U.S. patent application number 13/691087 was filed with the patent office on 2014-05-22 for device and method of treating heart valve malfunction.
The applicant listed for this patent is Didier De Canniere, Christophe Moureaux. Invention is credited to Didier De Canniere, Christophe Moureaux.
Application Number | 20140142689 13/691087 |
Document ID | / |
Family ID | 50728681 |
Filed Date | 2014-05-22 |
United States Patent
Application |
20140142689 |
Kind Code |
A1 |
De Canniere; Didier ; et
al. |
May 22, 2014 |
DEVICE AND METHOD OF TREATING HEART VALVE MALFUNCTION
Abstract
An assembly and method for treating heart valve malfunction
typically including treating of mitral regurgitation wherein an
instrument assembly includes an elongated chord movably disposed
within an introductory sheath and including an anchor secured to a
distal end thereof. An attendant method includes concurrently
introducing the sheath and the chord into the heart chamber through
an exterior wall and penetrating and passing the sheath and the
chord through the anterior mitral valve leaflet. The sheath and the
chord are then extended transversely across the heart chamber and
the distal end of the chord is anchored to an opposing portion of
the heart wall. The sheath is then withdrawn back along the length
of the anchored chord and through the anterior mitral valve leaflet
and a securing member connects the proximal end of the chord to the
valve leaflet. The chord is secured between the valve leaflet and
the opposing heart wall under sufficient tension to maintain an
intended positioning of the valve leaflet to overcome mitral
regurgitation.
Inventors: |
De Canniere; Didier; (Miami
Beach, FL) ; Moureaux; Christophe; (Besancon,
FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
De Canniere; Didier
Moureaux; Christophe |
Miami Beach
Besancon |
FL |
US
FR |
|
|
Family ID: |
50728681 |
Appl. No.: |
13/691087 |
Filed: |
November 30, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61729152 |
Nov 21, 2012 |
|
|
|
Current U.S.
Class: |
623/2.11 |
Current CPC
Class: |
A61B 17/0643 20130101;
A61F 2/2457 20130101; A61B 2017/0437 20130101; A61B 2017/0409
20130101; A61B 17/0401 20130101; A61B 17/068 20130101; A61F 2/2466
20130101; A61B 2017/045 20130101; A61B 17/0482 20130101; A61B
2017/0464 20130101 |
Class at
Publication: |
623/2.11 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An instrument assembly for treating heart valve malfunction,
said instrument assembly comprising: at least one elongated chord
and an introductory sheath, said sheath at least initially disposed
in enclosing relation to said one chord and movable with said chord
and along the length thereof, said sheath and said one chord
cooperatively structured to concurrently enter the heart chamber
through the heart wall and penetrate and pass through a
predetermined heart valve leaflet, an anchor connected to a distal
end of said one chord and disposable into an anchored relation with
the heart wall substantially oppositely disposed to the
predetermined valve leaflet, a securing assembly connectable to a
proximal extremity of said one chord in an interconnecting position
between said one chord and the predetermined valve leaflet, and
said anchored relation of said anchor and said interconnecting
position of said securing assembly collectively defining an
operative length of one said chord within the heart chamber and a
tensioning of the predetermined valve leaflet sufficient to
restrict prolapsing of the predetermined valve leaflet, by said one
chord.
2. An instrument assembly as recited in claim 1 wherein said
interconnecting position comprises said securing assembly disposed
in securing relation between said proximal extremity of said one
chord and an exterior surface exposed to the left atrium of the
predetermined valve leaflet.
3. An instrument assembly as recited in claim 1 wherein the
predetermined valve leaflet comprises a prolapsing one of the
anterior mitral valve leaflet and posterior mitral valve
leaflet.
4. An instrument assembly as recited in claim 1 wherein said
securing assembly comprises a securing member movably mounted on
and extendable along the length of said one chord into said
interconnecting position.
5. An instrument assembly as recited in claim 4 wherein said
securing assembly further comprises a sleeve connected to said
securing member, said sleeve concentrically mounted on and
positionable along the length of said one chord with said securing
member into said interconnecting position.
6. An instrument assembly as recited in claim 5 wherein said
interconnecting position further comprises said sleeve disposed
through the predetermined valve leaflet concurrently to said
securing member being disposed in securing relation between said
proximal extremity of said one chord and the predetermined valve
leaflet.
