U.S. patent application number 14/735974 was filed with the patent office on 2015-10-22 for vascular dilator systems, kits, and methods.
The applicant listed for this patent is Vascular Solutions,Inc.. Invention is credited to Deepa Deepa, Doug Fraser, Thomas Holman, Howard Root.
Application Number | 20150297875 14/735974 |
Document ID | / |
Family ID | 51421321 |
Filed Date | 2015-10-22 |
United States Patent
Application |
20150297875 |
Kind Code |
A1 |
Fraser; Doug ; et
al. |
October 22, 2015 |
VASCULAR DILATOR SYSTEMS, KITS, AND METHODS
Abstract
Vascular dilator systems, kits, and methods allowing for
sheathless introduction of a treatment device into a body vessel or
body cavity are disclosed. A vascular dilator system can include a
dilator assembly, including a tubular shaft and a deformable
member, and optionally, the treatment device. The deformable member
can include a non-biodegradable material and can have a diameter at
a proximal end portion that is greater than a diameter at a distal
end portion. The distal end portion of the deformable member can be
coupled to an outer surface of the tubular shaft, at or near a
shaft distal end portion. The proximal end portion of the
deformable member can include a diameter configured to receive or
stretch around a distal end portion of the treatment device. In
use, the deformable member can provide a tapered bridge between the
outer surface of the tubular shaft and an outer surface of the
treatment device.
Inventors: |
Fraser; Doug; (Wilmslow,
GB) ; Root; Howard; (Excelsior, MN) ; Holman;
Thomas; (Princeton, MN) ; Deepa; Deepa;
(Minneapolis, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Vascular Solutions,Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
51421321 |
Appl. No.: |
14/735974 |
Filed: |
June 10, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13784073 |
Mar 4, 2013 |
9078991 |
|
|
14735974 |
|
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|
Current U.S.
Class: |
604/164.1 |
Current CPC
Class: |
A61M 2025/0681 20130101;
A61M 25/0662 20130101; A61M 29/00 20130101 |
International
Class: |
A61M 29/00 20060101
A61M029/00; A61M 25/06 20060101 A61M025/06 |
Claims
1. A system comprising: a dilator assembly including a tubular
shaft and a deformable member, the tubular shaft having an outer
surface increasing in diameter between a shaft distal end portion
and a shaft proximal end portion, and the deformable member,
including a non-biodegradable material, having an inner surface
diameter at a deformable member proximal end portion, as positioned
during advancement within a body vessel or body cavity, which is
greater than an inner surface diameter at a deformable member
distal end portion, as positioned during advancement within the
body vessel or body cavity, the deformable member distal end
portion coupled to the outer surface of the tubular shaft at or
near the shaft distal end portion.
2. The system of claim 1, further comprising a treatment device
extending a length less than a length of the tubular shaft, from a
device proximal end portion to a device distal end portion, and
having a lumen diameter greater than a largest diameter of the
outer surface of the tubular shaft.
3. The system of claim 2, wherein the lumen diameter is
sufficiently sized such that the tubular shaft and the deformable
member can be removed through the treatment device lumen, when the
proximal end portion of the deformable member is folded back around
the shaft distal end portion.
4. The system of claim 2, wherein the device distal end portion is
configured to be received over the tubular shaft, at the shaft
proximal end portion, and advanced to a location adjacent the
deformable member proximal end portion.
5. The system of claim 4, wherein the inner surface diameter at the
deformable member proximal end portion, as positioned during
advancement within the body vessel or body cavity, is configured to
receive and surround an outer surface of the treatment device at
the device distal end portion.
6. The system of claim 5, wherein the inner surface diameter at the
deformable member proximal end portion, as positioned during
advancement within the body vessel or body cavity, is greater than
an outer surface diameter of the treatment device at the device
distal end portion.
7. The system of claim 5, wherein the deformable member proximal
end portion, as positioned during advancement within the body
vessel or body cavity, is configured to stretch around the outer
surface of the treatment device at the device distal end
portion.
8. The system of claim 2, wherein the shaft proximal end portion
includes a first locking mechanism portion and the device proximal
end portion includes a second locking mechanism portion, the second
locking mechanism portion configured to engage with the first
locking mechanism portion.
9. The system of claim 1, wherein the dilator assembly further
includes a marker element detectable by imaging or electronic
means.
10. The system of claim 1, wherein one or both of: the tubular
shaft includes a polyether ether ketone (PEEK) material, or the
deformable member includes an elastic material and a hydrophilic
coating.
11. A system comprising: a dilator assembly including a tubular
shaft, extending from a shaft proximal end portion to a shaft
distal end portion, and a deformable member, the deformable member
having an inner surface increasing in diameter between a deformable
member distal end, as positioned during advancement within a body
vessel or body cavity, and a deformable member proximal end, as
positioned during advancement within a body vessel or body cavity,
the deformable member distal end coupled to an outer surface of the
tubular shaft at or near the shaft distal end portion; and a
treatment device extending a length less than a length of the
tubular shaft, from a device proximal end to a device distal end,
and having a lumen diameter sized such that the tubular shaft and
the deformable member can be removed, from the device proximal end,
through the treatment device lumen when the proximal end portion of
the deformable member is folded back around the shaft distal end
portion.
Description
CLAIM OF PRIORITY
[0001] This patent matter is a divisional of U.S. patent
application Ser. No. 13/784,073 ("the '073 application"), which was
filed on Mar. 4, 2013 and is entitled "VASCULAR DILATOR SYSTEMS,
KITS, AND METHODS." The present patent matter claims the benefit of
priority of the '073 application and incorporates herein the
subject matter of said application in its entirety by
reference.
TECHNICAL FIELD
[0002] This patent document pertains generally to systems, kits,
and methods to introduce a treatment device into a body vessel or
body cavity. More particularly, but not by way of limitation, this
patent document pertains to vascular dilator systems, kits, and
methods configured to protect body vessel or body cavity wall
surfaces, while preserving vessel or cavity access size.
BACKGROUND
[0003] Minimally invasive procedures have been implemented in a
variety of medical settings, such as for vascular interventions,
stenting, embolic protection, electrical heart stimulation, heart
mapping and visualization, and the like. These procedures generally
rely on accurately navigating and placing treatment devices within
a body vessel or body cavity.
