U.S. patent number RE34,633 [Application Number 08/008,415] was granted by the patent office on 1994-06-07 for balloon guide.
This patent grant is currently assigned to Cook Incorporated. Invention is credited to Michael DeBruyne, Thomas A. Osborne, Thomas A. Sos.
United States Patent |
RE34,633 |
Sos , et al. |
June 7, 1994 |
Balloon guide
Abstract
A balloon guide is disclosed which includes a single lumen
useful alternately for fluid communication through the distal tip
or for inflation of a balloon when the distal end is closed. The
guide includes a body formed from coiled wire having a proximal
portion in which the coils are held together and a distal portion
in which the coils are separable. The balloon is located about the
separable coils. A restriction adjacent the distal tip of the guide
body is closable by a plug mandril extending through the central
lumen of the guide. With the distal tip open, fluid communication
is available through the central lumen for pressure measurements,
fluid infusion or the like. In an alternate condition, a plug is
positioned to close off the distal opening of the guide and also to
stretch the coiled wire to separate the coils in the region
underlying the balloon, preventing fluid communication through the
distal tip, but permitting inflation or deflation of the balloon
through the separated wire coils.
Inventors: |
Sos; Thomas A. (New Rochelle,
NY), DeBruyne; Michael (Bloomington, IN), Osborne; Thomas
A. (Bloomington, IN) |
Assignee: |
Cook Incorporated (Bloomington,
IN)
|
Family
ID: |
26818396 |
Appl.
No.: |
08/008,415 |
Filed: |
January 25, 1993 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
731195 |
Jul 15, 1991 |
|
|
|
Reissue of: |
120463 |
Nov 13, 1987 |
04848344 |
Jul 18, 1989 |
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Current U.S.
Class: |
600/585; 604/913;
604/96.01; 606/194 |
Current CPC
Class: |
A61M
25/09 (20130101); A61M 29/02 (20130101); A61M
2025/1093 (20130101); A61M 2025/09008 (20130101) |
Current International
Class: |
A61M
29/02 (20060101); A61M 029/02 () |
Field of
Search: |
;128/656-658,772
;606/192,194 ;600/18 ;604/95-103 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Thaler; Michael H.
Attorney, Agent or Firm: Woodard, Emhardt, Naughton,
Moriarty & McNett
Parent Case Text
.Iadd.This application is a continuation of application No.
07/731,195, filed Jul. 15, 1991, now abandoned. .Iaddend.
Claims
What is claimed is:
1. A balloon guide which comprises:
a guide body comprising a coiled wire forming a cylindrical body
having a central lumen open at the proximal and distal ends, said
coiled wire including a first, proximal portion in which the coils
are secured together with one another, and a second, distal portion
in which the coils are normally adjacent one another but are
separate from one another,
said guide body including a plug seat located within the central
lumen distal of the second portion of the coiled wire, the plug
seat defining a passageway communicating with the central lumen,
the plug seat being configured to provide a closing off of the
central lumen upon closing off of the plug seat,
said guide body further including a balloon attached to the coiled
wire, the balloon being positioned over and in fluid communication
with the second portion of the coiled wire to enable fluid passing
from within the central lumen and through the separated coils of
the second portion to enter into and inflate the balloon;
a plug mandril comprising an elongated mandril having proximal and
distal ends, said plug mandril further including a plug secured to
the distal end of the mandril, the mandril and plug being sized to
be receivable within the central lumen of said guide body and
extendable therethrough, the plug defining a seating portion sized
and configured to be received against the plug seat of said guide
body and to close off the plug seat when received thereagainst;
extension means for extending said plug mandril into and through
the central lumen of said guide body between first and second
positions, the first position locating the plug of the mandril
spaced from the plug seat of said guide body to permit fluid
communication through the plug seat, the second position locating
the plug in sealing position against the plug seat and preventing
fluid communication therethrough, said extension means extending
said plug mandril in the second position through the central lumen
a sufficient distance to cause separation of the normally adjacent
coils in the second portion of the coiled wire; and
inflation means communicating with the central lumen of said guide
body for introducing a fluid into the central lumen and through the
separated coils of the second portion of the coiled wire for
inflating the balloon when said plug mandril is in the second
position within the guide body.
