Note: Descriptions are shown in the official language in which they were submitted.
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DEVICE FOR INJECTING FLUID INTO A WALL OF A BLOOD VESSEL
This is a continuation-in-part patent application of co-pending U.S.
Patent Application Serial No. 08/541,526, filed on October 10, 1995 and
entitled "Catheter With Fluid Medication Injectors" which is a continuation-in-
part of patent application of co-pending U.S. Patent Application Serial No.
08/500,121, filed on July 10, 1995, and entitled "Catheter for injecting Fluid
Medication Into an Arterial Wall." This is also a continuation-in-part patent
application of co-pending U.S. Patent Application Serial No. 08/584,310, filed
on January 11, 1996 and entitled "Catheter With Fluid Medication Injectors."
The contents of the applications identified in this paragraph, are
incorporated
herein by reference.
FIELD OF THE INVENTION
The present invention pertains generally to medical devices useful for
injecting fluid into a patient. More specifically, the present invention
pertains
to medical devices inserted into a vessel of a patient's cardiovascular system
which are useful for injecting fluid directly into a vessel wall.
BACKGROUND
It is well known that fluid can be infused directly into wall of a blood
vessel to treat some ailments. For example, medicaments can be
administered into an arterial wall to inhibit or prevent the restenosis of
plaque
in the artery.
Due to the toxic nature of some fluids, the procedure must insure that
only minimal amounts of medication are washed away into the blood stream
and not actually infused into the vessel wall. Thus, the device for
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administering the fluid into the arterial wall must be easy to use, accurate
and
reliable.
Several devices have been suggested for the purpose of infusing fluid
directly into a vessel wall. For example, a device for medicating a vessel
wall
is disclosed in U.S. Patent Nos. 5,112,305 and 5,242,397 which issued to
Barath et al. Specifically, the device disclosed in the Barath et al. patents
employs a balloon which initial is slowly filled with a medicament to expand
the balloon and position the balloon's surface against the vessel wall.
Subsequently, the balloon is rapidly filled. The rapid filling of the battoon
reconfigures tubular extensions on the surface of the balloon for insertion
into
the vessel wall and infusion of medicaments through the tubular extensions.
However, this device has proved not to be entirely satisfactory.
Specifically, with this device, the mechanism for infusing a fluid into a
vessel
wall is not independent and separately operable from the mechanisms which
position the device in the artery and which cause penetration into the vessel
wall. Further, this device does have the capability of selectively applying a
variable force to the fluid injectors of the device as they penetrate into the
vessel wall.
In light of the above, it is an object of the present invention to provide a
device for injecting fluid into a wall of a vessel having a mechanism for
penetrating the vessel wall that is separate from the mechanism which injects
the fluid into the vessel wall. It is another object of the present invention
to
provide a device for injecting fluid into the wall of a vessel which can
selectively vary the force that is used to penetrate the vessel wall. Still
another object of the present invention is to provide a device for injecting
fluid
into the wall of a vessel which is easy to use, and relatively simple and
inexpensive to manufacture. Yet another object of the present invention is to
provide a device for injecting radioactive isotopes into a wall of a vessel.
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SUMMARY OF THE INVENTION
In accordance with the present invention, a device for injecting a fluid
from a fluid source into a treatment area of a wall of a vessel includes an
expander and one or more injectors. Preferably, the device includes a
plurality of injectors for distributing the fluid into a larger treatment
area.
In a first version of the present invention, the expander includes a
balloon which is expandable from a contracted, first configuration to an
expanded second configuration. The injectors extend radially from the
balloon and move radially with the balloon between the first configuration and
the second configuration. The injectors penetrate the treatment area and
selectively release the fluid when the balloon is at the second configuration.
Further, the balloon can simultaneously dilate the vessel when the balloon is
in its second configuration.
As provided below, an inflator selectively controls the expansion of the
balloon and the fluid source selectively provides a pressurized supply of
fluid
to the injectors. Thus, the mechanism which causes the injectors to penetrate
the vessel wall is separate from the mechanism which releases the fluid into
the vessel wall.
At least one fluid passageway connects the fluid source in fluid
communication with the injectors. For example, the fluid passageway can
include a flexible tubular sleeve which substantially encompasses and
encloses at least a portion of an outer surface of the balloon. The tubular
sleeve cooperates with the outer surface of the balloon to form a portion of
the fluid passageway. In this embodiment of the fluid passageway, a distal
end of the tubular sleeve attaches directly to the outer surface of the
balloon
and an open proximal end of the sleeve extends proximally from the balloon
for connection with the fluid source.
