U.S. patent application number 11/256121 was filed with the patent office on 2006-02-23 for catheter having a funnel-shaped occlusion balloon of uniform thickness and methods of manufacture.
Invention is credited to Rainier Betelia, Hung Van Vo.
Application Number | 20060041228 11/256121 |
Document ID | / |
Family ID | 29999340 |
Filed Date | 2006-02-23 |
United States Patent
Application |
20060041228 |
Kind Code |
A1 |
Vo; Hung Van ; et
al. |
February 23, 2006 |
Catheter having a funnel-shaped occlusion balloon of uniform
thickness and methods of manufacture
Abstract
Methods and apparatus are provided for removing emboli during an
angioplasty, stenting or surgical procedure comprising a catheter
having a funnel-shaped occlusion balloon of uniform thickness
disposed on a distal end of the catheter. The occlusion balloon is
fused to the distal end so that it provides a substantially
seamless flow transition into a working lumen of the catheter.
Additionally, a distal edge of the occlusion balloon is configured
to be in close proximity with an inner wall of a vessel to
facilitate blood flow into the catheter and efficiently remove
emboli.
Inventors: |
Vo; Hung Van; (Sacramento,
CA) ; Betelia; Rainier; (San Jose, CA) |
Correspondence
Address: |
GORE ENTERPRISE HOLDINGS, INC.
551 PAPER MILL ROAD
P. O. BOX 9206
NEWARK
DE
19714-9206
US
|
Family ID: |
29999340 |
Appl. No.: |
11/256121 |
Filed: |
October 21, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10187058 |
Jun 27, 2002 |
6960222 |
|
|
11256121 |
Oct 21, 2005 |
|
|
|
09418727 |
Oct 15, 1999 |
6423032 |
|
|
10187058 |
Jun 27, 2002 |
|
|
|
09333074 |
Jun 14, 1999 |
6206868 |
|
|
09418727 |
Oct 15, 1999 |
|
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PCT/US99/05469 |
Mar 12, 1999 |
|
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09333074 |
Jun 14, 1999 |
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09078263 |
May 13, 1998 |
6413235 |
|
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PCT/US99/05469 |
Mar 12, 1999 |
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Current U.S.
Class: |
604/101.04 ;
606/200 |
Current CPC
Class: |
A61B 17/12045 20130101;
A61M 25/1027 20130101; A61B 17/12109 20130101; A61M 25/1002
20130101; A61B 17/221 20130101; A61B 2017/22067 20130101; A61M
2025/0175 20130101; A61F 2/011 20200501; A61M 25/1029 20130101;
A61B 17/12136 20130101; A61B 17/22 20130101; A61B 2017/2215
20130101; A61B 2217/005 20130101; A61B 17/12 20130101; A61B
2017/00243 20130101; A61B 17/12172 20130101; A61M 25/104 20130101;
A61M 2025/1015 20130101; A61F 2230/0006 20130101; A61M 25/1034
20130101; A61M 2025/1065 20130101; A61M 2025/1031 20130101; A61M
25/10 20130101; A61F 2/014 20200501 |
Class at
Publication: |
604/101.04 ;
606/200 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. Apparatus for removing emboli from a vessel during an
interventional procedure, the apparatus comprising: a catheter
having proximal and distal ends, a working lumen extending
therethrough; and an occlusion balloon having a distal end affixed
to an interior surface of the working lumen and a proximal end
everted to surround, and affixed to, a portion of the catheter
proximal of the distal end of the catheter disposed on the distal
end of the catheter, the occlusion balloon having a contracted
state suitable for insertion into a vessel and a deployed state
configured to occlude antegrade flow in the vessel, wherein the
occlusion balloon comprises a wall having a substantially uniform
thickness along its length, and in the deployed state, provides a
funnel-shaped transition into the working lumen.
2. The apparatus of claim 1 wherein the working lumen has an
interior polymer cover.
3. The apparatus of claim 2 wherein the distal end of the occlusion
balloon is fused to the interior polymer cover.
4. The apparatus of claim 3 wherein the distal end of the occlusion
balloon is adhesively bonded to the interior polymer cover.
