U.S. patent application number 16/787573 was filed with the patent office on 2021-08-12 for temporary and retrievable expandable member.
The applicant listed for this patent is Amaitus, Inc.. Invention is credited to Alexander Nikanorov, Hugh Qinghong Zhao.
Application Number | 20210244551 16/787573 |
Document ID | / |
Family ID | 1000004690184 |
Filed Date | 2021-08-12 |
United States Patent
Application |
20210244551 |
Kind Code |
A1 |
Nikanorov; Alexander ; et
al. |
August 12, 2021 |
TEMPORARY AND RETRIEVABLE EXPANDABLE MEMBER
Abstract
A temporary expandable tissue support device includes a
plurality of helical filaments superimposed on top of one another
to form a tubular body. A first end of the tubular body is coupled
to an inner shaft, and a second end of the tubular body is coupled
to an outer shaft slidably disposed over the inner shaft. Actuation
of the inner and outer shafts in a first direction compresses the
plurality of filaments thereby radially expanding the tubular body
into an expanded configuration adapted to engage and support tissue
at a treatment site without obstructing a fluid from flowing past
the tubular body. Actuation of the shafts in a second direction
opposite the first direction tensions the plurality of filaments
thereby radially collapsing the tubular body into a collapsed
configuration that is adapted to be delivered to or removed from
the treatment site.
Inventors: |
Nikanorov; Alexander; (Palo
Alto, CA) ; Zhao; Hugh Qinghong; (Pleasanton,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Amaitus, Inc. |
Palo Alto |
CA |
US |
|
|
Family ID: |
1000004690184 |
Appl. No.: |
16/787573 |
Filed: |
February 11, 2020 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2250/0059 20130101;
A61F 2/88 20130101 |
International
Class: |
A61F 2/93 20060101
A61F002/93; A61F 2/88 20060101 A61F002/88 |
Claims
1. A temporary and expandable tissue support device, the device
comprising: a plurality of superimposed helical filaments forming
an inner layer of filaments and an outer layer of filaments, the
inner layer of filaments and the outer layer of filaments forming a
tubular body having a first end, a second end opposite the first
end, an intermediate portion between the first and second ends, and
a lumen extending between the first end and the second end, wherein
the outer layer of filaments remains disposed on top of the inner
layer of filaments and the inner layer of filaments remains
disposed underneath the outer layer of filaments, without
interweaving of the inner and outer layers of filaments in the
intermediate portion, and wherein the plurality of outer layer
filaments cross the plurality of inner layer filaments at a
plurality of crossing points, wherein at each crossing point a
filament in the inner layer is fused with a filament in the outer
layer to form a resilient joint that is flexible and moves as the
tubular body is expanded or collapsed while preventing sliding of
the fused filaments relative to one another; an inner shaft; and an
outer shaft slidably disposed over the inner shaft, wherein the
first end is coupled to the inner shaft, and the second end is
coupled to the outer shaft, wherein actuation of the inner shaft or
outer shaft relative to the other of the inner shaft or outer shaft
in a first direction compresses the plurality of filaments thereby
radially expanding the tubular body into an expanded configuration
that is adapted to engage and support tissue at a treatment site
without obstructing a fluid from flowing past the tubular body, and
wherein actuation of the inner shaft or outer shaft relative to the
other of the inner shaft or outer shaft in a second direction
opposite the first direction tensions the plurality of filaments
thereby radially collapsing the tubular body into a collapsed
configuration that is adapted to be delivered to or removed from
the treatment site.
2. The device of claim 1, wherein each crossing point comprises no
more than two of the plurality of helical filaments.
3. The device of claim 1, wherein the plurality of filaments is
disposed in a single circumferentially oriented planar layer.
4.-6. (canceled)
7. The device of claim 1, wherein the resilient joint is formed
with two of the plurality of helical filaments and the two helical
filaments form a crossing angle at the crossing point, and wherein
the crossing angle changes up to 90 degrees during movement between
the expanded configuration and the collapsed configuration.
8. (canceled)
9. The device of claim 1, further comprising a therapeutic agent
carried by the tubular body, wherein the therapeutic agent is
configured to be delivered therefrom to the tissue at the treatment
site.
10. The device of claim 1, further comprising a handle coupled to a
proximal end of the inner shaft and a proximal end of the outer
shaft, the handle further comprising an actuator element, wherein
actuation of the actuator element moves the inner shaft relative to
the outer shaft to expand or collapse the tubular body.
11. The device of claim 10, wherein the handle further comprises an
indicator element configurated to indicate to an operator a size of
the tubular body.
12. The device of claim 1, wherein the first end of the tubular
body is coupled to the inner shaft asymmetrically or the second end
of the tubular shaft is coupled to the outer shaft
asymmetrically.
13. The device of claim 1, wherein a fluid or a gas passes through
or around the tubular body without restriction when the tubular
body is in the expanded configuration or the collapsed
configuration.
14. The device of claim 1, wherein the tubular body in the expanded
configuration applies a constant force to the tissue.
15. The device of claim 1, wherein the tubular body has a first
expanded configuration and a second expanded configuration, and
wherein the first expanded configuration applies a force to the
tissue, and wherein the second expanded configuration applies a
second force greater than the first force to the tissue.
16.-30. (canceled)
31. A temporary and expandable tissue support device, the device
comprising: a plurality of superimposed helical filaments forming
an inner layer of filaments and an outer layer of filaments,
wherein the outer layer of filaments remains disposed on top of the
inner layer of filaments and the inner layer of filaments remains
disposed underneath the outer layer of filaments, without
interweaving of the inner and outer layers of filaments, the inner
layer of filaments and the outer layer of filaments forming a
tubular body having a first end, a second end opposite the first
end, and a lumen extending between the first end and the second
end, wherein at least some of the plurality of filaments in the
inner layer are fused with at least some of the plurality of
filaments in the outer layer to form resilient joints that are
flexible and move as the tubular body is expanded or collapsed
while preventing sliding of the fused filaments relative to one
another, and wherein each of the plurality of filaments has a
thickness and wherein the resilient joints have a thickness that is
greater than or equal to the thickness of one of the plurality of
filaments, and wherein the resilient joints have a thickness that
is less than the thickness of two of the plurality of filaments; an
inner shaft and an outer shaft slidably disposed over the inner
shaft, wherein the first end is coupled to the inner shaft, and the
second end is coupled to the outer shaft, wherein actuation of the
inner shaft or outer shaft relative to the other of the inner shaft
or the outer shaft in a first direction compresses the plurality of
filaments thereby radially expanding the tubular body into an
expanded configuration that is adapted to engage and support tissue
at a treatment site without obstructing a fluid from flowing past
the tubular body, and wherein actuation of the inner or outer shaft
relative to the other of the inner shaft or outer shaft in a second
direction opposite the first direction tensions the plurality of
filaments thereby radially collapsing the tubular body into a
collapsed configuration that is adapted to be delivered to or
removed from the treatment site.
32. The device of claim 31, wherein the plurality of helical
filaments crosses one another at a plurality of crossing points,
and wherein each crossing point comprises no more than two of the
plurality of helical filaments.
33. The device of claim 31, wherein the plurality of helical
filaments is disposed in a single circumferentially oriented planar
layer.
34. The device of claim 31, wherein one or more of the resilient
joints is formed with two of the plurality of helical filaments and
the two helical filaments form a crossing angle at the crossing
point, and wherein the crossing angle changes up to 90 degrees
during movement between the expanded configuration and the
collapsed configuration.
