U.S. patent application number 13/216046 was filed with the patent office on 2012-03-22 for methods, systems and devices for performing gynecological procedures.
This patent application is currently assigned to Hologic, Inc.. Invention is credited to Ronald David Adams, J. Christopher Flaherty, William Harwick Gruber.
Application Number | 20120067352 13/216046 |
Document ID | / |
Family ID | 39365357 |
Filed Date | 2012-03-22 |
United States Patent
Application |
20120067352 |
Kind Code |
A1 |
Gruber; William Harwick ; et
al. |
March 22, 2012 |
METHODS, SYSTEMS AND DEVICES FOR PERFORMING GYNECOLOGICAL
PROCEDURES
Abstract
Methods, systems and devices for performing gynecological
procedures. According to one embodiment, there is provided a device
for occluding a fallopian tube, the device including an outer
member and an inner member. The outer member may be a hollow,
frusto-conical structure shaped to include an open proximal end, an
open distal end, and a side wall. The outer member may be
self-expandable such that the distal end is biased radially
outwardly. In addition, the side wall may have a porous structure
to permit the ingrowth of tissue therethrough. Tines may be
provided on the outer surface of the side wall to promote the
anchoring of the outer member in a fallopian tube. The inner
member, which may be structured to induce scarring, may comprise an
elongated fibrous body fixed at its proximal end to the proximal
end of the outer member. A bore may extend distally from the
proximal end of the inner member to receive a delivery rod. The
inner member, which may have pores or interstices to permit the
ingrowth of tissue thereinto, is coated or impregnated with a
sclerosing agent.
Inventors: |
Gruber; William Harwick;
(Southborough, MA) ; Adams; Ronald David;
(Holliston, MA) ; Flaherty; J. Christopher;
(Topsfield, MA) |
Assignee: |
Hologic, Inc.
Bedford
MA
|
Family ID: |
39365357 |
Appl. No.: |
13/216046 |
Filed: |
August 23, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11936003 |
Nov 6, 2007 |
8025656 |
|
|
13216046 |
|
|
|
|
60857440 |
Nov 7, 2006 |
|
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Current U.S.
Class: |
128/831 |
Current CPC
Class: |
A61F 6/225 20130101;
A61B 2017/12054 20130101; A61B 17/12131 20130101; A61B 2017/00986
20130101; A61B 17/12022 20130101; A61F 6/208 20130101; A61B
17/12172 20130101; A61B 17/12159 20130101; A61B 17/12099
20130101 |
Class at
Publication: |
128/831 |
International
Class: |
A61F 6/22 20060101
A61F006/22 |
Claims
1. A device for use in occluding a fallopian tube, the device
comprising: a) a self-expandable structure, the self-expandable
structure being insertable into the fallopian tube and, once
expanded, being engageable with the inner wall of the fallopian
tube; and b) a sclerosing agent, the sclerosing agent being
delivered to the fallopian tube by the self-expandable
structure.
2. The device as claimed in claim 1 wherein the self-expandable
structure comprises a frusto-conical member.
3. The device as claimed in claim 2 wherein the frusto-conical
member is shaped to include an open proximal end, an open distal
end and a side wall, the open distal end being outwardly biasing,
the side wall being porous to permit the ingrowth of tissue
therethrough.
4. The device as claimed in claim 3 wherein the device further
comprises a scar-inducing structure, the scar-inducing structure
being fixed within the frusto-conical member and bearing the
sclerosing agent.
5. The device as claimed in claim 4 wherein the scar-inducing
structure comprises a fibrous polyester member.
6. The device as claimed in claim 4 wherein the sclerosing agent is
coated on the surface of the scar-inducing structure.
7. The device as claimed in claim 4 wherein the scar-inducing
structure is impregnated with the sclerosing agent.
8. The device as claimed in claim 1 wherein the sclerosing agent is
selected from the group consisting of quinacrine, talc, and
doxycycline.
9. The device as claimed in claim 4 wherein the scar-inducing
structure has an open distal end for receiving an insertion
rod.
10. The device as claimed in claim 3 wherein the side wall is
shaped to include at least one anchoring member.
11. The device as claimed in claim 1 wherein the self-expandable
structure comprises at least one malecot structure.
12. The device as claimed in claim 11 wherein the self-expandable
structure comprises a plurality of malecot structures.
13. The device as claimed in claim 1 wherein the self-expandable
structure comprises a Z-shaped stent.
14. The device as claimed in claim 1 wherein the self-expandable
structure comprises a spider filter.
15. The device as claimed in claim 1 wherein the self-expandable
structure comprises a wall-stent that has been twisted in opposite
directions at its two ends and then heat-set in the twisted
state.
16. A system for use in occluding a fallopian tube, the system
comprising: a) the device as claimed in claim 1; b) a protective
delivery sheath, the device being slidably disposed within the
protective delivery sheath; and c) means for translationally
positioning the device relative to the protective delivery
sheath.
17. The system as claimed in claim 16 wherein said positioning
means is detachably engageable with the device.
