U.S. patent application number 10/869221 was filed with the patent office on 2004-11-11 for single lumen balloon catheter apparatus.
Invention is credited to Ackerman, Bernard.
Application Number | 20040225257 10/869221 |
Document ID | / |
Family ID | 33418048 |
Filed Date | 2004-11-11 |
United States Patent
Application |
20040225257 |
Kind Code |
A1 |
Ackerman, Bernard |
November 11, 2004 |
Single lumen balloon catheter apparatus
Abstract
A catheter useful for non-surgical entry into a uterus to
dispense a diagnostic fluid therein. The catheter includes a
tubular body having a lumen extending from a first end thereof to a
second end thereof. The lumen includes an external opening adjacent
the first end for dispensing a diagnostic fluid into the interior
of a subject uterus, and a balloon disposed marginally adjacent to
the first end of the body for fluid sealing the interior of the
subject uterus. The lumen further includes a second opening in
fluid communication with the interior of the balloon for inflation
thereof with the diagnostic fluid. In most applications, the
catheter can be combined with a syringe to form a catheter
apparatus.
Inventors: |
Ackerman, Bernard;
(Metuchen, NJ) |
Correspondence
Address: |
LATHROP & GAGE LC
2345 GRAND AVENUE
SUITE 2800
KANSAS CITY
MO
64108
US
|
Family ID: |
33418048 |
Appl. No.: |
10/869221 |
Filed: |
June 16, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10869221 |
Jun 16, 2004 |
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09449096 |
Nov 24, 1999 |
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Current U.S.
Class: |
604/96.01 |
Current CPC
Class: |
A61M 2025/0175 20130101;
A61M 2025/1052 20130101; A61M 25/10 20130101; A61M 25/1027
20130101; A61M 31/00 20130101 |
Class at
Publication: |
604/096.01 |
International
Class: |
A61M 031/00 |
Claims
1. A catheter useful for non-surgical entry into a uterus to
dispense a diagnostic fluid therein, the catheter comprising: a
tubular body having a single lumen extending from a first end
thereof to a second end thereof, the lumen having an external
opening adjacent the first end for dispensing a diagnostic fluid
into the interior of a subject uterus; and a balloon disposed
marginally adjacent to the first end of the body for fluid sealing
the interior of the subject uterus; the lumen having a second
opening in fluid communication with the interior of the balloon for
inflation thereof with the diagnostic fluid; wherein the external
opening adjacent the first end generates a back-flow within the
lumen which causes the fluid to enter and inflate the balloon
through the second opening.
2. The catheter according to claim 1, wherein the body is
flexible.
3. The catheter according to claim 2, further comprising a movable
sheath that can be moved to a first position to cover a portion of
the body to add rigidity thereto thus aiding in the insertion of
the catheter, and which can be moved to a second position to
uncover the portion of the body thus allowing it to bend and flex
freely.
4. The catheter according to claim 1, wherein the balloon can be
sequentially inflated into first and second predetermined
shapes.
5. The catheter according to claim 4, wherein the first
predetermined shape is substantially elliptical and the second
predetermined shape is substantially spherical.
6. The catheter according to claim 4, wherein the balloon is made
from polyurethane.
7. The catheter according to claim 1, wherein the balloon is made
from polyurethane.
8. The catheter according to claim 1, wherein the second opening
prevents fluid back-flow in the lumen to maintain inflation of the
balloon.
9. A catheter apparatus useful for non-surgical entry into a uterus
to dispense a diagnostic fluid therein, the catheter apparatus
comprising: a catheter; a syringe for delivering the diagnostic
fluid into the catheter; the catheter having a balloon disposed
marginally adjacent to a first end thereof for fluid sealing the
interior of the subject uterus, a single lumen extending from the
first end to a second end of the catheter, the lumen having an
external opening adjacent the first end for dispensing the
diagnostic fluid into the interior of a subject uterus and a second
opening in fluid communication with the interior of the balloon for
inflation thereof with the diagnostic fluid; wherein the external
opening adjacent the first end generates a back-flow within the
lumen which causes the fluid to enter and inflate the balloon
through the second opening.