35. The device of claim 31, further comprising a handle coupled to
a proximal end of the inner shaft and a proximal end of the outer
shaft, the handle further comprising an actuator element, wherein
actuation of the actuator element moves the inner shaft relative to
the outer shaft to expand or collapse the tubular body.
36. The device of claim 31, wherein a fluid or a gas passes through
or around the tubular body without restriction when the tubular
body is in the expanded configuration or the collapsed
configuration.
37. The device of claim 31, wherein the tubular body in the
expanded configuration applies a constant force to the tissue.
38. The device of claim 31, wherein the tubular body has a first
expanded configuration and a second expanded configuration, and
wherein the first expanded configuration applies a force to the
tissue, and wherein the second expanded configuration applies a
second force greater than the first force to the tissue.
Description
CLAIM OF PRIORITY
[0001] N/A
CROSS-REFERENCE TO RELATED PATENT DOCUMENTS
[0002] N/A
BACKGROUND
[0003] Narrowing or occlusion of body lumens or other passageways
are a common medical condition, specifically in the blood vessels
(e.g. arteries and veins) and airways (e.g. nasal passageway,
sinuses, trachea, bronchi, etc.). Other examples include but are
not limited to peripheral artery disease (PAD) including the
superficial femoral artery (SFA), popliteal artery, vessels above
or below the knee (A/K or BTK), iliac artery, aorta, renal
arteries, coronary artery disease (CAD), and heart valves, etc.
Treatment options may include one or more of bare metal stents,
drug eluting stents, absorbable stents, plain old balloon
angioplasty (POBA), drug coated balloons (DCB), open surgery, and
other treatments known in the art.
[0004] Coronary artery disease (CAD) also referred to as coronary
heart disease (CHD) is the most common type of heart disease,
killing over 370,000 people annually. Every year about 735,000
Americans have a heart attack. Of these, 525,000 are a first heart
attack and 210,000 happen in people who have already had a heart
attack. Current treatments include but are not limited to stenting,
POBA, etc.
[0005] In the case of PAD, an estimated 200 million patients
worldwide suffer from this condition, including 20 million patients
in the USA. PAD has a five-year mortality rate of about 30% and is
estimated to cost the US healthcare system approximately $319
billion annually. The average cost to treat a Medicare beneficiary
was over $11,000 per patient in 2015 as compared to the average PAD
patient cost of over $72,000.
[0006] Obstruction or blockages of lumens or other body channels is
not limited to the vascular system and may include other lumen
occlusions and obstructions such as the trachea, nasal passageways,
or any other lumen or body channel where fluids such as a gas or
liquid pass through.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] In the drawings, which are not necessarily drawn to scale,
like numerals may describe similar components in different views.
Like numerals having different letter suffixes may represent
different instances of similar components. The drawings illustrate
generally, by way of example, but not by way of limitation, various
embodiments discussed in the present document.
[0008] FIG. 1 illustrates an example of a radially expandable
member.
[0009] FIG. 2 illustrates a proximal portion of the radially
expandable member in FIG. 1.
[0010] FIGS. 3A and 3B illustrate the radially expandable member of
FIG. 1 in the collapsed and expanded configurations,
respectively.
[0011] FIG. 4A shows a side view of an asymmetrical radially
expandable member.
[0012] FIG. 4B shows a perspective view of the radially expandable
member in FIG. 4A.
[0013] FIG. 4C shows and end view of the radially expandable member
in FIG. 4A.
[0014] FIG. 5A shows side view of an example of the helical
filaments in a radially expandable member in the expanded
configuration.
[0015] FIG. 5B shows a side view the radially expandable member of
FIG. 5A in the collapsed configuration.
[0016] FIG. 5C shows a side view of a radially expandable member
with an additional helical filament added to the example of FIG.
5A.
[0017] FIG. 5D shows a side view of a radially expandable member
with an additional helical filament added to the example of FIG.
5C.
[0018] FIGS. 6A-6C illustrate examples of overlapping
filaments.
[0019] FIG. 7A illustrates an example of a resilient joint formed
between filaments.
[0020] FIG. 7B shows woven filaments forming an expandable tubular
body.
[0021] FIG. 7C shows integrally connected struts forming an
expandable tubular body.
[0022] FIG. 8A illustrates a side view of compression of an
expandable tubular body due to inadequate radial strength.
[0023] FIG. 8B illustrates a side view of uniform radial strength
of an expandable tubular body.
[0024] FIGS. 9A-9D illustrate side views of various examples of
expanded radial tubular bodies.
[0025] FIG. 10 illustrates a side view of an example of an expanded
radial tubular body with varying diameter.
[0026] FIG. 11A illustrates a side view of an example of a handle
for actuating the radially expandable member.
[0027] FIG. 11B illustrates a side view of an example of an
actuator in a handle.
[0028] FIG. 11C illustrates an example of a handle with an actuator
coupled to an expandable member.
[0029] FIG. 11D highlights a distal region of the handle in FIG.
11C.
[0030] FIGS. 12A-12I illustrate side views of various actuator
configurations on a handle.
DETAILED DESCRIPTION
[0031] Narrowing or occlusion of body lumens are a common medical
condition, specifically in the blood vessels (e.g. arteries and
veins) and airways (e.g. nasal passageway, sinuses, trachea,
bronchi, etc.). Other examples include but are not limited to
Peripheral artery disease (PAD) including the superficial femoral
artery (SFA), popliteal artery, vessels above or below the knee
(A/K or BTK), iliac artery, aorta, renal arteries, coronary artery
disease (CAD), heart valves, etc. Treatment options may include one
or more of bare metal stents, drug eluting stents, absorbable
stents, plain old balloon angioplasty (POBA), drug coated balloons
(DCB), open surgery, and other treatments known in the art.
[0032] Obstruction or blockages of body channels is not limited to
the vascular system and may include other lumen occlusions and
obstructions including the trachea, nasal passageways, or any other
lumen or body channel where fluids such as a gas or a liquid pass
through.
[0033] Each of these treatments have their advantages and
disadvantages. It would be desirable to provide improved devices,
methods, and systems for treating at least some of these
diseases.
[0034] The examples disclosed herein generally relate to the field
of medical devices, systems, and methods. More particularly, the
devices, systems and methods are described in relation to
intraluminal devices such as endovascular, intraarterial,
intravenous, endolymphatic, endotracheal, endobronchial, nasal,
sinusoidal, ductal, ureteral) support scaffold-like devices for
temporary placement and removal. Other applicable devices, systems
and methods may be related to lumen wall support and medicinal
delivery that can perform the functions of repeated expanding and
collapsing, and so that the device can be delivered upon radially
collapsing into a lower profile that can be delivered to a targeted
anatomy and/or lesions, then radially expanded to support the lumen
opening for a desirable period of time, repositioned upon radially
collapsing and re-expanding, and then retrieved upon re-collapsing,
and its preparation method and use thereof. These examples are of
course not intended to be limiting and one of skill in the art will
appreciate that the devices, systems, and methods disclosed herein
may be used in many other applications.
[0035] FIG. 1 shows an example of a scaffold-like device 10 formed
from a plurality of superimposed helical filaments 3 such as wires.
FIG. 1 shows the device 10 in the expanded state and includes an
outer shaft 1, a proximal portion of the device 2 with the outer
shaft 1 (also referred to as outer tube) coupled to the proximal
portion of helical filaments 3. Inner shaft 4 is disposed under the
expandable tubular body formed by the helical filaments and may be
coaxially disposed under the expandable tubular body. The distal
portion of the helical filaments is coupled to a distal portion of
the inner shaft to form a distal joint 5. An optional guidewire 6
may be disposed through a lumen in the inner shaft 4, and the inner
shaft may extend slidably through a lumen in the outer shaft 1. The
helical filaments form a hollow tubular body with apertures in the
sidewall which allow fluids such as a gas like air, or a fluid like
blood to flow through the device when it is collapsed and being
delivered, or when it is expanded and engaged with the walls of the
lumen or other treatment site. An outer layer of heat shrink tubing
may be applied at the proximal and distal ends of the tubular body
where the filaments are coupled to the inner and outer shafts to
provide a smoother, atraumatic surface at the proximal and distal
ends.
