U.S. patent application number 13/400977 was filed with the patent office on 2012-06-14 for prosthetic valve implantation systems.
Invention is credited to Brian Beckey, David C. Forster, Scott Heneveld, Brandon Walsh.
Application Number | 20120150287 13/400977 |
Document ID | / |
Family ID | 38834359 |
Filed Date | 2012-06-14 |
United States Patent
Application |
20120150287 |
Kind Code |
A1 |
Forster; David C. ; et
al. |
June 14, 2012 |
Prosthetic Valve Implantation Systems
Abstract
Prosthetic valves implantation methods and systems, especially
as related to fitting a prosthetic valve at the site of a native
stenotic or incompetent valve are described. The subject devices,
systems and associated dock deployment and implant docking
techniques may be employed in percutaneous valve replacement
procedures.
Inventors: |
Forster; David C.; (Los
Altos Hills, CA) ; Beckey; Brian; (Woodside, CA)
; Walsh; Brandon; (Syracuse, UT) ; Heneveld;
Scott; (Whitmore, CA) |
Family ID: |
38834359 |
Appl. No.: |
13/400977 |
Filed: |
February 21, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12305624 |
Dec 18, 2008 |
8142492 |
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PCT/US2007/071689 |
Aug 15, 2008 |
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13400977 |
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Current U.S.
Class: |
623/2.11 |
Current CPC
Class: |
A61F 2/2418 20130101;
A61F 2/2433 20130101; A61F 2220/0083 20130101; A61F 2250/006
20130101; A61F 2250/0003 20130101; A61F 2250/0069 20130101 |
Class at
Publication: |
623/2.11 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A medical apparatus, comprising: a prosthetic valve support
structure; and a docking sleeve configured to interface with the
support structure and configured for implantation within a blood
vessel of a patient.
2. The medical apparatus of claim 1, wherein the docking sleeve is
configured to displace the native anatomy.
3. The medical apparatus of claim 1, wherein the docking sleeve is
configured to provide a seal with the native anatomy.
4. The medical apparatus of claim 1, wherein the docking sleeve is
configured to anchor against the native anatomy.
5. The medical apparatus of claim 1, wherein the docking sleeve
comprises a tissue graft.
6. The medical apparatus of claim 1, wherein the docking sleeve has
an inner lumen with a regular cross-sectional shape.
7. The medical apparatus of claim 1, further comprising: an
elongate member; an expandable member coupled with the elongate
member, the expandable member configured to deploy the docking
sleeve.
8. The medical apparatus of claim 1, wherein the docking sleeve is
configured to transition from an undeployed state suitable for
advancement through the vasculature of a patient to a deployed
state.
9. The medical apparatus of claim 1, wherein the docking sleeve is
compliant.
10. The medical apparatus of claim 1, wherein the docking sleeve
comprises an inner sleeve and an outer sleeve.
11. The medical apparatus of claim 10, wherein the docking sleeve
further comprises a spring member coupled between the inner sleeve
and the outer sleeve.
12. The medical apparatus of claim 10, further comprising a sealing
member configured to seal a space between the inner and outer
sleeves.
13. The medical apparatus of claim 10, wherein at least one of the
inner sleeve and the outer sleeve comprises a plurality of
hinges.
14. The medical apparatus of claim 10, wherein at least one of the
inner sleeve and the outer sleeve comprises a plurality of
deflectable panels.
15. The medical apparatus of claim 10, wherein the outer sleeve
comprises an aperture configured to receive the inner sleeve.
16. The medical apparatus of claim 1, wherein the docking sleeve is
coupled to the valve support structure by a spring member.
17. The medical apparatus of claim 16, wherein the spring member is
configured to center the valve support structure.
18. The medical apparatus of claim 1, further comprising a sealing
member configured to seal a space between the valve support
structure and the docking sleeve.
19. The medical apparatus of claim 1, wherein the valve support
structure and docking sleeve are each configured to transition from
an undeployed state suitable for advancement through the
vasculature of a patient to a deployed state.
20. The medical apparatus of claim 11, wherein the docking sleeve
is configured to transition from a tri-star configuration.