[0004] During minimally invasive procedures, a body vessel, for
example, can be accessed through a small access hole. The small
access hole can be initiated by piercing the skin, the body vessel,
and any intermediate structures using a hollow needle (e.g., a
trocar or a hypodermic needle). With the hollow needle in place, a
guide wire can be advanced within an inner lumen of the needle and
into the body vessel, thereby providing a "railway" to the vessel.
Upon removing the hollow needle, such as by sliding it off a
proximal end of the guide wire, one or more elongate treatment
devices (e.g., guide catheters, diagnostic catheters, electrical
leads, and other interventional devices) can be advanced over the
guide wire and into the body vessel, such as for use in a
diagnostic, therapeutic, or other procedure.
[0005] There are many risks involved with advancing treatment
devices over a guide wire and into a body vessel or body cavity.
For example, a distal end of a treatment device can skive or
otherwise damage a wall of a body vessel, particularly as the
device is introduced into the vessel or passes through narrow
passages or tortuous vessel anatomy involving sharp bends.
Advancement of treatment devices also risks dislodging embolic
material or even perforating the vessel wall due to an open distal
end edge of the treatment devices catching or "fish mouthing" on an
opening or other irregularity of the wall.
OVERVIEW
[0006] To help minimize or prevent damage to a wall of a body
vessel or body cavity during insertion of a treatment device, a
fixed-diameter tubular introducer sheath is often used by
caregivers to act as an intermediary between the treatment device
and the body vessel or body cavity wall. However, conventional
tubular introducer sheaths have relatively large cross-sectional
sizes and, after establishing vessel or cavity access, are
discarded. These large cross-sections occupy valuable access space
and make it impossible to internally advance treatment devices
having an outer diametrical size approximately equal to or greater
than a natural inner diameter of a body vessel or body cavity.
Accordingly, many minimally invasive procedures that would
desirably be performed by a caregiver using a radial artery, for
example, are rerouted to a larger femoral artery, which provides
the necessary access space for a tubular introducer sheath and the
desired treatment device. Similarly, other minimally invasive
procedures that would desirably be performed by caregivers using a
femoral artery are rerouted elsewhere.
[0007] The present inventors recognize that it can be desirable to
provide caregivers with the ability to introduce treatment devices,
such as guide, diagnostic, or therapeutic catheters, having an
outer surface diameter approximately equal to, or in some cases
greater than, the natural inner diameter of a body vessel or body
cavity. At the same time, the present inventors recognize the
importance of a system for introducing treatment devices in a safe
manner, such as a system which inhibits tearing or damage of a body
vessel or body cavity wall, patient discomfort, and/or involuntary
vessel or cavity spasm as the treatment device is internally
advanced.
[0008] Vascular dilator systems, kits, and methods allowing for
sheathless introduction of a treatment device into a body vessel or
body cavity in a safe and relatively pain free manner are
disclosed. A vascular dilator system can include a dilator
assembly, including a tubular shaft and a deformable member, and
optionally, the treatment device or a portion of the treatment
device. The vascular dilator system can position the treatment
device at a desired location within the body vessel or body cavity,
while preserving vessel or cavity access size.
[0009] The tubular shaft can be configured to be advanced over a
guide wire and into the body vessel or body cavity. The tubular
shaft can have an outer surface that increases in diameter between
a shaft distal end portion and a shaft proximal end portion,
thereby providing a gradual taper from a relatively small diameter
of the guide wire to a larger diameter of the surrounding treatment
device.
[0010] The deformable member can include a non-biodegradable
material and can have an inner surface that increases in diameter
between a distal end and a proximal end. A distal end portion of
the deformable member can be coupled to the outer surface of the
tubular shaft, at or near the shaft distal end portion. A proximal
end portion of the deformable member can include an inner surface
diameter configured to receive the outer surface at a distal end
portion of the treatment device. In some examples, the inner
surface of the deformable member's distal end and the inner surface
of the deformable member's proximal surface are part of the same
surface, such as when the deformable member is coupled to the outer
surface of the tubular shaft so that the proximal end initially has
a proximal-facing orientation to receive the distal end portion of
the treatment device. In other examples, the inner surface of the
deformable member's distal end and the inner surface of the
deformable member's proximal end are on opposite surfaces, such as
when the deformable member is coupled to the outer surface of the
tubular shaft so that the proximal end initially has a
distal-facing orientation and has to be inverted onto itself (i.e.,
overturned) before being coupled to the distal end portion of the
treatment device. In use, the deformable elastic member can provide
a smooth, edge free surface that provides a tapered bridge over a
gap between the outer surface of the tubular shaft and the outer
surface of the treatment device.
[0011] When the treatment device is positioned as desired within
the body vessel or body cavity of interest, the dilator assembly
can be retracted by pulling on the shaft proximal end portion.
During retraction, distal end portions of the dilator assembly are
slid through a lumen of the treatment device and, in the process,
the proximal end portion of the deformable member can be inverted
onto the reduced-diameter of the shaft distal end portion. The
inverting of the proximal end portion of the deformable member onto
the reduced-diameter portion of the tubular shaft allows the
deformable member and the tubular shaft to fit through the lumen of
the treatment device. The orientation of the proximal end of the
deformable member, when its distal end is coupled to the tubular
shaft, will determine whether one or two layers of the deformable
member are positioned (on a per side basis) between the outer
surface of the tubular shaft and lumen walls of the treatment
device during retraction.
[0012] To better illustrate the vascular dilator systems and
methods disclosed herein, a non-limiting list of examples is
provided here:
[0013] In Example 1, a system can comprise a dilator assembly
including a tubular shaft and a deformable member. The tubular
shaft can have an outer surface increasing in diameter between a
shaft distal end portion and a shaft proximal end portion. The
deformable member can include a non-biodegradable material and can
have an inner surface diameter at a deformable member proximal end
portion, as positioned during advancement within a body vessel or
body cavity, which is greater than an inner surface diameter at a
deformable member distal end portion, as positioned during
advancement within the body vessel or body cavity. The deformable
member distal end portion can be coupled to the outer surface of
the tubular shaft, at or near the shaft distal end portion.
[0014] In Example 2, the system of Example 1 can optionally further
comprise one or more treatment devices. A treatment device can
extend a length less than a length of the tubular shaft, from a
device proximal end portion to a device distal end portion, and can
have a lumen diameter greater than a largest diameter of the outer
surface of the tubular shaft.