5. The apparatus of claim 3 wherein the occlusion balloon further
comprises a distal section situated just proximal of the distal
end, wherein the distal section of the occlusion balloon is fused
to a distalmost end of the interior polymer cover.
6. The apparatus of claim 5 wherein an exterior surface of the
catheter comprises an exterior polymer cover.
7. The apparatus of claim 5 wherein the proximal end of the
occlusion balloon is fused to the exterior polymer cover.
8. The apparatus of claim 7 wherein the proximal end of the
occlusion balloon is affixed to the exterior polymer cover at a
distance between about 10-20 mm proximal of the distal end of the
catheter.
9. The apparatus of claim 7 wherein the proximal end of the
occlusion balloon is adhesively bonded to the exterior polymer
cover.
10. The apparatus of claim 2 further comprising an inflation lumen
disposed within the exterior polymer cover that is in fluid
communication with the occlusion balloon.
11. The apparatus of claim 2 further comprising a radiopaque marker
band disposed at the distal end of the catheter.
12. The apparatus of claim 11 wherein the catheter comprises a wire
braid disposed between the interior polymer cover and the exterior
polymer cover, the apparatus further comprising a radiopaque marker
band disposed between the wire braid and exterior polymer
cover.
13. The apparatus of claim 1 wherein the occlusion balloon further
comprises a proximal taper in the deployed state.
14. The apparatus of claim 1 further comprising a blood outlet port
coupled to the proximal end of the catheter.
15. A method of manufacturing an emboli catheter for use in an
interventional procedure, the method comprising: providing a
catheter having an exterior surface, proximal and distal ends and a
working lumen extending therethrough having an interior surface;
providing an occlusion balloon having first and second ends and a
uniform thickness therebetween; affixing a first end of the
occlusion balloon to the interior surface of the working lumen;
everting the second end of the occlusion balloon over the distal
end of the catheter so that the second end is disposed surrounding
the catheter at a position proximal of the distal end; and affixing
the second end of the occlusion balloon to the exterior surface of
the catheter at the location proximal of the distal end.
16. The method of claim 15 wherein the interior surface of the
working lumen comprises an interior polymer cover, and affixing the
first end of the occlusion balloon to the interior surface of the
working lumen comprises fusing the first end to the interior
polymer cover.
17. The method of claim 15 wherein the interior surface of the
working lumen comprises an interior polymer cover, and affixing the
first end of the occlusion balloon to the interior surface of the
working lumen comprises adhesively bonding the first end to the
interior polymer cover.
18. The method of claim 15 wherein the exterior surface of the
catheter comprises an exterior polymer cover, and affixing the
second end of the occlusion balloon to the exterior surface of the
catheter comprises fusing the second end to the exterior polymer
cover.
19. The method of claim 15 wherein the exterior surface of the
catheter comprises an exterior polymer cover, and affixing the
second end of the occlusion balloon to the exterior surface of the
catheter comprises adhesively bonding the second end to the
exterior polymer cover.
20. The method of claim 15 wherein providing a catheter further
comprises providing a catheter having a radiopaque marker band
disposed on the catheter adjacent to the distal end.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] The present application is divisional application of Ser.
No. 10/187,058 filed Jun. 27, 2002, which is a continuation-in-part
of U.S. patent application Ser. No. 09/418,727, filed Oct. 15,
1999, which is a continuation-in-part of U.S. patent application
Ser. No. 09/333,074, filed Jun. 14, 1999, now U.S. Pat. No.
6,206,868, which is a continuation-in-part of International
Application PCT/US99/05469, filed Mar. 12, 1999, which is a
continuation-in-part of U.S. patent application Ser. No.
09/078,263, filed May 13, 1998.
FIELD OF THE INVENTION
[0002] This invention relates to apparatus and methods for removing
emboli during vascular interventions. More particularly, the
apparatus and methods of the present invention provide a catheter
having an occlusion balloon of uniform thickness that facilitates
retrograde flow and removes emboli from a treatment vessel via a
funnel-shaped taper of the occlusion balloon.
BACKGROUND OF THE INVENTION
[0003] Today there is a growing need to provide controlled access
and vessel management during such procedures as stenting,
atherectomy and angioplasty. Generally during these procedures
there is a high opportunity for the release of embolic material.
