U.S. patent application number 11/189536 was filed with the patent office on 2005-11-24 for balloon occlusion device having a proximal valve.
Invention is credited to Burdulis, Albert JR., Crawford, Lynn D., Edmiston, Daryl, Johnson, Steve, Reynolds, Tim, Schlegel, Karri, Shumer, Dan.
Application Number | 20050261725 11/189536 |
Document ID | / |
Family ID | 22789926 |
Filed Date | 2005-11-24 |
United States Patent
Application |
20050261725 |
Kind Code |
A1 |
Crawford, Lynn D. ; et
al. |
November 24, 2005 |
Balloon occlusion device having a proximal valve
Abstract
A medical device for vessel occlusion, the medical device
including an elongated body having a distal end portion, a proximal
end portion, and a lumen disposed therethrough, an balloon disposed
at the distal end portion of the elongated body, the balloon in
fluid communication with the lumen. An opening defined at the
proximal end portion of the elongated body, the opening being in
fluid communication with the balloon via the lumen, and a valve
body moveably disposed at the proximal end portion of the elongated
body, the valve body movable between a closed position and an open
position, the valve body configured to engage a surface of the
elongated body, distal to the opening, to seal the opening when the
valve body is in the closed position.
Inventors: |
Crawford, Lynn D.; (Irvine,
CA) ; Burdulis, Albert JR.; (San Francisco, CA)
; Reynolds, Tim; (Sunnyvale, CA) ; Shumer,
Dan; (San Jose, CA) ; Edmiston, Daryl; (West
Jordan, UT) ; Johnson, Steve; (West Jordan, UT)
; Schlegel, Karri; (Salt Lake City, UT) |
Correspondence
Address: |
CROMPTON, SEAGER & TUFTE, LLC
1221 NICOLLET AVENUE
SUITE 800
MINNEAPOLIS
MN
55403-2420
US
|
Family ID: |
22789926 |
Appl. No.: |
11/189536 |
Filed: |
July 26, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11189536 |
Jul 26, 2005 |
|
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09882823 |
Jun 15, 2001 |
|
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6923822 |
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60212187 |
Jun 16, 2000 |
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Current U.S.
Class: |
606/194 |
Current CPC
Class: |
A61M 2025/1052 20130101;
A61M 25/104 20130101; A61M 25/10185 20131105; A61M 25/007 20130101;
A61M 25/0069 20130101; A61M 25/0075 20130101; A61M 39/06
20130101 |
Class at
Publication: |
606/194 |
International
Class: |
A61M 029/00 |
Claims
1. A medical device for vessel occlusion, the medical device
comprising: an elongated body having a distal end portion, a
proximal end portion, and a lumen disposed therethrough; an balloon
disposed at the distal end portion of the elongated body, the
balloon in fluid communication with the lumen; an opening defined
at the proximal end portion of the elongated body, the opening
being in fluid communication with the balloon via the lumen; and a
valve body moveably disposed at the porixmal end portion of the
elongated body, the valve body movable between a closed position
and an open position, the valve body configured to engage a surface
of the elongated body, distal to the opening, to seal the opening
when the valve body is in the closed position.
2-20. (canceled)
Description
CLAIM OF PRIORITY
[0001] The present application claims priority under 35 U.S.C.
.sctn. 119 to U.S. Provisional Application Ser. No. 60/212,187
filed on Jun. 16, 2000, entitled "Angioplasty Catheter", the
entirety of which is incorporated by reference herewith.
1. FIELD OF THE INVENTION
[0002] The present invention relates to medical devices,
specifically a medical device having a low profile valve for
selectively inflating and deflating an inflatable balloon disposed
upon the medical device, wherein the valve allows passage of
interventional devices over the medical device during use.
2. BACKGROUND OF THE INVENTION
[0003] In order to perform many vascular procedures a guidewire is
initially inserted into the patient's vasculature. The guidewire is
generally inserted into the patient through an incision created in
the patient's femoral artery. After the guidewire has been placed
within the patient's vasculature, other interventional devices such
as catheters may be passed over the guidewire. As used herein, the
term "interventional device" is intended to include, but not be
limited to, any known device capable of being inserted within the
human vasculature for diagnosis, treatment or inspection thereof.
Additionally the terms "catheter" and "guidewire" as utilized
herein are intended to be interchangeable when referring to the
medical device in accordance with the present invention.
[0004] One difficulty associated with this procedure however is
that the guidewire must be held in place while the interventional
device is passed over the guidewire. It is possible that the
guidewire may become dislodged from the position where it was
initially placed, therefore when a interventional device is
advanced over the guidewire it may not be advanced to the desired
position.
[0005] A common medical procedure where it is desirable to place a
guidewire and then advance interventional devices over the
guidewire are angioplasty and/or bypass procedures. In an
angioplasty procedure, the guidewire may be advanced up to or
through a blockage in a patient's vessel, wherein a catheter
containing a stent or other interventional device is then passed
over the guidewire to the occluded area.
[0006] A common procedure performed on occluded or narrowed vessels
is to place an angioplasty catheter having a balloon disposed on
one end within the occluded region and expanding the balloon,
thereby expanding the vessel. The balloon catheter is typically
formed of a flexible material wherein the catheter includes
radiopaque markings thereon in order to properly place the balloon
within the desired region. The balloon catheter is placed within
the patient's vasculature through a percutaneous access site such
as the femoral artery. The balloon catheter is placed within the
patient's vasculature by tracking the catheter over a guidewire
which has been placed first. The guidewire enables a user to more
easily track the flexible catheter into a proper position, wherein
the balloon may be inflated to expand the vessel and/or occlusion
therein.
[0007] Another commonly utilized cardiovascular procedure is
stenting. Stenting is a procedure wherein a expanding device is
placed within an obstructed vessel in order to hold open or expand
the constricted vessel. Stenting procedures are carried out in a
manner similar to the balloon angioplasty procedure described
above. Many times both procedures will be performed wherein the
vessel may be first expanded with a balloon catheter and
subsequently a stent will be deployed thereafter to maintain the
expanded diameter of the vessel.
[0008] During stenting and/or balloon angioplasty procedures there
is the risk that plaque or other debris may be dislodged from the
inner walls of the vessel. The plaque may be in the form of small
particles which may be carried within the patient's blood stream
and may lead to other complications such as embolism if the
particles become lodged into a branch vessel or artery and restrict
or prevent blood flow to that vessel or artery.