7. An instrument assembly as recited in claim 1 wherein said anchor
comprises an outer extremity comprising a configuration sufficient
to penetrate the opposing heart wall portion.
8. An instrument assembly as recited in claim 7 wherein said outer
extremity is disposable in penetrating relation to the
predetermined valve leaflet prior to a chord securing relation with
the opposing heart wall portion.
9. An instrument assembly as recited in claim 7 wherein said sheath
comprises an open distal end dimensioned to facilitate disposition
of said anchor into a penetrating orientation to the predetermined
valve leaflet and subsequently, the opposing heart wall
portion.
10. An instrument assembly as recited in claim wherein said anchor
comprises a gripping structure disposed laterally outward from said
outer extremity of said anchor; said gripping structure structured
to define a secure connection of said anchor with the opposing
heart wall portion.
11. An instrument assembly as recited in claim 10 wherein said
gripping structure is expandable radially outward from said outer
extremity of said anchor.
12. An instrument assembly as recited in claim wherein said anchor
comprises a gripping structure disposed laterally outward from said
outer extremity of said anchor; said gripping structure structured
to define a secure connection of said anchor with the opposing
heart wall.
13. A method of treating mitral valve regurgitation using the
instrument assembly as recited in claim 1, the method comprising:
introducing the sheath and at least one chord into the chamber of
the heart through the atrium wall thereof; passing the sheath and
one chord substantially concurrently through at least one mitral
valve leaflet in the siege of prolapse and there from into the left
ventricle of the heart chamber, extending the sheath and one chord
transversely across the left ventricle and securing the anchor into
an anchored relation with a substantially opposing portion of the
ventricular wall of the heart, withdrawing the sheath back along
the length of the anchored one chord from the ventricular wall and
back through the one mitral valve leaflet, and securing the
securing assembly along the length of the one chord into an
interconnecting position between a proximal extremity of the one
chord and the one mitral valve leaflet.
14. A method as recited in claim 13 disposing the securing assembly
along the length of the one chord into the interconnecting position
with an exterior of the one mitral valve leaflet which is exposed
to the left atrium.
15. A method as recited in claim 13 comprising passing the sheath
and one chord substantially concurrently through the anterior
mitral valve leaflet in the siege of prolapse and there from into
the left ventricle of the heart chamber.
16. A method as recited in claim 13 comprising passing the sheath
and one chord substantially concurrently through the posterior
mitral valve leaflet in the siege of prolapse and there from into
the left ventricle of the heart chamber.
17. A method as recited in claim 13 comprising disconnecting a
remaining distal portion of the one chord, extending between the
securing assembly and the atrium wall, subsequently to securing the
securing assembly in the interconnecting position.
18. A method of treating heart valve malfunction comprising:
passing an instrument into the heart chamber and into penetrating
relation to a predetermined valve leaflet under the siege of
prolapse, passing the instrument through the predetermined valve
leaflet, extending at least one chord of the instrument from the
predetermined valve leaflet across the heart chamber into anchored
relation with a portion of the heart wall substantially opposing
the predetermined valve leaflet, withdrawing a sheath of the
instrument back along a length of the anchored one chord from the
opposing portion of the heart wall and back through the
predetermined valve leaflet, and securing a corresponding proximal
extremity of the one chord to the predetermined valve leaflet.
19. A method as recited in claim 18 comprising disposing an anchor
of the instrument into a griping orientation when in the anchored
relation with the opposing portion of the heart wall.
20. A method as recited in claim 19 further comprising expanding
the anchor into the gripping orientation with the opposing portion
of the heart wall.
21. A method as recited in claim 19 further comprising defining the
gripping orientation of the anchor portion as a penetrating
engagement with an interior portion of the ventricular wall.
22. A method as recited in claim 21 further comprising tensioning
the one chord between the ventricular wall and the predetermined
valve leaflet by securing the corresponding proximal extremity of
the one chord to an exterior of the predetermined valve
leaflet.
23. A method as recited in claim 18 further comprising establishing
an operative length of said one chord between the predetermined
valve leaflet and the opposing portion of the heart wall to define
a tensioning of the predetermined valve leaflet sufficient to
restrict prolapsing of the predetermined valve leaflet, by the one
chord.
