U.S. patent application number 14/981317 was filed with the patent office on 2016-04-21 for method and device for distending a gynecological cavity.
The applicant listed for this patent is Hologic, Inc. Invention is credited to Ronald D. Adams, Brent L. Burchfield, Chris W. Cicenas, Ryan S. Crisp, Paul DiCesare, William H. Gruber, Michael A. Lorenz, Jeffrey Radziunas, Daniel Vigliotti.
Application Number | 20160106466 14/981317 |
Document ID | / |
Family ID | 39825881 |
Filed Date | 2016-04-21 |
United States Patent
Application |
20160106466 |
Kind Code |
A1 |
Gruber; William H. ; et
al. |
April 21, 2016 |
METHOD AND DEVICE FOR DISTENDING A GYNECOLOGICAL CAVITY
Abstract
Method and device for distending a gynecological cavity.
According to one embodiment, a mechanical, non-fluid device is used
to distend the gynecological cavity. Such devices include, for
example, self-expanding members, such as resilient baskets, coils,
whisks, prongs, and loops, or mechanically expanded members, such
as inflatable balloons, mechanically-expanded cages and loops, and
scissor jacks. The device may serve a purpose in addition to
distension, such as illumination, imaging, irrigation, drug
delivery, resection and cauterization.
Inventors: |
Gruber; William H.;
(Southborough, MA) ; Adams; Ronald D.; (Holliston,
MA) ; Lorenz; Michael A.; (Marlborough, MA) ;
Crisp; Ryan S.; (Marlborough, MA) ; Cicenas; Chris
W.; (Marlborough, MA) ; Burchfield; Brent L.;
(Marlborough, MA) ; DiCesare; Paul; (Easton,
CT) ; Radziunas; Jeffrey; (Wallingford, CT) ;
Vigliotti; Daniel; (Marlborough, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hologic, Inc |
Marlborough |
MA |
US |
|
|
Family ID: |
39825881 |
Appl. No.: |
14/981317 |
Filed: |
December 28, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11951853 |
Dec 6, 2007 |
9259233 |
|
|
14981317 |
|
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|
|
60910625 |
Apr 6, 2007 |
|
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60910618 |
Apr 6, 2007 |
|
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Current U.S.
Class: |
606/193 |
Current CPC
Class: |
A61B 2017/00862
20130101; A61M 25/09 20130101; A61B 2090/306 20160201; A61B
2017/00278 20130101; A61M 25/1002 20130101; A61B 17/32002 20130101;
A61B 5/6875 20130101; A61N 5/062 20130101; A61B 1/0661 20130101;
A61M 2025/1047 20130101; A61B 2017/00557 20130101; A61B 2017/320071
20170801; A61B 2017/12127 20130101; A61B 17/12099 20130101; A61B
2090/064 20160201; A61B 2017/00893 20130101; A61M 25/0026 20130101;
A61M 29/02 20130101; A61N 5/0603 20130101; A61B 17/12136 20130101;
A61B 1/0615 20130101; A61B 17/30 20130101; A61M 25/1011 20130101;
A61B 17/0218 20130101; A61B 17/02 20130101; A61B 2017/00876
20130101; A61B 17/42 20130101; A61B 1/303 20130101; A61B 17/12045
20130101; A61B 17/22 20130101; A61M 2025/105 20130101; A61N 7/022
20130101; A61B 17/4241 20130101; A61M 37/0092 20130101; A61B
2017/306 20130101; A61B 2017/00084 20130101; A61B 17/320783
20130101; A61B 2017/22038 20130101; A61B 2017/12018 20130101; A61F
6/20 20130101; A61F 6/225 20130101; A61B 2017/32007 20170801; A61B
17/12013 20130101; A61M 31/002 20130101 |
International
Class: |
A61B 17/42 20060101
A61B017/42; A61B 17/02 20060101 A61B017/02 |
Claims
1-12. (canceled)
13. A system for performing a transcervical surgical procedure in a
uterus, comprising: a deployment tool; an expandable support
structure detachably attached to the deployment tool, the
expandable support structure configured to be transcervically
introduced and positioned within a uterus using the deployment
tool, and thereafter expanded within the uterus and detached from
the deployment tool, wherein the deployment tool is configured to
be removed from the uterus after detachment of the expanded support
structure therein, and wherein the expanded support structure
comprises a three-dimensional configuration including an upper
portion and a lower portion spaced apart from the upper portion,
the support structure being configured so that expanding the
support structure delivers an expansion force against opposing
walls of the uterus to thereby create a three-dimensional working
space between the upper and lower portions of the expanded support
structure through non-fluid mechanical distention of the uterus;
and a surgical instrument configured to be transcervically inserted
into the uterus after insertion and expansion of the support
structure, so that a distal end of the surgical instrument may be
positioned within the three-dimensional working space created by
the expanded support structure and the surgical instrument is
further configured to remove uterine wall tissue while the expanded
support structure distends the uterus through non-fluid mechanical
distention.
14. The system of claim 13, wherein the surgical instrument is
configured to extend through an opening between the upper and lower
portions of the expanded support structure for removing uterine
wall tissue through the opening.
15. The system of claim 1, wherein the support structure is
configured to be introduced into the uterus through a lumen of the
deployment tool;
16. The system of claim 1, wherein the support structure is further
configured to be collapsed and transcervically removed from the
uterus.
17. The system of claim 16, further comprising a removal tool
configured to be transcervically introduced into the uterus,
coupled to the expanded support structure within the uterus, and
for collapsing and removing the support structure from the
uterus.
18. The system of claim 13, the support structure configured such
that expanding the support structure within the uterus delivers an
expansion force of at least about 0.5 lbs to mechanically distend
the uterus.
19. The system of claim 13, the support structure configured such
that expanding the support structure within the uterus delivers an
expansion force of at least about 1.0 lbs to mechanically distend
the uterus.
20. The system of claim 13, the support structure configured such
that expanding the support structure within the uterus delivers an
expansion force of at least about 5.0 lbs to mechanically distend
the uterus.
21. The system of claim 13, the support structure configured such
that expanding the support structure within the uterus achieves an
equivalent distension of the uterus to that achieved by
introduction of a liquid distension media at a pressure of at least
about 40 mm Hg.
22. The system of claim 13, the support structure configured such
that expanding the support structure within the uterus achieves an
equivalent distension of the uterus to that achieved by
introduction of a liquid distension media at a pressure of about 70
mm Hg.
23. The system of claim 13, the support structure configured such
that expanding the support structure within the uterus contacts a
fundus of the uterus.
24. A system for performing a transcervical surgical procedure in a
uterus, comprising: a deployment tool; an expandable support
structure detachably attached to the deployment tool, the
expandable support structure configured to be transcervically
introduced and positioned within a uterus using the deployment
tool, and thereafter expanded within the uterus and detached from
the deployment tool, wherein the deployment tool is configured to
be removed from the uterus after detachment of the expanded support
structure therein, and wherein the expanded support structure
comprises a three-dimensional array of filaments, with adjacent
filaments of the array defining windows there between, the array of
filaments being configured so that expanding the support structure
delivers an expansion force against opposing walls of the uterus,
the expanded filament array defining a three-dimensional volume
comprising a three-dimensional working space within the uterus
through non-fluid mechanical distention of the uterus; and a
surgical instrument configured to be transcervically inserted into
the uterus after insertion and expansion of the support structure,
so that a distal end of the surgical instrument may be positioned
within the three-dimensional working space created by the expanded
support structure and to remove uterine wall tissue through one or
more windows defined by adjacent filaments of the expanded support
structure while the support structure distends the uterus through
non-fluid mechanical distention.
25. The system of claim 24, wherein the support structure is
configured to be introduced into the uterus through a lumen of the
deployment tool.
26. The system of claim 24, wherein the support structure is
further configured to be collapsed and transcervically removed from
the uterus.
27. The system of claim 26, further comprising a removal tool
configured to be transcervically introduced into the uterus,
coupled to the expanded support structure within the uterus, and
for collapsing and removing the support structure from the
uterus.
28. The system of claim 24, the support structure configured such
that expanding the support structure within the uterus delivers an
expansion force of at least about 0.5 lbs to mechanically distend
the uterus.
29. The system of claim 24, the support structure configured such
that expanding the support structure within the uterus achieves an
equivalent distension of the uterus to that achieved by
introduction of a liquid distension media at a pressure of at least
about 40 mm Hg.
30. The system of claim 24, the support structure configured such
that expanding the support structure within the uterus contacts a
fundus of the uterus.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit under 35 U.S.C.
