U.S. patent application number 12/560404 was filed with the patent office on 2010-04-22 for tools, systems, and methods for remodeling tissue.
Invention is credited to Donnell W. Gurskis.
Application Number | 20100100174 12/560404 |
Document ID | / |
Family ID | 42005831 |
Filed Date | 2010-04-22 |
United States Patent
Application |
20100100174 |
Kind Code |
A1 |
Gurskis; Donnell W. |
April 22, 2010 |
TOOLS, SYSTEMS, AND METHODS FOR REMODELING TISSUE
Abstract
A tool for remodeling a tissue annulus includes an elongate
handle and a reshaping element on a distal end of the handle. The
reshaping element may be directable between a first configuration
to facilitate direction through a tissue annulus, and a second
curved configuration to remodel tissue adjacent the tissue annulus.
The tool may be used for treating a tissue annulus within a
patient's heart, e.g., by introducing the reshaping element through
the tissue annulus, and manipulating the tool to reshape the tissue
annulus substantially to a contour of the reshaping element. The
reshaping element may support the tissue while a prosthesis is
secured to the tissue annulus, or the reshaping element may itself
be secured to the tissue annulus and released from the tool.
Inventors: |
Gurskis; Donnell W.;
(US) |
Correspondence
Address: |
Vista IP Law Group LLP
2040 MAIN STREET, 9TH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
42005831 |
Appl. No.: |
12/560404 |
Filed: |
September 15, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61097193 |
Sep 15, 2008 |
|
|
|
Current U.S.
Class: |
623/2.11 |
Current CPC
Class: |
A61F 2250/001 20130101;
A61B 2017/00783 20130101; A61F 2/2445 20130101; A61F 2/2427
20130101; A61F 2/2466 20130101 |
Class at
Publication: |
623/2.11 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1-10. (canceled)
11. A tool for treating a tissue annulus, comprising: an elongate
handle including a proximal end and a distal end; and a reshaping
element on the distal end terminating in a distal tip and having a
shape to remodel tissue adjacent a tissue annulus.
12. The tool of claim 11, wherein the distal tip has an atraumatic
shape.
13. The tool of claim 1, wherein the reshaping element is
directable between a first configuration to facilitate direction
through a tissue annulus, and a second curved configuration to
remodel tissue adjacent the tissue annulus.
14. The tool of claim 13, wherein the reshaping element defines a
portion of a circle in the second configuration.
15. The tool of claim 13, further comprising an actuator on the
proximal end of the handle coupled to the reshaping element for
directing the reshaping element between the first and second
configurations.
16. The tool of claim 15, further comprising an actuator member
extending from the proximal end of the handle to the distal tip,
the actuator coupled to the actuator member for pulling the
actuator member to cause the reshaping element to be directed from
the first configuration to the second configuration.
17. The tool of claim 16, wherein the reshaping element comprises a
plurality of segments defining a passage, the actuator member
received through the passage and fixed to the distal tip such that
pulling the actuator member causes the plurality of segments to
compress to direct the reshaping element from the first
configuration to the second configuration.
18. The tool of claim 17, wherein the plurality of segments
comprise at least one of cylinders, balls, and coil segments.
19. The tool of claim 13, wherein the reshaping element is flexible
in the first configuration to facilitate introduction through a
tissue annulus.
20. The tool of claim 11, wherein the reshaping element is
releasable from the handle.
21. The tool of claim 20, wherein the reshaping element is at least
partially covered with fabric.
22. The tool of claim 20, further comprising an actuator on the
proximal end of the handle for releasing the reshaping element from
the handle.
23. A system for treating a tissue annulus, comprising: a tool
comprising an elongate handle including a proximal end, a distal
end, and a reshaping element extending from the distal end and
terminating in a distal tip, the reshaping element having a shape
to remodel tissue adjacent a tissue annulus; and a plurality of
fasteners receivable through tissue adjacent the tissue
annulus.
24. The system of claim 23, further comprising a tool for
delivering the fasteners into tissue adjacent the tissue
annulus.
25. (canceled)
26. The system of claim 24, wherein the fasteners are configured
for securing the reshaping element on the tool to tissue adjacent
the tissue annulus, and wherein the reshaping element is releasable
from the handle.
27. The system of claim 23, further comprising a prosthesis
configured for supporting the tissue annulus, the fasteners being
receivable through the prosthesis for securing the prosthesis to
tissue adjacent the tissue annulus.
28. The system of claim 27, wherein the prosthesis has at least one
of an annular shape and a "C" shape.
29. The system of claim 23, wherein the reshaping element is
directable between a first configuration to facilitate direction
through a tissue annulus, and a second curved configuration to
remodel tissue adjacent the tissue annulus.
30. The system of claim 29, further comprising: an actuator on the
proximal end of the handle coupled to the reshaping element for
directing the reshaping element between the first and second
configurations; and an actuator member extending from the proximal
end of the handle to the distal tip, the actuator coupled to the
actuator member for pulling the actuator member to cause the
reshaping element to be directed from the first configuration to
the second configuration.
31. A method for treating a tissue annulus within a patient's
heart, comprising: introducing a distal end of a remodeling tool
through the tissue annulus; and reshaping the tissue annulus
substantially to a contour of the tool distal end.
32-37. (canceled)
Description
RELATED APPLICATION DATA
[0001] This application claims benefit of co-pending provisional
application Ser. No. 61/097,193, filed Sep. 15, 2008, the entire
disclosure of which is expressly incorporated by reference
herein.
FIELD OF THE INVENTION
[0002] The present invention relates generally to tools, systems,
and methods for remodeling tissue, for example, for reshaping,
remodeling, or otherwise treating a tissue annulus, such as the
mitral valve annulus.
