U.S. patent application number 12/711100 was filed with the patent office on 2010-08-26 for rapid perfusion devices and methods.
This patent application is currently assigned to MINDFRAME, INC.. Invention is credited to Andrew Cragg, David A. Ferrera, John FULKERSON.
Application Number | 20100217187 12/711100 |
Document ID | / |
Family ID | 41065698 |
Filed Date | 2010-08-26 |
United States Patent
Application |
20100217187 |
Kind Code |
A1 |
FULKERSON; John ; et
al. |
August 26, 2010 |
RAPID PERFUSION DEVICES AND METHODS
Abstract
A microcatheter having an active segment reperfuses occluded
blood vessels above the junction of the subclavian artery and
common carotid artery. The microcatheter is used to penetrate
emboli. Once an embolus is penetrated, the active segment of the
microcatheter is activated, causing it to expand radially and
thereby open a channel in the embolus. Thus, a channel for restored
blood flow is created. The blood's natural lytic action further
degraded the embolus in some cases. Therapeutic agents may be
administered through the microcatheter to aid in the reperfusion
process.
Inventors: |
FULKERSON; John; (Rancho
Santa Margarita, CA) ; Cragg; Andrew; (Edina, MN)
; Ferrera; David A.; (Redondo Beach, CA) |
Correspondence
Address: |
Luce, Forward, Hamilton & Scripps LLP
2050 Main Street, Suite 600
Irvine
CA
92614
US
|
Assignee: |
MINDFRAME, INC.
|
Family ID: |
41065698 |
Appl. No.: |
12/711100 |
Filed: |
February 23, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12123390 |
May 19, 2008 |
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12711100 |
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12136737 |
Jun 10, 2008 |
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12123390 |
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12182370 |
Jul 30, 2008 |
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12136737 |
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60987384 |
Nov 12, 2007 |
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Current U.S.
Class: |
604/96.01 ;
606/194 |
Current CPC
Class: |
A61B 17/221 20130101;
A61B 2017/22038 20130101; A61M 29/02 20130101; A61F 2/82 20130101;
A61M 2025/1095 20130101; A61F 2/013 20130101; A61B 17/320725
20130101; A61F 2250/0059 20130101; A61B 2017/00845 20130101; A61M
2025/1097 20130101; A61B 2017/22082 20130101; A61B 17/3207
20130101; A61B 2017/00867 20130101 |
Class at
Publication: |
604/96.01 ;
606/194 |
International
Class: |
A61M 25/10 20060101
A61M025/10; A61M 29/02 20060101 A61M029/02 |
Claims
1. A microcatheter device, comprising, in combination: a first
segment; a second segment; a radially expandable active segment
connecting the first segment to the second segment and having an
unexpanded state and an expanded state; an activation member
connected to the second segment, wherein the activation member is
configured to radially expand and retract the active segment.
2. The microcatheter device of claim 1, wherein the activation
member allows a user to deploy the active segment.
3. The microcatheter device of claim 1, wherein the activation
member is configured to control the relative distance between the
first segment and the second segment.
4. The microcatheter device of claim 1, wherein the activation
member comprises a hollow lumen.
5. The microcatheter device of claim 4, wherein the hollow lumen of
the activation member is configured to receive a guidewire
therein.
6. The microcatheter device of claim 1, wherein the activation
member comprises a coil.
7. The microcatheter device of claim 1, wherein the active segment
comprises a mesh.
8. The microcatheter device of claim 1, further comprising a
plurality of revascularization ports disposed in at least one of
the first segment and the second segment.
9. The microcatheter device of claim 1, further comprising a lumen
configured to deliver at least one therapeutic agent.
10. A method comprising, in combination: providing a microcatheter
having at least a proximal segment, a distal segment, an active
segment between the proximal segment and the distal segment, an
activation member attached to the distal segment, and a guidewire;
delivering the guidewire to an embolus; crossing the embolus with
the guidewire; advancing the microcatheter along the guidewire,
whereby the active segment is aligned with the embolus; radially
expanding the active segment.
11. The method of claim 10, further comprising restoring perfusion
within a vessel containing the embolus.
