to reduce the circumference of the substantially circular
valve reinforcing device if appropriate constriction has not been
achieved, wherein reducing the circumference of the valve
reinforcing device further reduces the circumference of the heart
valve annulus by plicating the annular tissue between adjacent
segments of the substantially circular valve reinforcing device.
Utilizing the anchoring means further includes: (i) affixing the
anchor segment to a dilated heart valve annulus by passing one of
the surgical needles attached to the sutures through the heart
valve annulus; (ii) pulling the suture and surgical needle which
has passed through the heart valve annulus until the anchor segment
is aligned with the heart valve annulus; (iii) securing the anchor
segment to the heart valve annulus by tying the ends of the sutures
together; (iv) using the supportive drawstring to guide the
intermediate segment through a minimally-invasive tube or small
incision to the position above the heart valve annulus adjacent to
the anchor segment; (v) affixing the intermediate segment to the
heart valve annulus by passing one of the surgical needles attached
to the sutures through the heart valve annulus; (vi) pulling the
surgical needle and suture which has passed through the heart valve
annulus until the intermediate segment aligns with the heart valve
annulus; (viii) securing the intermediate segment to the heart
valve annulus by tying the ends of the sutures together; (viii)
repeating steps (iv)-(vii) until the desired circumference around
the heart valve annulus is covered by intermediate suture support
segments; (ix) using the supportive drawstring to guide the
terminal segment to the position above the heart valve annulus next
to the last intermediate segment; (x) affixing the terminal segment
to the heart valve annulus by passing one of the surgical needles
attached to the sutures through the heart valve annulus; (xi)
pulling the surgical needle and suture which has passed through the
heart valve annulus until the terminal segment is aligned with the
heart valve annulus; (xii) securing the terminal segment to the
heart valve annulus by tying the ends of the sutures together; and
(xiii) testing the repaired heart valve to verify that appropriate
constriction has been achieved. Utilizing the constricting means
further includes: (i) pulling the supportive drawstring to the
desired tension to further decrease the circumference of the heart
valve annulus; and (ii) tying the supportive drawstring that runs
through the terminal segment to the third suture attached to the
end portion of the terminal segment.
[0070] FIG. 2A illustrates a flexible single-supportive drawstring
annuloplasty system 200 having an anchor suture support segment 202
with a supportive drawstring 206 attached, a plurality of
intermediate suture support segments 204 threaded through the
supportive drawstring 206 and a terminal suture support segment 210
threaded through the supportive drawstring 206. The supportive
drawstring 206 has a free end 208 where the intermediate suture
support segments 204 and terminal suture support segments 210 are
added to the single-supportive drawstring annuloplasty system 200.
The terminal suture support segment 210 has a free suture 260 which
is tied with the free end 208 of the supportive drawstring 206
around the terminal segment 210 to complete the flexible
single-supportive drawstring annuloplasty system 200.
[0071] FIGS. 2B-2F illustrate various views of the elements that
comprise the single-supportive drawstring annuloplasty system 200.
FIG. 2B depicts the detail of an anchor suture support segment 202.
The anchor suture support segment 202 is made up of an anchor
suture support segment body 270, at least one surgical needle 272,
and at least one suture 274. The anchor suture support segment body
270 may be made from any material that is radio-opaque, preferably
inert, non-corrosive, non-thormbogenic and bio-compatible with
blood and tissue. By way of example, but not limitation, such
material might be a barium sulfate impregnated acetal resin Delrin.
The anchor suture support segment body 270 can be cylindrical,
tubular, square, round, oval, elongated oval or combinations
thereof shaped as necessary to achieve the desired configuration.
The anchor suture support segment body 270 may have a textured
blood-contacting surface or may be coated, in whole or in part, by
a material designed to promote tissue in-growth and reduce
thromboemblosim. By way of example, but not limitation, such
material might be Dacron, polyester velour or some other suitable
material. A preferred size of the intermediate suture support
segment body 270 is 1 mm to 4 mm in length but more preferably 2 mm
to 6 mm in length, with a circumference of 1 mm to 4 mm, although
other sizes and dimensions are possible. Attached to the anchor
suture support segment body 270 is at least one suture 274, but
more preferably two sutures 274. The anchor suture support segment
body 270 must be rigid or semi-rigid in the longitudinal direction,
and must not be deformable, such that when the sutures 274 are tied
against the anchor suture support segment body 270, the anchor
suture support segment body does not buckle. The material for the
suture 274 may be of any conventional type used in surgical
procedures such as 2/0 braided suture, mono-filament suture, or
polyfilament suture. The length of the suture 274 may range between
1 centimeter to 25 centimeters, and more preferably between 2
centimeters to 10 centimeters. The sutures 274 are attached to the
anchor suture support segment body 270 in such a way as to create a
dual-armed suture structure 276. Attached to the free ends of each
suture 274 is a surgical needle 272. The surgical needle 272 is
attached to the suture 274 by a conventional swedging process. The
surgical needle 272 is a conventional curved surgical needle. Such
surgical needles or suture needles are generally known and are
normally made from a corrosion-resistant metal, preferably
chrome-nickel steel.
[0072] As an alternate embodiment (not shown in the Figures) the
anchor suture support segment 202' has an anchor suture support
segment body 270' with attached suture 274'. The sutures 274' are
attached to the side of the anchor suture support segment body
270'. Only one of the sutures 274' has attached to the free end a
surgical needle 272' and the second suture 274' has a free end 278'
without a surgical needle 272'.
[0073] FIG. 2F shows a cross-sectional view of an anchor suture
support segment 202 specifically the anchor suture support segment
body 270 with a single channel 280 and the cross sectional view of
an intermediate suture support segment 204 specifically the
intermediate suture support segment body 220. One end of the
supportive drawstring 206 is attached in the channel 280 of the
anchor suture support segment body 270. The supportive drawstring
206 runs through the channel 280 of the anchor suture support
segment 202. The supportive drawstring 206 may be comprised of
suture material, Teflon strip, a band, a filament, a wire or a
strap. A space 232 will be present between the anchor suture
support segment 202 and the intermediate suture support segment 204
when the annuloplasty system 200 is implanted into the heart valve
annulus which will allow for flexibility between the individual
segments. The supportive drawstring 206 is threaded through the
single channel 230 running the length of the intermediate suture
support segment 204.
[0074] FIG. 2C depicts the detail of an intermediate suture support
segment 204. The intermediate suture support segment 204 is made up
of an intermediate suture support segment body 220, at least one
surgical needle 222, and at least one suture 224. The intermediate
suture support segment body 220 may be made from any material that
is radio-opaque, preferably inert, non-corrosive, non-thormbogenic
and bio-compatible with blood and tissue. By way of example, but
not limitation, such material might be a barium sulfate impregnated
acetal resin Delrin. The intermediate suture support segment body
220 can be cylindrical, tubular, square, round, oval, elongated
oval or combinations thereof shaped as necessary to achieve the
desired configuration. The intermediate suture support segment body
220 may have a textured blood-contacting surface or may be coated,
in whole or in part, by a material designed to promote tissue
in-growth and reduce thromboemblosim. By way of example, but not
limitation, such material might be Dacron, polyester velour or some
other suitable material. A preferred size of the intermediate
suture support segment body 220 is 1 mm to 4 mm in length but more
preferably 2 mm to 6 mm in length, with a circumference of 1 mm to
4 mm, although other sizes and dimensions are possible. Attached to
the intermediate suture support segment body 220 is at least one
suture 224, but more preferably two sutures 224. The intermediate
suture support segment body 220 must be rigid or semi-rigid in the
longitudinal direction, and must not be deformable, such that when
the sutures 224 are tied against the intermediate suture support
segment body 220, the intermediate suture support segment body does
not buckle. The material for the suture 224 may be of any
conventional type used in surgical procedures such as 2/0 braided
suture, mono-filament suture, or polyfilament suture. The length of
the suture 224 may range between 1 centimeter to 25 centimeters,
and more preferably between 2 centimeters to 10 centimeters. The
sutures 224 are attached to the side of the intermediate suture
support segment body 220 in such a way as to create a dual-armed
suture structure 226. Attached to the free ends of each suture 224
is a surgical needle 222. The surgical needle 222 is attached to
the suture 224 by a conventional swedging process. The surgical
needle 222 is a conventional curved surgical needle. Such surgical
needles or suture needles are generally known and are normally made
from a corrosion-resistant metal, preferably chrome-nickel
steel.