BACKGROUND
[0003] Mitral valve repair generally involves introducing a
prosthesis, e.g., using sutures, clips, and/or other fasteners, to
secure and/or reshape the mitral annulus. The tools, systems, and
methods disclosed herein may be used to temporarily or permanently
reshape a tissue annulus, such as the mitral annulus.
SUMMARY
[0004] The present invention is directed to tools, systems, and
methods for remodeling tissue, for example, for reshaping,
remodeling, or otherwise treating a tissue annulus, such as the
mitral valve annulus.
[0005] In accordance with one embodiment, a tool is provided for
treating a tissue annulus that includes an elongate handle
including a proximal end and a distal end; and a reshaping element
on the distal end terminating in a distal tip and having a shape to
remodel tissue adjacent a tissue annulus.
[0006] In one embodiment, the reshaping element is directable
between a first configuration to facilitate direction through a
tissue annulus, and a second curved configuration to remodel tissue
adjacent the tissue annulus. In the second configuration, the
reshaping element may define a portion of a circle, e.g., an arc
having an angle less than ninety degrees. Alternatively, the
reshaping element may have a more complicated curvilinear shape in
the second configuration.
[0007] An actuator may be provided on the proximal end of the
handle, e.g., coupled to the reshaping element for directing the
reshaping element between the first and second configurations. In
addition or alternatively, the actuator may allow the reshaping
element to be released from the handle of the tool. For example, an
actuator member may extend from the proximal end of the handle to
the distal tip, and the actuator may be coupled to the actuator
member for pulling or otherwise actuating the actuator member to
cause the reshaping element to be directed from the first
configuration to the second configuration.
[0008] In another embodiment, the reshaping element may be
releasable from the handle, e.g., to provide an implant for
supporting tissue adjacent a tissue annulus. In this embodiment,
the reshaping element may be at least partially covered with
fabric.
[0009] In accordance with another embodiment, a system is provided
for treating a tissue annulus that includes one or more tools, each
tool comprising an elongate handle including a proximal end and a
distal end, and a reshaping element on the distal end terminating
in a distal tip and having a shape to remodel tissue adjacent a
tissue annulus. In addition, the system may include a plurality of
fasteners receivable through tissue adjacent the tissue annulus, a
tool for delivering fasteners into tissue adjacent the tissue
annulus, and/or a prosthesis.
[0010] For example, the fasteners may be clips, such as elastic or
superelastic clips that are provided initially in a relaxed
configuration in which legs of the clips cross. During delivery,
the clips may be directed to a constrained configuration, e.g., in
which the legs are directed to a "U" shaped configuration, the legs
may be directed through tissue surrounding the annulus, and the
clip released, whereupon the clips resiliently return towards the
relaxed configuration. Alternatively, the fasteners may include
sutures, e.g., including needles on one or both ends for inserting
the sutures through and/or tying the sutures to tissue, e.g., to
secure a prosthesis relative to the tissue.
[0011] In one embodiment, the fasteners may be sized, shaped,
and/or otherwise configured for securing the reshaping element on
the tool to tissue adjacent the tissue annulus, and the reshaping
element may be releasable from the handle.
[0012] In another embodiment, a prosthesis may be provided that is
configured for supporting the tissue annulus, and fasteners may be
receivable through the prosthesis for securing the prosthesis to
tissue adjacent the tissue annulus. In exemplary embodiments, the
prosthesis may have an annular shape, a "C" shape, or other shapes,
e.g., to provide an annuloplasty ring for treating a mitral
valve.
[0013] In accordance with still another embodiment, a method is
provided for treating a tissue annulus within a patient's heart
that includes introducing a distal end of a remodeling tool through
the tissue annulus, and reshaping the tissue annulus substantially
to a contour of the tool distal end.
[0014] In one embodiment, the tool distal end may be introduced
through the tissue annulus in a first configuration, the tool
distal end may be directed to a second curved configuration below
the tissue annulus, and tissue adjacent the tissue annulus may be
lifted, supported, or otherwise remodeled using the tool distal end
in the second curved configuration.
[0015] Optionally, a prosthesis may be introduced into the
patient's heart adjacent the tissue annulus, and secured to tissue
adjacent the tissue annulus. Once the prosthesis is secured to the
tissue, the tool distal end may be removed from the tissue annulus.
The tool distal end may have a shape corresponding to the shape of
the prosthesis to support tissue adjacent the tissue annulus while
fasteners are delivered to secure the prosthesis to tissue adjacent
the tissue annulus.
[0016] In another option, the tool distal end may be secured to
tissue adjacent the tissue annulus, and then released from a handle
of the tool such that the tool distal end provides a reshaping or
support element that may remain implanted at the tissue annulus
site indefinitely.
[0017] Other aspects and features of the present invention will
become apparent from consideration of the following description
taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The drawings illustrate exemplary embodiments of the
invention, in which:
[0019] FIG. 1 is a perspective view of an exemplary embodiment of a
tool for remodeling tissue including a movable reshaping element
directed to a curved configuration.
[0020] FIG. 1A is a side view of the tool of FIG. 1.
[0021] FIG. 2 is a perspective view of a pair of tools including
curved reshaping elements on distal ends thereof.
[0022] FIG. 3 is a perspective view of another exemplary embodiment
of a tool for remodeling tissue including an actuator on a proximal
end thereof for changing a shape of a reshaping element on a distal
end thereof.
[0023] FIG. 4A is a perspective view of a handle of yet another
exemplary embodiment of a tool and a first exemplary embodiment of
a reshaping element that may be releasably attached to the
handle.
[0024] FIG. 4B is a perspective view of a second exemplary
embodiment of a reshaping element that may be releasably attached
to the handle of FIG. 4A.
[0025] FIG. 4B1 is a detail of the reshaping element of FIG. 4B,
showing connectors on the reshaping element for releasably
attaching the reshaping element to the handle of FIG. 4A.
