U.S. patent application number 14/198757 was filed with the patent office on 2015-09-10 for embolic filter balloon.
This patent application is currently assigned to MERIT MEDICAL SYSTEMS, INC.. The applicant listed for this patent is John William Hall. Invention is credited to John William Hall.
Application Number | 20150250577 14/198757 |
Document ID | / |
Family ID | 54016244 |
Filed Date | 2015-09-10 |
United States Patent
Application |
20150250577 |
Kind Code |
A1 |
Hall; John William |
September 10, 2015 |
EMBOLIC FILTER BALLOON
Abstract
An embolic filter balloon is disclosed. The embolic filter
balloon may comprise an inflatable balloon portion. Further, the
inflatable balloon portion may be coupled to a filter member. The
embolic filter balloon may be disposed in a body lumen. In some
embodiments, the embolic filter balloon may be configured such that
when the inflatable balloon portion is at least partially inflated
the filter member extends at least partially across the body lumen.
Such a configuration may allow the embolic filter balloon, when
deployed, to filter particles greater than a predetermined size
from a fluid in the body lumen.
Inventors: |
Hall; John William; (North
Salt Lake, UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hall; John William |
North Salt Lake |
UT |
US |
|
|
Assignee: |
MERIT MEDICAL SYSTEMS, INC.
South Jordan
UT
|
Family ID: |
54016244 |
Appl. No.: |
14/198757 |
Filed: |
March 6, 2014 |
Current U.S.
Class: |
606/194 |
Current CPC
Class: |
A61F 2/01 20130101; A61M
2025/1097 20130101; A61F 2002/016 20130101; A61F 2230/0069
20130101; A61M 2025/109 20130101; A61F 2230/0076 20130101; A61F
2210/0076 20130101; A61F 2/013 20130101; A61M 25/1011 20130101;
A61M 25/10 20130101; A61F 2250/0003 20130101; A61M 25/1002
20130101; A61F 2/011 20200501; A61F 2230/0006 20130101 |
International
Class: |
A61F 2/01 20060101
A61F002/01; A61M 25/10 20060101 A61M025/10 |
Claims
1. An embolic filter balloon, comprising: a first inflatable
balloon portion comprising an interior fluid flow path; a first
filter member coupled to the first inflatable balloon portion,
wherein the first filter member is configured to allow passage only
of particles smaller than a predetermined size; and a catheter
portion comprising an inflation lumen in fluid communication with
the first inflatable balloon portion.
2. The embolic filter balloon of claim 1, wherein the first
inflatable balloon portion is configured to substantially conform
to an interior diameter of a body lumen when deployed.
3. The embolic filter balloon of claim 1, wherein the first
inflatable balloon portion is configured for a balloon angioplasty
procedure.
4. The embolic filter balloon of claim 1, wherein the first
inflatable balloon portion is detachably coupled to the catheter
portion.
5. The embolic filter balloon of claim 1, wherein the first filter
member is positioned in the interior fluid flow path between a
proximal end and a distal end of the first inflatable balloon
portion.
6. The embolic filter balloon of claim 5, wherein a second lumen of
the catheter portion extends through the first inflatable balloon
portion and is in fluid communication with the distal end of the
first inflatable balloon portion, and wherein the second lumen of
the catheter portion is configured to provide at least one of: a
passageway for delivery of a medical device, a passageway for
delivery of a therapeutic agent, or a passageway for delivery of an
inflation fluid to one or more balloon catheters.
7. The embolic filter balloon of claim 1, wherein the first filter
member comprises a material selected from at least one of the
following: electrospun nano-fibers or micro-fibers, and
rotationally spun nano-fibers or micro-fibers.
8. The embolic filter balloon of claim 1, wherein the first
inflatable balloon portion and the first filter member are formed
of the same material.
9. The embolic filter balloon of claim 1, wherein the first
inflatable balloon portion is formed of a different material than
the first filter member.
10. The embolic filter balloon of claim 1, further comprising: a
second inflatable balloon portion; and a second filter member
coupled to the second inflatable balloon portion; wherein the
inflation lumen is in fluid communication with the second
inflatable balloon portion.
11. An embolic filter balloon, comprising: a first inflatable
balloon portion configured to at least partially conform to an
inside diameter of a first body lumen when the first inflatable
balloon portion is deployed, wherein the first inflatable balloon
portion is further configured to permit fluid flow through an
interior fluid flow path; and a first filter member coupled to the
first inflatable balloon portion such that the first filter member
is configured to allow passage only of particles of less than a
predetermined size through the first body lumen when the first
inflatable balloon portion is deployed.
12. The embolic filter balloon of claim 11, further comprising: a
catheter portion comprising an inflation lumen in fluid
communication with the first inflatable balloon portion.
13. The embolic filter balloon of claim 12, wherein a second lumen
of the catheter portion is configured to at least partially permit
fluid communication with a distal end of the first inflatable
balloon portion.
14. The embolic filter balloon of claim 11, wherein the first
filter member comprises a mesh.
15. The embolic filter balloon of claim 11, wherein the first
filter member comprises polytetrafluoroethylene (PTFE).
16. The embolic filter balloon of claim 11, wherein the first
inflatable balloon portion and the first filter member are formed
of the same material.
17. The embolic filter balloon of claim 11, wherein the first
inflatable balloon portion is formed of a different material than
the first filter member.
18. The embolic filter balloon of claim 11, further comprising: a
second inflatable balloon portion configured to at least partially
conform to an inside diameter of a second body lumen when the
second inflatable balloon portion is deployed; and a second filter
member coupled to the second inflatable balloon portion such that
the second filter member is configured to allow passage only of
particles of less than a predetermined size through the second body
lumen when the second inflatable balloon portion is deployed.
19. A method of filtering particles larger than a predetermined
size from a fluid within a body lumen, the method comprising:
introducing an embolic filter balloon into a body lumen; inflating
the embolic filter balloon such that a filter member coupled to the
embolic filter balloon extends at least partially across the body
lumen; and filtering particles larger than a predetermined size
from the fluid within the body lumen.
20. The method of claim 19, further comprising: deflating at least
partially the embolic filter balloon such that the filtered
particles remain trapped in the filter member; and retrieving the
embolic filter balloon and the filtered particles from the body
lumen.
Description
RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional
Application No. 61/773,999 filed on Mar. 7, 2013, titled EMBOLIC
FILTER BALLOON, the entire contents of which are hereby
incorporated by reference.
TECHNICAL FIELD
[0002] The present disclosure relates generally to medical devices.
More specifically, the present disclosure relates to medical
appliances such as embolic filters and related components for use
in capturing or filtering particles, emboli, fragments, thrombi, or
other debris from a fluid in a body lumen. In some embodiments, an
embolic filter may comprise an inflatable balloon portion,
including embodiments wherein the inflatable balloon portion is
coupled to a filter member. An embolic filter balloon may be
retrievably deployed in a body lumen, and the filter member may
capture or filter particles, emboli, fragments, thrombi, or other
debris from a fluid in the body lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] The embodiments disclosed herein will become more fully
apparent from the following description and appended claims, taken
in conjunction with the accompanying drawings. These drawings
depict only typical embodiments, which will be described with
additional specificity and detail through use of the accompanying
drawings in which:
[0004] FIG. 1 is a perspective view of a first embodiment of an
embolic filter balloon showing the distal end thereof.
[0005] FIG. 2 is a perspective view of the embolic filter balloon
of FIG. 1 showing the proximal end thereof.
[0006] FIG. 3 is a top view of the embolic filter balloon of FIG.
1.
[0007] FIG. 4 is a distal end view of the embolic filter balloon of
FIG. 1.
[0008] FIG. 5 is a cross-sectional view of the embolic filter
balloon of FIG. 2 taken through lines 5-5.
[0009] FIG. 6 is a cross-sectional perspective view of the embolic
filter balloon of FIG. 2 taken through lines 6-6.