[0009] Therefore it is desirable to provide a device which may be
utilized during a medical procedure such as those described above
wherein the device may be utilized to prevent dislodged particles
from flowing into a patient's blood stream and potentially causing
further blockage or a stroke. It is also desirable to provide a
device which may be utilized to temporarily occlude a vessel distal
an area where a surgical procedure is to be performed thereby
providing a contained area for the surgeon to operate within.
[0010] One such device has been disclosed in U.S. Pat. No.
5,807,330 to Teitelbaum, the entirety of which is incorporated by
reference herewith. However, there remains a desire for an improved
low profile valve for the device of Teitelbaum.
[0011] A further object of the present invention therefore is to
provide a medical device having a low profile valve means disposed
on the proximal end portion, wherein the valve may be selectively
opened and closed thereby enabling the inflation and deflation of a
balloon disposed at the distal end portion of the device.
Furthermore, the valve provides a sufficiently low profile area
wherein other interventional devices may be passed over the medical
device to conduct surgical procedures within the patient's
vasculature.
[0012] A further object of the present invention is to provide an
medical device wherein an balloon disposed upon the distal end
portion of the device may be selectively inflated or deflated
through a valve means wherein the inflation device is removable
from the valve means.
SUMMARY OF THE INVENTION
[0013] In one aspect of the invention there is provided a medical
device for vessel occlusion, the medical device including an
elongated body having a distal end portion, a proximal end portion,
and a lumen disposed therethrough. The medical device further
includes an inflatable balloon disposed at the distal end portion
of the elongated body, the balloon being in fluid communication
with the lumen, and an opening defined at the proximal end portion
of the elongated body, the opening being in fluid communication
with the balloon via the lumen. A valve body is moveably disposed
at the proximal end portion of the elongated body; the valve body
being movable between a closed position and an open position. The
valve body is configured to engage a surface of the elongated body,
distal to the opening, to seal the opening when the valve body is
in the closed position.
[0014] In another aspect of the invention, there is provided a
medical device for vessel occlusion. The medical device includes an
elongated body having a distal end portion, a proximal end portion,
and a lumen disposed therethrough. The medical device further
includes an inflatable balloon disposed at the distal end portion
of the elongated body, the balloon being in fluid communication
with the lumen. An opening is defined at the proximal end portion
of the elongated body, the opening being in fluid communication
with the balloon via the lumen. A valve body is moveably disposed
at the proximal end portion of the elongated body, the valve body
being movable between a closed position and an open position. The
valve body is configured to engage an outer surface of the
elongated body to seal the opening when the valve body is in the
closed position.
[0015] In another aspect of the present invention there is provided
a medical device for vessel occlusion, the medical device including
an elongated body having a distal end portion, a proximal end
portion, and a lumen disposed therethrough. The medical device
further includes an inflatable balloon disposed at the distal end
portion of the elongated body, the inflatable balloon being in
fluid communication with the lumen. An opening is defined at the
proximal end portion of the elongated body, the opening being in
fluid communication with the balloon via the lumen. A valve body is
moveably disposed at the proximal end portion of the elongated
body, the valve body being movable between a closed position and an
open position. The valve body is configured to engage an outer
surface at the proximal end portion of the elongated body, distal
to the opening, to seal the opening when the valve body is in the
closed position. The valve body includes a side wall having a
cavity defined therein to receive the proximal end portion of the
elongated body, and an outer surface substantially flush with an
outer surface of the distal end portion of the elongated body when
in the closed position. At least one of the valve body and the
elongated body has a projection extending therefrom for mating
engagement with the other body to prevent inadvertent movement of
the valve body at least when in the closed position.
DETAILED DESCRIPTION OF THE DRAWINGS
[0016] The objects and advantages of the invention will become
apparent from the following detailed description of preferred
embodiments thereof in connection with the accompanying drawings in
which like numerals designate like elements and in which:
[0017] FIG. 1 is a side view of the medical device according to the
present invention;
[0018] FIG. 2 is a partial cross-sectional side view of one
representative embodiment of the distal tip of the medical device
according to the present invention;
[0019] FIG. 2B is a partial cross-sectional side view of one
representative embodiment of a removable distal tip according to
the present invention;
[0020] FIG. 3 is a partial cross-sectional side view of another
representative embodiment of the distal tip of the medical device
according to the present invention;
[0021] FIG. 4 is a partial cross-sectional side view of yet another
representative embodiment of the distal tip of the medical device
according to the present invention;
[0022] FIG. 5 is a partial cross-sectional side view of still
another representative embodiment of the distal tip of the medical
device according to the present invention;
[0023] FIG. 6 is a partial cross-sectional side view of one
representative embodiment of the proximal end portion of the
medical device according to the present invention;
[0024] FIG. 7 is a partial cross-sectional side view of another
representative embodiment of the proximal end portion of the
medical device according to the present invention;
[0025] FIG. 8 is a partial cross-sectional side view of another
representative alternative embodiment of the proximal end portion
of the medical device according to the present invention;
[0026] FIG. 9 is a cross-sectional side view of a representative
embodiment of a valve body according to the present invention;
[0027] FIG. 10 is a cross-sectional side view of a representative
alternative embodiment of the valve body according to the present
invention;
[0028] FIG. 11 is a partial cross-sectional side view of a
representative embodiment of the proximal end portion of the
medical device according to the present invention illustrating the
valve body disposed thereabout;
[0029] FIG. 12 is a partial cross-sectional side view of the
proximal end portion of the medical device according to the present
invention showing the valve body in an opened position;
[0030] FIG. 13 is a partial cross-sectional side view of an
alternative representative embodiment of the proximal end portion
of the medical device according to the present invention
illustrating the valve body disposed thereabout;
[0031] FIG. 14 is a partial cross-sectional side view of the
alternative embodiment of the proximal end portion of the medical
device according to the present invention showing the valve body in
an opened position;
[0032] FIG. 15 is a partial cross-sectional side view of another
alternative embodiment of the proximal end portion of the medical
device according to the present invention illustrating the valve
body disposed thereabout;
[0033] FIG. 16 is a partial cross-sectional side view of of the
proximal end portion illustrating a plurality of apertures formed
within the wall of the medical device;
[0034] FIG. 17 is a partial cross-sectional side view of of the
proximal end portion illustrating a skive formed within the wall of
the medical device;
[0035] FIG. 18 is a partial cross-sectional side view of an
alternative embodiment of the proximal end portion of the medical
device according to the present invention illustrating a plurality
of elongated slots formed within the wall of the medical
device;
[0036] FIG. 19 is a partial cross-sectional side view of the
alternative embodiment of the proximal end of the medical device
according to the present invention illustrating a skive formed
within the proximal end portion of the medical device;
[0037] FIG. 20 is a partial side view of a representative
alternative embodiment of the proximal end of the medical device
according to the present invention;
[0038] FIG. 21 is a cross-sectional end view of the alternative
embodiment of the proximal end portion of the medical device shown
in FIG. 20;
[0039] FIG. 22 is a cross-sectional end view of the alternative
embodiment of the proximal end portion of the medical device shown
in FIG. 20;
[0040] FIG. 23 is a partial side view of another representative
alternative embodiment of the proximal end portion of the medical
device according to the present invention;
[0041] FIG. 24 is a partial cross-sectional side view of another
representative alternative embodiment of the proximal end portion
of the medical device according to the present invention;
[0042] FIG. 25 is a partial cross-sectional side view of another
representative alternative embodiment of the proximal end portion
of the medical device according to the present invention;
[0043] FIG. 26 is a partial cross-sectional top view of another
representative alternative embodiment of the proximal end portion
of the medical device according to the present invention;
[0044] FIG. 27 is a partial cross-sectional side view an
alternative embodiment of the valve body of the medical device
according to the present invention;
[0045] FIG. 28 is a partial cross-sectional top view of an
alternative embodiment of the medical device according to the
present invention;
[0046] FIG. 29 is a partial cross-sectional side view of the
alternative embodiment of the medical device as shown in FIG.