[0075] As an alternative embodiment as shown in FIG. 2C the
intermediate suture support segment 204' has an intermediate suture
support segment body 220' with attached suture 224'. The sutures
224' are attached to the side of the intermediate suture support
segment body 220' Only one of the sutures 224' has attached to the
free end a surgical needle 222' and the second suture 224' has a
free end 228' without a surgical needle 222'.
[0076] FIG. 2E is a cross sectional view of an intermediate suture
support segment 204. It shows the single channel 230 that runs the
length of the intermediate suture support segment body 220.
[0077] FIG. 2D depicts the detail of a terminal suture support
segment 210. The terminal suture support segment 210 is made up of
a terminal suture support segment body 250, at least one surgical
needle 252, and at least one suture 254. The terminal suture
support segment body 250 may be made from any material that is
radio-opaque, preferably inert, non-corrosive, non-thormbogenic and
bio-compatible with blood and tissue. By way of example, but not
limitation, such material might be a barium sulfate impregnated
acetal resin Delrin. The terminal suture support segment body 250
can be a cylindrical, a tubular, a square, a round, an oval, an
elongated oval or the like shaped as necessary to achieve the
desired configuration. The terminal suture support segment body 250
may have a textured blood-contacting surface or may be coated, in
whole or in part, by a material designed to promote tissue
in-growth and reduce thromboemblosim. By way of example, but not
limitation, such material might be Dacron, polyester velour or some
other suitable material. A preferred size of the terminal suture
support segment body 250 is 1 mm to 4 mm in length but more
preferably 2 mm to 6 mm in length, with a circumference of 1 mm to
4 mm, although other sizes and dimensions are possible. Attached to
the terminal suture support segment body 250 is at least one suture
254, but more preferably two sutures 254. The terminal suture
support segment body 250 must be rigid or semi-rigid in the
longitudinal direction, and must not be deformable, such that when
the sutures 254 are tied against the terminal suture support
segment body 250, the terminal suture support segment body does not
buckle. The material for the suture 254 may be of any conventional
type used in surgical procedures such as 2/0 braided suture,
mono-filament suture, or polyfilament suture. The length of the
suture 254 may range between 1 centimeter to 25 centimeters, and
more preferably between 2 centimeters to 10 centimeters. The
sutures 254 are attached to the side of the terminal suture support
segment body 250 in such a way as to create a dual-armed suture
structure 256. Attached to the free ends of each suture 254 is a
surgical needle 252. The surgical needle 252 is attached to the
suture 254 by a conventional swedging process. The surgical needle
252 is a conventional curved surgical needle. Such surgical needles
or suture needles are generally known and are normally made from a
corrosion-resistant metal, preferably chrome-nickel steel. The
terminal suture support segment 210 has a free suture 260 attached
to the end portion of the terminal suture segment body 250. The
material for the third suture 260 may be of any conventional type
used in surgical procedures such as 2/0 braided suture,
mono-filament suture, or polyfilament suture. The length of the
third suture 260 may range between 1 centimeter to 25 centimeters,
and more preferably between 2 centimeters to 10 centimeters. The
third suture 260 on the terminal suture support segment 210 has a
free end without a surgical needle 252.
[0078] FIG. 2D also shows an alternative embodiment where the
terminal suture support segment 210' has an terminal suture support
segment body 250' with attached suture 254'. The sutures 254' are
attached to the side of the terminal suture support segment body
250'. Only one of the sutures 254' has attached to the free end a
surgical needle 252' and the second suture 254' has a free end 258'
without a surgical needle 252'.
[0079] FIGS. 2G-2O depict a method of implantation of the
single-supportive drawstring annuloplasty system 200 described in
FIGS. 2A-2F. The surgical methods used to implant the annuloplasty
system 200 may be conventional open heart surgery techniques or
minimally invasive heart surgery techniques. FIGS. 2G-2O provide an
illustration of the superior view of the dilated mitral valve of a
human heart. The mitral valve includes a fibrous annulus 50 and
anterior and posterior leaflets 42, 40. In a healthy heart the
leaflets close tightly during systole and do not allow any of the
blood to flow backwards through the mitral valve into the left
atrium. However, one consequence of a number of cardiac diseases is
that mitral valve annulus 50 becomes dilated so that the anterior
and posterior leaflets 42 and 40 cannot close tightly during
systole, thereby creating gap 46 between the anterior and posterior
leaflets 42 and 40. As a result, mitral valve regurgitation occurs,
resulting in some of the blood flowing backwards through the
incompletely closed mitral valve leaflets into the left atrium.
FIG. 2G depicts the first step of the method of implantation in
which the surgical needle 272 and suture 274 will be passed through
the mitral valve annulus 50 in a conventional surgical technique so
as to make a horizontal mattress stitch. As shown in FIG. 2G the
anchor suture support segment 202 has attached to the distal end a
supportive drawstring 206 that has a free end 208.
[0080] FIG. 2H shows the next step in the method of implantation.
The surgeon will continue to pull the surgical needle 272 and
suture material 274, which has passed through surgical site 44,
away from the mitral valve annulus 50 which will bring the anchor
suture support segment 202 flush with the mitral valve annulus
50.
[0081] FIG. 21 depicts the anchor suture support segment 202
aligned with the mitral valve annulus 50. To secure the anchor
suture support segment 202 the surgeon will first cut off the
surgical needles 272 from each of the sutures 274 (not shown).
Next, as depicted in FIG. 2J the surgeon will tie the two free ends
of the sutures 274 together with sufficient tension thereby
securing the anchor suture support segment 202 in place on the
mitral valve annulus 50. After five or six knots have been made the
free tails of the sutures 274 are cut by any suitable means (not
shown). The suture 274 traverses a longer distance along the mitral
valve annulus 50 than the distance between two suture attachments
in the side of the anchor suture support segment body 270. Sutures
274, when tightened and tied, create an imbrication in the mitral
valve annulus 50 underneath the segment thereby reducing the
circumference of the annulus by an amount equal to the difference
between the length each suture travels in the tissue of the heart
annulus and the distance between the suture attachments in the
support segment (not shown).
[0082] FIG. 2K depicts the implantation of the intermediate suture
support segment 204. The surgeon will guide a surgical needle 222
to the surgical site 48 and then will pass the surgical needle 222
through the surgical site 48 on the mitral valve annulus 50 about
2-4 mm away from the proximal end of the anchor support segment
202. The surgical needle 222 and suture 224 will be passed through
the mitral valve annulus 50 in a conventional surgical technique so
as to make a horizontal mattress stitch.
[0083] FIG. 2L shows how the intermediate suture support segment
204 is guided onto the mitral valve annulus 50. The surgeon will
use the supportive drawstring 206 which runs through the channel in
the intermediate support segment 204 to guide the intermediate
support segment down toward the mitral valve while pulling on the
surgical needle 222 and the suture 224 to shuttle the intermediate
suture support segment 204 next to the anchor suture support
segment 202.