[0010] FIG. 7 is a cross-sectional view of the embolic filter
balloon of FIG. 4 taken through lines 7-7.
[0011] FIG. 8 is a cross-sectional perspective view of an embolic
filter balloon system having two inflatable balloon portions.
[0012] FIG. 9 is a perspective view of another embodiment of an
embolic filter balloon showing the distal end thereof.
[0013] FIG. 10 is a perspective view of the embolic filter balloon
of FIG. 9 showing the proximal end thereof.
[0014] FIG. 11 is a top view of the embolic filter balloon of FIG.
9.
[0015] FIG. 12 is a distal end view of the embolic filter balloon
of FIG. 9.
[0016] FIG. 13 is a cross-sectional view of the embolic filter
balloon of FIG. 10 taken through lines 13-13.
[0017] FIG. 14 is a cross-sectional perspective view of the embolic
filter balloon of FIG. 10 taken through lines 14-14.
[0018] FIG. 15 is a cross-sectional view of the embolic filter
balloon of FIG. 12 taken through lines 15-15.
[0019] FIG. 16A is a side view of an embolic filter balloon,
disposed in a vessel in a delivery configuration.
[0020] FIG. 16B is a side cross-sectional view of the embolic
filter balloon of FIG. 16A, disposed in a vessel in an inflated
configuration.
[0021] FIG. 16C is a side cross-sectional view of the embolic
filter balloon of FIG. 16B, illustrating flow of particles in the
blood of a vessel.
[0022] FIG. 16D is a side cross-sectional view of the embolic
filter balloon of FIG. 16C, illustrating capture of particles by
the embolic filter balloon.
[0023] FIG. 16E is a side cross-sectional view of the embolic
filter balloon of FIG. 16D, in a partially deflated
configuration.
DETAILED DESCRIPTION
[0024] The term "particle" or its variants are used broadly
throughout this disclosure to refer to any variety of emboli,
fragments, thrombi, or other debris that may be released or
dislodged into a fluid in a body lumen. Particles within the scope
of this disclosure may comprise biologic and/or synthetic material
and may or may not be introduced into the body by a medical
practitioner. Some medical procedures or therapies may include the
release of particles, including particles of body tissue or other
biologic matter, into a fluid in a body lumen. For example, during
expansion of a stent in a body lumen, particles may be dislodged
into a fluid in the body lumen. In another example, deployment of a
balloon catheter in a blood vessel during an angioplasty may result
in particles of plaque and/or other debris being dislodged into the
bloodstream. In yet another example, introduction of emboli (i.e.,
microspheres) into a target vessel to occlude blood flow to a tumor
or other undesirable growth or lesion may result in at least a
portion of the emboli being introduced into a non-target
vessel.
[0025] Particles, emboli, fragments, thrombi, or other debris
released into a fluid of a body lumen may result in ischemia,
myocardial infarction, stroke, and other potentially adverse
medical conditions. Some medical appliances may be configured for
capturing or filtering such particles from a fluid in a body lumen.
In some instances, medical appliances may be configured to filter
or capture particles larger than a predetermined size from a fluid
in a body lumen. For example, filters, meshes, or other porous
members may be used to capture such particles from a fluid in a
body lumen. Embolic filters may be introduced into a body lumen to
capture particles from a fluid in the body lumen. In some
embodiments, embolic filters may comprise inflatable balloon
portions, including configurations wherein the inflatable balloon
portion is coupled to a filter member. Such embolic filter balloons
may be configured to capture or filter particles from a fluid in a
body lumen.
[0026] It will be readily understood that the components of the
embodiments as generally described and illustrated in the figures
herein could be arranged and designed in a wide variety of
different configurations. Thus, the following more detailed
description of various embodiments, as represented in the figures,
is not intended to limit the scope of the disclosure, but is merely
representative of various embodiments. While the various aspects of
the embodiments are presented in drawings, the drawings are not
necessarily drawn to scale unless specifically indicated.
[0027] The term "balloon" is used broadly throughout this
disclosure to refer to a variety of inflatable components of
medical appliances having a variety of shapes, characteristics, and
uses. Further, disclosure of concepts provided in connection with
embodiments or examples reciting particular shapes, structures, or
uses may be analogously applied to any inflatable components of
medical appliances.
[0028] Also, the phrases "connected to," "coupled to," and "in
communication with" refer to any form of interaction between two or
more entities, including mechanical, electrical, magnetic,
electromagnetic, fluid, and thermal interaction. Two components may
be coupled to each other even though they are not in direct contact
with each other. For example, two components may be coupled to each
other through an intermediate component.
[0029] Additionally, the terms "proximal" and "distal" refer to
opposite ends of a medical appliance. As used herein, the proximal
end of a medical appliance is the end nearest a practitioner during
use, while the distal end is the opposite end. For example, the
proximal end of an embolic filter balloon refers to the end nearest
the practitioner when the embolic filter balloon is disposed
within, or being deployed from, a deployment device. For
consistency throughout, these terms remain constant in the case of
a deployed embolic filter balloon, regardless of the orientation of
the embolic filter balloon within the body. In the case of an
embolic filter balloon deployed through the radial artery of a
patient, for example, the proximal end will be nearer the wrist of
the patient and the distal end will be nearer the heart of the
patient when the embolic filter balloon is in a deployed
position.
[0030] An inflatable balloon portion of an embolic filter balloon
may comprise a wall defining the interior portion of the inflatable
balloon portion and separating the interior portion from the
external environment. As the inflatable balloon portion is
inflated, inflation fluid may be introduced into the interior
portion, exerting pressure on the wall of the inflatable balloon
portion. In some procedures, the wall may be used to conform the
inflatable balloon portion to the interior diameter of a body
lumen. Further, in some instances, an additional catheter or other
medical appliance may also be disposed within the body lumen
adjacent to the embolic filter balloon, in these instances the wall
may be used to conform the inflatable balloon portion to both the
interior diameter of the body lumen and the exterior surface of the
additional catheter or other medical appliance. Thus, an embolic
filter balloon may generally restrict fluid flow through a body
lumen while allowing a catheter or other instrument to bypass the
filter.
[0031] In some embodiments the inflatable balloon portion may be
configured with a "flow through" type design, which may allow blood
or other fluids to pass through the inflatable balloon portion
while the inflatable balloon portion is in an inflated state. For
example, an inflatable balloon portion may be shaped like a hollow
cylinder, allowing the inflatable balloon portion to be inflated
within a vessel, while still allowing blood to pass through the
center of the inflatable balloon portion. In another embodiment, an
embolic filter balloon may be comprised of an inflatable balloon
portion configured with an interior fluid flow path, wherein a
filter member may be coupled to the interior fluid flow path, which
may allow the embolic filter balloon to filter or capture particles
larger than a predetermined size from the fluid flowing through the
interior fluid flow path. An embolic filter balloon comprising an
interior fluid flow path may direct at least a portion of a fluid
flowing through a body lumen through the interior fluid flow path.
For example, an embolic filter balloon may be inflated within a
body lumen at a position downstream from a site of a vascular
procedure, during the vascular procedure particles may be dislodged
into the bloodstream, and the embolic filter balloon may filter or
capture the dislodged particles from the bloodstream.
[0032] FIG. 1 is a perspective view of a first embodiment of an
embolic filter balloon 101 showing a distal end 114 thereof. As
shown in FIG. 1, an embolic filter balloon 101 comprises an
inflatable balloon portion 103, a filter member 105, and a catheter
portion 107. In the illustrated embodiment, the filter member 105
is coupled to the inflatable balloon portion 103, and the catheter
portion 107 is in fluid communication with the inflatable balloon
portion 103. Other configurations of these and other components of
an embolic filter balloon are also within the scope of this
disclosure.