28;
[0047] FIG. 30 is a cross-sectional end view taken about line A-A
of FIG. 29, of the alternative embodiment of the medical device of
FIG. 29;
[0048] FIG. 31 is a partial side view of the valve body according
to FIG. 28;
[0049] FIG. 32 is a partial cross-sectional side view of the valve
body of FIG. 31 as disposed within the proximal end portion of the
medical device of FIG. 28; and
[0050] FIG. 33 is a partial cross-sectional side view of an
alternative embodiment of the proximal end portion and valve body
in accordance with the present invention.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
[0051] In accordance with the present invention there is shown and
described a medical device for vessel occlusion. The medical device
includes an elongated body having a distal end portion, a proximal
end portion, and a lumen disposed therethrough. A balloon is
disposed at the distal end portion of the elongated body, the
balloon being in fluid communication with the lumen. An opening is
defined at the proximal end portion of the elongated body, the
opening being in fluid communication with the balloon via the
lumen. A valve is disposed at the proximal end portion of the
elongated body, the valve including a valve body movable between a
closed position and an open position. The valve body is configured
to engage a surface of the elongated body, distal to the opening,
to seal the opening when the valve body is in the closed
position.
[0052] Referring now to FIGS. 1, 2, and 11, there is shown a
representative embodiment of a medical device 100 according to the
present invention. The medical device 100 includes an elongated
body 105 having a proximal end portion 104 and a distal end portion
102 and at least one lumen 101 disposed therethrough defining an
inner cavity. An inflatable balloon 120 is disposed proximate the
distal end portion 102, wherein the inner cavity of the balloon 120
is in fluid communication with the lumen 101 of the medical device
100.
[0053] If desired, at least one radiopaque marker 108 may be
disposed at the distal end portion of the elongated body 105
proximate the balloon 120. Preferably, at least one radiopaque
marker 108 is disposed within the distal end of the cavity defined
by the balloon, and if desired, at least one proximal radiopaque
marker 106 is disposed within the proximal end of the cavity
defined by the balloon. The medical device 100 also may include a
flexible tip 160. The flexible tip 160 may extend from the distal
end portion 102 of the medical device 100.
[0054] In accordance with the present invention, the medical device
100 includes at its proximal end portion 104 a valve body 150,
wherein the valve body 150 is movable between a closed position and
an open position; the valve body configured to engage a surface of
the elongated body to seal the opening when the valve body is in
the closed position. The medical device 100 will be described in
greater detail below.
[0055] The elongated body 105 of the medical device 100 may be
constructed of any suitable material including but not limited to
polymide material, alloy materials, and metallic materials such as
stainless steel hypodermic tubing which is available from
MicroGroup.RTM. Inc., Medway, Md. Preferably the elongated body 105
of the medical device 100 is constructed of a nickel titanium alloy
known as Nitinol. Materials such as these are available from
various suppliers such as Memry Corp., Menlo Park, Calif. US. The
above materials should not be considered limiting in any manner, it
is contemplated that the elongated body 105 may be constructed of
any bio-compatible material. For example, the elongated body may be
constructed of a polymer such as polymide tubing from HV
Technologies, Inc. of Trenton, Ga. US. The elongated body 105 may
be manufactured using well known techniques such as swaging,
machining, grinding, electropolishing, EDM, heat forming,
extruding, or by any other processes commonly used to shape and
configure small metal or polymer components. Additionally, the
elongated body 105 may be constructed from polypropylene or
urethane by an extrusion process using an extruder such as that
available from Medical Extrusion Technologies, Inc. Murieta, Calif.
US.
[0056] The elongated body 105 may be further coated with any of a
variety of materials to enhance performance if desired. For example
possible coating materials include lubricious materials such as
Teflon.RTM. available from DuPont De Nemours, Wilmington, Del. US,
and hydrophobic materials such as silicone lubricant dispersion PN
4097, available from Applied Silicone Corp., Ventura, Calif. US, or
a hydrophilic materials such as hydrogel available from Hydromer,
Branchburg, N.J. US, or lubricious coatings such as those available
from Hydro-Silk of Merritt Island, Fla., under the trade name TUA
Systems.
[0057] The elongated body 105 may have any suitable cross-sectional
shape, including elliptical, polygon, or prismatic, although a
circular cross-section generally is preferred. The cross-sectional
dimension generally is between about 0.01 millimeters to about 1.0
millimeters, preferably between about 0.10 millimeters and about
0.50 millimeters, most preferably between about 0.250 millimeters
and about 0.450 millimeters. Furthermore the medical device 100 may
have an overall length between about 180 centimeters and 400
centimeters, preferably between about 250 centimeters and about 350
centimeters, more preferably the medical device has a length
between about 290 centimeters and about 310 centimeters, and most
preferably about 300 centimeters.