2. The balloon guide of claim 1 in which the coiled wire of said
guide body is a flat wire.
3. The balloon guide of claim 1 in which said guide body includes a
cannula member positioned within the central lumen and defining the
plug seat.
4. The balloon guide of claim 1 in which the plug of said plug
mandril includes a tapered point facing in the distal direction and
defining the seating portion of the plug.
5. The balloon guide of claim 4 in which said guide body includes a
cannula member positioned within the central lumen and defining the
plug seat, the tapered point of the plug being received against the
cannula member in sealing relationship with the plug mandril in the
second position.
6. The balloon guide of claim 1 in which said guide body includes a
sleeve received over the first portion of the coiled wire, the
sleeve being sized to fit tightly about the first portion of the
coiled wire and securing the coils together with one another and
preventing separation thereof.
7. The balloon guide of claim 6 in which said guide body includes a
sleeve extending over the coiled wire from the proximal end of the
coiled wire to the proximal end of the balloon.
8. The balloon guide of claim 7 in which said guide body includes a
third portion of coiled wire distal of the second, separable
portion, the balloon of said guide body includes a central balloon
portion and first and second sleeve extensions therefrom, the first
sleeve extension being proximal of the central balloon portion and
being sealingly secured over the sleeve received over the coiled
wire, the second sleeve extension being distal of the central
balloon portion and being received over the third portion of coiled
wire, the second sleeve extension being sized to fit tightly about
the third portion of the coiled wire and securing the coils
together with one another and preventing separation thereof.
9. The balloon guide of claim 6 in which the coiled wire of said
guide body is a flat wire.
10. The balloon guide of claim 1 and which further includes locking
means for locking said plug mandril in the second position relative
said guide body.
11. The balloon guide of claim 10 in which said guide body includes
a sleeve received over the first portion of the coiled wire, the
sleeve being sized to fit tightly about the first portion of the
coiled wire and securing the coils together with one another and
preventing separation thereof.
12. The balloon guide of claim 10 in which the coiled wire of said
guide body is a flat wire.
13. The balloon guide of claim 12 in which said guide body includes
a sleeve received over the first portion of the coiled wire, the
sleeve being sized to fit tightly about the first portion of the
coiled wire and securing the coils together with one another and
preventing separation thereof.
14. The balloon guide of claim 13 in which said guide body includes
a cannula member positioned within the central lumen and defining
the plug seat.
15. The balloon guide of claim 13 in which the plug of said plug
mandril includes a tapered point facing in the distal direction and
defining the seating portion of the plug.
16. The balloon guide of claim 15 in which said guide body includes
a cannula member positioned within the central lumen and defining
the plug seat, the tapered point of the plug being received against
the cannula member in sealing relationship with the plug mandril in
the second position.
17. A method for inflating a balloon guide which comprises the
steps of:
a. providing a guide body having a coiled wire forming a
cylindrical body having a central lumen open at the proximal and
distal ends, the guide body including a first portion of the coiled
wire in which the coils are secured together with one another, and
a second portion of the coiled wire in which the coils are normally
adjacent one another but are separable from one another, the guide
body including a plug seat located within the central lumen distal
of the second portion of the coiled wire, the plug seat defining a
passageway communicating with the central lumen, the plug seat
being configured to provide a closing off of the central lumen upon
closing off of the plug seat, the guide body further including a
balloon attached to the coiled wire and positioned over the second
portion of the coiled wire to enable fluid passing from within the
central lumen and through the separated coils of the second portion
to enter into and inflate the balloon;
b. providing a plug mandril comprising an elongated mandril having
proximal and distal ends, the plug mandril further including a plug
secured to the distal end of the mandril, the mandril and plug
being sized to be receivable within the central lumen of said guide
body and extendable therethrough, the plug defining a seating
portion sized and configured to be received against the plug seat
of said guide body and to close off the plug seat when received
thereagainst;
c. extending the plug mandril into and through the central lumen of
said guide body to locate the plug in sealing position against the
plug seat and a sufficient distance to cause separation of the
normally adjacent coils in the second portion of the coiled wire;
and
d. after step c., introducing a fluid into the central lumen and
through the separated coils of the second portion of the coiled
wire for inflating the balloon. .Iadd.