[0033] In some embodiments, the inflatable balloon portion 103 of
the embolic filter balloon 101 may be configured to at least
partially conform to an interior diameter of a body lumen when the
inflatable balloon portion 103 is deployed or inflated. For
example, the inflatable balloon portion 103 may be tube-shaped,
cylindrical, or otherwise shaped. Any size of inflatable balloon
portion 103 of any geometry is also within the scope of this
disclosure. The shape of the inflatable balloon portion 103 may be
selected or designed to conform to the shape of an interior
diameter of a target body lumen. As used herein, a target body
lumen may be any body lumen, or any position within a body lumen,
wherein a practitioner or user may desire to deploy a medical
appliance such as an embolic filter balloon 101.
[0034] One or more additional catheters or other instruments may
also pass through the target body lumen or be disposed at or
adjacent to the target body lumen. In some embodiments, the
inflatable balloon portion 103 may be configured to conform to both
the interior diameter of the target body lumen and the exterior
surface of the one or more catheters or other instruments that may
pass through or be disposed at or adjacent to the target body
lumen. Further, the inflatable balloon portion 103, when at least
partially inflated, may be configured to substantially form a seal
between the exterior surface of the inflatable balloon portion 103
and both the interior diameter of the target body lumen and the
exterior surface or surfaces of the one or more catheters or other
instruments that may pass through or be positioned at or adjacent
to the target body lumen.
[0035] In the illustrated embodiment, the inflatable balloon
portion 103 comprises an interior fluid flow path 121. The interior
fluid flow path 121, comprising a distal opening 113 and a proximal
opening 111 as shown in FIG. 2, may allow a fluid or other material
to flow through an inflatable balloon portion 103 even though the
inflatable balloon portion 103 is in an inflated state. For
example, an inflatable balloon portion 103 comprising an interior
fluid flow path 121 may conform to an inside diameter of a vessel
when deployed, but may still permit flow of blood through the
interior fluid flow path 121. Such a configuration may permit a
substantially continuous flow of blood through the vessel. In some
instances, it may not be desirable to substantially decrease or
fully occlude flow of fluid through a body lumen. For example,
adverse medical conditions may result due to a flow decrease or
occlusion of blood flow through a vessel.
[0036] As illustrated in FIG. 1, the filter member 105 may be
positioned in the interior fluid flow path 121 at a position
between a proximal end 112 and a distal end 114 of the inflatable
balloon portion 103. In another embodiment, the filter member 105
may be coupled to the inflatable balloon portion 103 such that the
filter member 105 is configured to allow passage only of particles
of less than a predetermined size through a body lumen when the
inflatable balloon portion 103 is deployed or inflated.
[0037] Use of embolic filters comprising one or more inflatable
balloon portions, like the inflatable balloon portion 103, may
facilitate various aspects of procedures and/or therapies involving
embolic filters. For example, an embolic filter comprising one or
more inflatable balloon portions may possess enhanced flexibility
in comparison to embolic filters comprising wires, baskets,
netting, or analogous components. The inflatable balloon portion
may enable an embolic filter balloon, like the embolic filter
balloon 101, to be folded or otherwise packed into a smaller
delivery configuration. Embolic filters with smaller delivery
profiles may be introduced at more locations in a mammalian body
than larger embolic filters, which may facilitate treatment and
access. Additionally, smaller profiles may require smaller access
openings, which may decrease bleeding, trauma, and
complications.
[0038] Also, as further detailed below, an embolic filter
comprising one or more inflatable balloon portions may filter or
capture a greater proportion of particles from a fluid in a body
lumen than filtered or captured by an embolic filter comprising
wires, baskets, netting, or other analogous components. For
example, an embolic filter comprising one or more inflatable
balloon portions may form a better seal between an exterior surface
or surfaces of the one or more inflatable balloon portions and an
interior diameter of a body lumen than may be formed by analogous
components of an embolic filter comprising wires, baskets, netting,
or other analogous components. More specifically, when deployed,
the embolic filter comprising one or more inflatable balloon
portions may form substantially more points of contact with the
interior diameter of the body lumen than formed by the embolic
filter comprising wires, baskets, netting, or other analogous
components. Such an enhanced seal may provide enhanced filtration
or capture of particles from the fluid of the target body lumen.
Additionally, embolic filters comprising one or more inflatable
balloon portions may also pass more easily through body lumens,
cause less trauma to vessel walls, and be more easily retrieved
from body lumens than embolic filters comprising wires, baskets,
netting, or other analogous components. For example, an embolic
filter comprising one or more inflatable balloon portions may be
softer, more pliable, and/or less abrasive than an embolic filter
comprising wires, baskets, netting, or other analogous
components.
[0039] FIG. 2 is a perspective view of the embolic filter balloon
101 of FIG. 1 showing the proximal end 112 thereof. As shown, the
position of the filter member 105 coupled to the interior fluid
flow path 121 may be viewed from the proximal end 112 of the
embolic filter balloon 101. In some embodiments, the catheter
portion 107 may be coupled to the inflatable balloon portion 103 at
the proximal end 112 of the inflatable balloon portion 103, and/or
the catheter portion 107 may be coupled to the inflatable balloon
portion 103 at a position adjacent to the proximal opening 111 of
the inflatable balloon portion 103. The catheter portion 107 may be
coupled to the inflatable balloon portion 103 at any location on,
or adjacent to, the inflatable balloon portion 103. Further, any
positioning or variety of coupling between the catheter portion 107
and the inflatable balloon portion 103 is within the scope of this
disclosure.
[0040] As illustrated in FIG. 2, the catheter portion 107 may
comprise an inflation lumen 109. In some embodiments, the inflation
lumen 109 may be configured to deliver an inflation fluid from an
inflation device to the inflatable balloon portion 103 to at least
partially inflate the inflatable balloon portion 103. In yet
another embodiment, the inflation lumen 109 may be configured to
remove or evacuate an inflation fluid from the inflatable balloon
portion 103 to at least partially deflate the inflatable balloon
portion 103. For example, an inflation fluid may be removed from
the inflatable balloon device via the inflation lumen 109 to an
inflation device.
[0041] FIG. 3 is a top view of the embolic filter balloon 101 of
FIG. 1. The embodiment illustrated in FIG. 3 shows one possible
coupling between the inflatable balloon portion 103 and the
catheter portion 107, wherein the catheter portion 107 may be
coupled to the inflatable balloon portion 103 adjacent to the
proximal end 112 of the inflatable balloon portion 103.
[0042] FIG. 4 is a distal end 114 view of the embolic filter
balloon 101 of FIG. 1, and FIG. 5 is a cross-sectional view of the
embolic filter balloon 101 of FIG. 2 taken through lines 5-5. As
shown in the illustrated embodiment, the inflatable balloon portion
103 may be substantially cylindrical, comprising the distal end
114. One configuration of the catheter portion 107 comprising the
inflation lumen 109 is also illustrated. Additionally, the embolic
filter balloon 101 may further comprise the filter member 105
coupled to the inflatable balloon portion 103 at a position within
or adjacent to an interior diameter of the inflatable balloon
portion 103. When at least partially inflated, the inflatable
balloon portion 103 may substantially conform to the interior
diameter of a body lumen. Such a configuration may direct or result
in at least a portion of a fluid flowing through a body lumen to
flow or pass through the inflatable balloon portion 103 and the
filter member 105. In some instances, substantially all particles
greater than a predetermined size may be captured or filtered from
a fluid in a body lumen when the fluid flows or passes through the
inflatable balloon portion 103 and the filter member 105.
[0043] The filter member 105 may allow a fluid to flow through a
body lumen while controlling or limiting the flow of particles
through the body lumen. For example, the filter member 105 may be
configured to filter or capture particles larger than a
predetermined size from blood flowing through a vessel but allow
the blood to pass through the filter member 105.