[0036] The scaffold-like design uses superimposed helical wires
having distal ends joined with the tip of an inner shaft (also
referred to herein as an inner member) such as a hypotube, and the
proximal ends of the helical wires are joined to an outer shaft
(also referred to herein as an outer member) such as sheath. The
superimposed helical scaffold-like device may be fabricated from
any type of filament such as thin wires or threads with any
diameter, including a diameter ranging from 50 to 500 microns,
although any size may be used. The outer shaft may be made of a
thin-walled tube with good resistance to kinking. The inner shaft
may be made of a hypotube or any other material that can be
slidably passed through the lumen of outer member. The diameter of
the inner tube may range from 150 to 1500 microns, although this is
not intended to be limiting. Relative movement of the inner shaft
and outer shaft will actuate the plurality of filaments to either
expand or collapse the tubular body formed by the filaments, as
will be discussed in greater detail below.
[0037] FIG. 2 illustrates a close-up of the proximal portion of the
expandable device 10 illustrated in FIG. 1 above where the joint is
formed using techniques known in the art such as adhesive bonding,
welding, or other methods. The proximal portion 2 of superimposed
helical wires 3 are fixed onto the end portion of the outer shaft
1, and an inner member slides inside a lumen of the outer shaft via
a distal pushing or a proximal pulling motion as indicated by the
arrow, passing under the helical filaments. At the proximal joint,
the helical wires are welded, bonded, or otherwise fixedly coupled
to the outside surface of the outer member which may have a wall
thickness ranging from 100 to 500 microns, although this is not
intended to be limiting. The number of superimposed helical wires
may range from 2 to 12 depending on the helix pattern, although
this is not intended to limit the number of filaments used. An
outer heat shrink tubing or other sleeve may be disposed over the
proximal end of the plurality of filaments to provide a smooth
transition from the outer shaft to the filament region. The distal
joint may be similarly formed or may be formed using other
techniques known in the art.
[0038] FIGS. 3A and 3B illustrate the expandable member 10 of FIG.
1 in the collapsed and expanded configurations, respectively.
Optional guidewire 6 is also show extending from the inner shaft.
The superimposed helical scaffold-like device may be radially
expanded by moving the inner shaft relative to the outer shaft, for
example by pulling the inner movable shaft proximally into the
outer stable shaft as illustrated by the arrow in FIG. 3B. This
applies compression to the plurality of helical filaments which
then bow radially outward to radially expand and form the tubular
body. Continued movement of the inner shaft relative to the outer
shaft will further increase the diameter of the tubular body until
a maximum diameter is obtained. Additionally, with increased
diameter, the tubular body will exert higher radial force as it
engages and supports tissue. Since relative motion is required to
actuate the expandable member, a similar result may be obtained by
pushing the outer shaft over the inner shaft to compress and expand
the filaments, or a combination of pushing and pulling the inner
and outer shafts relative to one another may also be used to expand
the filaments into the tubular body.
[0039] Actuation of the inner and outer shafts relative to one
another in the opposite direction as required to expand the device
will also radially collapse the expanded tubular body and reduce
the applied radial force when the compression on the helical
filaments is released and tension is applied to the helical
filaments. For example, the inner shaft may be advanced distally
relative to the outer shaft as indicated by the arrow in FIG. 3A,
or the outer shaft may be retracted proximally relative to the
inner shaft, or a combination of both motions may be used to remove
the compression on the filaments thereby radially collapsing the
tubular body into the collapsed configuration. The collapsed
configuration has a small enough profile to permit delivery to the
target treatment area (e.g. through a blood vessel lumen or another
body channel). The diameter of the expanded device is determined by
the geometry of the superimposed helical structure and may be any
diameter, including but not limited to a diameter ranging from 2 to
35 millimeters. Similarly, the profile of the collapsed device
maybe any size, including but not limited to 1.4 mm to 3.2 mm in
diameter.
[0040] Thus, the tubular body may be expanded or collapsed to any
size and provide any desired radial force from the fully collapsed
configuration to the full expanded configuration and positions in
between. Additionally, the device may expanded and collapsed
multiple times without fatiguing.
[0041] FIG. 4A shows an expandable scaffold 400 which may be any of
the examples disclosed herein but with the proximal and distal ends
of the filaments coupled to the inner 401 and outer shafts 404
asymmetrically. For example, in the example of FIG. 1, the helical
filaments may be evenly distributed circumferentially around the
inner and outer shafts to form a symmetrical cylindrical tube when
expanded. However, in FIG. 4A, the distal ends of the filaments are
coupled to an upper portion 403 of the inner shaft while the lower
portion of the inner shaft is free of helical filaments. The
proximal ends of the filaments are coupled to a lower portion 402
of the outer shaft while the upper portion of the outer shaft is
free of filaments. The proximal and distal ends of the filaments
may be offset any amount, but in FIG. 4A, the ends are offset
approximately 180 degrees circumferentially from one another
relative to the longitudinal axis of the inner and outer coaxial
shafts. The middle section of the helical filaments between the
proximal and distal filament ends may be evenly distributed around
the inner and outer shafts to form a tubular body.
[0042] FIG. 4B shows the expanded tubular body formed when the
example of FIG. 4A is radially expanded. The tubular body has a
central portion that is substantially a cylindrical tube symmetric
in shape, while the distal end has a distally tapering pointed end
and the wall of the tubular body tapers from a full closed
cylindrical wall to a partial open wall that tapers down to a point
where the filaments are coupled to the inner shaft 401. And
similarly, the proximal end also tapers proximally down from a full
cylindrical closed wall to a partial open wall that tapers down to
a point where the filaments are coupled to the outer shaft 404.
This may also be described as the partially open wall flaring
distally to the fully closed cylindrical wall. In this example, the
proximal and distal coupling points are offset approximately 180
degrees from one another. The tapered proximal and distal open
walls are pointed protrusions that are offset by approximately 180
degrees from one another. Any offset may be established by
adjusting the proximal and distal connection points of the
filaments to the inner and outer shafts.
[0043] FIG. 4C shows the proximal and distal connection points
where the helical filaments are coupled to the inner shaft and the
outer shaft circumferentially offset from one another by
approximately 180 degrees, although this is not intended to be
limiting and the offset may be set to any value between 0 and 360
degrees relative to the first connection point.
[0044] FIGS. 5A-5D illustrate various examples of superimposed
helical filaments 502. FIG. 5A shows the tubular body 504 formed by
the superimposed helical filaments 502 in an expanded
configuration, and FIG. 5B shows the tubular body of FIG. 5A in the
collapsed configuration. In FIG. 5A the tubular body is formed from
a plurality of superimposed helical filaments. At no position are
there more than two filaments, so there is an inner-most layer of
filaments and an outer-most layer of filaments. Thus, the tubular
body has a wall that is a single layer formed by no more than two
filaments stacked on top of one another.
[0045] Additional details about how the filaments are stacked on
top of one another are disclosed below. Also, in the example of
FIG. 5A, the filaments are always either on top of another filament
or underneath a filament. The filaments never interweave with one
another, so a filament is never on top of another filament in one
position and then under the same filament at a different
position.