[0026] FIG. 4C is a perspective view of a third exemplary
embodiment of a reshaping element that may be releasably attached
to the handle of FIG. 4A.
[0027] FIG. 4C1 is a detail of the reshaping element of FIG. 4C,
showing a connector on the reshaping element for releasably
attaching the reshaping element to the handle of FIG. 4A.
[0028] FIG. 5 is a perspective view of a portion of a patient's
heart showing a tool remodeling tissue adjacent a mitral
annulus.
[0029] FIGS. 6-8 are perspective views of a patient's heart showing
a method for treating a mitral valve annulus that includes
remodeling tissue adjacent the valve annulus using a tool and
delivering fasteners through a prosthesis into tissue adjacent the
valve annulus to secure the prosthesis to the tissue while a tool
remodels the tissue.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0030] Turning to the drawings, FIG. 1 shows an exemplary
embodiment of a tool 10 for remodeling tissue that generally
includes an elongate handle 12 and a reshaping element 20 having a
shape to remodel tissue adjacent a tissue annulus, such as a mitral
valve annulus (not shown). Generally, the handle 12 is a
substantially rigid elongate member, e.g., a solid or hollow shaft,
including a proximal end 14 and a distal end 16 from which the
reshaping element 20 extends. The handle 12 may have a length
sufficient to introduce the reshaping element 20 into a target
tissue region, e.g., a tissue annulus, from outside the patient's
body, e.g., between about ten and forty centimeters (10-40 cm) or
between about ten and twenty centimeters (10-20 cm).
[0031] Optionally, the handle 12 may include one or more features
to facilitate manipulation of the tool 10 during use. For example,
as shown in FIG. 1, the handle 12 may include knurling 13, ridges,
or other raised or recessed features (not shown) along all or a
portion of the handle 12 to facilitate gripping the tool 10 and
reduce the risk of the handle 12 slipping, e.g., if exposed to
blood or other fluids. In addition or alternatively, the handle 12
may include an enlarged handpiece (not shown) on the proximal end
14, e.g., having an ergonomic or other shape to facilitate gripping
the tool 10 and/or including one or more actuators (also not shown)
for manipulating features on the tool 10 (e.g., as described
further below).
[0032] As shown in FIG. 1, the reshaping element 20 is integrally
formed with the handle 12, e.g., extending from the distal end 16
and terminating in a distal tip 22 of the tool 10. For example, the
handle 12 and reshaping element 20 may be integrally formed by
machining from stock material using a lathe or other equipment,
casting, injection molding, extruding, and the like. The tool 10
may be formed from metal, such as stainless steel, aluminum,
titanium, and the like, plastic, or composite material having
properties to provide a substantially rigid handle 12 and malleable
(or alternatively substantially fixed) reshaping element 20. If
desired, the material of the handle 12 and/or reshaping element 20
may be treated, e.g., to soften the material of the reshaping
element 20 relative to the handle 12 to allow the reshaping element
20 to be plastically curved or otherwise shaped as desired.
[0033] Alternatively, as shown in FIG. 2, the handle 12'' and
reshaping element 20'' may be formed separately and attached
together, e.g., by interference fit, bonding with adhesive,
cooperating connectors, and the like. In this alternative, the
handle 12'' and reshaping element 20'' may be formed from different
materials having desired rigidity and/or malleability. For example,
the handle 12'' may be formed from metal or plastic, while the
reshaping element 20'' may be formed from malleable metal.
Optionally, in this alternative, a shaft portion 21'' of the
reshaping element 20'' may be relatively rigid compared to the
portion extending to the distal tip 22," e.g., such that the shaft
portion 21'' does not bend substantially when the reshaping element
20'' is shaped or otherwise manipulated during use.
[0034] As shown in FIG. 1, the distal tip 22 may have rounded,
atraumatic shape, e.g., to facilitate introducing the reshaping
element 20 between tissue structures within a patient's body, such
as between valve leaflets, chordae tendinae, and the like (not
shown). Optionally, as shown in FIG. 2, the reshaping element 20'
may include a relatively large, e.g., bulbous, distal tip 22' to
further prevent risk of puncturing or otherwise damaging tissue
during use of the tool 10.' The bulbous distal tip 22' may also
facilitate manipulating tissue during use of the tool 10.'
[0035] Returning to FIG. 1, the reshaping element 20 may be
malleable or otherwise plastically deformable, e.g., such that the
reshaping element 20 may be manipulated into a desired shape that
will be retained after such manipulation to provide a desired shape
during use. Thus, a user may modify the shape of the reshaping
element 20 based upon the anatomy encountered and/or to correspond
to a shape of a prosthesis to be introduced into a tissue annulus.
For example, as shown in FIG. 1, the handle 12 may have a larger
diameter (or other cross-section) than the reshaping element 20,
e.g., such that the handle 12 is substantially rigid while the
reshaping element 20 is bendable. In an exemplary embodiment, the
handle 12 may have a diameter (or other maximum cross-section)
between about 0.5 and two centimeters (0.5-2.0 cm), while the
reshaping element 20 may have a diameter (or other maximum
cross-section) between about one and five millimeters (1.0-5.0
mm).
[0036] Alternatively, the reshaping element 20 may have a
substantially fixed shape, e.g., defining a predetermined arc or
other curvilinear shape. For example, as shown in FIG. 1A, the
reshaping element 20 may curve within a plane "P" that intersects a
longitudinal axis 18 of the handle 12, e.g., defining an angle "A"
between the axis 18 and plane "P." In exemplary embodiments, the
angle "A" may be between about ten and ninety degrees
(10-90.degree., e.g., between about thirty and sixty degrees
(30-60.degree., and the like. The reshaping element 20 may define
an arc having a substantially fixed radius of curvature "R," as
shown in FIG. 1, e.g., extending around an angle less than ninety
degrees (90.degree., e.g., between about forty five and ninety
degrees (45-90.degree.. Alternatively, the reshaping element may
have a varying radius of curvature along its length and/or more
complicated curvilinear shape than a simple arc, if desired, based
on the anatomy encountered. The length of the reshaping element 20
may be sufficient to define an arc length extending partially
around a tissue annulus, e.g., having a length between about twenty
and forty millimeters (20-40 mm).
