U.S. patent application number 15/423408 was filed with the patent office on 2019-07-04 for mitral valve inversion prostheses.
The applicant listed for this patent is MILLIPEDE, INC. Invention is credited to Randall Lashinski.
Application Number | 20190201197 15/423408 |
Document ID | / |
Family ID | 58719505 |
Filed Date | 2019-07-04 |
![](/patent/app/20190201197/US20190201197A9-20190704-D00000.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00001.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00002.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00003.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00004.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00005.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00006.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00007.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00008.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00009.png)
![](/patent/app/20190201197/US20190201197A9-20190704-D00010.png)
View All Diagrams
United States Patent
Application |
20190201197 |
Kind Code |
A9 |
Lashinski; Randall |
July 4, 2019 |
MITRAL VALVE INVERSION PROSTHESES
Abstract
Systems, devices and methods for resizing a valve annulus are
described. An implant is delivered proximate a mitral valve, the
implant comprising a tubular body and a plurality of piercing
helical anchors, the tubular body comprising an proximal diameter
and a distal diameter. Tissue proximate the mitral valve is engaged
by rotating the plurality of anchors with corresponding rotational
drivers. The tubular body may be transitioned from a first
structural configuration having the proximal diameter smaller than
the distal diameter to a second structural configuration having the
proximal diameter larger than the distal diameter.
Inventors: |
Lashinski; Randall;
(Windsor, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MILLIPEDE, INC |
Santa Rosa |
CA |
US |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20170143488 A1 |
May 25, 2017 |
|
|
Family ID: |
58719505 |
Appl. No.: |
15/423408 |
Filed: |
February 2, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14427909 |
Mar 12, 2015 |
9610156 |
|
|
PCT/US2013/059751 |
Sep 13, 2013 |
|
|
|
15423408 |
|
|
|
|
61700989 |
Sep 14, 2012 |
|
|
|
62291347 |
Feb 4, 2016 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2427 20130101;
A61F 2220/0016 20130101; A61F 2/2466 20130101; A61F 2/2442
20130101; A61F 2/2445 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A method for reshaping a heart valve annulus, the method
comprising: positioning a distal end of a delivery catheter in an
atrium of a heart, the delivery catheter including a plurality of
rotatable drivers and an implant for reshaping the heart valve
annulus, the implant comprising a tubular body and a plurality of
helical anchors, the tubular body comprising a proximal diameter
and a distal diameter, and the helical anchors coupled with the
distal diameter and configured to be advanced distally therefrom;
deploying the implant from the delivery catheter to a location
proximate the heart valve annulus in the atrium; rotating the
plurality of helical anchors with the plurality of rotatable
drivers to advance the plurality of helical anchors distally
relative to the tubular body and toward the heart valve annulus;
engaging the heart valve annulus with the plurality of helical
anchors to anchor the implant to the heart valve annulus; and
transitioning the tubular body from a first structural
configuration to a second structural configuration, the first
structural configuration having the proximal diameter smaller than
the distal diameter and the second structural configuration having
the proximal diameter larger than the distal diameter, thereby
reshaping the heart valve annulus.
2. The method of claim 1, wherein transitioning the tubular body
from the first structural configuration to the second structural
configuration comprises applying an expansive force to the tubular
body proximate the proximal diameter.
3. The method of claim 2, wherein the implant further comprises an
expandable tubular member coupled with the proximal diameter of the
tubular body, and wherein applying the expansive force to the
tubular body proximate the proximal diameter comprises applying the
expansive force to the expandable member.
4. The method of claim 1, further comprising: inserting and
positioning a location ring proximate the heart valve within a
ventricle of the heart opposite the atrium; and visualizing the
location ring to assist with positioning the implant.
5. The method of claim 4, further comprising removing the location
ring from the heart.
6. The method of claim 4, further comprising coupling at least one
of the helical anchors with the location ring by extending the at
least one of the helical anchors through the heart valve annulus to
connect the at least one of the helical anchors with the location
ring.
7. The method of claim 1, further comprising advancing the
plurality of helical anchors distally through a series of holes
formed in distal apices of the distal diameter of the tubular
body.
8. The method of claim 1, wherein the atrium is the left atrium and
the heart valve annulus is the mitral valve annulus.
9. A method for reshaping a heart valve annulus, the method
comprising: positioning an implant at a location proximate the
heart valve annulus in an atrium, the implant comprising a tubular
body and a plurality of rotatable piercing members, the tubular
body comprising a proximal diameter and a distal diameter, and the
piercing members coupled with a plurality of rotatable drivers and
with the distal diameter and configured to be advanced distally
therefrom; rotating the plurality of piercing members with the
plurality of rotatable drivers to advance the plurality of piercing
members distally relative to the tubular body and toward the heart
valve annulus; engaging the plurality of piercing members with the
heart valve annulus to anchor the implant to the heart valve
annulus; and transitioning the tubular body from a first structural
configuration to a second structural configuration, the first
structural configuration having the proximal diameter smaller than
the distal diameter and the second structural configuration having
the proximal diameter larger than the distal diameter, thereby
reshaping the heart valve annulus.
10. The method of claim 9, further comprising applying vibration to
at least one of the plurality of piercing members.
11. The method of claim 9, further comprising applying vibration to
tissue proximate the heart valve.
12. The method of claim 11, wherein the step of applying vibration
comprises applying vibration to tissue proximate the heart valve on
a same side of the heart valve as the implant.
13. The method of claim 11, wherein the step of applying vibration
comprises applying vibration to tissue proximate the heart valve on
a side of the heart valve opposite the implant.
14. The method of claim 9, wherein transitioning the tubular body
from the first structural configuration to the second structural
configuration comprises applying an expansive force to the tubular
body proximate the proximal diameter.
15. The method of claim 9, further comprising: inserting and
positioning a location ring proximate the heart valve within a
ventricle of the heart chamber; and visualizing the location ring
to assist with positioning the implant.
16. The method of claim 15, further comprising removing the
location ring from the heart.
17. The method of claim 15, further comprising coupling at least
one piercing member to the location ring by extending the piercing
member through the heart valve annulus to connect the piercing
member with the location ring.
18. The method of claim 9, wherein the plurality of piercing
members are helical anchors and the method further comprises
advancing the plurality of helical anchors distally through a
series of holes formed in distal apices of the distal diameter of
the tubular ring.
19. The method of claim 9, wherein the step of positioning the
implant comprises sliding a delivery catheter over a guide wire,
the delivery catheter including the implant and the plurality of
rotatable drivers.
20. The method of claim 9, wherein the atrium is the left atrium
and the heart valve annulus is the mitral valve annulus.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation-in-Part Application of
U.S. application Ser. No. 14/427,909, filed on Mar. 12, 2015, which
is a U.S. National Phase Application of PCT International
Application Number PCT/US2013/059751, filed on Sep. 13, 2013,
designating the United States of America and published in the
English language, which is an International Application of and
claims the benefit of priority to U.S. Provisional Application No.
61/700,989, filed on Sep. 14, 2012. Each of the above-referenced
applications are hereby expressly incorporated by reference in
their entireties for all purposes and form a part of this
specification. Any and all priority claims identified in the
Application Data Sheet, or any correction thereto, are hereby
incorporated by reference under 37 C.F.R. .sctn.1.57.
BACKGROUND
[0002] A. Field
[0003] This disclosure relates generally to cardiac treatment
devices and techniques, and in particular, to methods and devices
for repair of mitral valve defects such as mitral valve
regurgitation.
[0004] B. Background of Related Art
[0005] The mitral valve is one of four heart valves that direct
blood through the two sides of the heart. The mitral valve itself
consists of two leaflets, an anterior leaflet and a posterior
leaflet, each of which are passive in that the leaflets open and
close in response to pressure placed on the leaflets by the pumping
of the heart.