The emboli may travel downstream from the occlusion, lodging deep
within the vascular bed and causing ischemia. The resulting
ischemia may pose a serious threat to the health or life of a
patient if the blockage forms in a critical area, such as the
heart, lungs, or brain.
[0004] Several previously known apparatus and methods attempt to
remove emboli formed during endovascular procedures by aspirating
the emboli out of the vessel of interest using a catheter having an
occlusion balloon. These previously known occlusion balloons,
however, have various drawbacks, including variability in
deployment of the balloon to the desired shape, inefficiency in
removing emboli, and/or high cost and complicated processes
associated with manufacturing the balloon.
[0005] In applicant's co-pending U.S. patent application Ser. No.
09/418,727, filed Oct. 15, 1999, which is incorporated herein by
reference in its entirety, applicant describes the use of a bell or
pear-shaped occlusion balloon disposed on the distal end of an
arterial catheter. The occlusion balloon comprises a compliant
material having a variable thickness along its length to provide a
bell-shape when inflated. The balloon is affixed to distal end of
the catheter so that a distal portion of the balloon extends beyond
the distal end of the catheter to provide an atraumatic tip or
bumper for the catheter.
[0006] The balloon of that catheter may be formed using previously
known techniques, such as varying the thickness of the balloon wall
to achieve the preferred bell-shape in the deployed position. Such
processes, however, can lead to variability in the final product
due to the manufacturing process. Because variable thickness
balloons present greater difficulties during manufacture than
balloons having uniform wall thickness, the cost of such balloons
may be higher.
[0007] In view of the foregoing limitations of previously known
devices, it would be desirable to provide an apparatus for removing
emboli from a vessel comprising an occlusion balloon of uniform
thickness to enhance manufacturability of the occlusion
balloon.
[0008] It also would be desirable to provide an apparatus for
removing emboli from a vessel comprising an occlusion balloon of
uniform thickness to reduce manufacturing cost and enhance product
yield.
[0009] It further would be desirable to provide an apparatus for
removing emboli from a vessel comprising a catheter having an
occlusion balloon of uniform thickness that facilitates retrograde
flow and efficiently removes emboli.
SUMMARY OF THE INVENTION
[0010] In view of the foregoing, it is an object of this invention
to provide an apparatus for removing emboli from a vessel
comprising an occlusion balloon of uniform thickness to enhance
manufacturability of the occlusion balloon.
[0011] It also is an object of the present invention to provide an
apparatus for removing emboli from a vessel comprising an occlusion
balloon of uniform thickness to reduce manufacturing cost and
enhance product yield.
[0012] It further is an object of the present invention to provide
an apparatus for removing emboli from a vessel comprising a
catheter having an occlusion balloon of uniform thickness that
facilitates retrograde flow and efficiently removes emboli.
[0013] The foregoing objects of the present invention are
accomplished by providing interventional apparatus comprising a
catheter having proximal and distal ends, a working lumen extending
therethrough and an occlusion balloon having proximal and distal
ends disposed on the distal end of the catheter. The occlusion
balloon has a contracted state suitable for insertion into a vessel
and a deployed state configured to occlude antegrade flow in the
vessel.
[0014] In a preferred embodiment, the catheter comprises an inner
layer covered with a layer of flat stainless steel wire braid and a
polymer cover. A distal section of the occlusion balloon is
melt-bonded to a distalmost end of the inner layer and, optionally,
to a distalmost end of the polymer cover to form a substantially
seamless transition into the working lumen of the catheter. The
proximal end of the occlusion balloon is everted and affixed to the
polymer cover to form an inflation chamber between the polymer
cover and the balloon.
[0015] In the deployed state, the occlusion balloon is configured
to extend distal of the catheter and provides a funnel-shaped
transition into the working lumen of the catheter. A distal edge of
the occlusion balloon is configured to be in close proximity with
an inner wall of a vessel to facilitate retrograde flow into the
working lumen of the catheter and efficiently remove emboli.
Additionally, because the occlusion balloon of the present
invention comprises a uniform thickness, the balloon may be more
reliable, easier to manufacture and more cost-effective than an
occlusion balloon having a variable thickness along its length.