[0046] Also, in FIG. 5A, the closed diamond-shaped cell formed by
the helical filaments is elongated in the circumferential direction
such that the distance from peak to peak or valley in the
circumferential direction is longer than the distance from peak to
peak or valley in the longitudinal direction. In the collapsed
configuration, this changes so that the peak to peak or valley
distance in the longitudinal direction is greater than the peak to
peak or valley distance in the circumferential direction.
Additionally, the angle formed by the crossing filaments is greater
in the expanded configuration and smaller in the collapsed
configuration. The filaments may cross one another so that a
slightly raised thickness exists at the crossing point of two
filaments while the portion of the filaments that do not cross are
in the same circumferential plane as the other filaments, or
slightly raised in a second plane as will be disclosed in greater
detail below. Of course, one of skill in the art will appreciate
that any number of open or closed cell geometries may be used and
therefore diamond-shaped cells are not required or limiting in this
or any of the examples disclosed herein. Other examples of cells
may be square, rectangular, oval, elliptical, combinations thereof,
or any other shape, and the filaments may also have any
configuration including but not limited to linear, curved,
undulating, combinations thereof, or any other shape.
[0047] FIG. 5B shows the tubular body of FIG. 5A in the collapsed
configuration.
[0048] FIG. 5C illustrates how an additional filament 506 may be
added to the example of FIGS. 5A-5B. Here, the additional filament
506 (highlighted in a darker line) remains disposed on top of each
filament that it crosses and the point where two filaments crosses
is slightly deformed so that the portion of the filament that does
not cross another filament is in the same circumferential plane as
the other filaments. The portion of the filament that crosses
another filament may be slightly raised or other configurations are
possible as will be discussed below. In this example, the tubular
body is formed from an inner-most layer of filaments, a middle
layer of filaments, and an outer-most layer of filaments.
Therefore, the tubular body has a wall that is a single layer
formed by no more than three filaments stacked on top of one
another. Additionally, the inner-most layer of filaments maybe
aligned in one helical direction, the middle layer transverse to
the inner-most helical direction, and the outer-most layer of
filaments transverse to the middle helical direction (or
substantially parallel to the inner-most helical direction).
[0049] FIG. 5D adds yet another layer of filaments 508 to the
example in FIG. 5C so now there are four layers of filaments that
only cross one another so only two filaments are coupled together
at any crossing point. And in this example, there is an inner-most
layer of filaments, an inner middle layer of filaments, and outer
middle layer of filaments, and an outer-most layer of filaments.
Again, the filaments may alter their helical orientation from layer
to layer so that one layer is transverse to the adjacent layer. The
filaments maybe stacked on top of one another in any manner such as
previously described above, or in any of the stacking examples
described below.
[0050] Regardless of how many additional wires are superimposed,
the sections of the wires between superimposed cross-sections
result in a single layer of helical wires adjacent to the tissue,
or bodily lumen (vessel, airway). Regardless of how many
superimposed cross-sections of helical wires are present, the
superimposed sections are directed toward the vessel wall or the
airway wall. Each superimposed cross-section of helical wire may
have a separate semi-flexible joint as discussed below.
[0051] FIGS. 6A-6C illustrate various examples of how the filaments
may cross an adjacent filament and this may be used in any of the
examples of radially expandable devices disclosed herein.
[0052] FIG. 6A illustrates an example of two filaments 602, 604
that cross one another in any of the examples of radially
expandable devices disclosed herein. The lower filament 604 is
shown with a circular cross section that is undeformed. The upper
filament 602 is shown crossing the lower filament such that the
upper filament is slightly deformed around the lower filament to
keep the total thickness of both filaments less than equal to the
thickness of both filaments combined. Similarly, the thickness of
the wall of the tubular body formed by both filaments will have a
thickness that is also less than or equal to the thickness of both
filaments combined. The filaments 602, 604 may be coupled to one
another at the crossing point without any joint formed between the
filaments, or the filaments may be joined together with a weld,
adhesive, solvent bonded, or using any other techniques known in
the art to form a joint. The joint may be rigid or resilient as
will be discussed in greater detail below.
[0053] FIG. 6B shows the same filaments 602, 604 as in FIG. 6A
overlapping one another to form a crossing point which may be used
in any example of tubular body herein. However, in this example,
the lower filament 604 is partially fused with the upper filament
602 to form the joint. The joint may be formed by welding, solvent
bonding, etc. In this example, the thickness of the crossing point
will be less than or equal to the combined thickness of both
filament and greater than the thickness of either filament alone.
By fusing the filaments together, the overall thickness of the
tubular body will have a lower profile than if the filaments are
simply stacked on top of one another. The resulting joint may be
rigid or resilient as will be described below.
[0054] FIG. 6C shows another example of the crossing point formed
by two filaments 602, 604 overlapping one another and which may be
used in any tubular body example herein. Here, the two filaments
are fully fused together so that the thickness of the joint or
crossing point is less than or equal to the thickness of the upper
filament 602. Again, the fusing maybe accomplished by any technique
known in the art including welding, solvent bonding, etc. This
configuration results in the lowest profile of the crossing point
and the joint may be rigid, flexible or semi-flexible as discussed
below.
[0055] In any of the examples shown in FIGS. 6A-6C, the filaments
may have a round cross-section or any other cross-sectional shape
including square, rectangular, elliptical, oval, etc. Additionally,
as mentioned, the resulting joint between overlapping filaments may
be a rigid joint or it may be a resilient joint that is fully or
semi-flexible and configured to move as the tubular body is
expanded and collapsed while still constraining axial movement of
the filaments relative to one another. Thus, the filaments can
pivot or rotate relative to one another but they do not linearly
slide relative to one another. The thickness of the semi-flexible
joint can range from the diameter or thickness of a single filament
d.sub.1, or superimposed filament d.sub.2 and the sum of the two
filaments d.sub.1+d.sub.2. The filaments may all have the same
cross-section and thus same diameter or thickness, or they may be
different. Similarly, they may be the same material, or different
materials or hybrid materials. Examples of metallic materials that
may be used for the filaments include but are not limited to
stainless steel and metal alloys of nickel and titanium (e.g.
nitinol materials). The filaments maybe formed with polymeric
materials such as synthetic polymers, e.g. polyethylene
terephthalate, polyamide, polyurethane, bioresorbable polymers such
as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone
(PCL), polyanhydrides, poly(.beta.-hydroxybutyrate), polydioxanone,
poly(DTH iminocarbonate), polypropylene fumarate, etc. as well as
copolymers thereof and mixtures thereof. In the hybrid device, both
basic materials (metallic and polymeric) may be present in any
proportion.
[0056] One filament cross-sectional size may be larger than another
filament cross-sectional size, or smaller. Filament thickness may
be determined based on design considerations such as radial
strength and profile of the device in operation.
[0057] The expandable tubular body may have one joint or more than
one joint. And the joints may be all resilient joints, all rigid
joints, or combinations of resilient and rigid joints.
[0058] FIG. 7A shows the filaments forming a series of diamond
shaped cells and the crossing point of two filaments 702, 704 which
may be any filament described herein forming a joint 706 between
the filaments. As disclosed above, this example and any other
examples disclosed herein are not limited to diamond shaped cells.