18. A device for use in occluding a fallopian tube, the device
comprising: a) a tubular member, the tubular member comprising a
proximal end, a distal end and a longitudinal bore; b) an elongated
member, the elongated member comprising a proximal end, a distal
end, a bore extending distally from the proximal end, and a port
located intermediate to the proximal end and the distal end, the
port being in fluid communication with the bore, the distal end
being enlarged, the proximal end of the elongated member being
slidable within the longitudinal bore of the tubular member.
19. The device as claimed in claim 18 wherein the distal end bears
a sclerosing agent.
20. The device as claimed in claim 18 further comprising means for
providing suction to the bore of the elongated member.
21. The device as claimed in claim 18 further comprising means for
impeding the elongated member from sliding distally relative to the
tubular member.
22. A device for occluding a tube, the device comprising: a) a
tubular member, the tubular member comprising a proximal end, a
distal end and a longitudinal bore; b) a balloon, the balloon being
reversibly inflatable and being slidably disposed within the
longitudinal bore of the tubular member; c) a ligating band, the
ligating band being mounted around the tubular member; and d) means
for ejecting the ligating band distally from the tubular
member.
23-25. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 11/936,003, filed Nov. 6, 2007, which claims the benefit under
35 U.S.C. .sctn.119 of U.S. Provisional Patent Application No.
60/857,440, filed Nov. 7, 2006, all of which are hereby
incorporated by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to new methods, systems and
devices for performing gynecological procedures.
[0003] There are many types of situations when it may be desirable
to perform a medical procedure on a patient. The medical procedure
may be diagnostic and/or therapeutic in nature. For example, one
part of the human anatomy where medical procedures are commonly
performed is the female reproductive system. The female
reproductive system includes two main parts, the uterus and the
ovaries. The uterus is a pear-shaped organ made up of two distinct
anatomical regions: the cervix and the corpus. The cervix is a
narrow cylindrical passage (about 1.5-4.0 mm in diameter) which
connects at its lower end with the vagina. The corpus, which is the
portion of the uterus that grows during pregnancy to carry a fetus,
is shaped to include two portions: the lower uterine segment and
the fundus. The cervix widens at its upper end to form the lower
uterine segment of the corpus. The lower uterine segment, in turn,
widens at its upper end into the fundus of the corpus.
Dimensionally, the length of the uterus, measured from the cervix
to the fundus, is approximately 8-10 cm, and the maximum width of
the uterus, which is near the fundus, is about 4-5 cm. Extending
from the fundus of the uterus on either side are fallopian tubes.
The fallopian tubes are continuous with the uterine cavity and
allow the passage of an egg from an ovary to the uterus where the
egg may implant if fertilized.
[0004] One type of commonly-performed gynecological procedure
(i.e., a procedure relating to the female reproductive system) is a
sterilization procedure, i.e., a procedure intended to prevent
future pregnancies. One of the more common types of sterilization
procedures has been in the form of "tubal ligation," which has been
performed as follows: An appropriately-located incision is made in
the patient's abdomen, and a laparoscope is inserted through the
incision to provide access to a fallopian tube of the patient. A
suture is inserted through the laparoscope and is tied around the
fallopian tube in such a manner to cinch shut the fallopian tube,
thereby preventing the fertilization of an egg within the tube.
Because the inner surface of the fallopian tube is provided with a
number of folds, several such sutures are typically used to cinch
shut the fallopian tube at a plurality of spaced-apart locations.
In addition, it is also common to sever the fallopian tube at a
point between each pair of adjacent sutures as a further impediment
to the fertilization of an egg. The above-described procedure is
typically performed on both fallopian tubes.
[0005] One variant of the aforementioned "tubal ligation" procedure
involves laparoscopically introducing a hook into the patient and
using the hook to pull a portion of the fallopian tube into a
hairpin loop. Then, a ligating band is inserted tightly around the
looped portion of the tube so as to seal the tube shut. Another
variant of "tubal ligation" involves laparoscopically introducing
an electrocautery device into the patient and using the
electrocautery device to sever the tube and to seal the tube
shut.
[0006] Unlike the above-described sterilization procedures, all of
which involve accessing the fallopian tubes laparoscopically and
sealing the tubes shut by means located outside the fallopian
tubes, certain recently-developed techniques involve accessing the
fallopian tubes hysteroscopically and sealing the tubes shut by
occluding the tubes from within. One such approach involves
hysteroscopically placing within the fallopian tube a device
comprising a self-expanding coil surrounding a fibrous polyester
member. The fibrous polyester member induces scarring, i.e., the
ingrowth of tissue into the fallopian tube, thereby resulting in
occlusion of the fallopian tube. Examples of this type of "tubal
occlusion" procedure are disclosed in U.S. Pat. No. 6,684,884,
inventors Nikolchev et al., issued Feb. 3, 2004, and U.S. Pat. No.
6,705,323, inventors Nikolchev et al., issued Mar. 16, 2004, both
of which are incorporated herein by reference. One modification of
the aforementioned "tubal occlusion" procedure involves heating the
implanted fibrous polyester member to induce further the ingrowth
of tissue into the fallopian tube. An example of this modified
procedure is disclosed in U.S. Pat. No. 6,726,682, inventors
Harrington et al., issued Apr. 27, 2004, which is incorporated
herein by reference.