[0037] In this alternative where the reshaping element 20 has a
substantially fixed shape, it may be desirable to provide a set of
tools, with each tool including one or more of a different angle
"A," radius of curvature, arc length, and the like than the others.
Thus, a user may select an appropriate tool from the set based on
the particular anatomy encountered during a procedure. The tools
may be intended for single use, or may be reusable, e.g., such that
the tool(s) may be sterilized after use and used during a
subsequent procedure on another patient.
[0038] Turning to FIG. 5, the tool 10 of FIG. 1 is shown placed
through a mitral valve annulus 90 of a heart, e.g., between
leaflets 92 and/or around other valve structures, such as the
chordae tendinae 96 and the ventricular wall 94. The tool 10 may be
introduced into a patient's body using a sternotomy, thoracotomy,
port, or other access method to gain access to the valve annulus 90
being treated, e.g., under direct visualization. The distal tip 22
may be passed through the leaflets 92 and the reshaping element 20
may be threaded behind the leaflets 92 and chordae tendinae 96, as
shown in FIG. 5. The handle 12 may then be manipulated, e.g., to
lift or otherwise reshape the tissue of the valve annulus 90 for
treatment. If the reshaping element 20 is malleable, at any time,
the shape may be changed based on the anatomy encountered. Thus, if
the reshaping element 20 is introduced into the valve annulus 90
but does not provide a desired remodeled shape, the tool 10 may be
removed, the reshaping element 20 adjusted and the tool
reintroduced. Alternatively, if the reshaping element 20 is
substantially fixed, the tool 10 may be removed and another tool
with a different, desired reshaping element (not shown) may be
introduced instead and used to remodel the tissue.
[0039] In an exemplary method, shown in FIGS. 6-8, the tool 10 (or
set of tools) may be provided in a kit or system, e.g., including
one or more additional components. For example, as shown in FIGS. 7
and 8, a kit or system for treating a valve annulus may include one
or more tools 10 (one shown), a fastener tool 40 for delivering a
plurality of clips or other fasteners (not shown), and a prosthesis
50, such as an annuloplasty ring. Optionally, the kit or system may
also include one or more forceps, sutures, needles, and the
like.
[0040] Initially, as shown in FIG. 6, the reshaping element 22 of
tool 10 may be introduced through the tissue annulus 90, i.e.,
through the valve leaflets 92 and below the tissue surrounding the
tissue annulus 90, e.g., as described above with reference to FIG.
5. Optionally, one tool may be introduced to support each of the
existing valve leaflets (not shown). For example, as shown in FIG.
2, a first tool 10' may include a reshaping element 20' that curves
in a clockwise direction (viewed from the proximal end) and a
second tool 10'' may include a reshaping element 20'' that curves
in a counterclockwise direction. Thus, each reshaping element 20',
20'' may be introduced through the tissue annulus 90 and placed
under respective leaflets. The tool(s) may be manipulated to
support and/or remodel the tissue surrounding the tissue annulus
90, e.g., to correspond to the shape and/or facilitate apposition
of a prosthesis 50 intended for implantation within the tissue
annulus 90.
[0041] As shown in FIG. 7, a prosthesis 50 has been introduced into
the heart and positioned against or otherwise adjacent the tissue
annulus 90. In an exemplary embodiment, the prosthesis 50 may be an
annuloplasty ring including an annular core covered by fabric that
has sufficient structure to support the tissue annulus 90 while
accommodating beating of the heart and the opening and closing of
the leaflets. For example, the prosthesis 50 may include a core
biased to a predetermined shape yet sufficiently flexible to
accommodate normal movement of the leaflets. The prosthesis 50 may
be "parachuted" over one or more sutures 52 or otherwise introduced
into the tissue annulus 90 using known methods.
[0042] Also as shown in FIG. 7, a fastener tool may be used to
deliver a plurality of clips or other fasteners through the
prosthesis 50 and underlying tissue to substantially secure the
prosthesis 50 to the tissue annulus 50, as shown in FIG. 8.
Exemplary fasteners and tools that may be used are disclosed in
applications Ser. No. 10/681,700, filed Oct. 8, 2003, issued as
U.S. Pat. No. 7,556,647; Ser. No. 11/004,445, filed Dec. 3, 2004,
published as U.S. Publication No. 2006/0122634; and Ser. No.
12/115,543, filed May 5, 2008, published as U.S. Publication No.
2009/0036903. The entire disclosures of these references are
expressly incorporated herein by reference. Alternatively, sutures
or other fasteners (not shown) may be used to secure the prosthesis
50, e.g., in addition to or instead of clips.
[0043] If the tool has a substantially fixed reshaping element, the
curved shape of the reshaping element may correspond to the
predetermined shape of the prosthesis 50, e.g., to present the
tissue for apposition against the prosthesis 50 while the fasteners
are delivered. Alternatively, the reshaping element may be bent or
otherwise manipulated to provide support for the tissue when the
prosthesis 50 is pressed against the tissue and/or while fasteners
are delivered through the prosthesis 50 into the adjacent
tissue.
[0044] Once the prosthesis 50 is secured to the tissue, the
reshaping element 20 may be removed from the tissue annulus 90 and
the tool(s) 10 removed from the patient's body, leaving the
prosthesis 50 as shown in FIG. 8. As shown in FIG. 8, the
prosthesis 50 is an enclosed annular member. It will be appreciated
that other prostheses, e.g., defining a "C" or other curved shape
(not shown), may be provided that correspond to a tissue region to
be supported.