24. A method as recited in claim 18 comprising treating mitral
valve regurgitation by entering the heart through the atrial wall
into the left atrium and penetrating the predetermined mitral valve
leaflet under the siege of prolapse with a distal portion of the
one chord and passing the one chord through the mitral valve
leaflet and transversely across the left ventricle and disposing an
anchor, secured to the distal end of the one chord, into anchored
relation with an oppositely disposed portion of the ventricular
wall.
25. A method as recited in claim 24 comprising positioning the
anchor into a gripping orientation on the interior of the heart
chamber by penetrating interior portions of the ventricular
wall.
26. A method as recited in claim 25 further defining the gripping
orientation by expanding the anchor into penetrating engagement
with the interior portions of the papillary muscle of the
ventricular wall.
27. A method as recited in claim 24 further comprising tensioning
the one chord between the penetrated portion of the ventricular
wall and the one mitral valve leaflet by securing a proximal
extremity of the one chord to the one mitral valve leaflet.
28. A method as recited in claim 27 further comprising establishing
an operative length of said one chord between the predetermined
mitral valve leaflet and penetrated portion of the ventricular wall
to define a tensioning of the predetermine valve leaflet sufficient
to restrict prolapsing of the predetermined mitral valve leaflet,
by the one chord.
Description
CLAIM OF PRIORITY
[0001] The present application is based on and a claim of priority
is made under 35 U.S.C. Section 119(e) to a provisional patent
application that is currently pending in the U.S. Patent and
Trademark Office, namely, that having Ser. No. 61/729,152 and a
filing date of Nov. 21, 2012, and which is incorporated herein by
reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention is directed to an instrument assembly
and method of use and application in the treatment of heart valve
malfunction. In more specific terms the instrument assembly is
specifically adapted to treat mitral regurgitation by means of a
direct entry of the instrument through the atrial wall rather than
through the vascular system, in order to apply sufficient tension
to a prolapsing leaflet, including the anterior leaflet and/or the
posterior leaflet of the mitral valve, in order to overcome mitral
regurgitation.
[0004] 2. Description of the Related Art
[0005] The human heart is a four chambered pump that moves blood
efficiently through the vascular system. During normal operation,
blood enters the heart through the vena cava and flows into the
right atrium. Thereafter, blood flows from the right atrium through
the tricuspid valve and into the right ventricle. Upon contraction
of the right ventricle, blood is forced through the pulmonic valve
and into the lungs for oxygenation. The oxygenated blood returns
from the lungs and enters the heart through the left atrium and
passes through the mitral valve into the left ventricle. Upon
contraction of the left ventricle the blood therein flows through
the aortic valve and into the aorta and throughout the vascular
system.
[0006] The mitral valve is disposed in flow regulating
communication between the left atrium and the left ventricle. It is
composed of two valve leaflets, the mitral valve annulus, which
forms a ring that supports the valve leaflets; papillary muscles,
which tether the valve leaflets to the left ventricle wall, by
preventing them from prolapsing back into the left atrium. Chordae
tendineae serve to connect the mitral valve leaflets to the
papillary muscles thereby further preventing the leaflets from
prolapsing back into the left atrium. A dysfunction of any of these
components of the mitral valve can cause "mitral regurgitation".
Mitral regurgitation is a disorder of the heart in which the mitral
valve does not close properly when the heart pumps out blood. This
abnormal leaking of blood from the left ventricle, through the
mitral valve and, into the left atrium when the left ventricle
contracts, results in the "regurgitation" of blood back into the
left atrium. It is generally recognized in the medical profession
that mitral regurgitation is the second most common form of
valvular heart disease.
[0007] As generally set forth above, when properly functioning, the
anterior and posterior valve leaflets of the mitral valve overlap
during contraction of the left ventricle and prevent blood from
flowing back into the left atrium. This overlap of the 2 leaflets
leaning upon each other is called the coaptation and absorbs most
of the strain on the mitral apparatus during the ventricular
contraction. However, when the mitral valve malfunctions, due to
various cardiac diseases, the leaflets are no longer coapting
resulting in the mitral valve remaining partially open during
ventricular contraction. In turn this allows the "regurgitation" of
the blood back into the left atrium, as generally set forth above.
When the mitral valve does not close hermetically during the
ventricular contraction, the aforementioned back flow of blood to
the atrium and the pulmonary vasculature, results in a deleterious
condition. More specifically, this condition increases the work
load to the heart and may lead to heart failure.