[0058] Referring now to FIG. 2 there is shown a partial
cross-sectional side view of the distal end portion 102 of the
medical device 100. As shown in FIG. 2, a flexible tip 160 may
extend from the distal end portion 102 of the elongated body 105. A
variety of distal tip configurations are known an used in the art,
each generally capable of performing particular functions. For
example, and as embodied herein, the flexible tip 160 is
constructed of a solid inner core wire 162 of type 304 stainless
steel, wherein the solid core 162 is wrapped with a bio-compatible
wire 164. Examples of a bio-compatible wire 164 which may be
utilized include stainless steel, Nitinol, Titanium, Platinum,
Iridium, and similar bio-compatible materials. In a preferred
embodiment the bio-compatible wire 164 is platinum wire. Platinum
wire is preferably used because platinum wire is visible under
fluoroscopy thereby enabling a surgeon to locate the flexible tip
160 within a patient's body in use. By utilizing a solid inner core
162 for the flexible tip 160, the distal tip may include a
pre-formed curve 169 as shown in FIG. 2. The pre-formed curve 169
in addition to a blunt tip 167 form an atramatic tip thereby
allowing the medical device 100 to be inserted within a patient's
vasculature. The pre-formed curve 169 ensures that the blunt tip
167 does not pierce the vessel/artery or organ through which the
medical device 100 is being advanced. It shall be understood that
the pre-formed curve 169 remains sufficiently pliable and elastic
whereby an interventional device may be advanced over the outer
diameter of the medical device 100 such that the pre-formed curve
169 will straighten and allow the medical device to pass over. Such
tip designs are well known in the art.
[0059] As shown in FIG. 2, the proximal end 166 of the flexible tip
160 as embodied herein is adapted to be received within the lumen
101 of the medical device 100. The proximal end 166 of the flexible
tip 160 may be secured within the lumen 101 through the use of a
bio-compatible adhesive, such as Locktite.RTM. 4014, or through
mechanical fastening methods such as soldering or a friction fit.
In a preferred embodiment, the distal end portion 102 of the
elongated body 105 is deformed about the diameter of the distal end
166 of the flexible tip 160, thereby forming a fluid tight seal
between the lumen 101 and the flexible tip 160.
[0060] In accordance with another embodiment of the invention,
referring now to FIG. 2B there is shown an alternative embodiment
of the flexible tip 160 as described above. As shown in FIG. 2B,
the flexible tip 160 may be constructed in the same or similar
manner as that described above, wherein like reference numerals
have been utilized to denote similar features. The flexible tip 160
of FIG. 2B further includes a proximal end 166, wherein the
proximal end 166 is adapted to be detachably received within the
lumen 101 of the elongated body 105. In use, it is desirable to
pre-prime the medical device 100, that is to remove as much air as
possible from the lumen 101 as well as the chamber 123 defined by
the balloon 120. Typically this is done by drawing a vacuum within
the lumen 101 and chamber 123 and allowing a bio-compatible fluid
such as saline or contrast to fill the lumen 101 and chamber 123 of
the medical device 100. Although most air is removed from the
system, removal of 100% of the air typically may not be possible.
By constructing the medical device 100 with a removable tip as
shown in FIGS. 2B and 4, a bio-compatible fluid may be flushed
distally through the lumen 101 and the chamber 123 thereby forcing
air out of these spaces. After the air has been forced through the
medical device 100, the flexible tip 160 is attached to the distal
end portion 102 of the elongated body 105, wherein the medical
device 100 is ready for use.
[0061] As previously noted, an inflatable balloon is provided at
the distal end portion of the medical device of the present
invention. The balloon 120 may be constructed of any suitable,
flexible bio-compatible materials depending upon the intended
function of the medical device 100. The balloon may be inelastic,
if desired, although generally elastic materials are preferred.
Examples of materials of which the balloon 120 may be formed are
urethane, polyvinyl chloride, silicone or other similar materials
which have good elastomeric properties. Preferably the balloon 120
is constructed of C-Flex, which is available from Consolidated
Polymer Technologies, Inc. of Largo, Fla., USA. The C-Flex material
allows for the formation of a balloon having very specific
durometers, thereby enabling the balloon to be specifically tuned
to be responsive to a pre-determined force. For example, if a
pressure of one atmosphere or about 14 psi is available to be
applied to a balloon and it is desirable to inflate the balloon
from a first diameter of 0.90 millimeters to a second diameter of
about 6 millimeters, the durometer of the C-Flex may be adjusted
thereby allowing for a balloon to be formed which will expand from
the first diameter to the second desired diameter in response to
the applied force.
[0062] As embodied herein, specifically with reference to FIGS. 1
and 2, the balloon 120 may be radially disposed at the distal end
portion 102 of the elongated body 105, wherein the balloon 120 is
in fluid communication with the lumen 101 of the elongated body 105
through at least one aperture 107 formed within the wall of the
elongated body 105. The aperture 107 may be formed having a
generally cylindrical geometry or the aperture may be formed as an
elongated slit within the wall of the elongated body 105.
Furthermore, it is contemplated that the aperture 107 may be
embodied having many different geometric shapes and the examples
above and those which are shown in the Figures are merely
exemplary.
[0063] Alternatively, the balloon 120 may be disposed
asymmetrically upon only a portion of the outer wall circumference
if desired. Furthermore, if desired, the proximal end of the
balloon 120 may be disposed about the extreme distal end of the
elongated body 105 as shown in FIG. 3, and as further depicted by
U.S. Pat. No. 5,807,330, to George P. Teitelbaum, entitled
"Angioplasty Catheter," the entirety of which is hereby
incorporated by reference.
[0064] As shown in FIG. 3, the distal end 121 of the balloon 120
may be attached to a support member 180, wherein the support member
180 may be disposed within the lumen 101 of the elongated body 105.
The support member 180 may extend beyond the distal end 121 of the
balloon 120, such that the distal end 182 of the support member 180
functions in the manner as described above with reference to the
flexible tip 160. Inflation of the balloon 120 as shown in FIG. 3
is accomplished through the distal end portion 102 and lumen 101 of
the elongated body 105.
[0065] As embodied in FIGS. 4 and 5, the balloon 120 may be
disposed about a balloon support member 140, wherein the balloon
support member 140 is adapted to be received within the lumen 101
of the elongated body 105 as shown, or about the outer surface of
the elongated body 105. The balloon 120 as shown in FIGS. 4 and 5
is similar to that shown and described above with reference to
FIGS. 1-3, wherein like numerals designate similar features. As
shown in FIGS. 4 and 5, the chamber 123 of the balloon is in fluid
communication with the lumen 101 through an aperture 107' formed in
the balloon support member 140, wherein the balloon support member
may be constructed of the same material as that of the elongated
body 105. Alternatively, the balloon support member may be
constructed of any one of the materials described above with
reference to the elongated body 105 and the balloon 120.