[0084] FIG. 2M depicts the intermediate suture support segment 204
aligned with the mitral valve annulus 50 and adjacent to the anchor
suture support segment 202. To secure the intermediate suture
support segment 204 the surgeon will first cut off the surgical
needles 222 from each of the sutures 224 (not shown). Next, as
depicted in FIG. 2N the surgeon will tie the two free ends of the
sutures 224 together with sufficient tension thereby securing the
intermediate suture support segment 204 in place on the mitral
valve annulus 50 next to the anchor suture support segment 202.
After five or six knots have been made the free tails of the
sutures 224 are cut by any suitable means (not shown).
[0085] The above described steps shown in FIGS. 2K-2N are repeated
until the desired circumference around the mitral valve annulus 50
is covered by intermediate suture support segments 204. To complete
the annuloplasty system 200 the terminal suture support segment 210
is added to the supportive drawstring 206 like described in FIGS.
2K-2N and is secured into place as shown in FIG. 2M. The number of
support segments placed into annulus determines the overall
reduction in the circumference of the annulus. FIG. 20 depicts a
repaired mitral valve 52 surrounded by an anchor suture support
segment 202, intermediate suture support segments 204, and a
terminal suture support segment 210 that make up the flexible
single supportive drawstring annuloplasty system 200. When the
entire circumference of the valve annulus has been covered the
mitral valve is tested for competence by distending the left
ventricle with isotonic solution infused through rubber-bulbed
syringe. If needed the annuloplasty system 200 is further adjusted
and the suture support segments 202, 204, and 210 are further
aligned by pulling the supportive drawstring 206 that is found at
the distal end of the terminal suture support segment 210. Since
the support segments 202, 204 and 210 are slidably coupled with the
supportive drawstring 206 the annular tissue between adjacent
suture support segments will plicate and the circumference of the
valve annulus will reduce further. To complete the valve repair the
free end 208 of the supportive drawstring 206 is tied together with
the free suture 260 attached to the end of the terminal suture
support segment 210. After seven or eight knots are made with the
free end 208 of the supportive drawstring 206 and the free suture
260 of the terminal suture support segment 210 are cut at the point
beyond the terminal suture support segment 210 by any suitable
means.
[0086] FIGS. 2P-2Z depict an alternate embodiment of using short
sutures for robotic mitral valve repair procedures using either the
single-supportive drawstring annuloplasty system 200 or
double-supportive drawstring annuloplasty system 100, both systems
are described above. The system as depicted in FIGS. 2P-2Z uses the
single supportive drawstring annuloplasty system 200, but it may
also be used with the double-supportive drawstring annuloplasty
system 100. As shown in FIG. 2P, the anchor suture support segment
body 270' has attached to the side two short sutures 274' and a
single or double supportive drawstring 206 with a free end 208.
Attached to one of the sutures 274' is a surgical needle 272',
whereas the other suture 274' has a free end 278'. FIG. 2P shows
the implantation procedure of the anchor suture support segment
202'. Using robotic surgery instruments (not shown) the surgeon
will deliver the anchor suture support segment 202' to the surgical
site 44 and will held it approximately 5 cm above the mitral valve
annulus 50. Using robotic surgery instruments (not shown) the
surgical needle 272' and suture 274' will be passed through the
mitral valve annulus 50 at the surgical site 44 so as to make a
horizontal mattress stitch.
[0087] FIG. 2Q shows the anchor suture support segment 202' where
the anchor suture support segment body 270' is aligned with the
mitral valve annulus 50. The anchor suture support segment 202' is
put into place by pulling on the surgical needle 272' and suture
274' using robotic instruments to make the anchor suture support
segment body 270' flush with the mitral valve annulus 50. Once the
anchor suture support segment body 270' is in the proper place the
surgical needle 272' will be cut off of the suture 274' (not
shown).
[0088] FIG. 2R shows how the anchor suture support segment is
anchored to the mitral valve annulus 50. The free end 278' of the
anchor suture support segment 202' is tied together with the suture
274' that had the surgical needle 272' removed. These two ends are
tied together against the rigid or semi-rigid body of the anchor
suture support segment 270'. Five to seven knots are made with the
ends to hold the anchor sutures support segment 202' in place.
[0089] FIG. 2S shows how the first intermediate suture support
segment 204' is delivered into position above the mitral valve from
outside of the chest cavity by sliding the intermediate suture
support segment 204' down over the supportive drawstring 206 using
surgical knot pusher tool (not shown). There are two sutures 224'
attached to the sides of the intermediate sutures support segment
body 270'. Attached to one end of one sutures 224' is a surgical
needle 222' the other suture 224' has a free end 228', without a
surgical needle 222'.
[0090] FIG. 2T shows the implantation of the second intermediate
suture support segment 202' into the mitral valve annulus 50, using
robotic assisted surgery. The second support segment is delivered
into position over the mitral valve annulus 50 by sliding the
intermediate suture support segment 204' down over the supportive
drawstring 206' and then the intermediate suture support segment
204' is held above the mitral valve annulus 50. The surgical needle
222' is passed through the mitral valve annulus 50 at the surgical
site 48 using robotic surgical instruments so as to make a
horizontal mattress stitch. The intermediate suture support segment
204' will be guided into place by pulling on the surgical needle
222' and suture 224' to make the second intermediate suture support
segment body 220' flush with the mitral valve annulus 50 (not
shown). Once the intermediate suture support segment body 220' is
in the desired location the surgical needle 222' will be cut off of
the suture 224' (not shown).
[0091] FIG. 2U shows how the second intermediate suture support
segment 204' is secured to the mitral valve annulus 50 by
robotic-assisted knot tying. The short suture 224' which had the
surgical needle 222' removed is tied together with the free end
228' of the short suture 224'. The free end 228' and the sutures
224' are knotted together five to seven times against the
intermediate suture support segment body 220' to secure the
intermediate suture support segment 204' to the mitral valve
annulus 50.
[0092] FIG. 2V depicts the addition of another intermediate suture
support segment 204' to the mitral valve annulus 50. The supportive
drawstring 206 is used as a guide to deliver the intermediate
sutures support segment 204' into position above the mitral valve
annulus 50 from outside of the chest cavity through a small
incision or port (not shown). These steps are repeated until the
desired circumference is covered around the mitral valve annulus
50.
[0093] FIG. 2W depicts the implantation of the terminal suture
support segment 210'. First, the terminal suture support segment
210' is added by threading the free end 208 of the supportive
drawstring 206 through the channel that runs through the body of
the terminal suture support segment 250'. The terminal suture
support segment body 250' has two surgical sutures 254' attached to
the terminal suture support segment body 250'. One of the surgical
sutures 254' has a surgical needle 252' attached to the end and the
other surgical suture 254' has a free end 258'. Also attached to
the terminal suture support segment body 250' is a free terminal
suture 260'.
[0094] FIG. 2X shows how the terminal suture support segment 210'
is secured to the mitral valve annulus 50 after the surgical needle
252' and the surgical suture 254' have been passed through the
mitral valve annulus 50. The surgical suture 254' which had the
surgical needle 252' removed is tied together with the free end
258' of the second surgical suture to secure the terminal suture
support segment 210' to the mitral valve annulus 50. After five or
six knots have been made the free tails of the sutures are cut by
any suitable means (not shown). The mitral valve is tested for
competence by distending the left ventricle with isotonic solution
infused through rubber-bulbed syringe.
[0095] FIG. 2Y shows how the repair with the annuloplasty system
200' is completed. The free suture 260' attached to the terminal
suture support segment body 250' is tied together with the free end
208 of the single supportive drawstring 206 against the terminal
suture support segment body 250'. The free end of the suture 260'
and the free end 208 of the supportive drawstring 206 are knotted
together seven to eight times, and then the excess free tails are
cut at a point beyond the terminal suture support segment 210' by
any suitable means.
