U.S. patent application number 11/049019 was filed with the patent office on 2006-08-03 for filter system and method.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to William J. Drasler, Mark L. Jenson, Daniel M. Lafontaine.
Application Number | 20060173490 11/049019 |
Document ID | / |
Family ID | 36168792 |
Filed Date | 2006-08-03 |
United States Patent
Application |
20060173490 |
Kind Code |
A1 |
Lafontaine; Daniel M. ; et
al. |
August 3, 2006 |
Filter system and method
Abstract
A filter system, comprising an elongate filter body defining a
lumen and having a proximal end and a distal end. A valve can be
provided defining a lumen and having a reversibly sealable opening
for unidirectional flow of a fluid through the lumen. The valve can
be adjoined proximal the distal end of the elongate filter body,
wherein the elongate filter body filters the unidirectional flow of
the fluid passing through the lumen of the valve and the lumen of
the elongate filter body.
Inventors: |
Lafontaine; Daniel M.;
(Plymouth, MN) ; Jenson; Mark L.; (Greenfield,
MN) ; Drasler; William J.; (Minnetonka, MN) |
Correspondence
Address: |
BROOKS & CAMERON, PLLC
1221 NICOLLET AVENUE
SUITE 500
MINNEAPOLIS
MN
55403
US
|
Assignee: |
Boston Scientific Scimed,
Inc.
|
Family ID: |
36168792 |
Appl. No.: |
11/049019 |
Filed: |
February 1, 2005 |
Current U.S.
Class: |
606/200 |
Current CPC
Class: |
A61F 2002/018 20130101;
A61F 2210/0019 20130101; A61F 2002/016 20130101; A61F 2/2418
20130101; A61F 2/2433 20130101; A61F 2230/008 20130101; A61F
2230/0069 20130101; A61F 2230/0006 20130101; A61F 2/011 20200501;
A61F 2220/0066 20130101; A61F 2/013 20130101; A61F 2220/005
20130101; A61F 2/958 20130101 |
Class at
Publication: |
606/200 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. A filter system, comprising: an elongate filter body including
an expandable filter region defining a lumen; and a valve defining
a lumen and having a reversibly sealable opening for unidirectional
flow of a fluid through the lumen, the valve adjoined the
expandable filter region of the elongate filter body, wherein the
expandable filter region filters the unidirectional flow of the
fluid passing through the lumen of the valve and the lumen of the
expandable filter region.
2. The filter system of claim 1, wherein the expandable filter
region moves between a first configuration and a second
configuration.
3. The filter system of claim 2, wherein the expandable filter
region expands from the first configuration to the second
configuration under pressure of the unidirectional flow of the
fluid.
4. The filter system of claim 1, wherein the elongate filter body
further includes a fluid tight plug, wherein the fluid tight plug
directs the unidirectional flow of the fluid from the lumen through
the expandable filter region to filter the unidirectional flow of
the fluid.
5. The filter system of claim 1, wherein the lumen of the valve and
the lumen of the expandable filter region form a single lumen for
the unidirectional flow of the fluid.
6. The filter system of claim 1, wherein the valve includes a
support frame for supporting a cover, the cover including at least
one valve leaflet reversibly sealable for the unidirectional flow
of a fluid through the lumen of the valve.
7. The filter system of claim 6, wherein the support frame includes
a first configuration and a second configuration, the first
configuration being a compressed configuration and the second
configuration being an expanded configuration.
8. A filter system, comprising: an elongate filter body including
an elongate filter region having a lumen; and a valve having a
lumen, the valve adjoined to the elongate filter region, wherein
the lumen of the valve and the lumen of the elongate filter region
form a single lumen.
9. The filter system of claim 8, wherein the valve includes a
reversibly sealable opening for unidirectional flow of a fluid
through the single lumen.
10. The filter system of claim 9, wherein the elongate filter
region expands to filter the fluid.
11. The filter system of claim 10, wherein the expandable filter
region moves between a compressed configuration and an expanded
configuration.
12. The filter system of claim 11, wherein the expandable filter
region expands from the compressed configuration to the expanded
configuration under pressure of the unidirectional flow of the
fluid.
13. The filter system of claim 12, wherein the elongate filter body
further includes a fluid tight plug, wherein the fluid tight plug
directs the unidirectional flow of the fluid from the lumen through
the expandable filter region to filter the unidirectional flow of
the fluid.
14. The filter system of claim 13, wherein the fluid tight plug
includes a conical region to direct the fluid from the single lumen
through the expandable filter region to filter the fluid.
15. A filter system, comprising: an elongate filter body including
an expandable filter region defining a lumen; a valve defining a
lumen and having a reversibly sealable opening for unidirectional
flow of a fluid through the lumen of the valve, the valve adjoined
to the elongate filter region, wherein the elongate filter region
filters the unidirectional flow of the fluid passing through the
lumen of the valve and the lumen of the elongate filter region; and
a sheath having a lumen, the valve and at least a portion of the
elongate filter region reversibly positioned within the lumen of
the sheath.
16. The filter system of claim 15, wherein the valve and the
elongate filter region move longitudinally within the lumen of the
sheath to extend and retract the valve and at least a portion of
the elongate filter region.
17. The filter system of claim 16, wherein the valve and at least a
portion of the elongate filter region move between a compressed
configuration and an expanded configuration as the valve and the
portion of the elongate filter region extend from the lumen of the
sheath.
18. The filter system of claim 16, wherein the valve and at least a
portion of the elongate filter region move between the expanded
configuration and the compressed configuration as the valve and the
portion of the elongate filter region retracts into the lumen of
the sheath.
19. The filter system of claim 15, wherein the elongate filter body
further includes a fluid tight plug, wherein the fluid tight plug
directs the unidirectional flow of the fluid from the lumen through
the expandable filter region to filter the unidirectional flow of
the fluid.
20. The filter system of claim 19, further including a deployment
rod having a proximal and a distal end, the deployment rod
extending through a portion of the lumen of the elongate filter
body from a proximal end of the elongate filter body to the fluid
tight plug, wherein the deployment rod moves within the lumen of
the elongate filter body to extend and retract the valve and at
least a portion of the elongate filter region.
21. The filter system of claim 16, further including a catheter,
the catheter including: an elongate body having a first lumen
extending between a proximal end and a distal end of the elongate
body; a first cutting head having a blade and an elongate pulling
member, the first cutting head positioned proximal the distal end
of the elongate body with the elongate pulling member extending
through the first lumen, wherein the elongate pulling member slides
within the first lumen to move the first cutting head relative the
distal end of the elongate body; and a second cutting head having a
blade, the second cutting head positioned adjacent the distal end
of the elongate body between the distal end and the first cutting
head, where the blade of the first cutting head moves relative the
blade of the second cutting head to provide a shearing action for
cardiac tissue, wherein the catheter extends through the lumen of
the elongate filter body including the expandable filter region and
the lumen of the valve.
22. The filter system of claim 21, wherein the elongate body
further includes; a second lumen extending between the proximal end
and the distal end of the elongate body; an inflatable balloon
positioned adjacent the distal end of the elongate body and
proximal to the second cutting head, the inflatable balloon in
fluid tight communication with the second lumen; and an expandable
stent positioned over at least a portion of the inflatable balloon,
where the inflatable balloon deploys the expandable stent over
sheared cardiac tissue.
23. The filter system of claim 22, further including an annular
push ring positioned between the second cutting head and the
inflatable balloon for contacting and moving at least a portion of
the sheared cardiac tissue.
24. The filter system of claim 23, further including: a cardiac
valve including a reversibly sealable opening for unidirectional
flow of a liquid through a lumen of the cardiac valve, the cardiac
valve releasably positioned over the inflatable balloon.