119(e) of U.S. Provisional Patent Application Ser. No. 60/910,625,
filed Apr. 6, 2007, and U.S. Provisional Patent Application Ser.
No. 60/910,618, filed Apr. 6, 2007, all of which are incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] The invention is in the general field of medical tools, and
more specifically relates to tools and methods involving distending
a gynecological cavity.
DESCRIPTION OF RELATED ART
[0003] The present invention relates generally to methods and
devices for distending a gynecological cavity and relates more
particularly to a new method and device for distending a
gynecological cavity.
[0004] It is desirable in many types of situations for medical
personnel to perform diagnostic and/or therapeutic procedures
within a gynecological cavity. For example, one may wish to detect
and/or to treat conditions including, but not limited to, the
presence of fibroids, polyps, tumors, adhesions, or other
abnormalities within a uterus; endometriosis or other abnormal
bleeding; uterine prolapse; ectopic pregnancy; and fertility issues
(both the inability to conceive and the desire to avoid pregnancy).
To facilitate the detection and/or the treatment of the above and
like conditions, there should be ample space within the
gynecological cavity for the procedure(s) in question to be
performed. Unfortunately, however, in those instances in which the
gynecological cavity in question is the uterine cavity, adequate
space does not typically exist naturally. This is because the
uterus is a flaccid organ. As such, the walls of the uterus are
typically in contact with one another when in a relaxed state.
Consequently, active steps need to be taken to create a working
space within the uterus.
[0005] The conventional technique for creating such a working space
within the uterus is to administer a fluid to the uterus,
transcervically, under sufficient pressure to cause the uterus to
become distended. Examples of the fluid used conventionally to
distend the uterus include gases like carbon dioxide and liquids
like water or certain aqueous solutions (e.g., a saline solution or
a sugar-based aqueous solution).
[0006] Although the aforementioned technique of fluid distension is
commonly practiced, there are certain risks associated therewith.
For example, because the distending fluid is administered under
pressure (which pressure may be as great as 80-100 mm Hg or
greater), there is a risk that such fluids may be taken up by a
blood vessel in the uterus, i.e., intravasation, which uptake may
be quite harmful to the patient. This risk is particularly great
when the fluid distension technique is followed by a procedure in
which a blood vessel is cut, such as when an abnormal or undesired
tissue located in the uterus is removed or ablated.
[0007] Moreover, the above-described technique of fluid distension
suffers from additional shortcomings. For example, throughout the
entire period of time that the diagnostic and/or therapeutic
procedure is performed, the distension fluid must be continuously
administered under pressure to the patient to keep the uterus
distended. This requires the availability of an adequate supply of
the distending fluid. In addition, suitable equipment must be
available to provide the requisite continuous flow of distending
fluid to the patient. Furthermore, the above-described fluid
distension technique may become messy, particularly when a liquid
is used as the distension fluid, as some of the distension fluid
within the uterus may escape proper collection and, instead, may
leak from the patient to the surrounding environment.
SUMMARY OF THE INVENTION
[0008] The present invention provides a novel method and device for
distending a gynecological cavity, such as a uterine cavity.
[0009] In particular, the present invention provides methods and
devices for distending a gynecological cavity that overcome at
least some of the shortcomings described above in connection with
existing methods and devices for distending a gynecological
cavity.
[0010] Therefore, according to one aspect of the invention, there
is provided a novel method and device for distending a
gynecological cavity, said method and device utilizing a
mechanical, non-fluid structure to distend the gynecological
cavity. Such a structure may include, for example, self-expanding
members, such as resilient baskets, coils, whisks, prongs, and
loops, or mechanically expanded members, such as inflatable
balloons, mechanically-expanded cages and loops, and scissor jacks.
The distension structure may serve a purpose in addition to
distension, such as illumination, imaging, irrigation, drug
delivery, resection and cauterization.
[0011] More specifically, the distension structure could be
pre-shaped to form a specific geometry (spherical or
uterine-shaped) upon deployment.
[0012] The distension structure could act as an internal retractor,
holding non-target tissue away from the target tissue.
[0013] The distension structure or structure could be partially
covered to exclude some tissues via a covering of the distension
members with material either porous or not.
[0014] The distension structure could have a loop or two that are
independent from the others and that are electronically enabled to
provide cautery or loop resection or mechanically enabled to
provide grabbing and manipulation tasks while easily converting
back to a distension mechanism.
[0015] The distension structure could be used in conjunction with
another distension structure, i.e., "basket in a basket"
configuration to have the outer distension structure providing
retraction and visualization while the inner distension structure
is used to manipulate, excise or cauterize tissue.
[0016] The distension structure could be equipped with a camera to
allow for a "sky-cam" view of the operative area different than the
primary (gun sight view).
[0017] The distension members of a distension structure could be
illuminated if they are made of fiber optic material or glowing
material or filled with chemical luminescent solutions or
incorporate light sources (LED's).
[0018] The distension members of a distension structure could be
inflatable, providing the user with individual strut control via
preferential inflation (gases or liquids) of certain distension
members.
[0019] The distension member stiffness could be varied by adjusting
the pressure of inflatable or filled members.
[0020] The distension member geometry could be varied by changing
the pressure and/or by selective inflation or filling of
members.
[0021] The distension members could be hollow and equipped with
side holes or end holes to conduct flushing of the distended space
with therapeutic or non-therapeutic solutions.
[0022] The distension members could have uniform radial force or
non-uniform radial force such that forces in the coronal or
sagittal planes could be different. Likewise, the distension
members could provide more or less force proximally or distally
within the cavity.
[0023] The distension members could be made from shape memory
materials, malleable or elastic materials.
[0024] The distension members could have a circular or non-circular
cross-sectional shape to produce stiffness variations.
[0025] The distension members could include roller balls or roller
barrels that can be energized to enable an endometrial ablation to
be performed.
[0026] According to another aspect of the invention, there is
provided a novel method for distending a gynecological cavity, said
method comprising initially distending the gynecological cavity
using fluid means and, thereafter, using mechanical, non-fluid
means to maintain the gynecological cavity in a distended
state.
[0027] 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
[0028] 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:
[0029] FIGS. 1(a) and 1(b) are top views, partly in section, of an
embodiment of a device for distending a gynecological cavity, the
device being constructed according to the teachings of the present
invention and being shown in a compressed state and in an expanded
state, respectively;
[0030] FIGS. 2(a) and 2(b) are fragmentary, schematic top views,
partly in section, showing one way in which the device of FIGS.