The cells may be open or closed, and may have any number of shapes
including but not limited to rectangular, square, oval, elliptical,
combinations thereof, or any shape. As previously discussed, the
joint 706 may be simply the two filaments crossing and touching one
another but unattached to one another, or the filaments may be
attached to one another either fully fused together or partially
fused together. The resulting joint may be rigid and inflexible, or
the joint may be resilient and semi-flexible or fully flexible
while maintaining the coupling of the overlapping filaments
together. By joining the filaments together, the filaments are at
least partially or fully constrained from sliding relative to one
another thereby providing greater radial strength to the tubular
body in the expanded configuration. A flexible or semi-flexible
joint also allows the filaments to rotate or pivot relative to one
another during expansion or collapse to reduce collapsed profile
and still maintain radial strength as well as reducing the force
required to radially expand the tubular body. FIG. 7A also shows
how filaments 702 and 704 move away from one another as indicated
by the arrows during collapsing of the tubular body. Therefore, the
angle between the filaments will increase. The angle may be any
angle between the filaments, but in this example may be the angle
formed between adjacent filaments at a circumferentially oriented
peak or valley of a closed cell. During expansion of the device,
the filaments will move toward one another (in the opposite
direction of the arrows) and the angle between filaments will
decrease. The angle between adjacent filaments may move between 0
degrees and 90 degrees during expansion and collapse of the device.
Similarly, for the angle formed between adjacent struts forming a
peak or valley in the longitudinal direction, the angle decreases
during collapsing and increases during radial expansion. Thus, a
flexible or semi-flexible joint provides more desirable mechanical
properties to the device as compared to an example where the
filaments are woven together such that one filament passes on top
of another filament and then goes under the next filament allowing
the filaments to slide relative to one another during expansion and
contraction as discussed below with reference to FIG. 7B.
[0059] FIG. 7B shows an example where the filaments 720 are woven
with one another so that a filament is disposed under one filament
and then disposed over the adjacent filament in a repeating
pattern. This may not provide as much radial strength as the joints
described above in FIG. 7A because the filaments are unconstrained
and free to slide relative to one another during expansion and
collapsing of the device. Additionally, the profile of the device
will be larger due to the overlapping filaments.
[0060] FIG. 7C shows a radially expandable tubular member that is
formed from a plurality of slots 730 cut from a tube such as
hypotube. The slots expand into diamonds during radially expansion
and the slots flatten out during collapsing. Because the struts 732
are integral with one another this configuration provides radial
strength but may require greater expansion forces to move the
struts during expansion since there is no flexible or semi-flexible
joint as seen with the superimposed helical filament examples
disclosed herein, and the material around the joints must bend
either elastically or plastically. This also makes it harder to
uniformly collapse the tubular body once it is radially expanded,
and repeated expansion and collapsing may fatigue and break the
struts. Thus, the example of FIG. 7A provides many of the
advantages of both the woven configuration of FIG. 7B and the
integral strut or filament design of FIG. 7C, thereby providing
relatively easy expansion and collapsing as well as good radial
strength.
[0061] FIG. 8A shows a typical woven design for a radially
expandable member 802 where the wires extend under one adjacent
wire and over another adjacent wire such as previously described in
FIG. 7B above, and will be compared to the superimposed helical
filament design in FIG. 8B which includes joints between the
overlapping filaments. FIG. 8B provides some advantages over FIG.
8A.
[0062] In FIG. 8A the wires 804 are free to move relative to one
another and thus radial strength in the expanded configuration may
be reduced and the expanded tubular body may not have adequate
radial strength. When a force as indicated by the inwardly pointing
arrows is applied to the device, if the radial strength of the
tubular body is not strong enough, the body will collapse 806
radially inward either at a discrete location or all along the
tubular body, depending on how the force is applied to the tubular
body. If the tubular body collapses it will not provide adequate
support to the tissue and may not remain in apposition with the
tissue thereby preventing or hindering therapeutic agent to be
delivered to the tissue.
[0063] FIG. 8B shows a force (as indicated by the apposed arrows)
applied to a tubular body 820 with adequate radial strength.
Because the radial strength is greater than the force applied to
the tubular body, the tubular body does not collapse and maintains
its shape and continues to support and engage the tissue. The
helical filaments 824 and the flexible or semi-flexible joints 822
allow the device to have uniform radial strength along its
longitudinal axis, and that is greater than a traditionally woven
tubular body. The tubular body 820 in FIG. 8B may be any of
examples of superimposed helical filament examples disclosed
herein.
[0064] FIGS. 9A-9D illustrate various geometries of radially
expandable tubular bodies that may be formed using the helical
filament construction described above. An optional guidewire is
shown extending from the distal tip of the device.
[0065] FIG. 9A shows a radially expandable tubular body 902 that
tapers from the proximal end to the distal end. Diameter
.THETA..sub.1 is greater than diameter .THETA..sub.2 which is
greater than diameter .THETA..sub.3. Therefore, a brief shoulder
904 is coupled to the outer shaft 906 and then the maximum diameter
is shown at the proximal end of the tubular body and the diameter
tapers gradually down to the minimum diameter at the distal end
which is coupled to the inner shaft 908. Tapering allows the
radially expandable body to conform with the walls of a body
channel such as a vascular lumen that has a similar taper in the
proximal to distal direction. Actuation of the tubular body
functions generally the same way as previously described above in
FIGS. 3A-3B.
[0066] FIG. 9B shows an example similar to FIG. 9A with the major
difference being that the taper is reversed and therefor the
maximum diameter is near the distal end of the tubular body and
this tapers proximally to the small diameter on the proximal end,
thus the tubular body 920 has a diameter .THETA..sub.1 that is
smaller than diameter .THETA..sub.2 which is smaller than diameter
.THETA..sub.3. Again, this taper allows the expandable member to
conform to the walls of a body channel such as a vascular lumen
that has a similar taper in the distal to proximal direction. This
example may also be described as having a distal flared tubular
body.
[0067] FIG. 9C shows an expandable member 930 having a flared
proximal 932 end with increasing diameter, then a constant diameter
mid-section 934 that then transitions into a distally tapering
region 936. Thus, proximal diameter Oi is smaller than diameter
.THETA..sub.2 which is the same as diameter .THETA..sub.3 which is
greater than .THETA..sub.4. The constant diameter mid-section 934
may be the working portion that is used to support tissue and the
flared and tapered should sections 932, 936 may not support or
engage tissue. Or the body channel may have walls which match this
shape and are supported by some or all sections of the flared,
constant diameter or tapered sections.
[0068] FIG. 9D shows still another example of an expandable tubular
body 950 that may be formed from any of the helical filament
examples disclosed herein. In this example, the tubular body is
formed from helical filaments with any of the joints described
herein. A proximal section has a flared region 952, then the
tubular body has a constant diameter section 954 followed by a
taper 956 that tapers distally to a center section 958 that has a
constant diameter. The constant diameter center section then flares
outward 960 again increasing in diameter to another constant
diameter section 962, followed by a distally tapering section 964.
Again, any shape may be formed in order to support the target
treatment tissue. Thus, diameter Oi is smaller than diameter
.THETA..sub.2 which is larger than diameter .THETA..sub.3 which is
smaller than diameter .THETA..sub.4 which is larger than diameter
.THETA.5.