[0015] In Example 3, the system of Example 2 can be optionally
configured such that the lumen diameter is sufficiently sized to
allow the tubular shaft and the deformable member to be removed,
from the device proximal end, through the treatment device lumen
when the proximal end portion of the deformable member is folded
back around the shaft distal end portion.
[0016] In Example 4, the system of any one or any combination of
Examples 2 or 3 can be optionally configured such that the device
distal end portion is received over the tubular shaft, at the shaft
proximal end portion, and advanced to a location adjacent the
deformable member proximal end portion.
[0017] In Example 5, the system of Example 4 can be optionally
configured such that the inner surface diameter at the deformable
member proximal end portion, as positioned during advancement
within the body vessel or body cavity, receives and surrounds an
outer surface of the treatment device at the device distal end
portion.
[0018] In Example 6, the system of Example 5 can be optionally
configured such that the inner surface diameter at the deformable
member proximal end portion, as positioned during advancement
within the body vessel or body cavity, is greater than an outer
surface diameter of the treatment device at the device distal end
portion.
[0019] In Example 7, the system of any one or any combination of
Examples 5 or 6 can be optionally configured such that the
deformable member proximal end portion, as positioned during
advancement within the body vessel or body cavity, stretches around
the outer surface of the treatment device at the device distal end
portion.
[0020] In Example 8, the system of any one or any combination of
Examples 2-7 can be optionally configured such that the shaft
proximal end portion includes a first locking mechanism portion and
the device proximal end portion includes a second locking mechanism
portion. The second locking mechanism portion can be configured to
engage with the first locking mechanism portion.
[0021] In Example 9, the system of Example 8 can be optionally
configured such that the first and second locking mechanism
portions form a luer lock.
[0022] In Example 10, the system of any one or any combination of
Examples 1-9 can be optionally configured such that the deformable
member includes a hydrophilic coating or a hydrophobic, but
lubricious, coating.
[0023] In Example 11, the system of any one or any combination of
Examples 1-10 can be optionally configured such that the dilator
assembly further includes a marker element detectable by imaging or
electronic means. The marker element can be in the form of a marker
band and can be disposed between the deformable member proximal end
portion and the deformable member distal end portion.
[0024] In Example 12, the system of any one or any combination of
Examples 1-11 can be optionally configured such that the dilator
assembly is reusable.
[0025] In Example 13, the system of any one or any combination of
Examples 1-12 can be optionally configured such that the tubular
shaft includes a polyether ether ketone (PEEK), Nitinol, Ultem, or
nylon material, or the deformable member includes an elastic
material (e.g., polyether block amides, urethanes, styrene isoprene
butadienes (SIBS), styrene ethylene butadienes (SEBS), or
polyethylenes).
[0026] In Example 14, a system can comprise a dilator assembly and
a treatment device. The dilator assembly can include a tubular
shaft, extending from a shaft proximal end portion to a shaft
distal end portion, and a deformable member. The deformable member
can have an inner surface increasing in diameter between a
deformable member distal end and a deformable member proximal end,
wherein the distal and proximal ends are described in terms of
their positioning during advancement of the system within a body
vessel or body cavity. The deformable member distal end can be
coupled to an outer surface of the tubular shaft, at or near the
shaft distal end portion. The treatment device can extend a length
less than a length of the tubular shaft, from a device proximal end
to a device distal end, and can have a lumen diameter greater than
a largest diameter of the outer surface of the tubular shaft. As a
result, the tubular shaft and the deformable member can be removed,
from the device proximal end, through the treatment device lumen
when the proximal end portion of the deformable member is folded
back around the shaft distal end portion.
[0027] In Example 15, a method can comprise sheathless introduction
of a treatment device into a body vessel or body cavity, including
inserting the treatment device coupled with a dilator assembly into
the body vessel or body cavity; advancing the treatment device and
the dilator assembly to a target location within the body vessel or
body cavity; after reaching the target location within the body
vessel or body cavity, decoupling the treatment device from the
dilator assembly, including decoupling a distal end portion of the
treatment device from a proximal end portion of a deformable
member; and removing the dilator assembly from the treatment
device, including fully retracting a tubular shaft and the
deformable member through a lumen of the treatment device.
[0028] In Example 16, the method of Example 15 can optionally
further comprise coupling the treatment device and the dilator
assembly, including advancing the distal end portion of the
treatment device into the proximal end portion of the deformable
member.
[0029] In Example 17, the method of Example 16 can optionally
further comprise, prior to coupling the treatment device and the
dilator assembly, inverting the proximal end portion of the
deformable member from a distal-facing orientation to a
proximal-facing orientation to receive the distal end of the
treatment device.
[0030] In Example 18, the method of any one or any combination of
Examples 15-17 can optionally further comprise coupling the
treatment device and the dilator assembly, including configuring a
distal end portion of the tubular shaft to protrude beyond the
distal end portion of the treatment device during advancement of
the treatment device and the dilator assembly to the target
location.
[0031] In Example 19, the method of any one or any combination of
Examples 15-18 can optionally be configured such that inserting the
treatment device coupled with the dilatory assembly into the body
vessel or body cavity includes introducing a treatment device,
having an outer diameter greater than a natural body vessel or body
cavity diameter, into the body vessel or body cavity such that the
proximal end portion of the deformable member is positioned between
an outer surface of the distal end portion of the treatment device
and an inner surface of the body vessel or body cavity.
[0032] In Example 20, the method of any one or any combination of
Examples 15-19 can optionally be configured such that inserting the
treatment device coupled with the dilator assembly into the body
vessel or body cavity includes introducing a treatment device,
having an outer diameter equal to or greater than about 6-Fr, into
a radial artery such that the proximal end portion of the
deformable member is positioned between an outer surface of the
distal end portion of the treatment device and an inner surface of
the radial artery.
[0033] In Example 21, the method of any one or any combination of
Examples 15-20 can optionally be configured such that advancing the
treatment device and the dilator assembly to the target location
includes increasing an intersection of the proximal end portion of
the deformable member over an outer surface of the distal end
portion of the treatment device.
[0034] In Example 22, the method of any one or any combination of
Examples 15-21 can optionally further comprise identifying the
target location of the treatment device and the dilator assembly
within the body vessel or body cavity, including using a marker
element associated with the dilator assembly.
[0035] In Example 23, the method of any one or any combination of
Examples 15-22 can optionally be configured such that decoupling
the treatment device from the dilator assembly includes pushing a
proximal end portion of the tubular shaft forward to detach and
space the proximal end portion of the deformable member from the
distal end portion of the treatment device.