18. The balloon guide of claim 1, wherein said plug mandril further
includes a wire guide attached to said plug portion and extending
distally therefrom, said wire guide being of sufficient length to
extend beyond said distal end of said guide body when said plug
portion is received against said plug seat. .Iaddend. .Iadd.
19. A balloon guide comprising:
a guide body having an elongated cylindrical body, a proximal end,
a distal end, and a central lumen therethrough open at said
proximal end and said distal end, said guide body having a plug
seat adjacent said distal end, and at least part of said guide body
between said proximal end and said plug seat being formed of a
plurality of coils, said coils being separable from a normal
position;
a balloon attached to said guide body between said proximal end and
said plug seat with said plug seat distal said balloon, said
balloon positioned over and in fluid communication with at least a
portion of said plurality of coils to enable fluid passing from
within said central lumen and through said coils to enter into and
inflate the balloon; and
a plug mandril having an elongated body portion and a plug portion,
said plug mandril sized to be receivable through said central lumen
and extendable through said lumen and said balloon to engage said
plug seat, said plug portion being sized and configured to close
said central lumen at said distal end of said guide body when
pressed against said plug seat; and
means for separating said plurality of coils from said normal
position,
said balloon being inflatable by forcing fluid into said central
lumen while pressing said plug portion of said plug mandril against
said plug seat to close said central lumen at said plug seat with
the fluid passing through said central lumen and between said
plurality of coils, with said plurality of coils separated, into
said balloon to inflate said balloon. .Iaddend. .Iadd.
20. The balloon guide of claim 19 wherein,
said plug mandril further includes a wire guide attached to said
plug portion and extending distally therefrom, said wire guide
being of sufficient length to extend significantly beyond said
distal end of said guide body when said plug portion is pressed
against said plug seat. .Iaddend. .Iadd.
21. A method of performing a medical procedure for expansion of a
balloon within a vessel comprising the steps of:
providing a balloon guide including a guide body having an
elongated cylindrical body and a central lumen therethrough open at
the proximal and distal ends of the body, the guide body having a
plug seat adjacent the distal end, and at least part of the guide
body adjacent the plug seat being formed of a plurality of coils,
the balloon guide further including a balloon attached to the guide
body between the proximal end and the plug seat with the plug seat
distal the balloon, the balloon covering at least a portion of the
plurality of coils, the balloon guide also including a plug mandril
having an elongated body portion and a plug portion, the plug
mandril having a diameter capable of passing freely through the
central lumen to the distal end, the plug portion being capable of
closing the central lumen when pressed against the plug seat;
guiding the balloon guide to a desired location within a
patient;
pressing the plug mandril against the plug seat thereby closing the
central lumen of the guide body distally of the balloon;
forcing fluid into the central lumen at the proximal end of the
guide body and between the plurality of coils into the balloon,
thereby inflating the balloon;
deflating the balloon; and
withdrawing the balloon guide from the patient. .Iaddend.
.Iadd.
22. The method of claim 21 wherein,
said balloon guide is used as a coronary angioplasty balloon.
.Iaddend. .Iadd.23. The method of claim 21 wherein,
said balloon guide is used as an occlusion balloon catheter.
.Iaddend. .Iadd.24. The method of claim 21 wherein,
said balloon guide is used as a flow directed catheter during said
step of guiding the balloon guide. .Iaddend. .Iadd.25. The method
of claim 21 wherein,
said balloon guide is used as an infusion catheter. .Iaddend.