[0069] FIG. 10 shows how a superimposed helical filament design
1000 such as any of those disclosed herein may be used to provide a
personalized design that adapts to the local anatomy. Because the
filaments may have a resilient joint coupling overlapping
filaments, the outer diameter of the expanded tubular body may
expanded until it engages the treatment tissue, here a blood vessel
V, and thus the expanded tubular body will conform to the contours
of the treatment region so that diameter and curvature of the
tubular body may vary along its length. Thus, diameters
.THETA..sub.1, .THETA..sub.2, .THETA..sub.3, .THETA..sub.4,
.THETA..sub.5, and .THETA..sub.6 may be the same, may be different
than one another or some may be the same and some different
depending on the diameter of the vessel V. This customized
expandable device therefore adapts to the anatomy based on medical
information and imaging such as angiograms, computerized tomography
(CT), computerized tomography angiography (CTA), magnetic resonance
imaging (MRI), magnetic resonance angiography (MRA), ultrasound,
x-ray, optical coherence tomography (OCT), intravascular ultrasound
(IVUS), as well as any other imaging modality known in the art, and
provides a variable diameter tubular body that conforms to a vessel
wall or any other tissue wall. Here the proximal end of the tubular
body flares outward with increasing diameter to a maximum diameter
section which then gradually tapers distally to the distal end. The
tubular body is expanded and in engagement with the walls of a
vessel to support the vessel and/or elute a therapeutic agent to
the tissue that engages the tubular body. In addition, the diameter
of the device conforms to the walls of the treatment site, the
longitudinal axis of the device also conforms to the curvature of
the channel, vessel or other body cavity. A drug may be delivered
from the expandable tubular body and/or the device may simply
provide temporary support to the walls of the tissue until they can
remodel and remain patent. The helical filament construction with
flexible or semi-flexible joints also allows the tubular body to
provide a uniform radial outward force on the tissue even though
the diameter varies.
[0070] FIG. 11A shows an example of a support device 1100 having an
expandable tubular body 1102 which may be any of those disclosed
herein formed with any of the helical filament examples herein and
having any of the filament joints disclosed herein. Optional
guidewire 1104 extends past the distal end of the catheter. Inner
and outer shafts 1106 (only the outer shaft is visible in this
view) are coupled to the expandable member 1102 as described
previously and are used to expand and collapse the radially
expandable member. The proximal ends of the inner and outer shafts
are operatively coupled to a handle 1108 that is ergonomically
shaped to allow an operator to grasp and manipulate the handle. The
handle may include an actuator 1110 such as a slide, lever,
rotatable wheel or other actuation element that is operatively
coupled to the inner and outer shafts such that actuation of the
actuator in one direction will move the inner and outer shafts
relative to one another to radially expand the tubular body, while
actuation of the actuator in the opposite direction will move the
inner and outer shafts in an opposite direction relative to one
another thereby collapsing the radially expandable member. The
handle may also include a gage or other visual indicia (not shown)
to show the operator the diameter of the expandable tubular body.
An optional guidewire 1104 is shown slidably disposed in the
device.
[0071] FIG. 11B shows an example of a handle 1108 which may be used
in FIG. 11A or with any of the examples disclosed herein. Handle
1108 includes a housing 1202 which is ergonomically shaped to fit
in an operator's hand and houses at least some of the actuator
components including an actuator wheel 1204, a rack 1206, and a
locking element 1208. The inner shaft 1212 may be coupled to a
plunger 1210 that is coupled to the rack 1206. The rack includes a
number of teeth that engage with the teeth on actuator wheel 1204.
Thus, as actuator wheel 1204 is rotated in one direction, the rack
will move in one direction and the inner shaft will therefore also
move in one direction. When the actuator wheel is rotated in a
second opposite direction, the rack will move in a second opposite
direction thereby causing the inner shaft to move in a second
opposite direction.
[0072] FIG. 11C shows the handle of FIG. 11B coupled to an
expandable member 1218 which may be any of those described herein.
The outer shaft 1216 is fixed to the handle, thus resulting in
relative movement between the inner and outer shafts which can
therefore expand or collapse the expandable member 1218. The wheel
may be actuated multiple times back and forth to expand and
collapse the expandable member as needed. The inner shaft may
extend to the proximal end of the handle where a valve, Luer
connector or other connector may be coupled to the proximal end of
the inner shaft to prevent fluid from flowing past the proximal
end. A guidewire (not illustrated in this figure) may be inserted
into a lumen of the inner shaft and extend all the way through the
inner shaft lumen and exit at the distal end of the device as shown
in previous figures, and the lumen may also be flushed with a fluid
to remove air or other unwanted fluids or gases. As indicated
earlier, the outer shaft is fixed to the handle and therefore is
stationary in this example. The annular gap between the inner and
outer shafts may also be flushed with a second path 1214 that is
fluidly coupled to the annular gap. The proximal end of pathway
1214 may also have a Luer connector, stopcock, or any other
connector as needed to control fluid flow.
[0073] As the radially expandable member is expanded or collapsed,
it may be desired to lock the diameter at a certain size and hold
it at that size during a procedure. A lock 1208 may be included on
the handle. The lock can be any number of locks such as a pawl that
prevents movement of the actuator wheel unless the lock is
unlocked.
[0074] FIG. 11D highlights a distal section of the handle in FIG.
11C and illustrates how the flush lumen 1214 is coupled to the
annular space between the inner and outer shafts 1212, 1216.
[0075] And this example is not intended to be limiting. As
discussed previously, relative movement of the inner and outer
shafts is needed to expand and collapse the expandable member.
Therefore, the outer shaft may be coupled to the rack and the inner
shaft maybe fixed to the handle in another example. Other actuators
are known in the art and may also be used. Levers, slides, or any
other known actuators may be used instead of an actuator wheel. The
actuator wheel or other actuator may also have indicia that
indicate the diameter or size of the expandable member as it
expands and collapses. For example, the actuator wheel may have a
clicking noise to indicate size, or markings which show the
diameter.
[0076] FIGS. 12A-12I illustrate various examples of actuator
orientations relative to the handle that may be used in any
example. The handle H is coupled to the inner and outer shafts as
previously described above. An actuator, here a rotatable wheel W
is shown coupled to the handle H.
[0077] In FIG. 12A, the wheel W is on a proximal end of the handle
H and the wheel is transverse or orthogonal to the longitudinal
axis of the handle. The wheel rotates around the longitudinal axis
of the handle and inner/outer shafts.
[0078] FIG. 12B shows a similar example as FIG. 12A with the major
difference being that the wheel W has been moved so it is now
disposed over a middle portion of the handle H but otherwise is
substantially similar to the example in FIG. 12A.
[0079] FIG. 12C shows a similar example as FIG. 12A with the major
difference being that the wheel W has been moved so that it is now
disposed at the proximal end of the handle H but otherwise is
substantially similar to the example in FIG. 12A.
[0080] FIG. 12D illustrates an example where the handle H includes
the rotatable wheel W. Here, a proximal portion of the handle is
the rotatable wheel W and therefore as the handle is rotated in
different directions, the handle will be drawn into or away from
the rotatable wheel. The wheel may be concentric with the inner and
outer shafts.
[0081] FIG. 12E is similar to the example of FIG. 12D with the
major difference being that the handle body H has a larger size
than the rotatable wheel. Rotation of the wheel will draw the wheel
into or way from the handle. Rotation of the wheel is generally
concentric to the longitudinal axis of the inner and outer
shafts.
[0082] FIG. 12F shows the rotatable wheel W protruding from a top
or bottom surface of the handle H. Approximately half of the wheel
will be exposed while approximately the other half will be housed
in the handle. The wheel may be located in the middle portion of
the handle or anywhere on the handle and rotation of the wheel will
generally be in the same parallel direction to the inner and outer
shafts.
[0083] FIG. 12G shows another example of a wheel W that protrudes
from the top and the bottom surfaces of the handle H. Therefore,
the wheel may be actuated from either the top or bottom. Actuation
is generally in the same direction as above in FIG. 12F.