25. A system, comprising: an elongate filter body including an
expandable filter region, the elongate filter body and the
expandable filter region defining a lumen and having a proximal end
and a distal end; a first cutting head having a blade and an
elongate pulling member, the first cutting head positioned proximal
the distal end of the elongate body with the elongate pulling
member extending through a first lumen of a catheter, wherein the
elongate pulling member slides within the first lumen to move the
first cutting head relative the distal end of the elongate body; a
second cutting head having a blade, the second cutting head
positioned adjacent the distal end of the elongate body between the
distal end and the first cutting head, where the blade of the first
cutting head moves relative the blade of the second cutting head to
provide a shearing action for cardiac tissue, wherein the catheter
extends though the lumen of the elongate filter body and the lumen
of the valve; a second lumen of a catheter extending between the
proximal end and the distal end of the elongate body; the
inflatable balloon positioned adjacent the distal end of the
elongate body and proximal to the second cutting head, the
inflatable balloon in fluid tight communication with the second
lumen; a cardiac valve including a reversibly sealable opening for
unidirectional flow of a liquid through a lumen of the cardiac
valve, the cardiac valve releasably positioned over the inflatable
balloon; and the expandable stent positioned over at least a
portion of the inflatable balloon, where the inflatable balloon
deploys the cardiac valve and expandable stent over sheared cardiac
tissue.
26. The system of claim 25, further including an annular push ring
positioned between the second cutting head and the inflatable
balloon for contacting and moving at least a portion of the sheared
cardiac tissue.
27. A method, comprising: providing an elongate filter body
including an expandable filter region defining a lumen; providing a
valve defining a lumen and having a reversibly sealable opening for
unidirectional flow of a fluid through the lumen; and adjoining the
valve to the elongate filter region to form a single lumen through
which the fluid flows through the valve and the elongate filter
region to filter the fluid.
28. The method of claim 27, wherein the expandable filter region
filters the fluid.
29. The method of claim 28, wherein the expandable filter region
moves between a first configuration and a second configuration
under pressure of the unidirectional flow of the fluid, the first
configuration being a compressed configuration and the second
configuration being an expanded configuration.
30. The method of claim 27, wherein the elongate filter body
further includes a fluid tight plug, wherein the fluid tight plug
directs the unidirectional flow of the fluid from the lumen through
the expandable filter region to filter the unidirectional flow of
the fluid.
31. The method of claim 27, wherein the valve includes a support
frame for supporting a cover, the cover including at least one
valve leaflet reversibly sealable for the unidirectional flow of a
fluid through the lumen of the valve.
32. The method of claim 31, wherein the support frame includes a
first configuration and a second configuration, the first
configuration being a compressed configuration and the second
configuration being an expanded configuration.
33. The method of claim 27, further including: providing a catheter
having an elongate body with a proximal end and a distal end and
having a first lumen; providing a first cutting head having a blade
and an elongate pulling member, the first cutting head positioned
proximal the distal end of the elongate body with the elongate
pulling member extending through the first lumen, wherein the
elongate pulling member slides within the first lumen to move the
first cutting head relative the distal end of the elongate body;
and providing a second cutting head having a blade, the second
cutting head positioned adjacent the distal end of the elongate
body between the distal end and the first cutting head, where the
blade of the first cutting head moves relative the blade of the
second cutting head to provide a shearing action for cardiac
tissue, wherein the catheter extends though the lumen of the
elongate filter body and the lumen of the valve.
34. The method of claim 33, further including: providing a second
lumen extending between the proximal end and the distal end of the
elongate body; providing the inflatable balloon positioned adjacent
the distal end of the elongate body and proximal to the second
cutting head, the inflatable balloon in fluid tight communication
with the second lumen; and providing the expandable stent
positioned over at least a portion of the inflatable balloon, where
the inflatable balloon deploys the expandable stent over sheared
cardiac tissue.
35. The method of claim 34, further including: providing an annular
push ring positioned between the second cutting head and the
inflatable balloon for contacting and moving at least a portion of
the sheared cardiac tissue.
36. The method of claim 34, further including: providing a cardiac
valve positioned over the inflatable balloon, the cardiac valve
including a reversibly sealable opening for unidirectional flow of
a liquid through a lumen of the cardiac valve.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to apparatus,
systems, and methods for use in a lumen; and more particularly to a
valve and filter apparatus, system, and method for use in the
vasculature system.
BACKGROUND OF THE INVENTION
[0002] Cardiac valves can become damaged and/or diseased for a
variety of reasons. Damaged and/or diseased cardiac valves are
grouped according to which valve or valves are involved, and the
amount of blood flow that is disrupted by the damaged and/or
diseased valve. The most common cardiac valve diseases occur in the
mitral and aortic valves. Diseases of the tricuspid and pulmonary
valves are fairly rare.
[0003] The aortic valve regulates the blood flow from the heart's
left ventricle into the aorta. The aorta is the main artery that
supplies oxygenated blood to the body. As a result, diseases of the
aortic valve can have a significant impact on an individual's
health. Examples of such diseases include aortic regurgitation and
aortic stenosis.
[0004] Aortic regurgitation is also called aortic insufficiency or
aortic incompetence. It is a condition in which blood flows
backward from a widened or weakened aortic valve into the left
ventricle of the heart. In its most serious form, aortic
regurgitation is caused by an infection that leaves holes in the
valve leaflets. Symptoms of aortic regurgitation may not appear for
years. When symptoms do appear, it is because the left ventricle
must work harder relative to an uncompromised aortic valve to make
up for the backflow of blood. The ventricle eventually gets larger
and fluid backs up.
[0005] Aortic stenosis is a narrowing or blockage of the aortic
valve. Aortic stenosis occurs when the valve leaflets of the aorta
become coated with deposits. The deposits change the shape of the
leaflets and reduce blood flow through the valve. Again, the left
ventricle has to work harder relative to an uncompromised aortic
valve to make up for the reduced blood flow. Over time, the extra
work can weaken the heart muscle.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIGS. 1A-1B illustrate an embodiment of a filter system.
[0007] FIGS. 2A-2B illustrate another embodiment of a filter
system.
[0008] FIGS. 3A-3C illustrate another embodiment of the filter
system.
[0009] FIGS. 4A-4D illustrate another embodiment of the filter
system.
DETAILED DESCRIPTION
[0010] Embodiments of the present invention are directed to a
filter system and method for temporary placement and use in a
lumen. Embodiments of the present invention are also directed to
augmenting cardiac valve function while filtering fluid moving
within the lumen. For example, the filter system and method can be
used to temporarily replace, or augment, an incompetent valve in a
body lumen and/or can be used as a temporary valve during a
procedure to repair or to replace an incompetent valve with a
prosthetic valve.
[0011] Embodiments of the filter system can further include a
sheath that can be used to help position the filter system within a
body lumen, such as an artery or a vein, through minimally-invasive
techniques. In further embodiments, additional structures can be
used in conjunction with the filter system. For example, catheters
having tissue shearing capability, stent delivery capability, and
prosthetic valve delivery capability can also be used in
conjunction with the filter system to aid in the replacement of a
diseased native valve with a prosthetic valve. In an additional
embodiment, the sheath can include a deployment rod to extend and
retract the cardiac valve and filter. After replacement or repair
of a native valve, the filter system can be retracted into the
lumen of the sheath.
[0012] The Figures herein follow a numbering convention in which
the first digit or digits correspond to the drawing Figure number
and the remaining digits identify an element or component in the
drawing. Similar elements or components between different Figures
may be identified by the use of similar digits. For example, 110
may reference element "10" in FIG. 1, and a similar element may be
referenced as 210 in FIG. 2. As will be appreciated, elements shown
in the various embodiments herein can be added, exchanged, and/or
eliminated so as to provide any number of additional embodiments of
the filter system. In addition, the elements shown in the various
embodiments are not necessarily to scale.
[0013] Various embodiments of the invention are illustrated in the
figures. Generally, the filter system can be used to provide a
temporary valve for replacement or repair of a diseased and/or
damaged valve. Other embodiments can be used to provide a temporary
valve and filter during a procedure to repair a diseased or damaged
valve or replace a diseased and/or damaged valve with a permanent
valve. For example, the placement of the valve and filter apparatus
within a body lumen (e.g., within the aorta, adjacent the aortic
valve), can help to provide for a temporary valve and filter to
regulate fluid flow and filter particulate matter from fluid
flowing through the aorta during transluminal cardiac valve repair
and/or replacement.
[0014] FIGS. 1A and 1B illustrate one embodiment of a filter system
100 shown in perspective view. Filter system 100 includes an
elongate filter body 102 including an expandable filter region 150
and a valve 104. FIGS. 1A and 1B provide a perspective illustration
of the valve 104 of filter system 100 in an open configuration
(FIG. 1A) and a closed configuration (FIG. 1B). In addition, the
perspectives illustrated in FIGS. 1A and 1B show the filter system
100 in an expanded configuration, as will be discussed herein.