.Iadd.26. The method of claim 21 further comprising:
infusing radiopaque liquid through the central lumen and out the
distal end
of the balloon guide into the patient. .Iaddend. .Iadd.27. The
method of claim 21 further comprising:
taking pressure measurements from within the patient via fluid
communication between the distal and proximal ends of the guide
body. .Iaddend. .Iadd.28. The method of claim 21 wherein,
said step of deflating the balloon is accomplished by withdrawing
the fluid from the guide body. .Iaddend. .Iadd.29. The method of
claim 21 wherein,
said plug mandril further includes a wire guide attached to said
plug portion and extending distally therefrom, said wire guide
being positioned to extend beyond the distal end of the guide body;
and the method further comprises:
anchoring the distal end of the balloon guide at the desired
location
within the patient with said wire guide. .Iaddend. .Iadd.30. A
balloon guide comprising:
a guide body including:
a cylindrical body having a central lumen open at the proximal and
distal ends of said body, said cylindrical body including a distal
portion formed of a plurality of coils, said coils being separable
from a normal position; and
a plug seat located within said central lumen at said distal end of
said guide body, said plug seat defining a passageway communicating
with said central lumen and being configured to provide a closing
off of said central lumen upon closing off of said plug seat;
a balloon attached to said guide body between said proximal end and
said plug seat with said plug seat distal said balloon, said
balloon being positioned over and in fluid communication with said
plurality of coils to enable fluid passing from within said central
lumen and through said coils to enter into and inflate said
balloon;
a plug mandril sized to be receivable within and extendable through
said central lumen of said guide body and including an elongated
mandril having proximal and distal ends, and a plug portion secured
to said distal end of said mandril, said plug portion defining a
seating portion sized and configured to be received against said
plug seat of said guide body to close off said plug seat when
received thereagainst; and
extension means for extending said plug mandril into and through
said central lumen from said proximal end to said distal end of
said guide body between first and second positions, said first
position locating said plug portion spaced from said plug seat of
said guide body to permit fluid communication through said
passageway of said plug seat, and said second position locating
said plug portion in sealing position against said plug seat and
preventing fluid communication therethrough, said extension means
extending said plug mandril in said second position through said
central lumen a sufficient distance to cause separation of said
plurality of coils from said normal position. .Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the field of wire guides having an
inflatable balloon adjacent the distal tip, and more particularly
to a guide, such as an infusion guide, having a central lumen
useful for both fluid communication through the distal tip and also
for inflation of the balloon.
2. Description of the Prior Art
A great variety of wire guides have been known in the prior art for
addressing particular applications. In many instances, it is
desirable that a wire guide be readily advanced and maneuvered
through the vascular system and out into the small, distal arteries
and vessels with good efficiency. Some applications require the
presence of an inflatable balloon adjacent the distal tip of the
wire guide, such as in the performing of coronary
angioplasties.
Standard coronary balloon angioplasty catheters of the prior art
have employed two lumens to separately perform the roles of fluid
communication and balloon inflation. In one embodiment, the prior
art catheters have comprised a two lumen extruded tube, while other
embodiments have used two single lumen extruded tubes extending
coaxially. For the two lumen tube, the balloon is assembled to the
catheter as a separate assembly. On the coaxial construction, the
balloon is formed on the distal end of the outer tube and the
annular space between the tubes becomes the inflation channel for
the balloon.
Since these prior art catheters have used two separate lumens
through the length of the catheter, there have been limitations
regarding size. The inflation channel to the balloon needs to be as
large as possible to decrease the length of time required to
inflate and deflate the balloon. The balloon needs to inflate and
deflate quickly because blood flow out into the heart muscle is
stopped during the dilating process. The main or central lumen also
needs to be as large as possible to allow good pressure
measurements, the injection of radiopaque liquids in large enough
quantities to produce useful X-ray visualization, and to allow the
passage of various sized guide wires. The outside diameter for a
coronary balloon catheter is limited to about 4 French (0.054
inches). Consequently, the two lumens used in the prior art
catheters need to be fairly small. The inflation lumen of prior art
catheters has measured in the range of 0.010 inches to 0.018
inches. The central lumen of prior art catheters has measured in
the range of 0.018 inches to 0.021 inches in diameter.
A thrombectomy catheter or gallstone dislodger is described in U.S.
Pat. No. 4,561,439 issued to Bishop, et al. on Dec. 31, 1985. The
Bishop catheter has a closed, distal end, and includes a spring
portion near the distal end. A balloon is attached about the spring
portion, and the introduction of fluid into the lumen causes the
spring to extend and the balloon to fill.