Each injector can be a substantially tubular protrusion having an
attachment end and an open cutting edge. The attachment end includes a
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base plate which mounts directly onto the tubular sleeve. In an alternate
embodiment of the injectors, a plurality of tubular protrusions can be mounted
onto the same base plate.
Each tubular protrusion includes a fluid channel through the injector
which is placed in fluid communication with the fluid passageway. To
establish a fluid path from the fluid source to the fluid channel, the base
plate
of the injector can be mounted onto the tubular sleeve over holes that may
either be preformed into the tubular sleeve or formed into the tubular sleeve
after the injectors have been attached to the tubular sleeve.
As intended for the present invention, the inflator can be directly
connected to a lumen of a catheter. The catheter lumen, in turn, is in fluid
communication with an interior of the balloon to inflate and deflate the
balloon
between the first and second configurations.
The fluid source includes a fluid pump which is in fluid communication
with the fluid passageway for selectively providing a pressurized supply of
fluid from the fluid source to the injectors.
The invention is also a method for expanding the treatment area and
delivering fluid from the fluid source to the treatment area. The method
includes advancing the balloon in the vessel while the balloon at its first
configuration, expanding the balloon to its second configuration and
selectively releasing the fluid from the injector into the treatment area.
Basically, the balloon is advanced in the vessel until the balloon is
positioned
substantially adjacent the treatment area. Subsequently, the balloon is
expanded to its second configuration. The expansion of the balloon causes
the cutting edge of at least one injector which moves with the balloon to
penetrate the treatment area. The expansion of the balloon can also cause
simultaneous dilation of the vessel.
Depending upon the fluid and the desired treatment, the fluid can be
released substantially simultaneously with the cutting edge penetrating the
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treatment area or there can be a time delay between the cutting edge
penetrating the treatment area and the release of the fluid from the
injectors.
In a second version of the present invention, the expander includes a
multi-lumen catheter and a grommet. The catheter and the grommet are both
disposed about the same longifudinal axis with the grommet separated distally
from the distal end of the multi-lumen catheter. Importantly, the grommet is
movable in translation along the longitudinal axis to allow separation between
the
grommet and the multi-lumen catheter to either increase or decrease.
The second version includes a plurality of hollow, flexible, tubes which are
each formed with a lumen and which each have a distal end, a central region,
and a proximal end. The distal end of each of the tubes is attached to the
grommet. The proximal end of each of the tubes is attached to the catheter.
The
attachment between the tubes and the catheter, as well as the attachment
between the tubes and the grommet, arranges the plurality of tubes radially
around the catheter. In this arrangement, the attachment between the multi-
lumen catheter and the plurality of tubes is such that the lumen of each tube
is
connected in fluid communication with a respective lumen of the multi-lumen
catheter. As a result, fluid may be supplied under pressure to pass through
the
multi-lumen catheter and into the plurality of tubes. In general, each tube is
connected to an individual lumen within the catheter. Alternatively, the
plurality
of tubes may be connected singly, or in combination, to one or more common
lumens within the multi-lumen catheter.
In the second version of the expander, the plurality of injectors are
attached to the central region of each flexible tube and project radially
outward
from the longitudinal axis. The fluid is passed through the multi-lumen
catheter,
the lumens of the flexible tubes and out of the injectors.
For the second version, a push-pull wire is connected to the grommet and
passed through one of the lumens of the multi-lumen catheter. The insertion of
the push-pull wire through the multi-lumen catheter allows the push-pull wire
to
be moved translationally along the longitudinal axis of the present invention.
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Furthermore, the translational movement of the push-pull wire causes the
grommet to move translationally with respect to the multi-lumen catheter. In
this
fashion, the push-pull wire may be used to increase, or decrease, the
separation
between the grommet and the multi-lumen catheter.
As provided in detail below, as the separation between the grommet and
the multi-lumen catheter decreases, each of the flexible tubes arches, or
bows,
outwardly, from the longitudinal axis, giving the device an expanded
configuration. Alternatively, as the push-pull wire is advanced to increase
the
separation between the grommet and the multi-lumen catheter, each of the
flexible tubes straightens, or flattens, giving the device a contracted
configuration.