[0036] In Example 24, the method of Example 23 can optionally be
configured such that removing the dilator assembly from the
treatment device includes using the spacing between the proximal
end portion of the deformable member and the distal end portion of
the treatment device to provide a period of force-reduced pulling
of the tubular shaft from its proximal end portion.
[0037] In Example 25, the method of any one or any combination of
Examples 15-24 can optionally be configured such that decoupling
the treatment device from the dilator assembly includes disengaging
a first locking mechanism portion associated with a proximal end
portion of the dilator assembly and a second locking mechanism
portion associated with a proximal end portion of the treatment
device.
[0038] In Example 26, the method of any one or any combination of
Examples 15-25 can optionally be configured such that retracting
the tubular shaft and the deformable member through the lumen of
the treatment device includes causing the proximal end portion of
the deformable member to fold back towards a reduced-diameter
portion of the tubular shaft.
[0039] In Example 27, the method of Example 26 can optionally be
configured such that causing the proximal end portion of the
deformable member to fold back toward the reduced-diameter portion
of the tubular shaft includes causing the proximal end portion or
an intermediate portion of the deformable member to be positioned
proximal of a distal end portion of the deformable member, which is
coupled to an outer surface of the tubular shaft.
[0040] In Example 28, the method of Example 26 can optionally be
configured such that causing the proximal end portion of the
deformable member to fold back toward the reduced-diameter portion
of the tubular shaft includes causing the proximal end portion and
an intermediate portion of the deformable member to be positioned
distal of a distal end portion of the deformable member, which is
coupled to an outer surface of the tubular shaft.
[0041] In Example 29, the method of any one or any combination of
Examples 15-28 can optionally further comprise overturning the
deformable member, relative to the tubular shaft, for reuse.
[0042] In Example 30, the vascular dilator system or method of any
one or any combination of Examples 1-29 can optionally be
configured such that all elements or options recited are available
to use or select from.
[0043] These and other examples and features of the present
vascular dilator systems, kits, and methods will be set forth in
part in the following Detailed Description. This Overview is
intended to provide non-limiting examples of the present subject
matter--it is not intended to provide an exclusive or exhaustive
explanation of the invention. The Detailed Description below is
included to provide further information about the present vascular
dilator systems, kits, and methods.
BRIEF DESCRIPTION OF THE DRAWINGS
[0044] In the drawings, like numerals can be used to describe
similar elements throughout the several views. Like numerals having
different letter suffixes can be used to represent different views
or the progression of use of similar elements. The drawings
illustrate generally, by way of example, but not by way of
limitation, various embodiments discussed in the present
document.
[0045] FIG. 1 illustrates vascular structures, urinary tract
structures, and digestive tract structures in which vascular
dilator systems, kits, and methods, as constructed in accordance
with various embodiments, can be used.
[0046] FIG. 2A illustrates a first step of a minimally invasive
technique for accessing a body vessel or body cavity using a hollow
needle.
[0047] FIG. 2B illustrates a second step of the minimally invasive
technique for accessing a body vessel or body cavity using the
hollow needle and a guide wire.
[0048] FIG. 2C illustrates a third step of the minimally invasive
technique for accessing a body vessel or body cavity, including
removal of the hollow needle.
[0049] FIG. 2D illustrates a fourth step of the minimally invasive
technique for accessing a body vessel or body cavity, including
advancing a treatment device over the guide wire.
[0050] FIG. 3A illustrates an existing system for introducing a
treatment device into a body vessel, in which a distal end of the
treatment device is exposed.
[0051] FIG. 3B illustrates a close up view of a portion of an
existing system for introducing a treatment device into a body
vessel, such as the system illustrated in FIG. 3A, in which a
distal end of the treatment device can catch an opening or
irregularity in a vessel wall causing vessel deformation or damage
and patient pain.
[0052] FIG. 4 illustrates a distal end portion of a treatment
device partially advanced onto a dilator assembly, which is shown
in cross-section, as constructed in accordance with at least one
embodiment.
[0053] FIG. 5 illustrates a schematic view of a treatment device
mostly advanced onto a dilator assembly, as constructed in
accordance with at least one embodiment.
[0054] FIG. 6 illustrates a schematic view of a distal end portion
of a treatment device positioned within a proximal end portion of a
deformable member, such as when a proximal end portion of a tubular
shaft and a proximal end portion of the treatment device are fully
engaged, as constructed in accordance with at least one
embodiment.
[0055] FIG. 7 illustrates an example of a system for introducing a
treatment device into a body vessel, in which a distal end portion
of the treatment device is surrounded by a proximal end portion of
a deformable member, thereby protecting a body vessel wall during
insertion.
[0056] FIGS. 8A and 8B illustrate distal end portions of a
treatment device and a dilator assembly, at successive stages as
the dilator assembly is being withdrawn through an inner lumen of
the treatment device.
[0057] FIG. 9 illustrates an example method of using a vascular
dilator system or kit, as constructed in accordance with at least
one embodiment.
DETAILED DESCRIPTION
[0058] The present inventors recognize, among other things, a need
for gaining access into a body vessel or body cavity of a patient,
such as a radial or femoral artery, while protecting vessel or
cavity walls and preserving vessel or cavity access size (e.g.,
effective vessel diameter or cross-sectional area). Using this
larger-than-conventional access size, caregiver-selected treatment
devices can be efficiently introduced into a desired body vessel or
body cavity during a minimally invasive procedure.
[0059] The present vascular dilator systems, kits, and methods
comprise or use a dilator assembly including a tubular shaft and a
deformable member. Together, the tubular shaft and the deformable
member can allow for sheathless introduction of a treatment device
into a body vessel or body cavity in a safer and less painful
manner than is currently possible. The tubular shaft can have an
outer surface that gradually increases in diameter between a shaft
distal end portion and a shaft proximal end portion, thereby
gradually expanding an inner diameter of a body vessel, for
example, as the dilator assembly is introduced and advanced within
a patient. The deformable member can be coupled to the outer
surface of the tubular shaft, such as at or near the shaft distal
end portion, and can provide a smooth, edge free surface to inhibit
tearing or damage of the vessel wall as the treatment device is
advanced within the patient.