[0006] Among the problems that can develop or occur with respect to
the mitral valve is mitral valve regurgitation (MR), in which the
mitral valve leaflets become unable to close properly, thus causing
leakage of the mitral valve. Severe mitral regurgitation is a
serious problem that, if left untreated, can adversely affect
cardiac function and thus compromise a patient's quality of life
and life span.
[0007] Currently, mitral regurgitation is diagnosed by many
indicators, and the mechanism of mitral regurgitation can be
accurately visualized by trans-esophageal echocardiography or
fluoroscopy with dye injection. The most prevalent and widely
accepted current technique to correct mitral regurgitation is to
repair the mitral valve via open-heart surgery while a patient's
heart is stopped and the patient is on cardiopulmonary bypass, a
highly invasive procedure that has inherent risks.
SUMMARY
[0008] In one aspect, a method is described comprising inserting an
implant proximate a mitral valve, the implant comprising a tubular
body and a plurality of piercing members, the tubular body
comprising an upper (i.e. proximal) diameter and a lower (i.e.
distal) diameter. The method also includes engaging tissue
proximate the mitral valve by the plurality of piercing members and
transitioning the tubular body from a first structural
configuration to a second structural configuration by application
of an expansive force to the tubular body proximate the upper
diameter, the first structural configuration having the upper
diameter smaller than the lower diameter and the second structural
configuration having the upper diameter larger than the lower
diameter.
[0009] In another aspect, an implant is described comprising a
tubular body comprising an upper diameter and a lower diameter, the
tubular body having a first structural configuration in which the
upper diameter is smaller than the lower diameter and a second
structural configuration in which the upper diameter is larger than
the lower diameter, the tubular body configured to transition from
the first structural configuration to the second structural
configuration by application of an expansive force to the tubular
body proximate the upper diameter. The implant also comprises a
plurality of piercing members connected to the tubular body and
proximate the lower diameter to engage tissue proximate a mitral
valve.
[0010] In another aspect, a system is described comprising a guide
wire, a sheath over the guide wire, and an implant for delivery to
a body by traveling through the sheath and along the guide wire.
The implant comprises a tubular body comprising an upper diameter
and a lower diameter, the tubular body having a first structural
configuration in which the upper diameter is smaller than the lower
diameter and a second structural configuration in which the upper
diameter is larger than the lower diameter, the tubular body
configured to transition from the first structural configuration to
the second structural configuration by application of an expansive
force to the tubular body proximate the upper diameter. The implant
also comprises a plurality of barbs connected to the tubular body
and proximate the lower diameter to penetrate tissue proximate a
mitral valve.
[0011] In another aspect, a method for reshaping a heart valve
annulus is described. The method comprises positioning a distal end
of a delivery catheter in an atrium of a heart. The delivery
catheter includes a plurality of rotatable drivers and an implant
for reshaping the heart valve annulus, and the implant comprises a
tubular body and a plurality of helical anchors, with the tubular
body comprising a proximal diameter and a distal diameter. The
helical anchors are coupled with the distal diameter and configured
to be advanced distally therefrom. The method further comprises
deploying the implant from the delivery catheter to a location
proximate the heart valve annulus in the atrium. The method further
comprises rotating the plurality of helical anchors with the
plurality of rotatable drivers to advance the plurality of helical
anchors distally relative to the tubular body and toward the heart
valve annulus. The method further comprises engaging the heart
valve annulus with the plurality of helical anchors to anchor the
implant to the heart valve annulus, and transitioning the tubular
body from a first structural configuration to a second structural
configuration. The first structural configuration has the proximal
diameter smaller than the distal diameter and the second structural
configuration has the proximal diameter larger than the distal
diameter, thereby reshaping the heart valve annulus.
[0012] In some embodiments of the method, transitioning the tubular
body from the first structural configuration to the second
structural configuration comprises applying an expansive force to
the tubular body proximate the proximal diameter. The implant may
further comprise an expandable tubular member coupled with the
proximal diameter of the tubular body, and applying the expansive
force to the tubular body proximate the proximal diameter may
comprise applying the expansive force to the expandable member. The
method may further comprise inserting and positioning a location
ring proximate the heart valve within a ventricle of the heart
opposite the atrium, and visualizing the location ring to assist
with positioning the implant. The method may further comprise
removing the location ring from the heart. The method may further
comprise further comprising coupling at least one of the helical
anchors with the location ring by extending the at least one of the
helical anchors through the heart valve annulus to connect the at
least one of the helical anchors with the location ring. The method
may further comprise advancing the plurality of helical anchors
distally through a series of holes formed in distal apices of the
distal diameter of the tubular body. The atrium may be the left
atrium and the heart valve annulus may be the mitral valve
annulus.
[0013] In another aspect, a method for reshaping a heart valve
annulus is described. The method comprises positioning an implant
at a location proximate the heart valve annulus in an atrium. The
implant comprises a tubular body and a plurality of rotatable
piercing members, with the tubular body comprising a proximal
diameter and a distal diameter, and the piercing members are
coupled with a plurality of rotatable drivers and with the distal
diameter and configured to be advanced distally therefrom. The
method further comprises rotating the plurality of piercing members
with the plurality of rotatable drivers to advance the plurality of
piercing members distally relative to the tubular body and toward
the heart valve annulus. The method further comprises engaging the
plurality of piercing members with the heart valve annulus to
anchor the implant to the heart valve annulus. The method further
comprises transitioning the tubular body from a first structural
configuration to a second structural configuration. The first
structural configuration has the proximal diameter smaller than the
distal diameter and the second structural configuration has the
proximal diameter larger than the distal diameter, thereby
reshaping the heart valve annulus.
[0014] In some embodiments, the method may further comprise
applying vibration to at least one of the plurality of piercing
members. The method may further comprise applying vibration to
tissue proximate the heart valve. The step of applying vibration
may comprise applying vibration to tissue proximate the heart valve
on a same side of the heart valve as the implant. The step of
applying vibration may comprise applying vibration to tissue
proximate the heart valve on a side of the heart valve opposite the
implant. The method may comprise transitioning the tubular body
from the first structural configuration to the second structural
configuration by applying an expansive force to the tubular body
proximate the proximal diameter. The method may further comprise
inserting and positioning a location ring proximate the heart valve
within a ventricle of the heart chamber, and visualizing the
location ring to assist with positioning the implant. The method
may further comprise removing the location ring from the heart. The
method may further comprise coupling at least one piercing member
to the location ring by extending the piercing member through the
heart valve annulus to connect the piercing member with the
location ring. The plurality of piercing members may be helical
anchors and the method may further comprise advancing the plurality
of helical anchors distally through a series of holes formed in
distal apices of the distal diameter of the tubular ring. The step
of positioning the implant may comprise sliding a delivery catheter
over a guide wire, and the delivery catheter may include the
implant and the plurality of rotatable drivers. The atrium may be
the left atrium and the heart valve annulus may be the mitral valve
annulus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] For a more complete understanding of the present disclosure
and its features and advantages, reference is now made to the
following description, taken in conjunction with the accompanying
drawings, in which:
[0016] FIGS. 1A-1F illustrate an example embodiment of an implant
in accordance with the present disclosure;
[0017] FIGS. 2A-2D illustrate an alternative example embodiment of
an implant in accordance with the present disclosure;
[0018] FIGS. 3A-3B illustrate a further alternative example
embodiment of an implant in accordance with the present
disclosure;
[0019] FIGS. 4A-4B illustrate an additional example embodiment of
an implant in accordance with the present disclosure;
[0020] FIG. 5 illustrates examples of delivery routes of an
implant, in accordance with the present disclosure;
[0021] FIG. 6 illustrates an example embodiment of the present
disclosure utilizing vibrations, in accordance with the present
disclosure;
[0022] FIG. 7 illustrates an alternative example embodiment of the
present disclosure utilizing vibrations, in accordance with the
present disclosure; and
[0023] FIG. 8 illustrates an additional example embodiment of the
present disclosure utilizing vibrations, in accordance with the
present disclosure.