It is important to recognize that a device in accordance with the
present invention utilizes a mechanism which causes the injectors to
penetrate the vessel wall that is separate from the mechanism which releases
the fluid into the vessel wall. Further, the device can vary the force that is
used to penetrate the vessel wall and can simultaneously dilate the vessel
wall. Additionally, the present invention is particularly useful for injecting
radioactive isotopes directly into the vessel wall.
BRIEF DESCRIPTION OF THE DRAWINGS
The novel features of this invention, as well as the invention itself, both
as to its structure and its operation will be best understood from the
accompanying drawings, taken in conjunction with the accompanying
description, in which:
Figure 1 is a perspective view of a patient with a device having
features of the present invention positioned in an artery of the patient;
Figure 2 is a perspective view of a device having features of the
present invention;
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Figure 3 is a cross-sectional view of the device of Figure 2 taken on
line 3-3 in Figure 2 positioned in an artery of a patient;
Figure 4A is a perspective view of an embodiment for an injector
having features of the present invention;
Figure 4B is a perspective view of another embodiment for an injector
having features of the present invention;
Figure 5A is a perspective view of an embodiment of a plurality of
injectors having features of the present invention;
Figure 5B is a perspective view of another embodiment of a plurality
injector of the present invention;
Figure 6 is a perspective view of another embodiment of a device
having features of the present invention; and
Figure 7 is a cross-sectional view taken on line 7-7 of Figure 6.
Figure 8 is a perspective view of yet another embodiment of a device
having features of the present invention;
Figure 9 is a cross-sectional view of the device of Figure 8 shown in a
retracted configuration, as seen along line 9-9 in Figure 8;
Figure 10 is across-sectional view of the device of Figure 8 shown in
an expanded configuration, as seen along the line 9-9 in Figure 8; and
Figure 11 is a cross-sectional view of the device of Figure 8 positioned
in a blood vessel of the patient.
DESCRIPTION
Referring initially to Figure 1, a device 10 for injecting a fluid 13 into a
wall of a blood vessel 11 in accordance with the present invention is shown
positioned in an upper body, blood vessel 11 of a patient 12. However, the
use of the device 10 is not confined to only upper body blood vessels 11 but,
instead, can be used in arteries and vessels throughout the patient 12.
Importantly, as provided in detail below, the device 10 provided herein,
allows
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for symmetric injection of the fluid 13 directly in the vessel 11 around the
circumference of the vessel 11.
Referring to Figure 2, a first version of a device 10 having features of
the present invention includes a multi-lumen catheter 14, an expander
mounted thereon, a tubular sleeve 18 and a plurality injectors 20.
As shown in Figures 2-7, the expander can be an inflatable balloon 16.
The balloon 16 is at least inflated and deflated between a first,
substantially
retracted configuration and a second, substantially expanded configuration.
The balloon 16 when at the first configuration is substantially deflated. The
balloon 16 when at the second configuration can be anywhere from the
partially inflated to fully inflated depending upon the size of the vessel 11.
For purposes of the present invention, the balloon 16 and tubular sleeve 18
are preferably made of polyethylene terephthalate (PET).
Further, Figure 2 indicates that the tubular sleeve 18 surrounds a
substantial portion of the balloon 16, and that a plurality of injectors 20
are
mounted onto the tubular sleeve 18. Of these, the injectors 20 shown are
only exemplary.
A more complete appreciation of the structural cooperation between
balloon 16, tubular sleeve 18 and the injectors 20 is provided by Figure 3
wherein, it will be seen that a distal end 22 of tubular .sleeve 18 is
attached
directly to an outer surface 25 of balloon 16. Figure 3 also shows that the
tubular sleeve 18 substantially surrounds and encloses the balloon 16 and
that a proximal end 24 of tubular sleeve 18 extends proximally from and
beyond the balloon 16 over catheter 14. The tubular sleeve 18 cooperates
with the outer surface 25 of the balloon 16 to define a portion of a fluid
passageway 26. The proximal end 24 can be connected to an outer lumen
27 (not shown in Figure 3) of the catheter 14 to complete the fluid
passageway 26.
Figure 3 further shows that the distal end 28 of balloon 16 is affixed to
the catheter 14, and that the proximal end of the balloon 16 closes onto the
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catheter 14 to create an inflation chamber 32 in the interior of the balloon
16.