[0015] In the present embodiments, the elongate filter body 102
defines a lumen 106 extending from a proximal end 108 towards a
distal end 110. In one embodiment, the lumen 106 can be concentric
with an elongate axis of the elongate filter body 102. The valve
104 also defines a lumen 112. In one example, the valve 104 can be
adjoined proximal the distal end 110 of the elongate filter body,
where the lumen 112 of the valve 104 and the lumen 106 of the
elongate filter body 102 can form a single lumen 114. In other
words, the lumens 106 and 112 can be contiguous so as to form the
single lumen 114. Other configurations are also possible.
[0016] In the various embodiments, filter system 100 allows for
both unidirectional flow of fluid and filtering of the fluid
passing through the lumens 106 and 112. With respect to providing
unidirectional flow of the fluid through lumens 106 and 112, the
valve 104 includes a reversibly sealable opening 116. In one
embodiment, the reversibly sealable opening 116 can be formed by
one or more valve leaflets 118. In forming the reversibly sealable
opening 116, the valve leaflets 118 are configured to move between
an open configuration (e.g., FIG. 1A, allowing fluid to flow in a
first direction 193 through the lumens 106 and 112) and a closed
configuration (e.g., FIG. 1B, preventing fluid from flowing in a
second direction 197 opposite the first direction 193).
[0017] The valve 104 can include any number of configurations so as
to define the lumen 112 and provide the reversibly sealable opening
116 for unidirectional flow of the fluid through the lumen 112. For
example, the valve 104 can include a frame 120 that supports a
cover 122. In the various embodiments, the cover 122 defines the
reversibly sealable valve leaflets 118 that provide for the
unidirectional flow of a fluid through the lumen 112 of the valve
104.
[0018] Examples of a valve suitable for use as valve 104 is
illustrated in U.S. patent application Ser. No. ______, entitled
"Venous Valve Apparatus, System, and Method" (B&C Docket No.
201.0020001, BSCI Docket No. 03-340US), and in U.S. patent
application Ser. No. ______, entitled "Venous Valve Apparatus,
System, and Method" (B&C Docket No. 201.0120001, BSCI Docket
No. 04-0080US), both of which are hereby incorporated by reference
in their entirety. As illustrated, frame 120 includes a variety of
structural configurations. Generally, the frame 120 has a curved
structural configuration, as will be discussed herein. For example,
the frame 120 can include a first elliptical member 124 and a
second elliptical member 126, as illustrated in FIGS. 1A and
1B.
[0019] In the various embodiments, the first elliptical member 124
and the second elliptical member 126 meet at a first region 128 and
a second region 130, where the first region 128 and the second
region 130 are opposite each other across axis 132. The first
region 128 and the second region 130 can be located at any number
of locations along the first elliptical member 124 and the second
elliptical member 126. For example, the first region 128 and the
second region 130 can be at or near a minor axis of the first
elliptical member 124 and the second elliptical member 126. In an
additional embodiment, the first region 128 and the second region
130 can be positioned away from the minor axis of the first
elliptical member 124 and the second elliptical member 126.
[0020] While the term elliptical member is used herein, other
shapes are possible for the structural members that help to form a
valve according to the embodiments herein. For example, the frame
120 can include circular members that meet at the first region 128
and the second region 130. Other shapes besides elliptical and
circular are also possible.
[0021] The first elliptical member 124 and the second elliptical
member 126 meet at the first region 128 and the second region 130
at an angle 134. In one embodiment, the size of angle 134 when the
valve 104 is expanded can be selected based upon the type of body
lumen and the body lumen size in which the valve 104 is to be
placed. Additional factors include, but are not limited to, a
longitudinal length 136 and a width 138 of the valve 104. These
factors, along with others discussed herein, can be used to provide
the angle 134 that is sufficient to ensure that the first
elliptical member 124 and the second elliptical member 126 have an
appropriate expansion force against an inner wall of the body lumen
in which the valve 104 is being placed.
[0022] The valve 104 also includes a flexible joint at and/or
around axis 132 that allows the valve 104 to accommodate changes in
body lumen size (e.g., diameter of the body lumen) by increasing or
decreasing angle 134 when the valve 104 is expanded. In addition,
the frame 120 also has the ability to flex, as discussed herein, to
allow for the distance between the first region 128 and the second
region 130 to increase or decrease, thereby further accommodating
changes in the body lumen size (e.g., diameter of the body lumen).
The frame 120 also provides sufficient contact and expansion force
with the surface of a body lumen wall to encourage seating of the
valve 104 and to prevent retrograde flow, i.e., second direction
197, within the body lumen.
[0023] The frame 120 can be formed from a biocompatible metal,
metal alloy, polymeric material, or combinations thereof, which
allow the frame 120 to move radially between the collapsed and
expanded state, as discussed herein. To accomplish this, the
biocompatible metal, metal alloy, or polymeric material should
exhibit a low elastic modulus and a high yield stress for large
elastic strains that can recover from elastic deformations.
Examples of suitable materials include, but are not limited to,
medical grade stainless steel (e.g., 316L), titanium, tantalum,
platinum alloys, niobium alloys, cobalt alloys, alginate, or
combinations thereof. In an additional embodiment, the frame 120
may be formed from a shape-memory material. Examples of a suitable
shape-memory material include, but are not limited to, alloys of
nickel and titanium in specific proportions known in the art as
nitinol. Other materials are also possible.
[0024] The valve 104 can further include one or more radiopaque
markers 152 (e.g., tabs, sleeves, welds). For example, one or more
portions of the frame 120 can be formed from a radiopaque material.
Radiopaque markers can be attached to and/or coated onto one or
more locations along the frame 120. Examples of radiopaque
materials include, but are not limited to, gold, tantalum, and
platinum. The position of the one or more radiopaque markers can be
selected so as to provide information on the position, location and
orientation of the valve 104 during its implantation.
[0025] The valve 104 further includes the cover 122. In the various
embodiments, the cover 122 forms the valve leaflets 118 joined to
valve frame 120. The valve leaflets 118 can deflect between a
closed configuration (FIG. 1B) in which retrograde fluid flow
through the valve 104 is restricted, and an open configuration
(FIG. 1A) in which antegrade fluid flow through the valve 104 is
permitted. In one embodiment, valve leaflets 118 of the valve are
configured to open and close in response to the fluid motion and/or
pressure differential across the valve leaflets 118.
[0026] The example of valve 104 shown in FIGS. 1A and 1B provide
embodiments in which the surfaces defining the reversibly sealable
opening 116 include a first leaflet 140 and a second leaflet 142
coupled to the valve frame 120 to provide a two-leaflet
configuration (i.e., a bicuspid valve) for valve 104. Although the
embodiments illustrated in FIGS. 1A-1B of the present invention
show and describe a two-leaflet configuration for valve 104,
designs employing a different number of valve leaflets (e.g.,
tricuspid valve) are possible and considered within the scope of
the embodiments.
[0027] The valve leaflets 118 can have a variety of sizes and
shapes. For example, each of the valve leaflets 118 (e.g., first
leaflet 140 and second leaflet 142) can have a similar size and
shape. In an additional example, each of the valve leaflets 118
need not have valve leaflets 118 that are of a similar size and
shape (i.e., the valve leaflets can have a different size and
shape).
[0028] Valve frame 120 can include an open frame construction
(i.e., valve frame 120 defines an opening) through which valve
leaflets 118 can radially-collapse and radially-expand. The valve
leaflets 118 can be provided over the open frame construction of
the valve frame 120 to direct fluid flow through reversibly
sealable opening 116 under specific fluid flow conditions. In one
embodiment, the material of the valve leaflets 118 coupled to the
valve frame 120 can be sufficiently thin and pliable so as to
permit radially-collapsing of the valve leaflets 118 for delivery
by catheter to a location within a body lumen.
[0029] In one embodiment, each of the valve leaflets 118 includes
sufficient excess material spanning valve frame 120 such that fluid
pressure (e.g., antegrade flow) acting on the valve leaflets 118
forces the valve 104 into an open configuration (FIG. 1A). Valve
leaflets 118 can further include arcuate edges 144 and 146, as
shown in FIG. 1A, that are positioned adjacent each other along a
substantially catenary curve between the first region 128 and the
second region 130 in the closed configuration (FIG. 1B) of valve
104. Similarly, arcuate edges 144 and 146 can help to define lumen
112 when the valve 104 is in the open configuration (FIG. 1A).