[0016] Preferred methods of making and using the apparatus of the
present invention also are disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Further features of the invention, its nature and various
advantages will be more apparent from the accompanying drawings and
the following detailed description of the preferred embodiments, in
which:
[0018] FIGS. 1A-1B are, respectively, side and sectional views of a
previously known occlusion balloon in contracted and deployed
states;
[0019] FIGS. 2A-2B are, respectively, a schematic view of apparatus
in accordance with the present invention and a cross-sectional view
along line A--A of FIG. 2A;
[0020] FIGS. 3A-3B are side sectional views illustrating a
preferred configuration of the distal end of the catheter of FIG.
2;
[0021] FIGS. 4A-4B are side sectional views of the occlusion
balloon of the present invention in contracted and deployed states,
respectively; and
[0022] FIG. 5 is a schematic view of apparatus of the present
invention being used during an interventional procedure.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] Referring to FIGS. 1A-1B, a bell-shaped occlusion balloon,
as described in applicant's commonly assigned allowed U.S. patent
application Ser. No. 09/418,727, filed May 8, 2001, which is
incorporated herein by reference, is described. Occlusion balloon
20 is shown in contracted and deployed states in FIGS. 1A and 1B,
respectively. Balloon 20 is affixed to distal end 26 of catheter
22, for example, by gluing or a melt-bond, so that opening 27 in
balloon 20 leads into lumen 28 of catheter 22. Balloon 20
preferably is wrapped and heat treated during manufacture so that
distal portion 29 of the balloon extends beyond the distal end of
catheter 22 and provides an atraumatic tip or bumper for the
catheter. In accordance with manufacturing techniques which are
known in the art, occlusion balloon 20 comprises a compliant
material, such as polyurethane, latex or polyisoprene which has
variable thickness along its length to provide a bell-shape when
inflated.
[0024] As described hereinabove, the variable thickness
characteristic of occlusion balloon 20, which is used to deploy the
balloon to the preferred bell-shape, presents certain manufacturing
challenges. In particular, manufacturing a balloon having a
variable wall thickness can lead to reduced yield due to
variability of the manufacturing process. Additionally, a variable
thickness balloon may be difficult to manufacture and may have a
higher cost relative to a balloon having a uniform thickness.
[0025] Referring now to FIG. 2, a first embodiment of apparatus
constructed in accordance with principles of the present invention
is described. Apparatus 40 comprises catheter 41 having proximal
and distal ends and working lumen 58 extending therethrough.
Catheter 41 comprises occlusion balloon 42 having proximal and
distal ends affixed to the distal end of catheter 41, and
preferably comprises radiopaque marker band 65 disposed at the
distal end of catheter 41 to facilitate positioning of the distal
end of the catheter.
[0026] Occlusion balloon 42 comprises a uniform thickness material
having a contracted state suitable for insertion into a vessel and
a deployed state in which occlusion balloon 42 occludes antegrade
flow in the vessel. In the deployed state, occlusion balloon 42
comprises distal taper 66 that is configured to provide a
funnel-shaped transition into working lumen 58 so that blood flows
in a non-turbulent fashion from a treated vessel into catheter 41.
Additionally, distal edge 68 is configured to be in close proximity
with an inner wall of a vessel to facilitate blood flow into
catheter 41 and efficiently remove emboli.
[0027] Catheter 41 preferably comprises inner layer 60 of
low-friction polymeric material, such as polytetrafluoroethylene
("PTFE"), covered with a layer of flat stainless steel wire braid
61 and polymer cover 62 (e.g., polyurethane, polyethylene, or
PEBAX), as shown in FIG. 2B. Working lumen 58 is defined as a lumen
within an interior surface of inner layer 60. Inflation lumen 63
preferably is disposed within polymer cover 62 so that the
inflation lumen does not substantially increase the overall profile
of catheter 41.
[0028] Apparatus 40 preferably further includes proximal hemostatic
port 43, e.g., a Touhy-Borst connector, inflation port 44, and
blood outlet port 48. Inflation port 44 is coupled to inflation
lumen 63, which in turn is coupled to occlusion balloon 42.
