U.S. patent application number 14/316466 was filed with the patent office on 2014-10-16 for methods and apparatus for determining fallopian tube occlusion.
The applicant listed for this patent is Bayer Essure Inc.. Invention is credited to Betsy Swann.
Application Number | 20140309561 14/316466 |
Document ID | / |
Family ID | 43217154 |
Filed Date | 2014-10-16 |
United States Patent
Application |
20140309561 |
Kind Code |
A1 |
Swann; Betsy |
October 16, 2014 |
METHODS AND APPARATUS FOR DETERMINING FALLOPIAN TUBE OCCLUSION
Abstract
Devices and methods for determining fallopian tube occlusion.
The methods may include determining fallopian tube occlusions
through a pressurization or volumetric determination.
Inventors: |
Swann; Betsy; (Grass Valley,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bayer Essure Inc. |
Milpitas |
CA |
US |
|
|
Family ID: |
43217154 |
Appl. No.: |
14/316466 |
Filed: |
June 26, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14042047 |
Sep 30, 2013 |
8777876 |
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14316466 |
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12577108 |
Oct 9, 2009 |
8585616 |
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14042047 |
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Current U.S.
Class: |
600/591 |
Current CPC
Class: |
A61B 5/4325 20130101;
A61B 17/12136 20130101; A61M 2205/3331 20130101; A61B 5/6853
20130101; A61B 17/12099 20130101; A61M 2025/1088 20130101; A61M
2025/1072 20130101; A61B 5/036 20130101; A61M 13/003 20130101; A61M
25/10 20130101; A61B 17/42 20130101; A61M 2025/1052 20130101 |
Class at
Publication: |
600/591 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Claims
1. A system for determining fallopian tube occlusion comprising:
means for distending a uterus with a first fluid, the uterus
including a first cornua of a first fallopian tube; means for
coupling a device to the first cornua to fluidly separate a first
sealed portion of the first cornua from the remainder of the
distended uterus; means for evacuating a first volume of the first
fluid from the first sealed portion; means for measuring the first
volume of the first fluid; means for supplying a second fluid to
the first sealed portion; means for measuring a second volume of
the second fluid supplied to the first sealed portion; means for
comparing the first volume of the first fluid to the second volume
of the second fluid to determine if the first fallopian tube is
occluded.
2. The system of claim 1, wherein the first fallopian tube is
determined to be occluded if the second volume is within 10% of the
first volume.
3. The system of claim 1, wherein means for measuring the first
volume comprise a marked syringe.
4. The system of claim 1, wherein the means for measuring the
second volume comprise a marked syringe.
5. The system of claim 1, wherein measuring the first volume
comprises measuring 1 cc or less.
6. The system of claim 1, wherein the device comprises a first
catheter, and coupling the device to the first cornua to fluidly
separate the first sealed portion of the first cornua from the
remainder of the distended uterus comprises: expanding a first
balloon end portion of the first catheter against the first cornua
to engage the first cornua.
7. The system of claim 6, further comprising: means for expanding
the first balloon end portion with a single air or fluid
source.
8. The system of claim 6, further comprising: means for applying a
vacuum to a first vacuum cavity in the first balloon end portion to
further engage the first cornua.
9. The system of claim 1, wherein the means for coupling the device
to the first cornua to fluidly separate the first sealed portion of
the first cornua from the remainder of the distended uterus
comprise: means for expanding a uterine balloon and engaging the
first cornua with the expanded uterine balloon.
10. The system of claim 1, wherein the second fluid is not soluble
with the first fluid.
11. A catheter for use in a system for determining fallopian tube
occlusion, comprising: an elongated flexible portion having a
proximal end and a distal end, the distal end configured for
fluidly sealing a cornua of a fallopian tube in a uterus from the
remainder of the uterus, the elongated flexible portion comprising:
an inflatable portion at the distal end, the inflatable portion
configured to seal the cornua from the uterus when the inflatable
portion is inflated; a first lumen configured to receive a first
fluid at the proximal end and deliver a first volume of the first
fluid to the sealed cornua at the distal end; a second lumen
configured to evacuate at least a portion of the first volume of
the first fluid at the distal end and evacuate the at least a
portion of the first volume of the first fluid from the sealed
cornua.
12. The catheter of claim 11, wherein the inflatable portion
comprises: first and second radial portions extending in a
substantially perpendicular direction transverse to the
longitudinal axis of the elongated flexible portion, wherein the
first and second radial portions form a substantially circular
vacuum space between the catheter a wall of the cornua and are
configured to engage the wall of the cornua.
13. The catheter of claim 12, wherein the elongated flexible
portion further comprises one or more additional lumens fluidly
coupled to the substantially circular vacuum space, wherein the one
or more additional lumens are configured to provide a vacuum source
to the substantially circular vacuum space.
14. The catheter of claim 12, further comprising: a biocompatible
adhesive on the outer circumference of one or both of the first and
second radial portions where the radial portions engage the wall of
the cornua.