Description
CROSS-REFERENCE To RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/305,624, filed Dec. 18, 2008, which claims priority to PCT
Application Serial No. PCT/US2007/71689, filed Aug. 15, 2008, which
claims priority to U.S. Provisional Application Ser. No.
60/805,420, filed Jun. 21, 2006, each of which is fully
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] Diseases and other disorders of the heart valves affect the
proper flow of blood from the heart. Two categories of heart valve
disease are stenosis and incompetence. Stenosis refers to a failure
of the valve to open fully, due to stiffened valve tissue.
Incompetence refers to valves that cause inefficient blood
circulation by permitting backflow of blood in the heart.
[0003] Medication may be used to treat some heart valve disorders,
but many cases require replacement of the native valve with a
prosthetic heart valve. Prosthetic heart valves can be used to
replace any of the native heart valves (aortic, mitral, tricuspid
or pulmonary), although repair or replacement of the aortic or
mitral valves is most common because they reside in the left side
of the heart where pressures are the greatest.
[0004] Conventional heart valve replacement surgery involves
accessing the heart in the patent's thoracic cavity through a
longitudinal incision in the chest. For example, a median
sternotomy requires cutting through the sternum and forcing the two
opposing halves of the rib cage to be spread apart, allowing access
to the thoracic cavity and heart within. The patient is then placed
on cardiopulmonary bypass support which involves stopping the heart
to permit access to the internal chambers. Such open heart surgery
is particularly invasive and involves a lengthy and difficult
recovery period.
[0005] Percutaneous implantation of a prosthetic valve is a
preferred procedure because the operation is performed under local
anesthesia, may not require cardiopulmonary bypass, and is less
traumatic. Various types of prosthetics are adapted for such use.
One class employs a stent like outer body and internal valve
leaflets attached thereto to provide one way blood flow. These
stent structures are radially contracted for delivery to the
intended site, and then expanded/deployed to achieve a tubular
structure in the annulus. Another more advantageous class is
offered by the assignee hereof. US Patent Publication No.
2005/0203614 (hereinafter "the '614 application," which application
is incorporated by reference herein in its entirety) describes a
system in which various panels define the implant body carrying
valve leaflets. These prosthetic valve structures are delivered in
a contracted state and then unfolded and/or unrolled into an
expanded state at the treatment location. An example of such a
valve is depicted in FIG. 1A. As shown, valve prosthesis 101 is
adapted to carry a valve 107 having multiple leaflets 108. The
valve support structure 106 includes a plurality of panels 109 that
can transition from the state shown to an inverted state as
described in the '614 publication.
[0006] With either type of structure, a sufficient engagement
between patient body tissue and the prosthesis body is desired to
secure the position of the implant and form a peripheral seal.
However, when implanting the prosthetic device at the site
of/within the envelope of the native valve, the condition of the
native valve can interfere with fit. Stated otherwise, irregularity
in the shape of the implantation site, surface features, texture,
and composition pose challenges for developing an implant of a
regular size able to accommodate all such variability.
[0007] Aspects of the invention optionally address the challenges
presented by prosthetic member interface with calcific and/or
irregular valve leaflet and annulus geometry. In addition, other
advantages of the present invention may be apparent to those with
skill in the art upon review of the subject disclosure.
BRIEF SUMMARY OF THE INVENTION
[0008] This summary is provided by way of exemplary embodiments. In
no way is this summary intended to provide limitation to the scope
of the appended claims.
[0009] Accordingly, the systems and methods described herein
include "docking" type devices for interfacing with replacement
prosthetic valves. In some exemplary embodiments, these docking
devices are in the form of a sleeve adapted to secure a valve body
within a central lumen, and interface with native tissue around its
periphery. The docking sleeves can be adapted to provide a seal
between the native valve or vessel and the valve body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The figures provided herein are not necessarily drawn to
scale, with some components and features being exaggerated for
clarity. Each of the figures diagrammatically illustrates aspects
of the invention. Variation of the invention from the embodiments
pictured is contemplated.
[0011] FIG. 1A is a perspective view depicting an exemplary valve
prosthesis.
[0012] FIG. 1B is an illustrative view depicting an exemplary
embodiment of a docking system drawing relation to a heart.
[0013] FIGS. 2A-C are cross-sectional views depicting an exemplary
embodiment of a docking system 100.