[0007] In addition to the above-described sterilization procedures,
many other types of gynecological procedures are commonly
performed. Some of these procedures take place outside of the
uterine cavity and include the draining of ovarian cysts, the
treatment of endometriosis in the peritoneal cavity, and the
removal of fibroids on the external surface of the uterus. At
present, all of the foregoing types of procedures are typically
performed using laparoscopic surgery. As can be appreciated,
laparoscopic surgery requires suitable equipment and is typically
performed in a hospital setting. As a result, such procedures often
bear a large cost due to the setting and the support personnel
required.
SUMMARY OF THE INVENTION
[0008] It is an object of the present invention to provide new
methods, systems and devices for performing gynecological
procedures.
[0009] According to one aspect of the invention, there is provided
a device for use in occluding a fallopian tube, the device
comprising (a) a self-expandable structure, the self-expandable
structure being insertable into the fallopian tube and, once
expanded, being engageable with the inner wall of the fallopian
tube; and (b) a sclerosing agent, the sclerosing agent being
delivered to the fallopian tube by the self-expandable
structure.
[0010] More specifically, according to one embodiment, the device
may include an outer member and an inner member. The outer member
may be a hollow, frusto-conical structure shaped to include an open
proximal end, an open distal end, and a side wall. The outer member
may be self-expandable such that the distal end is biased radially
outwardly. In addition, the side wall may have a porous structure
to permit the ingrowth of tissue therethrough. Tines may be
provided on the outer surface of the side wall to promote the
anchoring of the outer member in a fallopian tube. The inner
member, which may be structured to induce scarring, may comprise an
elongated fibrous body fixed at its proximal end to the proximal
end of the outer member. A bore may extend distally from the
proximal end of the inner member to receive a delivery rod. The
inner member, which may have pores or interstices to permit the
ingrowth of tissue thereinto, is coated or impregnated with a
sclerosing agent.
[0011] According to another aspect of the invention, there is
provided a system for use in occluding a fallopian tube, the system
comprising (a) a device, the device comprising (i) a
self-expandable structure, the self-expandable structure being
insertable into the fallopian tube and, once expanded, being
engageable with the inner wall of the fallopian tube; and (ii) a
sclerosing agent, the sclerosing agent being delivered to the
fallopian tube by the self-expandable structure; (b) a protective
delivery sheath, the device being slidably disposed within the
protective delivery sheath; and (c) means for translationally
positioning the device relative to the protective delivery
sheath.
[0012] According to still another aspect of the invention, there is
provided a device for use in occluding a fallopian tube, the device
comprising (a) a tubular member, the tubular member comprising a
proximal end, a distal end and a longitudinal bore; (b) an
elongated member, the elongated member comprising a proximal end, a
distal end, a bore extending distally from the proximal end, and a
port located intermediate to the proximal end and the distal end,
the port being in fluid communication with the bore, the distal end
being enlarged, the proximal end of the elongated member being
slidable within the longitudinal bore of the tubular member.
[0013] According to still yet another aspect of the invention,
there is provided a device for occluding a tube comprising (a) a
tubular member, the tubular member comprising a proximal end, a
distal end and a longitudinal bore; (b) a balloon, the balloon
being reversibly inflatable and being slidably disposed within the
longitudinal bore of the tubular member; (c) a ligating band, the
ligating band being mounted around the tubular member; and (d)
means for ejecting the ligating band distally from the tubular
member.
[0014] According to a further aspect of the invention, there is
provided a method for accessing the peritoneal cavity of a patient,
the method comprising the steps of (a) inserting the distal end of
a guidewire through the vagina, the cervix, the uterus, and a
fallopian tube and into the peritoneal cavity; and (b) inserting
the distal end of a scope distally over the guidewire until the
distal end of the scope is positioned in the peritoneal cavity.
[0015] According to yet a further aspect of the invention, there is
provided a method for performing a gynecological procedure in the
peritoneal cavity of a patient, the method comprising the steps of:
(a) inserting the distal end of a guidewire through the vagina, the
cervix, the uterus, and a fallopian tube and into the peritoneal
cavity; (b) inserting the distal end of a scope distally over the
guidewire until the distal end of the scope is positioned in the
peritoneal cavity; (c) removing the guidewire from the patient and
from the scope, thereby leaving the guidewire lumen unoccupied; (d)
delivering a tool to the peritoneal cavity through the unoccupied
lumen of the scope, the tool having at least one of a diagnostic
utility and a therapeutic utility; and (e) using the tool to
perform at least one of a diagnostic procedure and a therapeutic
procedure in the peritoneal cavity.
[0016] According to still yet a further aspect of the invention,
there is provided a method for performing a gynecological procedure
in the peritoneal cavity of a patient, the method comprising the
steps of (a) inserting the distal end of a guidewire through the
vagina, the cervix, the uterus, and a fallopian tube and into the
peritoneal cavity; (b) inserting the distal end of a scope distally
over the guidewire until the distal end of the scope is positioned
in the peritoneal cavity; (c) inserting the distal end of the
guidewire through one of the uterus and the fornix; (d) withdrawing
the distal end of the guidewire from the patient through the
vagina; (e) delivering a tool to the peritoneal cavity by passing
the tool over one of the proximal end of the guidewire and the
distal end of the guidewire until the tool is positioned in the
peritoneal cavity, the tool having at least one of a diagnostic
utility and a therapeutic utility; and (f) using the tool to
perform at least one of a diagnostic procedure and a therapeutic
procedure.