[0096] FIG. 2Z shows the suture support segments in place in the
mitral valve annulus 50 whose circumference is thereby reduced
after the implantation of the annuloplasty system 200' according to
the present invention.
[0097] FIGS. 2AA-2AC depict using the single supportive drawstring
annuloplasty system 200 (as shown) or the dual-supportive
drawstring annuloplasty system 100 (not shown) in infants and
growing children, where the supportive drawstring 206 will either
be made from biodegradable material or will be removed after
implantation onto the mitral valve annulus 50. The method of
implantation of the annuloplasty system 200 in children and
adolescents is similar to that described previously in FIGS. 2G-2O.
As shown in FIG. 2AB when the entire circumference of the mitral
valve annulus 50 has been sutured the mitral valve is tested for
competence by distending the left ventricle with isotonic solution
infused through rubber-bulbed syringe. The repair is completed by
tightening the free ends of the biodegradable supportive
drawstrings 206 over the last support segment 204. After seven or
eight knots have been made the free end of the supportive
drawstring 206 are cut by any suitable means. After mitral valve
repair surgery the absorbable supportive drawstring 206 is
eventually resorbed by the patient. The absence of the supportive
drawstring 206 allows normal annular growth 292 between the suture
support segments, 202 and 204 as the child grows, shown in FIG.
2AC. The biodegradable supportive drawstrings degrade at a rate
that allows substantially complete healing of the patient's annular
structure. The resulting time period to complete resorption may be
on the order of 4 to 6 months to the order of 1 to 2 years.
[0098] In accordance with a further aspect of the present
invention, as shown in FIG. 2AA, the surgeon removes the supportive
drawstring 206 once the annuloplasty system 200 has been implanted
in children or adolescents. When the entire circumference of the
mitral valve annulus 50 has been sutured the mitral valve is tested
for competence. The repair is completed by cutting the supportive
drawstring 290 between the anchor suture support segment 202 and
the first intermediate support segments 204 and then gently pulling
on the free ends of the supportive drawstring 206 to withdraw the
supportive drawstring 206 from the annuloplasty system 200, as
shown in FIG. 2AB. The absence of the supportive drawstrings allows
normal annular growth 292 between the suture support segments as
the child grows, as shown in FIG. 2AC.
[0099] Alternatively, the surgeon can implant desirable number of
free intermediate support segments (not shown) without supportive
drawstrings and the anchor support segment until the entire
circumference or at list a portion of the mitral valve annulus has
been covered. The absence of the supportive drawstrings allows
normal annular growth 292 between the suture support segments as
the child grows, as shown in FIG. 2AC.
[0100] FIG. 5 depicts another exemplary embodiment of the
annuloplasty system for minimally invasive or robotic valve repair
procedures. This system is an alternate embodiment of the
single-supportive drawstring annuloplasty system 200 or
double-supportive drawstring annuloplasty system 100 described
previously. As depicted the system has a single supportive
drawstring but it can be used with a double supportive drawstring.
The annuloplasty system 500 partially shown in FIG. 5A uses an
anchor suture support segment 502 with an attached single
supportive drawstring 506 that has a free end 508. The anchor
suture support segment 502 shown in FIG. 5A has an anchor suture
support segment body 570 with an attached suture 574 that may or
may not have a surgical needle 572 (as shown it does not have an
attached surgical needle 572) attached. The unique aspect of the
embodiment is that the second suture 575 with attached surgical
needle 572 is stored inside the anchor suture support segment body
570. The stored portion of the suture 575 is drawn out of the
storage area so that the anchor sutures support segment 502 can be
attached.
[0101] FIG. 5B shows an intermediate suture support segment 504 of
the annuloplasty system 500. The intermediate suture support
segment 504 is made up of an intermediate suture support segment
body 520. Attached to the intermediate suture support segment body
520 is a suture 524 which may or may not have an attached surgical
needle 522 (as shown no surgical needle 522 is attached). The
second suture 525 has an attached surgical needle 522. This second
suture 525 is stored within the intermediate suture support segment
body 570. The stored portion of the suture 525 is drawn out of the
storage area so that the anchor sutures support segment 502 can be
attached.
[0102] FIG. 6 is an illustration of the superior view of the
dilated mitral valve of a human heart. The anchor suture support
segment 502 is already shown as being attached to the mitral valve
annulus 50. The anchor suture support segment is attached by the
same process described in FIGS. 2G-2J. FIG. 6 shows how the first
intermediate suture support segment 504 is delivered into position
above the mitral valve from outside of the chest cavity by sliding
the intermediate suture support segment 504 down over the
supportive drawstring 506 using surgical knot pusher tool (not
shown). Once the desired location is reached the surgeon will pull
on the surgical needle 522 attached to the second suture 525, which
will pull the second suture 525 from the intermediate suture
support segment body 520 (see also FIG. 7). The intermediate suture
support segment 504 is attached in the same manner as described
above for the single-supportive drawstring annuloplasty system 200
in FIGS. 2K-20.
[0103] A third embodiment of the present invention (shown in FIGS.
3A-E) also provides an annuloplasty system for repairing
incompetent heart valves. This system includes: (a) a substantially
circular valve reinforcing device adapted to be surgically
implanted around a heart valve annulus; (b) anchoring means for
attaching the substantially circular valve reinforcing device to
the heart valve annulus, wherein attaching the substantially
circular valve reinforcing device to the heart valve annulus
reduces the circumference of the heart valve annulus by plicaing
annular tissue underneath the valve reinforcing device; and (c)
constricting means for reducing the circumference of the
substantially circular valve reinforcing device, wherein reducing
the circumference of the substantially circular valve reinforcing
device further reduces the circumference of the annulus. The valve
reinforcing device further includes: (i) a plurality of individual
suture support segments, wherein the plurality of suture support
segments further includes: a) at least one anchor segment covered
with a sewing cuff, wherein the at least one anchor segment further
includes a channel passing lengthwise therethrough; b) at least one
terminal segment covered with a sewing cuff, wherein the at least
one terminal segment further includes a channel passing lengthwise
therethrough; and c) a plurality of intermediate segments disposed
between the at least one anchor segment and the at least one
terminal segment, wherein each intermediate segment is covered with
a sewing cuff, and wherein each intermediate segment further
includes a channel passing lengthwise therethrough. The anchoring
means further includes: (i) a dual-armed suture, wherein at least
one end of the suture is attached to surgical needle, and wherein
the surgical needle passes through the sewing cuff of the anchor
segment; (ii) a dual-armed suture, wherein at least-one end of the
suture is attached to a surgical needle, and wherein the surgical
needle passes through the sewing cuff of the intermediate segment;
and (iii) a dual-armed suture, wherein at least one end of the
suture is attached to a surgical needle, and wherein the surgical
needle passes through the sewing cuff of the terminal segment. The
constricting means further includes: (i) a supportive drawstring,
wherein one end of the drawstring is secured to one end of the
anchor segment, wherein the supportive drawstring passes through
the channel in each intermediate segment and the channel in the
terminal segment.