[0014] FIGS. 3A-B are axial and radial cross-sectional views,
respectively, depicting additional exemplary embodiments of docking
sleeve.
[0015] FIGS. 4A-B are axial cross-sectional and perspective views,
respectively, depicting another exemplary embodiment of a docking
sleeve.
DETAILED DESCRIPTION OF THE INVENTION
[0016] As opposed to known systems, an aspect of the systems and
methods described herein contemplates more than a simple docking
ring with a limited implant-retention interface. In the systems and
methods described herein, the sleeve is adapted to receive at least
half, and more typically the entire valve body. Such overlap
provides for valve/sleeve interface or securing approaches
elaborated upon below. FIG. 1B is a illustrative view depicting a
docking system 100 having a support structure 106 of a valve
prosthesis 101 as described in the '614 publication and a
corresponding docking sleeve 102 adapted to receive valve support
structure 106. Placement of the docking sleeve 102 can occur in a
location corresponding to the presence of a native valve, such as
the aortic valve within the aorta 103 of the heart 104 of a
patient.
[0017] Another aspect of the systems and methods described herein
that distinguish them from known stent-like and simple stent-graft
docking structures is that the sleeves described herein offer a
space-filling function to provide each of a good interface with
irregular anatomy and a central lumen having a regular shape (e.g.,
circular, oval or elliptical) to accommodate corresponding valve
body geometry. Stated otherwise, docking sleeves are provide that
adapt to or take-up space and/or compress or expand in sections to
provide a superior vessel-side interface while offering an inner
lumen with more regular geometry than the implantation site for
valve body retention.
[0018] FIGS. 2A-C are cross-sectional views depicting an exemplary
embodiment of a prosthesis 101 during various stages of deployment
within aorta 103. In this embodiment, docking sleeve 102 is
configured as a tissue graft with a variable thickness to conform
to the underlying vessel anatomy (in this example, within aorta
103). Of course, in other embodiments, docking sleeve 102 can be
composed of man-made materials and/or can be configured in a manner
that does not enact full conformation with the underlying anatomy.
FIG. 2A depicts graft 102 carried on an expandable member (e.g., a
balloon) 110 in its unexpanded state disposed on an elongate member
(e.g., a catheter shaft) 111. FIG. 2B depicts graft 102 in a
deployed configuration against the walls of aorta 103 and filling
sinus 112. The deployment of graft 102 is accomplished by inflation
of balloon 110. FIG. 2C depicts graft 102 following the removal of
balloon 110 and shaft 111 and the deployment of valve structure 106
(leaflets not shown). Here, it can be seen that structure 106 has a
lesser length that graft 102, allowing greater freedom in the
placement of structure 106. Also, graft 102 provides space-filling
conformance with the underlying anatomy.
[0019] Such space-filling may be provided by a compliant body or
body portion (e.g., biocompatible "spongy" foam such as expanded
PTFE, deflectable panels or leaf springs for a metallic material
such as NiTi, a microporous polymer or metal/metal alloy, etc.), a
multi-component/segment or composite body, or a body with a rigid
implant-interface lumen and expandable exterior (e.g., as provided
by a hydrogel, or permanently inflatable structure--via air, saline
or another biocompatible fluid).
[0020] For a multi-component sleeve body, inner and outer tubular
(e.g., cylindrical) sections may be provided with a spring media
provided therebetween. Multiple elastomeric beams or metal spring
(coil, torsion, zig-zag, etc.) elements may be employed for such
purposes. Alternatively, an air-spring approach with an interposed
balloon (distensible or non-distensible) may be utilized. In the
latter case, no additional seal element is required between the
inner and outer sleeve housings. However, in the former case, one
or more baffle structures (e.g. provided by woven fabric/fiber) may
be employed to seal the body from inadvertent blood flow or
passage/leakage. In order to avoid inadvertently supplying a cavity
prone to thrombus formation, multi-piece sleeve bodies will
typically be sealed-off at both ends.