[0044] Embolic filter balloons 101 and components of embolic filter
balloons 101 may be formed of a variety of materials, including,
for example, elastic materials, elastomers, polymers, flexible
materials, and so forth. Specifically, in some embodiments embolic
filter balloons and the various components of embolic filter
balloons may be formed of PEBAX, polytetrafluoroethylene (PTFE),
nylon, silicone, or any thermoplastic material. A practitioner
using an embolic filter balloon 101 comprising an elastic material,
for example, may modify an inflation pressure of the embolic filter
balloon 101 to optimize the seal between the exterior surface of
the embolic filter balloon 101 and the interior diameter of a body
lumen. In some instances, the interior diameter of the body lumen
may comprise a challenging anatomy, defined as a body lumen
wherein, for example: the interior diameter of the body lumen is
not uniform; the body lumen is curved or abnormally shaped; the
body lumen is altered by an injury, medical condition, or medical
treatment; and so forth. In such situations, the embolic filter
balloon 101 comprising the elastic material may provide enhanced
conformance between the outside surface of the embolic filter
balloon 101 and the interior diameter of the body lumen comprising
the challenging anatomy, as compared to embolic filter balloons
comprising non-elastic materials.
[0045] In some other embodiments, at least one of the inflatable
balloon portion 103 and the filter member 105 may comprise
electrospun nano-fibers or micro-fibers, or rotationally spun
nano-fibers or micro-fibers. Specifically, the electrospun
nano-fibers or micro-fibers, or the rotationally spun nano-fibers
or micro-fibers may be comprised of at least one of the following:
polyamide, aromatic polyimide, polyethylene, and polypropylene.
Processes for electrospinning nano-fibers or micro-fibers are
described in U.S. Provisional Application No. 61/703,037, filed on
Sep. 19, 2012, and titled "Electrospun Material Covered Medical
Appliances and Methods of Manufacture"; and U.S. application Ser.
No. 13/360,444, filed on Jan. 27, 2012, and titled "Electrospun
PTFE Coated Stent and Method of Use." Both of these two
applications are hereby incorporated by reference in their
entirety. Likewise, processes for rotationally spinning nano-fibers
or micro-fibers are described in U.S. application Ser. No.
13/742,025, filed on Jan. 15, 2013, and titled "Rotational Spun
Material Covered Medical Appliances and Methods of Manufacture,"
which is hereby incorporated by reference in its entirety.
[0046] In one embodiment, the filter member 105 may be formed of a
mat of electrospun nano-fibers or micro-fibers. In another
embodiment, the filter member 105 may be formed of a mat of
rotationally spun nano-fibers or micro-fibers. The porosity of the
electrospun nano-fiber or micro-fiber mat may be modified as
desired to create a filter that captures particles at a
predetermined size. For example, a more porous mat will allow
larger particles to pass, while a less porous mat can limit the
size of particles to pass the filter.
[0047] Electrospun coatings and rotational spun coatings may be
applied to any balloon substrate and may be configured to provide
additional strength to the balloon, increase the puncture
resistance of the balloon, provide a lubricious coating, and so
forth. Electrospinning and rotational spinning may be used to coat
a balloon with a matrix of fibers, including nano-fibers and/or
micro-fibers. In some embodiments, the fibers may be on the
nano-scale, meaning smaller than one micron in diameter. In other
embodiments, the fibers may be on the micro-scale, meaning smaller
than one millimeter in diameter.
[0048] In one embodiment, at least one of the inflatable balloon
portion 103 and the filter member 105 may comprise a single layer.
In another embodiment, at least one of the inflatable balloon
portion 103 and the filter member 105 may comprise a plurality of
layers. Multilayered balloon constructs and/or filter constructs
may further increase the strength and usability of balloons and/or
filters by decreasing the risk that manufacturing or material
defects within the balloon and/or filter will compromise the
integrity of the balloon and/or filter. In other words, a single
layer balloon having a defect in the wall of the balloon will
likely have a weak point at the defect. However, it is unlikely
that a defect in one layer of a multilayered design will be aligned
with a defect in an adjacent layer. Thus, the effect of any single
defect may be minimized, as the defect area will be reinforced by
portions of adjacent layers which are likely defect-free.
[0049] Similarly, the outside layer of a multilayer balloon may
contact bodily structures or other medical appliances during
delivery and/or use. Such contact may stretch, scratch, pierce, or
otherwise weaken the layer. As with material defects, however,
these points may be reinforced by adjacent layers which are not
compromised. Conversely, such points on a single-layer design may
more significantly affect the overall strength of the balloon.
Thus, as opposed to a single-layer design, a multilayered design
may be more robust, particularly for use in potentially damaging
conditions.
[0050] FIG. 6 is a cross-sectional perspective view of the embolic
filter balloon 101 of FIG. 2 taken through lines 6-6. In the
illustrated embodiment, the filter member 105 may be positioned in
the interior fluid flow path 121 of the inflatable balloon portion
103 at a position between the proximal opening 111 and the distal
opening 113 of the inflatable balloon portion 103. The inflatable
balloon portion 103 and the filter member 105 may be formed of the
same material. Alternatively, the inflatable balloon portion 103
may be formed of a different material than the filter member 105.
Additionally, the catheter portion 107, comprising the inflation
lumen 109, may be formed of the same material as the inflatable
balloon portion 103 and/or the filter member 105. Alternatively,
the catheter portion 107 may be formed of a different material than
the inflatable balloon portion 103 and/or the filter member 105.
The filter member 105 may be formed of any porous material. For
example, the filter member 105 may comprise a porous material, such
as a mesh, a woven material, and so forth. Specifically, the filter
member 105 may comprise a material that may be formed by expansion,
extrusion, melt blowing, molding, sewing, weaving, and other
comparable techniques. The filter member 105 may be coupled to the
inflatable balloon portion 103, for example, by adhesive, bonding,
heat bonding, stitching, and other analogous methods.
[0051] In some embodiments, the filter member 105 may be coated,
loaded or associated with a therapeutic agent, such as a drug. The
therapeutic agent may be configured to be released into a fluid in
a body lumen, or into tissue adjacent a body lumen. For example,
the filter member 105 may be positioned in a vessel, and as blood
flows through the filter member 105, the therapeutic agent may be
controllably released into the blood. Such a configuration may
provide an interoperative method for enhanced delivery of a
therapeutic agent into the bloodstream of a patient. In embodiments
where the filter member 105 comprises electrospun or rotationally
spun nano-fibers or micro-fibers, the filter member 105 may
comprise an increased surface area as compared to embodiments where
the filter member 105 does not comprise electrospun or rotationally
spun nano-fibers or micro-fibers. Such an increased surface area,
when coated with or coupled to a therapeutic agent, may provide for
enhanced or controlled delivery of the therapeutic agent into the
bloodstream.
[0052] In a more specific embodiment, the filter member 105 may be
coated with or coupled to an anti-thrombotic agent. In one
embodiment, the anti-thrombotic agent is covalently or ionically
bound to the filter member 105. The anti-thrombotic agent may be
configured to reduce or prevent thrombus formation on the filter
member 105. Anti-thrombotic agents, when coating or coupled to the
filter member 105, may allow the filter member 105 to capture or
filter particles larger than a predetermined size from a fluid in a
body lumen while also reducing thrombus formation on the filter
member 105. Additionally, reduction in thrombus formation may
reduce shear on the fluid flowing through the filter member 105.
For example, a practitioner may position an embolic filter balloon
101 in a vessel, where the filter member 105 is coated with or
otherwise associated with an anti-thrombotic agent. The
anti-thrombotic agent may reduce or prevent thrombus formation on
or adjacent to the filter member 105, and such reduction and/or
prevention of thrombus formation on or adjacent to the filter
member 105 may allow substantially continuous flow of blood through
the filter member 105.