[0104] A method for surgically implanting this annuloplasty system
includes: (a) utilizing the anchoring means for securing the
substantially circular valve reinforcing device to the heart valve
annulus, wherein securing the substantially circular valve
reinforcing device to the heart valve annulus reduces the
circumference of the heart valve annulus by plicating annular
tissue underneath the valve reinforcing device, and (b) utilizing
the constricting means to further reduce the circumference of the
substantially circular valve reinforcing device, wherein reducing
the circumference of the valve reinforcing device further reduces
the circumference of the heart valve annulus by plicating the
annular tissue between adjacent segments of the substantially
circular valve reinforcing device, if further adjustments are
required. Utilizing the anchoring means further includes: (i)
affixing the suture to the heart valve annulus by passing one of
the surgical needles attached to the sutures through a heart valve
annulus; (ii) threading the surgical needles attached to the suture
through the sewing cuff of the anchor segment; (iii) pushing the
anchor segment down over the strands of the suture until the anchor
segment is aligned with the heart valve annulus; (iv) securing the
anchor segment to the heart valve annulus by tying the ends of the
sutures together; (v) affixing another suture to a heart valve
annulus as a horizontal mattress stitch by passing one of the
surgical needles attached to the sutures through the heart valve
annulus; (vi) threading the surgical needles attached to the suture
through the sewing cuff on the first intermediate segment; (vii)
using the supportive drawstring and the strands of the suture to
guide the intermediate segment to the desired position above the
heart valve annulus; (viii) pushing the intermediate segment down
over the suture strands until the intermediate segment is aligned
with the heart valve annulus; (ix) securing the intermediate
segment to the heart valve annulus by tying the ends of the sutures
together; (x) repeating steps (v-ix) until the desired
circumference around the heart valve annulus is covered by
intermediate suture support segments; (xi) threading the supportive
drawstring through the channel which passes through the length of
the terminal segment; (xii) affixing the suture to a heart valve
annulus by passing one of the surgical needles attached to the
sutures through the heart valve annulus; (xiii) threading the
surgical needles attached to the suture through the sewing cuff on
the terminal segment; (xiv) using the supportive drawstring and the
strands of the suture to guide the terminal segment to the desired
position above the heart valve annulus; (xv) pushing the terminal
segment down over the strands of the sutures until the terminal
segment is aligned with the heart valve annulus; (xvi) securing the
terminal segment to the heart valve annulus by tying the ends of
the sutures together; and (xvii) testing the repaired heart valve
to verify that appropriate constriction has been achieved.
Utilizing the constricting means further includes: (i) pulling the
supportive drawstring to the desired tension to further decrease
the circumference of the heart valve annulus if further adjustment
is needed; and (ii) tying the supportive drawstring that runs
through the terminal segment to the third suture attached to the
end portion of the terminal segment.
[0105] FIGS. 3A-3E illustrate the third exemplary embodiment of
this invention. Annuloplasty system 300 includes of an anchor
suture support segment 302 with a supportive drawstring 306
attached, a plurality of identical intermediate suture support
segments 304, a terminal suture support segment 310 and a plurality
of identical surgical sutures 340 with attached surgical needles
342. The surgical methods used to implant the annuloplasty system
300 may be conventional open heart surgery techniques or minimally
invasive heart surgery techniques.
[0106] The suture support segments, the anchor sutures support
segment 302, the intermediate suture support segments 304, and
terminal suture support segment 310, provide sites for suturing of
the annuloplasty system 300 about the mitral valve annulus 50. Each
of the suture support segments 302, 304, and 310 accommodate a
single horizontal mattress suture incorporating a portion of the
circumference of the mitral valve annulus 50 beneath it. The suture
traverses a longer distance along the heart annulus than the size
of the support segments. Sutures, when tightened and tied, create
an imbrication in the valve annulus underneath the segment thereby
reducing the circumference of the annulus by an amount equal to the
difference between the length each suture travels in the tissue of
the heart annulus and the distance between the suture bites in the
support segment.
[0107] FIG. 3A depicts a cross-sectional view of a suture support
segment 301. The suture support segment 301 could function as an
anchor suture support segment 302, an intermediate suture support
segment 304 or a terminal suture support segment 310. The support
segments, 302, 304, and 310, can be cylindrical, tubular, square,
round, oval, elongated oval or combinations thereof shaped as
necessary to achieve the desired configuration. The suture support
segment 301 has a rigid core 331 which surrounds the channel 330
that will hold the supportive drawstring 306. As shown it is a
single-channel 330 but it could also be a dual channel in the
suture support segment 301. The rigid core 331 is covered with a
silicon rubber 313 which is covered by a polyester fabric 312. The
silicon rubber 313 and the polyester fabric 312 together make up
the sewing cuff 311.
[0108] The suture support segments 302, 304, and 310 have a
cylindrical rigid core which includes a channel 330 passing
lengthwise therethrough. The rigid core 331 can be made of any
suitable material that is preferably inert, non-corrosive,
non-thrombogenic and biocompatible with blood and tissue. By way of
example, but not limitation, such material might be an acetal resin
Delrin. The core 331 is covered with a layer of barium sulfate
impregnated silicon rubber 313 and polyester knit fabric 312. The
layer of silicon rubber 313 around the rigid core 331 and the
polyester cover 312 provide a sewing cuff 311 for suturing of the
support segments 301 about the heart valve annulus. A preferred
size of the suture support segment body 320, 350, 370 is 1 mm to 4
mm in length but more preferably 2 mm to 6 mm in length, with a
circumference of 1 mm to 4 mm, although other sizes and dimensions
are possible. The suture support segments 302, 304, and 310 must be
rigid or semi-rigid in the longitudinal dimension, and must not be
deformable, such that when the sutures 340 are tied against the
suture support segment body 370, 320, 350 to secure the suture
support segment 302, 304, 310 to the mitral valve annulus 50, the
suture support segment body 370, 320, 350 does not buckle.
[0109] FIG. 3A is an illustration of the superior view of the
dilated mitral valve of a human heart. As depicted the dilated
mitral valve has a gap 46 between the anterior and posterior
leaflets 42 and 40. FIG. 3A also depicts a side view of a suture
support segment 302, 304 or 310. As depicted it is labeled 302. The
suture support segment has channel passing lengthwise
therethrough.
[0110] FIGS. 3A and B depict the implantation of the anchor suture
support segment 302 into the mitral valve annulus 50. A double-arm
suture 340 is placed as a mattress horizontal stitch in the
posterior annulus of the mitral valve and then passed through the
sewing cuff 311 of the anchor suture support segment 302. As shown
in FIG. 3B the surgical needles 342 are used to pierce the sewing
cuff 311 of the anchor suture support segment 302. The sutures 340
that have passed through the surgical cuff 311 of the anchor
support segment 302 are then used to slide the anchor suture
support segment 302 down onto the desired location of the mitral
valve annulus 50.
[0111] FIG. 3C depicts the securing of the anchor suture support
segment 302 to the mitral valve annulus 50. Once the anchor support
segment 302 is aligned with the mitral valve annulus 50 the
surgical needles 342 are cut off from the sutures 340 and the free
ends of the sutures 340 are knotted together, with sufficient
tension thereby securing the anchor suture support segment 302 in
place on the mitral valve annulus 50.
[0112] FIG. 3D shows the implantation of the first intermediate
suture support segment 304 according to the current embodiment of
the invention. A new horizontal mattress stitch is placed 2-4 mm
from the proximal end of the anchor support segment 302 at the
surgical site 48. The supportive drawstring 306 is used to guide
the intermediate suture support segment 304 toward the mitral valve
annulus 50.
[0113] FIG. 3E depicts the sliding down of the intermediate suture
support segment 304 to the mitral valve annulus 50. As shown in
FIG. 3D the supportive drawstring 306 and the sutures 340 that have
passed through the sewing cuff 311 of the intermediate suture
support segment 304 are used to lower the intermediate suture
support segment 304 to the desired location. The surgical needles
342 of the sutures 340 are used to pierce the sewing cuff 311 of
the intermediate suture support segment 304. Once the intermediate
support segment 304 is aligned with the mitral valve annulus 50 the
surgical needles 342 are cut off from the sutures 340 and the free
ends of the sutures 340 are knotted together, with sufficient
tension thereby securing the intermediate suture support segment
304 in place on the mitral valve annulus 50. This process described
in FIGS. 3D-3E is repeated until the desired circumference around
the mitral valve annulus 50 is covered with intermediate suture
support segments 304.