[0008] Methods of treating conditions relating to the
malfunctioning of the heart valve specifically including valve
incompetencies, mitral valve leakage and other heart failure
conditions may be in various stages of development such as the
extending of an elongate member transverse across a corresponding
or affected heart chamber. Each end of the elongate member extends
through a wall of the heart such as the septum wall and an
oppositely disposed wall portion, wherein first and second
anchoring members are connected to corresponding ends of the
elongate member but are disposed external of the heart chamber.
Connecting clips or the like are applied to the corresponding
exterior ends of the elongate member, resulting in the papillary
muscles within the chamber to be effectively repositioned. A
predetermined force is applied to the heart itself and/or the
affected portions of the heart chamber.
[0009] Other specific treatments associated with mitral
regurgitation sometimes may include the replacement of the mitral
valve, resulting in traumatic and frequently dangerous surgical
procedures being performed on a patient.
[0010] Accordingly, there is a need in the medical arts for
appropriate instrumentation and attendant methods of overcoming
heart valve malfunctions, specifically including mitral
regurgitation.
SUMMARY OF THE INVENTION
[0011] The present invention is directed to an instrument assembly
and attendant method for treating heart valve malfunction. In more
specific terms, the instrumentation and method are specifically,
but not exclusively, adapted for the treatment of mitral
regurgitation. However, for purposes of clarity and in order to
emphasize the versatility of the various embodiments of the present
invention, the subject instrument assembly and method will be
described generically regarding treatment of a predetermined heart
valve. In addition, the present invention will be more specifically
described in regard to a procedure involving correction of a
prolapsing mitral valve leaflet, which may include the anterior
mitral valve leaflet and/or the posterior valve leaflet correcting
of mitral regurgitation.
[0012] Accordingly, the instrument assembly of the present
invention includes an introductory sheath formed of a material of
sufficient rigidity to facilitate the penetration and passage
through various portions of the heart and mitral valve. As such,
the introductory sheath may be said to be formed of at least a
"semi-rigid" material. However, this term is to be understood to
include material having sufficient flexibility to be manipulated or
"steered" through and/or along a predetermined path during the
delivery of the sheath and associated components of the instrument
assembly to predetermined portions of the heart. Moreover, in one
preferred embodiment the sheath will be sufficiently maneuverable
to pass through the atrial wall into interior portions of the heart
such as the left atrium and left ventricle. In addition and as
described in greater detail hereinafter, an introduction assembly
and a delivery catheter will be used to facilitate the positioning
the introductory sheath into the thoracic cavity and through the
atrial wall or other preferred exterior locations of the heart
wall.
[0013] Additional structural operative features of the instrument
assembly include the provision and utilization of at least one, or
under required circumstances, more than one elongated chord formed
of a biocompatible material and being at least partially flexible.
The material from which the chord is formed should have sufficient
and/or predetermined tensile strength to exert a predetermined
tension on the predetermined, prolapsing valve leaflet as the chord
extends between a corresponding portion of the heart wall, such as
the ventricular wall, as also more fully described hereinafter. The
chord is initially housed concentrically within the interior of the
introductory sheath, wherein the sheath and the chord are
concurrently movable relative to the heart as well as throughout a
portion of the interior thereof. As set forth above, the
introductory sheath is formed of a material having physical
characteristics that allow it to be accurately manipulated so as to
be steerable in such a manner that its tip can aim towards the
different designated portions of the anterior or posterior mitral
valve leaflets that are in the siege of the prolapse.
[0014] Also, the exteriorly concentric introductory sheath is
movable relative to and along the length of the chord so as to
accommodate proper and intended placement and anchoring of the
chord within the heart chamber. Therefore, the sheath is movable
with the chord into and through predetermined portions of the heart
chamber and movable relative to the chord after proper anchoring,
securing and/or intended placement of the chord within the heart
chamber. Accordingly, the instrument assembly of the present
invention also includes an anchor secured to an outer or distal end
of the chord. The anchor may also be sufficiently sharpened,
pointed or otherwise configured to penetrate an intended heart
valve leaflet, such as a prolapsing leaflet of the mitral valve.
Further, the penetration and passage of the anchor, the chord, and
the introductory sheath substantially through the predetermined
valve leaflet may thereby be facilitated.