[0021] FIGS. 3A-B are axial and radial cross-sectional views,
respectively, depicting additional exemplary embodiments of docking
sleeve 102 having an inner sleeve 114 and an outer sleeve 115. In
FIG. 3A, inner sleeve 114 (which can also be valve support
structure 106) and outer sleeve 115 are in spaced relation to each
other in the deployed configuration with multiple spring elements
117, which are coiled springs in this embodiment, located and
exerting force between the outer surface of inner sleeve 114 and
the inner surface of outer sleeve 115. Spring elements 118 serve to
provide conformance to the underlying anatomy as well as to center
inner sleeve 114 with respect to outer sleeve 115. Empty region 116
is configured to receive valve support structure 106 (not shown).
Covering 118, which is a flexible fabric in this embodiment, is
placed over the gap between sleeves 114 and 115 to seal the region
therebetween from blood flow.
[0022] In FIG. 3B, docking sleeve 102 is shown in an exemplary
intermediate undeployed configuration. Here, sleeves 114 and 115
are in a "tri-star" configuration similar to that described in the
incorporated '614 application. Here, device 102 has three segments
123 arranged in a star-like manner. From this configuration, the
profile of the device to be reduced further by rolling each segment
towards the center axis 124. Sleeves 114 and 115 can be made to
enter this configuration by inverting or deflecting each of panels
121 and 122, respectively, towards the center axis 124 of the
device in a manner similar to that described in the '614
application. Hinges 119 and 120 are included between panels 121 and
122, respectively, to facilitate transition between the tri-star
and deployed configurations. Although spring elements 117 can also
be seen, covering 118 is not shown for clarity.
[0023] The length of the sleeve may vary as alluded to above. In
order to bridge irregular anatomy such as the aortic sinus, the
docking sleeve may be elongated relative to the valve body.
[0024] In a procedure for implanting a docking sleeve and
prosthetic valve according to the present invention, various tissue
modification techniques as described in commonly assigned,
"Prosthetic Valve Implant Site Preparation Techniques," provisional
application Ser. No. 60/805,333, filed on Jun. 20, 2006 and
incorporated by reference in its entirety, can be performed.
However, in many instances, the current invention will allow
foregoing approach without ill effect.
[0025] In one variation of the invention, a method is provided in
which the docking sleeve is situated where its implantation is
desired during a valvuloplasty procedure. After crossing the native
valve leaflets, a balloon is expanded to simultaneously open the
leaflets and deploy the docking sleeve.
[0026] In order that the interfacing valve is readily available to
complete the procedure without compromising patient hemodynamics
for an extended period during a beating heart procedure (given that
the native valve leaflets are pinned behind the docking sleeve),
the valve delivery device may also already be positioned in the
aorta for immediate valve body insertion following docking sleeve
or station deployment. Such a situation is facilitated by accessing
the femoral artery in each leg of a patient to feed the different
implant delivery systems (one from the right, and one from the
left) into the aortic arch where there is sufficient room to
accommodate both.
[0027] Alternatively, a temporary valve structure such as described
in US Publication No. 2004/0225354 may be provided to allow
advancement and delivery of the sleeve, withdrawal of its delivery
catheter or guide and substitution for a valve body delivery guide
for secondary implant delivery. US Publication No. 2001/0044591
discloses other approaches for percutaneous implant delivery that
may alternatively be employed for delivering the docking sleeve and
valve body.
[0028] As described above, the docking sleeve may be delivered upon
a balloon--similar to delivery of a graft. In other variations
where the implant comprises a plurality of flexible and/or hinged
panels, it may be delivered in a fashion identical to the approach
to valve body delivery described directly below.
[0029] Specifically, in delivering a prosthetic valve assembly as
described in US Publication No. 2005/0203614, after advancing the
subject delivery system over the guidewire to the treatment
location, its outer sheath is retracted to expose the delivery
tube. The gripper provided is then rotated relative to the delivery
tube (or the delivery tube rotated relative to the gripper) to
cause folded segments of the prosthetic valve to uncurl and to
extend radially outward through longitudinal slots of the delivery
tube. The delivery tube is then retracted (or the gripper advanced)
to cause the prosthetic valve (restrained by the fingers) to
advance distally out of the delivery tube. The gripper is then
retracted relative to the prosthetic valve, releasing the
prosthetic valve into the treatment location. Preferably, the
inverted segments then revert to the expanded state, causing the
valve to lodge against the internal surface of the body lumen
(e.g., the aortic valve root or another biologically acceptable
aortic position). Additional expansion of the prosthetic valve may
be provided, if needed, by a suitable expansion member, such as an
expansion balloon or an expanding mesh member (described elsewhere
herein), carried on the delivery catheter or other carrier.