[0060] In the absence of the deformable member being placed between
an outer surface of the treatment device and an inner wall surface
of the body vessel, the vessel wall may be damaged, a patient may
experience pain or discomfort as the treatment device is being
introduced into the vessel (e.g., due to an open distal end edge of
the treatment device catching on vessel wall tissue), and/or the
vessel may involuntarily spasm, preventing internal advancement of
the treatment device.
[0061] By design, a proximal end portion of the deformable member
can be sized to receive or stretch over and surround a
distally-located outer surface portion of the treatment device
during insertion. Post-insertion, the deformable member and the
tubular shaft can be removed through a lumen of the treatment
device by pulling on a proximal end portion of the tubular shaft.
As the tubular shaft is pulled rearwards, from the shaft proximal
end portion, the proximal end portion of the deformable member can
be caused to deform and fold back towards the reduced-diameter of a
shaft distal end portion (i.e., the proximal end portion of the
deformable member can invert). The inverting of the proximal end
portion of the deformable member onto the reduced-diameter portion
of the tubular shaft allows the deformable member and the tubular
shaft to fit through the lumen of the treatment device.
[0062] FIG. 1 illustrates vascular structures 101 (e.g., radial and
femoral arteries), urinary tract structures 102, and digestive
tract structures 103, which provide suitable environments for using
the present vascular dilator systems 180, kits, and methods. A
radial artery 104 is located in a patient's forearm and, for a
typical adult, has a natural inner diameter sufficient to allow
percutaneous placement of a tubular introducer sheath or a
treatment device having a size of up to 6-Fr. A femoral artery 105
is partially located in a patient's groin area and, for a typical
adult, has a natural inner diameter sufficient to allow
percutaneous placement of a tubular introducer sheath or a
treatment device having a size of up to 9-Fr. The present vascular
dilator systems 180, kits, and methods can be guided within the
vascular 101, urinary tract 102, and digestive tract structures 103
using minimally invasive access techniques, such as the Seldinger
technique.
[0063] FIGS. 2A-2D illustrate steps of the Seldinger technique for
accessing a body vessel 241, for example. At FIG. 2A, a small
access hole can be initiated by piercing a patient's skin 290, a
wall of the body vessel 241, and any intermediate structures using
a hollow needle 201. With the hollow needle 201 in place, a guide
wire 230 can be advanced within an inner lumen of the needle 201
and into the body vessel 241, as illustrated in FIG. 2B. The guide
wire can provide a railway into the body vessel 241. As illustrated
in FIG. 2C, the hollow needle 201 can be removed, such as by
sliding it off a proximal end of the guide wire 230, and the guide
wire 230 can be further advanced within the body vessel 241 until
it reaches a desired location. As illustrated in FIG. 2D, a
treatment device 210 (e.g., a guide catheter) can be advanced over
the guide wire and into the body vessel for use in a diagnostic,
therapeutic, or other procedure. Advancement of the treatment
device 210 into the body vessel can include the use of a tubular
introducer sheath or a sheathless introducer system.
[0064] In certain circumstances, it can be advantageous to perform
a minimally invasive procedure through a radial artery 104 (FIG. 1)
rather than a larger, femoral artery 105 (FIG. 1). For example,
vascular access through the radial artery 104 can help to reduce
recovery time. However, typical minimally invasive procedures
performed using a conventional thick, fixed-diameter tubular
introducer sheath cannot be achieved through the smaller radial
artery 104, because the sheath itself occupies too much of the
valuable cross-sectional access space afforded by the radial artery
104. Conventional sheathless vascular introducer systems seek to
solve this problem and provide the advantage of not losing part of
a vessel's cross-section to a sheath. However, such sheathless
systems suffer from the lack of any vessel protection during a
minimally invasive procedure, such as during the introduction of a
treatment device.
[0065] FIGS. 3A and 3B illustrate an example of an existing
sheathless system 380 for introducing a treatment device 310 into a
body vessel 341 using a guide wire 330. The guide wire 330 can be
placed by the Seldinger technique. The existing sheathless system
380 can include a tubular shaft 320, positionable within a lumen of
the treatment device 310, configured to ride the guide wire 330
rail within the body vessel 341. As illustrated in FIG. 3B, the
existing sheathless system 380 fails to provide a suitable means to
prevent an open distal end edge 316 of the treatment device 310
from catching (or "fish mouthing" on) an opening 332 or other
irregularity of a vessel wall as the tubular shaft 320 is advanced
along the guide wire 330 rail. Any time a distal end portion of the
existing sheathless system 380 is inserted within a patient or is
advanced at a non-parallel angle relative to an adjacent vessel or
cavity wall, such as during initial insertion or while moving
around a bend, the distal end edge of the treatment device 310 can
be prone to catching on and damaging bodily tissue or rolling back
on itself and causing tissue damage due to its overlapped size.
[0066] In an attempt to prevent catching of the distal end edge 316
of the treatment device 310 on bodily tissue, other existing
sheathless systems include a tubular shaft having a distal end
portion diametrically-sized greater than a distal end portion of a
treatment device. The enlarged distal end portion of the tubular
shaft is intended to expand an inner diameter of a natural body
vessel, for example, over a distal end portion of the treatment
device. However, the enlarged distal end portion makes it difficult
to remove the tubular shaft after the treatment device has reached
a desired location within the body vessel and further, the enlarged
portion may tear a wall of the body vessel as it is advanced within
a patient.
[0067] A technological concept of the present vascular dilator
systems, kits, and methods is to provide or use a sheathless
configuration for introducing a treatment device within a body
vessel or body cavity, while protecting bodily tissue during
insertion, and having components that are easily removed after the
treatment device reaches a desired location within the body vessel
or body cavity. The sheathless configuration can allow for the
introduction of treatment devices having an outer surface diameter
approximately equal to, or in some cases greater than, the natural
inner diameter of the body vessel or body cavity. For example, the
sheathless configuration can allow for the introduction of
treatment devices having an outer surface diameter approximately
equal to or greater than 4-French (Fr), 5-Fr, or 6-Fr for radial
arteries 104 (FIG. 1) and approximately equal to or greater than
6-Fr, 7-Fr, 8-Fr, or 9-Fr for femoral arteries 105. Various
examples of the present vascular dilator systems, kits, and methods
are illustrated in FIGS. 4-9. The vascular dilator systems 480,
580, 680, 780, 880 and kits are available in various sizes, such as
4-Fr, 5-Fr, 6-Fr, 7-Fr, 8-Fr, and 9-Fr and can include a dilatory
assembly and, optionally, a treatment device or a portion of a
treatment device. Similar configurations of the vascular dilator
systems, kits, and methods can be used for its various size
offerings.