1(a) and 1(b) may be used to distend a gynecological cavity, such
as a uterine cavity;
[0031] FIGS. 3(a) and 3(b) are top views, partly in section, of
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in a compressed state and in
an expanded state, respectively;
[0032] FIG. 4 is a fragmentary top view, partly in section, of
still another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state;
[0033] FIGS. 5(a) and 5(b) are top views, partly in section, of
still yet another embodiment of a device for distending a
gynecological cavity, the device being constructed according to the
teachings of the present invention and being shown in a compressed
state and in an expanded state, respectively;
[0034] FIGS. 6(a) through 6(h) are top views of a number of
alternate embodiments to the device shown in FIGS. 5(a) and 5(b),
the alternate embodiments being constructed according to the
teachings of the present invention and being shown in their
respective expanded states;
[0035] FIG. 7 is a top view, partly in section, of still yet
another device for distending a gynecological cavity, the device
being constructed according to the teachings of the present
invention and being shown in an expanded state within a uterus;
[0036] FIG. 8 is a top view, partly in section, of still yet
another device for distending a gynecological cavity, the device
being constructed according to the teachings of the present
invention and being shown in an expanded state within a uterus;
[0037] FIGS. 9(a) and 9(b) are top views of still yet another
device for distending a gynecological cavity, the device being
constructed according to the teachings of the present invention and
being shown in a compressed state and in an expanded state,
respectively;
[0038] FIGS. 10(a) through 10(e) are schematic top views, partly in
section, showing one way in which the device of FIGS. 9(a) and 9(b)
may be used to distend a gynecological cavity, such as a uterine
cavity;
[0039] FIGS. 11(a) and 11(b) are top views, partly in section, of
still yet another embodiment of a device for distending a
gynecological cavity, the device being constructed according to the
teachings of the present invention and being shown within a uterus
in a compressed state and in an expanded state, respectively;
[0040] FIGS. 12(a) and 12(b) are top views, partly in section, of
still yet another embodiment of a device for distending a
gynecological cavity, the device being constructed according to the
teachings of the present invention and being shown in a
non-expanded state and in an expanded state, respectively;
[0041] FIGS. 13(a) and 13(b) are top views, partly in section, of
still yet another embodiment of a device for distending a
gynecological cavity, the device being constructed according to the
teachings of the present invention and being shown in a
non-expanded state and in an expanded state, respectively;
[0042] FIG. 14 is a top view of still yet another embodiment of a
device for distending a gynecological cavity, the device being
constructed according to the teachings of the present invention and
being shown in an expanded state;
[0043] FIGS. 15(a) through 15(e) are schematic top views, partly in
section, showing one way in which the device of FIG. 14 may be used
to distend a gynecological cavity, such as a uterine cavity;
[0044] FIGS. 16(a) and 16(b) are fragmentary top and rear views,
respectively, of an alternate embodiment to the device shown in
FIG. 14, the alternate embodiment being constructed according to
the teachings of the present invention and being shown in its
expanded state;
[0045] FIGS. 17(a) through 17(c) are perspective views of
additional alternate embodiments to the device shown in FIG. 14,
the alternate embodiments being constructed according to the
teachings of the present invention and being shown in their
respective expanded states;
[0046] FIGS. 18(a) and 18(b) are section views of still yet another
embodiment of a device for distending a gynecological cavity, the
device being constructed according to the teachings of the present
invention and being shown in a non-expanded state and in a
partially-expanded state, respectively;
[0047] FIG. 19 is a section view of still yet another embodiment of
a device for distending a gynecological cavity, the device being
constructed according to the teachings of the present invention and
being shown in a non-expanded state;
[0048] FIGS. 20 (a) and 20(b) are top views, partly in section, of
still yet another embodiment of a device for distending a
gynecological cavity, the device being constructed according to the
teachings of the present invention and being shown in a
non-expanded state and in a partially expanded state,
respectively;
[0049] FIG. 21 is a top view, partly in section, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state with
visualization means associated therewith;
[0050] FIG. 22 is a top view, partly in section, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state with
visualization means associated therewith;
[0051] FIG. 23 is a top view, broken away in part, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state;
[0052] FIG. 24 is a top view, partly in section, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state;
[0053] FIG. 25 is a top view, partly in section, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state with a
syringe attached thereto;
[0054] FIG. 26 is a top view, partly in section, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state;
[0055] FIG. 27 is a top view, partly in section, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state;
[0056] FIG. 28 is a top view, partly in section, of still yet
another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being shown in an expanded state;
[0057] FIGS. 29(a) and 29(b) are top views, partly in section,
illustrating a two-part method for distending a gynecological
cavity in accordance with the teachings of the present
invention;
[0058] FIG. 30 is a top view of an alternate device for use in
practicing the two-part distension method illustrated in FIGS.
29(a) and 29(b);
[0059] FIGS. 31(a) and 31(b) are top views, partly in section,
showing one way in which the device of FIG. 30 may be used to
practice the two-part method of FIGS. 29(a) and 29(b); and
[0060] FIGS. 32(a) and 32(b) are top views, partly in section,
showing an alternate device being used to practice the two-part
method of FIGS. 29(a) and 29(b).
[0061] FIGS. 33(a) and 33(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using an inflatable or bladder cage.
[0062] FIGS. 34(a) and 34(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using a restricted balloon.
[0063] FIGS. 35(a) and 35(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using a film air bladder having a pre-shaped structure.
[0064] FIGS. 36(a) and 36(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using a spring mesh.
[0065] FIGS. 37(a) and 37(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using an expandable foam pill.
[0066] FIG. 38 is a top view, partly in section, illustrating an
alternate embodiment for distending a gynecological cavity using
magnet blocks.
[0067] FIG. 39 is top view, partly in section, illustrating an
alternate embodiment for distending a gynecological cavity using
external and/or internal magnets.
[0068] FIGS. 40(a) and 40(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using an extendible piston.
[0069] FIGS. 41(a) and 41(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using a device with expandable arms.
[0070] FIGS. 42(a) and 42(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using expandable hinged bars.
[0071] FIGS. 43(a) and 43(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using an expandable clip.
[0072] FIGS. 44(a) and 44(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using expandable wires, and in certain embodiments the wires
are formed into a wisp or cage configuration.
[0073] FIGS. 45(a) and 45(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using expandable bands.
[0074] FIGS. 46(a) and 46(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using expandable bands having a central drive shaft.
[0075] FIGS. 47(a) and 47(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using expandable arms.
[0076] FIGS. 48(a) and 48(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using a helical deformable anchor.
[0077] FIGS. 49(a) and 49(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using expandable arms having an over center linkage.
[0078] FIGS. 50(a), 50(b), and 50(c) are top views, partly in
section, illustrating an alternate embodiment for distending a
gynecological cavity using an expandable T-bar.
[0079] FIGS. 51(a) and 51(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using a spine linkage.
[0080] FIGS. 52(a) and 52(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using linked bars having springs and an actuation rod.
[0081] FIGS. 53(a) and 53(b) are top views, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using nitinol wire having pivots.
[0082] FIGS. 54(a), 54(b), 54(c), and 54(d) are top views, partly
in section, illustrating an alternate embodiment for distending a
gynecological cavity using a bellows device.
[0083] FIGS. 55(a), 55(b), 55(c), 55(d), and 55(e) are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using an umbrella device.
[0084] FIGS. 56(a), 56(b), and 56(c) are top views, partly in
section, illustrating an alternate embodiment for distending a
gynecological cavity using an inflatable balloon.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0085] Referring now to FIGS. 1(a) and 1(b), there are shown top
views, partly in section, of an embodiment of a device for
distending a gynecological cavity, the device being constructed
according to the teachings of the present invention and being
represented generally by reference numeral 11. Additional features,
methods and systems relating to the present invention are disclosed
in U.S. patent application Ser. No. 11/923,357 filed Oct. 24, 2007,
entitled Mechanical Distension Systems for Performing a Medical
Procedure in a Remote Space, the disclosure of which is hereby
incorporated in its entirety herein by reference.
[0086] Device 11, which is particularly well-suited for distending
a uterus of a patient, comprises expandable means. In the present
embodiment, said expandable means comprises a self-expanding basket
21. Basket 21 may be a resiliently-biased foldable weave of
filaments 22 made of Nitinol (nickel-titanium alloy) shape-memory
alloy, spring steel or a similar shape-memory material. Basket 21
may be constructed so that, when fully expanded within a uterus, it
distends the uterus or a portion of the uterus to a desired extent.
If desired, basket 21 may be constructed so that its expanded shape
mimics the shape of the uterus. Preferably, basket 21 is
constructed to distend the uterus to an extent equivalent to that
which would be attained using the above-described conventional
fluid distension technique at a pressure of at least 40 mm Hg but
not greater than 100 mm Hg, often within the range of from about 60
mm Hg and about 80 mm Hg and preferably at a pressure of
approximately 70 mm Hg for a typical patient. If desired, basket 21
may be constructed to provide a uniform radial force in all
directions or may be constructed to provide different radial forces
in different directions, such as along the coronal and sagittal
planes.
[0087] The woven filaments 22 making up basket 21 may be sized and
spaced (e.g., diameter, length, width) to effectively cover a small
portion of the contacted surface area, thereby leaving large
"windows" between adjacent filaments 22 through which diagnostic
and/or therapeutic procedures may be performed; alternatively,
filaments 22 may be sized and spaced to cover a large portion of
the contacted surface area, with comparatively smaller "windows."
It should be noted that, by appropriately sizing and positioning
such "windows" over a target tissue, basket 21 may cause a target
tissue to avulse through a window and into the interior of basket
21, where it may then be treated.
[0088] Device 11 may additionally comprise an elongated shaft 31,
shaft 31 having a proximal end 33 and a distal end 35. Distal end
35 of shaft 31 may be coupled to basket 21 so that placement of
basket 21 may be effected by moving shaft 31. Shaft 31 may be a
solid member or may be a tubular structure.
[0089] Device 11 may further comprise an outer sheath 41. Sheath
41, which may be a unitary, tubular member, has a proximal end 47
and a distal end 49. Distal end 49 is adapted to be inserted into
the uterus transcervically, with proximal end 47 preferably
remaining external to the patient. To minimize discomfort to the
patient, such as by obviating the need for administration of an
anesthetic to the patient, the outer diameter of sheath 41 (or at
least that portion of sheath 41 inserted into the patient) is
preferably less than about 5.5 mm. Also to minimize discomfort to
the patient, sheath 41 may be bendable along its length. Shaft 31
may be slidably disposed within sheath 41, with proximal end 33 of
shaft 31 preferably extending proximally relative to proximal end
47 of sheath 41 to facilitate access thereto by medical personnel.