[0030] In other methods, different types of prosthetic valves are
delivered and deployed within the docking sleeve. In any case,
either the valve body or the lumen of the docking sleeve (or both)
may be specially adapted to provide a secure interface between the
members. Such adaptation may involve complementary VELCRO type
hooks, protrusions, tines and loops, dimples, lattice spaces and/or
cutouts. Otherwise, a frictional type interface or an interference
fit may hold the bodies together. Another means for securing the
relative position of the members involves magnets. A plurality of
discrete magnetic and/or ferromagnetic elements may be provided.
Otherwise, one or both members may be at least partially
constructed with magnetic impregnated material (such as polymeric
sheet).
[0031] Common to all of the approaches, in accordance with another
possibly independent aspect of the invention, is the manner in
which a large portion or the entirety of the axial length of the
implant is engaged with the docking sleeve. The preferred valve
body variations have an axial length in which the valve leaflets
are set. These "high walls" may help protect the leaflets
(especially when closed-wall valve body structures are provided)
and offer an advantageous docking member interface in terms of
lateral stability as well as providing significant surface area for
sturdy frictional, interlocking or other types of engagement
between the members. Since the valve body will not be sutured to
the docking sleeve (either an inner or outer portion thereof--as
applicable) maximizing such contact, while still minimizing device
size to aid in deliverability, can be important in providing a
secure structure able to handle many millions of cycles of pulsing
blood pressure.
[0032] Regarding the construction of the docking sleeve, its
construction may substantially follow that in the '614 application
for its valve bodies. Materials and assembly approaches for
providing various "tri-star" and other types of docking sleeves
configured as valve bodies presented in the '614 application are
specifically contemplated. In some instances, the construction
approaches will be modified to provide double-walled,
double-cylinder or double-shelled valve docking/retention sleeves
as provided herein. With such an endpoint in mind, those with skill
in the art can apply the relevant teachings. Generally speaking,
the valve body is polymeric, NiTi alloy (where the Af is set for
superelastic or SMA use), Beta Titanium alloy, or another suitable
biocompatible material or another material with a robust
biocompatible coating.
[0033] However constructed, it may be desirable to utilize largely
closed or uninterrupted sleeve walls to avoid inward migration of
native leaflets that can damage the prosthetic leaflets. In other
instances, it may be desirable to strategically locate open
sections in the sleeve walls to accommodate nested inner and outer
portions without overlapping material. Stated otherwise, use of
nesting cylinders/shells will avoid overlap resulting in thicker
wall sections that can be more difficult to manipulate into a
reduce cross-section profile; or stack-up in size making fit within
a percutaneous delivery system difficult.
[0034] In the latter case, overall valve system patency can be
ensured by coordinating the valvular body configuration with the
docking sleeve configuration so that holes provided in the outer
member of the docking sleeve pair are covered or spanned when the
valve body is set in place.
[0035] FIGS. 4A-B are axial cross-sectional and perspective views,
respectively, depicting another exemplary embodiment of docking
sleeve 102 having inner sleeve 114 and outer sleeve 115. FIG. 4A
depicts sleeve 102 during deployment. Here, outer sleeve 115 has an
aperture 126 configured to receive inner sleeve 114 (which can also
be valve support structure 106) Inner sleeve 114 is coupled to
outer sleeve 115 by way of a sealing device, which in this
embodiment is a fabric 128 Inner sleeve 114 can be positioned
within aperture 128 to prevent stack-up of the two sleeves 114 and
115 (i.e., an overlap between the sleeves 114 and 115 that
increases the overall wall thickness). FIG. 4B depicts this
embodiment while in the tri-star configuration. Fabric 128 is not
shown.
[0036] In certain methods according to the present invention, the
docking sleeve and valve body may be delivered simultaneously. Such
an approach avoids the need for temporary valve approaches as
described above. In yet another approach, the devices (i.e., the
docking sleeve and valve member) are situated in series on a single
delivery guide to allow for rapid, sequential deployment utilizing
the same delivery device.