[0045] Turning to FIG. 3, another exemplary embodiment of a
remodeling tool 110 is shown that includes a handle 112 including a
proximal end 114, a distal end 116, and a reshaping element 120
extending from the distal end 116 and terminating in a distal tip
122, e.g., a bulbous and/or rounded distal tip 122, similar to the
previous embodiments. The handle 112 may be a substantially rigid
elongate member, e.g., a hollow shaft, including a lumen or other
passage 115 extending between the proximal and distal ends 114, 116
for receiving a core member 132, as described further below. The
handle 112 may have a length sufficient to introduce the reshaping
element 120 into a target tissue region, e.g., a tissue annulus,
from outside the patient's body similar to the previous
embodiments.
[0046] Optionally, the handle 112 may include one or more features
to facilitate manipulation of the tool 110 during use. For example,
the handle 112 may include knurling, ridges, and/or other raised or
recessed features (not shown) along all or a portion of the handle
112 to facilitate gripping the tool 110. In addition or
alternatively, the handle 112 may include an enlarged handpiece
(not shown) on the proximal end 114, e.g., having an ergonomic or
other shape to facilitate gripping the tool 110.
[0047] As shown in FIG. 3, an actuator 130 may be provided on the
proximal end 114 of the handle 112 coupled to the reshaping element
120, e.g., for directing the reshaping element between different
shapes or configurations. For example, the actuator 130 may be a
wheel coupled to the core member 132 extending from the actuator
130 to the reshaping element 120, which may be rotated to pull,
twist, or otherwise direct the core member 132 axially within the
handle 112, as described further below. Alternatively, other
actuators, e.g., dials, slider buttons, and the like (not shown)
may be provided on a handpiece or otherwise on the proximal end 114
of the handle 112 for controlling the shape of the reshaping
element 120.
[0048] With continued reference to FIG. 3, the reshaping element
120 may be directable between a first configuration, e.g., to
facilitate direction through a tissue annulus, and a second
configuration, e.g., to remodel tissue adjacent the tissue annulus.
For example, the reshaping element 120 may include plurality of
segments 124, e.g., cylinders, balls, coil segments, and the like,
including respective passages therethrough that are aligned with
one another to generally define an actuator passage 126 extending
along the reshaping element 120. The core member 132, e.g., a solid
or hollow wire, cable, and the like, may be slidably received in
the actuator passage 126, e.g., such that the core member 132
extends from the actuator 130 on the proximal end 114 of the handle
112, through the lumen 115 of the handle 112 and the actuator
passage 126 to the distal tip 122 of the reshaping element 120. The
core member 132 may be fixed or otherwise coupled to the distal tip
122, e.g., by interference fit, bonding with adhesive, fusing,
cooperating connectors (not shown), and the like.
[0049] In this configuration, the actuator 130 may be manipulated
to direct the core member 132 axially relative to the distal tip
122, e.g., to direct the reshaping element 120 between a relaxed,
first configuration (shown in phantom in FIG. 3) and a curved,
second configuration. For example, initially, the actuator 130 may
be provided in a first position in which the core member 132 is not
subjected to a proximal force or substantial stress. Thus, the
segments 124 of the reshaping element 120 may be relaxed and free
to move somewhat relative to one another. In this relaxed
configuration, the reshaping element 120 may be relative soft and
flexible, which may facilitate introduction through a valve annulus
without substantial risk of puncture or otherwise damaging leaflets
or other tissue within the valve annulus.
[0050] When the actuator 130 is manipulated to direct the core
member 132 proximally, a compressive force may be applied to the
reshaping element 120, causing the segments 124 to engage one
another. The shape and/or spacing of the segments 124 may be
selected such that this engagement causes the reshaping element 120
to curve into a predetermined shape, e.g., a curvilinear shape
defining a predetermined radius of curvature and/or arc length,
similar to the previous embodiments. For example, end surfaces of
the segments 124 may be non-orthogonal to a longitudinal axis of
the reshaping element 120. For example, the end surfaces of
adjacent segments 124 may be beveled or rounded such that, when the
segments are compressed together, the end surfaces cause the
segments 124 to rotate and/or align axially relative to one another
to adopt a curvilinear shape. The angles defined by the end
surfaces may extend laterally relative to the longitudinal axis,
e.g., between forty five and ninety degrees (45-90.degree., or
between sixty and eighty degrees (60-80.degree., to define a
desired radius of curvature for the reshaping element 120. The
angles of the end surfaces may be the same as one another to
provide a uniform radius of curvature or may vary to provide a
variable radius of curvature.
[0051] Optionally, the actuator 130 may be directed to two or more
tensioned positions in which the reshaping element 120 is directed
to different curved shapes, e.g., including a first larger radius
curved configuration and a second smaller radius curved
configuration, if desired, to provide multiple shapes with a single
tool 110. Alternatively, similar to the previous embodiments,
different tools may be provided that may be directed between
relaxed configurations and curved configurations having different
shapes such that an appropriate tool may be selected based on the
anatomy encountered during a particular procedure.
[0052] Optionally, the reshaping element 120 may be biased to one
of the relaxed or curved configurations. For example, a spring or
other biasing element (not shown) may be provided within the handle
112 and/or actuator 130 for biasing the core member 132 to extend
distally, thereby biasing the reshaping element 120 to the relaxed
configuration. The actuator 130 may be selectively activated to
pull the core member 132, thereby compressing the segments 124 and
thereby directing the reshaping element 120 to the curved
configuration. If desired, the actuator 130 may include a lock or
other mechanism (not shown) that may be selectively activated to
temporarily secure the reshaping element 120 in the curved
configuration.