(Alternatively, instead of proximal end 33 of shaft 31 extending
proximally relative to proximal end 47 of sheath 41, proximal end
33 of shaft 31 may be coupled to a handle, pull-wires, or
comparable structure that extends proximally relative to the
proximal end 47 of sheath 41 or that is otherwise easily accessible
to medical personnel.) As can be seen, by appropriately positioning
distal end 35 of shaft 31 relative to distal end 47 of sheath 41,
basket 21 may be positioned within sheath 41, where it is
maintained in a compressed state by sheath 41, or may be positioned
distally relative to sheath 41, where it is free to expand to its
expanded state.
[0090] Referring now to FIGS. 2(a) and 2(b), there is shown one way
in which device 11 may be used to distend a gynecological cavity,
in particular, a uterine cavity. First, as shown in FIG. 2(a),
while positioning shaft 31 relative to sheath 41 so that basket 21
is disposed within sheath 41 and is maintained therein in a
compressed state, one inserts distal end 49 of sheath 41 into a
patient first through vagina V and cervix C and then into uterus U
(see FIG. 2(a)). Next, as shown in FIG. 2(b), while keeping sheath
41 stationary, one moves shaft 31 distally relative to sheath 41
until basket 21 emerges fully from distal end 49 of sheath 41,
whereby basket 21 self-expands and, in so doing, distends the walls
of uterus U (see FIG. 2(b)). With uterus U thus distended, one may
perform one or more desired diagnostic and/or therapeutic
procedures within uterus U. Such procedures may be performed by
inserting one or more instruments coaxially through sheath 41
alongside of shaft 31 or, if shaft 31 is tubular, by inserting such
one or more instruments coaxially through shaft 31 (and,
thereafter, through the "windows" of basket 21). Alternatively,
such instruments may be inserted transcervically into uterus U by
being inserted alongside of, but not through, sheath 41. When
distension of uterus U is no longer desired, shaft 31 is pulled
proximally relative to sheath 41 until basket 21 is retracted into
sheath 41, where it is compressed by sheath 41. Device 11 may then
be withdrawn from the patient.
[0091] It should also be noted that, although neither described
above nor shown in FIGS. 2(a) and 2(b), a separate introducer
device may first be inserted transcervically into the patient, with
device 11 thereafter inserted into the patient through a lumen in
the introducer device. It should further be noted that, where such
a separate introducer device is first inserted into the patient,
sheath 41 may be omitted from device 11, with the lumen of the
introducer device serving the same purpose as sheath 41 of
maintaining the expandable means in a compressed state during
delivery to the uterus and withdrawal from the uterus.
[0092] It should also be understood that, although basket 21 is
self-expanding in the present embodiment, basket 21 may or may not
be resiliently biased and its expansion may be caused or assisted
by other mechanical means, such as by an inflatable balloon,
advanceable push rods which exert radial forces upon different
portions of basket 21 and/or other mechanical means.
[0093] Referring now to FIGS. 3(a) and 3(b), there are shown top
views, partly in section, of another embodiment of a device for
distending a gynecological cavity, the device being constructed
according to the teachings of the present invention and being
represented generally by reference numeral 51.
[0094] Device 51 is similar in certain respects to device 11, the
principal difference between the two devices being that, whereas
device 11 includes expandable means in the form of basket 21,
device 51 includes expandable means in the form of a self-expanding
loop 53. Loop 53 is joined at its proximal end to shaft 31 and may
be made from Nitinol (nickel-titanium alloy) shape-memory alloy,
spring steel or a similar shape memory material. Loop 53 is
appropriately constructed so that, when positioned within sheath
41, it is maintained in a radially compressed state (FIG. 3(a)) and
so that, when positioned distally beyond sheath 41, it self-expands
(FIG. 3(b)) to distend, to a desired extent, a gynecological
cavity, such as a uterine cavity, or a portion thereof. Preferably,
loop 53 is constructed to distend a uterus to an extent equivalent
to that which would be attained using the above-described
conventional fluid distension technique at a pressure of at least
40 mm Hg but not greater than 100 mm Hg and preferably at a
pressure of approximately 70 mm Hg.
[0095] Device 51 may be used in a fashion similar to that described
above in connection with device 11.
[0096] Referring now to FIG. 4, there is shown a top view, partly
in section, of still another embodiment of a device for distending
a gynecological cavity, the device being constructed according to
the teachings of the present invention and being represented
generally by reference numeral 71.
[0097] Device 71 is similar in most respects to device 51, the
principal difference between the two devices being that, whereas
device 51 includes expandable means in the form of loop 53, device
71 includes expandable means in the form of a self-expanding
structure 73. Structure 73 includes a resilient loop 74, which is
similar to loop 53, and further includes a resilient arm 75, which
is fixed at its proximal end 76 to the proximal end of loop 74 and
is fixed at its distal end 77 to the distal end of loop 74. When
structure 73 is in its expanded state, arm 75 serves to distend the
gynecological cavity in a direction substantially perpendicular to
that of loop 74. (Where, for example, structure 73 is oriented
within the uterus so that arm 75 is pressing in the direction of
the bowels, it may be desirable to make arm 75 of a stiffer
material than that which is used to make loop 74 so that arm 75 may
counteract pressure exerted on the uterus by the bowels.) Structure
73 is joined at its proximal end to shaft 31 and may be made from
Nitinol (nickel-titanium alloy) shape-memory alloy, spring steel or
a similar shape memory material. Structure 73 is appropriately
dimensioned so that, when positioned within sheath 41, it is
maintained in a radially compressed state and so that, when
positioned distally beyond sheath 41, it self-expands to distend a
gynecological cavity, such as a uterine cavity, or a portion
thereof. Preferably, structure 73 is constructed to distend the
uterus to an extent equivalent to that which would be attained
using the above-described conventional fluid distension technique
at a pressure of at least 40 mm Hg but not greater than 100 mm Hg
and preferably at a pressure of approximately 70 mm Hg.
[0098] Device 71 may be used in a fashion similar to that described
above in connection with device 11.
[0099] Referring now to FIGS. 5(a) and 5(b), there are shown top
views, partly in section, of still yet another embodiment of a
device for distending a gynecological cavity, the device being
constructed according to the teachings of the present invention and
being represented generally by reference numeral 101.
[0100] Device 101, which is particularly well-suited for distending
the uterus of a patient, may comprise an outer sheath 103. Sheath
103, which may be a unitary, tubular member, may be shaped to
include a longitudinal lumen 106, a proximal end 107 and a distal
end 109. Proximal end 107, which may remain external to the
patient, may be shaped to include an outwardly-extending radial
flange 108. Flange 108 may be appropriately dimensioned to
accommodate, on its distal surface 110, two fingers of an operator,
each finger on an opposite side of lumen 106. Distal end 109 may be
adapted to be inserted into the uterus transcervically. To minimize
discomfort to the patient, such as by obviating the need for
administration of an anesthetic to the patient, the outer diameter
of that portion of sheath 103 inserted into the patient is
preferably less than about 5.5 mm.
[0101] Device 101 also may comprise an elongated shaft 111, shaft
111 having a proximal end 113 and a distal end 115. Proximal end
113 may be shaped to include an outwardly-extending radial flange
117, flange 117 being appropriately dimensioned to prevent its
insertion into lumen 106 of sheath 103. Substantially the remainder
of shaft 111 may be slidable within lumen 106 of sheath 103.
[0102] Device 101 additionally may comprise expandable means. In
the present embodiment, said expandable means may comprise a
plurality of elongated prongs 121. Each prong 121 may have a
proximal end 123 and a distal end 125, each proximal end 123 being
fixed to distal end 115 of shaft 111, each distal end 125 being
free. Prongs 121 may be equally spaced apart around the perimeter
of distal end 115 of shaft 111 and may be constructed to be
outwardly-biased relative to the longitudinal axis of shaft 111.
Prongs 121 may be made of Nitinol (nickel-titanium alloy)
shape-memory alloy, spring steel, a shape-memory polymer, or a
similar shape-memory material. As can be seen, by appropriately
positioning distal end 115 of shaft 111 relative to distal end 107
of sheath 103, prongs 121 may be positioned within sheath 103,
where they are maintained in a compressed state by sheath 103, or
may be positioned distally relative to sheath 103, where they are
free to assume their expanded configuration. Prongs 121 may be
configured so that, when unrestrained by sheath 103, they distend
the uterus or a portion of the uterus to a desired extent.