[0017] Additional objects, as well as aspects, features and
advantages, of the present invention will be set forth in part in
the description which follows, and in part will be obvious from the
description or may be learned by practice of the invention. In the
description, reference is made to the accompanying drawings which
form a part thereof and in which is shown by way of illustration
various embodiments for practicing the invention. The embodiments
will be described in sufficient detail to enable those skilled in
the art to practice the invention, and it is to be understood that
other embodiments may be utilized and that structural changes may
be made without departing from the scope of the invention. The
following detailed description is, therefore, not to be taken in a
limiting sense, and the scope of the present invention is best
defined by the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The accompanying drawings, which are hereby incorporated
into and constitute a part of this specification, illustrate
various embodiments of the invention and, together with the
description, serve to explain the principles of the invention. In
the drawings wherein like reference numerals represent like
parts:
[0019] FIGS. 1(a) and 1(b) are perspective and longitudinal section
views, respectively, of a first embodiment of a tubal occlusion
device constructed according to the teachings of the present
invention;
[0020] FIGS. 2(a) through 2(d) are schematic views, partly in
section, showing how the tubal occlusion device of FIGS. 1(a) and
1(b) may be used;
[0021] FIGS. 3(a) and 3(b) are exploded side and longitudinal
section views, respectively, of a second embodiment of a tubal
occlusion device constructed according to the teachings of the
present invention;
[0022] FIGS. 4(a) through 4(d) are schematic views, partly in
section, showing how the tubal occlusion device of FIGS. 3(a) and
3(b) may be used;
[0023] FIG. 5 is a fragmentary side view of a third embodiment of a
tubal occlusion device constructed according to the teachings of
the present invention;
[0024] FIGS. 6(a) and 6(b) are side views in a compressed state and
in an expanded state, respectively, of a fourth embodiment of a
tubal occlusion device constructed according to the teachings of
the present invention;
[0025] FIG. 7 is a side view of a fifth embodiment of a tubal
occlusion device constructed according to the teachings of the
present invention;
[0026] FIG. 8 is a side view of a sixth embodiment of a tubal
occlusion device constructed according to the teachings of the
present invention;
[0027] FIG. 9 is a longitudinal section view of a seventh
embodiment of a tubal occlusion device constructed according to the
teachings of the present invention;
[0028] FIG. 10 is an enlarged fragmentary view of the distal end of
the device of FIG. 9;
[0029] FIG. 11 is a side view, partly in section, of an eighth
embodiment of a tubal occlusion device constructed according to the
teachings of the present invention;
[0030] FIGS. 12(a) through 12(c) are schematic diagrams, partly in
section, illustrating a first embodiment of a method for performing
gynecological procedures in the peritoneal cavity, said method
being performed in accordance with the teachings of the present
invention;
[0031] FIG. 13(a) is a section view of the scope shown in FIGS.
12(a) through 12(c);
[0032] FIG. 13(b) is a section view of an alternate scope suitable
for use in the method of FIGS. 12(a) through 12(c), the scope
having a teardrop cross-sectional shape;
[0033] FIGS. 14(a) through 14(d) are schematic diagrams, partly in
section, illustrating a second embodiment of a method for
performing gynecological procedures in the peritoneal cavity, said
method being performed in accordance with the teachings of the
present invention;
[0034] FIG. 15 is a schematic diagram, partly in section,
illustrating an application of the method shown in FIGS. 14(a)
through 14(d) for treating a fibroid on the exterior surface of the
uterus; and
[0035] FIG. 16 is a schematic diagram, partly in section,
illustrating a variation to the method shown in FIGS. 14(a) through
14(d).
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0036] Referring now to FIGS. 1(a) and 1(b), there are shown
perspective and longitudinal section views, respectively, of a
first embodiment of an occlusion device for a fallopian tube, the
occlusion device being constructed according to the teachings of
the present invention and being represented generally by reference
numeral 11.
[0037] Device 11 may include an outer member 13 and an inner member
15. Outer member 13, which may be a self-expandable structure
adapted to engage the inner wall of a fallopian tube, may comprise
a hollow, frusto-conical structure shaped to include an open
proximal end 17, an open distal end 19, and a side wall 21. Outer
member 13 may be made of a resilient or shape-memory material, such
as Nitinol (nickel-titanium alloy), so that distal end 19 may be
biased radially outwardly. In addition, outer member 13 may be
fabricated so that side wall 21 has a mesh structure or other
porous structure to permit the ingrowth of tissue therethrough. A
plurality of anchoring tines 23 may be provided on the outer
surface of side wall 21 proximate to distal end 19, tines 23 being
adapted to promote the anchoring of outer member 13 in a fallopian
tube wall once outer member 13 has assumed an expanded state
therein. Preferably, tines 23 are arranged to take advantage of the
peristaltic contractions of the fallopian tube to drive the
anchoring members into the intima of the fallopian tube. Thus, as
peristalsis tries to expel device 11, tines 23 will be driven into
the intima, thereby anchoring device 11 deeper and deeper.