10. The catheter apparatus according to claim 9, wherein the second
opening prevents fluid back-flow in the lumen to maintain inflation
of the balloon.
11. The catheter apparatus according to claim 9, wherein the
catheter is flexible.
12. The catheter apparatus according to claim 11, further
comprising a movable sheath that can be moved to a first position
to cover a portion of the body to add rigidity thereto thus aiding
in the insertion of the catheter, and which can be moved to a
second position to uncover the portion of the body thus allowing it
to bend and flex freely.
13. The catheter apparatus according to claim 9, wherein the
balloon can be sequentially inflated into first and second
predetermined shapes.
14. The catheter apparatus according to claim 13, wherein the first
predetermined shape is substantially elliptical and the second
predetermined shape is substantially spherical.
15. The catheter apparatus according to claim 13, wherein the
balloon is made from polyurethane.
16. The catheter apparatus according to claim 9, wherein the
balloon is made from polyurethane.
17. A method for making a catheter which is useful for non-surgical
entry into a uterus to dispense a diagnostic fluid therein, the
method comprising the steps of: providing a tubular body having a
single lumen extending from a first end thereof to a second end
thereof, creating an external opening adjacent the first end of the
body, the external opening for dispensing a diagnostic fluid into
the interior of a subject uterus; attaching a balloon marginally
adjacent to the first end of the body, the balloon for fluid
sealing the interior of the subject uterus; and creating a second
opening in the lumen which is in fluid communication with the
interior of the balloon for inflation thereof with the diagnostic
fluid.
18. The method according to claim 17, further comprising the step
of providing a syringe that delivers the diagnostic fluid into the
catheter, the syringe and the catheter forming a catheter
apparatus.
19. The method according to claim 17, wherein the second opening
prevents fluid backflow in the lumen to maintain inflation of the
balloon.
20. The method according to claim 17, wherein the catheter is
flexible.
21. The method according to claim 20, further comprising the step
of providing a movable sheath that can be moved to a first position
to cover a portion of the body to add rigidity thereto thus aiding
in the insertion of the catheter, and which can be moved to a
second position to uncover the portion of the body thus allowing it
to bend and flex freely.
22. The catheter according to claim 1, wherein the external opening
has a predetermined area and the second opening has a predetermined
area, the predetermined area of the second opening being greater
than the predetermined area of the external opening.
23. The catheter apparatus according to claim 9, wherein the
external opening has a predetermined area and the second opening
has a predetermined area, the predetermined area of the second
opening being greater than the predetermined area of the second
opening.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to catheters, and in
particular, to a balloon-bearing single lumen catheter for
injecting diagnostic fluids into a body cavity and a catheter
apparatus employing same.
BACKGROUND OF THE INVENTION
[0002] Diagnostic procedures which require a non-surgical entry
into the uterus are well known. One such procedure known as
hysterosalpingography, is a radiographic method for imaging the
anatomical structures of the uterus and fallopian tubes.
Hysterosalpingography involves inserting a fine flexible catheter
through the cervical canal and injecting a contrast medium, such as
an iodinated fluid, into the uterus. Radiography is then carried
out to provide imaging information pertaining to the subject
uterus.
[0003] Another well known diagnostic procedure which entails the
non-surgical entry into the uterus is called hysterosonography.
This procedure also employs a fine flexible catheter that is
inserted into the cervical canal of the uterus. The catheter in
this procedure enables the physician or technician to inject a
sterile saline solution into the uterus to expand it so that an
ultrasound scanner can be used to sonographically observe the
uterus.
[0004] The catheters used in both procedures typically have means
for sealing off the uterus after injection of the fluid to prevent
backflow into the vaginal canal. One such means includes an
inflatable intrauterine balloon made from an elastomeric material
disposed adjacent the distal tip of the catheter. The catheter
includes a first lumen that communicates with the interior of the
balloon to enable inflation and deflation with an inflation
syringe, and second lumen that is open at the distal tip of the
catheter to enable injection of a desired diagnostic fluid into the
uterus with a injection syringe.