Preferably, prongs 121 distend the uterus to an extent equivalent
to that which would be attained using the above-described
conventional fluid distension technique at a pressure of at least
40 mm Hg but not greater than 100 mm Hg and preferably at a
pressure of approximately 70 mm Hg.
[0103] As can be appreciated, although the present embodiment
includes three prongs 121, there may be a greater number of prongs
121 or a lesser number of prongs 121. Also, if desired, prongs 121
may be constructed from a resectable material so that an
obstructing prong (e.g., a prong positioned over a target, such as
a fibroid) may be removed, for example, by a morcellating
device.
[0104] Device 101 further may comprise means for biasing shaft 111
proximally relative to sheath 103. In the present embodiment, said
biasing means may comprise a coil spring 131. Coil spring 131 may
be inserted coaxially over shaft 111, with the proximal end 133 of
spring 131 engaging proximal end 113 of shaft 111 and with the
distal end 135 of spring 131 engaging proximal end 105 of sheath
103. Spring 131 serves to bias shaft 111 proximally relative to
sheath 103 and, therefore, biases prongs 121 towards their
non-expanded configuration.
[0105] Device 101 further may comprise disengageable means for
permitting movement of shaft 111 distally, but not proximally,
relative to sheath 103. In the present embodiment, said means may
comprise a ratchet 141, a pawl 143 and a spring 145. Ratchet 141
may be integrally formed along a portion of the length of shaft
111. Pawl 143 may be partially inserted through a transverse
opening 144 in sheath 103. Spring 145 may be inserted coaxially
over a portion of pawl 143 to bias pawl 143 towards engagement with
ratchet 141. Pawl 143 may be shaped to include a handle 147. Handle
147 may be used to pull pawl 143 away from ratchet 141 when one
wishes to disengage pawl 143 from ratchet 141.
[0106] To use device 101 to distend a gynecological cavity, such as
a uterine cavity, one may first position shaft 111 relative to
sheath 103 so that prongs 121 are disposed within sheath 103 and,
as a result, are compressed by sheath 103 to their non-expanded
configuration (as in FIG. 5(a)). One may then insert distal end 107
of sheath 103 into a patient first through the vagina and the
cervix and then into the uterus. Next, while keeping sheath 103
stationary, one may then move shaft 111 distally relative to sheath
103 until prongs 121 emerge fully from distal end 107 of sheath
103, whereby prongs 121 assume their expanded configuration (as in
FIG. 5(b)). Such movement of shaft 111 relative to sheath 103 may
be accomplished by operating device 101 like a syringe, with the
forefinger and the middle finger of one hand spaced apart against
distal surface 110 of flange 108 and with the thumb of the same
hand positioned against the proximal surface of proximal end 113 of
shaft 111. As shaft 111 is moved distally relative to sheath 103,
spring 131 becomes compressed; however, engagement of pawl 143 with
ratchet 141 prevents spring 131 from returning to its decompressed
state.
[0107] With prongs 121 in their expanded configuration, the walls
of the uterus are distended, and one may perform one or more
desired diagnostic and/or therapeutic procedures within the uterus.
Such procedures may be performed by inserting one or more
instruments coaxially through sheath 103 alongside of shaft 111 or,
if shaft 111 is tubular, by inserting such one or more instruments
coaxially through shaft 111 (and, thereafter, between adjacent
prongs 121). Alternatively, such instruments may be inserted
transcervically into uterus U by being inserted alongside of, but
not through, sheath 103. When distension of the uterus is no longer
desired, pawl 143 is pulled away from engagement with ratchet 141.
This disengagement of pawl 143 from ratchet 141 removes the only
restraint against spring 131 returning to its decompressed state;
as a result, the disengagement of pawl 143 from ratchet 141 causes
spring 131 to return to its decompressed state, thereby causing
shaft 111 to be moved proximally relative to sheath 103 and, in
turn, prongs 121 to be retracted into sheath 103. Device 101 may
then be withdrawn from the patient.
[0108] It should be noted that coil 131 and/or the combination of
ratchet 141, pawl 143, and spring 145 could be omitted from device
101, in which case the operator would manually maintain the
relative axial positions of shaft 111 and sheath 103. It should
also be noted that, although not described above, a separate
introducer device may first be inserted transcervically into the
patient, with device 101 thereafter inserted into the patient
through a lumen of the introducer device. It should further be
noted that, where such a separate introducer device is first
inserted into the patient, sheath 103 (as well as coil 131, ratchet
141, pawl 143 and spring 145) may be omitted from device 101, with
the lumen of the introducer device serving the same purpose as
sheath 103 of maintaining the expandable means in a compressed
state during delivery to the uterus and withdrawal from the
uterus.
[0109] Referring now to FIGS. 6(a) through 6(h), there are shown
top views, partly in section, of a number of alternate embodiments
to device 101, said alternate embodiments differing from device 101
only in the construction of their respective self-expanding,
expandable means. More specifically, in FIG. 6(a), there is shown a
device 151, device 151 comprising expandable means in the form of a
self-expanding loop 153. Loop 153 may have a quasi-triangular shape
as shown to correspond generally to the shape of a uterus. In FIG.
6(b), there is shown a device 161, device 161 comprising expandable
means in the form of a pair of self-expanding loops 163-1 and 163-2
arranged in a whisk-like configuration, with the distal end of loop
163-2 being positioned just inside the distal end of loop 163-1 and
with loop 163-2 being oriented generally perpendicularly to the
plane of loop 163-1. (Although, in the present embodiment, the
distal end of loop 163-2 is positioned just inside the distal end
of loop 163-1, device 161 may be modified so that loops 163-1 and
163-2 are of equal size and/or have a common distal end.) The
radial forces applied by loops 163-1 and 163-2 may be substantially
equal; alternatively, the radial forces applied by loops 163-1 and
163-2 may differ, for example, to apply different forces in the
coronal and sagittal planes. In FIG. 6(c), there is shown a device
181, device 181 comprising expandable means in the form of a
self-expanding cage-like structure 183, structure 183 comprising a
plurality of rod-like members 185-1 through 185-4 pivotally joined
end-to-end at joints 187-1, 187-2 and 187-3, respectively.
Structure 183 may have a heart-like shape as shown to correspond
generally to the shape of a uterus. In FIG. 6(d), there is shown a
device 191, device 191 comprising expandable means in the form of a
pair of self-expanding, cage-like structures 193 and 195. Structure
195 has a distal end positioned just inside the distal end of
structure 193, with structure 195 being oriented generally
perpendicularly to the plane of structure 193. As in the case of
device 161, the radial forces applied by cage-like structures 193
and 195 may be substantially equal or may differ, for example, to
apply different forces in the coronal and sagittal planes.
[0110] In FIG. 6(e), there is shown a device 197, device 197
comprising expandable means in the form of an asymmetric,
self-expanding loop 199. Loop 199 may be useful in situations in
which it is advantageous to distend only a portion of the uterus in
order to create ample space to observe and/or to treat the
non-distended portion. In FIG. 6(f), there is shown a device 201,
device 201 comprising expandable means similar to the expandable
means of device 161, except that device 201 comprises a symmetric
loop 203 and an asymmetric loop 205 arranged in a whisk-like
configuration, with the distal end of loop 205 being positioned
just inside the distal end of loop 203 and with loop 205 being
oriented generally perpendicularly to the plane of loop 203 but
positioned only to one side of the plane of loop 203. Like device
197, device 201 may be useful in situations in which it is
advantageous to distend only a portion of the uterus. In FIG. 6(g),
there is shown a device 211, device 211 comprising expandable means
in the form of an asymmetric, self-expanding, jointed structure
213. Like devices 197 and 201, device 211 may be useful in
situations in which it is advantageous to distend only a portion of
the uterus. In FIG. 6(h), there is shown a device 221, device 221
comprising expandable means in the form of a pair of cage-like
structures 223 and 225. Device 221 is similar to device 191, the
principal difference between the two devices being that cage-like
structure 225 is asymmetric and is positioned only to one side of
structure 223. Like devices 197, 201 and 211, device 221 may be
useful in situations in which it is advantageous to distend only a
portion of the uterus.
[0111] Referring now to FIG. 7, there is shown a fragmentary top
view, partly in section, of still yet another embodiment of a
device for distending a gynecological cavity, the device being
constructed according to the teachings of the present invention and
being represented generally by reference numeral 231.