A balloon port 34 provides fluid access into the inflation chamber 32. For
purposes of the present invention, the balloon port 34 can be connected in
fluid communication with a balloon lumen (not shown) of the catheter 14.
Figure 3 also shows that catheter 14 is formed with an inner lumen 36 which
is dimensioned to receive a guidewire 38 therethrough.
Referring now to Figure 4A, each injector 20 includes a base plate 40
and a tubular protrusion 42 having an attachment end 44 and a cutting edge
46. Further, it is seen that the attachment end 44 of the tubular protrusion
42
affixes to and is an integral part of the base plate 40. Preferably, the
injector
is made of nickel and the tubular protrusion 42 is formed by punching out
the base plate 40. The cutting edge 46 is opposite the base plate 40. The
tubular protrusion 42 defines a fluid channel 48 which extends through the
injector 20. Each injector 20 shown in Figure 4A is substantially annular
15 shaped.
Figure 4B shows another embodiment of the injector 20. Each tubular
protrusion 42 shown in Figure 4B is substantially conical shaped. Similarly,
the injector 20 in Figure 4B is preferably made of nickel and is formed to
have
a fluid channel 48 which extends through the injector 20.
20 Figure 5A shows a plurality of injectors 20 formed upon the same base
plate 50. Specifically, Figure 5A shows an elongated base plate 50 from
which the tubular protrusions 42 have been formed. In all important respects,
the protrusions 42 shown in Figure 5A are structurally the same as the
tubular protrusion 42 discussed above with reference to Figure 4A. The only
difference being that they are collectively mounted on the same base plate
50.
Similarly, Figure 5B shows a plurality injectors 20 formed upon the
same base plate 50. In all important respects, the protrusions 42 shown in
Figure 5B are structurally the same as the tubular protrusion 42 discussed
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above with reference to Figure 4B. Again, the only difference being that they
are collectively mounted on the same base plate 50.
In the embodiment shown in Figure 3, the injectors 20 are mounted
onto the tubular sleeve 18 so that the fluid channel 48 of each respective
injector 20 is aligned with a hole 52 in the tubular sleeve 18. This is done
to
establish fluid communication between the particular injector 20 and the
infusion chamber 26. As a practical matter, it may be preferable in the
construction of the device 10 to first mount the injector 20 onto the tubular
sleeve 18, which can be done in any manner well known in the pertinent art,
such as by ~c ndi~g, and then pierce the tubular sleeve 18 through the fluid
channel 48.
The injectors 20 of the present invention extend between about 0.005
inches and about 0.02 inches away from the tubular sleeve i8 when the
balloon 16 is inflated.
In another embodiment of the present invention shown in Figure 6, the
basic components of the device 10 include the multi-lumen catheter 14 formed
to
accommodate the guide wire 38, the balloon 16, the plurality of injectors 20
and a
plurality of tubular channels 64 mounted on the outer surface 25 of balloon
16.
Each tubular channel 64 has a smaller diameter than the balloon 16 and is
positioned to be substantially parallel with a longitudinal axis 65 of the
balloon
16.
Figure 6 further shows that mounted on the surface of each tubular
channel 64 is the injectors 20. The injectors 20 are positioned on the surface
of
tubular channel 64 so that when balloon 16 is inflated, the injectors 20 move
outwardly in a radial direction. Note, however, the showing of injectors 20 is
for
illustration purposes only and it should be appreciated that any injector 20
or
combination of injectors 20 discussed in association with the previous
embodiments may be used.
Referring now to Figure 7, the cross-sectional view of device 10 shows
the tubular channel 64 in more detail. More specifically, a distal end 66 of
tubular
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channel 64 is sealed to create a portion of the fluid passageway 26 which
connects the injectors 20 to the fluid source 60. Referring to Figures 6 and
7, it is
appreciated that the proximal (extracorporeal~ end 68 of the tubular channel
64 is
in fluid communication with the outer lumen 27 of the catheter, which is
connected in fluid communication with the fluid pump 58 and the fluid source
60.
Returning to Figure 7, the injectors 20 are shown mounted on the surface
of tubular channel 64. As Figure 7 further shows in detail, base 40 of each
injector 20 is mounted on the tubular channel 64 over a corresponding hole 70.