[0024] FIGS. 9A-9B are perspective views of other embodiments of
implants having rotatable helical anchors for securing the implants
to a valve annulus.
[0025] FIG. 10-12 are perspective views of another embodiment of an
implant, having an expandable tubular element, and configured to be
secured to a valve annulus with helical anchors.
[0026] FIG. 13 is a perspective view of an embodiment of a delivery
system shown delivering an embodiment of the implant of FIGS.
10-12.
[0027] FIG. 14 is a perspective view of an embodiment of a delivery
system shown delivering the implant of FIG. 9A.
[0028] FIGS. 15A-15D are sequential views of an embodiment of a
transcatheter delivery system for delivering the implant of FIG. 9A
showing an embodiment of a method for the delivery, positioning and
anchoring of the implant.
DETAILED DESCRIPTION
[0029] The present disclosure relates to an implant including a
tubular body and piercing members for reshaping a mitral valve
suffering from mitral regurgitation. The implant may include two or
more structural configurations. In a first structural
configuration, an upper, i.e. proximal, diameter (away from the
mitral valve) may be smaller than a lower, i.e. distal, diameter
(proximate the mitral valve). In this first structural
configuration, the piercing members of the implant may engage the
tissue proximate the mitral valve, for example, the mitral valve
annulus. The implant may then be transitioned from the first
structural configuration to a second structural configuration in
which the size of the upper diameter is larger than the lower
diameter. This may be facilitated by an expansive force causing the
upper diameter to expand, in turn causing the lower diameter to
contract. As the lower diameter contracts, the penetrating members
engaged with the tissue proximate the mitral valve may cause the
mitral valve to also contract to a smaller diameter. This may allow
the valve leaflets to close properly, addressing mitral
regurgitation.
[0030] FIGS. 1A-F illustrate one embodiment of an implant. For
example, as shown in FIG. 1A, in some embodiments, repair of a
mitral valve may be achieved by a catheter system and
catheterization procedure, wherein a catheter may be configured for
percutaneous access to the mitral valve through the left ventricle.
Access may be granted to the left ventricle through the apex of the
heart where an incision may be made to insert a dilator and sheath
150 for access of a repair catheter 140. Sheath 150 may measure
about six French to about thirty French and a closure device may be
used in conjunction with the entry of this access catheter 140.
[0031] In one embodiment of the present disclosure, catheter 140
may include an extendable guide wire assembly 160, which may guide
the system into position. Guide wire 160 may measure between 0.010
inches and 0.038 inches in diameter, and may be 0.035 inches in
diameter. Catheter 140 or sheath 150 when accessed through the apex
of the heart may measure about twenty to thirty centimeters in
length.
[0032] As shown in FIG. 1B, once access has been achieved, a
delivery system may be introduced through sheath 150 along guide
wire 160 with implant 110 for reducing the diameter of the mitral
valve annulus. Catheter 140 may deliver implant 110 to resize the
mitral valve to reduce the mitral valve cross sectional area or
move the posterior leaflet back into position limiting or reducing
mitral valve regurgitation.
[0033] Implant 110 may include a tubular body with portions of the
tube removed similar to a stent structure where a portion of the
material may be removed via laser cutting or other means to
selectively cut portions of the tube away forming a
radially-expandable tubular body. Implant 110 may be introduced in
a collapsed structural configuration. This collapsed structural
configuration may allow implant 110 to fit within sheath 150 to
allow for a percutaneous procedure rather than an open-heart
procedure. As shown in FIG. 1B, once implant 110 arrives in the
left atrium, implant 110 may be expanded to a larger first
structural configuration to engage tissue proximate the mitral
valve, for example, the mitral valve annulus. In one embodiment,
implant 110 may have a tubular shape with a free diameter of about
twenty five to about thirty five millimeters in diameter, a height
of about ten to about thirty millimeters, and a wall thickness of
between about 0.005 inches and about 0.040 inches. Implant 110 may
be constructed of a metallic material such as stainless steel,
MP35N alloy, Nitinol or other implantable material.
[0034] In some embodiments, implant 110 may be tapered such that
one end may be larger in diameter than the other end, appearing
generally frustoconical in shape. The diameters of the ends may be
approximately twenty five millimeters on the smaller end and
approximately thirty five millimeters on the larger end. Implant
110 may also be non-circular where a portion of the implant may be
elliptical or include a radial portion that is flat. This flat
portion may be oriented toward the aortic valve and the circular
portion may be positioned toward the posterior leaflet. To
facilitate discussion of implant 110, an upper portion and lower
portion may be described. The lower portion may refer to the end of
implant 110 proximate mitral valve 170 while the upper portion may
refer to the end of implant 110 free in the left atrium.
[0035] Implant 110 may include piercing members 115 proximate the
lower portion of implant 110 proximate mitral valve 170 to engage
with tissue proximate mitral valve 170, for example, the mitral
valve annulus. Piercing members 115 may include barbs or hooks
similar to fish hook barbs or other similar feature to resist
withdrawal from tissue once pierced. Piercing members 115, barbs or
hooks of the piercing members 115, or any combination thereof may
pierce the tissue to engage with the tissue. Piercing members 115
may include a singular barb or hook, or a plurality of barbs or
hooks per piercing member 115. Piercing members 115 may be
immediately exposed or covered for delivery. They may number from
one to fifty and may have a length of about four to twenty
millimeters in length. They may have the same wall thickness as a
wall of the tubular body of implant 110 or may differ with an
increased or decreased thickness or taper in either direction to
allow for mechanical integrity.
[0036] Piercing members 115 of implant 110 may be integral or
attached to implant 110 as a secondary component glued, welded, or
attached as an ancillary part. Piercing members 115 may also be
laser cut into implant 110, and therefore attached to implant 110.
The barbs or hooks may be fatigue resistant from fracture or
separation from piercing members 115. For example, the barbs or
hooks may have additional strength or wall thickness at the
connection to piercing members 115. The barbs or hooks may also be
attached with a hinged attachment allowing motion relative to the
heart, but not longitudinally where the barbs or hooks may separate
from piercing member 115.
[0037] The barbs or hooks of piercing member 115 may be active or
passive meaning that the barbs or hooks may be activated with heat
to bend or expose or mechanically formed through an external force
to bend or expose. For example, each barb or hook may be sheathed
inside a tube and removal of this tube may allow the barb or hook
to be activated by, for example, body heat or some other activation
factor, such that the barb or hook is exposed so as to engage the
surrounding tissue. In a passive configuration, the barbs or hooks
may be static in nature and either always exposed or exposed as
soon as a covering is removed. The barbs or hooks may be hidden
until deployment limiting the exposure during delivery and
positioning and only exposed once positioning is finalized. The
exposure may be completed as individual barbs or as multiples of
barbs. In some embodiments, the covering is thus only a temporary
covering.