15. A system for determining fallopian tube occlusion comprising:
an elongated substantially circular outer sheath configured for
insertion into a uterus; an outer sheath balloon surrounding a
circumference of the outer sheath, the outer sheath balloon
configured to fluidly seal the uterus when inflated; a first and a
second catheter substantially enclosed by the outer sheath, each
catheter comprising: an elongated flexible portion having a
proximal end and a distal end, the distal end configured for
fluidly sealing a cornua of a fallopian tube in the uterus, the
elongated flexible portion including: an inflatable portion at the
distal end, the inflatable portion configured to fluidly seal the
cornua from the uterus when the inflatable portion is inflated; a
first lumen configured to receive a first fluid at the proximal end
and deliver a first volume of the first fluid to the fluidly sealed
cornua at the distal end; a second lumen configured to evacuate at
least a portion of the first volume of the first fluid at the
distal end and the second lumen is further configured to deliver
the evacuated at least a portion of the first volume of the first
fluid to the proximal end of the second lumen.
16. The system of claim 15, wherein the proximal end of the second
lumen is further configured for coupling to a measuring means, and
the measuring means comprises a marked syringe.
17. The system of claim 15, further comprising: a first fluid
source coupled to the proximal end of the first lumen of each of
the first and second catheters.
18. The system of claim 15, wherein each catheter further
comprises: first and second radial portions extending in a
substantially perpendicular direction transverse to the
longitudinal axis of the elongated flexible portion, wherein the
first and second prominent radial portions form a substantially
circular vacuum space, configured to engage a wall of a cornua of
the uterus.
19. The system of claim 18, wherein the elongated flexible portion
of each catheter further comprises one or more additional lumens
fluidly coupled to the substantially circular vacuum space, wherein
the one or more additional lumens are configured to provide a
vacuum source to the substantially circular vacuum space.
20. The system of claim 19, further comprising: a vacuum source
coupled to the proximal end of the one or more additional lumens
within each catheter.
21. The system of claim 15, further comprising: a biocompatible
adhesive on the outer circumference of at least one of the first
and second radial portions of each catheter, where the radial
portions engage the wall of the cornua.
22. The system of claim 15, wherein the further comprising: a
spring mechanism disposed between the first and catheter, the
spring mechanism configured to expand the first and second
catheters into a Y-position to facilitate placement of each of the
first and second catheters into a respective first and second
cornua of the uterus; and a retractable member coupled to the
spring mechanism, wherein the retractable member is configured to
activate the first and second catheters into the Y-position, or
retract the spring mechanism so that the first and second catheters
are in a closed or collapsed position.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/042,047, filed on Sep. 30, 2013, entitled
"METHODS AND APPARATUS FOR DETERMINING FALLOPIAN TUBE OCCLUSION",
which in turn is a continuation of U.S. patent application Ser. No.
12/577,108, filed on Oct. 9, 2009, entitled, "METHODS AND APPARATUS
FOR DETERMINING FALLOPIAN TUBE OCCLUSION", and issued as U.S. Pat.
No. 8,585,616, both of which are incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] 1). Field of the Invention
[0003] The field of the invention relates to methods and
apparatuses for determining fallopian tube occlusion.
[0004] 2). Discussion of Related Art
[0005] Female sterilization prevents pregnancy by occluding or
mechanically blocking the fallopian tubes. There are several
different occlusion techniques--tubes can be tied or "ligated,"
blocked with mechanical devices such as clips or rings, or scarred
closed with electric current.
[0006] In partial salpingectomy, the fallopian tubes are cut and
tied with suture material. The Pomeroy technique, a widely used
version of partial salpingectomy, involves tying a small loop of
the tube and cutting off the top segment of the loop.
[0007] Clips are used to block the fallopian tubes by clamping down
and cutting off the blood supply to a portion of the tubes, causing
a small amount of scarring or fibrosis that prevents fertilization
from occurring. The two most common clips are the Filshie clip,
made of titanium, and the Wolf clip (also known as the Hulka clip),
made of plastic. Clips are simple to use, but each type requires a
special applicator.
[0008] Tubal rings, like clips, also block the tubes mechanically.
A very small loop of the fallopian tube is pulled through the
stretched ring. When the ring is released, it stops the blood
supply to that small loop. The resulting scarring blocks passage of
the sperm or egg. The Yoon Ring, made of silicone, is widely
used.
[0009] Electrocoagulation uses electric current to coagulate or
burn a small portion of each fallopian tube. Unipolar coagulation
passes current through the forceps applied on the tubes, and the
current leaves a woman's body through an electrode placed under her
thigh. In bipolar coagulation, current enters and leaves a woman
through two ends of the forceps.
[0010] Occlusion device applied transcervically such as the
ESSURE.RTM. device manufactured by CONCEPTUS, INC. are also used to
permanently block the fallopian tubes.
[0011] Hysterosalpingography (HSG) is a known method for
determining whether a fallopian tube has been successfully
occluded. In HSG, the uterus is pressurized with a fluoroscopically
visual fluid. A radiologist fluoroscopically monitors the fallopian
tubes to see if the fluid escapes past the occluded portion. Fluid
seen escaping and filling the fallopian tubes, for example near the
ovaries would indicate that the fallopian tubes are not occluded
and that the patient may still be fertile. HSG is problematic in
that it requires a radiologist to be present and also requires the
use of specialized equipment. Thus HSG also cannot be performed in
a doctor's office.
SUMMARY OF THE DESCRIPTION
[0012] The invention includes in one embodiment a method to detect
fallopian tube occlusion, including visually identifying the cornua
of a fallopian tube through a transcervical approach, wherein the
fallopian tube was subjected to a procedure to attempt to occlude
the fallopian tube, coupling a device to a cornua to fluidly
separate the cornua from the remainder of the uterus, pressurizing
the cornua, and monitoring the pressurization of the cornua to
determine if the fallopian tube is occluded.