[0038] Inner member 15, which may be a structure adapted to induce
scarring, may comprise an elongated, cylindrical member shaped to
include a proximal end 31 and a distal end 33. Proximal end 31 of
inner member 15 may be secured by an adhesive or other suitable
means to proximal end 17 of outer member 13. A bore 35 may extend
distally from proximal end 31 of inner member 15, bore 35 being
adapted to receive a delivery rod or other like structure. Distal
end 33, which may extend distally beyond distal end 19 of outer
member 13, may be rounded to facilitate the insertion of device 11
into a patient. Inner member 15, which may have pores or
interstices to permit the ingrowth of tissue thereinto, may
comprise a fibrous polyester member, a mesh metal member or the
like and may additionally be coated or impregnated with a
sclerosing agent to induce scarring. Examples of suitable
sclerosing agents include quinacrine, talc and doxycycline.
[0039] Although the dimensions of device 11 may vary, certain
exemplary dimensions of outer member 13 may be as follows: length
of outer member 13 (i.e., distance from proximal end 17 to distal
end 19)--3 cm or less; diameter of proximal end 17--1 mm; diameter
of distal end 19 in expanded state--2.0 to 2.5 mm.
[0040] Referring now to FIGS. 2(a) through 2(d), there is
schematically shown one way in which device 11 may be used to
occlude a fallopian tube. First, as seen in FIG. 2(a), the distal
end 41 of an insertion rod 43 is inserted distally into bore 35 of
inner member 15, rod 43 being appropriately dimensioned to engage
bore 35 by a friction-fit. (It should be understood that, instead
of a friction-fit, rod 43 may be detachably engaged with inner
member 15 by other mechanisms, such as a ball-detent mechanism.)
Next, the distal end 45 of an outer sheath 47 is inserted over
outer member 13 of device 11, sheath 47 being constructed to
radially compress distal end 19 of outer member 13 sufficiently to
permit transcervical delivery of device 11 to the fallopian tube.
Next, as seen in FIG. 2(b), the combination of device 11, distal
end 41 of insertion rod 43, and distal end 45 of sheath 47 is
inserted into a fallopian tube F of a patient, preferably having
been inserted along a vaginal-cervical-uterine pathway. Next, as
seen in FIG. 2(c), sheath 47 is retracted proximally from device
11, thereby allowing outer member 13 to self-expand and causing
tines 23 to engage fallopian tube F. Finally, as seen in FIG. 2(d),
rod 43 is pulled away from device 11, and the combination of rod 43
and sheath 47 is withdrawn from the patient, leaving device 11
secured within fallopian tube F. Although not shown, due to
scarring caused by device 11 and by the presence of the sclerosing
agent on inner member 15, the tissue on the inner surface of
fallopian tube F will, over time, grow into and around device 11,
thereby effectively occluding fallopian tube F.
[0041] Referring now to FIGS. 3(a) and 3(b), there are shown
exploded side and longitudinal section views, respectively, of a
second embodiment of an occlusion device for a fallopian tube, the
occlusion device being constructed according to the teachings of
the present invention and being represented generally by reference
numeral 101.
[0042] Device 101 may comprise a first portion 103, a second
portion 105, and a third portion 107. First portion 103 may
comprise a tube 109. Tube 109, which may be appropriately
dimensioned to be inserted coaxially into a fallopian tube, may be
shaped to include an open proximal end 111, an open distal end 113
and a side wall 115. Side wall 115, which may be cylindrical in
shape, may possess a mesh or other porous structure to permit the
ingrowth of tissue therethrough. (For clarity and simplicity, the
porosity of side wall 115 is not shown in FIG. 3(b).) A first end
116 of a pawl 117 may be pivotally mounted on a pivot pin 119 on
the inner surface of side wall 115 proximate to distal end 113. A
second end 120 of pawl 117 may be fixed to a distal end 121 of a
tensioning cable 123 used to pivot pawl 117, with tensioning cable
123 also being drawn around a pin 125.
[0043] Second portion 105 of device 101 may comprise an elongated
member shaped to include a proximal end 131 and a distal end 133.
Proximal end 131 may have a concave shape for receiving the distal
end of third portion 107 in a snap-fit. Distal end 133 may be in
the shape of a dome or other enlarged structure preferably at least
as large in diameter as first portion 103. Distal end 133 may be
coated or impregnated with a sclerosing agent to induce scarring.
Examples of suitable sclerosing agents include quinacrine, talc and
doxycycline. A bore 135 may extend longitudinally from proximal end
131 to a port 137, port 137 being located at an intermediate point
along the length of second portion 105. As will be discussed
further below, port 137 is used to apply vacuum pressure so that,
when device 101 is inserted into a fallopian tube, the fallopian
tube may be pulled radially inwardly. A series of barbs 139 may be
provided along the length of second portion, barbs 139 being
engageable with second end 120 of pawl 117.
[0044] Third portion 107 may comprise an elongated tubular member
shaped to include a proximal end 141, a distal end 143 and a
longitudinal bore 145. Proximal end 141 may be adapted to be
coupled to a source of vacuum pressure. Distal end 143 may have an
appropriate shape so that distal end 143 may be coupled to proximal
end 131 of second portion 105 by a snap-fit. (It should be
understood that, instead of a snap-fit, distal end 143 of third
portion 107 and proximal end 131 of second portion 105 may be
coupled together in some other detachably engageable manner.)