An elongatable balloon catheter is described in U.S. Pat. No.
4,276,874 issued to Wolvek, et al. on July 7, 1981. The Wolvek
catheter includes an extendable, helical coil portion adjacent the
distal, closed end. A balloon is secured about the coil portion. A
rod extended through the central lumen of the catheter is used to
extend the coil portion and thereby stretches the balloon to reduce
the outside diameter of the balloon to facilitate movement of the
catheter through a passageway.
Several other patents in the prior art have provided a variety of
features in association with a balloon catheter. In U.S. Pat. No.
4,467,790 issued to Schiff on Aug. 28, 1984, there is disclosed a
percutaneous balloon catheter which includes a balloon at the
distal tip. A stylet extends through the balloon and is secured to
the distal tip and upon rotation is used to wrap and unwrap the
balloon to facilitate the percutaneous insertion of the catheter. A
similar balloon catheter having a rotatable support for twisting
and untwisting the balloon is shown in U.S. Pat. No. 4,261,339
issued to Hanson, et al. on Apr. 4, 1981.
A steerable guide wire for a balloon dilatation procedure is
described in U.S. Pat. No. 4,545,390 issued to Leary on Oct. 8,
1985. The Leary device includes a balloon which is positioned in
the region surrounding a coiled wire portion of the guide wire, but
the balloon is inflated by means of a separate inflation lumen. In
U.S. Pat. No. 4,540,404 issued to Wolvek on Sept. 10, 1985 there is
described a balloon catheter which includes a movable sheath which
is positioned over the balloon during insertion and then removed
from the balloon for inflation.
There has remained a need for a balloon guide which can serve dual
purposes in providing a fluid communicating lumen and also an
inflatable balloon. The need has also remained for a balloon guide
of this type which is a single lumen device that is able to perform
two functions through one lumen and which achieves the advantages
of a smaller outside diameter with a relatively larger inflation
lumen.
SUMMARY OF THE INVENTION
Briefly describing one aspect of the present invention, there is
provided a balloon guide which includes a guide body comprising a
coiled wire having a first, proximal portion in which the coils are
inseparable and a second, distal portion in which the coils are
normally adjacent, but are separable, the guide body including a
plug seat distal of the second wire portion and a balloon
surrounding the second wire portion and inflatable therethrough, a
plug mandril including an elongated mandril and a plug secured to
the distal end for being received within and closing off the plug
seat, means for extending the plug mandril into and through the
central lumen and between a first position with the plug spaced
from the plug seat and a second position locating the plug in
sealing position against the plug seat and causing separation of
the normally adjacent coils of the second portion of the coiled
wire, and means for introducing a fluid into the central lumen and
through the separated coils to inflate the balloon. In another
aspect of the present invention, there is provided a method for
inflating a balloon guide as disclosed.
It is an object of the present invention to provide a balloon guide
which includes a central lumen for fluid communication through the
distal end of the guide as well as an inflatable balloon adjacent
the distal tip.
Another object of the present invention is to provide a balloon
guide which is a single lumen device capable of both fluid
communication and balloon inflation.
It is a further object of the present invention to provide a
balloon guide that has a desirably small outside diameter and
suitably large inflation lumen.
It is also an object of the present invention to provide a method
for operating a single lumen device to be useful either for fluid
communication through the distal end of the catheter or for
inflation of a balloon.
Further objects and advantages of the present invention will become
apparent from the description of the preferred embodiment which
follows.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side, elevational view of a balloon guide constructed
in accordance with a preferred embodiment of the present
invention.
FIG. 2 is a partial, cross-sectional view of the distal end of the
balloon guide of FIG. 1, particularly showing the attachment of the
balloon to the guide body.
FIG. 3 is a plan view of a balloon used in connection with the
balloon guide of the present invention.
FIG. 4 is a side, elevational view of a plug mandril useful with
the present invention.
FIG. 5 is a partial, cross-sectional view of the distal end of the
balloon guide of the present invention, and particularly showing
the plug mandril seated in position to close off the distal end of
the balloon guide.