[0030] In an additional embodiment, in the open configuration the
sufficient excess material spanning the valve frame 120 can allow
the valve leaflets 118 to take on a semi-tubular structure, as
shown in FIG. 1A, when fluid pressure opens the valve 104. In an
additional embodiment, arcuate edge 144 and 146 of valve 100 can
open to approximately the full inner diameter of body lumen.
[0031] Each of the valve leaflets 118 can further include a curve
imparted thereto so as to provide a concave structure 148 to the
leaflet 118. The concave structure 148 allows the valve leaflets
118 to better collect retrograde fluid flow to urge valve leaflets
118 towards the closed configuration. For example, as retrograde
flow begins, the valve leaflets 118 respond by moving towards the
center of valve 104. As the valve leaflets 118 approach the center
of the device the valve leaflets 118 make sufficient contact to
effectively close the reversibly sealable opening 116 of valve 104
and thereby restrict retrograde fluid flow.
[0032] In an additional embodiment, the valve leaflets 118 can
include one or more support structures. For example, the valve
leaflets 118 can include one or more support ribs having a
predetermined shape. In one embodiment, the predetermined shape of
the support ribs can include a curved bias so as to provide the
valve leaflets 118 with a curved configuration. Support ribs can be
constructed of a flexible material and have dimensions (e.g.,
thickness, width and length) and cross-sectional shape that allows
the support ribs to be flexible when valve leaflets 118 are urged
into an open position, and stiff when the valve leaflets 118 are
urged into a closed position upon experiencing sufficient back flow
pressure from the direction downstream from the valve. In an
additional embodiment, support ribs can also be attached to valve
frame 120 so as to impart a spring bias to the valve leaflets in
either the open or the closed configuration.
[0033] The valve leaflets 118 can be constructed of a
fluid-impermeable biocompatible material that can be either
synthetic or biologic. Possible synthetic materials include, but
are not limited to, expanded polytetrafluoroethylene (ePTFE),
polytetrafluoroethylene (PTFE),
polystyrene-polyisobutylene-polystyrene, polyurethane, segmented
poly(carbonate-urethane), Dacron, polyethlylene (PE), polyethylene
terephthalate (PET), silk, urethane, Rayon, Silicone, or the like.
Possible biologic materials include, but are not limited to
allogeneic or xenograft material. These include explanted veins and
decellularized basement membrane materials, such as small intestine
submucosa (SIS) or umbilical vein.
[0034] Valve leaflets 118 can be coupled to the various embodiments
of valve frame 120, as described herein, in any number of ways. For
example, a variety of fasteners can be used to couple the material
of the valve leaflets 118 to the valve frame 120. Fasteners can
include, but are not limited to, biocompatible staples, glues, and
sutures. In one embodiment, the material of the valve leaflets 118
can be wrapped at least partially around the valve frame 120 and
coupled using the fastener. In an additional embodiment, valve
leaflets 118 can be coupled to the various embodiments of valve
frame 120 through the use of heat sealing, solvent bonding,
adhesive bonding, or welding the valve leaflets 118 to either a
portion of the valve leaflet 118 (i.e., itself) and/or the valve
frame 120. Valve leaflets 118 can also be attached to valve frame
120 according to the methods described in U.S. Patent Application
Publication US 2002/0178570 to Sogard et al., which is hereby
incorporated by reference in its entirety.
[0035] In an alternative embodiment, the valve 104 can include
three leaflets, with the various frames and covering configurations
as described herein. Further, valve 104 can be configured to extend
proximally and distally in a curvilinear manner to accommodate the
coronary ostia and the diseased valve. For example, leaflets can
extend past the coronary ostia in the central portion of the
leaflets, and extend to accommodate the attachment points of the
diseased valve by incorporating a tri-lobar saddle shaped
configuration. In one embodiment, the valve 104 can include a
configuration that allows the valve 104 to be place functionally
distal to the coronary ostia for proper coronary perfusion, while
maintaining sufficient clearance for the diseased valve and the
repair or replacement of the diseased valve to be performed.
Examples of a three leaflet valve suitable for use as valve 104 are
illustrated in U.S. patent application Ser. No. ______, entitled
"Valve Apparatus, System and Method" (BSCI Atty Docket No.
04-0223US and B&C Atty. Docket No. 201.0170001), and U.S.
patent application Ser. No. ______, entitled "Cardiac Valve,
System, and Method" (BSCI Atty Docket No. 03-487US and B&C Atty
Docket No. 201.0070001), which is hereby incorporated by reference
in its entirety.
[0036] In various embodiments, a portion of the elongate filter
body 102 can include an expandable filter region 150 to filter the
unidirectional flow of the fluid moving through the valve 104. As
used herein, filtering of fluid can be accomplished through use of
the expandable filter region 150 by trapping and/or inhibiting the
passage of particular matter released into and/or present in the
fluid moving through the valve 104. Trapped particulate matter can
then be removed with the filter system 100 through the lumen
106.
[0037] As illustrated in FIGS. 1A-1B, the valve 104 can be adjoined
proximal the distal end 110 of the elongate filter body 102. For
example, the frame 120 of the valve 104 can be coupled to the
expandable filter region 150 proximal the distal end 110 of the
elongate filter body 102. Methods of coupling the frame 120 to the
expandable filter region 150 of the elongate filter body 102 can be
as described herein for coupling the valve leaflets 118 to the
frame 120.
[0038] As will be illustrated herein, the expandable filter region
150 can move between a first configuration (e.g., a compressed
state, shown in FIG. 3A) and a second configuration (e.g., an
expanded state, shown in FIGS. 1A-1B and FIGS. 2A-2B). In one
embodiment, the expandable filter region 150 can expand from the
first configuration to the second configuration due to force
imparted by the frame 120 as it expands. In addition, the
expandable filter region 150 can expand from the first
configuration to the second configuration by a combination of force
imparted by the frame 120 as it expands and under pressure of the
unidirectional flow of the fluid. Additionally, the force imparted
by the frame when the valve is in the open configuration can help
to maintain the expandable filter region expanded when under
retrograde fluid flow, such as when the valve is in a closed
configuration. In an additional embodiment, the expandable filter
region 150 can be configured to radially self-expand when released
from a compressed state.
[0039] In the various embodiments, the expandable filter region 150
in its deployed state can fill the cross-section area of the lumen
in which the expandable filter region 150 and valve 104 are
deployed. In addition, filter region 150 in its deployed state can
apply sufficient pressure to the inner wall of the lumen to reduce
the volume of fluid (e.g., blood) that may pass between the filter
region 150 and the surface of the lumen wall. In one embodiment,
the valve frame 120 can be used at least in part to apply the
sufficient pressure to the inner wall of the body lumen. As will be
appreciated, the area and shape defined by the expandable filter
region 150 (e.g., the diameter of the expandable filter region) in
its deployed state can be dependent upon the location in which the
apparatus is intended to be used.
[0040] Examples of expandable filter region 150 include those
having a woven, braided and/or a knit configuration as the same
will be known and understood by one of ordinary skill in the art.
Alternatively, the expandable filter regions 150 can be formed of a
material having pores formed therein or imparted thereto. In the
various embodiments, the expandable filter regions 150 can be
formed of a number of materials. Materials can include polymers,
such as ePTFE, PTFE, polystyrene-polyisobutylene-polystyrene,
polyurethane, segmented poly(carbonate-urethane), Dacron, PE, PET,
silk, urethane, Rayon, Silicone, polyamid, mixtures, and block
co-polymers thereof.
[0041] In one embodiment, expandable filter region 150 can be
configured to reduce passage of potentially injurious emboli to
arteries feeding the brain, heart, kidneys, and other tissues and
organs. For example, expandable filter region 150 can help to
reduce or prevent passage of emboli greater than about 5 to 1000
micrometers in cross-sectional size. Expandable filter region 150
may also prevent passage of emboli larger than 50 to 200
micrometers in cross-sectional size. Multiple regions or layers of
expandable filter region 150 may be incorporated to more
efficiently filter emboli, such as a 200 micrometer portion of the
expandable filter region 150 to capture larger particles and a 75
micrometer portion of the expandable filter region 150 to capture
smaller particles.