[0045] Although the dimensions of device 101 may vary, the combined
length of first portion 103 and second portion 105 (with distal end
133 of second portion 105 lying flush against distal end 113 of
first portion 103) may be approximately 30 mm, more preferably
approximately 20 mm, even more preferably approximately 10 mm. The
outer diameter of device 101, when assembled, may be less than 3
mm, more preferably less than 2 mm, even more preferably less than
1 mm.
[0046] Referring now to FIGS. 4(a) through 4(d), there is
schematically shown one way in which device 101 may be used to
occlude a fallopian tube. First, as seen in FIG. 4(a), with device
101 assembled and mounted on the distal end 150 of a delivery
catheter 151, device 101 is inserted into a fallopian tube F of a
patient, preferably having been inserted along a
vaginal-cervical-uterine pathway. Next, as seen in FIG. 4(b), with
tension applied to cable 123 in such a way as to move pawl 117 away
from barbs 139, third portion 107 is moved distally until port 137
is positioned distally relative to distal end 113 of first portion
103. As can be seen, this movement of second portion 105 relative
to first portion 103 creates a waist or length of narrowed diameter
between first portion 103 and distal portion 133 of second portion
105. Next, as seen in FIG. 4(c), tension is released from cable
123, causing pawl 117 to engage barbs 139 and preventing further
distal movement of second portion 105 relative to first portion
103. In addition, vacuum pressure is applied to third portion 107,
causing fallopian tube F to be drawn radially inwardly towards port
137. Next, as seen in FIG. 4(d), third portion 107 and delivery
catheter 151 are withdrawn proximally from the patient. The
proximal movement of third portion 107 initially causes second
portion 105 to be moved proximally towards first portion 103,
resulting in the drawn portion of fallopian tube F being securely
clamped between distal end 113 of first portion 103 and distal end
133 of second portion 105. The continued proximal movement of third
portion 107 then causes third portion 107 to become disengaged from
second portion 105, leaving first portion 103 and second portion
105 secured within fallopian tube F. Although not shown, due to
scarring caused by device 101 and by the presence of the sclerosing
agent on distal end 133 of second portion 105, the tissue on the
inner surface of fallopian tube F will, over time, grow into and
around device 101, thereby effectively occluding fallopian tube
F.
[0047] As can be appreciated, in accordance with the teachings of
the present invention, one could use any of a variety of
self-expandable structures that have been coated or impregnated
with a sclerosing agent as an occlusion device for a fallopian
tube. Examples of such coated or impregnated structures are shown
in FIGS. 5 through 8. More specifically, in FIG. 5, there is shown
a self-expandable device 201 having two malecot structures 202-1
and 202-2 in its expanded state. Barbs 203 may be provided on
malecot structures 202-1 and 202-2 to improve the anchoring of
device 201 within a fallopian tube. It should be understood that,
although two malecot structures are shown in device 201, device 201
could be modified to have as few as one malecot structure or to
include three or more malecot structures. Moreover, although the
malecot structures of device 201 are aligned with one another,
device 201 could be modified by rotating the relative positions of
the two malecot structures so that they are staggered relative to
one another. In FIGS. 6(a) and 6(b), there is shown a device 251
that may self-expand from a compressed or lower-profile state (FIG.
6(a)) to an expanded or higher-profile Z-shaped state (FIG. 6(b)).
Barbs 253 may be provided on device 251 to improve the anchoring of
device 251 within a fallopian tube. In FIG. 7, there is shown a
device 271 in the form of a spider filter in its expanded state. In
FIG. 8, there is shown a device 291 in the form of a modified
wallstent, the modified wallstent being twisted in opposite
directions at its two ends and then heat-set in this twisted state.
In use, the devices of FIGS. 5 through 8 may be delivered to the
fallopian tube along a vaginal-cervical-uterine pathway while in a
compressed state within a delivery catheter and then may be ejected
distally from the delivery catheter using an ejector rod to
self-expand into engagement with the fallopian tube of the patient.
Due to scarring caused by the device and by the presence of the
sclerosing agent on the device, the tissue on the inner surface of
the fallopian tube will, over time, grow radially inwardly, thereby
effectively occluding the fallopian tube.
[0048] Referring now to FIG. 9, there is shown a longitudinal
section view of a seventh embodiment of a tubal occlusion device
constructed according to the teachings of the present invention,
the tubal occlusion device being represented generally by reference
numeral 301.
[0049] Device 301, which is similar in certain respects to the
device disclosed in U.S. Pat. No. 4,735,194, which is incorporated
herein by reference, may include a flexible scope 310 equipped with
a suction channel 311 and a fiberoptics illumination channel 312,
both exiting at a terminal 313 which may be connected to a control
box (not shown) for supplying suction and illumination. In
addition, scope 310 may be equipped with a balloon channel 305 for
slidably receiving an inflation catheter 307 for a balloon. An
eyepiece 314 may provide means for viewing the procedure either
directly or by video camera and subsequent projection onto a video
monitor. A trip wire 315, located in a channel 316, may be equipped
with a weighted handle 317 and may be fastened to an inner tube 318
at a notch 319. A ligating band 320 may be mounted on inner tube
318, which may be positioned within an outer tube 321. Outer tube
321 may be fastened securely to scope 310 by means of a threaded
connection 322. An inflatable balloon 325 may be coupled to the
distal end of inflation catheter 307, balloon 325 being slidably
disposed within inner tube 318.