[0015] When properly positioned, the anchor is structured to be
secured to a substantially opposing portion of the heart wall, such
as the ventricular wall associated with the left ventricle and/or
the papillary muscles associated therewith. In order to assure
secure anchoring of the distal end of the chord with the
corresponding ventricular wall, a gripping structure may be
operatively attached to a remainder of the anchor and disposable
into an outwardly and/or radially extending orientation. When so
disposed, the gripping structure, in combination with the remainder
of the anchor, eliminates or significantly restricts the
inadvertent detachment of the anchor, and the distal end of the
chord attached thereto, from the corresponding ventricular wall
portion. In at least one preferred embodiment of the present
invention, the anchor and the gripping structure are disposed and
applied so as to penetrate the corresponding portion of the
ventricular wall but not extend there through. Therefore, the
anchored relation of the gripping structure, anchor and the
connected distal end of the chord may be defined by a penetration
into the interior of the ventricular wall rather than a passage
completely there through. Complications associated with sealing and
exterior attachment of the chord to the exterior of the ventricular
wall are thereby eliminated.
[0016] As provided, the present invention further comprises a
method of treating heart and valve malfunction utilizing the
instrument as generally set forth above. Accordingly, the attendant
method comprises, at least in more generic terms, the passing of a
portion of the instrument assembly into an intended heart chamber
and into penetrating relation to a predetermined valve leaflet,
such as a prolapsing leaflet. The sheath, with the chord
concentrically disposed on the interior thereof, is passed through
the predetermined valve leaflet. Therefore, by virtue of the
enclosed disposition of the chord, the chord and sheath will
concurrently enter and extend through the predetermined valve
leaflet. By manipulation and the application of a positioning force
on the sheath, the sheath and the chord will extend across a
corresponding heart chamber and into an anchored relation with a
substantially opposing portion of the heart wall.
[0017] Once the anchor and the connected distal end of the chord
are secured to the opposing heart wall portion, the sheath, still
concentrically mounted exteriorly of and in enclosing relation to
the chord, is withdrawn from heart chamber in which the chord is
anchored. More specifically, the sheath is withdrawn by moving
relative to and back along the length of the anchored chord in a
direction away from the anchor and connected distal end of the
chord. The introductory sheath is further withdrawn back through
the predetermined valve leaflet while the proximal portion of the
chord remains within the valve leaflet. Once the sheath is disposed
exteriorly of the valve leaflet and possibly on the exterior of the
heart itself, a securing assembly is operatively disposed within
the heart chamber in interconnecting relation between a proximal
extremity of the chord and the predetermined valve leaflet.
[0018] In more specific terms, the securing assembly may include a
securing member, which will be mounted on or connected to a
proximal portion of the chord and moved along the length thereof
into a predetermined, interconnecting position relative to the
prolapsing valve leaflet. The position of the securing member will
be tailored to and disposed at the exact position needed to achieve
correction of the mitral regurgitation, which may be determined by
preoperative transoesopageal echography or other preoperative
manner, to quantify the occurring mitral regurgitation
preoperatively. The securing member then securely interconnects the
proximal extremity of the chord to the predetermined valve leaflet
and any excess length of the chord will be severed or detached from
the proximal extremity of the chord, which is secured to the
surface of the leaflet associated with the atrium. The chord is
thereby properly tensioned between the opposing, interior
corresponding wall portion of the heart and the predetermined valve
leaflet so as to overcome the malfunction of the predetermined
valve leaflet as explained in more specific details
hereinafter.
[0019] As emphasized throughout this description, the instrument
assembly and attendant method of the present invention is
specifically adapted for the treatment of mitral regurgitation. As
such, the introductory sheath and the chord, substantially
concurrently enter the atrial wall of the left atrium and pass into
the interior thereof. Further, the sheath and the chord penetrate
and are passed, substantially concurrently, through a prolapsing
(flail) anterior or posterior leaflet of the mitral valve into the
left ventricle of the heart chamber. Thereafter the sheath and
chord are concurrently extended transversely across the left
ventricle, wherein the anchor penetrates and is thereby secured in
an anchored relation with a substantially opposing portion of the
ventricular wall and/or corresponding papillary muscles. The distal
end of the chord is connected to the anchor and is thereby secured
in an anchored relation to the ventricular wall, by virtue of the
penetrating anchor.
[0020] Once the distal end of the chord and anchor are in the
anchored relation to the ventricular wall, the sheath is withdrawn
back along the length of the chord, away from the anchor and the
ventricular wall to which the distal portion of the chord is
secured. Moreover, the introductory sheath continues to travel back
along the length of the chord through the prolapsing anterior or
posterior mitral valve leaflet to a location at least exterior to
the leaflet, such as within the left atrium and possibly exteriorly
of the heart itself.