[0042] Additional examples of the expandable filter region 150
include the radially self-expanding configurations formed from
temperature-sensitive memory alloy which changes shape at a
designated temperature or temperature range. Examples of such
materials include, but are not limited to, nitinol and nitinol-type
metal alloys. Alternatively, self-expanding configurations for the
expandable filter region 150 include those having a spring-bias
imparted into the members forming the filter region 150. The
expandable filter region 150 can have a woven, braided and/or a
knit configuration that can also impart a self-expanding aspect to
the expandable filter region 150.
[0043] In an additional embodiment, the filter region 150 can
further include radiopaque markers 152. For example, radiopaque
markers (e.g., attached or coated) can be used to mark the location
of the valve 104 and/or the expandable filter region 150. Other
portions of filter system 100 can also be marked with radiopaque
markers as necessary to allow for visualization of the location and
position of parts of the filter system 100.
[0044] The elongate filter body 102 can further include a fluid
tight plug 154 positioned within the lumen 106 of the elongate
filter body 102. In one embodiment, the fluid tight plug 154 can be
positioned proximal the expandable filter region 150 so as to
occlude the lumen 106, thereby directing the unidirectional flow of
the fluid from the lumen 106 through the expandable filter region
150.
[0045] The fluid tight plug 154 can have a variety of shapes and
configurations. For example, a first end 155 and a second end 157
of the fluid tight plug 154 can include a flat planar surface. In
an alternative embodiment, the first end 155 of the fluid tight
plug can include a conical configuration, as shown in FIGS. 1A and
1B. Other shapes and configurations for the fluid tight plug 154
are also possible.
[0046] FIGS. 2A and 2B illustrate an additional embodiment of a
filter system 200. FIGS. 2A and 2B provide a perspective
illustration of the filter system 200 that includes both the
elongate filter body 202, as described herein, and the valve 204.
In the present example, however, the valve 204 includes a frame 220
and a cover 222, including valve leaflets 240 and 242 (shown in
FIG. 2A), having a different configuration as compared to the valve
104 described above in FIGS. 1A and 1B. One example of valve 204 is
illustrated in U.S. patent application Ser. No. ______, entitled
"Venous Valve Apparatus, System, and Method" (B&C Docket No.
201.0010001, BSCI Docket No. 03-341US), which is hereby
incorporated by reference in its entirety.
[0047] The frame 220 of valve 204 includes an outer surface 256 and
an inner surface 258 opposite the outer surface 256. The inner
surface 258 defines the lumen 212 of the valve 204 for passing
fluid therethrough. The frame 220 also includes a first end 262 and
a second end 260. In one embodiment, the cover 222 can be located
over at least the outer surface 256 of the frame 220. For example,
the cover 222 can extend around a perimeter of the frame 220 so as
to completely cover the outer surface 256 of the frame 220. In
other words, the cover 222 extends over the outer surface of the
frame 220 so that there are no exposed portions of the outer
surface 256 of the frame 220. In an additional embodiment, the
cover 222 can also be located over at least the inner surface 258
of the frame 220. A further embodiment includes the cover 222
located over at least the outer surface 256 and the inner surface
258.
[0048] In one embodiment, the frame 220 can include an open frame
configuration that includes a first vertex 263 and a second vertex
264 relative the second end 260 of the frame 220. Frame 220 can
further include a first valley 266 and a second valley 268 adjacent
the second end 260 relative the first vertex 263 and the second
vertex 264. As illustrated in FIGS. 2A and 2B, the first vertex 263
and the second vertex 264 can be positioned opposite each other
along a common axis 270 (shown in FIG. 2B). FIGS. 2A and 2B also
illustrate that the first valley 266 and the second valley 268 can
be positioned opposite each other and perpendicular to axis 270.
Other relative positions for the first and second vertex 263 and
264, and the first and second valley 266 and 268 are also possible.
As one of ordinary skill will understand, more than two vertexes
and valleys may be included in the embodiments. For example, where
an embodiment includes three valve leaflets, e.g., a tricuspid
valve, three vertexes and three valleys can also be included to
help form the three leaflets.
[0049] The cover 222 can further include valve leaflets 240 and 242
that define the reversibly sealable opening 216 for the
unidirectional flow of the fluid through the lumen 212. For
example, the surfaces of the cover 222 can be deflectable between a
closed configuration (FIG. 2B) in which fluid flow through the
lumen 212 can be restricted and an open configuration (FIG. 2A) in
which fluid flow through the lumen 212 can be permitted in response
to the fluid motion and/or pressure differential across the valve
leaflets 240 and 242.
[0050] The example of valve 204 shown in FIGS. 2A and 2B provide
embodiments in which the surfaces defining the reversibly sealable
opening 216 include the first leaflet 240 and the second leaflet
242 coupled to the valve frame 220 to provide a two-leaflet
configuration (i.e., a bicuspid valve) for valve 204. Although the
embodiments illustrated in FIGS. 2A and 2B of the present invention
show and describe a two-leaflet configuration for valve 204,
designs employing a different number of valve leaflets (e.g.,
tricuspid valve) are also possible.
[0051] In one embodiment, each of the valve leaflets 240 and 242
include sufficient excess material spanning valve frame 220 such
that fluid pressure (e.g., antegrade flow) acting on the valve
leaflets 240 and 242 forces the valve 204 into an open
configuration (FIG. 2A). Valve leaflets 240 and 242 further include
arcuate edges, as illustrated in FIGS. 1A and 1B and shown as 144
and 146, that are positioned adjacent each other along a
substantially catenary curve between the first vertex 263 and the
second vertex 264 in the closed configuration (Figure B) of valve
204. Similarly, arcuate edges 244 and 246 can help to define lumen
212 when the valve 204 is in the open configuration (FIG. 2A).
[0052] In an additional embodiment, in the open configuration the
sufficient excess material spanning the valve frame 220 between the
first vertex 263 and the second vertex 264 can allow the valve
leaflets 240 and 242 to take on a semi-tubular structure, as shown
in FIG. 2A, when fluid pressure opens the valve 204. In an
additional embodiment, arcuate edge 244 and 246 of valve 204 can
open to approximately the full inner diameter of body lumen.
[0053] Each of the valve leaflets 240 and 242 can further include a
curve imparted thereto so as to provide a concave structure to the
leaflet 240 and 242. The concave structure allows the valve
leaflets 240 and 242 to better collect retrograde fluid flow to
urge valve leaflets 240 and 242 towards the closed configuration
(FIG. 2B). For example, as retrograde flow begins, the valve
leaflets 240 and 242 respond by moving towards the center of valve
204. As the valve leaflets 240 and 242 approach the center of the
device the valve leaflets 240 and 242 can make sufficient contact
to effectively close the reversibly sealable opening 116 of valve
104 and thereby restrict retrograde fluid flow, i.e., second
direction 197 as shown in FIGS. 1A and 1B.
[0054] FIGS. 3A and 3B provide a further illustration of the filter
system 300 (i.e., the elongate filter body 302, valve 304, and
filter region 350) that includes a sheath 374 having a lumen 376.
FIGS. 3A and 3B provide a sectional illustration of the filter
system 300 at least partially contained within a lumen 376 of the
sheath 374 (FIG. 3A) and of the filter system 300 at least
partially deployed from the lumen 376 of the sheath 374 (FIG.
3B).
[0055] In various embodiments, both the valve 304 and the filter
region 350 of the elongate filter body 302 can be releasably
positioned in a coaxial arrangement within the lumen 376 of the
sheath 374. As discussed herein, the configuration of the support
frame 320 provides the valve 304 with sufficient flexibility to
move between the first configuration 342 (e.g., a retracted state
within the lumen 376 of the sheath 374 as shown in FIG. 3A) and the
second configuration 344 (e.g., an extended state outside the lumen
376 of the sheath 374 as shown in Figures FIG. 3B).
[0056] In one embodiment, the valve 304 can be configured to reside
in the compressed state when retracted within the lumen 376 of the
sheath 374, as illustrated in FIG. 3A, and in an expanded state
when extended from the lumen 376 of the sheath 374, as illustrated
in FIG. 3B. In one embodiment, the valve 304 expands from its
compressed state within the lumen 376 to the deployed state when
the sheath 374 is retracted from around the valve 304.
[0057] The sheath 374 can be formed of a number of materials.