[0013] The device may be coupled to the cornua by an inflatable
member of the device.
[0014] The inflatable member may be coupled to the cornua by
applying force against the cornua.
[0015] The inflatable member may be coupled to the cornua by a
applying a vacuum between the inflatable member and the cornua.
[0016] The cornua may be inflated to a pressure greater than 500
mmHg.
[0017] The method may be used with no fluoroscopic visualization of
the procedure.
[0018] The inflatable member is configured to separate the first
cornua and a second cornua from the remainder of the uterus by
occupying a uterine cavity.
[0019] The inflatable member has at least one first lumen that is
configured to pressurize the first cornua, the at least one first
lumen extending through the inflatable member to align with the
first fallopian tube. The inflatable member has at least one second
lumen that is configured to pressurize the second cornua. The at
least one second lumen extends through the inflatable member to
align with a second fallopian tube and is capable of being
activated simultaneously with the at least one first lumen.
[0020] The invention includes in one embodiment a method to
determine fallopian tube occlusion, comprising distending a uterus
with a first fluid, the uterus including at least one fallopian
tube and cornua of the fallopian tube, wherein the fallopian tube
was subjected to a procedure to attempt to occlude the fallopian
tube, visually identifying the cornua of a fallopian tube through a
transcervical approach, coupling a device to the cornua to fluidly
separate a sealed portion of the cornua from the remainder of the
uterus, applying a vacuum to the sealed portion of the cornua to
evacuate a first fluid in the sealed portion of the cornua,
pressurizing the cornua with a second fluid, and monitoring the
volume of the cornua to determine if the fallopian tube is
occluded.
[0021] The device may be coupled to the cornua by an inflatable
member of the device.
[0022] The inflatable member may be coupled to the cornua by
applying force against the cornua.
[0023] The inflatable member may be coupled to the cornua by a
applying a vacuum between the inflatable member and the cornua.
[0024] The cornua may be inflated to a pressure greater than 500
mmHg.
[0025] The second fluid may be visually differentiated from the
first fluid.
[0026] The method may additionally include visually confirming that
the second fluid does not leak into the first fluid past the
device.
[0027] The first fluid removed from the cornua portion may be
measured.
[0028] The fallopian tube may be determined to be permanently
occluded by the implanted occlusion device by determining if there
is more of the second fluid inserted in the evacuated portion of
the cornua than of the first fluid removed from the evacuated
portion of the cornua.
[0029] The second fluid may be non-soluble with the first
fluid.
[0030] The method may be used with no fluoroscopic visualization of
the procedure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The invention is further described by way of example(s) with
reference to the accompanying drawings, wherein:
[0032] FIG. 1 is a cross section of a uterus including a
utero-tubal junction and cornua, and a previously implanted
fallopian tube occlusion device.
[0033] FIGS. 2A-2C show cross sections of a uterus including a
utero-tubal junction and cornua, and a previously implanted
fallopian tube occlusion device and a method to determine if the
fallopian tube is fully occluded.
[0034] FIGS. 3A and 3B show cross sections of a uterus including a
utero-tubal junction and cornua, and a previously implanted
fallopian tube occlusion device and a method to determine if the
fallopian tube is fully occluded.
[0035] FIGS. 4A-4C show cross sections of devices which may be used
to determine if a fallopian tube is fully occluded.
[0036] FIGS. 5A-5D show cross sections of a uterus including a
utero-tubal junction and cornua, and a method to determine if the
fallopian tube is fully occluded, according to another
embodiment.
[0037] FIGS. 6A and 6B show cross sections of a uterus including a
utero-tubal junction and cornua, and a method to determine if the
fallopian tube is fully occluded, according to another
embodiment.
[0038] FIG. 7 shows a pump for providing pressure, according to one
embodiment.
[0039] FIGS. 8A and 8B show cross sections of various embodiments
of devices which may be used to determine if a fallopian tube is
fully occluded.
[0040] FIGS. 9A-9D show catheter cross sections of various
embodiments used to determine if a fallopian tube is fully
occluded.
DETAILED DESCRIPTION OF THE INVENTION
[0041] FIG. 1 shows a cross section 100 of an ostium or cornua 102
of a uterus. The ostium or cornua 102 is considered to be the
flower like opening of a fallopian tube and lies between the
greater uterus and the utero-tubal junction 104 (hereinafter,
"UTJ"). A previously placed implant 106 is shown placed in the UTJ.
The function of the implant is to serve as a platform for
encouraging tissue growth occlusion, as shown by the cross-hatched
area. When the UTJ has been fully occluded by tissue growth,
typically 3 months after implantation, the fallopian tube will no
longer be viable for fertilization. The fallopian tube may also be
sealed by other known operations, such as partial salpingectomy,
electro-cauterization, or clips or rings applied externally to the
fallopian tube. The methods and apparatuses described herein apply
equally to all forms of tubal ligation.
[0042] The implant 106 includes a proximal portion that extends
into the ostium or cornua 102. The proximal portion of the implant
106 serves as a visual indicator of the placement of the implant
106. Devices such as the ESSURE.RTM. device manufactured by
CONCEPTUS, INC. include tail like visual indicators. Not all
fallopian tube implants include such indicators. Even with a visual
indicator, which shows only positive placement, the device may not
fully occlude the utero-tubal junction 104.