[0114] After the last intermediate suture support segment 304 is
secured on the mitral valve annulus 50, a terminal suture support
segment 310 will be implanted like described in FIGS. 3E-3E. Next,
the mitral valve will be tested for competence by distending the
left ventricle with isotonic solution infused through rubber-bulbed
syringe. If needed the annuloplasty system will be adjusted by
pulling the supportive drawstring 306. To complete the annuloplasty
system 300 the free end 308 of the supportive drawstring 306 then
will be tied together with the free suture attached to the end of
the terminal suture support segment 310. After seven or eight knots
are made the free tails are cut at the point beyond the terminal
suture support segment 310 by any suitable means completing the
annuloplasty.
[0115] A fourth embodiment of this invention (shown in FIGS. 4A-H)
also provides an annuloplasty system for repairing incompetent
heart valves without traditional knotting. This system includes: a
substantially circular flexible valve reinforcing device adapted to
be surgically implanted into a heart valve; anchoring means for
attaching the substantially circular valve reinforcing device to
the heart valve annulus and for pleating the annulus to reduce its
circumference to substantially that of the valve reinforcing
device. The valve reinforcing device further includes: a core
formed of a plurality of thin fibers which are held together by a
tubular polyester velour cloth. The anchoring means further
includes: (i) a suture containing at least one surgical needle at
each proximal end of the suture; and (ii) a plurality of barbed
structures formed at a medial point on the suture with a first barb
structure being placed a distance away from a second barb structure
to create a bridge area, wherein the first barbed structure is
oriented to permit passage of the suture through the heart valve
annulus in a forward direction and prevent movement in a reverse
direction, and wherein the second barbed structure is oriented to
prevent passage of the suture through the heart valve annulus in a
forward direction
[0116] A method for surgically implanting this annuloplasty system
includes: (a) utilizing the anchoring means to secure the
substantially circular valve reinforcing device to the heart valve
annulus. Utilizing the anchoring means further includes: (i)
inserting one of the surgical needles of the suture apparatus into
the heart valve annulus and pulling the surgical needle which draws
the first portion of the suture through the heart valve annulus
until the barbs of the second barbed structure engage the surface
of the annulus at the insertion point preventing further
advancement of the suture into the heart valve annulus; (ii)
inserting another suture apparatus into the heart valve annulus 2-4
mm apart from the previous stitch and pulling the surgical needle
which draws the first portion of the suture through the heart valve
annulus until the barbs of the second barbed structure engage the
surface of the heart valve annulus at the insertion point
preventing further advancement of the suture into the heart valve
annulus; and (iii) repeating step (ii) until the entire
circumference of the posterior annulus of the mitral valve is
evenly sutured. (iv) using both surgical needles of each of the
suture apparatus to pierce the annuloplasty ring wherein the suture
attached to the surgical needles lower the annuloplasty ring over
the sutures into position above the heart valve annulus; (v)
pushing the annuloplasty ring onto the barbed structures wherein
the barbed structures catch the thin fibers in the annuloplasty
ring; (vi) using the barbed structures to hold the annuloplasty
ring into place; and (vii) cutting off the surgical needles and the
remaining suture material.
[0117] FIGS. 4A-4H depict the fourth embodiment and method for
attaching an annuloplasty system to a damaged mitral valve
according the present invention. The annuloplasty system 400
includes a double-armed barbed suture 420 which further includes a
plurality of elongated sutures 424 having one or more spaced barbs
426 and 428 projecting from the surface of the suture 424. Barbs
426 and 428 are configured to allow passage of the suture 424 in
one direction through the heart tissue and an annuloplasty ring or
band 450 but resist movement of the suture 424 relative to the
heart tissue and the annuloplasty ring or band in the opposite
direction. The surgical methods used to implant the annuloplasty
system 400 may be conventional open heart surgery techniques or
minimally invasive heart surgery techniques.
[0118] FIG. 4A depicts one of the double-armed barbed sutures 420
of annuloplasty system 400. The double-armed barbed suture 420 is
comprised of a suture 424, surgical needles 422, barbs 426, 428 and
a bridge between the barbs 430. The suture 424 has attached to each
end a surgical needle 422. The suture 424 also has attached to the
surface thereof a set of barbs 426 and 428 facing in opposite
directions. The suture 424 includes a set of barbs 426 oriented in
one direction on one side of a bridge 430 and another set of barbs
428 oriented in the opposite direction on the other side of the
bridge 430. The barbs 426 and 428 are configured to only allow
passage of the suture 424 in one direction through mitral valve
annulus 50.
[0119] FIG. 4B is an illustration of the superior view of the
dilated mitral valve of a human heart. As depicted the dilated
mitral valve has a gap 46 between the anterior and the posterior
leaflets 42 and 40. FIG. 4B also depicts the method of implantation
of annuloplasty system 400 into heart valve annulus 50. The surgeon
will insert one of the surgical needles 422 into the mitral valve
annulus 50 at the surgical site 44 and will advance the surgical
needle 422 through the mitral valve annulus 50 until the needle 422
emerges from the mitral valve annulus 50.
[0120] FIG. 4C shows the next step in which the surgeon will grip
the surgical needle 422 and pull the surgical needle 422 out of the
mitral valve annulus which draws the first portion 424' of the
suture body 424 through the mitral valve annulus 50 until the barbs
428 of the second portion of the suture body 424 engage the surface
of the mitral valve annulus 50 at the insertion point preventing
further advancement of the suture 424 into the mitral valve annulus
50.
[0121] FIG. 4D shows many double-armed barbed sutures 420 attached
to the mitral valve annulus 50 by the means described above in
FIGS. 4B-4C. For clarity, FIG. 4E shows only one of the
double-armed barbed sutures 420 attached to the mitral valve
annulus 50 but it also depicts how the annuloplasty band or ring
450 is pierced with the surgical needles 422. In FIG. 4E the
annuloplasty band/ring 450 has been penetrated by the surgical
needles 422 attached to the sutures 424 which has been passed
through the mitral valve annulus 50 by means of the method
described above in FIGS. 4B-4C. FIG. 4F is a detailed view of the
annuloplasty band/ring 450. This view shows how the annuloplasty
band/ring 450 is comprised. The annuloplasty band/ring 450 has a
core 452. The core 452 of the annuloplasty band is made up of a
plurality of distinct thin fibers 454. The plurality of thin fibers
454 that make up the core 452 of annuloplasty band/ring 450 are
covered with a tubular polyester velour cloth 456.
[0122] FIG. 4G shows the full annuloplasty system 400 with all of
the double-armed barbed sutures 420 attached to the mitral valve
annulus 50 and passed through the annuloplasty ring 450 wherein the
annuloplasty ring 450 is lowered in place above the mitral valve
annulus 50 over the strands of the double-armed barbed sutures 420.
The next step will be for the surgeon to secure the annuloplasty
ring 450 onto the barbed structures 426 and 428 wherein the barbed
structures 426 and 428 catch the thin fibers 454 in the
annuloplasty ring 450. The barbs 426 and 428 facing upwards from
the mitral valve annulus 50 will catch the annuloplasty ring 450
and will hold the annuloplasty ring 450 onto the mitral valve
annulus 50 with out having to tie the sutures. Once the
annuloplasty ring 450 is secured into place on the mitral valve
annulus 50 the excess suture 424 protruding through the
annuloplasty ring 450 is cut at a point against the annuloplasty
ring 450. The barbs 426 and 428 will hold the annuloplasty ring 450
in place on the mitral valve annulus 50 because the barbs 426 and
428 grip the thin fibers 454 and the polyester velour cloth cover
of the annuloplasty band/ring 450. FIG. 4H is a superior view of a
repaired mitral valve annulus 50 with attached and completed
annuloplasty system 400.
[0123] FIGS. 8-26 depict various alternate methods used to attach
suture support segments quickly in the heart valve annulus without
traditional knotting.