[0068] FIG. 4 illustrates a distal end portion of a treatment
device 410 partially advanced onto a dilator assembly 470, the
latter of which is shown in cross-section and according to one
embodiment. The dilator assembly 470 can include a tubular shaft
420 and a deformable member 450.
[0069] The tubular shaft 420 can be made of a PEEK, Nitinol, Ultem,
or nylon material and can include a relatively narrow distal end
portion 461, a tapered intermediate portion 460, and a proximal end
portion 462 having a diameter less than the treatment device 410.
The distal end portion 461 of the tubular shaft 420 can include an
outer surface diameter 473 of about 0.02 inches to about 0.04
inches, inclusive, such as about 0.027 inches. The proximal end
portion 462 of the tubular shaft can include an outer surface
diameter that can slide inside a lumen of the treatment device 410.
In an example, the proximal end portion 462 can include an outer
surface diameter 474 of about 0.030 inches to about 0.80 inches,
inclusive, such as about 0.074 inches. The intermediate portion 460
can include a taper 477 of about 5 degrees to about 45 degrees,
inclusive, which provides a transition from the relatively narrow
distal end portion 461 to the proximal end portion 462.
[0070] The tubular shaft 420 can be configured with sufficient
flexibility to be advanced into body vessels or body cavities and
navigate bends as its inner lumen, having a diameter about 0.010
inches to about 0.040 inches (e.g., 0.020 inches), follows a guide
wire rail. A tip 463 of the tubular shaft 420 can be atraumatically
configured to aid in the advancement along the guide wire rail
through curves or bends in a body vessel or body cavity. The tip
463 can include a radius 475 of about 0.008 inches to about 0.080
inches, such as about 0.016 inches.
[0071] A distal end or distal end portion of the deformable member
450 can be coupled to an outer surface of the distal end portion
461 of the tubular shaft 420. In the example illustrated, the
distal end portion of the deformable member 450 can include an
inner surface diameter that closely fits a reduced outer surface
diameter 473 at the distal end portion 461 of the tubular shaft
420. As shown, the deformable member 450 can be positioned such
that its proximal end portion initially has a proximal-facing
orientation to receive a distal end band portion 423 of the
treatment device 410. Optionally, the deformable member 450 can be
positioned such that its proximal end portion initially has a
distal-facing orientation and has to be inverted onto itself to
receive the distal end band portion 423 of the treatment device
410. When the proximal end portion is oriented to receive the
distal end band portion 423, the tubular shaft 420 protrudes from
the deformable member's proximal and distal end portions.
[0072] In both orientations, the proximal end portion of the
deformable member 450 can include a larger inner surface diameter
than the diameter of the distal end portion. The distal end portion
of the deformable member 450 can include an outer surface diameter
478 of about 0.03 inches to about 0.08 inches, inclusive, such as
0.056 inches. The proximal end portion of the deformable member 450
can at least partially expand over the tapered intermediate portion
460 of the tubular shaft 420, such that sufficient space is present
between its inner surface diameter 481 and the outer surface
diameter of the adjacent tubular shaft 420 portion. The space can
create a flap 451 configured to receive or stretch around a distal
end band portion 423 of the treatment device 410. The flap 451 can
prevent a distal end edge of the treatment device 410 from catching
on an opening, irregularity, or bend in the body vessel or body
cavity or on a wall of the body vessel or body cavity. The flap 451
can include a length 482 of about 0.050 inches to about 0.250
inches, inclusive, such as about 0.125 inches. The proximal end
portion of the deformable member 450 can include an outer surface
diameter 479 of about 0.03 inches to about 0.80 inches, inclusive,
such as about 0.094 inches and an inner surface diameter 481 of
about 0.03 inches to about 0.77 inches, inclusive, such as about
0.084 inches.
[0073] The deformable member 450 can be made of a non-biodegradable
and elastic material, such as polyether block amides, urethanes,
styrene isoprene butadienes (SIBS), styrene ethylene butadienes
(SEBS), or polyethylenes, and can include a hydrophilic coating or
a hydrophobic, but lubricious, coating to facilitate advancement
within a patient. The hydrophilic coating or hydrophobic, but
lubricious, coating can be wholly or partly applied to an outer
and/or inner surface of the deformable member 450. It has been
found that similar functionality can be achieved with hydrophilic
coatings and with lubricious hydrophobic coatings. In some
examples, lubricious hydrophobic coatings can be a cost effective
alternative to hydrophilic coatings. Non-biodegradable deformable
members 450 can provide internal use that is not dependent on a
degradation time period. This flexibility can be advantageous for
many present and future medical procedures and removes potentially
dangerous unknowns, including premature degradation.
[0074] FIG. 5 illustrates a schematic view of a treatment device
510 mostly advanced onto a dilator assembly 570, including a
tubular shaft 520 and a deformable member 550. Proximal end
portions of the tubular shaft 520 and the treatment device 510 can
include locking mechanism portions. For example, a first locking
mechanism portion 521 can be disposed at the proximal end portion
of the treatment device 510 and a second locking mechanism portion
522 can be disposed near the proximal end portion of the tubular
shaft 520. The first and second locking mechanism portions 521, 522
can lock the tubular shaft 520 and the treatment device 510 as the
system 580 is advanced into a body vessel or body vessel. In an
example, the locking mechanism portions 521, 522 form a luer lock.
As the locking mechanism portions 521, 522 converge toward one
another, but before engagement, a distal end band portion 523 of
the treatment device 510 can advance (e.g., slide) into a flap 551
at a proximal end portion of the deformable member 550. When the
distal end band portion 523 is positioned in the flap 551 as
desired, the locking mechanism portions 521, 522 can be engaged,
thereby preventing relative movement between the treatment device
510 and the dilator assembly 570. As illustrated, the tubular shaft
520 can extend a length greater than a length of the treatment
device 510 such that when the locking mechanism portions 521, 522
are fully engaged, portions of the tubular shaft 520 protrude at
proximal and distal ends of the system 580. In an example, the
length of the tubular shaft 520 is about 130 centimeters.