[0053] Alternatively, the tool 110 may be configured in an opposite
manner. For example, the actuator 130 may be biased to pull the
core member 132 and direct the reshaping element 120 to the curved
configuration, with the actuator 130 activatable to push the core
member 132 distally and thereby direct the reshaping element 120 to
the relaxed configuration. Optionally, the actuator 130 may include
a lock to temporarily secure the reshaping element 120 in the
relaxed configuration, if desired.
[0054] The tool 110 of FIG. 3 may be used similar to the previous
embodiments, e.g., to remodel tissue within a mitral valve annulus
or other tissue annulus, e.g., during an annuloplasty procedure.
For example, with reference to the anatomy shown in FIG. 5, with
the reshaping element 120 in its relaxed configuration (shown in
phantom in FIG. 3), the tool 110 may be introduced into a patient's
body until the reshaping element 120 passes through the tissue
annulus 90 and behind leaflets 92. The distal tip 122 may
facilitate directing the reshaping element 120 through the leaflets
92 without substantial risk of damaging the leaflets 92 or other
tissue structures.
[0055] The actuator 130 may then be activated to direct the
reshaping element 120 to its curved configuration, e.g., extending
between mitral valve structures and the ventricular wall 94. The
tool 110 may then be manipulated to lift or otherwise manipulate
tissue within valve annulus 90 while a prosthesis is introduced and
secured to the valve annulus 90, such as the prosthesis 50 shown in
FIGS. 7-8. After the prosthesis has been secured, the reshaping
element 120 may be returned to its relaxed configuration, and the
tool 110 removed from the patient's body.
[0056] Turning to FIG. 4A, another exemplary embodiment of a tool
210 for remodeling tissue is shown that includes an elongate handle
212 and a reshaping element 220, which may be generally similar to
the previous embodiments. However, unlike the previous embodiments,
the reshaping element 220 is detachable or releasable from the
handle 212, e.g., to provide an implant for supporting or otherwise
treating a tissue annulus.
[0057] Generally, similar to the previous embodiments, the handle
212 is a substantially rigid elongate member, e.g., a hollow shaft,
including a proximal end 214 and a distal end 216, and having a
length sufficient to introduce the reshaping element 220 into a
target tissue region, e.g., a valve or other tissue annulus, from
outside the patient's body. Unlike the previous embodiments, one or
more connectors 217 may be provided on the distal end 216 for
releasably engaging the reshaping element 220. One or more
actuators 230 may be provided on the proximal end 214 of the handle
212, e.g., to engage or release the connector(s) 217, for example,
to secure or release the reshaping element 220 relative to the
handle 212 and/or to direct the reshaping element 220 between
different shapes or configurations, as described further below.
[0058] For example, in the embodiment shown in FIG. 4A, the
reshaping element 220 includes a substantially rigid or malleable
shaft 224, e.g., similar to the reshaping elements 20, 20', 20''
shown in FIGS. 1 and 2 and described further elsewhere herein. As
shown, the reshaping element 220 includes a bulbous and/or
atraumatic distal tip 222 on one end and one or more connectors 228
on the opposite end.
[0059] Optionally, if the reshaping element 220 is intended for
implantation, a fabric covering 226 may be provided over at least a
portion of the shaft 224, e.g., to facilitate tissue ingrowth
and/or enhance biocompatibility of the reshaping element 220. For
example, the fabric covering 226 may extend from connectors 228 to
the distal tip 222, either of which may be covered with fabric or
exposed, as desired. In addition or alternatively, the shaft 224
may be formed from biocompatible material, e.g., including a
thrombolytic or other coating, if desired.
[0060] In an exemplary embodiment, the connector(s) 217 on the
handle 212 may include one or more collets or graspers and the
connector(s) 228 on the reshaping element 220 may include a lip or
other feature that may be selectively captured or engaged by the
grasper(s). In this embodiment, the actuator 230 may include a
dial, button, or other feature that may be depressed or otherwise
activated to open the graspers, e.g., to release or receive the lip
on the reshaping element 220. When the button is released, the
graspers may be biased to a closed position, thereby engaging the
lip and securing the reshaping element 220 relative to the handle
212. Alternatively, the connectors 217, 228 may simply be mating
threads that may be engaged together or disengaged from one another
by rotating the handle 212 relative to the reshaping element 220.
In a further alternative, the connector(s) 217 may be carried by a
core member (not shown) extending through the handle 212 that is
coupled to the actuator 230 such that the core member may be
manipulated to engage or disengage the connector(s) 217 with mating
connector(s) 228 on the reshaping element 220.
[0061] Optionally, a plurality of reshaping elements (not shown)
may be provided having different shapes and/or sizes. During use, a
reshaping element having a desired configuration, such as reshaping
element 220, may be selected and attached to the handle 212 using
the connectors 217, 228. A set of reshaping elements may be useful
if each reshaping element has a substantially fixed shape or is
malleable to provide greater flexibility to a user.
[0062] During use (with reference again to the anatomy shown in
FIG. 5), a desired reshaping element 220 may be secured to the
handle 212 to provide a tool 210. The tool 210 may be introduced
into a patient's body, e.g., by directing the distal tip 222 and
the reshaping element 220 through and behind valve leaflets 92 of a
mitral valve annulus 90. The tool 210 may then be manipulated to
lift or otherwise remodel tissue surrounding the valve annulus 90,
similar to the previous embodiments. One or more fasteners, e.g.,
clips and/or sutures, as described above, may be directed through
the tissue and through at least a portion of the reshaping element
220, e.g., to secure the reshaping element 220 relative to the
valve annulus 90. For example, a plurality of fasteners may be
directed through the fabric covering 226 of the reshaping element
220 and/or around the shaft 224 along the length of the reshaping
element 220 to secure the reshaping element 220 to the adjacent
tissue.