[0005] The balloon catheter is operated by inserting the distal tip
thereof through the cervical canal and into the uterus with the
intrauterine balloon deflated. The insertion of the distal tip
operates to position the deflated intrauterine balloon in the
uterus. Once positioned, the inflation syringe is used to inflate
the intrauterine balloon with air to seal block the cervical canal
and the injection syringe is used to inject the desired diagnostic
fluid into the uterus.
[0006] One problem associated with balloon catheters of this design
is that they are relatively expensive to manufacture because they
include two lumens and double syringes. Therefore, a less expensive
balloon bearing catheter is needed.
SUMMARY OF THE INVENTION
[0007] A catheter used for non-surgically entry into a uterus to
dispense a diagnostic fluid therein; the catheter comprising a
tubular body having a lumen extending from a first end thereof to a
second end thereof. The lumen includes an external opening adjacent
the first end for dispensing a diagnostic fluid into the interior
of a subject uterus, and a balloon disposed marginally adjacent to
the first end of the body for fluid sealing the interior of the
subject uterus. The lumen further includes a second opening in
fluid communication with the interior of the balloon for inflation
thereof with the diagnostic fluid.
[0008] The catheter is typically combined with a syringe to form a
catheter apparatus if desired.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The advantages, nature, and various additional features of
the invention will appear more fully upon consideration of the
illustrative embodiments now to be described in detail in
connection with accompanying drawings wherein:
[0010] FIG. 1 is an elevational view of a catheter apparatus
according to an embodiment of the invention;
[0011] FIG. 2 is a sectional view of the catheter of the
apparatus;
[0012] FIG. 3A is a diagrammatic view of the catheter of the
invention anchored in the cervical canal of a subject uterus;
[0013] FIG. 3B is a diagrammatic view of the catheter of the
invention anchored in the uterine cavity of a subject uterus;
and
[0014] FIG. 4 is an enlarged diagrammatic view of the distal
portion of the catheter of the invention.
[0015] It should be understood that the drawings are for purposes
of illustrating the concepts of the invention and are not
necessarily to scale.
DETAILED DESCRIPTION OF THE INVENTION
[0016] FIG. 1 shows a catheter apparatus according to an embodiment
of the invention. The catheter apparatus 10 is an inline assembly
comprised of a flexible, single lumen catheter 11 and a
conventional syringe 12. The catheter apparatus 10 is primarily
intended for non-surgical entry into the uterine cavity, however,
one of ordinary skill in the art will recognize its usefulness in
other related procedures.
[0017] The catheter 11 of the apparatus 10 includes a flexible
tubular body 16 which is preferably made from a clear polyurethane
or like material. The body 16 has a distal end 17 and proximal end
18 and is threadedly disposed in a semi-rigid sheath 13 which is
preferably made from polypropylene or any other suitable material.
The sheath 13 has a distal end 24, a proximal end 25, and a length
which is about 40% percent less than the length of the catheter
body 16. The sheath 13 can be slidably moved back and forth along
the catheter body 16 to uncover the distal portion of the body 16
to allow it to bend and flex freely or to cover it to prevent
bending and flexing thus aiding the insertion of the catheter 11 in
the vaginal canal. A conventional female Luer hub connector 14 is
provided at the proximal end 18 of the catheter body 16 for
detachably fluid coupling the syringe 12 (which should be equipped
with a male Luer connector) to the catheter 11. An inflatable
balloon 20 (shown in the deflated state) is affixed to and encloses
a marginal distal end portion of the body 16. The balloon 20 can be
of the type described in U.S. Pat. No. 5,624,399 issued to Bernard
Ackerman the disclosure of which is incorporated herein by
reference.
[0018] The balloon 20 taught in U.S. Pat. No. 5,624,399 is
typically constructed from an elastomeric material such as
polyurethane or any other elastomeric material having a Shure A
durometer of between approximately 70 and 95. U.S. Pat. No.