[0053] FIG. 7 is a cross-sectional view of the embolic filter
balloon 101 of FIG. 4 taken through lines 7-7. As illustrated, the
filter member 105 extends across the internal fluid flow path 121
at a position between the proximal 111 and the distal 113 openings
of the inflatable balloon portion 103. Further, as illustrated, the
catheter portion 107 may comprise the inflation lumen 109 in fluid
communication with the inflatable balloon portion 103. As described
above, the inflation lumen 109 may be configured to deliver an
inflation fluid from an inflation device to the inflatable balloon
portion 103 to at least partially inflate the inflatable balloon
portion 103. The inflation lumen 109 may also be configured to
remove an inflation fluid from the inflatable balloon portion 103
to at least partially deflate the inflatable balloon portion 103.
In embodiments, the degree of inflation or deflation of the
inflatable balloon portion 103 may be controlled by increasing or
decreasing the amount of an inflation fluid flowing into or out of
the inflatable balloon portion 103. In other embodiments, the rate
of inflation or deflation of the inflatable balloon portion 103 may
be controlled by increasing or decreasing the flow rate of an
inflation fluid into or out of the inflatable balloon portion
103.
[0054] In another embodiment, an inflation lumen, like the
inflation lumen 109, may extend through an inflatable balloon
portion, like the inflatable balloon portion 103, and may be in at
least partial fluid communication with a distal end, like the
distal end 114, of the inflatable balloon portion. A catheter
portion, like the catheter portion 107, may also comprise a
plurality of catheter lumens. For example, the catheter portion may
comprise a double-D lumen catheter. In embodiments, the catheter
portion may comprise a first lumen comprising an inflation lumen in
fluid communication with the inflatable balloon portion. The
catheter portion may also extend through the inflatable balloon
portion and further comprise a second lumen comprising, for
example, a delivery lumen configured to provide a sleeve or sheath
for delivery of a medical appliance to a position in a body lumen
distal to the inflatable balloon portion. In another example, the
first catheter lumen may comprise an inflation lumen in fluid
communication with the inflatable balloon portion, and the second
catheter lumen may comprise, for example, a delivery lumen
configured to provide a sleeve or sheath for delivery of a medical
appliance to a position proximal to the embolic filter balloon.
[0055] In yet another example, the catheter portion may comprise
more than two lumens wherein a first lumen is in fluid
communication with the inflatable balloon portion, a second lumen
comprises a delivery lumen configured to provide a sleeve or sheath
for delivery of a medical appliance or appliances to a position
distal to and/or proximal to the embolic filter balloon, a third
lumen comprises a delivery lumen configured to provide a sleeve or
sheath for delivery of a medical appliance or appliances to a
position distal to and/or proximal to the embolic filter balloon,
and so forth. In some embodiments, the lumens may comprise
inflation lumens, delivery lumens, or other varieties of lumens.
For example, a lumen or lumens of the catheter portion may be
configured to provide at least one of the following: a sleeve or
sheath for delivery of a medical device, a passageway for delivery
of a therapeutic agent, and a passageway for delivery of an
inflation fluid to one or more balloon catheters.
[0056] In some embodiments, the catheter portion may comprise a
lumen configured to deliver medications, embolic microspheres, or
other therapies to a position in a body lumen either upstream or
downstream of a filter member, like filter member 105. For example,
a practitioner may desire to deliver embolic microspheres to a
target vessel in order to intentionally occlude blood flow to a
fibroid, tumor, cancer, or other undesirable growth or lesion. To
prevent the embolic microspheres from migrating to and at least
partially occluding a non-target vessel, the practitioner may
deliver the embolic microspheres via the catheter portion to a
position upstream from the filter member, wherein the filter member
may capture or filter misdelivered embolic microspheres. In
additional embodiments, the number of lumens may correspond to the
number of medical appliances coupled to or delivered through the
catheter portion. Medical appliances in these and other embodiments
herein disclosed comprise, but are not limited to: balloons,
catheters, embolic delivery devices, filters, guide wires,
introducers, retrieval devices, snares, and stents.
[0057] In another embodiment, a filter member, like the filter
member 105, may be coupled to an inflatable balloon portion, like
the inflatable balloon portion 103, at or adjacent to at least one
of a distal end or a proximal end of the inflatable balloon
portion. Further, the inflatable balloon portion may be configured
to perform a balloon angioplasty procedure. For example, a
practitioner may use such an embodiment to perform a balloon
angioplasty procedure, wherein the filter member may capture or
filter particles or emboli greater than a predetermined size that
may be released during the balloon angioplasty procedure.
Specifically, such an embodiment may be used by a practitioner for
a carotid percutaneous transluminal angioplasty (PTA).
[0058] FIG. 8 is a cross-sectional perspective view of an embolic
filter balloon system 201 having a first inflatable balloon portion
203a and a second inflatable balloon portion 203b. The embodiment
of FIG. 8 may include components that resemble components of the
embodiment of FIGS. 1-7 in some respects. For example, the
embodiment of FIG. 8 includes the first inflatable balloon portion
203a that may resemble the inflatable balloon portion 103 of FIGS.
1-7. It will be appreciated that all the illustrated embodiments
have analogous features. Accordingly, like features are designed
with like reference numerals, with leading digits added to
increment each reference numeral by 100. (For instance, the
inflatable balloon portion is designated "103" in FIG. 1 and
analogous inflatable balloon portions are designated as "203a" and
"203b" in FIG. 8.) Relevant disclosure set forth above regarding
similarly identified features thus may not be repeated hereafter.
Moreover, specific features of the embolic filter balloon system
and related components shown in FIG. 8 may not be shown or
identified by a reference numeral in the drawings or specifically
discussed in the written description that follows. However, such
features may clearly be the same, or substantially the same, as
features depicted in other embodiments and/or described with
respect to such embodiments. Accordingly, the relevant descriptions
of such features apply equally to the features of the embolic
filter balloon system and related components of FIG. 8. Any
suitable combination of the features, and variations of the same,
described with respect to the embolic filter balloon and components
illustrated in FIGS. 1-7, can be employed with the embolic filter
balloon system and components of FIG. 8, and vice versa. This
pattern of disclosure applies equally to further embodiments
depicted in subsequent figures and/or described hereafter.
[0059] In the embodiment of FIG. 8, an embolic filter balloon
system 201 may comprise a bifurcated catheter portion 207
comprising a first arm 208a and a second arm 208b. The embolic
filter balloon system 201 may further comprise the first inflatable
balloon portion 203a coupled to the first arm 208a and the second
inflatable balloon portion 203b coupled to the second arm 208b. The
first 203a and second 203b inflatable balloon portions may both be
configured to at least partially conform to an inside diameter of a
single body lumen when the first 203a and second 203b inflatable
balloon portions are deployed or inflated. In another embodiment,
the first 203a and second 203b inflatable balloon portions may be
configured to at least partially conform to two inside diameters of
two separate body lumens respectively when the first 203a and
second 203b inflatable balloon portions are deployed or
inflated.
[0060] Additionally, the first inflatable balloon portion 203a may
be coupled to a first filter member 205a, and the second inflatable
balloon portion 203b may be coupled to a second filter member 205b.
The first 205a and second 205b filter members may be configured to
allow passage only of particles less than a predetermined size in
the fluid of the one or more body lumens when the first 203a and
second 203b inflatable balloon portions are deployed or inflated.
The bifurcated catheter portion 207 may further comprise a
bifurcated inflation lumen 209, wherein the bifurcated catheter
portion 207 may be in fluid communication with the first inflatable
balloon portion 203a and the second inflatable balloon portion
203b, and may further be configured to at least partially inflate
or deploy the first inflatable balloon portion 203a and the second
inflatable balloon portion 203b. In such an embodiment, the first
203a and the second 203b inflatable balloon portions may be
inflated or deflated substantially together.