[0043] FIG. 2A illustrates one embodiment of the invention for
determining whether a fallopian tube is occluded. The fallopian
tube shows a previously placed occlusion device 106. A device 200
is shown coupled to the ostium or cornua 102 of a uterus. The
device 200 may be delivered to the ostium or cornua 102 by a
hysteroscope which is transcervically approached through the vagina
of the patient. The uterus is also typically distended with a
working fluid, such as saline. The cornua 102 is visually
identified using an image provided by hysteroscope, which may also
be coupled to a monitor.
[0044] As shown, the device 200 includes an a sealing member 210 to
fluidly seal and separate a portion of the ostium or cornua 102
from the remainder of the uterus to create a sealed region. The
sealing member 210 is preferably inflatable, although this is not a
requirement of this embodiment of the invention. Force is applied
by the operator of the device 200 to seal the sealing member 210
against the ostium or cornua 102. In one embodiment, the sealing
member 210 has an inflated diameter of the cornua 102 so that a
sealed region is created regardless of the expansion and
contractions of the cornua 102.
[0045] In one embodiment, the sealing member 210 includes a
biocompatible adhesive 212 capable of creating a seal between the
sealing member 210 and the endometrium of the uterus. In one
embodiment, the biocompatible adhesive 212 is located along an
outer circumference of the sealing member 210 between the sealing
member 210 and endometrial layer. It is understood that the
adhesive 212 may be strategically applied in specific locations
around the sealing member 210 circumference to ensure the sealing
member 210 engages with the endometrium. It is also understood that
the biocompatible adhesive 212 can be any known adhesive such as
wet adhesives, synthetic, natural, bio-adhesives, hydrogels, resins
or any other adhesive suitable for application in the uterus.
[0046] In one embodiment, the adhesive 212 is a temporary adhesive
application and may remove a portion of the endometrium upon
removal of the sealing member 210. However, the adhesive 212 should
not cause the removal of any portion of the myometrium upon removal
of the sealing member 210.
[0047] FIG. 2B shows the device 200 applying a positive pressure
through lumen 210, as shown by the "+" marks, within a sealed
portion of the cornua 102. A pressure monitor, such as a pressure
gauge, is also coupled to the lumen 210. Pressure is applied for a
set amount of time, for example 30 seconds to 3 minutes, to
determine if the sealed portion will hold pressure. If the sealed
portion is able to maintain a desired amount of pressure for a
predetermined amount of time, one may be able to positively
determine whether the fallopian tube is fully occluded. A pressure
drop will show that the fallopian tube is not fully occluded.
[0048] The amount of pressure applied must be large enough to
determine whether the fallopian tube is positively occluded. The
fallopian tube may also be naturally and temporarily blocked. Past
tests have determined that as much as 500 mmHg is required to
remove a temporary blockage from a fallopian tube. In another
embodiment, a minimum pressure is about 50 mmHg while a maximum
pressure is about 350 mmHg. In one embodiment, an ideal range of
pressure is about 90-120 mmHg. Care should be taken such that
enough pressure is applied to the cornua 102 to determine whether
the fallopian tube is positively occluded while preserving the
temporarily blocked fallopian tube. Pressures greater than 500 mmHg
may be applied in order to determine intentional fallopian tube
occlusion, for example 700-2000 mmHg.
[0049] This method is advantageous over previous method of
determining whether a fallopian tube is occluded by previously
implanted occlusion devices. Previous methods required
pressurization of the entire uterus with a fluoroscopically visible
fluid, known as Hysterosalpingography (HSG). A radiologist
monitored the fallopian tubes via an x-ray device to determine if
the fluoroscopically visible fluid leaks past the previously
implanted occlusion devices. This prior art procedure is costly,
because it requires the presence of a radiologist and specialized
x-ray equipment. The current invention does not require
fluoroscopic visualization of the procedure, and may be performed
with a less specialized environment, such as a doctor's office. The
sealing member 210 may also include an adhesive as previously
described above.
[0050] FIG. 2C shows an alternative embodiment of a method for
determining whether a fallopian tube is occluded. The fallopian
tube shows a previously placed occlusion device 106. A device 220
is shown coupled to the ostium or cornua 102 of a uterus. The
device 220 may be delivered to the ostium or cornua 102 by a
hysteroscope which is transcervically approached through the vagina
of the patient. The uterus is also typically distended with a
working fluid, such as saline. The cornua is visually identified
using an image provided by hysteroscope, which may also be coupled
to a monitor.
[0051] As shown, the device 220 includes an a sealing member 230 to
fluidly seal and separate a portion of the cornua from the
remainder of the uterus. The sealing member 230 is preferably
inflatable, although this is not a requirement of this embodiment
of the invention. The sealing member 230 features sealing chambers
240 circumferentially surrounding the sealing member 230. The
sealing member may be defined by two prominent sections of the
sealing member 230. A vacuum is applied through vacuum lumens 250
to positively seal the sealing member to the cornua 102. A vacuum
source (not shown) as known to one commonly skilled in the art,
such as a pump, is also coupled to the vacuum lumens 250.
[0052] FIG. 2C shows the device 200 applying a positive pressure
through lumen 260, as shown by the "+" marks, with in sealed
portion of the cornua. A pressure monitor (not shown) as commonly
known to ones skilled in the art, such as a pressure gauge, is also
coupled to the lumen 260. Pressure is applied for a set amount of
time, for example 30 seconds to 3 minutes, to determine if the
sealed portion will hold pressure. If the sealed portion is able to
maintain a desired amount of pressure for a predetermined amount of
time, one may be able to positively determine whether the fallopian
tube is fully occluded. A pressure drop will show that the
fallopian tube is not fully occluded.