[0063] Once the reshaping element 220 is sufficiently secured, the
actuator 230 may be activated to release the reshaping element 220
from the handle 212, whereupon the handle 212 may be removed,
leaving the reshaping element 220 indefinitely within the valve
annulus 90 as an implant to support the valve annulus 90, similar
to an annuloplasty ring. Optionally, one or more additional
reshaping elements (not shown) may be introduced and secured to the
valve annulus 90, e.g., one under each of the valve leaflets 92, in
a similar manner, if desired.
[0064] Turning to FIGS. 4B and 4B1, an alternative embodiment of a
detachable reshaping element 320 is shown that includes one or more
connectors 328 for releasably attaching the reshaping element 320
to a handle, such as handle 212 shown in FIG. 4A. In addition, the
reshaping element 320 is adjustable between one or more shapes,
e.g., between a relaxed, first configuration and a curved, second
configuration, which may be similar to the reshaping element 120 of
the tool 110 of FIG. 3. For example, as shown in FIG. 4B, the
reshaping element 320 includes a plurality of segments 324, e.g.,
cylinders, balls, coil segments, and the like, that are slidably
received over a core member 332, e.g., a solid or hollow wire, rod,
and the like. The core member 332 may be fixed or otherwise coupled
on one end to a distal tip 322 of the reshaping element 320 and may
include a connector 328b on the other end that cooperates with a
locking element 328a.
[0065] Optionally, the reshaping element 320 may include a fabric
covering (not shown) at least partially covering the segments 324
and/or core member 332. For example, a layer of fabric may be
provided over the entire reshaping element 320, e.g., from the
distal tip 322 to the locking element 328a, with the connector 328b
extending from the fabric covering.
[0066] In this embodiment (with reference generally to the handle
212 shown in FIG. 4A), the handle 212 may include one or more
connectors 217 on the distal end 216 that may releasably engage the
connector 328b and/or the locking element 328a. For example, the
actuator 230 may be coupled to a shaft or other actuator member
(not shown) that extends from the proximal end 214 to the distal
end 216 of the handle 12. The actuator member may include a
connector 217, e.g., a grasper, threads, and the like, that may
selectively engage the connector 328b on the core member 332 of the
reshaping element 320.
[0067] For example, during use, the reshaping element 320 may be
attached to the handle 212, e.g. by engaging the connector 328b on
the core member 332 to the connector 217 on the handle 212. Thus,
the core member 332 in the reshaping element 320 may be coupled to
the actuator member within the handle 212, thereby coupling the
core member 332 to the actuator 230. With the reshaping element 320
attached to the handle 212, the locking element 328a may abut or be
disposed immediately adjacent the distal end 216 of the handle 212,
e.g., to prevent excessive movement of the reshaping element 320
relative to the handle 212. Alternatively, the locking element 328a
and/or distal end 216 of the handle 212 may include one or more
connectors (not shown) for securing the locking element 328a
directly to the distal end 216 of the handle 212.
[0068] Thus, with the connectors 217, 328b engaged, the segments
324 of the reshaping element 320 may be free to move, e.g., thereby
providing the reshaping element 320 in a floppy or relaxed
configuration, which may facilitate introduction into a tissue
annulus, similar to the previous embodiments. In addition or
alternatively, when the connectors 217, 328b are engaged, the
actuator 230 may apply a minimal proximal tension on the core
member 332, thereby pulling the segments 324 proximally to abut one
another to prevent excessive movement of the reshaping element 320
without causing the reshaping element to adopt a fixed, rigid
shape.
[0069] Once the reshaping element 320 is introduced into a tissue
annulus or otherwise positioned as desired, the actuator 230 on the
handle 212 may be activated to direct the actuator member
proximally. The actuator member consequently pulls the core member
332 within the reshaping element 320, thereby causing the segments
326 to compress against one another and direct the reshaping
element 320 to a curved, relatively rigid configuration. The
locking element 328a may prevent the core member 332 from
subsequently moving distally to release the reshaping element 320
from the curved configuration. For example, the locking element
328a may include one or more internal ratchets or other detents
(not shown) that may engage the core member 332 adjacent the
connector 328a. Thus, the tension applied to the core member 332 by
the actuator 230 may be indefinitely stored in the core member 332
to secure the reshaping element 320 in the curved configuration.
Alternatively, the locking element 328a may include internal
threads or other features (not shown) that may cooperate with
mating threads or other features (also not shown) on the core
member 332 adjacent the connector 328b. These features may allow
tension to be applied to the core member 332, e.g., by rotating the
core member 332 in a first direction relative to the locking
element 328a, yet allow the tension to be released if desired,
e.g., by rotating the core member 332 in a second opposite
direction. In this alternative, the core member 332 may be fixed
axially relative to the distal tip 322 of the reshaping element 320
but rotatable relative to the distal tip 322.
[0070] Once sufficient tension is applied to the core member 332 to
direct the reshaping element 320 to the curved configuration, the
reshaping element 320 may be manipulated within the tissue annulus
and/or secured to tissue adjacent to the tissue annulus, e.g.,
using one or more fasteners, similar to the previous embodiments.
The reshaping element 320 may then be released from the handle 212,
e.g., by manipulating the actuator 230 to disengage the connectors
217, 328b. The handle 212 may then be removed, leaving the
reshaping element 320 implanted within the tissue annulus.
Optionally, if desired, after implantation, the reshaping element
320 may be accessed, e.g., to adjust the shape of the reshaping
element 320. The connector 328b may be reengaged and then the core
member 332 may be directed axially relative to the locking element
328a, e.g., to adjust the radius and/or shape of the reshaping
element 320.