[0124] FIG. 8 provides an illustration of the superior view of the
dilated mitral valve of a human heart. As depicted the mitral valve
has a gap 46 between the anterior and posterior leaflets 42 and 40.
Any of the above described annuloplasty systems (100, 200, 300,
400, 500) are compatible with this method but the single supportive
drawstring annuloplasty system 200 is depicted. FIG. 8 depicts the
use of an intracardiac ultrasonic suture welder 70, a novel tool
that allows one to secure interrupted sutures under tension without
tying knots. As pictured the anchor suture support segment 202 has
already been implanted in the mitral valve annulus 50. Instead of
knotting the sutures 274 together to secure the anchor suture
support segment body 270 to the heart valve annulus 50, the two
ends of each suture 274 (not shown) can be threaded through the end
of an intracardiac ultrasonic suture welder 70. Tension in the
sutures 274 is adjusted using downward pressure with the tip of the
intracardiac ultrasonic suture welder 70 as well as upward traction
on the end of each suture 274 strand. The intracardiac ultrasonic
suture welder 70 is then actuated (not shown). Successful welding
of each suture 274 is confirmed by visual inspection, and the
suture tails are cut 1-2 mm from the weld. This process is repeated
for each intermediate suture support segment 204 until the desired
circumference around the mitral valve annulus 50 is covered.
[0125] FIGS. 9-11 depict another alternative embodiment of a suture
support segment that does not use traditional knotting to secure
the suture support segment body to the mitral valve annulus. The
annuloplasty system can be any of the above described having a
single supportive drawstring (200) or a dual-supportive drawstring
(100).
[0126] FIG. 9 depicts an intermediate suture support segment 604.
The intermediate suture support segment 604 is made up of an
intermediate suture support segment body 620, a suture 624, a
surgical needle 622, an eye 630, and barbs 632. A supportive
drawstring 606 (may be a single or dual supportive drawstring, the
dual supportive drawstring is not shown) is threaded through the
channel(s) in the intermediate suture support segment body 620.
This supportive drawstring 606 is used to guide the intermediate
suture support segment 604 to the desired location on the mitral
valve annulus. The intermediate suture support segment body 620 has
an eye 630 with ratchet means. Attached to the other end of the
intermediate suture support segment body 620 is a suture 624 with
an attached surgical needle 622. The suture 624 has attached on the
exterior distal surface a set of barbs 632. The orientation of the
barbs 632 make the suture 624 a one-way suture because barbs 632
will only allow passage of the surgical needle 622 and suture 624
in one direction through the heart tissue and the eye 630, but not
in the opposite direction.
[0127] FIG. 10 shows how the surgical needle 622 is used to thread
the suture 624 through the heart tissue and is then passed through
the eye 630 to lead the suture 624 there through, whereby the
suture 624 is formed into a loop 634. FIG. 11 shows how the
latching means of the eye 630 and barbs 632 permits forward
movement of the suture 624 through the eye 630 but retains the
suture 624 securely against reverse movement through the eye 630.
Note that the anchor suture support segment (not shown) used with
this embodiment will have the same configuration as the
intermediate suture support segment 604, except that the supportive
drawstring 606 is attached to the anchor suture support segment
instead of running through a channel(s) of the anchor suture
support segment body.
[0128] FIGS. 12-13 depict another means of attachment without
traditional knotting using a suture support segment 704 that has an
opening 730 with a one-way suture-retaining device 734 with
flexible fingers, barbs or series of sheets 736 that are configured
to engage the braided suture 724. The fingers or barbs 736
preferably have sharp points inclined in a common axial direction
for purposes of preventing the braided suture 724 from sliding
relative to suture support segment 704 in a direction opposite to
the direction of inclination of barbs 736. The suture-retaining
device 734 has a passage of a sufficient diameter to allow a
braided suture 724 to easily pass through opening 730 with little
resistance, but small enough to allow flexible fingers or barbs 736
to engage the braided suture 724 when the braided suture 724 in the
suture-retaining device 734 is moved in a direction opposite to the
direction of inclination of barbs or fingers 736. Thus, the braided
suture 724 is locked into position (see FIG. 13).
[0129] FIGS. 14-15 depict yet another embodiment of the present
invention that uses a method to secure the suture support segment
in place without traditional knotting and an annuloplasty system
using the securing method. FIG. 14 depicts an intermediate suture
support segment 804 which is comprised of an intermediate suture
support segment body 820, a braided suture 824, a surgical needle
822, a locking device 830, and a channel(s) which is not shown. The
braided suture 824 has a core 832, formed of a plurality of fibers
which are held together by a tubular braided cover 836. The fibers
are thermally bonded together, to form rigid bridges 834, at
selected short intervals along the longitudinal axis of the braided
suture 824. These rigid bridges 834 are formed from thermally
bonded fibers which are configured to allow passage of the braided
suture 824 in one direction through locking device 830 but
significantly resist movement of the braided suture 824 in the
opposite direction and prevent the braided suture 824 from slipping
back through the locking device 830.
[0130] FIG. 15 provides an illustration of the superior view of the
dilated mitral valve of a human heart. As depicted the dilated
mitral valve has a gap 46 between the anterior and posterior
leaflets 42 and 40. As shown an anchor suture support segment 802
with an attached supportive drawstring 806 is already secured to
the mitral valve annulus 50. The channel of intermediate suture
support segment 804 is threaded through the free end 808 of the
supportive drawstring 806, which is shown as a single supportive
drawstring but it could be a dual-supportive drawstring. The
supportive drawstring 806 is used to guide each intermediate suture
support segment 804 to the desired location on the mitral valve
annulus 50. The surgical needle 822 attached to the intermediate
suture support segment 804 is used to make a horizontal mattress
stitch in the mitral valve annulus 50. Once this is completed the
surgical needle 822 is passed through the eye of the locking device
830 of the intermediate suture support segment body 820. The
braided suture 824 is pulled through the eye of the locking device
830 while the intermediate suture support segment body 824 is
pushed down toward the mitral valve annulus 50 until the required
tension is obtained in the loop and thereafter the excess length of
the braided suture 824 protruding through the eye of the locking
device 830, is cut away. Such an embodiment allows accurate control
over the braided suture 824 tension without having to tie a knot.
Alternatively a specially constructed tool (not shown) similar to a
cable tie tension and cutter tool can be used. The tool would have
a tensioning mechanism for tensioning the suture to a predetermined
tension setting and a cutting mechanism for cutting the excess
portion of the suture tail after the desired tension is
achieved.
[0131] FIG. 16 depicts still another embodiment of the present
invention that uses an opening 930 which provides a slot or
passageway 932 for enabling a lateral insertion of suture 924 into
opening 930. As described above in both single and dual supportive
drawstring systems the intermediate suture support segments 904 are
be slid down over the supportive drawstring 906 into position above
the mitral valve (not shown). The surgical needle 922 is passed
through the mitral valve annulus, and then the surgical needle 922
would be slipped through slot or passageway 932 into opening 930 of
the suture-retaining device. The suture is then pulled through the
opening 930 while the intermediate support segment 904 is pushed
down toward the heart annulus until the required tension is
obtained in the loop and thereafter the excess length of the suture
924 protruding through the opening 930, is cut away.
[0132] FIG. 17 illustrates another locking device utilizable with
the method discussed above. The suture support segment 1004 has a
lumen 1030 formed along the entire axial length of the suture
support segment body 1020. Attached to the outside of the sutures
support segment 1004 on the suture support segment body 1020 is a
braided suture 1024 with an attached surgical needle 1022. The
interior of the suture support segment body 1020 is made up of a
lumen 1030 which is comprised of a plurality of barbs 1036 inclined
in a common axial direction for purposes of preventing braided
suture 1024 from sliding relative to suture support segment body
1020 in a direction opposite to the direction of inclination of
barbs 1036. As can be seen in FIG. 18, the barbs 1036 are
constructed such that if braided suture 1024 is pulled in the
direction indicated by the arrow, the braided suture 1024 may pass
freely with little resistance. However, if braided suture 1024 is
pulled in the opposite direction, the barbs 1036 engage the braid
of the braided suture 1024. Thus, braided suture 1024 is locked
into position.