[0066] The balloon 120 may be integrally formed onto the elongated
body 105 adjacent to the distal end portion 102 of the elongated
body 105 through dip forming, spray forming, extrusion, heat
forming, or similar manufacturing processes. Preferably the balloon
120 is formed independent of the elongated body 105 by employing
one of or a plurality of the processes above and then fixedly
attached to the elongated body 105. Prior to affixing the balloon
120 to the elongated body 105, any coating applied to the elongated
body 105 in the area where the balloon 120 is to be affixed is
first removed if necessary. The balloon 120 is then positioned
adjacent the distal end portion 102 such that the proximal end 124
and the distal end 122 of the balloon 120 extend beyond the
apertures 107 formed in the elongated body 105. The balloon 120 may
be fixedly attached to the elongated body with a bio-compatible
adhesive such as Loctite.RTM. 4014. Heat shrink tubing 125 may be
disposed about the proximal end 124 and the distal end 122 of the
balloon to further affix the balloon 121 to the elongated body
105.
[0067] As shown in FIGS. 2-5, a distal marker band 108 and a
proximal marker band 106 may be disposed about the distal and
proximal ends of the balloon 120, wherein the marker bands 106/108
may be constructed of a bio-compatible material such as stainless
steel, titanium, silver, platinum, gold, radiopaque plastics, or
similar materials which may be readily viewed under fluoroscopy.
Preferably the marker bands 106/108 are formed of gold. The marker
bands 106/108 may be separate pieces which are fixedly attached to
the diameter of the elongated body utilizing mechanical methods or
adhesives. Preferably, the marker bands are integrally formed upon
the diameter of the elongated body through the use of spray
coating, electroplating or similar methods which will deposit the
marker band material upon the elongated body. It shall be
understood that additional marker bands may be disposed upon the
elongated body 105 at any distance along the distal portion
102.
[0068] A bio-compatible adhesive 112 may be applied to the edges of
the heat shrink tubing 125 as shown in FIGS. 2-5 in order to
provide a smooth transition surface between the heat shrink tubing
125 and the outer diameter of the elongated body 105. An example of
a bio-compatible adhesive which may be utilize is Loctite.RTM.
3311, an ultra-violet cured adhesive.
[0069] It shall be understood that the balloon 120 may be disposed
about the elongated body 105 at any distance along the distal end
portion 102 of the elongated body 105, so long as the balloon is
sealingly disposed in fluid communication with the lumen 101 of the
elongated body 105.
[0070] As previously noted, and in accordance with the present
invention the medical device also has a valve including a valve
body configured to be moveably disposed at the proximal end portion
of the elongated body. The valve body is movable between a closed
position and an open position, wherein the valve body is configured
to engage a surface of the elongated body, to seal the opening when
the valve body is in the closed position.
[0071] The valve body may be configured to be movable in either an
axial or radial direction. In a preferred embodiment, the valve
body can be moved axially between a sealed position and an opened
position, and moved radially to engage or disengage a locking
mechanism disposed upon the proximal end portion of the medical
device.
[0072] The valve body when in a closed position is preferably flush
with the outer diameter of the elongated body 105. By providing
such a low profile valve body, interventional devices may be easily
passed over the medical device. In an alternative embodiment, it is
contemplated that the valve body may have a diameter greater than
that of the elongated body 105, so long as the outer diameter of
the valve body is not so large as to inhibit the passage of
interventional devices thereover.
[0073] Referring now to FIG. 9, there is shown a preferred
embodiment of the valve body 150 in accordance with one aspect of
the present invention. The valve body 150 includes a proximal end
portion 154 and a distal end portion 152, and a cavity 156 formed
therebetween. The distal end portion 152 of the valve body is
adapted to sealingly engage the outer diameter of the elongated
body as shown in FIG. 11.
[0074] The cavity 156 of the valve body 150 may further include a
pliable coating to aid in the sealing of the valve body to the
elongated body 105. The coating may be silicone, urethane, TFE. In
a preferred embodiment the pliable coating is a parylene coating.
The valve body 150 may be constructed of a bio-compatible material
such as titanium, stainless steel, polyurethane, polyvinyl
chloride, Nitinol, or similar materials, wherein the valve body
further has a closed proximal end portion 154, such as a plug 158
disposed within the lumen 151 of the valve body 150. The plug 158
may be formed of the materials listed above. In a preferred
embodiment the plug 158 may be formed of solder, wherein a solder,
such as that described above may be utilized to form the plug
158.
[0075] Referring now to FIG. 10 there is shown another embodiment
of the valve body 150 in accordance with the present invention. The
valve body 150 shown in FIG. 10 may further include a beveled
section 156, wherein the beveled section 156 may be formed at an
angle .beta. between about 0 and about 90 degrees, preferably
between about 30 and about 60 degrees, more preferably the bevel
156 is formed having an angle of about 45 degrees. The bevel 156 is
adapted to receive the step 117, as shown in FIG. 11, wherein the
step may be formed adjacent the proximal end portion 104 of the
elongated body 105, wherein the bevel 156 and step 117 form a fluid
tight seal between the valve body 150 and the elongated body
105.
[0076] In accordance with the present invention, referring now to
FIGS. 6, 9, and 11 there are shown partial cross-sectional side
views of a first representative embodiment of the medical device
100. The proximal end portion 104 of the medical device 100 is
shown in FIGS. 6, 9, and 11. FIGS. 9 and 11 illustrate a first
representative embodiment of the valve body 150, wherein as shown
in FIG. 11, the valve body 150 can be disposed about the proximal
end portion 104 of the elongated body 105. The valve body 150
includes an elongated body having a proximal end portion 154 and a
distal end portion 152, wherein the distal end portion 152 is
adapted to sealingly receive the elongated body 105 of the medical
device 100, and the proximal end portion has a closed or blind end
158. As embodied herein, the valve body 150 therefore is moved
axially between an open position and a closed position as described
in greater detail below.
[0077] The valve body may be constructed of any suitable
bio-compatible material such as titanium, Nitinol, polymide, and
other bio-compatible plastics. In a preferred embodiment the valve
body is constructed of a stainless steel tube, wherein the proximal
end 154 of the tube is sealed with a plug 158. The plug 158 may be
constructed of a bio-compatible material such as titanium, Nitinol,
stainless steel, nylon, delrin, and other similar materials. In a
preferred embodiment the plug 158 is constructed of solder
available from Kester of Des Plains, Ill., wherein the solder is
preferably lead-free. It is further contemplated that the valve
body may be constructed of a unitary body wherein the valve body
may be injection molded and being constructed of plastics or
metals.
[0078] The valve body 150 defines a cavity 151 therein to receive
the outer diameter of the elongated body 105. If cylindrical in
shape, the valve body may have an inner diameter between about 0.10
millimeters and about 2.0 millimeters, preferably between about
0.25 millimeters and about 1.0 millimeters and most preferably
between about 0.300 millimeters and about 0.500 millimeters. The
valve body further has a wall thickness between about 0.001
millimeters and about 0.10 millimeters, preferably between about
0.025 millimeters and about 0.05 millimeters, most preferably
between about. 0.03 millimeters and about 0.04 millimeters.