[0084] FIG. 12H shows another example of an actuator wheel W
coupled to a handle H. Here the wheel W may be disposed outside the
handle and is now canted relative to the handle and therefore the
wheel rotates in a plane that is transverse or oblique to the
longitudinal axis of the inner and outer shaft. Here, a left side
of the wheel is canted proximally, while a right side of the wheel
canted distally in this side view of the handle. The wheel may
extend partially or completely around the handle to form a closed
or open ring.
[0085] FIG. 12I is another example of a canted wheel W that is
disposed around the outside of the handle H. Here the wheel will
rotate in a plane that is transverse or oblique the longitudinal
axis of the inner and outer shafts. In this example which is a side
view of the handle, the top of the wheel is canted proximally and
the bottom of the wheel is canted distally. The wheel may extend
completely or partially around the handle to form a closed ring or
an open ring.
[0086] Any example disclosed herein may include a therapeutic
agent. The helical filaments or any portion of the device may be
coated with a coating layer that contains a therapeutic agent or a
mixture of therapeutic agents. The therapeutic agent may be carried
by the helical filaments or any part of the device and may include
paclitaxel, sirolimus also known as rapamycin, corticosteroids,
nonsteroidal anti-inflammatory drugs, anticoagulants, etc. The
therapeutic agent may be disposed in a coating coupled to the
helical filaments such as a mixture of polymers and therapeutic
agents. The polymers are drug carriers such as, polyvinyl alcohol,
polyethylene glycol, polyvinyl polypyrrolidone, poly(L-lactide),
polylysine, etc. The ratio of polymer to therapeutic agent may be
any ratio but examples of this ratio may include: 1:9; 2:8; 3:7;
4:6, 5:5, 6:4 as well as any tenth of the ratio. For example, in a
1:9 ratio of polymer to therapeutic agent, the ratio may include
any of 1.1; 1.2; 1.3; 1.4; 1.5; 1.6; 1.7; 1.8; or 1.9 to any of
9.1; 9.2; 9.3, 9.4; 9.5; 9.6; 9.7; 9.8; or 9.9.
[0087] In any example disclosed herein a fluid such as blood or any
body fluid or any liquid, or a gas such as air is free to pass by
the tubular body in the expanded or collapsed configuration because
the tubular body has a lumen for fluid flow and the walls of the
tubular body are porous. Additionally, the tubular body may be
expanded and held in an expanded configuration for any length of
time such as less than or equal to 30 seconds, or less than or
equal to 30 minutes, or less than or equal to 60 minutes, or even
longer than 60 minutes until a desired therapeutic effect is
obtained. Desired therapeutic effects may include delivery of a
therapeutic agent to the target treatment tissue or remodeling of
the target treatment tissue so that it is self-supporting. Any of
the examples of superimposed helical tubular bodies may be used to
deliver therapeutic agents to a target treatment area. The
therapeutic agent maybe delivered continuously over a short initial
period of time, or during the entire time the device contacts the
target treatment area. Moreover, the same device maybe used
repeatably to expand and support one or different areas in the same
patient as well as deliver a therapeutic agent in one or different
areas in the same patient. Thus, any of the examples disclosed
herein may be used to expand and collapse multiple times and be
held in the expanded configuration for a desired time before being
removed from the patient.
Notes and Examples
[0088] The following, non-limiting examples, detail certain aspects
of the present subject matter to solve the challenges and provide
the benefits discussed herein, among others.
[0089] Example 1 is a temporary and expandable tissue support
device, the device comprising: a plurality of helical filaments
superimposed on top of one another to form a tubular body having a
first end, a second end opposite the first end, and a lumen
extending between the first end and the second end; an inner shaft;
and an outer shaft slidably disposed over the inner shaft, wherein
the first end is coupled to the inner shaft, and the second end is
coupled to the outer shaft, wherein actuation of the inner and
outer shafts in a first direction compresses the plurality of
filaments thereby radially expanding the tubular body into an
expanded configuration that is adapted to engage and support tissue
at a treatment site without obstructing a fluid from flowing past
the tubular body, and wherein actuation of the inner and outer
shafts in a second direction opposite the first direction tensions
the plurality of filaments thereby radially collapsing the tubular
body into a collapsed configuration that is adapted to be delivered
to or removed from the treatment site.
[0090] Example 2 is the device of Example 1, wherein the tubular
body comprises a sidewall with a plurality of apertures
therethrough.
[0091] Example 3 is the device of any of Examples 1-2, wherein the
plurality of helical filaments crosses one another at a plurality
of crossing points, and wherein each crossing point comprises no
more than two of the plurality of helical filaments.
[0092] Example 4 is the device of any of Examples 1-3, wherein the
plurality of filaments is disposed in a single circumferentially
oriented planar layer.
[0093] Example 5 is the device of any of Examples 1-4, wherein the
plurality of helical filaments each have a thickness and the
plurality of helical filaments cross one another at a plurality of
crossing points, and wherein each crossing point has a thickness
greater than or equal to the thickness of one of the plurality of
filaments, and the thickness is less than or equal to the thickness
of two of the plurality of filaments.
[0094] Example 6 is the device of any of Examples 1-5, wherein the
plurality of helical filaments crosses one another at a plurality
of crossing points, and wherein at least some of the plurality of
crossing points comprises two of the plurality of helical filaments
attached to one another with a resilient joint.
[0095] Example 7 is the device of any of Examples 1-6, wherein the
resilient joint is configured to flex as the tubular body moves
between the expanded configuration and the collapsed
configuration.
[0096] Example 8 is the device of any of Examples 1-7, wherein the
two helical filaments form a crossing angle at the crossing point,
and wherein the crossing angle changes up to 90 degrees during
movement between the expanded configuration and the collapsed
configuration.
[0097] Example 9 is the device of any of Examples 1-8, wherein the
plurality of helical filaments crosses one another at a plurality
of crossing points, and wherein at least some of the plurality of
crossing points comprises two of the plurality of helical filaments
crossing one another without an attachment therebetween.
[0098] Example 10 is the device of any of Examples 1-9, further
comprising a therapeutic agent carried by the tubular body, wherein
the therapeutic agent is configured to be delivered therefrom to
the tissue at the treatment site.
[0099] Example 11 is the device of any of Examples 1-10, wherein
the therapeutic agent comprises an anti-restenosis,
anti-inflammatory or anticoagulant agent.
[0100] Example 12 is the device of any of Examples 1-11, further
comprising a handle coupled to a proximal end of the inner shaft
and a proximal end of the outer shaft, the handle further
comprising an actuator element, wherein actuation of the actuator
element moves the inner shaft relative to the outer shaft to expand
or collapse the tubular body.
[0101] Example 13 is the device of any of Examples 1-12, wherein
the handle further comprises an indicator element configurated to
indicate to an operator a size of the tubular body.
[0102] Example 14 is the device of any of Examples 1-13, wherein
the first end of the tubular body is coupled to the inner shaft
asymmetrically or the second end of the tubular shaft is coupled to
the outer shaft asymmetrically.
[0103] Example 15 is the device of any of Examples 1-14, wherein an
outer diameter of the tubular body varies along a longitudinal axis
of the tubular body.
[0104] Example 16 is the device of any of Examples 1-15, wherein a
fluid or gas passes through or around the tubular body without
restriction when the tubular body is in the expanded configuration
or the collapsed configuration.
[0105] Example 17 is the device of any of Examples 1-16, wherein
the tubular body in the expanded configuration applies a constant
force to the tissue.
[0106] Example 18 is the device of any of Examples 1-17, wherein
the tubular body has a first expanded configuration and a second
expanded configuration, and wherein the first expanded
configuration applies a force to the tissue, and wherein the second
expanded configuration applies a second force greater than the
first force to the tissue.