From this view, it can be appreaated that any number of tubular channels 64
could be mounted on the external surface of balloon 16. It is further
appreciated
that any number of injectors 20 could be mounted on a single tubular channel
64.
The composition of the fluid 13 to be injected into the vessel 11
depends upon the treatment being performed and the physical characteristics
of the patient 12. For example, depending upon the patient 12 and the
treatment, the fluid 13 can be antibodies such as receptor site monoclonal
antibodies, a toxic agent such as saponin, a genetic material such as DNA, a
cellular material such as endothelial cells and/or medicaments such as
heparin.
Alternately, the fluid 13 could be a radioactive isotope. It is believed
that radioactive isotopes injected into the vessel 11 reduce and inhibit
tissue
and/or cell growth of the vessel wall. Since the radioactive isotopes are
injected directly in the vessel 11 and are symmetrically injected around the
circumference of the vessel 11, relatively low energy radioactive isotopes can
be utilized. A radioisotope such as technetium 99 or thallium 205, which
have a relatively short half life can be utilized with the present invention.
These relatively low energy radioactive isotopes should cause less trauma to
the patient 12. Additionally, the radioisotope can be encapsulated within a
suitable carrier such as amino-mannose modified liposome, which is rapidly
absorbed into smooth muscle cells.
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Figure 8 shows a second version of the expander which includes a multi-
lumen catheter 80 and a grommet 82. Both the multi-lumen catheter 80 and the
grommet 82 are disposed about the same longitudinal axis with the grommet 82
positioned distally, and separated from, the distal end of the multi-lumen
catheter
80.
Some type of apparatus is used to move the grommet 82 translationally
along the longitudinal axis. For example, referring to Figure 8, a push-pull
wire
84, is shown connected to the grommet 82. The push-pull wire 84 extends
through one of the lumens of the multi-lumen catheter 80 allowing the push-
pull
wire 84 to move translationally in line with the longitudinal axis. The
translational
movement of the push-pull wire 84 causes the grommet 82 to undergo a similar
translational displacement. In many cases, it will be desirable to use the
device
10 of the present invention in combination with the guidewire 38. In such
cases,
the push-pull wire 84 may be formed with an internal lumen through which the
guidewire 38 may be passed.
In the second version, a plurality of hollow, flexible tubes 86 are attached
between the grommet 82 and the multi-lumen catheter 80. Each of the flexible
tubes 86 includes a distal end 88, a proximal end 90 and a central region 92.
The proximal end 90 of each tube 86 is joined to the multi-lumen catheter 80.
The .distal end 88 of each tube 86 is joined to the grommet 82. Preferably,
the
tubes 86 are distributed radially around the multi-lumen catheter 80 and
grommet
82 in a manner substantially as shown in Figure 8.
Turning now to Figures 9 and 10, it may be seen that each flexible tube 86
is formed with a lumen 94. The lumen 94 of flexible tubes 86 passes through
flexible catheter 80 allowing fluid 13 to be passed through multi-lumen
catheter
80 and into flexible tubes 86. The lumen 94 of each flexible tube 86 passes
separately through multi-lumen catheter 80 allowing a different fluid i 3 to
be
passed into each flexible tube 86. Alternatively, the lumen 94 of each
flexible
tube 86 may be attached to one or more common lumens within multi-lumen
catheter 80.
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Figures 9 and 10 also show that the plurality of injectors 20 are attached
to the central region 90 of each tube 86. Each flexible tube 86 is formed with
a
plurality of holes 96 which correspond to a respective injector 20.
Functionally,
each hole 96 connects the channel of a respective injector 20 to lumen 94
5 allowing the fluid pump 58 to pump fluid 13 from the fluid source 60 into
lumen 94
to be expelled through the injectors 20.
Figures 9, and 10 also show that the present invention is movable
between the first, contracted configuration (shown in Figure 9) and the
second,
expanded configuration (shown in Figure 10). In greater detail, it may be seen
10 that the grommet 82 and the multi-lumen catheter 80 are distanced by a
first
separation 98. The device 10 shown in Figure 9 also has a first overall width
designated 100. In comparison, the grommet 82 and the multi-lumen catheter
80, shown in Figure 10 is distanced by a second separation 102 which is
smaller
than the first separation 98 of Figure 9. The device 10, shown in Figure 10
also
15 has a second overall width 104 which is greater than the first overall
width 100
shown in Figure 9.