[0038] As shown in FIG. 1B, in some embodiments, implant 110 may be
positioned at the annulus of mitral valve 170 where the mitral
valve hinge meets the left ventricle and the left atrium meets
mitral valve 170. Positioning implant 110 at this location may be
facilitated using a location ring 120. For example, location ring
120 may be positioned within the left ventricle, under mitral valve
170. A catheter to deliver location ring 120 may be placed in the
left ventricle via the same access point through sheath 150. In
some embodiments, a catheter 130 may extend through the aorta to
deliver and/or remove the location ring 120. The catheter 130 as
shown may extend through the aorta and through the aortic valve,
and enter the left ventricle. In some embodiments, the location
ring 120 may be delivered and/or removed from the apical entry
point, as mentioned, or from trans-aortic entry via a femoral
entry. In some embodiments, location ring 120 may comprise a
metallic ring or coiled section, which may be viewed via
fluoroscopy or echo guidance to confirm the location of location
ring 120. This may allow confirmation of a positive location for
implant 110 to be located with respect to the mitral valve annulus.
In addition to the use of a location ring, other methods for
determining a desired location to attach implant 110 may could
include echo guidance, CT, fluoroscopy or MRI other imaging
techniques to highlight the mitral valve hinge.
[0039] As shown in FIG. 1C, while in a first expanded structural
configuration, and once a proper position has been achieved,
implant 110 may have a downward force "A" applied to cause piercing
members 115 to engage with and/or pierce the mitral valve annulus.
This force may be applied by the delivery system itself, or may be
applied by a secondary catheter that may be introduced for engaging
piercing members 115 with the tissue proximate mitral valve
170.
[0040] As shown in FIG. 1D, the location ring 120 may be used to
locate the relative position of the implant 110 after anchoring the
implant 110 to the annulus. For example, the location ring 120 may
comprise a metallic ring or coiled section, which may be viewed via
fluoroscopy or echo guidance to confirm the location of location
ring 120 and implant 110. After confirmation of acceptable
placement of the implant 110, or after inversion of the implant 110
as described below, the location ring 120 may then be removed.
Thus, the location ring 120 may be temporary. The location ring 120
may thus be separate from the implant 110 and configured to be
located on a side of the heart valve opposite the implant 110 to
assist in positioning the implant 110. The location ring 120 may be
configured to be removed from the heart after the implant 110 is
positioned and the plurality of helical anchors penetrate the heart
valve annulus. The location ring 120 may be removed by the same
delivery system by which it was inserted, for example the delivery
system shown in FIGS. 1A-1F, the catheter 130, etc.
[0041] In some embodiments, location ring 120 may also act as an
anchor for implant 110. In such an embodiment, implant 110 above
mitral valve 170 (i.e. in the left atrium side of mitral valve 170)
may attach to location ring 120 below mitral valve 170 (i.e. in the
left ventricle side of mitral valve 170). For example, the hooks or
barbs of piercing members 115 may engage with location ring 120.
This may be accomplished by a through suture, a barbed means,
wrapping or clipping location ring 120 to implant 110. Magnetic
forces may also hold location ring 120 and implant 110 together
either temporarily or permanently. Alternatively, the hooks or
barbs may also be attached to some other separate implant below
mitral valve 170 in the left ventricle. This may be a wire, ring,
or tee anchor to secure implant 110 to via wires, threads or
mechanical means to attach through the tissue median. For
convenience, this implant below mitral valve 170 may be referred to
as location ring 120, even if not used in locating implant 110
proximate mitral valve 170.
[0042] In some embodiments, the shape of location ring 120 may be a
circular cross section measuring about 0.010 inches to about 0.090
inches in diameter and may encircle the mitral annulus. The shape
may also be non-circular, oval, biased to one axis or multi-axis to
accommodate the multi-plane shape of mitral valve 170, which is
more saddle shaped. It may also have a variable stiffness in
different sections to accommodate tighter bends in the placement of
location ring 120. Location ring 120 and or a delivery catheter may
also be steerable to navigate the area under mitral valve 170 for
ease of placement. Utilizing push pull wires to compress or load
portions of the catheter or location ring 120 to predictably bend
and orient the catheter or location ring 120 may allow a user to
access difficult anatomical features en route to and around mitral
valve 170.
[0043] As shown in FIG. 1E, once piercing members 115 have engaged
the tissue proximate mitral valve 170, for example, the mitral
valve annulus, an expansive force "B" may be applied to the upper
portion of implant 110. By applying expansive force "B" to implant
110, a reactive reducing force "C" may also be produced at the
lower portion of implant 110. As the diameter of the lower portion
is decreased from reactive reducing force "C," the diameter of
mitral valve 170 is also reduced due to the attachment of implant
110 to the tissue around mitral valve 170. For example, once a
sufficient reducing force "C" has been generated to reshape mitral
valve 170 to a desired size, implant 110 may be left in a final
position in which the size change of mitral valve 170 may be
maintained. This may be a second structural configuration.
[0044] As shown in FIG. 1F, in some embodiments, piercing members
115 may engage the tissue proximate mitral valve 170 but not engage
location ring 120. In such an embodiment, the barbs or hooks of
piercing members 115 may bind, engage with, and/or resist
withdrawal from tissue proximate mitral valve 170 in a manner
sufficient to keep implant 110 attached to the tissue proximate
mitral valve 170. Additionally, the binding, engaging, and/or
resisting withdrawal may be sufficient to decrease the surface area
of mitral valve 170 as expansive force "B" and reactive reducing
force "C" are applied. In such an embodiment, location ring 120 may
or may not be used to facilitate placing implant 110 at a positive
location proximate mitral valve 170. In some embodiments, as
described, the location ring 120 may not couple with the implant
110 but may be used to facilitate positioning of the implant 110,
such as by temporarily positioning the location ring 120, etc. A
positive location for implant 110 may be one in which implant 110
is able to engage tissue proximate mitral valve 170 without
impairing the function of mitral valve 170 and further implant 110
may be used to decrease the surface area of mitral valve 170 as
expansive force "B" and reactive reducing force "C" are
applied.
[0045] FIGS. 2A-2D illustrate an example of implant 110 in
accordance with the present disclosure. As shown in FIG. 2A,
implant 110 may be made of a metal and cut to form a mesh, a cage,
or series of repeating units to allow variations in diameter. For
example, implant 110 may include a tubular body of repeating
squares, diamonds, hexagons, or any other shape allowing a
variation in diameter of implant 110. In first structural
configuration as shown in FIG. 2A, implant 110 may have the larger
diameter portion initially oriented toward mitral valve 170 (the
lower portion with lower diameter 220) and the smaller diameter may
be oriented in the left atrium (the upper portion with upper
diameter 210). The upper portion may be in free space in the left
atrium and have a smaller diameter ready to be expanded in this
first structural configuration.
[0046] The construction of implant 110 may include a tapered laser
cut tube expanded to a predetermined diameter with wall thickness
approximately 0.005 inches to approximately 0.050 inches and a
strut thickness of approximately 0.010 inches to approximately
0.070 inches and an expanded diameter of approximately 1.00 inch.
If the implant is tapered, the large diameter may measure about
thirty five millimeters in diameter and the smaller diameter may
measure about twenty five millimeters in diameter. In the first
structural configuration, the lower portion (i.e. the larger
diameter section) may have penetrating members 115 to engage the
mitral annulus and hold implant 110 in position during annuls
reduction and remain as a permanent implant.
[0047] As shown in FIG. 2B, downward force "A" may be applied to
implant 110. In some embodiments, piercing members 115A-H may be
driven to engage the tissue one at a time. For example, a linear
force may drive the hooks or barbs of piercing member 115A into the
tissue by pushing at the top of implant 110 above piercing member
115A, thus transmitting a force through to the piercing member
115A, driving it into the tissue. The delivery system or catheter
applying the force may then be rotated and actuated again to engage
another piercing member 115, for example adjacent piercing member
115B. Once piercing member 115B has been engaged with the tissue,
this may be repeated until all piercing members 115 have been
engaged with the tissue. Alternatively, in some embodiments, force
"A" may be sufficient to engage multiple piercing members 115 at
once, rather than engaging only a single piercing member 115 at a
time. In some embodiments, all of piercing members 115 may be
engaged at once.