12. The method of claim 10, wherein radially expanding the active
segment comprises applying tension to the activation member.
13. The method of claim 10, wherein radially expanding the active
segment comprises causing a distance between the proximal segment
and the distal segment to decrease.
14. The method of claim 10, wherein radially expanding the active
segment comprises shortening the longitudinal length of the
activation member.
15. The method of claim 10, wherein radially expanding the active
segment comprises allowing the activation member to transition from
an extended state to a native state, the native state having a
shorter longitudinal length than the extended state.
16. The method of claim 10, wherein the embolus is above the
juncture of the subclavian artery and common carotid artery.
17. An improved medial device, comprising, in combination: a
proximal segment; a distal segment; an active segment having an
expanded state and an unexpanded state, wherein the active segment
is connected to the proximal segment at a distal end thereof and to
the distal segment at a proximal end thereof; an activation member
having a shortened state and an extended state, wherein the
activation member is connected to the active segment at a proximal
end and a distal end thereof and disposed concentrically within the
active segment, wherein the activation member is configured to
radially expand and retract the active segment.
18. The improved medial device of claim 17, wherein the shortened
state of the activation member corresponds to the expanded state of
the active segment and wherein the extended state of the activation
member corresponds to the unexpanded state of the active
segment.
19. The improved medial device of claim 18, wherein the activation
member is serpentine in the shortened state and substantially
straight in the extended state.
20. The improved medial device of claim 18, wherein the activation
member is a coiled wire selectably providing each of the shortened
state and the extended state.
21. The improved medial device of claim 18, wherein the activation
member comprises a hollow lumen.
22. The improved medial device of claim 21, further comprising a
guidewire advanceable within the hollow lumen of the activation
member.
Description
RELATED APPLICATIONS
[0001] This application claims the full Paris Convention benefit
of, claims priority to, and is a continuation of each of U.S.
patent application Ser. No. 12/123,390, filed May 19, 2008; U.S.
patent application Ser. No. 12/136,737, filed Jun. 10, 2008; U.S.
patent application Ser. No. 12/182,370, filed Jul. 30, 2008; each
of which claims priority to and incorporates by reference U.S.
Provisional Patent Application Ser. No. 60/987,384, filed Nov. 12,
2007, the contents of each of the above being incorporated by
reference herein in its entirety, as if fully set forth herein.
BACKGROUND
[0002] The present disclosure relates to minimally invasive and
catheter delivered reperfusion systems for use in the
vasculature.
SUMMARY
[0003] A microcatheter having an active segment reperfuses occluded
blood vessels above the junction of the subclavian artery and
common carotid artery. The microcatheter is used to penetrate
emboli. Once an embolus is penetrated, the active segment of the
microcatheter is activated, causing it to expand radially and
thereby open a channel for restored blood flow in the embolus. The
blood's natural lytic action further degrades the embolus in some
cases. Therapeutic agents may be administered through the
microcatheter to aid in the reperfusion process. Active and passive
reperfusion are thus both enabled.
[0004] According to a feature of the present disclosure, a device
is disclosed comprising a distal segment having attached thereto a
radially expandable active segment, a proximal segment comprising
an active segment activator for radially expanding or retracting
the active segment, an activation member connecting the active
segment activator to the active segment. The distal segment is of a
suitable diameter for use above the juncture of the subclavian
artery and common carotid artery.
[0005] According to a feature of the present disclosure, a method
is disclosed comprising providing a microcatheter having at least a
distal segment, proximal segment, and active segment for use above
the subclavian artery and common carotid artery, wherein the active
segment is radially expandable.