[0071] Turning to FIGS. 4C and 4C1, another exemplary embodiment of
an adjustable, detachable, and/or implantable reshaping element 420
is shown. Similar to the previous embodiments, the reshaping
element 420 includes one or more connectors 428 for releasably
attaching the reshaping element 420 to a handle, such as handle 212
shown in FIG. 4A. The reshaping element 420 includes a roll of
fabric 426 that extends between a distal tip 422 and a locking
element 428a of the reshaping element 420. Optionally, a core,
shaft or other elongate member (not shown) may be provided within
the fabric roll 426, e.g., to provide a desired shape and/or
stiffness to the fabric roll 426. Alternatively, a fabric covering
may be provided around a core member having a desired rigidity to
provide an adjustable reshaping element.
[0072] In addition, the reshaping element 420 includes an actuator
member 432, e.g., a solid or hollow wire, rod, suture, and the
like, that is coupled on one end to the distal tip 422 of the
reshaping element 420 and to the locking element 428a. For example,
the locking element 428a may include a passage (not shown)
therethrough that includes one or more ratchets, detents, threads,
and/or other features, similar to the previous embodiment, that
allow the actuator member 432 to be pulled proximally through the
locking element 428a, yet prevent undesired subsequent distal
movement, to maintain an applied tension on the actuator member
432.
[0073] The actuator member 432 may also be slidably secured to the
fabric roll 426 at one or more locations between the distal tip 422
and locking element 428a. For example, during assembly, the
actuator member 432 may be directed through the fabric roll 426 to
pick up one or more threads of the fabric roll 426 at a plurality
of intermediate locations between the distal tip 422 and locking
element 428a. Alternatively, if the reshaping element 420 includes
a core member within the fabric roll 426, the actuator member 432
may be slidably received in one or more pockets, apertures, or
passages (not shown) in the core member such that actuator member
432 is free to slide axially relative to the core member.
[0074] The actuator member 432 may include one or more connectors
(not shown) adjacent the locking element 428a, e.g., for releasably
attaching the reshaping element 420 to a handle, e.g., that may be
engaged with the connector(s) 217 on the handle 212 shown in FIG.
4A. Alternatively, the actuator member 432 may extend through a
passage in the handle 212 and be coupled to the actuator 230 during
manufacturing and/or assembly. In this alternative, when it is
desired to release the reshaping element 420 from the handle 212,
the actuator member 432 may be cut, severed, or broken at a
location beyond the locking element 428a.
[0075] During use, the reshaping element 420 may be attached to the
handle 212, e.g. by engaging a connector (not shown) on the
actuator member 432 to the connector 217 on the handle 212 or by
coupling the actuator member 432 directly between the actuator 230
on the handle 212 and the distal tip 422, e.g., during assembly.
Thus, the actuator member 432 of the reshaping element 420 may be
coupled to the actuator 230 on the handle 212. With the reshaping
element 420 attached to the handle 212, the locking element 428a
may abut or be disposed immediately adjacent the distal end 216 of
the handle 212, e.g., to prevent excessive movement of the
reshaping element 420 relative to the handle 212. Alternatively,
the locking element 428a and/or distal end 216 of the handle 212
may include one or more connectors (not shown) for securing the
locking element 428a directly to the distal end 216 of the handle
212.
[0076] Thus, with the reshaping element 420 attached to the handle
212, the distal tip 422 may be free to move, e.g., thereby
providing the reshaping element 420 in a floppy or relaxed
configuration, which may facilitate introduction into a tissue
annulus, similar to the previous embodiments.
[0077] Once the reshaping element 420 is introduced into a tissue
annulus or otherwise positioned as desired, the actuator 230 on the
handle 212 may be activated to direct the actuator member 432
proximally. Because the actuator member 432 is attached to outer
surface of the fabric roll 426, the tension on the actuator member
432 causes the fabric roll 426 to bend into a curved configuration,
as shown in FIG. 4C. The locking element 428a may prevent the
actuator member 432 from subsequently moving distally to release
the reshaping element 420 from the curved configuration. Thus, the
tension applied to the actuator member 432 by the actuator 230 may
be indefinitely stored in the actuator member 432 to maintain the
reshaping element 420 in the curved configuration. Alternatively,
the locking element 428a may include internal threads or other
features (not shown) that may cooperate with mating threads or
other features (also not shown) on the actuator member 432. These
features may allow tension to be applied to and/or released from
the actuator member 432, similar to the previous embodiments.
[0078] Once sufficient tension is applied to the actuator member
432 to direct the reshaping element 420 to the curved
configuration, the reshaping element 420 may be manipulated within
the tissue annulus and/or secured to tissue adjacent to the tissue
annulus, e.g., using one or more fasteners, similar to the previous
embodiments. The reshaping element 420 may then be released from
the handle 212, e.g., by manipulating the actuator 230 to disengage
the connector(s) 217. Alternatively, if the actuator member 432 is
coupled directly to the actuator 230, the actuator member 432 may
be cut or otherwise severed adjacent the locking element 428a. For
example, the handle 212 may include a release button to allow
excess length of the actuator member 432 to be exposed and cut.
Alternatively, the actuator member 432 may include a weakened
region, e.g., within the handle 212 or otherwise adjacent the
locking element 428a that may be severed by applying a
predetermined axial tension on the actuator member 432 greater than
the tension applied to direct the reshaping element 420 to the
curved configuration. The handle 212 (and any excess actuator
member length) may then be removed, leaving the reshaping element
420 implanted within the tissue annulus.
[0079] It will be appreciated that elements or components shown
with any embodiment herein are exemplary for the specific
embodiment and may be used on or in combination with other
embodiments disclosed herein.
[0080] While the invention is susceptible to various modifications,
and alternative forms, specific examples thereof have been shown in
the drawings and are herein described in detail. It should be
understood, however, that the invention is not to be limited to the
particular forms or methods disclosed, but to the contrary, the
invention is to cover all modifications, equivalents and
alternatives falling within the scope of the appended claims.
* * * * *