[0048] As shown in FIG. 2C, implant 110 may be in a first
structural configuration in which upper diameter 210 may be smaller
than lower diameter 220. An expansive force "B" may be applied to
the upper portion of implant 110. As the expansive force "B" is
applied such that the upper diameter 210 is increased, the lower
diameter 220 may be decreased due to a reactive reductive force "C"
which is generated. A wall of the tubular body of implant 110 may
act as a beam in deflection where the upper portion of implant 110,
when deflected (e.g. expanded), may cause the lower portion of
implant 110 to bend (e.g. contract). This may facilitate the
transition from this first structural configuration to a second
structural configuration. The lower diameter 220 may be proximate
piercing members 115, which are engaged with the mitral valve
annulus. Thus, as lower diameter 220 becomes smaller, the diameter
of mitral valve 170 becomes smaller. The expansive force "B" may be
applied via balloon dilation, mechanical expansion or other means
to increase upper diameter 210, thus reducing lower diameter 220.
This may effectively invert implant 110's dimensions about axis
200, which may be referred to as an axis of inversion or axis of
reflection. In some embodiments, the diameter of implant 110 at
axis 200 may remain approximately uniform in a first structural
configuration, transitioning between structural configurations, and
a second structural configuration. As shown in FIG. 2D, the
application of expansive force "B" and thus reactive reducing force
"C" may result in implant 110 with upper diameter 210 having a
larger length and lower diameter 220 having a shorter length. This
may in turn reduce barb-engaged mitral valve 170 to a smaller
annulus cross-sectional area, lessening the mitral regurgitation.
The structural configuration shown in FIG. 2B may be the second
structural configuration of implant 110 in which mitral valve 170
has been reduced in annulus cross-sectional area. Additionally,
this second structural configuration may be a final structural
configuration that may maintain the size change of mitral valve
170.
[0049] As shown in FIGS. 3A and 3B, an alternative method for
applying an expansive force to implant 310 may be the deployment of
a ring 320 within implant 310. FIG. 3A illustrates implant 310 in a
first structural configuration and FIG. 3B illustrates implant 310
in a second structural configuration. The ring 320 may be formed of
a shape memory material, such as nitinol. The ring 320 may be
collapsed into a delivery catheter for delivery therethrough to the
heart and ejected into or around the implant 310. In some
embodiment, one or more releasable tethers may be attached to the
ring 320. The releasable tethers may be pulled on to move the ring
320 and to release the tethers from the ring 320 after the ring 320
is in the desired location.
[0050] In some embodiments, a fixed ring 320 may be utilized. Fixed
ring 320 may be moved vertically to expand the upper portion to
increase upper, i.e. proximal, diameter 330, thus causing the lower
portion to reduce lower, i.e. distal, diameter 340 along with the
engaged tissue and mitral valve. For example, upward force "D" may
be applied to ring 320. However, because of the frustoconical shape
of implant 310, the upward force "D" may be translated to an
expansive lateral force causing an increase in upper diameter 330.
Ring 320 may lock into implant 310 by an interference fit or a
mechanical stop built in ring 320 or implant 310, and may maintain
implant 310 in the second structural configuration. In some
embodiments, the fixed ring 320 may have a smaller diameter and
initially be located at or near the upper diameter 330, thus
restraining the upper diameter 330 and causing and/or maintaining
the first structural configuration of the implant 310 shown in FIG.
3A. The fixed ring 320 may then be moved vertically downward as
oriented toward the lower diameter 340, thereby allowing the upper
diameter 330 to expand and increase in size and causing the lower
diameter 340 to contract and reduce in size. The fixed ring 320 may
then be located at or near the lower diameter 340 to cause and/or
maintain the second structural configuration of the implant 310
shown in FIG. 3B.
[0051] Alternatively, an expandable ring 320 may be used rather
than a fixed ring. Expandable ring 320 may be positioned within
implant 310 and may be delivered and expanded by a catheter, for
example using hydraulic or mechanical force to expand ring 320.
Ring 320 may be introduced into implant 310's inner diameter where
ring 320 may be tilted to allow for manipulation or positioning.
Alternatively, ring 320 may be placed at a defined vertical
position in implant 310 and ring 320 may be expanded, for example
with mechanical or hydraulic force or an extension of the radial
dimension. Ring 320 may also serve as a locking mechanism for
implant 310 once the second structural configuration or the final
position has been reached. The expansion and/or locking of ring 320
may be reversible in nature, thus undoing the expansion of the
upper portion. Ring 320 may lock into implant 310, for example by
an interference fit or a mechanical stop built in ring 320 and/or
implant 310.
[0052] FIGS. 4A and 4B illustrate an additional embodiment of an
implant 410 for reshaping mitral valve 170. FIG. 4A illustrates
implant 410 in a first structural configuration and FIG. 4B
illustrates implant 410 in a second structural configuration. As
shown in FIG. 4A, in some embodiments, implant 410 may include one
or more support beams 420 (for example, support beams 420A and
420B). Support beams 420 may facilitate the transition of expansive
force "B" to the reductive force "C." For example, support beam 420
may operate as a beam in deflection about axis 450. Thus, as
expansive force "B" is applied to the upper portion of implant 410,
beams 420A and 420B may act as levers with axis 450 as the fulcrum
or point of rotation, causing reductive force "C" to reduce lower
diameter 440. As expansive force "B" is applied to increase upper
diameter 430 and decrease lower diameter 440, implant 410 may
transition from a first structural configuration shown in FIG. 4A
to a second structural configuration shown in FIG. 4B. As described
above, this may reduce the cross-sectional area of mitral valve
170.
[0053] Support beams 420A and 420B may be integrally formed with
implant 410, for example, as a thicker portion of a wall of the
tubular body of implant 410, or a specific alignment of repeating
units or elements of the structure of the wall of the tubular body.
Alternatively, support beams 420A and 420B may be an additional
support component added to implant 410. For example, they may be
glued, welded, or otherwise permanently affixed to implant 410.
[0054] As shown in FIG. 5, in addition to access to mitral valve
170 through the apex of the heart as shown by 510, access to mitral
valve 170 may also be gained via the femoral artery as shown by
530, or via the femoral artery and through the aortic valve (for
example, as described above with respect to delivery/removal of the
location ring 120 through the aortic valve) or through the venous
system and then via trans-septal puncture directly into the left
atrium as shown by 520. When accessed via the femoral artery or
trans-septally, a delivery catheter may measure about ninety to one
hundred and fifty centimeters in length. The end of the catheter
may be deflectable via deflection wires creating tension of bias to
allow adjustments due to anatomical variations.
[0055] As shown in FIG. 6, vibration may be applied directly to
penetrating members 115 to facilitate the barbs or hooks and/or
penetrating members 115 penetrating the tissue. Low frequency
vibration, ultrasonic, or Radio Frequency energy may allow a lower
insertion force compared to the barb or hook's and/or penetrating
members' normal penetration force. Coupling this energy source to
implant 110 may allow transmission of small vibrations 620 to the
tip of each barb or hook and/or penetrating member 115.
Alternatively, each barb or hook and/or penetrating member 115 may
have its own independent energy source allowing a variable pattern
of frequency or energy around implant 110. Direct tissue contact of
the energy element or a coupling to implant 110 may be used but
there may be a decrease in efficiency by coupling vibration 620
thereto. The frequency of vibration 620 may be about ten to one
hundred Hz (cycles per second) or may be about twenty Hz.