[0075] One or both of a locator band 524, positioned near the
distal end of the treatment device 510, or a marker band 540,
positioned on the deformable member 550, can be used by a caregiver
to locate the system 580 as it travels through a body vessel or
body cavity. In an example, the marker band 540 can be crimped
around an intermediate portion of the deformable member 550 and can
include a material that can be detected by imaging or electronic
means.
[0076] FIG. 6 illustrates a distal end portion of a treatment
device 610 positioned within a flap 651 at a proximal end portion
of a deformable member 650, such as when proximally-located locking
mechanism portions of the treatment device 610 and a tubular shaft
are fully engaged with one another. The distal end band 523 of the
treatment device, as illustrated in FIG. 5, can no longer be seen,
while a locator band 624 is positioned adjacent the proximal end
portion of the deformable member 650.
[0077] FIG. 7 illustrates how a present vascular dilator system
780, including a dilator assembly 770 and, optionally, a treatment
device 710 can be deployed into a body vessel 741 or body cavity. A
tubular shaft 720 of the dilator assembly 770 can guide the
treatment device 710 over a guide wire rail 730, while a deformable
member 750 of the dilator assembly 770 can provide a smooth, edge
free surface to inhibit tearing or damage of a body vessel wall,
for example, as the treatment device 710 is internally advanced
within a patient. As discussed above in relation to FIG. 5, locking
mechanism portions of the treatment device 710 and the tubular
shaft 720 can prevent relative movement between the elements during
advancement within the patient. If the deformable member 750
deforms during advancement, such deformation advantageously results
in further coverage, and prevents roll-up, of a distal end of the
treatment device 710.
[0078] After the vascular dilator system has been pushed along the
guide wire 730 to a target location within the body vessel 741, for
example, the tubular shaft 720 can be pulled rearwards from its
proximal end portion, after disengaging the locking mechanism
portions, as the treatment device is held in place. The pulling of
the tubular shaft 720 can cause the proximal end portion of the
deformable member 750 to deform and fold back towards the
reduced-diameter of a distal end portion of the tubular shaft 720
(i.e., the proximal end portion of the deformable member can
invert) and the dilator assembly 770 can be removed through an
inner lumen of the treatment device 710. A dilator assembly 770
that is completely removable through a treatment device lumen can
provide a quick and safe removal method in body vessels and body
cavities where a risk of blockage or foreign matter can be highly
dangerous. Thus, not only does the present vascular dilator system
780 provide a sheathless configuration, allowing for the safe
introduction of various sized treatment devices into body vessels
and body cavities, but the system 780 is designed so that its
components are easily removed after a treatment device reaches a
desired location within the body vessel or body cavity.
[0079] FIGS. 8A and 8B illustrate distal end portions of a
treatment device 810 and a dilator assembly 870, including a
tubular shaft 820 and a deformable member 850, at successive stages
as the dilator assembly 870 is being withdrawn through an inner
lumen of the treatment device 810. As illustrated in FIG. 8A, the
dilator assembly 870 can initially be pushed forward a small
distance, from a proximal end portion of the tubular shaft 820, so
that a proximal end portion of the deformable member 850 can become
disengaged and spaced from a distal end band portion 823 of the
treatment device 810. Alternatively, the dilator assembly 870 can
be retracted by pulling on the proximal end portion of the tubular
shaft 820 and the proximal end portion of the deformable member 850
will subsequently be pulled from the distal end band portion 823 of
the treatment device 810. Pulling on the proximal end portion of
the tubular shaft 820 can cause a marker band 840, positioned on
the deformable member 850, to retract towards a proximal end of the
treatment device 810. Pulling on the proximal end portion of the
tubular shaft 820 can also cause a flap 851 at the proximal end
portion of the deformable member 850 to invert towards the distal
end portion of the tubular shaft 820, as illustrated in FIG. 8B.
Once inverted, the distal end portion of the tubular shaft 820 and
the deformable member 850 can fit through the lumen of the
treatment device 810, and the dilator assembly 870 can be removed
from the body vessel or body cavity.
[0080] A kit can include a hollow needle, a guide wire, a vascular
dilator system 480, 580, 680, 780, 880 including a dilator assembly
and, optionally, a treatment device or a portion of the treatment
device, and instructions for using the vascular dilator system to
insert the treatment device into a body vessel or body cavity. In
some examples, the instructions can provide guidance for inserting
a treatment device or a portion of a treatment device into a radial
artery 104 (FIG. 1) or a femoral artery 105 (FIG. 1).
[0081] FIG. 9 illustrates an example method 980 of using a vascular
dilator system or kit including a hollow needle, a guide wire, a
dilator assembly and, optionally, a treatment device, as conceived
by the present inventors. The treatment device can be implanted by
first inserting the hollow needle into a body vessel in operation
902. As an alternative to a body vessel, the target can be a hollow
body organ, solid tissue location, body cavity, or the like. The
guide wire can then be inserted through an inner lumen of the
hollow needle, in operation 904, and into the body vessel, thereby
providing a railway to the body vessel. Once the guide wire is in
place, the hollow needle can be removed in operation 906.
[0082] The treatment device can be coupled to the dilator assembly
in operation 908. A distal end portion of the treatment device can
be inserted into a proximal end portion of a deformable member, of
the dilator assembly, and a proximal end portion of the treatment
device can be engaged with a proximal end portion of a tubular
shaft, of the dilator assembly. In an example, a locking mechanism
portion associated with the treatment device is engaged with a
locking mechanism portion associated with the tubular shaft. In an
example, the proximal end portion of the deformable member can be
inverted from a distal-facing orientation to a proximal-facing
orientation prior to receiving the distal end portion of the
treatment device.
[0083] In operation 910, the dilator assembly and the treatment
device can be introduced into the body vessel using an
over-the-guide wire technique, with the guide wire passing through
an inner lumen of the tubular shaft. The tubular shaft can include
an atraumatic distal end portion that leads the way into the body
vessel. The dilator assembly and the treatment device can be
advanced to a target location within the body vessel, in operation
912. A caregiver can guide the dilator assembly and the treatment
device to the target location using one or both of a locator band,
positioned near the distal end of the treatment device, or a marker
band, positioned on the deformable member, and imaging or
electronic means. Advancement of the dilator assembly can cause the
deformable member to deform and result in further coverage of the
distal end portion of the treatment device.