FIG. 6 is a partial, cross-sectional view of a fitting useful with
the present invention, and particularly adapted for locking the
plug mandril in a desired position relative the balloon guide and
permitting fluid communication with the central lumen of the
balloon guide to facilitate inflation of the balloon.
FIG. 7 is a side, elevational view showing an alternate design for
a plug mandril useful with the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
For the purposes of promoting an understanding of the principles of
the invention, reference will now be made to the embodiment
illustrated in the drawings and specific language will be used to
describe the same. It will nevertheless be understood that no
limitation of the scope of the invention is thereby intended, such
alterations and further modifications in the illustrated device,
and such further applications of the principles of the invention as
illustrated therein being contemplated as would normally occur to
one skilled in the art to which the invention relates.
The present invention provides a single lumen balloon guide which
is useful for a variety of procedures, such as coronary
angioplasties. Referring in particular to the drawings, there is
shown a balloon guide 10 constructed in accordance with a preferred
embodiment of the present invention. Balloon guide 10 includes a
guide body 11 comprised of a coiled wire 12 defining a cylindrical
body having a central lumen 13 (FIG. 2). The coiled wire 12 may
comprise a variety of suitable materials. Preferably the wire is a
coiled, flat wire which is stiff enough to give the guide body good
strength and stiffness and which permits the construction of a
fairly small outside diameter for a reasonably large inside
diameter without requiring the use of extremely fine or thin
wire.
The central lumen 13 is open at the proximal and distal ends to
permit fluid communication therethrough. A plug mandril 14 is
extendable through the central lumen 13, and is operable to open or
close the distal end of the central lumen in accordance with the
operation of the present invention.
The coiled wire 12 includes two distinguishable portions. The wire
includes a first, proximal portion 15 in which the coils are
secured together with one another to inhibit their separation. This
securement may be accomplished in a variety of suitable ways, with
it being preferred that the first portion of the coiled wire be
received within a cylindrical sleeve 16 (FIG. 2). The sleeve 16
preferably extends over the coiled wire from the proximal end of
the coiled wire to the proximal end of the inflatable balloon 24.
This sleeve 16 may comprise, for example, a polyethylene shrink
tube that is supplied over the first portion of the coiled wire and
reduced in size to snugly fit the coiled wire and thus hold the
coils together.
The coiled wire 12 also includes a second, distal portion 17 in
which the coils are normally adjacent (FIG. 2), but are separable
from one another, as shown in FIG. 5. A pair of collars 18 and 19
are secured to the proximal and distal ends of the second portion
17. Since there are no restrictions as to separation of the coils
in the portion 17 between the collars, the normally adjacent coils
may be separated by an appropriate, external force. The separation
of the coils in the second portion 17 is accomplished by the
insertion of the plug mandril 14 through the central lumen 13 and
against a stop, with further insertion causing the coiled wire 12
to be extended longitudinally, and the coils within the second
portion 17 to separate.
The mandril and plug may be formed from a variety of materials. The
mandril may, for example, be formed from stainless steel and may
preferably be tapered in the direction of the distal end to provide
varying flexibility of the mandril. The plug may similarly be
formed from a variety of materials, and preferably is formed from
vinyl. The shape and material of the plug 30 and the cannula 21
should be complementary to ensure a reliable seal when the plug is
seated against the cannula.
Distal of the second portion 17, there is provided an additional
portion 20 of the coiled wire 12. Secured, as by soldering, at the
distal tip of the third portion 20, in which the wire coils are
inseparable, is a cannula 21 (FIG. 5). The cannula 21 thereby
provides a plug seat located within the central lumen 13 and distal
of the second portion 17 of the coiled wire. This plug seat defines
a passageway 22 communicating with the central lumen 13 and the
distal opening 23 of the balloon guide. Closing off of the plug
seat defined by cannula 21 therefore provides a closing off of the
central lumen 13 and prevents fluid communication from the central
lumen through the distal opening 23.
The guide body 11 further includes a balloon 24 attached to the
coiled wire 12. The balloon is positioned over the second portion
17 of the coiled wire and is in fluid communication therewith.