[0061] In another embodiment, a bifurcated catheter portion, like
the bifurcated catheter portion 207, may comprise a plurality of
lumens and/or bifurcated lumens. For example, a first inflatable
balloon portion, like the inflatable balloon portion 203a, may be
in fluid communication with a first inflation lumen, and a second
inflatable balloon portion, like the second inflatable balloon
portion 203b, may be in fluid communication with a second inflation
lumen. In such a configuration, the first inflatable balloon
portion and the second inflatable balloon portion may be inflated
or deflated substantially independent of one another. For example,
a practitioner may inflate a first inflatable balloon portion while
maintaining a second inflatable balloon portion in a pre-inflated
state, or vice versa.
[0062] In an embodiment, the embolic filter balloon system 201 may
be deployed in two separate lumens of a branched body lumen. For
example, a single vessel may branch into two or more vessels in a
region downstream of a site of a vascular procedure or therapy. The
embolic filter balloon system 201 may be deployed to capture or
filter particles from a fluid flowing through such branched
vessels.
[0063] In other embodiments, an embolic filter balloon system, like
the embolic filter balloon system 201, may comprise more than two
inflatable balloon portions. For example, a body lumen may branch
into three body lumens. In such a body lumen, an embolic filter
balloon system comprising three inflatable balloon portions may be
used. Embodiments with a plurality of inflatable balloon portions
and a plurality of other embolic filter balloon components are also
within the scope of this disclosure.
[0064] FIG. 9 is a perspective view of another embodiment of an
embolic filter balloon 301 showing the distal end 314 thereof. The
embolic filter balloon 301 of FIG. 9 may be comprised of an
inflatable balloon portion 303, a filter member 305, and a catheter
portion 307. In the illustrated embodiment, the filter member 305
is coupled to the inflatable balloon portion 303, and the catheter
portion 307 is in fluid communication with the inflatable balloon
portion 303. Other configurations of these and other components of
an embolic filter balloon, however, are also within the scope of
this disclosure.
[0065] In some embodiments, the inflatable balloon portion 303 of
the embolic filter balloon 301 may be configured to at least
partially conform to an interior diameter of a body lumen when the
inflatable balloon portion 303 is deployed or inflated. In the
embodiment of FIG. 9, the inflatable balloon portion 303 is
cylindrical and comprises substantially rounded proximal 312 and
distal 314 ends. Such a configuration may facilitate deployment
and/or adjustment of the embolic filter balloon 301 within a body
lumen. For example, the substantially rounded proximal 312 and
distal 314 ends may decrease the potential for the embolic filter
balloon 301 to damage or injure a body lumen or other body feature.
As described above, the inflatable balloon portion 303 may also be
tube-shaped, cylindrical, or otherwise shaped. The shape of the
inflatable balloon portion 303 may be selected or designed to
conform to the shape of an interior diameter of a target body
lumen. Any size of inflatable balloon portion 303 of any geometry
is also within the scope of this disclosure.
[0066] In the illustrated embodiment, the inflatable balloon
portion 303 comprises an interior fluid flow path 321. The interior
fluid flow path 321 may allow a fluid to flow through the
inflatable balloon portion 303 even though the inflatable balloon
portion 303 is in an inflated state. In the embodiment as
illustrated in FIGS. 9 and 10, the embolic filter balloon 301
comprises three proximal openings 311 at the proximal end 312 of
the embolic filter balloon 301 and three distal openings 313 at the
distal end 314 of the embolic filter balloon 301. The proximal
openings 311 and the distal openings 313 may provide communication
between the interior fluid flow path 321 and a fluid in or flowing
through a body lumen at either or both the proximal 312 and distal
314 ends of the embolic filter balloon 301. In other embodiments
there may be one, two, four, or more openings to the interior fluid
flow path 321. As described above, the embolic filter balloon 301
may conform to an inside diameter of a blood vessel when deployed
but may still permit flow of blood through the inflatable balloon
portion 303. Such a configuration may permit an at least partial
flow of blood through a vessel.
[0067] As illustrated in FIG. 9, the filter member 305 may be
positioned in the interior fluid flow path 321 at a position
between the proximal openings 311 and the distal openings 313 of
the inflatable balloon portion 303. In another embodiment, the
filter member 305 may be coupled to the inflatable balloon portion
303 such that the filter member 305 is configured to allow passage
only of particles of less than a predetermined size through the
body lumen when the inflatable balloon portion 303 is deployed or
inflated.
[0068] FIG. 10 is a perspective view of the embolic filter balloon
301 of FIG. 9 showing the proximal end 312 thereof. As illustrated,
the position of the filter member 305 within the interior diameter
of the inflatable balloon portion 303 may be viewed through the
proximal openings 311. In some embodiments, the catheter portion
307 may be coupled to the inflatable balloon portion 303 at the
proximal end 312 of the inflatable balloon portion 303, or the
catheter portion 307 may be coupled to the inflatable balloon
portion 303 at a position adjacent to the proximal end 312 of the
inflatable balloon portion 303. As described above, the catheter
portion 307 may couple the inflatable balloon portion 303 at any
location on, or adjacent to, the inflatable balloon portion 303,
and any variety of coupling between the catheter portion 307 and
the inflatable balloon portion 303 is within the scope of this
disclosure.
[0069] The catheter portion 307 may comprise an inflation lumen
309. In some embodiments, the inflation lumen 309 may be configured
to deliver an inflation fluid from an inflation device to the
inflatable balloon portion 303 to at least partially inflate the
inflatable balloon portion 303. In yet another embodiment, the
inflation lumen 309 may be configured to remove or evacuate an
inflation fluid from the inflatable balloon portion 303 to at least
partially deflate the inflatable balloon portion 303. For example,
an inflation fluid may be removed from the inflatable balloon
portion 303 via the inflation lumen 309 to an inflation device.
[0070] FIG. 11 is a top view of the embolic filter balloon 301 of
FIG. 9. The catheter portion 307 may couple to the inflatable
balloon portion 303 at the proximal end 312 of the inflatable
balloon portion 303. Additionally, proximal openings 311 and distal
openings 313 are positioned adjacent to the proximal end 312 and
the distal end 314, respectively, of the embolic filter balloon
301. In the embodiment of FIG. 11, the catheter portion 307 is
coupled to the inflatable balloon portion 303 at a position
parallel to and adjacent to a central axis of the inflatable
balloon portion 303. Such a configuration may, at least partially,
prevent the catheter portion 307 from contacting the interior
diameter of the body lumen at or near the site of deployment of the
embolic filter balloon 301, and may decrease the potential for
injury to an interior surface of the body lumen. Such a
configuration may also enhance fluid flow in a region of the body
lumen adjacent to the deployment of the embolic filter balloon
301.
[0071] FIG. 12 is a distal end 314 view of the embolic filter
balloon 301 of FIG. 9, and FIG. 13 is a cross-sectional view of the
embolic filter balloon 301 of FIG. 10 taken through lines 13-13. In
some embodiments, the inflatable balloon portion 303 may be
substantially cylindrical. Further, the embolic filter balloon 301
may comprise the filter member 305 coupled to the inflatable
balloon portion 303 at a position within, or adjacent to, the
interior diameter of the inflatable balloon portion 303. Distal
openings 313 may allow fluid to flow through the interior diameter
of the inflatable balloon portion 303. When at least partially
inflated, the inflatable balloon portion 303 may substantially
conform to the interior diameter of a body lumen. Such a
configuration may direct or result in at least a portion of a fluid
flowing through a body lumen to flow or pass through the filter
member 305. In some instances, substantially all particles greater
than a predetermined size may be captured or filtered by the filter
member 305 from the fluid in the body lumen.
[0072] As previously described, the filter member 305 may capture
particles larger than a predetermined size from the fluid and may
allow the fluid to flow through the body lumen while controlling or
limiting the flow of particles through the body lumen. In another
embodiment, the filter member 305 may be configured to allow
passage only of particles smaller than a predetermined size in a
fluid of a body lumen.