[0079] In accordance with the present invention, the elongated body
105 of the medical device may include a reduced cross-sectional
dimension at the proximal end portion 104 to enhance sealing
properties and to create a low profile valve configuration, as
shown in FIGS. 6 and 11. For example, with a circular
cross-sectional profile, a step 117 provides a transition between
the reduced diameter area 115 and the diameter of the elongated
body 105. The step 117 may be formed by grinding, molding, swaging,
extruding, or other known techniques, and may be configured at any
of a variety of angles, although the preferred angle .alpha. is
between about 0 and about 90 degrees, preferably between about 30
and about 60 degrees and more preferably the angle is about 45
degrees. In this manner, the outer surface of the valve body is
substantially flush with the outer surface of the elongated body
105 distal to the step 117. It is further contemplated that the
step 117 may be formed having a convex or concave radius (not
shown). That is instead of being formed as a linear transition
between the two diameters, the step 117 may form a gradual radius
between the two diameters, the gradual radius embodied as either
convex, concave or a combination thereof.
[0080] If desired, the proximal end portion 104 of the elongated
body 105 may have a closed or blind end, such as by providing a
plug 103 disposed to seal the lumen 101 as shown in FIG. 6. The
plug may be constructed of a bio-compatible material such as
titanium, stainless steel, Nitinol, delrin, nylon, or similar
materials. The plug 103 embodied herein is affixed within the lumen
101 of the elongated body with a bio-compatible adhesive which will
adhere to the plug 103 and the inner wall of the lumen 101. In a
preferred embodiment, the plug 103 is formed of solder such as that
described above with regard to the valve body 150. Alternatively,
the plug 103 is not necessary because the distal end 152 of the
valve body 150 sealingly contacts the outer diameter of the
elongated body 105 thereby creating hemostasis within the medical
device 100. It shall be understood that if the plug 103 is not
disposed within the lumen 101 of the elongated body 105, the valve
body 150 must include the plug 158 in order to form a fluid tight
seal within the elongated body 105.
[0081] Referring now to FIGS. 11 and 12 there is shown the medical
device 100 in accordance with one aspect of the present invention
in use. As shown in FIG. 11, the valve body 150 is disposed upon
the proximal end portion 104 of the elongated body 105, wherein the
valve body is in a closed position. The distal end 152 of the valve
body forms a fluid tight seal with the step 117 of the elongated
body 105. The fluid tight seal may be formed through an
interference fit between the distal tip 152 of the valve body and
the step 117 or altertnatively, as described herein the inner
diameter of the valve body may include a parylene coating for
enhanced sealing properties. Referring now to FIG. 12 there is
shown the valve body 150 in an open configuration. Wherein, when
the valve body 150 is in an open configuration, inflation fluid may
be introduced into the lumen 101 of the elongated body 105 thereby
inflating the balloon 120 of the distal tip portion 102. Inflation
fluid may be introduced in a manner such as that disclosed by
Teitlebaum, U.S. Pat. No. 5,807,330. Alternatively, inflation fluid
may be withdrawn from the lumen 101, thereby deflating the balloon
120. As shown in FIGS. 11 and 12, the valve body 150 may be
selectively opened and closed in order to control the inflation and
deflation of the balloon 120. To move the valve body between an
opened and closed position as shown an axial force or a radial
force or a combination thereof may be applied to either or both the
valve body 150 or the elongated body 105. Additionally, the valve
body 150 only need be moved between about 0.005 inches and about
1.0 inches, preferably between about 0.02 inches and about 0.75
inches, most preferably between about 0.05 inches and about 0.25
inches.
[0082] Another alternative embodiment in accordance with the
present invention is illustrated in FIG. 33, wherein there is shown
a medical device 100 having a valve body 150 disposed upon the
proximal end portion 104 of the elongated body, wherein the plug
158' of the valve body forms a fluid tight seal with the very
proximal end 137 of the elongated body 105. The plug 158' may
further include a pliable coating as those described above in order
to effectuate a better seal with the proximal end 137 of the
elongated body 105. Furthermore, frictional interference between
the chamber 156 of the valve body and the outer diameter of the
elongated body 150 act to retain the valve body 150 upon the
proximal end portion 104 of the elongated body 105. It shall be
understood that the medical device 100 embodied and described with
reference to FIG. 33 may be adapted to include any other feature
described herein in relation to other embodiments of the medical
device 100.
[0083] Referring now to FIGS. 7, 13-14, 18, and 19 there is shown
an alternative representative embodiment of the reduced diameter
area according to the present invention. As shown in FIGS. 7,
13-14, 18, and 19, the reduced diameter area may include a
plurality of steps, wherein the first step 117 transitions the
outer diameter of the elongated body 105 to a first reduced
diameter section 115 as described above. A second step 118 may be
disposed proximal to the first step 117, wherein the second step
118 provides a transition between the first reduced diameter
portion 115 and a second reduced diameter portion 116.
[0084] The second step 118 may be formed at an angle between about
0 and about 90 degrees, preferably between about 30 and about 60
degrees, more preferably between about 40 and about 50 degrees.
[0085] As shown in FIGS. 13 and 14, the second step 118 can provide
improved inflation and deflation of the balloon when the valve
sleeve 150 is moved proximally into an opened position. This is
because, as the valve body is moved from a closed position to an
opened position, the valve body 150 does not have to be moved past
the openings 113 formed in the wall of the elongated body 105. That
is, once the distal end 152 of the valve body 150 passes proximal
the second step 118 as shown in FIG. 14, a fluid flow path is
formed between the second reduced diameter portion and the cavity
151 of the valve body 150. Indeed, by providing such a flow path,
the extreme proximal end of the elongated body as shown in FIGS. 13
and 14, can be used to define an opening for inflation of the
balloon such that additional openings need not be provided in the
wall of the elongated body 105.
[0086] Referring now to FIGS. 8 and 15 there is shown yet another
alternative embodiment of the proximal end portion 104 of the
medical device 100 in accordance with the present invention. As
shown in FIGS. 8 and 15, the proximal end portion 104 of the
medical device 100 may include tapered section 515, which can be
formed by known techniques, such as grinding, milling, EDM, laser
cutting, or swagging. The embodiment herein defines a constant
angle of between about 0 and about 45 degrees, preferably between
about 0 and about 10 degrees, more preferably between about 0.5 and
about 3 degrees. As shown in FIG. 15 a valve body 150 is disposed
about the tapered section 515, wherein the distal end 152 of the
valve body contacts the outer surface of the elongated body 105
thereby sealing the openings 113 when in a closed position. The
valve body 150 may be moved axially, whereby an annular space is
created about the distal end 152 of the valve body 150 and the
tapering outer diameter of the elongated body 105, thereby allowing
for fluid to flow from the annular space into the lumen 101 and the
chamber 123 of the balloon.