[0053] This method is particularly advantageous because it allows
an operator remove his hands from device 220, while simultaneously
maintaining a positive seal against the cornua. In one embodiment,
a bio-adhesive 262 may located on circumferential portions of the
prominent sections of the sealing member 230 to ensure a sealed
engagement between the sealing member 230 and the endometrium.
[0054] FIG. 3A illustrates one embodiment of the invention for
determining whether a fallopian tube is occluded. The fallopian
tube shows a previously placed occlusion device 106. A device 300
is shown coupled to the cornua 102 of a uterus. The device 300 may
be delivered to the cornua by a hysteroscope which is
transcervically approached through the vagina of the patient. The
uterus is also typically distended with a working fluid, such as
saline. The cornua is visually identified using an image provided
by hysteroscope, which may also be coupled to a monitor.
[0055] As shown, the device 300 includes a sealing member 310 to
fluidly seal and separate a portion of the cornua from the
remainder of the uterus. The sealing member 310 is preferably
inflatable, although this is not a requirement of this embodiment
invention. Force is applied by the operator of the device 300 to
seal the sealing member 310 against the cornua 102. Alternatively
the device 300 may use a vacuum to seal the sealing member 310
against the cornua such as shown in FIG. 2C.
[0056] FIG. 3A shows the device 200 applying a negative pressure
through a first lumen 320, as shown by the "-" marks, within the
sealed portion of the cornua. Distension fluid is then evacuated
from the sealed portion and measured using a measuring device as
known to one commonly skilled in the art, such as a marked syringe.
The amount of fluid evacuated will typically be small, for example
1 cc or less, given that the volume of the sealed cornua is
small.
[0057] FIG. 3B shows a second lumen 330 supplying a second fluid to
replace the distension fluid. The second fluid is pressurized in a
device as described in FIGS. 2A-2C, however it is not necessary to
monitor the pressure. The pressure may be mechanically set by a
pressure source as known to one commonly skilled in the art, such
as a syringe or pump coupled to a lockable leur, which is in turn
coupled to lumen 330.
[0058] The volume of the second fluid applied is measured to
determine if it is greater than the amount of distension fluid
removed. If the volumes are equal or close, for example within 10%,
then the fallopian tube is determined to be positively occluded by
the occlusion device I.
[0059] If the volume of the second fluid is significantly greater
than the amount removed, for example more than 20%, then the second
fluid likely leaked past the utero-tubal junction and occlusion
device 106. Thus it follows that the occlusion device is not fully
occluding the utero-tubal junction. The volume of the lumen 330
should be considered when calculating the volume of the second
fluid applied into the evacuated portion of the cornua.
[0060] The second fluid may be visually differentiated from the
distension fluid, for example colored with a green dye. This aids
in visually determining if any leaks exist between the sealing
member 310 and cornua. The second fluid may also be non-soluble
along with the distension fluid, for example bio-compatible
vegetable or mineral oil. In that case, both the distension fluid
and second fluid may be measured using the same container, e.g. a
single syringe, without intermixing between the fluids.
[0061] This method is advantageous over previous method of
determining whether a fallopian tube is occluded by previously
implanted occlusion devices. Previous methods required
pressurization of the entire uterus with a fluoroscopically visible
fluid, known as Hysterosalpingography (HSG). This embodiment does
not require fluoroscopic visualization of the procedure, and may be
performed with a less specialized environment, such as a doctor's
office.
[0062] FIG. 4A shows one embodiment of a catheter 400 for use in
methods described herein. The catheter includes an inflatable
member 410, and a lumen 420 for pressurizing a cornua of a
fallopian tube. The inflatable member 410 may be characterized as a
circular shaped balloon. Balloon catheters, materials, and methods
of construction are well known in the art, for example as shown in
U.S. patents: U.S. Pat. No. 5,522,961, U.S. Pat. No. 6,585,687, and
U.S. Pat. No. 6,024,722, all of which are respectively incorporated
herein by reference in their respective entirety. Appropriate
coupling devices, such as leurs (not shown) are coupled to the
proximal portion of the catheter 400 for adding suitable pressures
or vacuums to inflatable member 440 and the remaining lumens. The
catheter is of a suitable working length for use in a transcervical
environment, for example 400 mm.
[0063] In one embodiment, a back portion 482 of the inflatable
member 410 is a concave shape. In another embodiment, the back
portion 484 of the inflatable member 410 is a convex shape. A
specific concave or convex shape can be selected depending on the
curvature of the cornua.
[0064] FIG. 4B shows one embodiment of a catheter 430 for use in
methods described herein. The catheter includes an inflatable
member 440, and a lumen 450 for pressurizing a cornua of a
fallopian tube. It is understood that the lumen 450 can also
include a first and second lumen, as shown in FIG. 4C. The
inflatable member 440, may be characterized as a circular shaped
balloon with at least two prominent sections 440a and 440b. A
vacuum space exists between sections 440a and 440b for application
of a vacuum by lumens 460 for sealing the inflatable member to a
cornua of a fallopian tube. Appropriate coupling devices, such as
leurs (not shown) are coupled to the proximal portion of the
catheter 430 for adding suitable pressures or vacuums to inflatable
member 440 and the remaining lumens. The catheter is of a suitable
working length for use in a transcervical environment, for example
400 mm.