[0037] In another aspect of the method, the size of each of the
prosthetic valve body and docking sleeve may be determined in
various ways. Techniques described in U.S. patent application Ser.
No. 11/420,189 entitled, "Assessment of Aortic Heart Valve to
Facilitate Repair or Replacement," filed May 24, 2006, may be
helpful in this regard. Based on such measurement, appropriately
sized docking sleeve and valve bodies may be selected for a given
patient from stock or an organized panel of different-sized
prostheses.
[0038] Various exemplary embodiments of the invention are described
below. Reference is made to these examples in a non-limiting sense.
They are provided to illustrate more broadly applicable aspects of
the invention. Various changes may be made to the invention
described and equivalents may be substituted without departing from
the true spirit and scope of the invention. In addition, many
modifications may be made to adapt a particular situation,
material, composition of matter, process, process act(s) or step(s)
to the objective(s), spirit or scope of the present invention.
Further, as will be appreciated by those with skill in the art that
each of the individual variations described and illustrated herein
has discrete components and features which may be readily separated
from or combined with the features of any of the other several
embodiments without departing from the scope or spirit of the
present inventions. All such modifications are intended to be
within the scope of the appended claims.
[0039] Any of the devices described for carrying out the subject
methods may be provided in packaged combination for use in
executing the method(s). These supply "kits" may further include
instructions for use and be packaged in sterile trays or containers
as commonly employed for such purposes.
[0040] The invention includes methods that may be performed using
the subject devices. The methods may all comprise the act of
providing such a suitable device. Such provision may be performed
by the end user. In other words, the "providing" act merely
requires the end user obtain, access, approach, position, set-up,
activate, power-up or otherwise act to provide the requisite device
in the subject method. Methods recited herein may be carried out in
any order of the recited events which is logically possible, as
well as in the recited order of events.
[0041] Exemplary aspects of the invention, together with details
regarding material selection and manufacture have been set forth
above. As for other details of the present invention, these may be
appreciated in connection with the above-referenced patents and
publications as well as generally know or appreciated by those with
skill in the art. For example, one with skill in the art will
appreciate that a lubricious coating (e.g., hydrophilic polymers
such as polyvinylpyrrolidone-based compositions, fluoropolymers
such as tetrafluoroethylene, hydrophilic gel or silicones) may be
used in connection with the devices, if desired, to facilitate low
friction manipulation or advancement to the treatment site. The
same may hold true with respect to method-based aspects of the
invention in terms of additional acts as commonly or logically
employed.
[0042] In addition, though the invention has been described in
reference to several examples, optionally incorporating various
features, the invention is not to be limited to that which is
described or indicated as contemplated with respect to each
variation of the invention. Various changes may be made to the
invention described and equivalents (whether recited herein or not
included for the sake of some brevity) may be substituted without
departing from the true spirit and scope of the invention. In
addition, where a range of values is provided, it is understood
that every intervening value, between the upper and lower limit of
that range and any other stated or intervening value in that stated
range is encompassed within the invention.
[0043] Also, it is contemplated that any optional feature of the
inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein. Reference to a singular item, includes
the possibility that there are plural of the same items present.
More specifically, as used herein and in the appended claims, the
singular forms "a," "an," "said," and "the" include plural
referents unless the specifically stated otherwise. In other words,
use of the articles allow for "at least one" of the subject item in
the description above as well as the claims below. It is further
noted that the claims may be drafted to exclude any optional
element. As such, this statement is intended to serve as antecedent
basis for use of such exclusive terminology as "solely," "only" and
the like in connection with the recitation of claim elements, or
use of a "negative" limitation.
[0044] Without the use of such exclusive terminology, the term
"comprising" in the claims shall allow for the inclusion of any
additional element--irrespective of whether a given number of
elements are enumerated in the claim, or the addition of a feature
could be regarded as transforming the nature of an element set
forth n the claims. Except as specifically defined herein, all
technical and scientific terms used herein are to be given as broad
a commonly understood meaning as possible while maintaining claim
validity.
[0045] The breadth of the present invention is not to be limited to
the examples provided and/or the subject specification, but rather
only by the scope of the claim language.
* * * * *