[0050] FIG. 10 illustrates in enlarged detail (in phantom)
inflatable balloon 325 disposed within inner tube 318. Also
illustrated in enlarged detail is ligating band 320 mounted on
inner tube 318, which may be inserted within outer tube 321. Trip
wire 315 may be secured to notch 319 which provides for the
rearward movement of tube 318 that is required to slide band 320
around the tissue to be banded.
[0051] In use, the distal end of device 301 may be inserted into
the fallopian tube of a patient along the vaginal-cervical-uterine
pathway. Next, inflation catheter 307 may be moved distally until
balloon 325 (in a deflated state) is positioned distally a short
distance beyond the distal end of inner tube 318. Next, balloon 325
may be inflated, balloon 325 preferably engaging the walls of the
fallopian tube. (The exterior of balloon 325 may be treated with a
sclerosing agent to induce scarring.) Next, with balloon 325 thus
inflated, suction may be applied to suction channel 311, such
suction causing a portion of the fallopian tube to become
invaginated and drawn into inner tube 318. Next, trip wire 315 may
be pulled, causing band 320 to slide off inner tube 318 and to
become securely fixed around the folded tissue. Next, balloon 325
may be deflated and withdrawn proximally through the banded tissue.
Next, device 301 (except for band 320, which is left in place
around the folded tissue) may be removed from the patient.
[0052] Whereas device 301 is described above as having a single
ligating band, it should be understood that one could provide a
similar device capable of dispensing a plurality of ligating bands.
An example of such a device is shown in FIG. 11 and is represented
generally by reference numeral 410.
[0053] Device 410, which is similar in certain respects to the
device disclosed in U.S. Pat. No. 5,857,585, which is incorporated
herein by reference, is shown attached to the distal end 412 of a
scope 414. Device 410 includes a support 416 which engages a
flexible connector 418 on a shoulder 420. The other portion 422 of
connector 418 attaches to the distal end 412 of scope 414. A
passage 424 in support 416 communicates with a lumen 426 in scope
414. A plurality of ligating bands 430, 432, 434, 436 and 438 are
stretched onto support 416. The entire assembly of device 410 and
scope 414 are typically circularly symmetrical about longitudinal
axis 440 and are circular in cross section; however, this is not a
necessary feature.
[0054] Displacement element 442 extends through passage 424, then
lumen 426, and then outwardly over the distal edge 444 of support
416 through notch 446. From there, displacement element 442 loops
over at 448, around at 450, and under at 452 the first ligating
band 430 and then returns to that same notch 446, extends at 454
along the inside edge and exits radially outwardly once again and
exits once again through notch 456, whereupon it moves under 458,
around 460 and over 462 the first ligating band 430, then under 464
it moves under 458, around 460 and over 462 the first ligating band
430, then under 464 ligating band 430, over 466 the second ligating
band 432, around 468 ligating band 432, and under it 470, back to
notch 458. The paths of subsequent loops 474, 476, 478, 480, 482
and 488 and their engagement with notches 490, 492 and 494 can be
easily traced. A knot 496 or device of similar function can be
placed at the end at 498 of displacement element 442 to prevent it
from being pulled through retaining hole 422. Displacement element
442 can be connected to operator element 400 which extends all the
way to the proximal end 402 of scope 414. Displacement element 442
and operator element 400 may in fact be one and the same thread,
filament, wire or string.
[0055] An inflation catheter 421, whose proximal end is adapted to
be coupled to an inflation source (not shown), is slidably mounted
within a lumen 423 in scope 414. The distal end of inflation
catheter 421 is fluidly coupled to an inflatable balloon 425
slidably disposed within passage 424.
[0056] In use, the distal end of device 401 is introduced into a
fallopian tube through the vaginal-cervical-uterine pathway.
Inflatable balloon 425 is then extended distally relative to
support 416 and is inflated. Suction is then applied to invaginate
a portion of the fallopian tube and to draw the invaginated portion
into support 416. Next, displacement element 442 and/or operator
element 400 is pulled to the right, causing the first band 430 to
be moved and/or rolled to the left toward distal end 444 of support
416. Continued pulling on element 442 and/or 400 causes band 430 to
slide free of distal end 444 of support 416. At the moment, the
loop 410 of the displacement element 442, being free of notches 446
and 456, will unwrap from around band 430, causing the next pull on
element 442 to begin movement of the next band 432. At this time,
band 430 collapses about the tissue that has been vacuum-drawn into
the end of the support 416. If no further bands are to be
dispensed, balloon 425 is then deflated and withdrawn proximally
through the banded tissue. If further bands are to be dispensed,
movement of element 442 to the right draws up the slack so that
further pulling on elements 442 or 400 begins moving band 432 to
the left in the same way as band 430. A limiter is provided within
support 416 to catch the knot 498 or other device of similar
function so that even after the last band 438 is dispensed, element
442 cannot be completely withdrawn from device 410. This serves to
keep device 410 tethered to the distal end 412 of scope 414 so that
device 410 cannot be inadvertently lost inside the patient. The
limiter employs a hole which is smaller than knot 498 so that knot
498 cannot be pulled through it.