[0084] After reaching the target location within the body vessel,
the dilator assembly can be removed in operation 914. Removal of
the dilator assembly can include disengaging a first locking
mechanism portion associated with the proximal end portion of the
tubular shaft and a second locking mechanism portion associated
with the proximal end portion of the treatment device. After the
locking mechanism portions are disengaged, removal of the dilator
assembly can optionally include pushing the tubular shaft, from a
proximal end portion, about 1 centimeter to about 3 centimeters,
inclusive, to uncover the distal end of the treatment device and
then pulling on the proximal end portion of the tubular shaft while
maintaining a position of the treatment device. This can cause a
decoupling between the distal end portion of the treatment device
and the proximal end portion of the deformable member (if not
already decoupled), the inversion of the proximal end portion of
the deformable member towards the distal end portion of the tubular
shaft, and the full retraction of the tubular shaft and the
deformable member through a lumen of the treatment device.
[0085] The inversion of the proximal end portion of the deformable
member can vary depending on its orientation when the distal end
portion of the deformable member is coupled to the tubular shaft.
If, for example, the deformable member is positioned such that its
proximal end portion initially has a proximal-facing orientation to
receive the distal end portion of the treatment device, the
inversion of the proximal end portion can include positioning the
proximal end portion or an intermediate portion of the deformable
member proximal of the distal end portion of the deformable member.
If, for example, the deformable member is positioned such that its
proximal end portion initially has a distal-facing orientation and
has to be inverted onto itself to receive the distal end portion of
the treatment device, the inversion of the proximal end portion can
include positioning the proximal end portion and the intermediate
portion of the deformable member distal of the distal end portion
of the deformable member. The orientation of the proximal end
portion of the deformable member, when its distal end portion is
coupled to the tubular shaft, can also determine whether one or two
layers of the deformable member are positioned (on a per side
basis) between the outer surface of the tubular shaft and lumen
walls of the treatment device during removal. If the deformable
member's proximal end portion has a proximal-facing orientation,
two layers of the deformable member (per side) exist between the
outer surface of the tubular shaft and lumen walls of the treatment
device. If the deformable member's proximal end portion has a
distal-facing orientation, one layer of the deformable member (per
side) exists between the outer surface of the tubular shaft and the
lumen walls of the treatment device, thereby providing greater
removal spacing.
[0086] In operation 916, the inverted elastic member can optionally
be overturned, relative to the tubular shaft, for later reuse.
[0087] Closing Notes:
[0088] Body vessel and body cavity cross-sectional access size
constitutes one of the principal limitations of minimally invasive
medical procedures. The present vascular dilator systems, kits, and
methods can include or use a dilator assembly, including a tubular
shaft and a deformable member, and optionally, a treatment device
or a portion of a treatment device. Advantageously, the tubular
shaft and the deformable member enable the treatment device to be
inserted into a body vessel or body cavity of interest (e.g., a
radial artery) without using a tubular introducer sheath and
without causing harm to bodily tissue (e.g., a vessel wall, cavity
wall, or tissue along an insertion track outside of the vessel or
cavity and under the skin surface). Additionally, the deformable
member can provide a tapered bridge between an outer surface of the
tubular shaft and an outer surface of the treatment device. The
tapered bridge can gradually stretch the natural inner diameter of
the body vessel or body cavity of interest allowing treatment
devices having an outer surface diameter approximately equal to or
greater than the natural inner diameter to be used.
[0089] A proximal end of the deformable member can include a larger
inner surface diameter than a distal end, the latter of which can
be secured to an outer surface of the tubular shaft. The outer
surface of the tubular shaft can increase in diameter between a
shaft distal end portion, to which the distal end of the deformable
member is secured, and a shaft proximal end portion, thereby
providing a gradual taper to the larger diameter of a treatment
device. The larger inner surface diameter of the proximal end of
the deformable member can be configured to receive or stretch
around a distal end portion of the treatment device. During
advancement within the body vessel or body cavity of interest, the
deformable member bridges a gap between the outer surface of the
tubular shaft and an outer surface of the treatment device. If the
deformable member deforms during insertion, such deformation
advantageously results in further coverage, and prevents roll-up,
of the distal end of the treatment device.
[0090] When the treatment device is positioned as desired within
the body vessel or body cavity of interest, the dilator assembly
can be retracted by pulling on a proximal end portion of the
tubular shaft. During retraction, the distal end portion of the
dilator assembly is slid through a lumen of the treatment device
and, in the process, a proximal end portion of the deformable
member can be inverted onto the reduced-diameter of the shaft
distal end portion. The inverting of the proximal end portion of
the deformable member onto the reduced-diameter portion of the
tubular shaft allows the deformable member and the tubular shaft to
fit through the lumen of the treatment device. Advantageously, the
deformable member can be everted, relative to the tubular shaft,
and reused in a later procedure.
[0091] Among other things, it is believed that the dilator
assembly, including the tubular shaft and the deformable member,
can: (a) reduce axial stress on a body vessel or body cavity and
associated pain or discomfort experienced by a patient, (b) inhibit
involuntary vessel or cavity spasm, (c) protect body vessel and
body cavity walls as a treatment device is introduced into a body
vessel or body cavity, (d) without compromising vessel or cavity
access size, and (e) be easily removed from a patient after the
treatment device reaches a desired location within the body vessel
or body cavity.
[0092] 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 present vascular dilator systems, kits,
and methods can be practiced. These embodiments are also referred
to herein as "examples."
[0093] The above Detailed Description is intended to be
illustrative, and not restrictive. For example, the above-described
examples (or one or more elements thereof) can 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. Also, various features or elements can 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 can lie in
less than all features of a particular disclosed embodiment. Thus,
the following claims are hereby incorporated into the Detailed
Description, with each claim standing on its own as a separate
embodiment. The scope of the present vascular dilator systems,
kits, and methods should be determined with reference to the
appended claims, along with the full scope of equivalents to which
such claims are entitled.
[0094] In this document, the terms "a" or "an" are used 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 "about" and "approximately"
are used to refer to an amount that is nearly, almost, or in the
vicinity of being equal to a stated amount. In this document, the
terms "proximal" and "distal" are used to refer to a system element
location relative to a caregiver user. For example, a proximal
element portion is a portion closer to the user of the system,
whereas a distal element portion is a portion farther away from the
user of the system, such as the portion interacting with a patient
recipient. In this document, the term "patient" is meant to include
mammals, such as for human applications or veterinary
applications.
[0095] In the appended claims, 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
vascular dilator system, kit, or method 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.
[0096] 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.
* * * * *