Materials include polymers, such as PVC, PE, POC, PET, polyamid,
mixtures, and block co-polymers thereof. In addition, the sheath
374 can have a wall thickness and an inner diameter sufficient to
maintain both the valve 304 and the expandable filter region 350 in
the retracted state when they are positioned within the lumen 376.
In an additional embodiment, the sheath 374 can further include
radiopaque markers 352. For example, radiopaque markers (e.g.,
attached or coated) can be used to mark the location and allow for
visualization of the location and position of parts of the sheath
374.
[0058] In the various embodiments, the support frame 320 of the
cardiac valve 304 expands to increase the diameter 312 of the lumen
306 of the valve 304 as the valve 304 is extended from the sheath
374. In one embodiment, the diameter 312 of the lumen 306 can be
determined based upon the type of body lumen and the body lumen
size in which the valve 304 is to be placed. In an additional
example, there can also be a minimum value for the width for the
support frame 320 that ensures that the valve 304 will have an
appropriate expansion force against the inner wall of the body
lumen to prevent retrograde flow within the body lumen.
[0059] In addition, the lumen 306 of the elongate filter body 302
in the filter region 350 also increases in diameter as the valve
304 and the elongate filter body 302 are extended from the sheath
374. In one embodiment, the expandable filter region 350 can expand
from the first configuration to the second configuration due in
part to force imparted by the frame 320 as it expands and under
pressure of the unidirectional flow of the fluid. In an additional
embodiment, the expandable filter region 350 can be configured to
radially self-expand, as the same has been described herein, when
released from its compressed state within the lumen 376 of the
sheath 374.
[0060] The expandable filter region 350 in its deployed state can
fill the cross-section area of a body lumen in which the valve 304
and expandable filter region 350 are deployed. In addition, filter
region 350 in its deployed state can apply sufficient pressure to
the inner wall of the body lumen to reduce the volume of fluid
(e.g., blood) that may pass between the filter region 350 and the
surface of the body lumen wall. As will be appreciated, the area
and shape defined by the expandable filter region 350 (e.g., the
diameter of the expandable filter) in its deployed state will be
dependent upon the location in which the filter system is intended
to be used.
[0061] The filter system 300 can be extended and retracted from the
lumen 376 of the sheath 374 in any number of ways. For example, the
elongate filter body 302 can be pulled longitudinally within the
lumen 376 of the sheath 374 so as to retract the valve 304 and the
filter region 350 of the elongate filter body 302. In this
embodiment, the elongate filter body 302, supported by the sheath
374, provides sufficient column strength to allow force imparted at
the proximal end 308 of the elongate filter body 302 to retract the
valve 304 and the filter region 350.
[0062] In an additional embodiment, a portion of the elongate
filter body 302 extending from the filter region 350 to the
proximal end 308 can be reinforced and/or have an alternative
construction relative the filter region 350 so as to impart
sufficient column strength to the elongate filter body 302. The
elongate filter body 302 can then be pushed longitudinally within
the lumen 376 of the sheath 374 so as to extend the valve 304 and
the filter region 350 of the elongate filter body 302.
[0063] In an additional embodiment, the valve 304 and the filter
region 350 can be deployed and retracted by moving the sheath 374
relative the elongate filter body 302. In this embodiment, the
elongate filter body 302 can be held while the sheath 374 is moved
longitudinally so as to either deploy or retract the valve 304 and
the filter region 350.
[0064] The filter system 300 and the sheath 374 can further include
handles positioned at the proximal end 308 of the elongate filter
body 302 and a first sheath end 378 of the sheath 374. In one
embodiment, the sheath 374 includes a handle 382 and the elongate
filter body 302 includes a handle 384. Handles 382 and 384 allow
the sheath 374 and the elongate filter body 302 to move relative to
each other so as to extend and/or retract the valve and a portion
of the elongate filter body from the lumen 376 of the sheath 374.
In one embodiment, the distance between the handles 382 and 384 can
correspond approximately to the length of the compacted valve 304
and the filter region 350 to effectively deploy the expandable
filter region 350 and valve 304. Other configurations and
relational lengths are possible.
[0065] In an additional embodiment, filter system 300 and the
sheath 374 can further include a sleeve 386 having a slit 388 and a
pull tab 390 positioned between the handles during delivery to
prevent inadvertent exposure of the valve 304 and filter region
350. For example, the sleeve 386 can be stripped from the filter
system 300 by pulling the pull tab once the sheath 374 has been
placed at the predetermined location at which the valve 304 and the
filter region 350 are to be deployed. Other removable structures
for preventing inadvertent exposure of the valve 304 and filter
region 350 are also possible.
[0066] In an additional embodiment, the filter system 300, as shown
in FIG. 3C can be extended and/or retracted from the sheath 374
through the use of a deployment rod 394. In one embodiment, the
deployment rod 394 extends from the proximal end 308 of the
elongate filter body 302 through the lumen 376 to the fluid tight
plug 354, as the same has been described in connection with FIGS.
1A and 1B. In one embodiment, the deployment rod 394 can be used to
move the elongate filter body 302 and the valve 304 relative the
sheath 374.
[0067] For example, the deployment rod 394 can extend through the
lumen 312 to the fluid tight plug 354, where the deployment rod 394
can be used to push the filter system 300 relative the sheath 374
to deploy the valve 304 and the filter region 350 and/or pull the
filter system 300 relative the sheath 374 to draw the valve 304 and
the filter region 350 back into its compressed state within the
lumen 376 of the sheath 374. Alternatively, the deployment rod 394
can be used to change the position of the valve 304 and filter
region 350 once deployed from a first position within the lumen to
a second position.
[0068] In the various embodiments, the deployment rod 394 and the
fluid tight plug 354 can further include releasably interconnecting
members to allow the deployment rod 394 and the fluid tight plug
354 to be separated. For example, the fluid tight plug 354 can
include a socket having threads to receive and interact with a
threaded portion of the deployment rod 394. This structure allows
for the deployment rod 394 to be inserted through the lumen 376 of
the elongate filter body 302 to the fluid tight plug 354, where the
treaded portion of the deployment rod 394 can be screwed into the
threaded socket of the fluid tight plug 354. The deployment rod 394
can then be removed from the lumen 376 by unscrewing the threaded
portion of the deployment rod 394 from the threaded socket of the
fluid tight plug 354. As will be appreciated, other ways of
decoupling the deployment rod 394 and the fluid tight plug 354 are
also possible.
[0069] In one embodiment, the deployment rod 394 can be formed of a
number of materials. Materials include polymers, such as PVC, PE,
POC, PET, polyamid, mixtures, and block co-polymers thereof. In
addition, the deployment rod 394 can be formed of medical grade
stainless steel (e.g., 316L), titanium, tantalum, platinum alloys,
niobium alloys, cobalt alloys, alginate, or combinations
thereof.
[0070] FIGS. 4A-4D provides a further illustration of the filter
system 400 that includes the sheath 474, as previously discussed,
and a catheter 401 and an apparatus 445. FIGS. 4A-4D provide
perspective illustrations of the filter system 400 at least
partially contained within the lumen 476 of the sheath 474, with
the catheter 401 and the apparatus 445 at least partially contained
within a lumen 406 of the elongate filter body 402.
[0071] Examples of the catheter 401 and the apparatus 445 are
illustrated in U.S. patent application Ser. No. ______, entitled
"Vascular Catheter, System, and Method" (B&C Docket No.
201.0080001, BSCI Docket No. 03-498US), which is hereby
incorporated by reference in its entirety. In the various
embodiments, the catheter 401 includes an elongate body 403 having
a first lumen 405 extending between a proximal end 407 and a distal
end 409. In one embodiment, the first lumen 405 allows for
additional elongate members to travel along a longitudinal axis of
the elongate body 402.
[0072] The catheter 401 further includes a first cutting head 411
having a blade 413 and an elongate pulling member 415. The first
cutting head 411 can be positioned adjacent the distal end 409 of
the elongate body 403 of the catheter 401 with the elongate pulling
member 415 extending through the first lumen 405. In one
embodiment, the elongate pulling member 415 can slide within the
first lumen 405 to move the first cutting head 411 relative the
distal end 409 of the elongate body 403 of the catheter 401.