[0112] Device 231, which is shown in an expanded state within a
uterus, is similar in many respects to device 11, the principal
difference between the two devices being that, whereas device 11
comprises expandable means in the form of self-expanding basket 21,
device 231 comprises expandable means that includes a
self-expanding whisk 233 that is partially or completely covered on
its inside or outside surface by a cover 235. Preferably, whisk 233
is constructed to distend the uterus to an extent equivalent to
that which would be attained using the above-described conventional
fluid distension technique at a pressure of at least 40 mm Hg but
not greater than 100 mm Hg and preferably at a pressure of
approximately 70 mm Hg.
[0113] Cover 235 may be made, for example, from a suitable fabric
or polymer. In the present embodiment, cover 235 only partially
covers whisk 233, with the uncovered portion of whisk 233 forming a
window 237. The covered portions of whisk 233 may be used to keep
the non-targeted portions of the gynecological cavity from entering
into the interior space of whisk 233 whereas window 237 may be used
to provide access to a target tissue through the interior space of
whisk 233 or may be used to avulse a target tissue into the
interior space of whisk 233.
[0114] In use, whisk 233 may be deployed within a gynecological
cavity and then oriented, for example, by rotating shaft 31
(preferably partially compressing whisk 233 before rotating shaft
31), so that window 237 is aligned with a target mass, such as a
fibroid. The radial pressure exerted by whisk 233 on the tissue
surrounding the target mass may cause the target mass to avulse
through the window 237 and into the interior space of whisk 233,
where it may then be treated.
[0115] Alternatively, the covered portions of whisk 233 may be used
to apply a tamponade force on a bleeding tissue location. Also,
whisk 233 and/or cover 235 may be coated, impregnated or otherwise
include one or more drugs, such as clotting agents and anesthetics.
According to one embodiment, the drug may be "released" by a
clinician on demand, such as by an integral iontophoretic delivery
element (e.g., integral to whisk 233), or by applying a force to an
integral pressure-activated drug depot (e.g., integral to whisk
233), and cover 235 may be used to administer such drugs to tissue
by contact with the tissue. Additionally, whisk 233 and/or cover
235 may be coated or treated with one or more compounds to change a
property, such as echogenicity, lubricity and radiopacity.
[0116] Referring now to FIG. 8, there is shown a top view of still
yet another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being represented generally by reference
numeral 241.
[0117] Device 241, which is shown in an expanded state within a
uterus, is similar in certain respects to device 11. One difference
between the two devices is that, whereas device 11 comprises basket
21 and shaft 31, device 241 instead comprises a self-expanding wire
243. Wire 243 is appropriately constructed so that, when pushed
distally through sheath 41 or a similar introducer device, it
adopts a spiral shape that may mimic the shape of the uterus or
other gynecological cavity. Preferably, wire 243 is constructed to
distend the uterus to an extent equivalent to that which would be
attained using the above-described conventional fluid distension
technique at a pressure of at least 40 mm Hg but not greater than
100 mm Hg and preferably at a pressure of approximately 70 mm Hg. A
ball 245 or similar structure may be provided on the distal end of
wire 243 to prevent perforating tissue within the cavity. A Touhy
Borst valve 247 or similar structure may be positioned at the
proximal end of sheath 41 to maintain wire 243 at a desired
longitudinal position relative to sheath 41.
[0118] Referring now to FIGS. 9(a) and 9(b), there are shown top
views of still yet another embodiment of a device for distending a
gynecological cavity, the device being constructed according to the
teachings of the present invention and being represented generally
by reference numeral 251.
[0119] Device 251, which is shown in a compressed state in FIG.
9(a) and in an expanded state in FIG. 9(b), is a self-expanding
structure in the form of a Hoberman sphere (icosidodecahedron).
Device 251 is appropriately dimensioned so that, in a compressed
state, it may be passed through the vagina and the cervix of a
patient and, in its expanded state, it may distend the uterus of a
patient to a desired extent. Preferably, device 251 is constructed
to distend the uterus to an extent equivalent to that which would
be attained using the above-described conventional fluid distension
technique at a pressure of at least 40 mm Hg but not greater than
100 mm Hg and preferably at a pressure of approximately 70 mm
Hg.
[0120] Referring now to FIGS. 10(a) through 10(e), there is shown a
series of top views, illustrating one way in which device 251 may
be used to distend a gynecological cavity, in particular, a uterine
cavity. First, as seen in FIG. 10(a), device 251 is loaded into a
lumen 253 of a sheath 255 or other suitable gynecological
introducer device, lumen 253 being appropriately dimensioned to
maintain device 251 in a compressed state. Next, as seen in FIG.
10(b), with device 251 thus loaded in sheath 255, the distal end
257 of sheath 255 is inserted through the vagina V and the cervix C
of a patient, and an ejector rod 259 is inserted distally into
lumen 253 to move device 251 distally through lumen 253. Next, as
seen in FIG. 10(c), ejector rod 259 ejects device 251 from lumen
253 into uterus U, where device 251 immediately self-expands to its
expanded state and distends uterus U. With device 251 now in place
distending uterus U, sheath 255 and ejector rod 259 may be removed
from the patient. Next, as seen in FIG. 10(d), when distension of
uterus U is no longer desired, sheath 255 may be re-introduced into
the patient through the vagina and the cervix, and a snare 260 may
be distally inserted through lumen 253 to grab device 251. Next, as
seen in FIG. 10(e), snare 260 and device 251 are then withdrawn
proximally through lumen 253, device 251 being compressed by lumen
253.
[0121] In another embodiment (not shown), device 251 could be
modified to include a tie-line or the like having a first end
secured to device 251 and a second end remaining external to the
patient. In this manner, instead of using a snare to pull device
251 through lumen 253, one could simply pull proximally on tie-line
to pull device 251 through lumen 253.
[0122] Referring now to FIGS. 11(a) and 11(b), there are shown top
views, partly in section, of still yet another embodiment of a
device for distending a gynecological cavity, the device being
constructed according to the teachings of the present invention and
being represented generally by reference numeral 271.
[0123] Device 271 is similar in many respects to device 11. One
difference between the two devices is that, whereas device 11
includes a basket 21 fixed to distal end 33 of shaft 31, device 271
instead includes a self-expanding basket 273, a tie-line 275 having
a proximal end 276 preferably extending proximally from sheath 41
and a distal end fixed to basket 273, and an ejector rod 277
slidably and removably mounted within sheath 41 for ejecting basket
273 distally from sheath 41.
[0124] In use, basket 273 may be loaded into sheath 41 or a similar
introducer device, with proximal end 276 of line 275 preferably
extending proximally from sheath 41. The distal end of the
thus-loaded sheath may then be inserted through the vagina V and
the cervix C of a patient. Ejector rod 277 may then be inserted
distally into sheath 41 until basket 273 is ejected from sheath 41
into the uterus U of the patient, at which time basket 273
self-expands to distend the uterus. Preferably, proximal end 276 of
line 275 is held in place while ejector rod is inserted into sheath
41 to ensure that end 276 remains external to sheath 41. With
basket 273 thus deployed, ejector rod 277 may then be removed
proximally from sheath 41. To remove basket 273 from the uterus U,
one may pull line 275 proximally until basket 273 is drawn into
sheath 41. Basket 273 and sheath 41 may then be removed from the
patient.
[0125] As can be appreciated, device 271 may be modified to replace
basket 273 with other self-expanding structures that may be
compressed and withdrawn from a gynecological cavity by being
pulled into sheath 41 or a similar introducer device.
[0126] Although all of the distension devices described above
include self-expanding, expandable means, the present invention is
not limited to expandable means that are self-expanding and may
alternatively include expandable means that are not self-expanding,
but rather, are expanded by some other means. An example of such a
device is shown in FIGS. 12(a) and 12(b) and is represented
generally by reference numeral 301.
[0127] Device 301 is similar in many respects to device 151, the
principal difference between the two devices being that, whereas
device 151 includes a self-expanding loop 153, device 301 includes
(i) a mechanically-expandable loop 303 and (ii) a tensioning wire
305. Tensioning wire 305 is fixed at one end to the distal end 307
of loop 303. The opposite end of tensioning wire 305 is passed
through a lumen (not shown) in shaft 111 and terminates proximally
beyond proximal end 113 of shaft 111.