[0065] FIG. 4C shows one embodiment of a catheter 470, and a first
476 and second 478 lumen, similar to the embodiment shown in FIG.
3A. Again, the inflatable member 472 is characterized by a circular
shape and two prominent radial portions 472a, 472b extending in a
perpendicular direction transverse to the longitudinal axis of the
first 476 and second lumen 478. The first 472a and second 472b
prominent portions form a circular vacuum space 474 which will
engage the cornual wall, as already described. A vacuum suction is
created within the vacuum space 474 through the vacuum lumen 480.
The same fluid distension technique can be applied to the catheter
470 through the first 476 and second 478 lumen, as already
described in FIGS. 3A and 3B.
[0066] FIG. 5A shows an arrangement 500 having an outer catheter or
sheath 502 with a proximal end and a distal end being inserted into
a uterus 510 with previously occluded portions 514. The sheath 502
is made from a material such as stainless steel, Teflon, silicone,
or other known materials and may be flexible or rigid. In one
embodiment, the sheath 502 can have a length in a range of about 12
cm to about 25 cm and a diameter in a range of 0.4 cm to about 0.8
cm.
[0067] The sheath 502 contains two inner catheters 504. The two
inner catheters 504 are shown in a collapsed position within the
outer sheath 502 with respective balloon end portions 506 located
near the distal end of the sheath 502. As shown, the balloon end
portions 506 are not inflated when located within the outer
catheter or sheath 502.
[0068] In addition, an outer sheath balloon 508 is connected with
the outer sheath 502. The outer sheath balloon 508 remains in a
deflated configuration upon insertion of the outer sheath 502 into
the cervix.
[0069] FIG. 5B shows the outer sheath 502 being inserted into the
uterus so that a distal portion of the outer sheath 502 is located
near the fundus region 512 of the uterus 510. The inner catheters
504 are exposed by either advancing the inner catheters 504 or by
retracting the outer sheath 502. The balloon end portions 506 are
in a deflated configuration when the inner catheters 504 are in a
collapsed position. Upon reaching a desired position, FIG. 5B
illustrates the outer sheath balloon 508 being inflated to engage
the walls of the cervical canal to create a sealed upper region of
the uterus 510. The engagement of the outer sheath balloon 508
prevents unwanted movement during subsequent procedures. The outer
sheath balloon 508 is connected with a first air or fluid source
516 for inflating the outer sheath balloon 508. The sheath 502 is
also connected with a second air or fluid source 520 and a vacuum
source 526 as will be discussed in further detail.
[0070] FIG. 5C shows the inner catheters 504 being moved from a
collapsed position to an open and extended Y-shaped position. The
first catheter 504a is movable to seal a first cornua 518a and the
second catheter 504b is movable to seal a second cornua 518b. The
inner catheters 504 can be configured to create pressure within a
respective cornua region 518 according to any of the embodiments
previously described. Moreover, the inner catheters 504 can be
configured to apply a fluid distension technique according to any
of the embodiments already described.
[0071] FIG. 5C further shows a first balloon end portion 506a being
inflated by the first air or fluid source 516. In one embodiment,
the air or fluid source can be a single source that can selectively
allow air or fluid to flow to the outer sheath balloon 508 or the
end balloon portions 506 through the use of a valve (not shown). It
is understood that, in one embodiment, the outer sheath balloon 508
may not be necessary and may be removed or inactivated. In another
embodiment, separate air or fluid sources may be used. In one
embodiment, a separate air or fluid source 520 is provided to apply
pressure or fluid distension to the cornua regions 518a, 518b
through lumens within the inner catheters 504 as already described.
In one embodiment, the air source 520 is a hand pump with a gauge
of pressure. In another embodiment, the fluid source 520 is a
syringe.
[0072] In one embodiment, a spring mechanism 522 is biased to
expand the inner catheters 504 to an open Y-position. A wire 524 is
connected with the spring mechanism 522 to activate or retract the
spring mechanism 522 so that the inner catheters 504 can move from
an open Y-position to a closed collapsed position. In one
embodiment, the user may pull on the wire 524 to cause the spring
mechanism 522 to retract causing the inner catheters 504 to
collapse. It is understood that a spring mechanism that expands
upon pulling of the wire 524 may be provided.
[0073] FIG. 5D further shows an embodiment 528 similar to FIG. 5C.
However, the end balloon portions 506 have a vacuum cavity as
described in FIGS. 2C, 4B, and 4C. The vacuum cavity engages the
cornual walls and creates a sealed region for determining whether a
fallopian tube is patent as previously described. A vacuum is
created within the vacuum cavity through a vacuum source 526 and
lumens within the catheter as previously described. The vacuum
source 526 can also be utilized to deflate the outer sheath balloon
508 and end balloon portions 506 to a collapsed position for
withdrawal from the uterus. A collapsed withdrawal position would
be similar to the insertion configuration shown in FIG. 5A.
[0074] FIG. 6A shows another embodiment 600 where a catheter or
sheath 602 having similar dimensions as already described is
inserted into the uterus 604 having occluded regions 614. The
sheath 602 has a proximal end and a distal end. FIG. 6A further
shows the proximal end of the catheter including a uterine balloon
606 in a collapsed position. An outer sheath balloon 608 is shown
in a collapsed position located at a mid-portion of the sheath 602.
In a collapsed position, the uterus balloon 606 is inserted through
the cervix and into the uterus toward the fundus region. The
uterine balloon 606 is connected with an air or fluid source 610
through a lumen of the catheter 602. The uterine balloon 606 is
also connected with a vacuum source 612 through a catheter lumen.