[0073] The catheter 401 also includes a second cutting head 417
having a blade 419. The second cutting head 417 can be positioned
adjacent the distal end 409 of the elongate body 403 between the
distal end 409 and the first cutting head 411. The blade 413 of the
first cutting head 411 can move relative the blade 419 of the
second cutting head 417 to provide a shearing action. In one
example, the shearing action can be sufficient for cutting cardiac
tissue.
[0074] FIG. 4A further illustrates an embodiment in which the
second cutting head includes an elongate pushing member 421. In one
embodiment, the elongate pushing member 421 can slide within the
first lumen 405 to move the second cutting head 417 relative the
distal end 409 of the elongate body 403 and the first cutting head
411. In one embodiment, the elongate pulling member 415 can be
arranged concentrically with the elongate pushing member 421 in the
first lumen 405.
[0075] As illustrated, the elongate pulling member 415, the
elongate pushing member 421 and the first lumen 405 of the elongate
body 403 can be positioned coaxially. In one embodiment, the lumen
405 has a diameter sufficient to accommodate the elongate pushing
member 421. Similarly, the elongate pushing member 421 had a
diameter sufficient to accommodate the elongate pulling member
415.
[0076] In addition, the elongate pulling member 415 and the
elongate pushing member 421 can be structured such that their
relative rotational movement is restricted. In other words,
relative axial rotation of the elongate pulling member 415 and the
elongate pushing member 421 is restricted due to the structure of
the members 415 and 421. For example, this can be accomplished
using one or more physical structures formed in and/or attached to
the members 415 and 421. In one embodiment, one of the members 415
or 421 can include a channel through which an extension from the
other of the members 415 or 421 can travel so as to inhibit axial
rotation of the members 415 and 421. Alternatively, the members 415
and 421 could have a cross-sectional shape that inhibits relative
axial rotation. Examples of such cross-sectional shapes include
oval or elliptical cross-sectional shapes. Other shapes are also
possible.
[0077] In addition to providing a sufficient diameter, a gap can
exist between the opposing surfaces of the first lumen 405 and the
elongate pushing member 421 to allow the elongate pushing member
421 to move through the first lumen 405 from force applied at the
proximal end of the elongate pushing member 421. Similarly, a gap
can exist between the opposing surfaces of the elongate pushing
member 421 and the elongate pulling member 415 to allow the
elongate pushing member 421 and the elongate pulling member 415 to
move relative each other from force applied at the proximal end of
the elongate pushing member 421 and/or the elongate pulling member
415. The elongate pull member 415 can further include a lumen 471
for tracking over a guidewire. A lubricant can be included on the
surfaces of the elongate pulling member 415, the elongate pushing
member 421 and the first lumen 405.
[0078] The first cutting head 411 further includes a shape
conducive to passing the catheter 401 and the filter system 400
through a body lumen (e.g., a lumen of the cardiovascular system).
For example, the first cutting head 411 can include a conical shape
having a first end 423 and a second end 425, where the first end
423 has a diameter that is less than a diameter of the second end
425. Other shapes are also possible. In addition, the shape of the
first cutting head 411 can be configured to protectively house the
blade 413 from structures passing by the first end 423 towards the
second end 425. In other words, the shape of the first cutting head
411 can be used to shield the blade 413 from unintentionally
interfering and/or cutting tissue within a body lumen.
[0079] In one embodiment, the blade 413 can be radially positioned
relative the elongate pulling member 415 generally along the second
end 425 of the first cutting head 411. As will be appreciated, the
first cutting head 411 can include more than one blade 413. Each
blade 413 and 419 further includes a cutting edge 427 and 429,
respectively, in alignment so as to provide shearing action between
a pair of the cutting edges 427 and 429 of the blades 413 and 419.
For example, the first cutting head 411 can move relative the
second cutting head 417 to allow the cutting edge 427 of the blade
413 of the first cutting head 411 to slide past the cutting edge
429 of the blade 417 of the second cutting head 417. Example of
suitable materials for the blades 413 and 419 include, but are not
limited to, stainless steel (e.g., 316L) and titanium.
[0080] In one embodiment, blades 413 and 419 can be secured to the
first cutting head 411 and the second cutting head 417,
respectively, in any number of ways. For example, blades 413 and
419 can be secured to the cutting heads 411 and 417 through the use
of mechanical fasteners, such as screws, and/or interlocking pins
and sockets. In addition, blades 413 and 419 can be secured to the
cutting heads 411 and 417 through the use of chemical adhesives.
Examples of such chemical adhesives include, but are not limited
to, medical grade adhesives such as cyanoacrylate, acrylic,
silicone, and urethane adhesives.
[0081] In an additional embodiment, the first cutting head 411 can
be configured to receive and house at least a portion of the second
cutting head 417, including the blade 419, such that the second
blade 419 does not pass beyond the first cutting head 411. For
example, the first cutting head can include a socket that extends
radially relative the elongate pulling member 415 and distally from
the blade 413 to receive the blade 419 of the second cutting head
417 as the blade 419 passes the blade 413. In one embodiment, the
blade 419 can be positioned within the socket of the first cutting
head 411 as the catheter 401 is moved through a lumen.
[0082] Catheter 401 can have various lengths between the proximal
end 407 and the first cutting head 411. In one embodiment, the
length between the proximal end 407 and the first cutting head 411
is sufficient to allow the catheter 401 to be percutaneously
implanted through a patient's vasculature to position the cutting
heads (e.g., the first and second cutting heads) at a predetermined
location. Examples of the predetermined locations include, but are
not limited to, cardiovascular locations such as on or adjacent to
a cardiac valve of the heart (e.g., the aortic valve), including
within a chamber of the patient's heart (e.g., the left ventricle
of the heart). As will be appreciated, the length between the
proximal end 407 and the first cutting head 411 will be dependent
upon each patient's physiological structure and the predetermined
location within the patient.
[0083] The elongate body 403 of the catheter 401, the elongate
pulling member 415, the elongate pushing member 421, the second
cutting head 417 and the first cutting head 411 can be formed from
a wide variety of materials and in a wide variety of
configurations. For example, the materials may include, but are not
limited to, one or more of polyvinyl chloride (PVC), polyethylene
(PE), polyolefin copolymer (POC), polyethylene terephthalate (PET),
polyamid, mixtures, and block co-polymers thereof. Alternatively,
the materials may include one or more alloys in any number of
configurations. For example, the materials may include stainless
steel (e.g., 316L), titanium, or other medical grade alloys as are
known. These materials may also have a woven configuration or a
solid extruded configuration.
[0084] The selection of material and configuration allows for the
elongate body 403, the elongate pulling member 415, the elongate
pushing member 421, the second cutting head 417 and the first
cutting head 411 to each have the flexibility, and the ability to
be either pushed and/or pulled thereby accomplishing the actions
described for the components herein. As will be appreciated,
selection of the material can be based generally on a broad range
of technical properties, including, but not limited to, modulus of
elasticity, flexural modulus, and Shore A hardness required for the
embodiments of the present invention. Components of the present
apparatus and/or system can also be coated for lubrication, for
abrasion resistance, or to deliver an anticoagulatory drug.
[0085] As an alternative configuration, the cutting mechanism of
first cutting head 411 and second cutting head 417 can be
accomplished by alternate cutting, shearing, slicing, grinding or
ablative means as are known for other purposes. For example,
thermal energy can be used to weaken or slice the diseased valve,
rolling cutters could be incorporated, or a "cutting balloon"
mechanism could be incorporated.
[0086] In an additional embodiment, the catheter 401 can further
include radiopaque markers 431. For example, radiopaque markers
(e.g., attached or coated) can be used to mark the location of the
first cutting head 411 and the second cutting head 417. In
addition, radiopaque markers can be used to mark the location of
blades 413 and 419. Other portions of catheter 401 can also be
marked with radiopaque markers as necessary to allow for
visualization of the location and position of parts of the catheter
401.
[0087] As illustrated in FIG. 4A, catheter 401 can reside at least
partially within the lumen 406 of the elongate filter body. FIG. 4B
provides an example in which both the valve 404 and the filter
region 450 have been extended from the sheath 474, as discussed
herein, with the catheter 401 at least partially extending distally
from the valve 404. In the various embodiments, the valve leaflets
of valve 404 can seat around the elongate body 403 of the catheter
401 to provide the reversibly sealable opening of the valve
404.