DRAWINGS
[0006] The above-mentioned features and objects of the present
disclosure will become more apparent with reference to the
following description taken in conjunction with the accompanying
drawings wherein like reference numerals denote like elements and
in which:
[0007] FIG. 1 shows a perspective view of an embodiment of a rapid
reperfusion device in an unexpanded state;
[0008] FIG. 2 shows a perspective view of an embodiment of a rapid
reperfusion device in an expanded state;
[0009] FIG. 3A shows a side view of an embodiment of a rapid
reperfusion device;
[0010] FIG. 3B shows a sectional view of an embodiment of a rapid
reperfusion device;
[0011] FIG. 3C shows a sectional view of an embodiment of a rapid
reperfusion device;
[0012] FIG. 4A shows a side view of an embodiment of a rapid
reperfusion device;
[0013] FIG. 4B shows a sectional view of an embodiment of a rapid
reperfusion device;
[0014] FIG. 4C shows a sectional view of an embodiment of a rapid
reperfusion device;
[0015] FIG. 5 shows a side view of an embodiment of a rapid
reperfusion device in an unexpanded state;
[0016] FIG. 6 shows a side view of an embodiment of a rapid
reperfusion device in an expanded state;
[0017] FIG. 7 shows a perspective view of an embodiment of a rapid
reperfusion device in an unexpanded state;
[0018] FIG. 8 shows a perspective view of an embodiment of a rapid
reperfusion device in an expanded state;
[0019] FIG. 9 shows a side view of an embodiment of a rapid
reperfusion device in an unexpanded state;
[0020] FIG. 10 shows a side view of an embodiment of a rapid
reperfusion device in an expanded state;
[0021] FIG. 11A shows a view of a rapid reperfusion device near a
target embolus;
[0022] FIG. 11B shows a view of a rapid reperfusion device across a
target embolus;
[0023] FIG. 11C shows a view of a rapid reperfusion device deployed
against a target embolus;
[0024] FIG. 12A shows a view of a rapid reperfusion device near a
target embolus;
[0025] FIG. 12B shows a view of a rapid reperfusion device across a
target embolus; and
[0026] FIG. 12C shows a view of a rapid reperfusion device deployed
against a target embolus.
DETAILED DESCRIPTION
[0027] In the following detailed description of embodiments of the
invention, reference is made to the accompanying drawings in which
like references indicate similar elements, and in which is shown by
way of illustration specific embodiments in which the invention may
be practiced. These embodiments are described in sufficient detail
to enable those skilled in the art to practice the invention, and
it is to be understood that other embodiments may be utilized and
that logical, mechanical, biological, electrical, functional, and
other changes may be made without departing from the scope of the
present invention. The following detailed description is,
therefore, not to be taken in a limiting sense, and the scope of
the present invention is defined only by the appended claims. As
used in the present disclosure, the term "or" shall be understood
to be defined as a logical disjunction and shall not indicate an
exclusive disjunction unless expressly indicated as such or notated
as "xor."
[0028] According to embodiments, a catheter system for use above
the juncture of the subclavian artery and common carotid artery,
for example, as well as other uses as determined appropriate by
qualified medical personnel, may be introduced via a guidewire. The
device operates as a microcatheter during introduction into a
patient. An active segment of the device or system may expand
radially to reperfuse, lyse, or macerate emboli, thombi, clots,
occlusion, blockage, or other matter in a vessel (which terms may
be used interchangeably according to embodiments of the present
disclosure). After reperfusion is achieved, the active segment may
be returned to its configuration maintained prior to expansion, and
the catheter system may be removed.
[0029] According to embodiments, and as illustrated by an exemplary
embodiment in FIG. 1, there is shown microcatheter 100 with active
segment 110 in an unexpanded state. Microcatheter 100 comprises
proximal segment 102 and distal segment 104. Proximal segment 102
or portions thereof may remain accessible outside of the patient
and may be used to insert and retract microcatheter 100, as well as
to deploy active segment no during operation. As illustrated by an
exemplary embodiment in FIG. 2, active segment 110 may be deployed
to an expanded state, at least a portion thereof having a radius
greater than in an unexpanded state.
[0030] According to embodiments, catheter length and diameter are
suitable for inserting into a human patient and capable of reaching
a target embolus, for example, in the region above the subclavian
and common carotid arteries. For example, microcatheter 100 may be
about 150 cm long; proximal segment 102 may be about 115 cm with an
outer diameter of about 4 French and distal segment 104 is about 35
cm with an outer diameter of about 2.7 French. According to
embodiments, a gradual decrease (e.g., stepwise, tapered, etc.) in
the outer diameter dimension may be provided as a function of the
distance along proximal segment 102. For example, proximal segment
102 may be 4 French at the most proximal end and distal segment 104
may be 2.7 French at the most distal end. Disposed between may be
at least one segment having one or more intermediate outer
diameters between 4 French and 2.7 French (e.g., 3.4 French, 3.0
French, etc. (see FIGS. 1, 2, 5, and 6). Microcatheter 100 may have
at least one lumen having an inner diameter of about 0.012 to about
0.021 inches, which allows microcatheter to be inserted along a
preinserted guidewire or used to infuse therapeutic agents.