5,624,399 further teaches attaching the balloon 20 to the body 16
so that its longitudinal axis L is longer than its transverse axis
T upon initial inflation thereof. This allows the balloon 20 to be
progressively transformed from an ellipsoidal shape to a spherical
shape with increasing inflation pressure. The balloon 20 in the
ellipsoidal shape as shown in FIG. 3A, can be used for occluding
the cervical canal 32 of a subject uterus 31 thus preventing
obstruction of the uterus 31 during imaging. If pain and/or
cramping is experienced with the balloon 20 in the cervical canal
32, it can be moved into the uterine cavity 33 of the subject
uterus 31 and further expanded into the spherical shape to block
the opening 34 of the cervical canal 32 as shown in FIG. 3B to
obviate the pain and/or cramping.
[0019] It should be understood that other embodiments of the
invention can employ more conventional balloon designs. Such
balloon designs typically inflate into a spherical shape and are
made from latex.
[0020] FIG. 2 shows a cross-sectional view through the catheter 11
of the apparatus 10. As can be seen, the body 16 of the catheter 11
is constructed with a single lumen 21 that extends virtually the
entire length thereof. The wall 19 of the lumen 21 includes a first
slit 22 (best shown in FIG. 4) adjacent to the distal end 17 of the
body 16. The first slit 22 allows the lumen 21 to communicate with
the external environment to provide a fluid communication path for
injecting a diagnostic fluid such as saline or a contrast dye into
a the uterine cavity of a subject uterus. The lumen 21 also
communicates with the interior of balloon 20 via a second slit 23
(best shown in FIG. 4) provided in the wall 19 of the lumen 21. The
second slit 23 is equal to or up to 28 percent larger in area than
the first slit 22 to provide a communication path for inflating the
balloon 20 with diagnostic fluid as will be explained further on.
In other embodiments of the invention, either one or both of the
slits 22, 23 can be replaced with a correspondingly placed
aperture(s).
[0021] The apparatus 10 is typically operated by moving the sheath
13 toward the distal end 17 of the catheter 11, to cover the most
of the distal portion of the catheter body 16 (the balloon 20
should be deflated). The catheter 11 is then inserted into the
vaginal canal so that the distal end 17 of the catheter 11 just
enters the cervical canal of a subject uterus and the distal end 24
of the sheath 13 abuts against the end of the cervix. The catheter
11 is then threaded through the sheath 13 to position the balloon
20 in the cervical canal, or just past the cervical canal inside
the uterine cavity of the uterus (FIG. 3A).
[0022] The syringe 12 of the apparatus 10, which is filled with a
diagnostic fluid such as saline or a contrast dye, is then operated
to inject the diagnostic fluid into the uterine cavity of the
uterus. The fluid pressure generated within the lumen 21 by the
operation of the syringe 12 causes the first slit 22 at the distal
end 17 of the catheter body 16 to open and allow the diagnostic
fluid to flow from the catheter 11 into the uterine cavity of the
uterus. At the same time as the uterus is being filled with the
fluid, back-pressure within the lumen 21 of the catheter 11 caused
by restricted fluid flow through the first slit 22 causes the
second slit 23 to open to allow fluid to enter and inflate the
balloon 20, thus preventing leakage of fluid through the cervical
canal.
[0023] Once the balloon 20 is inflated, the slits 22, 23 operate as
check valves by automatically closing to prevent the balloon 20
from deflating. The inflated balloon 20 locks the position of the
apparatus 10 and seals the uterine cavity to prevent leakage of the
diagnostic fluid therefrom. Radiography or sonography can then be
performed to provide imaging information pertaining to the subject
uterus or fallopian tubes.
[0024] When it is desirable to deflate the balloon 20, the syringe
12 is uncoupled from the catheter 11 and the catheter is withdrawn
slightly through the cervix. This causes the muscular tissue of the
cervix to compress the balloon 20 slightly thus forcing the fluid
in the balloon back into the lumen 21 of the catheter 11 through
the slit 23. Once the balloon 20 is deflated, the catheter 11 of
the apparatus 10 can be fully withdrawn from the uterus through the
cervical canal.
[0025] While the foregoing invention has been described with
reference to the above embodiments, various modifications and
changes can be made without departing from the spirit of the
invention. Accordingly, all such modifications and changes are
considered to be within the scope of the appended claims.
* * * * *