It is understood that the outer sheath balloon 608 may be connected
with the same air or fluid source 610 and vacuum source 612 for
selective inflation and collapse. In one embodiment, the outer
sheath balloon 608 may be inflated or collapsed independently from
the uterine balloon 606.
[0075] FIG. 6B shows the same embodiment described in FIG. 6A when
the uterine balloon 606 and outer sheath balloon 608 are expanded.
It is understood that the outer sheath balloon 608 may be removed
or inactive, according to one embodiment. However, as shown in FIG.
6B, the outer sheath balloon 608 is expanded to engage the cervical
canal wall while the uterine balloon 606 fills the uterine cavity
and engages with the cornual regions of the uterus 604. In one
embodiment, the balloon 606 may not conform or fill the entire
uterine cavity but it is configured to provide a full engagement
with the cornual regions of the uterus without filling the entire
uterine cavity.
[0076] The uterine balloon 606 has a triangular or heart-shaped
configuration when inflated. The uterine cavity is expandable so
that it may stretch or adjust to the inflated uterine balloon 606
so that two sealed regions 620a, 620b are created. The sealed
regions 620a, 620b created are air tight or fluid tight if the
occluded areas 614 are not patent. The uterine balloon 606 engages
the fundus and the cornua of the uterus to create a sealed region.
As mentioned, the uterine balloon 606 is inflatable with air,
water, saline solution, or any other known fluid.
[0077] The uterine balloon 606 also includes a first tube 616 and a
second tube 618 within the inflated balloon 606. The first tube 616
extends from a distal end of the catheter 602 to an upper corner
region of the uterine balloon 606 to align with the tubal ostia.
The first tube 616 includes a distal opening into the first sealed
region 620a of the uterus 604. The second tube 618 includes a
distal opening into the second sealed region 620b of the uterus 604
to align with the tubal ostia. It is understood that the first 616
and second tubes 618 may remain flush with an outer surface of the
uterine balloon 606 or may extend beyond the outer surface of the
uterine balloon 606 protruding into the sealed regions 620a, 620b.
The first 616 and second tube 618 are coupled to lumens within the
catheter 602, as will be described in further detail.
[0078] After the sealed regions 620a, 620b are created, a second
air or fluid pressure source 622 creates a pressure within the
first tube 616, second tube 618, and sealed regions 620a, 620b. In
one embodiment, a hand pump provides the necessary pressure. In
another embodiment, bio-adhesives (as previously described) may be
strategically applied on the outer surface of the uterine balloon
606 to ensure the balloon 606 is engaged with the endometrium to
create a sealed region.
[0079] FIG. 7 shows an exemplary hand pump 700 for providing a
pressure to the sealed regions 620a, 620b. The hand pump 700
includes a pump handle 702, a dial 704, a connecting piece 706, and
a relief valve 708. The pump handle 702 is made of an elastic
material such as rubber or silicone that compresses air when a user
closes his or her grip. When a user releases his or her grip, the
handle 702 returns to an initial uncompressed state. The dial 704
indicates to the user how much pressure is created within the
sealed regions 620a, 620b. In one embodiment, a minimum pressure of
50 mmHg is provided or a maximum of 350 mmHg. An ideal pressure
range is 90-120 mmHg to determine whether the fallopian tube is
successfully occluded. A check valve 708 is connected with the hand
pump 700 to allow excess pressure to escape when a predetermined
value is reached. For example, in one embodiment, the check valve
can be configured to release pressure above 350 mmHg to opening a
fallopian tube or dislodging an implant. Therefore, when the user
squeezes the pump handle 702 when the dial is reading 350 mmHg, the
check valve releases any excess pressure. The connecting piece 706
is connected to a catheter 710. The catheter 710 can be of the same
configuration and type of any catheter described in this
application. Of course, if a fallopian tube is patent, the dial 704
will indicate a pressure drop so the user will know the regions
620a, 620b are not sealed. It is understood that negative or
positive pressure can be applied by the hand pump 700 and the pump
may be an automatic pump, according to one embodiment.
[0080] FIG. 8A illustrates an exemplary embodiment of a uterine
balloon 800 similar to the one shown in FIG. 6B. The first 802 and
second 804 tubes are shown protruding slightly beyond an outer
surface 806 of the uterine balloon 800. The inner wall 808 of the
uterine balloon 800 defines an inflation cavity 810 where the air,
water, saline, or other liquid fills the balloon 800 for inflation.
The balloon 800 can be made from an elastic material such as
silicone, latex, urethane, and other known flexible polymers. In
one embodiment, the uterine balloon 800 is slightly larger than a
typical uterus size. In one embodiment, the balloon 800 has an
inflated width dimension 812 of 1.6-3.0 cm depending on the size of
a patient's uterus. In another embodiment, the inflated width
dimension 812 is at least 3.0 cm to ensure the balloon seals and
engages with the fundal width. In one embodiment, the balloon 800
has an inflated length dimension 814 of 5-8 cm. In another
embodiment, the inflated length dimension 814 is at least 8 cm to
ensure the balloon seals and engages the uterus length. In yet
another embodiment, the balloon can have an inflated width in a
range from about 3-4 cm, a height in a range of about 5-7 cm, and a
depth range of about 1-1.5 cm. A pressure of about 150-250 mmHg can
be used to inflate the balloon.