According to embodiments, the performance of microcatheter 100 is
comparable to various microcatheters and is designed to track over
guidewire 300 or other guidance structures through the
neuro-vasculature. Those having ordinary skill in the art will
recognize yet other ranges of measurements, dimensions, or
attributes that may be varied based on the needs and specification
of the vasculature provided.
[0031] According to embodiments, activation member 120 may be
provided to selectably radially expand and retract active segment
110. Activation member 120 may be a structure that connects distal
segment 104 to proximal segment 102 or another component of
microcatheter 100. According to embodiments, activation member 120,
components thereof, devices attached thereto, or devices capable of
acting upon activation member 120 may be directly accessible by a
user, for example, at a proximal end of microcatheter 100 (via hub,
luer, fitting, etc.). Activation member 120 may allow a user of
microcatheter 100 to deploy active segment 110.
[0032] According to embodiments, activation member 120 may be made
from various materials, including stainless steel wire or braid,
composites polymers and metal braids, ribbon or wire coils. As
illustrated by an exemplary embodiment in FIG. 3A, 3B, and 3C,
activation member 120 may extend through a lumen of microcatheter
100. For example, as shown in FIG. 3B, activation member 120 may be
a wire extending through at least a portion of proximal segment
102. Likewise, guidewire 300 may be provided in the same or another
lumen of microcatheter 100. By further example, activation member
120 may attach to at least a portion of distal segment 104, such
that distal or proximal travel of activation member 120 relative to
proximal segment 102 causes corresponding distal or proximal travel
of distal segment 104 relative to proximal segment 102.
[0033] As illustrated by an exemplary embodiment in FIGS. 4A, 4B,
and 4C, activation member 120 may have a hollow lumen and extend
through a lumen of microcatheter 100. Guidewire 300 may be disposed
within the hollow lumen of activation member 120, as shown in FIG.
4B. Activation member 120 may slidably move over guidewire 300 to
reach distal segment 104. Other devices operable during a procedure
may be delivered via a hollow lumen of activation member 120.
[0034] According to embodiments, activation member 120 may be a
braid (stainless steel, nitinol, composite, polymer, metal, etc.)
structure or a ribbon or wire coil. Accordingly, activation member
120 may be longitudinally or radially compressible, extendable,
distensible, or otherwise responsive to forces applied thereto. For
example, activation member 120 may cause distal segment 104 to move
relative to proximal segment 102 by causing activation member 120
to compress or extend longitudinally. By further example, the
longitudinal compression or extension of activation member 120 may
result in adjustment of the relative position of proximal segment
102 and distal segment 104 where activation member 120 is attached
to at least a portion of each of proximal segment 102 and distal
segment 104. Another device (guidewire 300, etc.) may be provided
to activation member 120 to effect its compression, extension, etc.
According to embodiments, deployment of active segment 110 may be
achieved by shortening of activation member 120, whereby the
distance between proximal segment 102 and distal segment 104 is
decreased.
[0035] According to embodiments, when active segment 110 is
expanded in a vessel, the radial expansion causes a channel to be
formed in a thrombus for restored blood flow past the occlusion and
thereby reperfuse the vessel. Activation of active segment no may
be accomplished by mechanical methods, such as with activation
member 120 or by using a liner of microcatheter 100. Use of the
liner is accomplished by leaving the liner unfused with active
segment 110, such that the liner may be independently operable to
deploy active segment 110.
[0036] According to embodiments, activation member 120 may be fused
to the distal-most portion of active segment 110 or the
proximal-most portion of distal segment 104. Activation member 120
may further be fused to the proximal-most portion of active segment
110 or the distal-most portion of proximal segment 102.