[0073] As described for other embodiments, in the embodiment of
FIGS. 9-15, at least one of the inflatable balloon portion 303 and
the filter member 305 may comprise a single layer. In another
embodiment, at least one of the inflatable balloon portion 303 and
the filter member 305 may comprise a plurality of layers. The
various characteristics of multilayered balloon constructs, as
described above for other embodiments, may similarly apply to this
embodiment.
[0074] FIG. 14 is a cross-sectional perspective view of the embolic
filter balloon 301 of FIG. 10 taken through lines 14-14. In the
illustrated embodiment, the filter member 305 may be positioned in
an interior fluid flow path 321 of the inflatable balloon portion
303 at a position between the proximal openings 311 and the distal
openings 313 of the inflatable balloon portion 303. The inflatable
balloon portion 303 and the filter member 305 may be formed of the
same material. Alternatively, the inflatable balloon portion 303
may be formed of a different material than the filter member 305.
Additionally, the catheter portion 307, comprising the inflation
lumen 309, may be formed of the same material as the inflatable
balloon portion 303 and/or the filter member 305. Alternatively,
the catheter portion 307 may be formed of a different material than
the inflatable balloon portion 303 and/or the filter member 305. In
embodiments, the filter member 305 may comprise a porous material,
a mesh, a woven material, or so forth. The filter member 305 may be
coupled to the inflatable balloon member 303, for example, by
adhesive, bonding, heat bonding, stitching, and other analogous
methods.
[0075] FIG. 15 is a cross-sectional view of the embolic filter
balloon 301 of FIG. 12 taken through lines 15-15. As illustrated,
the filter member 305 extends across the internal fluid flow path
321 at a position between the proximal 311 and the distal 313
openings of the inflatable balloon portion 303. Further, as
illustrated, the catheter portion 307 may comprise the inflation
lumen 309 in fluid communication with the inflatable balloon
portion 303. As described above, the inflation lumen 309 may be
configured to deliver an inflation fluid from an inflation device
to the inflatable balloon portion 303 to at least partially inflate
the inflatable balloon portion 303. The inflation lumen 309 may
also be configured to remove an inflation fluid from the inflatable
balloon portion 303 to at least partially deflate the inflatable
balloon portion 303. In embodiments, the degree of inflation or
deflation of the inflatable balloon portion 303 may be controlled
by increasing or decreasing the amount of an inflation fluid
flowing into or out of the inflatable balloon portion 303. In other
embodiments, the rate of inflation or deflation of the inflatable
balloon portion 303 may be controlled by increasing or decreasing
the flow rate of an inflation fluid into or out of the inflatable
balloon portion 303.
[0076] In another embodiment, an inflation lumen, like the
inflation lumen 309, may extend through an inflatable balloon
portion, like the inflatable balloon portion 303, and may be in at
least partial fluid communication with a distal end, like the
distal end 314, of the inflatable balloon portion. A catheter
portion, like the catheter portion 307, may also comprise a
plurality of catheter lumens. For example, the catheter portion may
comprise a double-D lumen catheter. In embodiments, the catheter
portion may comprise a first lumen comprising an inflation lumen in
fluid communication with the inflatable balloon portion. The
catheter portion may also extend through the inflatable balloon
portion and further comprise a second lumen comprising, for
example, a delivery lumen configured to provide a sleeve or sheath
for delivery of a medical appliance to a position in a body lumen
distal to the inflatable balloon portion. In another example, the
first catheter lumen may comprise an inflation lumen in fluid
communication with the inflatable balloon portion, and the second
catheter lumen may comprise, for example, a delivery lumen
configured to provide a sleeve or sheath for delivery of a medical
appliance to a position proximal to the embolic filter balloon.
[0077] In yet another example, the catheter portion may comprise
more than two lumens wherein a first lumen is in fluid
communication with the inflatable balloon portion, a second lumen
comprises a delivery lumen configured to provide a sleeve or sheath
for delivery of a medical appliance or appliances to a position
distal to and/or proximal to the embolic filter balloon, a third
lumen comprises a delivery lumen configured to provide a sleeve or
sheath for delivery of a medical appliance or appliances to a
position distal to and/or proximal to the embolic filter balloon,
and so forth. In some embodiments, the lumens may comprise
inflation lumens, delivery lumens, or other varieties of lumens. In
additional embodiments, the number of lumens may correspond to the
number of medical appliances coupled to or delivered through the
catheter portion. As described above, medical appliances in these
and other embodiments herein disclosed comprise, but are not
limited to: balloons, catheters, embolic delivery devices, filters,
guide wires, introducers, retrieval devices, snares, and
stents.
[0078] Any of the embodiments disclosed above may be used in
connection with a variety of procedures and/or uses. FIGS. 16A-16E
illustrate one potential use of the embodiment of the embolic
filter balloon 101 of FIGS. 1-7. The use illustrated in FIGS.
16A-16E may also use the embodiment of the embolic filter balloon
301 of FIGS. 9-15. The labeled components of the embodiment of an
embolic filter balloon of FIGS. 16A-16E are substantially similar
to the labeled components of the embodiment of the embolic filter
balloon 101 of FIGS. 1-7 unless otherwise noted. Moreover, as
described above, specific features of the embolic filter balloon
and related components shown in FIGS. 16A-16E may not be shown or
identified by a reference numeral in the drawings and/or
specifically discussed in the written description that follows.
However, such features may clearly be the same, or substantially
the same, as features depicted in other embodiments and/or
described with respect to such embodiments. Accordingly, the
relevant descriptions of such features apply equally to the
features of the embolic filter balloon and related components of
FIGS. 16A-16E. Any suitable combination of the features, and
variations of the same, described with respect to the embolic
filter balloon and components illustrated in FIGS. 1-7, can be
employed with the embolic filter balloon and components of FIG.
16A-16E, and vice versa. As previously stated, this pattern of
disclosure applies equally to further embodiments described
hereafter.
[0079] Referring to FIG. 16A, the embolic filter balloon 101 may
first be disposed in a vessel 117. In some procedures, a
practitioner may select an entry site on an exterior surface of a
patient. The entry site, for example, may be adjacent to a radial
artery, a femoral artery, or another suitable vessel. At the entry
site, the practitioner may use a needle, trochar, or other
vesicular access appliance to access a lumen of the vessel 117. The
practitioner may then dispose an introducer sheath 125 or other
delivery appliance into the vessel 117. The practitioner may also
dispose one or more of a catheter, dilator, guide wire, or other
relevant appliance into the vessel 117 via the introducer sheath
125 at the entry site. In some instances, the practitioner may
advance one or more of the catheter, dilator, guide wire, or other
relevant appliance to a site proximal to a treatment site. The
practitioner may then utilize one or more of the catheter, dilator,
guide wire, or other relevant appliance to assist in advancing the
introducer sheath 125 to the site proximal to the treatment site.
In other instances, the practitioner may advance the introducer
sheath 125 through the vessel 117 to the site proximal to the
treatment site without the assistance of an appliance such as a
catheter, dilator, or guide wire.
[0080] The practitioner may also advance the embolic filter balloon
101 and one or more medical appliances via the introducer sheath
125 to the site proximal to the treatment site. In some instances,
the practitioner may advance the embolic filter balloon 101 and/or
the one or more medical appliances to a site adjacent to or at the
treatment site without utilizing an introducer sheath 125. From the
site proximal to the treatment site, the practitioner may advance
the embolic filter balloon 101 to a site distal to the treatment
site, and the practitioner may also advance the one or more medical
appliances to the treatment site. In an angioplasty, for example,
the one or more medical appliances may include a balloon catheter.
During advancement, the embolic filter balloon 101 may be in a
delivery or pre-inflated configuration, as illustrated in FIG. 16A.
Such a configuration may facilitate advancement of the embolic
filter balloon 101 through the vessel 117 or via the introducer
sheath 125 to the site distal to the treatment site. A compact,
pre-inflated configuration may also facilitate advancement of the
embolic filter balloon 101 along a pathway that may be
tortuous.