[0128] Device 301 may be used in a fashion similar to that for
device 151, the only difference being that, after loop 303 has been
inserted into the uterus or other gynecological cavity, loop 303
must be actively expanded by pulling proximally on tensioning wire
305. (Although not shown, device 301 may include a hook or similar
structure around which the proximal end of tensioning wire 305 may
be wrapped or otherwise fixed in order to maintain a constant
amount of tension on wire 305.) Preferably, when loop 303 is
expanded, loop 303 distends the uterus to an extent equivalent to
that which would be attained using the above-described conventional
fluid distension technique at a pressure of at least 40 mm Hg but
not greater than 100 mm Hg and preferably at a pressure of
approximately 70 mm Hg. When distension of the gynecological cavity
is no longer desired, tensioning wire 305 may be moved distally to
its original position, thereby restoring loop 303 to its
non-expanded state.
[0129] One notable attribute of device 301 is that the distending
pressure exerted by device 301 may be varied by varying the amount
of tension applied to tensioning wire 305.
[0130] Another example of a device having expandable means that are
not self-expanding is shown in FIGS. 13(a) and 13(b) and is
represented generally by reference numeral 351.
[0131] Device 351 is similar in many respects to device 181, the
principal difference between the two devices being that, whereas
device 181 includes self-expanding cage 183, device 351 includes
(i) a mechanically-expandable cage 353 and (ii) a tensioning wire
355. Tensioning wire 355 is fixed at one end to the distal end 357
of cage 353. The opposite end of tensioning wire 355 is passed
through a lumen (not shown) in shaft 111 and terminates proximally
beyond proximal end 113 of shaft 111.
[0132] Device 351 may be used in a fashion similar to that for
device 181, the only difference being that, after cage 353 has been
inserted into the uterus or other gynecological cavity, cage 353
must be actively expanded by pulling proximally on tensioning wire
355. (Although not shown, device 351 may include a hook or similar
structure around which the proximal end of tensioning wire 355 may
be wrapped or otherwise fixed in order to maintain a constant
amount of tension on wire 355.) Preferably, when cage 353 is
expanded, cage 353 distends the uterus to an extent equivalent to
that which would be attained using the above-described conventional
fluid distension technique at a pressure of at least 40 mm Hg but
not greater than 100 mm Hg and preferably at a pressure of
approximately 70 mm Hg. When distension of the gynecological cavity
is no longer desired, tensioning wire 355 may be moved distally to
its original position, thereby restoring cage 353 to its
non-expanded state.
[0133] In a manner similar to that described above in connection
with device 301, device 351 may be used to exert a variable
distending pressure by varying the amount of tension applied to
tensioning wire 355.
[0134] Referring now to FIG. 14, there is shown a top view of still
yet another embodiment of a device for distending a gynecological
cavity, the device being constructed according to the teachings of
the present invention and being represented generally by reference
numeral 371.
[0135] Device 371 may comprise a proximal inflation line 373 and a
distal balloon portion 375, line 373 and balloon portion 375 being
in fluid communication with one another. An inflation valve 377 may
be disposed at the proximal end of inflation line 373. In the
present embodiment, balloon portion 375 has an asymmetric- or
lobed-shape to distend approximately one-half of a uterus or
similar gynecological cavity. In this manner, balloon portion 375
may occupy a portion of a uterus while the remaining, unoccupied
portion may be left accessible for observation, diagnosis and/or
treatment. Balloon portion 375 may be either compliant or
non-compliant.
[0136] Referring now to FIGS. 15(a) through 15(e), there is
schematically shown one way in which device 371 may be used. First,
as seen in FIG. 15(a), with balloon portion 375 deflated, the
distal end of device 371 may be inserted through the vagina V and
the cervix C of the patient through a sheath 379 or similar
introducer device. Next, as seen in FIG. 15(b), device 371 may be
moved distally relative to sheath 379 so that balloon portion 375
may be positioned within the uterus U. Next, as seen in FIG. 15(c),
fluid may be dispensed from syringe 380 through line 373 and into
balloon portion 375, thereby causing balloon portion 375 to become
inflated and the uterus U to become distended. The fluid dispensed
from syringe 380 may be, for example, a gas, such as carbon
dioxide, or a liquid, such as a saline solution. Next, as seen in
FIG. 15(d), with balloon portion 375 fully inflated, syringe 380
may be removed from device 371. Next, as seen in FIG. 15(e), when
distension of the uterus U is no longer desired, syringe 380 may be
reattached to device 371 and balloon portion 375 deflated. Device
371 may then be withdrawn from the patient.
[0137] Referring now to FIGS. 16(a) and 16(b), there are shown
fragmentary top and rear views, respectively, of an alternate
balloon portion to the balloon portion 375 of device 371, the
alternate balloon portion being represented by reference numeral
401. As can be seen best in FIG. 16(a), balloon portion 401 has an
I-shape and, therefore, may be well-suited for contacting opposing
walls of a uterus or similar gynecological cavity in such a way as
to keep the cavity distended.
[0138] Additional alternate balloon portions are shown in FIGS.
17(a) through 17(c), respectively, and are represented by numerals
421, 441 and 461, respectively. Each of balloon portions 421, 441
and 461 may be dimensioned to contact opposing walls of a uterus or
other gynecological cavity in such a way as to keep the cavity
distended. Further alternate balloon portions (not shown) may
include, for example, annular, annular oval, rectangular, and
T-shaped balloon portions.
[0139] Referring now to FIGS. 18(a) and 18(b), there are shown
section views of still yet another embodiment of a device for
distending a gynecological cavity, the device being constructed
according to the teachings of the present invention and being
represented generally by reference numeral 481.
[0140] Device 481 is similar in certain respects to device 371, the
principal difference between the two devices being that, whereas
device 371 includes a single balloon portion 373, device 481
instead includes two balloon portions 483 and 485. Balloon portion
483 is fluidly connected to an inflation line 487, and balloon
portion 485 is fluidly connected to an inflation line 489.
Inflation valves 491 and 493 are positioned at the proximal ends of
inflation lines 487 and 489, respectively. As can be seen best in
FIG. 18(b), because balloon portions 483 and 485 are
independently-operable, one may inflate one without inflating the
other. Consequently, a desirable attribute of device 481 is that,
with a single insertion of device 481 into a patient, one may
inflate only one of balloon portions 483 and 485, for example, to
create the space necessary to perform a procedure on one side of a
gynecological cavity, and then inflate only the other one of
balloon portions 483 and 485, for example, to create the space
necessary to perform a procedure on the opposite side of the
cavity.
[0141] Referring now to FIG. 19, there is shown a section view of
still yet another embodiment of a device for distending a
gynecological cavity, the device being constructed according to the
teachings of the present invention and being represented generally
by reference numeral 501.
[0142] Device 501 is similar in certain respects to device 481, the
principal difference between the two devices being that, whereas
device 481 includes two independently-operable balloon portions 483
and 485, device 501 includes three independently-operable balloon
portions 503, 505 and 507. Balloon portion 503 is fluidly connected
to an inflation line 511, balloon portion 505 is fluidly connected
to an inflation line 513, and balloon portion 507 is fluidly
connected to an inflation line 515. Inflation valves 517, 519 and
521 are positioned at the proximal ends of inflation lines 511, 513
and 515, respectively.
[0143] Referring now to FIGS. 20(a) and 20(b), there are shown top
views, partly in section, of still yet another embodiment of a
device for distending a gynecological cavity, the device being
constructed according to the teachings of the present invention and
being represented generally by reference numeral 551.
[0144] Device 551 may include a scissor jack 553. Scissor jack 553,
which may be conventional in configuration, is preferably
dimensioned for use in a gynecological cavity, such as the uterus.
Consequently, scissor jack 553 preferably has a maximum length, as
measured from proximal end 555 to distal end 557, of about 4-10 cm.
In addition, scissor jack 553 is preferably constructed so that,
when expanded, jack 553 distends the uterus to an extent equivalent
to that which would be attained using the above-described
conventional fluid distension technique at a pressure of at least
40 mm Hg but not greater than 100 mm Hg and preferably at a
pressure of approximately 70 mm Hg.
[0145] Device 551 may additionally include a jack crank 561. Jack
crank 561 may have a hook 563 or similar structure at its distal
end suitable for mating with a loop 565 at proximal end 555 of jack
553. With crank 561 coupled to jack 553, for example, by inserting
hook 563 through loop 565, one may rotate crank 561 about its
longitudinal axis to cause jack 553 to expand laterally.
[0146] Device 551 may further include a delivery sheath 571. Sheath
571, which may be a unitary tubular member, may be shaped to
include a proximal end (not shown), a distal end 573, and a
longitudinal lumen 575. Lumen 575 may be dimensioned to permit jack
553 to be passed therethrough, particularly with jack 553 is in its
non-expanded state. Distal end 573 may be adapted to be inserted
into the uterus transcervically, with the proximal end of sheath
571 remaining external to the patient. To minimize discomfort to
the patient, such as by obviating the need for administration of an
anesthetic to the patient, the outer diameter of that portion of
sheath 571 inserted into the patient is preferably less than about
5.5 mm.