[0087] In accordance with the present invention an opening is
provided at the proximal end portion 104 of the elongated body 105,
the opening being in fluid communication with the balloon 120 via
the lumen 101 of the elongated body 105, wherein the opening may be
embodied in a variety of configurations. As previously noted, the
opening may be defined as the extreme proximal end of the elongated
body. Alternatively, and as embodied herein, the opening may
include at least one opening 113 disposed through the wall of the
elongated body 105 at the proximal end portion 104 thereof.
Preferably, and when the proximal end portion 104 is provided with
an area of reduced cross-section, the opening is located within the
reduced diameter area 115 of the proximal end portion 104 of the
elongated body 105.
[0088] In accordance with the present invention, the opening 113
may be formed in a variety of manners, some of which are
illustrated in FIGS. 6-8, and 11-32. As shown in FIGS. 6-8 and
11-32, a plurality of openings may be formed through the wall of
the reduced diameter sections 115 and 116, wherein the openings are
disposed along the proximal end portion 104 of the elongated body
105. The openings 113 may be formed within the wall of the
elongated body utilizing manufacturing processes such as laser
drilling, EDM, drilling, milling, electrochemical milling, and
other similar procedures that will produce an opening through the
wall of the elongated body 105.
[0089] Referring now to FIGS. 16 and 18, there is shown a first
alternative embodiment of the opening 213 in accordance with the
present invention, wherein like numerals denote similar features as
described above with reference to the medical device 100 of the
present invention. The opening 213 may be embodied in the form of
at least one axially extending slit formed within the wall of the
reduced diameter portion 115 or second reduced diameter portion
116.
[0090] Referring now to FIGS. 17, 19, and 29 there is shown a
second alternative embodiment of the opening 313 in accordance with
the present invention. The opening 313 may be embodied as a skive
within the wall of the reduce diameter portion 115 or second
reduced diameter portion 116. The skive may be formed within the
wall of the elongated body 105 by passing a grinding wheel over the
portion of the elongated body where the skive 313 is to be
formed.
[0091] In accordance with the invention, there are provided
additional alternative embodiments in accordance with the medical
device of the present invention. As previously discussed, the
medical device includes a proximal end portion and a valve body
disposed thereon, wherein the valve body is movable between an open
position and a closed position, in a closed position the valve body
sealingly engages the outer wall of the elongated body. In an open
position the valve body allows for the inflation or deflation of
the balloon as previously discussed.
[0092] Referring now to FIG. 24, the elongated body 105 and the
valve body 450 includes each of the elements described above and
illustrated in FIG. 11. Additionally, the elongated body 105
includes a slot 413 formed within the wall of the elongated body
105 wherein the slot 413 is axially aligned with the elongated body
105. The slot 413 may be formed partially into the outer wall, such
as by a groove or dimple, or extend entirely through the wall of
the elongated body 105 as an opening. The valve body 450 is
disposed about the proximal end portion 104 of the elongated body
105 in the manner as described above. The valve body 450 may
further include a protrusion 455 extending into the cavity 456 of
the valve body. The protrusion 455 is slidably received within the
slot 413 of the elongated body 105. The protrusion 455 therefore
may retain the valve body 450 upon the proximal end 104 of the
elongated body 105, and limit the proximal movement of the valve
body. The protrusion 455 also may further provide tactile feedback
to a user indicating whether the valve body is in an opened or
closed configuration. The protrusion may be formed as a separate
body attached to the valve body 450, or the protrusion may be
formed integral with the valve body 450. Alternatively, the reduced
diameter section may include a protrusion, either integrally formed
therewith or fixedly attached thereto and the valve body may
include a slot or groove adapted to receive the protrusion of the
reduced diameter section.
[0093] Referring now to FIGS. 20-22, there is shown an alternative
embodiment of the valve body 550 and reduced diameter portion 515.
The reduced diameter portion 515 further includes a groove 519,
formed in the wall of the elongated body 105. The groove 519 may be
formed in the wall of the elongated body by machining, grinding,
EDM milling, or similar manufacturing processes. Alternatively, the
groove 519 may be formed by deforming the wall of the elongated
body as shown in FIG. 30. The valve body 550 includes a pin 555 or
similar protrusion extending into the cavity 556. When the valve
body 550 is disposed about the reduce diameter portion 515, the pin
555 is received within the groove 519, wherein the groove 519
guides the pin 555 during translation of the valve body 550 between
an opened position and a closed position. The groove 519 may be
axially aligned with the lumen 101 of the elongated body 105 as
shown in FIGS. 20-22, or extend helically to induce rotational
movement of the valve body during displacement. Alternatively, the
groove 519' may be both axially and radially aligned with the lumen
101 of the elongated body 105 as shown in FIG. 23. By having a
groove 519' that is both axially and radially aligned requires that
the valve body 550 be rotationally translated first and then
axially translated in order to open the seal between the valve body
and the elongated body. This greatly reduces or eliminates the
possibility of the valve body 550 from being accidentally
opened.
[0094] Referring now to FIGS. 25-27 there is shown another
alternative embodiment in accordance with the medical device of the
present invention. Referring now to FIG. 25 there is shown a
partial cross-sectional side view of an alternative embodiment of
the proximal end portion 904 of an elongated body 905, wherein the
proximal end portion 904 further includes a pin 990 disposed
axially through the walls and lumen 901 of the proximal end portion
904. Better understanding of the location of the pin 990 may be
understood with reference to the cross-sectional top view of FIG.
26 illustrating the pin 990 being disposed through the proximal end
portion 904 of the elongated body 905 perpendicular to the top
view. Referring now to FIG. 27, there is shown a corresponding
embodiment of a valve body 950, wherein the valve body 950 includes
a track 930. The track provides a guide for positioning the valve
body 950 when the groove 930 engages the pin 990. A step 917 forms
a tapered portion on the proximal end of the valve body 950,
wherein then the valve body 990 is inserted within the lumen 901 of
the elongated body 905 the tapered portion engages the inner
diameter of the proximal end portion of the elongated body
therefore forming a fluid tight seal. In order to effectuate a seal
between the tapered portion of the valve body 950 and the lumen 901
of the proximal end portion 904 of the elongated body 905 involves
two movements, one axial movement and a second rotational force.