[0037] According to embodiments, active segment no and activation
member 120 may provide opposing forces. For example, active segment
110 may be heat set into a native configuration in an expanded
state. When activation member 120 tensions active segment 110, its
state changes from an expanded state into a deliverable state. Such
tension may be provided by longitudinal extension of activation
member 120 or travel thereof causing proximal segment 102 to
distance itself from distal segment 104. Once delivered to the site
of an embolus, activation member 120 is adjusted to allow active
segment 110 to relax and thereby expand. Such adjustment may
achieved by shortening the longitudinal length of activation member
120 or travel thereof causing proximal segment 102 to approach
distal segment 104.
[0038] By further example, active segment no may be heat set into a
native configuration in an unexpanded state. Activation member 120
may be used to tension active segment no when delivered to the site
of an embolus, thereby expanding it. Such tension may be provided
by shortening the longitudinal length of activation member 120 or
travel thereof causing proximal segment 102 to approach distal
segment 104. Shortening of activation member 120 may be achieved in
a variety of ways, as recognized by those having ordinary skill in
the art. For example, activation member 120 may be radially
expanded, whereby its longitudinal length is decreased. By further
example, activation member 120 may be transitioned from a
substantially straight shape to serpentine shape, whereby its
longitudinal length is decreased. Guidewire 300 may act upon or
within activation member 120 to effect such transitions.
[0039] Other activation methods include electrical, chemical, and
thermal activators, as is known and understood by those having
ordinary skill in the art. Hydraulic activation may be accomplished
with activation member 120 as a balloon in the interior of the
catheter that is filled with a fluid, thereby expanding the
balloon, which expands active segment 110. Fluids, devices, or
other materials may be provided to activation member 120 to effect
a change in the shape, geometry, size, orientation, or position
thereof, thereby deploying active segment 110.
[0040] According to embodiments, active segment 110 comprises a
radially expandable material. For example, as shown in FIGS. 1, 2,
5 and 6, active segment 110 may include a woven mesh. A mesh may be
made from materials well known and understood by artisans,
including polymers, flouropolymers, nitinol, stainless steel,
vectran, or kevlar. Other biocompatible materials that may be woven
or coiled are similarly contemplated. Active segment 110 is,
according to embodiments, about 5 mm to about 50 mm in length when
expanded and is designed to substantially return to its
pre-expansion configuration for removal of microcatheter 100 after
reperfusion.
[0041] According to embodiments, active segment 110 comprises a
mesh. The mesh comprises a plurality of individual units, having a
uniform size or spacing geometry or a variable size or spacing
geometry. According to embodiments where the size or spacing
geometry is variable, smaller size or spacing geometry is used to
provide a tight mesh for expanding a channel through the thrombus.
Larger size or spacing geometry units allow from blood flow through
active segment 110.
[0042] According to embodiments, as shown in FIG. 6, active segment
110 may comprise both mesh 110A and tethers 110B. According to
embodiments, mesh 110A comprises an open braid, a covered braid, or
other supporting structure which may provide at least some
porosity. The covering may comprise a distal protection mechanism
and may be a polymer, such as polyurethane, or other biocompatible
cover materials such as ePTFE or related thin film. Tethers 110B
may serve to provide structure and support for mesh 110A as well as
attachment to at least one of proximal segment 102 and distal
segment 104. Tethers 110B may further provide openings whereby
blood may freely flow from the proximal to distal end of active
segment 110 through a lumen formed therein. Tethers 110B may
include braids, wires, coils, etc. Those skilled in the art will
readily understand that materials for tethers 110B and mesh 110A
may be the same, different, or interchangeable, as needed.
[0043] According to embodiments, as shown in FIGS. 7, 8, 9, and 10,
active segment no may comprise expandable coiled wires. The coiled
wires may be made from stainless steel wire or braid, composite
metal polymers, memory shape alloys such as nitinol, etc., wherein
the coil is able to stably expand and return to an original state.
As illustrated in Figure 9, the diameter of coil may be
substantially the same as that of microcatheter 100 when in a
non-expanded state. However, when expanded (as illustrated in FIG.