[0057] As noted above, gynecological procedures are not limited to
sterilization procedures. Other common types of gynecological
procedures include, for example, the draining of ovarian cysts, the
treatment of endometriosis in the peritoneal cavity, and the
removal of fibroids on the external surface of the uterus. One
feature common to the aforementioned procedures is that such
procedures take place outside of the uterine cavity and the
fallopian tubes. As noted above, it would be desirable to perform
such procedures without having to resort to laparoscopic access
through the abdomen.
[0058] Referring now to FIGS. 12(a) through 12(c), there are shown
schematic diagrams, partly in section, illustrating a new method
for performing gynecological procedures in the peritoneal cavity.
As seen in FIG. 12(a), this method may first comprise
transcervically inserting the distal end of an introducer 501 into
a patient, then inserting the distal end of a flexible scope 503
through introducer 501 and into the uterus U of the patient to
permit visualization of the fallopian tube F of the patient, and
then inserting the distal end of a flexible guidewire 505 through a
guidewire lumen in scope 503, across uterus U, through fallopian
tube F, and into the peritoneal cavity. Next, as seen in FIG.
12(b), scope 503 may be advanced distally over guidewire 505 until
the distal end of scope 503 is positioned in the peritoneal cavity.
To minimize painful insertion and movement of scope 503 through the
fallopian tube, scope 503 preferably has an outer diameter less
than about 3 mm, more preferably less than about 2 mm, even more
preferably less than about 1 mm. In addition, guidewire 505 and/or
scope 503 may be coated with a hydrophilic coating to facilitate
their easy passage through the fallopian tube. Next, as seen in
FIG. 12(c), guidewire 505 may be withdrawn from the patient, and
the distal end of a diagnostic and/or treatment tool 507 may be
inserted through the guidewire lumen of scope 503 and into the
peritoneal cavity. In FIG. 12(c), tool 507 is shown as a
retractable needle for draining an ovarian cyst. However, tool 507
is not so limited and may include, for example, a laser or RF
ablation device, for example, for treating endometriosis, an
ultrasound probe for diagnostic purposes, a biopsy forceps, or a
morcellator, for example, for treating a fibroid on the exterior of
the uterus. The cross-sectional shape of scope 503 may take a
circular shape (see FIG. 13(a)) or may take a non-circular shape,
such as a teardrop shape (see scope 503-1 of FIG. 13(b)), to allow
for the passage of a desired tool 507.
[0059] Referring now to FIGS. 14(a) through 14(d), there are shown
schematic diagrams, partly in section, illustrating another new
method for performing gynecological procedures in the peritoneal
cavity. As seen in FIG. 14(a), this method may first comprise
transcervically inserting the distal end of an introducer 601 into
a patient, then inserting the distal end of a flexible scope 603
through introducer 601 and into the uterus U of the patient to
permit visualization of the fallopian tube F of the patient, and
then inserting the distal end of a flexible guidewire 605 through a
guidewire lumen in scope 603, across uterus U, through fallopian
tube F, and into the peritoneal cavity. Next, as seen in FIG.
14(b), scope 603 may be advanced distally over guidewire 605 until
the distal end of scope 603 is positioned in the peritoneal cavity.
To minimize painful insertion and movement of scope 603 through the
fallopian tube, scope 603 preferably has an outer diameter less
than about 3 mm, more preferably less than about 2 mm, even more
preferably less than about 1 mm. In addition, guidewire 605 and/or
scope 603 may be coated with a hydrophilic coating to facilitate
their easy passage through the fallopian tube. Next, as seen in
FIG. 14(c), the distal end of guidewire 605 may be inserted through
uterus U, where it is then captured by a snare 609. (If desired,
the scope 603 may be retracted into the uterus to provide
visualization of the capture of the guidewire 605 by snare 609.)
Next, as seen in FIG. 14(d), snare 609 and the distal end of
guidewire 605 are withdrawn from the patient, thereby creating a
guidewire track over which instruments may be passed to desired
locations. For example, in FIG. 15, a morcellator 611 is advanced
over guidewire 605 and is inserted through the uterine wall into
the peritoneal cavity to treat a fibroid located on the exterior
surface of the uterus. Other possible applications of the present
method include passing a clamp through the fallopian tube using
guidewire 605 and then using said clamp to seal shut the fallopian
tube.
[0060] Referring now to FIG. 16, there is shown a schematic
diagram, partly in section, illustrating a variation to the method
shown in FIGS. 14(a) through 14(d). In FIG. 16, the distal end of
guidewire is not passed from the peritoneal cavity through the
uterine wall into the uterine cavity, but rather, is passed from
the peritoneal cavity through the vaginal fornix X and into the
vagina.
[0061] The embodiments of the present invention described above are
intended to be merely exemplary and those skilled in the art shall
be able to make numerous variations and modifications to it without
departing from the spirit of the present invention. All such
variations and modifications are intended to be within the scope of
the present invention as defined in the appended claims.
* * * * *