The second rotational force requires that a deliberate action on
the part of an operator to disengage the seal once the seal has
been formed. The second action of the rotational force also makes
it more difficult for the operator to inadvertently open the port
by merely pulling axially on the valve body 950. Alternatively, the
pin 990 can extend beyond the outer surface of the elongated body,
and the valve body can be configured to be disposed about the
outside of the proximal end portion of the elongated body with the
groove being formed on an inside surface of the valve body.
[0095] The track 930 may be formed within the outer surface of the
valve body 950 utilizing any of the processes as described
above.
[0096] Referring now to FIGS. 28-32, there is shown an additional
alternative embodiment in accordance with the present invention.
Referring to FIG. 28 there is shown partial cross-sectional top
view of a medical device 800, wherein the medical device 800
includes an elongated body 805 having a distal portion (not shown)
and a proximal end portion 804, wherein the proximal end portion
804 includes at least one groove formed therein as shown in FIG.
30. The medical device 800 further includes an opening 815 disposed
adjacent to the proximal end portion 804 of the elongated body 805.
As shown in FIG. 29, the opening 815 may be formed as a skive.
Although the opening 815 is shown to be embodied as a skive this
should not be considered limiting in any manner, it is contemplated
that any of the openings described herein may be utilized in
addition to or as an alternative to the skive. The skive 815 may be
formed utilizing any of the methods described above.
[0097] Referring now to FIG. 31 there is shown a valve body 850,
wherein the valve body includes a proximal end portion 854 and a
distal end portion 852 and a tapered portion 817 disposed
therebetween.
[0098] As shown in FIGS. 28 and 32, the valve body 850 is disposed
proximally within the lumen 801 of the medical device 800 when in
the opened position, To close the medical device, the valve body
850 is advanced distally within the lumen 801 of the elongated body
805 until the tapered section 817 passes the distal portion of the
opening 815 and engages the inner surface of the proximal end
portion of the elongated member. If desired, a groove and
protrusion configuration also can be provided. In this manner, the
valve body 850 is then rotated to lock the valve body 850 into
place. Therefore, as described above with regard to FIGS. 25-27 the
valve body cannot be inadvertently removed from the inner lumen 801
of the elongated body 805 without first applying a rotational force
to the valve body 850.
[0099] The alternative embodiments of the medical device 900 and
800 illustrated in FIGS. 25-32 may be constructed according to the
aspects and methods described above wherein the same materials may
also be utilized. In addition, the valve bodies 950 and 850 may
further include a coating such as that described above with regard
to FIGS. 9 and 10 and the valve body 150 disclosed therein to
effectuate a better seal upon the medical device 900 and 800.
[0100] The groove 830 formed within the proximal end portion 804 of
the elongated body 805 may be formed utilizing any of the methods
described above with reference to the medical device 100.
Preferably the groove 830 is formed within the side wall of the
elongated body through a crimping or dimpling process.
[0101] The medical device 100 descried and illustrated herein may
be utilized in vascular interventional procedures such as
angioplasty or stenting. In such procedures, an access site to the
patient's vasculature is formed, typically within the patient's
femoral artery. The patient is systematically heparinized during
the procedure. Via the femoral artery approach, a long 9-French
access sheath is inserted through the common femoral artery and is
advanced into a desired position. Once access has been established,
the medical device 100 is inserted into the patient's
vasculature.
[0102] Through the use of fluoroscopy and the soft steerable
flexible tip 160 of the medical device 100, the medical device 100
is placed adjacent a site in which a medical procedure is to be
performed. Placement of the medical device 100 can be confirmed by
fluoroscopy confirmation of the plurality of marker bands 108/106
disposed upon the distal end portion 102 of the medical device 100.
The balloon 120 may then be inflated by opening the valve body 150,
wherein inflation fluid may be introduced through the openings 113
in the proximal end portion of the medical device 100, such as
described by Teitelbaum, U.S. Pat. No. 5,807,330. After the balloon
120 is inflated to a sufficient diameter, the valve body 150 may be
moved into a closed position thereby forming a fluid tight seal.
The balloon 120 remains inflated, while the source of inflation
fluid may then be removed from the proximal end portion 104 of the
medical device 100. An example of a device which may be utilized to
introduce inflation fluid is a Tuohy-Borst device, wherein the
Tuohy-Borst device may be removed from the medical device 100 as
desired. Alternatively, a removable inflator box may be provided,
which is capable of creating a sealed chamber about the proximal
end portion of the elongated member, and allowing selective
movement of the valve body between the open and closed positions as
known in the art. Examples of inflation fluid which may be utilized
are saline or carbon dioxide, preferably contrast fluid is utilized
as the inflation fluid thereby enabling visualization of the
balloon 120 under fluoroscopy.
[0103] At this point a balloon angioplasty catheter may be inserted
over the medical device 100, wherein the balloon 120 acts to anchor
the medical device 100 within the patient's vasculature as well as
to occlude the vessel. If desired, the medical device 100 may be
utilized to pre-dilate the stenosis within the vessel is the
appropriate balloon construction is provided. Alternatively, an
angioplasty balloon catheter, and/or a stent delivery device and/or
other known interventional devices may be advanced over the medical
device 100 to the site to perform a desired procedure as is known
in the art. Debris thus created by the interventional device during
an interventional procedure can be removed through an aspiration
catheter which may be advanced over the medical device 100 as
described below.
[0104] Following the interventional procedure, the interventional
device is removed from the medical device 100 and an aspiration
catheter may be advanced over the medical device 100 to a position
near the site. Vigorous flushing of the site may be performed by
injecting a large volume of saline into the site. Alternatively or
additionally, debris may be removed distal the lesion through a
lumen of an aspiration catheter by selectively positioning the
aspiration catheter within the site.
[0105] After debris has been removed from the site and the
aspiration catheter is removed from the medical device 100, the
valve body 150 is moved from a closed position to an open position
wherein the inflation fluid may be removed, thereby deflating the
balloon 120 of the medical device 100. At this time the medical
device 100 may be withdrawn from the patient's vasculature.
Alternatively, the medical device 100 may remain as positioned,
wherein additional interventional procedures may be performed at
the site, wherein the site may be aspirated as described following
any interventional procedure. The medical device 100 may remain as
positioned as long as there is a need to perform additional
interventional procedures.
[0106] Although the present invention has been described in
considerable detail with reference to certain preferred
embodiments, it is contemplated that one skilled in the art may
make modifications to the device herein without departing from the
scope of the invention. Therefore, the scope of the amended claims
should not be considered limited to the embodiments described
herein.
* * * * *