[0021] A securing assembly is then operatively associated with the
instrument and is movably disposed along the length of a proximal
portion of the chord. In even more specific terms, the movement of
the securing assembly and its associated securing member are
disposed into an interconnecting position between a proximal
extremity of the chord and the mitral valve leaflet penetrated by
the chord. As indicated above, proper tensioning is thereby placed
on the prolapsing mitral valve leaflet in order to restore a
sufficient surface of coaptation between its counterpart, opposing
leaflet and maintain the suppressed leaflet in an operative
position sufficient to overcome the mitral regurgitation.
[0022] These and other objects, features and advantages of the
present invention will become clearer when the drawings as well as
the detailed description are taken into consideration.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] For a fuller understanding of the nature of the present
invention, reference should be had to the following detailed
description taken in connection with the accompanying drawings in
which:
[0024] FIG. 1 is a perspective view of one preferred embodiment of
the instrument assembly of the present invention used in the
treatment of heart valve malfunction.
[0025] FIG. 1A is a perspective view of the instrument assembly of
the embodiment of FIG. 1 in an initially introductory position.
[0026] FIGS. 2 through 9 are schematic representations of
successive steps in the attendant method of utilizing and applying
the instrument assembly of the embodiment of FIGS. 1 and 1A
specifically for the treatment and correction of mitral
regurgitation.
[0027] Like reference numerals refer to like parts throughout the
several views of the drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0028] As represented in the accompanying drawings and with
specific reference to FIGS. 1 and 1A, the instrument assembly of
the present invention is schematically and generally indicated as
10 and is used for the treatment of heart valve malfunction
generally and more specifically for the treatment of mitral
regurgitation. As such, the instrument assembly 10 includes an
elongated delivery catheter or tube 12 having a hollow interior and
structured to deliver operative portions of the instrument assembly
10 to the treatment site within the heart of a patient. As such,
the elongated delivery catheter or tube 12 is dimensioned and
configured to enter the chest cavity through appropriate
introduction instrumentation. The delivery tube 12 is formed of a
material and/or includes positioning structure or linkage
incorporated therein which facilitates the maneuvering or steering
thereof to a point at least generally exterior the heart and more
specifically the atrial wall of the left atrium. However, the at
least semi-rigid material of the delivery tube 12 should be
sufficient to also facilitate proper manipulation so as to position
or "steer" the remainder of the instrument assembly 10 to the
intended location within the interior thereof, as well as
facilitate penetration of and anchoring to intended tissue
portions.
[0029] The instrument assembly 10 also includes an introductory
sheath 14 movable within the delivery tube 12 and an elongated
flexible material chord 16. The introductory sheath 14 is
concentrically and movably enclosed within the delivery tube 12 and
the sheath 14 is movably disposed concentrically about the chord
16. It is emphasized that FIG. 1 represents a completely assembled
instrument assembly 10. However, as will be described in detail
with the schematic representations of FIGS. 1 through 9, the
various portions of the instrument assembly 10 are used in
successive steps to accomplish installation relative to the
affected portions of the heart valve being treated.
[0030] Accordingly, the instrument assembly 10 further includes the
elongated flexible material chord 16 which may be formed of a
synthetic, biocompatible material. An anchor 18 is fixedly secured
to the outer or distal end of the chord 16 and is movable therewith
relative to the introductory sheath 14. As clearly represented in
FIG. 1A chord 16 is at least initially enclosed concentrically
within the interior of the introductory sheath 14, wherein the
sheath 14 is movable along the length of the chord 16. Further, the
sheath includes an open distal end 14' serving to at least
partially encloses or be registered alignment with the anchor 18.
Therefore, FIG. 1A represents cooperative portions of the
instrument assembly 10 at least upon initial entry of the
introductory sheath 14 and anchor 18 into the interior of the heart
30, as specifically described in detail in FIGS. 2 through 9,
hereinafter described.