[0088] In the various embodiments, the elongate body 403 can travel
longitudinally within the lumen 406 of the elongate filter body 402
to extend and retract the distal end 409 of the catheter 401
relative the valve 404 of the filter system 400. The elongate
filter body 402 can further include a sealing ring that allows the
elongate body 403 of the catheter 401 to move longitudinally while
maintaining a fluid tight seal within the lumen 406 of the elongate
filter body 402.
[0089] In addition to the structures described herein, the elongate
body 403 of catheter 401 further includes a second lumen 435, as
shown in FIG. 4A. In one embodiment, the second lumen 435 can
extend between the proximal end 407 and the distal end 409 of the
elongate body 403, where the second lumen 435 can be coupled in
fluid tight communication to an inflatable balloon 437 on the
elongate body 403. The catheter 401 can further include an
inflation device 495 that can reversibly couple in fluid tight
communication with the second lumen 435 to provide fluid pressure
to inflate and deflate balloon 437.
[0090] In one embodiment, the inflatable balloon 437 can be
positioned adjacent the distal end 409 of the elongate body 403 and
proximal to the second cutting head 417. The inflatable balloon 437
can be inflated from a deflated state to an inflated state by
pressure applied by fluid moving through the second lumen 435. In
addition, the catheter 401 further includes an expandable stent 439
positioned over at least a portion of the inflatable balloon 437.
The expandable stent 439 can move between a compressed state, as
shown in FIG. 4B, and an expanded state, as shown in FIG. 4C, using
the inflatable balloon 437. In one embodiment, the expandable stent
439 can be deployed over cardiac tissue sheared using the first and
second cutting heads 411 and 417 using the inflatable balloon
437.
[0091] Catheter 401 can further include an annular push ring 441
positioned between the second cutting head 417 and the inflatable
balloon 437. The annular push ring 441 can be used for contacting
and moving at least a portion of cardiac tissue sheared with the
first and second cutting heads 411 and 417. For example, the first
and second cutting heads 411 and 417 can be used to shear cardiac
tissue (e.g., one or more cusps of a valve). The annular push ring
441 can then be advanced into contact with the sheared cardiac
tissue. As the annular push ring 441 advances the sheared cardiac
tissue can be directed towards the wall of the lumen. Stent 439 can
then be positioned over at least a portion of the sheared cardiac
tissue positioned using the annular push ring 441. Stent 439 can
then be deployed using the inflatable balloon 437 to position at
least a portion of the sheared cardiac tissue between the expanded
stent 439 and the wall of the lumen. As will be appreciated, the
dimensions and physical characteristics of the stent 439 will be
dependent upon the location in which the stent 439 is to be
implanted.
[0092] The apparatus 445 can further include a cardiac valve 455.
The cardiac valve 455 can be releasably positioned adjacent the
expandable stent 439 over at least a portion of the inflatable
balloon 437. Generally, cardiac valve 455 can be implanted within
the fluid passageway of a body lumen, such as for replacement of a
valve structure within the body lumen to regulate the flow of a
bodily fluid through the body lumen in a single direction.
[0093] With respect to the apparatus 445, the cardiac valve 455 can
be configured to reside in a compressed state over at least a
portion of the inflatable balloon 437. Using the inflatable
balloon, the cardiac valve 455 can be expanded into a deployed
state as illustrated in FIGS. 4C and 4D.
[0094] One example of cardiac valve 455 includes valve 204 as
described herein. An additional embodiment of cardiac valve 455 is
illustrated in U.S. patent application Ser. No. ______, entitled
"Vascular Catheter, System, and Method" (B&C Docket No.
201.0080001, BSCI Docket No. 03-498US), which is hereby
incorporated by reference in its entirety.
[0095] Generally, the cardiac valve 455 includes a support frame
and a cover. The cover of the cardiac valve 455 can be positioned
over at least the outer surface of the support frame. In one
embodiment, the cover includes surfaces defining a reversibly
sealable opening for unidirectional flow of a liquid through the
lumen of the cardiac valve 455.
[0096] The filter system 400, catheter 401 and the apparatus 445
can further include handles to allow the various components to be
moved relative each other. For example, handles 479 can allow the
elongate pushing member 421 and/or the elongate pulling member 415
to be moved relative each other. Handle 481 can allow the catheter
401 to be moved relative the apparatus 445 and the sheath 474. In
addition, handles 483 can allow the sheath 474 and the filter
system 400 to be moved relative each other. As will be appreciated,
other structures may be used in place of or in addition to the
handles to allow the various components of the filter system 400,
catheter 401, and apparatus 445 to move relative each other.
[0097] The embodiments of the present invention further include
methods for forming the filter system and apparatus, as discussed
herein. For example, embodiments of the present invention can be
formed by providing an elongate filter body that includes the
expandable filter region defining a lumen. The valve can further be
provided, where the valve can be adjoined proximal the distal end
of the elongate filter body to form a single lumen through which
fluid flows unidirectionally through the valve and the elongate
filter body to filter the fluid. As provided herein, the valve can
define a reversibly sealable opening for the unidirectional flow of
fluid through the lumen of the valve.
[0098] In one embodiment, the expandable filter region can be
configured to move between a first configuration and a second
configuration. In one embodiment, the movement from the first
configuration to the second configuration can occur as the valve
expands in addition to under pressure of the unidirectional flow of
the fluid. The elongate filter body can also be provided with the
fluid tight plug to direct the unidirectional flow of the fluid
from the lumen through the expandable filter region to filter the
unidirectional flow of the fluid. In these embodiments, the fluid
tight plug can include various shapes and sizes and can be
positioned according to the embodiments described herein.
[0099] In various embodiments, the valve can be provided with a
support frame having various configurations. A first configuration
can include a compressed configuration and a second configuration
can include an expanded configuration. In various embodiments,
expansion of the support frame can be supplemented by fluid flowing
into the lumen of the elongate filter body.
[0100] The filter system and apparatus, as discussed herein, can
further include providing the catheter having the first cutting
head and the second cutting head, as discussed herein. The first
cutting head can include the blade and the elongate pulling member,
where the first cutting head can be positioned proximal the distal
end of the elongate body with the elongate pulling member extending
through the first lumen of the catheter. The elongate pulling
member can then slides within the first lumen to move the first
cutting head relative the distal end of the elongate body. The
second cutting head can also include a blade, and be positioned
adjacent the distal end of the elongate body between the distal end
and the first cutting head. The blade of the first cutting head can
be moved relative the blade of the second cutting head to provide
the shearing action for cardiac tissue. The catheter extends though
the lumen of the elongate filter body and the lumen of the
valve.
[0101] In additional embodiments, the filter system and apparatus
further include providing a second lumen to the elongate body,
where the second lumen can be in fluid tight communication with the
inflatable balloon positioned adjacent the distal end of the
elongate body and proximal to the second cutting head. The
expandable stent can then be positioned over at least a portion of
the inflatable balloon, where the inflatable balloon deploys the
expandable stent over sheared cardiac tissue. In further
embodiment, the annular push ring can also be provided between the
second cutting head and the inflatable balloon for contacting and
moving at least a portion of the sheared cardiac tissue. The
embodiments can also include providing the cardiac valve positioned
over the inflatable balloon, where the cardiac valve can be
deployed through the use of the inflatable balloon.
[0102] While the present invention has been shown and described in
detail above, it will be clear to the person skilled in the art
that changes and modifications may be made without departing from
the spirit and scope of the invention. As such, that which is set
forth in the foregoing description and accompanying drawings is
offered by way of illustration only and not as a limitation. The
actual scope of the invention is intended to be defined by the
following claims, along with the full range of equivalents to which
such claims are entitled.
[0103] In addition, one of ordinary skill in the art will
appreciate upon reading and understanding this disclosure that
other variations for the invention described herein can be included
within the scope of the present invention. For example, the support
frame 120 and/or the cover 122 can be coated with a
non-thrombogenic biocompatible material, as are known or will be
known.
[0104] In the foregoing Detailed Description, various features are
grouped together in several embodiments for the purpose of
streamlining the disclosure. This method of disclosure is not to be
interpreted as reflecting an intention that the embodiments of the
invention require more features than are expressly recited in each
claim. Rather, as the following claims reflect, inventive subject
matter lies in less than all features of a single disclosed
embodiment. Thus, the following claims are hereby incorporated into
the Detailed Description, with each claim standing on its own as a
separate embodiment.
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