Thus, fluid passing from within the central lumen 13 and through
the separated coils 17 (FIG. 5) will enter into and inflate the
balloon 24.
The balloon 24 preferably includes a central balloon portion 25
(FIG. 3) and first and second sleeve extensions 26 and 27 extending
therefrom. The first, proximal sleeve extension 26 is sealingly
secured over the sleeve 16 received over the coiled wire 12. The
second, distal sleeve extension 27 is received over the third
portion 20 of the coiled wire 12. The second sleeve extension 27
operates in the same manner as the sleeve 16 and is sized to fit
tightly about the third portion 20 of the coiled wire. Sleeve
extension 27 thereby secures the coils together with one another
and prevents separation of the coils in the third portion 20 of the
coiled wire 12.
The guide body design of the present invention is adaptable to a
variety of applications, and is sized accordingly. Procedures with
which the balloon guide of the present invention could be used
would include, but are not limited to, use as a coronary
angioplasty catheter, an occlusion balloon catheter, a flow
directed catheter, an infusion catheter, and the like. It would be
apparent to those skilled in the art that appropriate changes or
modifications to the design of the balloon guide could be made in
order to adapt the guide to these and other types of uses and
procedures.
A balloon guide useful for coronary angioplasty is described herein
as exemplary of a preferred embodiment of the present invention. In
this embodiment, the balloon guide preferably has an outside
diameter of 0.038 inches (3 French) and an inside diameter of
0.0185-0.019 inches, and is useful with conventional wire guides up
to 0.018 inches in outside diameter. Also for this application, the
balloon diameter may range from 2 mm to 5 mm and the length may
range from 1.0 to 5.0 centimeters. The balloon material would
preferably comprise a clear, non-radiopaque, cross-linked
polyethylene tubing having a wall thickness for the balloon portion
of 0.001 inches to 0.005 inches. In the deflated condition, shown
at 28 in FIG. 2, the balloon is flattened and folded
circumferentially around the coiled wire in typical fashion. It
will be appreciated, however, that modification to these and other
design parameters may be adopted to render the balloon guide
suitable for other applications.
The plug mandril 14 includes an elongated mandril 29 having
proximal and distal ends. The plug mandril further includes a plug
30 secured to the distal end of the mandril. The mandril and plug
sized to be receivable within the central lumen 13 of the guide
body and extendable therethrough. The plug 30 defines a seating
portion 31 sized and configured to be received against the plug
seat of the guide body and to close off the plug seat when received
thereagainst. Preferably, the plug 30 includes a tapered point 31
facing in the distal direction and defining the seating portion of
the plug. This tapered point 31 is received against the proximal
end of the cannula 21 in sealing relationship when the plug mandril
is extended a sufficient distance within the central lumen of the
guide body.
Referring in particular to FIGS. 5 and 6, the plug mandril 14 is
shown in the position with the plug 30 seated against the cannula
21 and with the coils in the second portion 17 being separated to
permit fluid communication therethrough. The plug mandril 14 also
includes another position in which the plug 30 displaced proximally
from the cannula. In this alternate position, the central lumen
remains open through the distal opening 23, thus permitting fluid
communication through the guide.
The plug mandril is extendable through the central lumen between
the alternate positions with the plug 31 spaced from or seated
against the cannula 21. Means are provided for positioning the plug
mandril in each of the two alternate positions, and typically
include a fitting 32 secured to the proximal end of the mandril
29.
Assembly 33 is secured to the proximal end of the guide body 11.
Assembly 33 preferably includes a T-connector 34 to which is
secured a collar 35. The collar is tapered in the distal direction
and has a nose portion 36 to which is secured the proximal end of
the guide body 11. The T-connector 34 defines a T-shaped passageway
37 communicating with the central lumen 13 of the guide body, and
also with the balloon and mandril connectors 38 and 39,
respectively. The balloon connector 38 has an outwardly extending
flange 40 including threads 41 for reception of a balloon inflation
device 42 in standard fashion.
The mandril connector 39 preferably includes an external thread
upon which is threadedly received a locking connector 43. An O-ring
44 is positioned adjacent the end of the mandril connector 39 to
provide a fluid tight seal between the locking connector 43 and
mandril connector 39.