[0031] Therefore, with further regard to FIG. 1A, the positioning
of the anchor 18, the introductory sheath 14 and the chord 16 is
such that the chord 16 is disposed within the interior of the
introductory sheath 14. Further, the anchor 18 is disposed at least
partially within and/or in an exposed relation to the open distal
end 14' of the sheath 14. In addition, the anchor 18 has a
sharpened, pointed or other appropriate configuration for
penetrating portions of the heart. The anchor 18 may also include a
gripping structure 20 which may be initially disposed in a
collapsed position when the anchor 18 is in registry with the
distal opening 14' of the sheath 14. However, upon removal or
exposure of the anchor 18 and a length of the chord 16 from an
interior of the sheath 14, the gripping structure 20 may include an
inherent bias causing it to expand outwardly and/or radially from
the remainder of the anchor 18. This gripping structure 20 is
provided to facilitate a secure engagement of the anchor 18 with
predetermined heart wall portions, when the instrument assembly 10
is properly applied in the treatment of the heart valve
malfunction.
[0032] With further reference to FIG. 1 the assembled
representation of the instrument assembly 10 further includes the
provision of a securing member 22 which may travel along the length
of the chord 16. The securing member may be forcibly positioned
into an intended interconnecting location relative to a heart valve
leaflet in order to accomplish a secure attachment of the chord 16
to the leaflet as will be explained in greater detail hereinafter.
Such an interconnecting placement of the securing member 22
relative to both the chord 16 and the affected valve leaflet serves
to establish and maintain a sufficient tension and/or positioning
force on the predetermined valve leaflet to suppress movement
thereof, as explained hereinafter with regard to FIGS. 2 through
9.
[0033] As schematically represented in FIGS. 2 through 9, the heart
is generally indicated as 30 and includes the representative
portions including the left atrium 32, the left ventricle 34 and
the mitral valve 36, including the anterior and posterior mitral
valve leaflets 38 and 38', respectively. As additionally
represented, the left ventricle 34 is at least partially bordered
or surrounded by ventricular wall 40 which may be directly
associated with corresponding papillary muscles (not shown)
facilitating the proper positioning of the mitral valve leaflets 38
and 38' through organic tissue tethering, as generally outlined
above.
[0034] For purposes of clarity, FIGS. 2-9 schematically represent
the instrument assembly 10 used on the anterior leaflet 38 of the
mitral valve 30 in order to treat and correct mitral regurgitation.
However, it is emphasized the instrument assembly 10 and the
attendant method of the present invention may be applied to an
anterior and/or the posterior prolapsing leaflet in the manner
described herein, in correcting a mitral regurgitation condition of
the heart. Moreover, while the various embodiments of the present
invention are described using a single chord 16, a plurality of
chords 16 may be used with the cooperative instrument components of
the instrument assembly 10.
[0035] With initial reference to FIGS. 2 and 3, the instrument
assembly 10 is introduced into the interior of the heart 30 and
more specifically into the left atrium 32, through the atrium wall
33, using an appropriate introduction assembly 42. Therefore, the
introductory sheath 14 and the chord 16 located concentrically
within the sheath 14 will concurrently pass through the atrial wall
33 of the heart into the left atrium 32, as it is directed towards
the anterior leaflet 38 of the mitral valve 36. It should be
further noted that the anchor 18 is at least initially in the
position generally represented in FIG. 1A. Due to its predetermined
configuration the anchor 18 will serve to approach and penetrate
the anterior leaflet 38 of the mitral valve 36 as clearly
represented in FIG. 3.
[0036] In addition, the penetration of the anterior leaflet 38
initially by the anchor 18 will facilitate the penetration and
passage, substantially concurrently, of the chord 16 and the
introductory sheath 14 through the anterior leaflet 38 as
schematically represented. As further represented in FIG. 3, a
continued force will be applied to the introductory sheath 14
causing the sheath 14 and interiorly disposed chord 16, as well as
the anchor 18 to continue concurrent passage through the anterior
valve leaflet 38 until the anchor 18 reaches, penetrates and is
secured to the ventricular wall 40 and/or correspondingly disposed
papillary muscles associated therewith.