[0081] As previously mentioned, the first 802 and second 804 tubes
can be individually connected with a pressure source 816 such as
the hand pump and gauge described in FIG. 7. The advantage of
having an individual tube and gauge connection is that each
fallopian tube can be verified independently of the other fallopian
tube. In one embodiment, a different pressure is provided in the
first tube 802 and second tube 804 so that the individual
verification of each tube can be easily achieved. In one
embodiment, more than one hand pump or gauge 816 can be connected
with the balloon 800.
[0082] The first 802 and second 804 tubes can be made from a
material including nylon, Teflon, silicone, tygon, polyethylene,
and any other known flexible polymer. In one embodiment, the tubal
openings can be in the range of about 0.1-0.3 cm.
[0083] FIG. 8B illustrates another embodiment of a uterine balloon
818 having the same shape and dimensions as described above. The
uterine balloon 818 includes a first pair of tubes 820 and a second
pair of tubes 822 extending from a distal end of the catheter 824
to a respective sealed region in alignment with a tubal ostia. The
first 820 and second pair of tubes 822 together form a Y-shape as
previously described.
[0084] The first pair of tubes 820 include a first lumen 820a and a
second lumen 820b. As described in FIG. 3A, a negative pressure is
applied through the first lumen 820a within the sealed portion of
the cornua. Distension fluid is evacuated from the sealed portion
and measured using a measuring device 826 such as a marked syringe.
It is understood that a separate syringe may be provided for each
individual lumen or the same single syringe may be movable between
each lumen. Again, a small amount of fluid can be evacuated such as
1 cc or less.
[0085] The second lumen 820b can supply a second fluid to replace
the distension fluid. The volume of the second fluid applied is
measured to determine if it is greater than the amount of
distension fluid removed. As previously mentioned, if the volumes
are equal or close (within 10%), the fallopian tube is determined
to be positively occluded by the occlusion device.
[0086] On the other hand, if the volume of the second fluid is
significantly greater than the amount removed, the second fluid is
assumed to have leaked past the utero-tubal junction and occlusion
device as previously described.
[0087] The second pair of tubes 822 include a first lumen 822a for
removing distension fluid and a second lumen 822b for replacing the
fluid. The second pair of tubes 822 operate in the exact same
manner as described above with respect to the first pair of tubes
820.
[0088] FIGS. 9A-9D illustrate various catheter cross-sectional
views that may be implemented in any of the embodiments previously
discussed. FIG. 9A illustrates a catheter cross-section embodiment
having a first lumen 902, a second lumen 904 and a third lumen 906
within the outer sheath. In one embodiment, the first lumen 902 is
used to deliver air, fluid, saline, or any gas or liquid to inflate
an outer sheath balloon 508, 608 or end balloon 506, 606. In
addition, the first lumen 902 may be used to evacuate or vacuum the
air or fluid. In one embodiment, the second 904 and third 906 lumen
can be connected to inner catheters 504, 616 or the inner catheters
can be located within the second and third lumen.
[0089] FIG. 9B shows another embodiment 908 having a first lumen
910, a second lumen 912, a third lumen 914, a fourth lumen 916, and
a fifth lumen 918. Again, the first lumen 902 provides air or fluid
to the balloons and may also evacuate or vacuum the air or fluid.
The second 912 and third 914 lumens operate to evacuate a
distension fluid from respective catheters, as previously
described. The fourth 916 and fifth 918 lumens allow a replacement
fluid to be injected into a sealed region, as previously
described.
[0090] FIG. 9C shows yet another cross-sectional embodiment 920
having a first lumen 922, a second lumen 924, a third lumen 926, a
fourth lumen 928, a fifth lumen 930, a sixth lumen 932, and a
seventh lumen 934. The first lumen 922 acts primarily as a vacuum
source while the second lumen 924 operates to fill the outer sheath
balloon with air or fluid. The third lumen 926 primarily operates
to fill the end balloon portions or uterine balloon with air or
fluid. The fourth lumen 928 and fifth lumen 930 operate to vacuum
or evacuate a distension fluid. The sixth 932 and seventh lumen 934
operate to inject a second fluid into the sealed region as
previously described.
[0091] FIG. 9D shows another embodiment 936 having a first lumen
938, a second lumen 940, a third lumen 942, a fourth lumen 944, and
a fifth lumen 946. The first 938, second 940, and third lumen 942
operate in the same manner as the embodiment described in FIG. 9C.
The fourth 944 and fifth 946 lumen are provided to supply a
monitoring pressure to the sealed region to determine if a
respective fallopian tube is patent. The fourth lumen 944
correlates to one sealed region and the fifth lumen 946 correlates
to a second sealed region of the cornua.
[0092] Although the lumens show are generally a circular shape, it
is understood that the lumen passages can be a variety of
cross-sectional shapes including semi-circles, squares, rectangles
and any other known shape for delivering air or fluid to a cornua
for determining whether a fallopian tube is occluded.
[0093] A significant advantage of the embodiments of the present
invention is that the fallopian tubes can be tested for patency
either individually or simultaneously. Having both cornual regions
tested simultaneously results in reduced testing time and minimizes
patient discomfort.
[0094] While certain exemplary embodiments have been described and
shown in the accompanying drawings, it is to be understood that
such embodiments are merely illustrative and not restrictive of the
current invention, and that this invention is not restricted to the
specific constructions and arrangements shown and described since
modifications may occur to those ordinarily skilled in the art.
* * * * *