10) the coiled wires expand radially according to the reperfusion
principles disclosed herein. Such radial expansion may be achieved
by a variety of methods, including shortening of the longitudinal
length of active segment 110, travel of distal segment 104 relative
to proximal segment 102, rotation of distal segment 104 relative to
proximal segment 102. Other methods include mechanical, electrical,
heat, chemical, etc.
[0044] According to embodiments, as shown in FIGS. 5, 6, 9, and 10,
revascularization ports 112 may provide increased blood flow
through the lumen of microcatheter 100, as disclosed further
herein.
[0045] According to embodiments, variable cell size or spacing
geometry may be accomplished with points where the braid crosses
over fixed filaments (PICS). Thus, the cell size or spacing
geometry varies by varying the density of the braid. Where high
radial force is needed to open a channel in an embolus, for
example, the filaments of the mesh are denser and therefore cross
each other more often, yielding small cell size or spacing geometry
that leads to the application of greater radial force when the mesh
expands. Where reperfusion is desired, the PICS may be less dense
and the resulting cell size or spacing geometry is increased.
Additionally, drug delivery through microcatheter 100 will be more
effective in mesh configurations having a large size or spacing
geometry.
[0046] Active segment 110 may be coated or covered with substances,
such as lubricious agents or pharmacologically active agents,
according to embodiments. For example, active segment 110 may be
covered with heparin or other agents that are used in clot therapy,
such as those that aid in dissolving clots or mitigating
vasospasms.
[0047] According to embodiments, microcatheter 100 is designed to
follow a path of least resistance through a thrombus. Guidewire 300
inserted through a thrombus tends to follow the path of least
resistance through the softest parts of the thrombus. When
microcatheter 100 crosses the thrombus, it likewise follows this
path of least resistance. As blood flow is restored, a natural
lytic action further helps to break up the thrombus.
[0048] According to similar embodiments, thereapeutic agents are
deployable through the lumen of microcatheter 100, thereby allowing
users of microcatheter 100 to determine on a case-by-case basis
whether to administer an agent. Accordingly, the braid/geometry of
active segment 110 is porous to allow the agent to pass from lumen
of microcatheter 100 into the blood vessel at the site of an
embolus, for example.
[0049] According to embodiments, and as illustrated in FIG. 11A,
microcatheter 100 is inserted into a vessel having an occlusion. As
previously discussed, microcatheter 100 is insertable along
guidewire 300 through a vessel lumen, according to certain
embodiments. Microcatheter 100 penetrates embolus 210 in the
vessel. As shown in FIG. 11B, active segment 110 is positioned to
coincide with the position of embolus 210, according to techniques
well known and understood by artisans. As shown in FIG. 11C, active
segment 110 is expanded, thereby opening a channel in thrombus 210
and restoring blood flow. According to embodiments illustrated in
FIGS. 12A, 12B, and 12C, similar principles may be applied where
active segment 110 comprises coiled wires.
[0050] Once activated, active segment 110 allows blood to flow
around or through microcatheter 100 and active segment 110 to
create therapeutic benefits associated with reperfusion. For
example and according to embodiments, the portions of proximal
segment 102 and distal segment 104 immediately proximal and distal
to active segment 110 may have a diameter of about 2.0 French to
about 3.0 French.
[0051] According to embodiments, portions of proximal segment 102
and distal segment 104 may have installed therein revascularization
ports 112, as shown in FIGS. 11A, 11B, 11C, 12A, 12B, and 12C.
Revascularization ports 112 comprise openings in microcatheter 100
that allow vascular fluids to flow through portions of
microcatheter 100. For example, as shown in FIGS. 11C and 12C,
fluid on a proximal side of embolus 210 may enter microcatheter 100
through at least one revascularization port 112 of proximal segment
102. The vascular fluids may travel through portions of
microcatheter 100, including active segment 110, and exit through
at least one revascularization port 112 of distal segment 104.
Additionally, revascularization ports 112 provide additional
delivery points for therapeutic agents delivered through
microcatheter 100.
[0052] According to embodiments, a filter may be placed distal of
active segment to prevent embolus pieces detached in the
reperfusion process from escaping and causing distal occlusions.
Accordingly, active segment 110 may be designed to capture pieces
of embolus during the reperfusion processes. These pieces are
captured within active segment 110 when active segment 110 is
returned to its initial confirmation after expansion.