[0037] As best represented in FIGS. 4 and 5, once the anchor 18 is
secured to the ventricular wall 40 and/or the corresponding
papillary muscles, the distal end of the chord 16 will be affixed
to the ventricular wall 40 and remain in place as the introductory
sheath 14 is withdrawn back along the length of the chord 16, as
indicated by the directional arrows. As the introductory sheath 14
is withdrawn back along the length of the chord 16, the
aforementioned gripping structure 20 will have been expanded into a
gripping orientation. When the gripping structure 20 is so
oriented, the anchor 18 and the distal end of the chord 16
connected thereto will be reliably anchored or connected to the
ventricular wall 40. Continued withdrawal of the introductory
sheath 14 will result in its passage back through the initially
penetrated and suppressed mitral valve leaflet 38, as clearly
represented in FIG. 5. As such, the majority of the length of the
chord 16 will thereby be exposed and maintained in the represented
position within the left ventricle and between the ventricular wall
40 and the penetrated (suppressed) leaflet 38, while the
introductory sheath 14 passes back through the introduction
assembly 42 and out of the interior of the left atrium 32, through
the atrium wall 33. Therefore, the proximal portion 16' of the
chord 16 remains in place, within the left atrium 32, and may serve
effectively as a guide or otherwise facilitate the placement of the
securing member 22, as represented in FIGS. 6 through 9.
[0038] More specifically, once the introductory sheath 14 is
removed from the left atrium 32, through the introduction assembly
42, the securing assembly, including securing member 22, will move
along the length of the chord 16 as it is introduced into the left
atrium 32 such as through the atrium wall via, the introduction
assembly 42. As schematically represented, the securing member 22
will be forced, moved, positioned, etc. along the proximal portion
or length 16' of the chord 16 by any appropriate technique and/or
appropriate positioning instrument/device, which may be
incorporated or operatively associated with the chord 16.
Positioning of the securing member 22 will continue until it is
disposed in engaging, interconnecting and at least partially
protective or sealing engagement with an exterior surface portion
of the suppressed anterior mitral valve leaflet 38 located within
the left atrium 32. The position of the securing member 22 will be
disposed in the exact position, on and along the length of the
chord 16 needed to position and or suppress movement of the leaflet
38 to achieve correction of the mitral regurgitation. Such exact
positioning may be determined by preoperative transoesopageal
echography or other preoperative manner to quantify online mitral
regurgitation preoperatively.
[0039] With further regard to the positioning of the securing
member 22 into the interconnecting relation between the proximal
extremity of chord 16 and the anterior leaflet 38. One embodiment
may also include a guiding element or sleeve 25, as represented in
FIG. 1. When utilized, the element 25 will be disposed at a
predetermined position along the length on the artificial chord 16
and be mounted concentrically about and/or along a portion of the
chord 16. As applied, the guiding element 25 may assume and or be
at least partially defined by a variety of different structures,
devices and/or mechanisms other than, but possibly including, the
schematically represented sleeve. Accordingly, the guiding element
is operative to accurately center or otherwise dispose the securing
member 22 in sealing and/or covering relation to the aperture or
area where the chord 16 remains in its extended position through
the anterior leaflet 38. Further, the securing member 22 securely
connects the proximal extremity 16'' of the chord 16 to the valve
leaflet 38 and any excess length of the proximal portion 16' of the
chord 16 will be severed or detached from the extremity 16'' of the
chord 16 and the securing member 22, which interconnects the
proximal extremity 16'' to the "exterior" surface of the leaflet 38
exposed to the left atrium 32.
[0040] With continued reference to FIGS. 5 through 8, manipulation
of the instrument of the assembly 10, such as by medical personnel
manipulating the delivery catheter 12 causes a severing of the
proximal extremity from a remainder of the chord 16. As a result,
the securing member 22 serves to securely connect and fasten the
chord 16 to the exterior of the anterior leaflet 38, disposed
within the left atrium 32. Upon a secure connection of the securing
member 22 to the exterior side or surface of the anterior leaflet
38, the introductory sheath 14 passes back through the introduction
assembly 42 so as to exit the left atrium 32 and the remainder of
the heart. Thereafter, the introduction assembly 42 is also removed
from its initial operative position.
[0041] Therefore, as represented in FIG. 9 the heart 30 is
represented with the synthetic chord 16 properly anchored between
the ventricular wall 40 and the penetrated anterior leaflet 38. In
this position, proper tensioning or positioning forces are applied
to the anterior leaflet 38 causing it to be positioned in a manner
which effectively overcomes mitral regurgitation, as set forth
above.
[0042] Since many modifications, variations and changes in detail
can be made to the described preferred embodiment of the invention,
it is intended that all matters in the foregoing description and
shown in the accompanying drawings be interpreted as illustrative
and not in a limiting sense. Thus, the scope of the invention
should be determined by the appended claims and their legal
equivalents.
[0043] Now that the invention has been described,
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