[0056] As shown in FIGS. 7 and 8, to aid in the engagement of the
penetrating members 115, additional energy may be added to vibrate
the tissue surrounding or below mitral valve 170. For example, as
shown in FIG. 7, vibration pads 710A and 710B may deliver vibration
620 to the surrounding tissue near the barbs or hooks of
penetrating members 115. Pads 710A and 710B may be used to vibrate
the tissue near the barb insertion site. Pads 710A and 710B may be
completely separate from implant 110 or may be connected to the
same delivery system. A separate control for linear and radial
motion of pads 710A and 710B may be provided to control the
location to provide precise delivery of vibration 620.
[0057] As shown in FIG. 8, vibration pads 810A and 810B may also be
located below mitral valve 170. This may still provide vibration
620 to facilitate the engagement of barbs or hooks of penetrating
members 115 with tissue proximate mitral valve 170. As with the
embodiment of FIG. 7, vibration pads 810A and 810B may be
completely separate from implant 110 or may be connected to the
same delivery system. A separate control for linear and radial
motion of pads 810A and 810B may be provided to control the
location to provide precise delivery of vibration 620.
[0058] Radio frequency (RF) is a rate of oscillation in the range
of about three kHz to three hundred GHz, which corresponds to the
frequency of radio waves, and the alternating currents, which carry
radio signals. RF usually refers to electrical rather than
mechanical oscillations. Below is a chart of common nomenclature
for different frequency ranges. The range utilized for barb
penetration may be somewhere between ELF and HF as the goal is
small vibration and not heating of the tissue. Possible user range
selection would allow for different tissue types and densities.
TABLE-US-00001 TABLE 1 Abbre- Frequency Wavelength Designation
viation 3-30 Hz 10.sup.5-10.sup.4 km Extremely low ELF frequency
30-300 Hz 10.sup.4-10.sup.3 km Super low frequency SLF 300-3000 Hz
10.sup.3-100 km Ultra low frequency ULF 3-30 kHz 100-10 km Very low
frequency VLF 30-300 kHz 10-1 km Low frequency LF 300 kHz-3 MHz 1
km-100 m Medium frequency MF 3-30 MHz 100-10 m High frequency HF
30-300 MHz 10-1 m Very high frequency VHF 300 MHz-3 GHz 1 m-10 cm
Ultra high frequency UHF 3-30 GHz 10-1 cm Super high SHF frequency
30-300 GHz 1 cm-1 mm Extremely high EHF frequency 300 GHz-3000 GHz
1 mm-0.1 mm Tremendously high THF frequency
[0059] Vibration to enhance tissue penetration by the anchor may be
delivered from a vibration source to tissue adjacent the
penetration site, such as by the vibration pads discussed above.
The vibration source may be embedded in the pad or other vibration
interface at the distal end of an elongate control element such as
a wire or tube. Alternatively, the vibration source may be located
in a proximal manifold and propagate vibrational energy distally
through an elongate wire or tube extending through the catheter
body. The vibration source can alternatively be coupled in
vibration propagating communication with either the implant frame
or with each individual anchor directly, such as through the anchor
driver, depending upon desired performance.
[0060] FIG. 9A depicts another embodiment of an implant 910. The
implant 910 may have the same or similar features and/or
functionalities as other implants described herein, and vice versa,
except as otherwise described. Implant 910 comprises a frame 920,
piercing members or anchors 930, and may include an expandable
member 940. The frame 920 has a free or unconstrained state or,
otherwise stated, nominal configuration as shown in FIG. 9A. The
frame 920 may be made of a nickel titanium alloy, i.e. nitinol, or
other shape memory alloy or metal. The frame 920 may be a
dissimilar material as that of the expandable member 940. The frame
920 may be tubular with a wall circumferentially defining a central
axis. The frame 920 may include angled segments as shown, and/or
other segments, configurations, etc. The frame 920 as shown may be
sinusoidally shaped, although its architecture could be of a
diamond lattice or hexagonal lattice, for example. The frame 920 or
portions thereof may incline radially outward with respect to the
axis and/or with respect to the expandable member 940. The frame
920 may pivot about pivot joints located at or near interfaces with
the expandable member 940. In some embodiments, fixed attachments
are located at one or more of the joints between the frame 920 and
the expandable member 940, for example at the interfaces of
abutting apices of the frame 920 and the expandable member 940.
[0061] Anchors 930 may be metallic helical members. The anchors 930
may threadingly engage with the lower, i.e. distal, apices of frame
920. The anchors 930 may wind through a series of holes through
holes drilled in the distal ends or distal apices of frame 920
(more clearly indicated by reference numerals 1050 in FIGS. 10, 11
and 12). The frame 920 may include a series of distal apices formed
by the frame 920 proximate the distal diameter. A series of holes
in each of the distal apices may be sized and spaced to receive
therethrough a corresponding helical anchor 930 for rotational
engagement of the distal apex by the corresponding helical anchor
930. The holes may be the same or similar to holes 1050 described
for example with respect to FIG. 10. The anchors 930 may be
advanced distally, and in some embodiments retracted proximally, in
a rotational or corkscrew type manner. The anchors 930 may extend
distally relative to the frame 920. For example, as the anchors 930
are rotated, the anchors 930 may move in the distal direction while
the frame 920 is stationary. In some embodiments, the frame 920 may
move distally while the anchors 930 move farther distally relative
to the frame 920. Thus, the frame 920 may be located in the
preferred position and the anchors 930 may then be moved distally
to secure into heart tissue while the frame 920 remains axially
stationary or approximately axially stationary. This allows for
better accuracy with positioning of the implant 910 because there
is less movement of the frame 920 while the anchors 930 are being
secured to heart tissue. Further, the anchors 930 engage the frame
920, as described, for example through the series of holes in
distal apices of the frame 920. This allows for a secure attachment
between the anchors 930 and the frame 920 without the need for
additional structure or features. The arrangement of the holes and
the corresponding receiving of the anchor 930 therethrough in each
apex allows for an axially secure engagement of the anchor 930 and
the frame 920 while still allowing for movement of the anchor 930
by driving it with the driver 952. By axially secure it is meant
that the anchor 930 will not move axially relative to the frame 920
in the absence of sufficient rotational force acting on the anchor
930, such that the anchor 930 and frame 920 are rotationally
secured together after removal of the rotational force from the
driver 952 thereby impeding further axial movement of the anchor
930 relative to the frame 920. The configuration of the series of
holes in the frame 920 and the helical shape of the anchors 930
allows for such advantages. In FIG. 9A, the anchors 930 are shown
extended distally, for example in the final stage of deployment
into cardiac tissue proximate the mitral annulus. The mitral
annulus is that region of transition from the left atrium to the
left ventricle and proximate and above the area where the leaflets
of mitral valve 170 (see FIG. 5) hinge from the left ventricle.
[0062] The implant 910 may include the expandable portion or member
940. The expandable member 940 may be stent-like. The expandable
member 940 may be tubular with a wall circumferentially defining a
central axis. The expandable member 940 may include angled segments
as shown, and/or other segments, configurations, etc. While shown
in the shape of a sinusoid, the expandable member 940 may otherwise
have a diamond lattice or hexagonal lattice architecture, for
example. The expandable member 940 may be a dissimilar material as
that of the frame 920. The expandable member 940 may be made of
metallic alloys such as stainless steel, cobalt chromium, platinum
iridium and the like. The expandable member 940 may be collapsed or
crimped for insertion into a delivery system and forcibly expanded,
so as to undergo plastic deformation, to invert the frame 920. As
shown in FIG. 9A, expandable member 940 may be integral with frame
920, for example a unified, monolithic portion or region of the
frame 920. In some embodiments, the expandable member 940 is
fixedly attached to frame 920 by bonding, welding, sutures,
metallic bands crimped on to each structure, or otherwise connected
in a fixed relationship to frame 920. In some embodiments, the
expandable member 940 can have other coupling interactions with the
frame 920, such as a friction fit, expansive force keeping the
frame 920 secured with the expandable member 940, etc.