The fitting 32 on the plug mandril 14 is preferably configured to
be lockingly and sealingly received by the locking connector 43. As
shown particularly in FIG. 6, the locking connector includes an
extension 45 having a series of circumferential ribs 46. The plug
mandril fitting 32 includes a complementary extension 47 having a
plurality of locking ribs 48. The respective extensions 45 and 47
are sized to be received one within the other with the locking ribs
operating to engage the two together in a locked and sealing
relationship. The plug mandril 13 includes a head 49 sealed within
the fitting 32, as by epoxy 50, thus providing a secured and sealed
connection between the plug mandril and fitting.
From the foregoing description, it will be apparent that the
balloon guide of the present invention is operable between two
alternate conditions to provide for fluid communication through the
end opening 23 or to seal the end opening and provide for inflation
or deflation of the balloon 24. In a first condition, the plug of
the plug mandril is spaced apart from the cannula and fluid
communication is available through the central lumen to the distal
end 23. Such communication is available either through the balloon
connector 38 or the locking connector 43, and may be used in a
variety of procedures including for pressure measurements or for
fluid infusion. If large volume injections are to be made, of if a
small conventional type wire guide is to be used through the
balloon guide, the plug mandril may be simply withdrawn out of the
balloon guide.
In the alternate condition, the plug mandril is extended into and
through the central lumen of the guide body to locate the plug 31
in sealing position against the plug seat of the cannula 21.
Further, in this condition, the plug mandril is extended through
the central lumen a sufficient distance to cause separation of the
normally adjacent coils in the second portion 17 of the coiled wire
12. The plug mandril is preferably sized such that the appropriate
positioning of the plug and stretching of the coiled wire is
accomplished when the fitting 32 is received in the locked and
sealed position connected with the locking connector 43. Thus, the
plug mandril is pushed through the lumen and the fitting is
positioned over the locking connector into the sealing
relationship. In this condition, fluid communication through the
distal end opening 23 is occluded by the plug. Moreover, fluid
communication to the interior of balloon is available through the
separated coil 17. In this condition, the balloon inflation device
42 may be operated to introduce fluid into and through the central
lumen and through the separated coils of the second portion 17 for
inflating the balloon. Conversely, fluid may be withdrawn from the
interior of the balloon 24 in order to deflate the balloon when the
balloon guide is in this condition.
Referring in particular to FIG. 7, there is shown an alternate
design for a plug mandril useful with the present invention. Plug
mandril 51 includes a mandril 52 and a plug 53 attached to the
distal end thereof. As shown in FIG. 7, the mandril 52 may comprise
simply a more conventional wire guide without the distal taper as
shown in the embodiment of FIG. 4. Attached to the distal end of
the plug 53 is a wire 54 and wire guide 55. The wire 54 and guide
55 may comprise a variety of suitable configurations, including a
typical coiled wire as shown for the guide 55. These components are
sized to fit through the cannula 21 and to extend out through the
distal end opening 23 when the plug 53 is seated in the sealing
position against the cannula 21 in the same fashion as shown in
FIG. 5. This alternate design for the plug mandril 51 enables the
user of the balloon guide to manipulate the balloon guide with a
wire guide extending beyond its tip, while still being able to plug
the central lumen of the balloon guide for balloon inflation while
the wire guide extends therefrom. This alternate configuration may
be necessary occasionally to anchor the balloon guide in place
while inflating the balloon.
The balloon 24 may be formed in any of a variety of known
techniques, such as by blow molding. Attachment of the balloon may
be accomplished by heat bonding the balloon to the shrink tube 16
and also by heat shrinking the distal extension 27 to the coiled
wire 20. Other shapes and compositions of balloon may alternately
be used to adapt the balloon guide for the variety of other
procedures with which it would be useful. The use of a small latex
balloon, for example, would make the guide suitable as an occlusion
balloon catheter or the like.
While the invention has been illustrated and described in detail in
the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiment has been shown
and described and that all changes and modifications that come
within the spirit of the invention are desired to be protected.
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