[0133] FIGS. 19-20 show parts of an annuloplasty system 1100 using
suture support segments having a self-closing single-arm clip
assembly to secure the suture support segment to the mitral valve
annulus 50 instead of using traditional knotting. FIG. 19 is a
detailed drawing of an intermediate suture support segment 1104
having an intermediate suture support segment body 1120, a
self-closing single-arm clip assembly 1128, a suture 1124, and a
surgical needle 1122. The self-closing single-arm clip assembly
1128 is generally U, C or J-shaped with two end points separated
from each other when it is constrained to be in an open
configuration, but tends to coil up to assume its naturally closed
configuration if the constraint is removed. The self-closing
single-arm clip assembly 1128 is attached to the intermediate
suture support segment body 1120 by conventional means. Attached to
the end of the self-closing single-arm clip assembly 1128 is a
suture 1124 which has an attached surgical needle 1122.
[0134] FIG. 20 provides an illustration of the superior view of the
mitral valve of a human heart. As depicted the mitral valve has a
gap 46 between the anterior and posterior leaflets 42 and 40. FIG.
20 depicts how an anchor suture support segment 1102 of the current
embodiment is attached to the mitral valve annulus 50. First, the
surgeon guides the surgical needle 1172 to the surgical site and
passes the surgical needle 1172 through the tissue of the mitral
valve annulus 50 similar to interrupted suture placement and then
pulls the suture 1174 until the self-closing single-arm clip
assembly 1128 passes partially through the mitral valve tissue 50
such that the end point of the self-closing single-arm clip
assembly 1128 which is connected to the suture 1174 completely
passes through the mitral valve annulus 50. The other end of the
self-closing single-arm clip assembly 1128 does not enter the
mitral valve annulus 50 because it is attached to the anchor suture
support segment body 1120 which prevents this end of the
self-closing single-arm clip assembly 1128 from entering the mitral
valve annulus 50. After the suture 1124 is released from the
self-closing single-arm clip assembly 1128 the clip moves to its
predetermined closed-loop configuration, reducing the distance
between the two end points and securing the anchor suture support
segment 1102 to the mitral valve annulus 50. The internal force of
the clip keeps the anchor suture support segment 1102 firmly
attached to the mitral valve annulus and reduces the distance
separating the two end points thereby reducing the portion of the
circumference of the mitral valve annulus 50 between the two end
points. After one clip is thus placed in the annulus, the same
procedure is repeated with a plurality of other clips. The
intermediate suture support segments 1104 are lowered down
one-by-one over the supportive drawstring 1106 into position above
the mitral valve annulus 50. Using this method a desired number of
suture support segments can be linked together to form a line of
linked segments of a desired length, corresponding to the unique
size of the heart annulus of the individual patient.
[0135] FIGS. 21-26 illustrate a superior view of the repaired
mitral valve of a human heart with a plurality of support segments
in place. As depicted the mitral valve has a residual gap 46
between the anterior and posterior leaflets 42 and 40 as a result
of a post-repair residual mitral valve incompetence. FIGS. 21-26
highlight one of the advantageous features of this annuloplasty
system 1100 which is the ability to provide further adjustment or
"fine tuning" of the repair once the annuloplasty system 1100 is
implanted. In other words, the annuloplasty system 1100 may be
adjusted in diameter during or after implantation which will allow
the surgeon to correct certain technical errors that might have
occurred during implantation and eliminate post-repair residual
regurgitation.
[0136] FIG. 21 depicts how the plurality of suture support segments
are slidably coupled with a supportive drawstring(s) and how the
tissue between adjacent suture support segments will placate so
that the circumference of the valve annulus will be reduced by
applying tensile force to the supportive drawstring 1106 in a
proximal direction. This will effectuate any residual annulus
plication not already effectuated beneath suture support segments
1104. Tension may be adjusted on the supportive drawstring 1106
under direct visualization or while using ultrasound Doppler
echocardiography for precise adjustment of the annular correction.
When the entire circumference of the mitral valve annulus 50 has
been sutured the mitral valve is tested for competence by
distending the left ventricle with isotonic solution infused
through a rubber-bulbed syringe. In case of residual regurgitation
46 shown in FIG. 21 the supportive drawstring(s) 1106 (FIGS. 20 and
21) can be used to further cinch the segments and thereby reduce
the annular diameter and correct postrepair residual regurgitation
(FIG. 23). Once proper adjustment is achieved, or in the absence of
need for any adjustment, the supportive drawstring(s) 1106 are
knotted together to maintain the desired degree of annular
constriction and prevent further annular dilatation, thereby
completing the annuloplasty (FIG. 22).
[0137] FIG. 24 illustrates a method of implanting suture support
segments from opposite ends. In FIG. 24 two anchor suture support
segments would be used and implanted at opposite ends of the mitral
valve. The supportive drawstrings attached to the end of the anchor
suture support segments would be used to lower the intermediate
suture support segments onto the mitral valve.
[0138] FIG. 25 shows how one of the two partial supportive
drawstrings from the annuloplasty systems is used to achieve a
selective reduction of the inferior limb of the posterior annulus.
FIG. 25 depicts post-repair residual asymmetric incompetence 49 of
the inferior limb of the posterior annulus an dhow a partial
supportive drawstring corresponding to the area of asymmetric
incompetence is pulled by the left hand of the surgeon to achieve a
selective reduction of the inferior limb of the posterior annulus.
FIG. 26 shows a completed system.
[0139] Another embodiment of this invention provides a suturing
method for quickly attaching the suture support segments to the
heart tissue without traditional knotting, which is not shown.
Suture support segment has an eye sealed with a meltable material
(polypropylene) being soft enough to be penetrated by the needle.
Alternatively the meltable seal in the eye may have a central
passage of a sufficient diameter to allow the needle and the suture
to pass through the passage. In the annuloplasty procedure the
needle would be passed through the heart annulus, and then the
needle would be passed through the eye of the suture support
segment. The suture pulled through the eye while the support
segment is pushed down toward the heart annulus until the required
tension is obtained. A specially constructed tool similar to a
cable tie tension and cutter tool then will be used. The tool would
have a tensioning mechanism for tensioning the suture to a
predetermined tension setting, an ultrasonic welder and a cutting
mechanism for cutting the excess portion of the suture tail after
the desired tension is achieved and the suture joined to the
polypropylene seal in a weld within the eye.
[0140] The suture is comprised of a melt-resistant braided core or
a stainless steel core covered with a meltable sheath made from the
same material as the seal in the eye of the support segment. Upon
activation of the ultrasonic welder the meltable sheath of the
suture and the meltable seal of the eye will melt so that the
suture could attach to the support segment in the weld within the
eye. The core of the suture will not melt and will remain intact so
that the suture will not break upon melting of the meltable sheath
of the suture. The tensioning and cutting tool will cut the excess
portion of the suture tail after the desired tension is achieved
and the suture joined to the polypropylene seal in a weld within
the eye.
[0141] While the present invention has been illustrated by the
description of exemplary embodiments thereof, and while the
embodiments have been described in certain detail, it is not the
intention of the Applicant to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications will readily appear to those skilled in the art.
Therefore, the invention in its broader aspects is not limited to
any of the specific details, representative devices and methods,
and/or illustrative examples shown and described. Accordingly,
departures may be made from such details without departing from the
spirit or scope of the applicant's general inventive concept.
* * * * *