[0063] Implant 910 is loaded into the distal end of a delivery
system (not shown), by compressing or collapsing the frame 920.
Anchors 930 would be initially retracted for loading and delivery.
Once positioned in a desired location proximate the mitral valve
annulus, frame 920 is advanced out of the delivery system and its
distal apices are abutted to the target heart tissue for anchor
placement. The helical anchors are then advance, by rotation
thereof, into the target cardiac tissue thereby anchoring implant
910 into the region of the mitral valve annulus. Implant 910 is
then fully released from the delivery system.
[0064] After implant 910 is fully released from the delivery
system, expandable member 940 is then forcibly expanded, such as by
a dilatation balloon, causing frame 920 to invert. Inversion of
frame 920 causes the anchor bearing distal end of frame 920 to
taper or contract, causing the mitral valve annulus to reduce in
size thus limiting the mitral valve regurgitation.
[0065] FIG. 9B is another embodiment of an implant 912. The implant
912 may have the same or similar features and/or functionalities as
the implant 910, and vice versa, except as otherwise noted. The
implant 912 comprises the expandable member 940 and piercing
members or anchors 930. A frame 922 extends circumferentially about
a central longitudinal axis. The frame 922 is formed to have as its
free or unconstrained configuration somewhat opposite to that of
the frame 920 of the implant 910. For example, as shown the lower,
distal end as oriented, the end engaging anchors 930, may be
smaller in diameter than the opposite upper, proximal end of the
frame 922. The frame 922 may therefore incline radially inward
relative to the central axis and/or relative to the expandable
member 940. The frame 922 and the expandable member 940 may be
formed of dissimilar materials. The frame 922 may be formed of
similar materials as the frame 920 described with respect to FIG.
9A.
[0066] To perform the procedure of influencing the size of the
mitral annulus, for example for treating the patient's mitral
regurgitation, the expandable member 940 and the larger, proximal
end of frame 922 are compressed or crimped and loaded into the
distal end of a delivery system (not shown). This action also
causes the distal or narrower end of frame 930 to invert. Such
inversion must be restrained for loading into the delivery
system.
[0067] Once positioned in the desired location proximate the heart
valve annulus, such as the mitral valve annulus, the frame 922 is
advanced out from the distal end of the delivery system, inverting
as it is no longer constrained by the delivery system and
expandable member 940 remains in the crimped configuration. The
distal ends or distal apices of frame 922 are then positioned in
abutting relationship to the target cardiac tissue proximate the
mitral valve annulus. Helical piercing members 930 are then
rotationally advanced into and in engagement with the target heart
tissue in a manner very similar to the helical screw of a corkscrew
advancing through a cork. The expandable member 940 is then
expelled from the delivery system and forcibly expanded, for
example by dilatation balloon which balloon could be an integral
component of the delivery system. Expansion of the stent-like
expandable member 940 causes frame 922 to revert to its nominal or
free state thereby causing its distal apices and helical anchors to
become narrower in diameter reducing the size of the mitral annulus
and limiting the degree or extent of mitral regurgitation.
[0068] FIGS. 10, 11 and 12 are various views of another embodiment
of an implant 1010. In this embodiment, the implant 1010 has a
frame 1020 and an expandable member 1040 that are not formed as an
integral implant, as for example in FIGS. 9A and 9B. Rather
expandable member 1040 is positioned within frame 1020 proximate
the proximal end thereof. Frame 1020 is made from a nickel titanium
alloy, such as Nitinol, whereas expandable member 1040 is
preferably made of metallic alloys such as stainless steel, cobalt
chromium, platinum iridium and the like.
[0069] FIG. 10 shows frame 1020 in its free or unconstrained state
with expandable member 1040 crimped and positioned within frame
1020. One or more holes 1050 are pre-drilled in the distal ends or
apices of frame 1020 and oriented to accommodate the pitch of
helical anchors (not shown for clarity) such as the anchors 930 of
FIGS. 9A and 9B. The anchors 930 may be rotated through the holes
1050 to advance the anchors 930 distally, i.e. downward as oriented
in the figure. In some embodiments, the anchors 930 may be rotated
in the opposite direction through the holes 1050 to retract the
anchors 930 in the opposite, proximal direction. FIG. 11 shows the
frame 1020 in a constrained configuration and implant 1010 ready
for loading into the distal end of a delivery system (not shown).
FIG. 12 shows implant 1010 in what would be its deployed
configuration. While expandable member 1040 is shown to have a
diamond like lattice configuration, it is contemplated that it may
also take the form of a sinusoid or a hexagonal configuration.
[0070] Delivery of implant 1010 may be conducted in similar respect
to the embodiment of FIG. 9A. More specifically, implant 1010 is
loaded into the distal end of a delivery system (not shown), by
compressing or collapsing frame 1020 as shown in FIG. 11. Once
positioned in a desired location proximate the mitral valve
annulus, frame 1020 is advanced out of the delivery system and its
distal apices are abutted to the target heart tissue for anchor
placement. The helical anchors (not shown) are then advance, by
rotation thereof, into the target cardiac tissue thereby anchoring
implant 1010 into the region of the mitral valve annulus. Implant
1010 is then fully released from the delivery system.
[0071] After implant 1010 is fully released from the delivery
system, expandable member 1040 is then forcibly expanded, such as
by a dilatation balloon, causing frame 1020 to invert as shown in
FIG. 12. Inversion of frame 1020 causes the anchor bearing distal
end of frame 1020 to taper or contract, causing the mitral valve
annulus to reduce in size thus limiting the mitral valve
regurgitation.
[0072] FIG. 13 shows an exemplary steerable delivery system 950,
including for example a catheter or catheter lumen, suitable for
delivery of the various implant embodiments described herein. FIG.
13 depicts an embodiment of the implant 1010 of FIGS. 10-12, but it
is understood that the delivery system 950 can be used to delivery
other implants, including but limited to the implant 912 of FIG. 9B
and the implant 910 of FIG. 9A, the latter of which is further
shown in and described with respect to FIG. 14. For example, a
similar delivery system 950 may be used for the implant 912
embodied in FIG. 9B. For brevity and since the expandable members
are different between the aforementioned embodiments, the
expandable members 1040 are not shown in FIG. 13.
[0073] The delivery system 950 may include a tube or tube-like
structure having one or more lumens extending therethrough. For
instance, the delivery system 950 may include an elongated tube or
delivery catheter having one or more openings, i.e. lumens,
extending therethrough and configured to receive therein, or having
therein, corresponding features of the delivery system 950,
including but not limited to the guide wire 160, the catheter 140,
one or more of the drivers 952, and the intracardiac echo catheter
960. In some embodiments, the delivery system 950 includes a
delivery catheter having a lumen to guide the delivery catheter
over the guide wire, another lumen or lumens that include(s) the
rotatable drivers 952, the implant 912 in a constrained delivery
configuration located at a distal end of the delivery catheter, and
a sheath covering the distal end of the catheter. Delivery system
950 is advanced transfemorally, either through the femoral vein and
transeptally to the left atrium or through the femoral artery up
through the aortic arch and then passed the aortic and mitral
valves into the left atrium. Once positioned above mitral annulus
and proximate the target heart tissue, the implant is partially
released, releasing the frame portion 920, 1020. Frame 920, 1020 is
now unconstrained and able to return to its nominal or free state
as shown in FIG. 13.