[0081] Referring now to FIG. 16B, the embolic filter balloon 101
may be at least partially inflated in the vessel 117 at the site
distal to the treatment site, such that the inflatable balloon
portion 103 at least partially conforms to the inside diameter of
the vessel 117. As illustrated in FIGS. 16A-16E, the embolic filter
balloon 101 may be disposed in the vessel 117 such that the
direction of blood flow, as indicated by arrows, proceeds from a
proximal end 112 of the embolic filter balloon 101 to a distal end
114 of the embolic filter balloon 101. Other configurations of the
embolic filter balloon 101 within a body lumen are also within the
scope of this disclosure. For example, a configuration wherein the
direction of blood flow proceeds from a distal end 114 of the
embolic filter balloon 101 to proximal end 112 of the embolic
filter balloon 101 is also within the scope of this disclosure.
[0082] Referring now to FIG. 16C, a plurality of particles 115 may
be present in blood 119 flowing through the vessel 117. The
particles 115 may be released during a vascular procedure or
therapy conducted upstream from the position of the embolic filter
balloon 101. For example, during an angioplasty a practitioner may
deliver an embolic filter balloon 101 via an introducer sheath 125
to a site distal to a treatment site in a vessel 117. The
practitioner may also deliver a balloon catheter through the
introducer sheath 125 to the treatment site. At the treatment site,
the practitioner may deploy or inflate the balloon catheter. As the
balloon catheter inflates, an exterior surface of the balloon
catheter may press against an interior diameter of the vessel 117
and may also press a plaque deposit against the interior diameter
of the vessel 117. During this procedure, particles 115 of plaque
or other debris may be dislodged or released into the blood 119. If
the released particles 115 or debris remain in the blood 119 the
particles 115, as described above, may at least partially occlude
blood 119 flow in the vessel 117 or another vessel or vessels
downstream of the treatment site and may result in ischemia,
myocardial infarction, stroke, and other potentially adverse
medical conditions. To substantially avoid such potentially adverse
conditions, the practitioner may deploy the embolic filter balloon
101 at the site distal to the treatment site to filter or capture
the particles 115 or debris from the blood 119.
[0083] As described above, particles 115 within the scope of this
disclosure may comprise biologic and/or synthetic material and may
or may not be introduced into the body by the practitioner. For
example, some procedures or therapies may include the release of
particles 115, including particles 115 of body tissue or other
biologic matter, into a fluid in a body lumen. A variety of
additional procedures or therapies may also result in the release
of particles 115 into a fluid flowing through a body lumen. For
example, during expansion of a stent in a body lumen, particles 115
may be dislodged into the fluid in the body lumen. The particles
115, as illustrated in FIG. 16D, may be captured by the filter
member 105 as blood 119 flows through the interior flow path 121 of
the deployed or inflated embolic filter balloon 101.
[0084] FIG. 16E illustrates that after the particles 115 have been
captured by the filter member 105, for example, after an upstream
procedure, as described above, releases particles 115 into the
blood 119, the embolic filter balloon 101 may be at least partially
deflated. Partial deflation of the inflatable balloon portion 103
of the embolic filter balloon 101 may act to secure the captured
particles 115 in the embolic filter balloon 101. Deflation of the
inflatable balloon portion 103 of the embolic filter balloon 101
may also decrease the size or geometric profile of the embolic
filter balloon 101, and may facilitate retrieval of the embolic
filter balloon 101 from the vessel 117.
[0085] The filter member 105 may be biased to collapse into a
basket-like shape upon deflation of the inflatable balloon portion
103. In another embodiment, the filter member 105 may be folded
into the delivery configuration in a manner that may provide the
filter member 105 with a memory that may prompt the filter member
105 to refold into a similar configuration upon deflation of the
embolic filter balloon 101. Such a configuration may keep the
particles 115 from escaping from the filter member 105 as the
embolic filter balloon 101 is deflated. The embodiment as shown in
FIGS. 9-15 may also aid in keeping captured particles, like the
particles 115, from escaping from the filter member 305. For
example, the rounded distal 314 and proximal 312 ends may aid in
maintaining the filter member 305 in a basket-like configuration
upon deflation of the embolic filter balloon 301.
[0086] In some embodiments, a band or a portion of the embolic
filter balloon, like the embolic filter balloon 101, may be coupled
to or coated with a radiopaque material. Such a configuration may
facilitate imaging of the embolic filter balloon during: delivery
of the embolic filter balloon to a target body lumen, use of the
embolic filter balloon, and/or retrieval of the embolic filter
balloon from a body lumen.
[0087] In another example, a practitioner may desire to deliver
embolic microspheres to a target vessel in order to intentionally
occlude blood flow to a fibroid, tumor, cancer, or other
undesirable growth or lesion. The target vessel, however, may
branch off from a non-target vessel that the practitioner may
desire to avoid occluding with the embolic microspheres. To prevent
the embolic microspheres from at least partially occluding the
non-target vessel, the practitioner may deploy an embolic filter
balloon, like the embolic filter balloon 101, in the lumen of the
non-target vessel to filter or capture misdelivered embolic
microspheres.
[0088] In another procedure for filtering particles, like the
particles 115, larger than a predetermined size from a fluid within
a body lumen, an embolic filter balloon, like the embolic filter
balloon 101, may be introduced into a body lumen. The embolic
filter balloon may be at least partially inflated such that a
filter member, like the filter member 105, coupled to the embolic
filter balloon extends at least partially across the body lumen.
The at least partially extended filter member may filter or capture
particles larger than a predetermined size from a fluid within a
body lumen.
[0089] In some procedures or therapies, an additional medical
device or devices may be introduced into the body lumen before,
during, or after introduction of the embolic filter balloon into
the body lumen. As described above, such a medical device or
devices may be one or more of the following, but is not limited to:
balloons, catheters, embolic delivery devices, filters, guide
wires, introducers, retrieval devices, snares, and stents. The
filtered particles may comprise particles that are released into
the fluid within the body lumen by such a medical device.
[0090] An inflatable balloon portion, like the inflatable balloon
portion 103, may also be at least partially deflated such that any
filtered particles remain trapped in the coupled filter member.
Additionally, in some instances, the embolic filter balloon and the
filtered particles may be retrieved from the body lumen. In another
embodiment, the inflatable balloon portion and the coupled filter
member may be detachably coupled to a catheter portion, like
catheter portion 107. For example, the inflatable balloon portion
and the coupled filter member may remain in a body lumen of a
patient and the catheter portion may be retrieved from the patient.
In yet another embodiment, the inflatable balloon portion and the
coupled filter member may be re-coupled to a catheter portion, like
catheter portion 107. For example, a practitioner may detach the
inflatable balloon portion and coupled filter member from the
catheter portion, and may allow the inflatable balloon portion and
coupled filter member to remain in a patient for a period of time.
The practitioner may then re-couple the inflatable balloon portion
and coupled filter member to a catheter portion, the practitioner
may then at least partially deflate the inflatable balloon portion,
and the practitioner may retrieve the inflatable balloon portion
and coupled filter member from the body lumen of the patient. In
some embodiments, at least a portion of the embolic filter balloon
may be coated with or coupled to an agent or coating material that
may reduce or prevent tissue ingrowth. In such an embodiment, the
practitioner may retrieve the embolic filter balloon from the body
lumen of the patient without problems associated with tissue
ingrowth.
[0091] Without further elaboration, it is believed that one skilled
in the art can use the preceding description to utilize the present
disclosure to its fullest extent. The examples and embodiments
disclosed herein are to be construed as merely illustrative and
exemplary and not as a limitation of the scope of the present
disclosure in any way. It will be apparent to those having skill in
the art, and having the benefit of this disclosure, that changes
may be made to the details of the above-described embodiments
without departing from the underlying principles of the disclosure
herein.
* * * * *