[0107] Example 19 is a method for temporarily supporting tissue at
a treatment site in a patient, the method comprising: providing a
tubular body formed from a plurality of helical filaments
superimposed on top of one another, the tubular body comprising a
first end, a second end opposite the first end and a lumen
extending therebetween; advancing the tubular body in a collapsed
configuration to the treatment site; actuating an inner shaft in a
first direction relative to an outer shaft slidably disposed over
the inner shaft, wherein the first end is coupled to the inner
shaft, and the second end is coupled to the outer shaft thereby
compressing the plurality of filaments and radially expanding the
tubular body into an expanded configuration that engages and
supports the tissue without obstructing a fluid or gas from flowing
past the tissue; maintaining the tubular body in the expanded
configuration for a predetermined amount of time and supporting the
tissue; actuating the inner shaft in a second direction opposite
the first direction relative to the outer shaft thereby tensioning
the plurality of filaments and radially collapsing the tubular body
into the collapsed configuration; and removing the inner shaft, the
outer shaft, and the tubular body from the patient.
[0108] Example 20 is the method of Example 19, wherein the
plurality of helical filaments crosses one another at a plurality
of crossing points, and wherein each crossing point comprises no
more than two of the plurality of helical filaments.
[0109] Example 21 is the method of any of Examples 19-20, wherein
the plurality of helical filaments each have a thickness and the
plurality of helical filaments cross one another at a plurality of
crossing points, and wherein each crossing point has a thickness
greater than or equal to the thickness of one of the plurality of
filaments, and the thickness is less than or equal to the thickness
of two of the plurality of filaments.
[0110] Example 22 is the method of any of Examples 19-21, wherein
the plurality of helical filaments crosses one another at a
plurality of crossing points, wherein each crossing point comprises
two of the plurality of helical filaments attached to one another
with a resilient joint, and wherein radially expanding or radially
collapsing the tubular body comprises flexing the resilient
joint.
[0111] Example 23 is the method of any of Examples 19-22, wherein
the two helical filaments form a crossing angle at the crossing
point, and wherein radially expanding or radially collapsing the
tubular body comprises changing the crossing angle up to 90 degrees
during movement between the expanded configuration and the
collapsed configuration.
[0112] Example 24 is the method of any of Examples 19-23, wherein
the tubular body further comprises a therapeutic agent, the method
further comprising delivering the therapeutic agent to the
tissue.
[0113] Example 25 is the method of any of Examples 19-24, wherein
delivering the therapeutic agent comprises delivering the
therapeutic agent continuously during the predetermined time that
the tubular body is maintained in the expanded configuration.
[0114] Example 26 is the method of any of Examples 19-25, wherein
the therapeutic agent comprises an anti-restenosis,
anti-inflammatory or anticoagulant agent.
[0115] Example 27 is the method of any of Examples 19-26, further
comprising a handle coupled to a proximal end of the inner shaft
and a proximal end of the outer shaft, the handle further
comprising an actuator, the method further comprising actuating the
actuator thereby moving the inner shaft relative to the outer shaft
and expanding or collapsing the tubular body.
[0116] Example 28 is the method of any of Examples 19-27, further
comprising displaying a size of the tubular body with an indicator
element on the handle as the actuator is being actuated.
[0117] Example 29 is the method of any of Examples 19-28, wherein
the first end of the tubular body is coupled to the inner shaft
asymmetrically or the second end of the tubular shaft is coupled to
the outer shaft asymmetrically.
[0118] Example 30 is the method of any of Examples 19-29, wherein
radially expanding the tubular body comprises radially expanding
the tubular body so that an outer diameter of the tubular body
varies along a longitudinal axis of the tubular body.
[0119] Example 31 is the method of any of Examples 19-30, wherein
the outer diameter is personalized to match contours of the
treatment site in the patient.
[0120] Example 32 is the method of any of Examples 19-31, further
comprising adjusting a position of the tubular body to a new
location along the treatment site before removing the tubular body
from the patient.
[0121] Example 33 is the method of any of Examples 19-32, further
comprising permitting a fluid to pass the tubular body without
restriction when the tubular body is in the expanded configuration
or the collapsed configuration.
[0122] Example 34 is the method of any of Examples 19-33, wherein
maintaining the tubular body in the expanded configuration applies
a constant force to the tissue.
[0123] Example 35 is the method of any of Examples 19-34, wherein
maintaining the tubular body in the expanded configuration
comprises increasing an applied force to the tissue over a desired
period of time.
[0124] Example 36 is the method of any of Examples 19-35, wherein
maintaining the tubular body in the expanded configuration
comprises supporting the tissue until the tissue remodels to a
desired status.
[0125] Example 37 is the method of any of Examples 19-36, wherein
actuating the inner shaft in the first direction comprises
actuating the inner shaft in the first direction a plurality of
times and radially expanding the tubular body into the expanded
configuration a plurality of times.
[0126] Example 38 is the method of any of Examples 19-37, wherein
actuating the inner shaft in the second direction comprises
actuating the inner shaft in the second direction a plurality of
times and radially collapsing the tubular body into the collapsed
configuration a plurality of times.
[0127] In Example 39, the apparatuses or methods of any one or any
combination of Examples 1-38 can optionally be configured such that
all elements or options recited are available to use or select
from.
[0128] The above detailed description includes references to the
accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which the invention can be practiced. These
embodiments are also referred to herein as "examples." Such
examples can include elements in addition to those shown or
described. However, the present inventors also contemplate examples
in which only those elements shown or described are provided.
Moreover, the present inventors also contemplate examples using any
combination or permutation of those elements shown or described (or
one or more aspects thereof), either with respect to a particular
example (or one or more aspects thereof), or with respect to other
examples (or one or more aspects thereof) shown or described
herein.
[0129] In the event of inconsistent usages between this document
and any documents so incorporated by reference, the usage in this
document controls.
[0130] In this document, the terms "a" or "an" are used, as is
common in patent documents, to include one or more than one,
independent of any other instances or usages of "at least one" or
"one or more." In this document, the term "or" is used to refer to
a nonexclusive or, such that "A or B" includes "A but not B," "B
but not A," and "A and B," unless otherwise indicated. In this
document, the terms "including" and "in which" are used as the
plain-English equivalents of the respective terms "comprising" and
"wherein." Also, in the following claims, the terms "including" and
"comprising" are open-ended, that is, a system, device, article,
composition, formulation, or process that includes elements in
addition to those listed after such a term in a claim are still
deemed to fall within the scope of that claim. Moreover, in the
following claims, the terms "first," "second," and "third," etc.
are used merely as labels, and are not intended to impose numerical
requirements on their objects.
[0131] The above description is intended to be illustrative, and
not restrictive. For example, the above-described examples (or one
or more aspects thereof) may be used in combination with each
other. Other embodiments can be used, such as by one of ordinary
skill in the art upon reviewing the above description. The Abstract
is provided to allow the reader to quickly ascertain the nature of
the technical disclosure. It is submitted with the understanding
that it will not be used to interpret or limit the scope or meaning
of the claims. Also, in the above Detailed Description, various
features may be grouped together to streamline the disclosure. This
should not be interpreted as intending that an unclaimed disclosed
feature is essential to any claim. Rather, inventive subject matter
may lie in less than all features of a particular disclosed
embodiment. Thus, the following claims are hereby incorporated into
the Detailed Description as examples or embodiments, with each
claim standing on its own as a separate embodiment, and it is
contemplated that such embodiments can be combined with each other
in various combinations or permutations. The scope of the invention
should be determined with reference to the appended claims, along
with the full scope of equivalents to which such claims are
entitled.
* * * * *