[0074] Helical piercing members 930 are then rotationally advanced
into the target cardiac tissue, anchoring the implant to the
interior heart wall above the mitral annulus. The implant and
expandable member 940, 1040 is then released from delivery system
950. At such time, the stent like member 940, 1040 is forcibly
expanded causing the frame 920, 1020 to invert. The distal end of
apices and helical anchors 930 are then cinched inwardly reducing
the diameter of the distal end of frame 920, 1020 causing a
corresponding reduction in the size of the mitral annulus. This
reduction in size of the mitral annulus, allows the mitral valve
leaflets to better, if not completely, coapt reducing the severity
of the patient's mitral regurgitation.
[0075] In a further embodiment of the present invention, an
intracardiac echo catheter 960 is incorporated in delivery system
950. Catheter 960 could be included in a lumen of delivery system
950, either internally as shown, or alongside implant delivery
system 950. By rotating catheter 960 within the left atrium and
proximate the mitral valve annulus, the relative position of the
implant with respect to the mitral valve leaflets can be
determined. This allows for accurate positioning of helical anchors
930 into the target heart tissue proximate the mitral annulus
without piercing the mitral valve leaflets.
[0076] FIG. 14 depicts the steerable delivery system 950 being used
to deliver the implant 910 of FIG. 9A. The description of the
delivery system 950 above with respect to FIG. 13 applies to use of
the system 950 with the implant 910, and vice versa, except as
otherwise noted. As shown in FIG. 14, the implant 910 thus includes
the frame 920 and expandable member 940, shown as integral with the
frame 920. In some embodiments, the implant 910 may only include
the frame 920. The delivery system 950 may or may not include the
intracardiac echo catheter 960, as described above.
[0077] As shown in FIG. 14, a plurality of rotational drivers 952
extends out through a distal opening of a lumen of the delivery
catheter and/or sheath of the delivery system 950. Each driver 952
may extend through a corresponding lumen of the delivery system
950. In some embodiments, more than one or all of the drivers 952
may extend through the same lumen of the delivery system 950. A
guide wire, such as the guide wire 160, may also be incorporated
into the delivery system 950, and may extend through a lumen of the
delivery system 950.
[0078] The drivers 952, only some of which are labelled for
clarity, are each engaged with a corresponding rotational anchor
930. The drivers 952 may be pre-engaged with the anchors 930 within
the delivery catheter of the delivery system 950 before insertion
of the distal end of the delivery system 950 into the atrium. The
drivers 962 may be mechanically engaged with the anchors 930 in a
variety of suitable approaches. For example, the drivers 962 may
have a clevis type fitting as shown configured to surround the
proximal end of the anchors 930. The drivers 952 may extend over,
on, under, etc. the proximal ends of the anchors 930 and then be
rotated to transmit rotation to the anchors 930. In some
embodiments, the anchors 930 may have recesses or other
tool-receiving portions engaged by the drivers 952 such that
rotation of the drivers 952 is transmitted to the anchors 930. In
some embodiments, the drivers 952 may include socket type fittings
that surround the anchors 930. In some embodiments, the anchors 930
may have internally-threaded blind holes through which
corresponding externally-threaded members of the drivers 952 are
received. These are merely some examples of how the drivers 952 may
be engaged with the anchors 930, and other suitable approaches may
be implemented. With the implant 910 in position for anchoring to
the annulus, a proximal end of the drivers 962 may be manipulated
by the user, for example rotated by the surgeon, to rotate the
anchors 930 and thereby advance the anchors 930 into heart tissue,
as described herein, to secure the implant 910 with the heart
tissue. Each driver 952 may be actuated simultaneously, some may be
actuated simultaneously, or they may be actuated sequentially. The
anchors 930 may extend distally relative to the frame, as described
herein.
[0079] FIGS. 15A-15D show sequential views of an embodiment of a
transcatheter delivery system for delivering the implant 910
showing an embodiment of a method for the delivery, positioning and
anchoring of the implant 910 for resizing the native valve annulus.
The various delivery systems as described herein may be used. As
shown, the delivery system may include the sheath 150, the catheter
140 and the guide wire 160. The sheath 150, the catheter 140, the
guide wire 160 and the implant 910 are configured for transcatheter
delivery of the implant 910 to the heart. The implant 910 may be
delivered by the delivery system percutaneously by catheter through
an opening in the femoral vein. The implant 910 may be advanced
through the femoral vein into the vena cava and into the right
atrium. The distal ends of the sheath 150, catheter 140, and guide
wire 160 are configured to extend through the opening in the
femoral vein, through the femoral vein and into the right atrium of
the heart, and through the septum of the heart into the left
atrium.
[0080] As shown in FIG. 15A, the guidewire 160 may be advanced
through the septum separating the upper chambers of the heart and
the sheath 150 and catheter 140 may be advanced to that position
along the guide wire 140. The distal end of the catheter 140 is
advanced to a position above the heart valve annulus, for example,
the mitral valve annulus, as shown in FIG. 15B. FIG. 15C shows the
implant 910 expelled from the distal end of the sheath 150 above
and proximate to the mitral valve annulus. In some embodiments, a
series of images may be taken, for example with an intracardiac
echo catheter, to properly position the anchors 930 for insertion
into the mitral valve annulus tissue. As shown in FIGS. 15C and
15D, the anchors 930 may be rotationally engaged by rotational
drivers of the delivery system, such as the drivers 952 described
herein, for rotation and distal advancement of the anchors 930 into
the heart valve annulus. In some embodiments, a circumferential
image may be captured to confirm that all anchors 930 are
appropriately placed and anchored in the mitral valve annulus
tissue above the mitral valve leaflets. If one or more anchors 930
are not positioned or anchored properly, the drivers 952 may
reverse the direction of rotation to rotationally retract the
anchors in the proximal direction. The anchors 930 can then be
repositioned and re-anchored prior to removal of the drivers
952.
[0081] Though a particular path of transcatheter delivery is
described with respect to FIGS. 15A-15D, a variety of other
delivery paths and approaches may be employed, including but not
limited to the paths shown and described with respect to FIGS.
1A-1F, trans-apical delivery, etc. In addition, any of the features
and/or functionalities of the delivery system and associated
methods described with respect to FIGS. 1A-1F may be incorporated
with respect to the delivery system and methods described with
respect to FIGS. 15A-15D, and vice versa. Therefore, for example,
with regard to the delivery system and methods described with
respect to FIGS. 15A-15D, the implant 910 may "invert" as described
herein, an expandable or fixed ring 320 may be utilized as
described, the location ring 120 may be inserted below the valve,
etc.
[0082] This disclosure encompasses all changes, substitutions,
variations, alterations, and modifications to the example
embodiments herein that a person having ordinary skill in the art
would comprehend. Similarly, where appropriate, the appended claims
encompass all changes, substitutions, variations, alterations, and
modifications to the example embodiments herein that a person
having ordinary skill in the art would comprehend. Moreover,
reference in the appended claims to an apparatus or system or a
component of an apparatus or system being adapted to, arranged to,
capable of, configured to, enabled to, operable to, or operative to
perform a particular function encompasses that apparatus, system,
component, whether or not it or that particular function is
activated, turned on, or unlocked, as long as that apparatus,
system, or component is so adapted, arranged, capable, configured,
enabled, operable, or operative. For example, various embodiments
may perform all, some, or none of the steps described above.
Various embodiments may also perform the functions described in
various orders.
[0083] Although the present disclosure has been described above in
connection with several embodiments; changes, substitutions,
variations, alterations, transformations, and modifications may be
suggested to one skilled in the art, and it is intended that the
present disclosure encompass such changes, substitutions,
variations, alterations, transformations, and modifications as fall
within the spirit and scope of the appended claims.
* * * * *