Proximal hemostatic port 43 and working lumen 58 of catheter 41 are
sized to permit interventional devices, such as angioplasty balloon
catheters, atherectomy devices and stent delivery systems to be
advanced through the working lumen when a guidewire (not shown) is
positioned within the working lumen.
[0029] Blood outlet port 48, which is in fluid communication with
working lumen 58, may be coupled to an external aspiration device,
e.g., a syringe, to cause blood flow distal of occlusion balloon 42
to flow into working lumen 58. Alternatively, in a preferred
embodiment, blood outlet port 48 may be coupled to a venous return
catheter to form an arterial-venous shunt suitable for providing
retrograde flow in a treatment vessel. This aspiration embodiment
comprising an arterial-venous shunt is described in detail in
applicant's commonly-assigned, above-incorporated U.S. patent
application Ser. No. 09/418,727.
[0030] Referring now to FIG. 3, a preferred configuration of
catheter 41 and a preferred method for affixing occlusion balloon
42 to the distal end of catheter 41 are described. In FIG. 3A, the
distal end of catheter 41 is shown from a side sectional view as
comprising inner layer 60 covered with a layer of flat stainless
steel wire braid 61 and polymer cover 62. Radiopaque marker band 65
preferably is disposed at the distal end of catheter 41 between
wire braid 61 and polymer cover 62, as shown in FIG. 3A. In
accordance with principles of the present invention, occlusion
balloon 42 comprises a uniform thickness along its length, as
illustrated in FIGS. 3A-3B.
[0031] In a preferred method of manufacture, distal end 50 of
occlusion balloon 42 is positioned atop polymer cover 62 near the
distal end of catheter 41 and just distal of opening 70 of polymer
cover 62, as shown in FIG. 3A. Distal end 50 of occlusion balloon
42 then is affixed to polymer cover 62, preferably using a
melt-bond or, alternatively, using a biocompatible glue. At this
time, proximal end 52 of occlusion balloon 42 extends freely beyond
the distal end of catheter 41, as shown in FIG. 3A. For purposes of
clarifying terminology used herein, although proximal end 52 of
occlusion balloon 42 appears situated distal of distal end 50 in
FIG. 3A, this is because proximal end 52 will subsequently be
everted to extend proximal of distal end 50, as described
hereinbelow.
[0032] In a next manufacturing step, distal section 51 of occlusion
balloon 42, which is situated just proximal of distal end 50, is
melt-bonded to at least one polymeric layer of catheter 41.
Specifically, in a preferred embodiment, distal section 51 of
occlusion balloon 42 is melt-bonded to distalmost end 85 of inner
layer 60 and, optionally, to distalmost end 87 of polymer cover 62
to form fusion joint 67, as shown in FIG. 3A. The melt-bonding of
the plurality of polymeric materials at fusion joint 67 provides
substantially seamless transition 72 between occlusion balloon 42
and inner layer 60. Additionally, because fusion joint 67 is formed
from a plurality of compliant polymeric materials, fusion joint 67
is capable of achieving a flexible range of motion.
[0033] Proximal end 52 of occlusion balloon 42 then is everted so
that it extends proximally and radially outward from catheter 41,
as shown in FIGS. 3B and 4A. Proximal end 52 is affixed to polymer
cover 62, preferably using a melt-bond or, alternatively, using a
biocompatible glue, at a distance between about 10-20 mm proximal
of the distal end of catheter 41, as shown in FIG. 4A. This creates
inflation chamber 74 between polymer cover 62 and an interior
surface of balloon 42. Opening 70, which is disposed in a lateral
surface of polymer cover 62, is in fluid communication with
inflation lumen 63 and inflation chamber 74, as shown in FIG. 3B.
Proximal end 52 of occlusion balloon 42 may be stretched while it
being affixed to polymer cover 62 so that apparatus 40 may achieve
a reduced profile in the contracted state.
[0034] The fusion of occlusion balloon 42 to catheter 41 at fusion
joint 67 and subsequent eversion of the balloon creates
substantially seamless transition 72 into working lumen 58, as
shown in FIG. 3B. In accordance with principles of the present
invention, the provision of substantially seamless transition 72
may help reduce flow impedance into working lumen 58 and enhance
flow within a treated vessel.