The difference between the first, contracted configuration shown in Figure
9 and the second, expanded configuration shown in Figure 10 is accomplished,
by translationa! movement of the grommet 82 along the longitudinal axis. In
20 more detail, as the push-pull wire 84 causes the grommet 82 to move towards
the
multi-lumen catheter 80, each of the flexible tubes 86 bows outwardly away
from
the longitudinal axis. In this fashion, the push-pull wire 84 may be used to
move
the grommet 82 translationally to cause the flexible tubes 86 to alternately
bow,
as seen in Figure 10, and straighten, as seen in Figure 9. In some cases, it
will
25 be preferable to fabricate the flexible tubes 86 from resilient material
which
biases the tubes 86 into either the bowed or straight configuration.
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OPERATION
An example of the operation of the balloon 16 version of the expander
can best be visualized with initial reference to Figures 1-3. First, the
guidewire 38 is positioned into the vessel 11 of the patient i 2. This is done
to establish a mechanical pathway through the vessel 11 to the treatment
area 54 where the fluid 13 is to be released. The extracorporeai end of the
guidewire 38 is then inserted into the catheter 14 lumen.
Next, the balloon 16, which is attached to the catheter 14, is moved
over the guidewire 38 to the treatment area 54. The balloon 16 is at its first
configuration during movement in the vessel 11. Once the balloon 16 is
properly positioned proximate the treatment area 54, an inflator 56 is
activated to inflate the balloon 16 to its second configuration. As shown in
Figure 2, the inflator 56 is connected to the proximal (extracorporeal) end of
the device 10.
Referring back to Figure 3, it will be appreciated that, as the balloon
16 is inflated, the expanding balloon 16 urges against the tubular sleeve 18
and causes the tubular sleeve 18 to likewise expand. Consequently, the
injectors 20 mounted on the tubular sleeve 18 move radially from the catheter
14 and embed into the treatment area 54. Further, the balloon 16 can be
used to simultaneously dilate the balloon.
With the injectors 20 embedded into the treatment area 54, the fluid
pump 58 shown in Figure 2 is activated to pump fluid 13 from the fluid source
60 into the fluid passageway 26. Importantly, this pumping action also
causes any fluid 13 which has already been pumped into the fluid
passageway 26 to be expelled through the fluid channels 48 of injectors 20
and into the tissue of treatment area 54.
Alternatively, the fluid pump 58 could be activated prior to embedding
the injectors 20 into the vessel wall 11 and a valve 62 could be used to
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prevent the flow of fluid 13 until the injectors 20 are embedded in the
treatment area 54. The valve 62 can then be opened when the injectors 20
penetrate into the treatment area 54 so that injection occurs substantially
simultaneously with the embedding of the injectors 20 in the treatment area
54. Alternately, the injection of the fluid 13 could happen after a time delay
by waiting to open the valve 62 for at least about one second to about twenty
seconds.
After the fluid 13 from the fluid source 60 has been infused into the
treatment area 54, the balloon 16 can be deflated to the first configuration
by
reversing the inflator 56. This action will cause the balloon 16 to collapse
and withdraw the injectors 20 from the treatment area 54. The entire device
10 can then be withdrawn from the patient 12 over the guidewire 38.
The embodiment shown in Figures 6 and 7 utilizes a plurality of individual,
tubular channels 64. With this embodiment, it is possible to either maintain
fluid
communication with, or fluid isolation between, each tubular channel 64. For
example, fluid communication between each tubular channel 64 can be
established by fluidly connecting each tubular channel 64 together within one
outer lumen 27 of the catheter 14 so that each tubular channel 64 is supplied
fluid 13 from the same fluid pump 58. Alternatively, fluid isolation may be
maintained between each tubular channel 64 by providing each tubular channel
64 with a corresponding and independent outer lumen 27 and establishing its
own fluid connection to a corresponding and independent fluid pump 58.
Consequently, it is possible to inject a variety of alternate fluids 13
simultaneously by using a plurality of tubular channels 64 which are each
connected to a separate fluid pump 58.
While the particular device 10 for injecting fluid 13 into the treatment
area 54 as herein shown and disclosed in detail is fully capable of obtaining
the objects and providing the advantages herein before stated, it is to be
understood that it is merely illustrative of the presently preferred
embodiments of the invention and that no limitations are intended to the
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details of the construction or design herein shown other than as defined in
the appended claims.
16