[0053] According to embodiments, a kit of parts is disclosed. The
kit may comprise components, devices, and systems disclosed herein,
as well as any other compatible with the same, and instructions for
use. Likewise, directions for use ("DFU") are included and the
device may be part of a surgical tray or other packaged accessory
set for surgeries. The kit may be a sub-component of a surgical
tray.
[0054] While the apparatus and method have been described in terms
of what are presently considered to be the most practical and
preferred embodiments, it is to be understood that the disclosure
need not be limited to the disclosed embodiments. It is intended to
cover various modifications and similar arrangements included
within the spirit and scope of the claims, the scope of which
should be accorded the broadest interpretation so as to encompass
all such modifications and similar structures. The present
disclosure includes any and all embodiments of the following
claims.
[0055] It should also be understood that a variety of changes may
be made without departing from the essence of the invention. Such
changes are also implicitly included in the description. They still
fall within the scope of this invention. It should be understood
that this disclosure is intended to yield a patent covering
numerous aspects of the invention both independently and as an
overall system and in both method and apparatus modes.
[0056] Further, each of the various elements of the invention and
claims may also be achieved in a variety of manners. This
disclosure should be understood to encompass each such variation,
be it a variation of an embodiment of any apparatus embodiment, a
method or process embodiment, or even merely a variation of any
element of these.
[0057] Particularly, it should be understood that as the disclosure
relates to elements of the invention, the words for each element
may be expressed by equivalent apparatus terms or method
terms--even if only the function or result is the same.
[0058] Such equivalent, broader, or even more generic terms should
be considered to be encompassed in the description of each element
or action. Such terms can be substituted where desired to make
explicit the implicitly broad coverage to which this invention is
entitled.
[0059] It should be understood that all actions may be expressed as
a means for taking that action or as an element which causes that
action.
[0060] Similarly, each physical element disclosed should be
understood to encompass a disclosure of the action which that
physical element facilitates.
[0061] Any patents, publications, or other references mentioned in
this application for patent are hereby incorporated by reference.
In addition, as to each term used it should be understood that
unless its utilization in this application is inconsistent with
such interpretation, common dictionary definitions should be
understood as incorporated for each term and all definitions,
alternative terms, and synonyms such as contained in at least one
of a standard technical dictionary recognized by artisans and the
Random House Webster's Unabridged Dictionary, latest edition are
hereby incorporated by reference.
[0062] Finally, all referenced listed in the Information Disclosure
Statement or other information statement filed with the application
are hereby appended and hereby incorporated by reference; however,
as to each of the above, to the extent that such information or
statements incorporated by reference might be considered
inconsistent with the patenting of this/these invention(s), such
statements are expressly not to be considered as made by the
applicant(s).
[0063] In this regard it should be understood that for practical
reasons and so as to avoid adding potentially hundreds of claims,
the applicant has presented claims with initial dependencies
only.
[0064] Support should be understood to exist to the degree required
under new matter laws--including but not limited to United States
Patent Law 35 USC 132 or other such laws--to permit the addition of
any of the various dependencies or other elements presented under
one independent claim or concept as dependencies or elements under
any other independent claim or concept.
[0065] To the extent that insubstantial substitutes are made, to
the extent that the applicant did not in fact draft any claim so as
to literally encompass any particular embodiment, and to the extent
otherwise applicable, the applicant should not be understood to
have in any way intended to or actually relinquished such coverage
as the applicant simply may not have been able to anticipate all
eventualities; one skilled in the art, should not be reasonably
expected to have drafted a claim that would have literally
encompassed such alternative embodiments.
[0066] Further, the use of the transitional phrase "comprising" is
used to maintain the "open-end" claims herein, according to
traditional claim interpretation. Thus, unless the context requires
otherwise, it should be understood that the term "compromise" or
variations such as "comprises" or "comprising", are intended to
imply the inclusion of a stated element or step or group of
elements or steps but not the exclusion of any other element or
step or group of elements or steps.
[0067] Such terms should be interpreted in their most expansive
forms so as to afford the applicant the broadest coverage legally
permissible.
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