[0035] Referring now to FIGS. 4A-4B, deployment of apparatus 40
within vessel V of a patient is described. In FIG. 4A, occlusion
balloon 42 is shown in a contracted state suitable for percutaneous
and transluminal insertion into a patient's vessel. Occlusion
balloon 42 is inflated via inflation port 44, inflation lumen 63
and opening 70, and deploys to a predetermined configuration having
proximal taper 64 and distal taper 66, as shown in FIG. 4B. The
predetermined configuration may be determined, for example, using a
pre-molding process in accordance with manufacturing techniques
that are known in the art. In the deployed state, an outer surface
of central section 75, which is formed between proximal and distal
tapers 64 and 66, is substantially flush with an inner wall of
vessel V. As will be understood by those skilled in the art, the
expanded diameter of central section 75 may be sized accordingly
for different vessels.
[0036] Distal edge 68 is defined as a section of occlusion balloon
42 that is formed between central section 75 and distal taper 66.
In the deployed state, distal edge 68 is configured to be in close
proximity with an inner wall of vessel V to facilitate blood flow
into working lumen 58 and efficiently remove emboli.
[0037] Distal taper 66 provides a funnel-shaped flow transition
from distal edge 68 into working lumen 58. Additionally, as
described hereinabove, fusion joint 67 provides substantially
seamless transition 72 from occlusion balloon 42 into working lumen
58 due to the melt-bond between balloon 42 and inner layer 60 of
catheter 41.
[0038] Referring now to FIG. 5, a preferred method for using
apparatus 40 of FIG. 2A during an interventional procedure, such as
balloon angioplasty, is described. In a first step, guidewire 83 is
inserted into a patient's vasculature and a distal end of guidewire
83 is disposed just proximal of stenosis S, which is located in
vessel V. A dilator (not shown) that is disposed within catheter 41
then is inserted over guidewire 83 to advance catheter 41 to a
desired position proximal of stenosis S. When catheter 41 is
properly positioned, e.g., as determined under fluoroscopy using
radiopaque marker band 65, the dilator may be removed. Occlusion
balloon 42 then is inflated via inflation port 44 of FIG. 2A,
preferably using a radiopaque contrast solution, to occlude
antegrade flow in vessel V. Aspiration is provided through working
lumen 58 of catheter 41 to cause retrograde flow to occur in vessel
V distal of occlusion balloon 42, as illustrated by the arrows in
FIG. 5.
[0039] Aspiration may be provided through working lumen 58 via
blood outlet port 48 using an external aspiration device, e.g., a
syringe, or alternatively using a venous return catheter to form an
arterial-venous shunt, as described hereinabove.
[0040] An interventional instrument, such as conventional
angioplasty balloon catheter 80 having balloon 82, may be loaded
through hemostatic port 43 and working lumen 58 and positioned
within stenosis S, preferably via guidewire 83. Hemostatic port 43
is closed and the angioplasty balloon is actuated to disrupt
stenosis S. As seen in FIG. 5, emboli E formed during the
interventional procedure are directed into working lumen 58 via the
retrograde flow established.
[0041] Occlusion balloon 42 provides a substantially uniform
funnel-shaped transition from an inner wall of vessel V into
working lumen 58 of catheter 41. Distal edge 68, which is
configured to be in close proximity with an inner wall of vessel V,
facilitates flow into working lumen 58 and efficiently removes
emboli. Additionally, the funnel-shaped transition provided by
distal taper 66 and substantially seamless transition 72 into the
working lumen via fusion joint 67 improves retrograde flow dynamics
into working lumen 58.
[0042] Advantageously, because the present invention utilizes an
occlusion balloon having a uniform thickness and relies on
pre-molding of the occlusion balloon to obtain the desired deployed
shape, a variable thickness occlusion balloon is not required. As
noted hereinabove, use of an occlusion balloon having a uniform
thickness provides several advantages, including enhanced
manufacture, reduced cost and increased reliability.
[0043] While preferred illustrative embodiments of the invention
are described above, it will be apparent to one skilled in the art
that various changes and modifications may be made. The appended
claims are intended to cover all such changes and modifications
that fall within the true spirit and scope of the invention.
* * * * *