[0147] In use, crank 561 may be coupled to jack 553, and jack 553
may then be inserted distally into lumen 575 of sheath 571. Distal
end 573 of sheath 571 may then be inserted through the vagina and
the cervix of the patient. Next, jack 553 may be moved distally
through distal end 573 of sheath 571 and into the uterus of the
patient. Next, crank 561 may be rotated about its longitudinal
axis, thereby causing jack 553 to expand laterally. Preferably,
crank 561 is rotated until jack 553 engages opposing walls of the
uterus and distends the uterus to a desired extent. Next, crank 561
may be decoupled from jack 553 and removed proximally from the
patient. When, distension of the uterus is no longer desired, one
may re-insert crank 561 through shaft 571, re-attach crank 561 to
jack 553, and rotate crank 561 in the opposite direction to return
jack 553 to its non-expanded state. Thus returned to its
non-expanded state, jack 553 and crank 561 may then be withdrawn
proximally from the patient through sheath 571.
[0148] Although jack 553 and crank 561 may be coupled together in
the present embodiment by means of a hook and loop mechanism, jack
553 and crank 561 may be coupled together by other means, such as
by magnets.
[0149] In addition to being used to distend the gynecological
cavity of a patient, the distension device of the present invention
may be designed to perform one or more additional functions. An
example of such a multi-purpose device is shown in FIG. 21 and is
represented by reference numeral 601.
[0150] Device 601, which may be used both to distend a
gynecological cavity and to permit observation of the inside of the
gynecological cavity, may include elongated, resilient members 603
and 605. Members 603 and 605 may be arranged relative to one
another so that their respective proximal portions form a unified
shaft 607 and so that their respective distal portions form
expandable means. In the present embodiment, said expandable means
comprises a self-expanding heart-shaped structure 609. Preferably,
when structure 609 expands, structure 609 distends the uterus or
other gynecological cavity to an extent equivalent to that which
would be attained using the above-described conventional fluid
distension technique at a pressure of at least 40 mm Hg but not
greater than 100 mm Hg and preferably at a pressure of
approximately 70 mm Hg.
[0151] Member 603 is a tubular structure having an open proximal
end (not shown) and an open distal end 610. In this manner, the
distal end 612 of fiber optics 611 may be passed through member 603
and into the gynecological cavity to permit illumination and/or
observation of the cavity.
[0152] In use, the distal end of device 601 may be inserted into a
gynecological cavity, such as a uterus, using an appropriately
dimensioned introducer device. (The proximal end of device 601
preferably remains external to the patient.) While positioned
within the introducer device, structure 609 is compressed to a
small profile. However, once structure 609 passes completely
through the introducer device, structure 609 self-expands to its
expanded state, where it distends the gynecological cavity. The
distal end 612 of fiber optics 611 may then be passed through
member 603 and into the distended cavity. (The proximal end of
optics 611 preferably remains external to the patient.) When
observation of the distended cavity is no longer desired, fiber
optics 611 may be withdrawn proximally from member 603. When
distension of the cavity is no longer desired, device 601 may be
removed from the patient by withdrawing structure 609 through the
introducer device, the introducer device serving to compress
structure 609.
[0153] One desirable attribute of device 601 is that it may be used
to visualize the uterus from the vantage point of the uterine
fundus, as opposed to the cervical-uterine junction, which would be
the case if one merely inserted the fiber optics into the uterus
through an introducer device.
[0154] Referring now to FIG. 22, there is shown a top view, partly
in section, of another embodiment of a multi-purpose device, the
multi-purpose device being constructed according to the teachings
of the present invention and being represented by reference numeral
651.
[0155] Device 651 is similar in most respects to device 601.
However, one difference between the two devices is that device 651
may include an elongated, resilient member 653, instead of
elongated, resilient member 603. Member 653 differs principally
from member 603 in that member 653 may additionally include (i) an
inwardly-facing, transverse opening 655 at an intermediate location
within its distal portion and (ii) an integrally-formed, hinged
deflector 657 for deflecting fiber optics 611 through opening 655.
As in the present embodiment, deflector 657 may be biased in the
direction of opening 655. Accordingly, device 651 may additionally
include a wire 659 fixed at its distal end 660 to deflector 657 so
that, by pulling proximally on wire 659, deflector 657 may be
pivoted away from opening 655. (The proximal end of wire 659
preferably remains external to the patient.) In this manner, if one
wishes to pass distal end 612 of fiber optics 611 through distal
end 661 of member 653, one may pull wire 659 sufficiently
proximally to cause deflector 657 to be moved out of the lumen of
member 653. Alternatively, if one wishes to pass the distal end of
fiber optics 611 through opening 655, one would not pull wire 659,
and deflector 657 would cause fiber optics 611 to be directed
through opening 655.
[0156] As can be appreciated, a desirable attribute of device 651
is that it may be used to observe the uterus from a plurality of
alternate vantage points.
[0157] Referring now to FIG. 23, there is shown a top view, broken
away in part, of another embodiment of a multi-purpose device, the
multi-purpose device being constructed according to the teachings
of the present invention and being represented by reference numeral
701.
[0158] Device 701, which may be used both to distend a
gynecological cavity and to illuminate the inside of the
gynecological cavity, may include an elongated member 702 shaped to
include a proximal shaft portion 703 and distal expandable means.
In the present embodiment, said distal expandable means includes a
self-expanding loop 705. Preferably, when loop 705 self-expands,
loop 705 distends the uterus or other gynecological cavity to an
extent equivalent to that which would be attained using the
above-described conventional fluid distension technique at a
pressure of at least 40 mm Hg but not greater than 100 mm Hg and
preferably at a pressure of approximately 70 mm Hg.
[0159] To illuminate the gynecological cavity, member 702 may be
designed so that light inputted at its proximal end is both
transmitted along its length and scattered through its side wall.
This may be accomplished, for example, by incorporating particulate
matter 706, such as titanium dioxide particles, into a
light-conductive material, such as silicone. The light-scattering
particles may be located over only a portion of member 702 (for
example, only within loop 705) or may be dispersed over the
entirety of its length. A light source connector 707 may be
disposed at the proximal end 709 of member 702 to permit a light
source (not shown) to be coupled to member 702.
[0160] In use, the distal end of device 701 may be inserted into a
gynecological cavity, such as a uterus, using an appropriately
dimensioned introducer device. (The proximal end of device 701
preferably remains external to the patient.) While positioned
within the introducer device, loop 705 is compressed to a small
profile. However, once loop 705 passes completely through the
introducer device, loop 705 self-expands to its expanded state,
where it distends the gynecological cavity. A light source may then
be connected to connector 707. The input of light into member 702
causes light to be scattered from member 702, thereby illuminating
the cavity. When illumination of the distended cavity is no longer
desired, the light source may be disconnected from connector 707.
When distension of the cavity is no longer desired, device 701 may
be removed from the patient by withdrawing loop 705 through the
introducer device, the introducer device serving to compress loop
705.
[0161] Referring now to FIG. 24, there is shown a top view, partly
in section, of another embodiment of a multi-purpose device, the
multi-purpose device being constructed according to the teachings
of the present invention and being represented by reference numeral
751.
[0162] Device 751, which may be used both to distend a
gynecological cavity and to illuminate the inside of the
gynecological cavity, may include an elongated member 752 shaped to
include a proximal shaft portion 753 and distal expandable means.
In the present embodiment, said distal expandable means includes a
self-expanding loop 755. Preferably, when loop 755 self-expands,
loop 755 distends the uterus or other gynecological cavity to an
extent equivalent to that which would be attained using the
above-described conventional fluid distension technique at a
pressure of at least 40 mm Hg but not greater than 100 mm Hg and
preferably at a pressure of approximately 70 mm Hg.
[0163] To illuminate the gynecological cavity, member 752 may be a
tubular member having a light conductive side wall 756, and device
751 may further include a string of LED's 757 disposed within
member 752 and coupled to a power source 759. Although, in the
present embodiment, LED's 757 are positioned along substantially
the entire length of member 752, one could position LED's 757 over
only a portion of the length of member 752 (for example, only
within loop 755). Alternatively, instead of using LED's for
illumination, member 752 may be filled with a chemiluminescent
material that is activated in some manner, such as by heat (e.g.,
the heat of the patient) or by the self-expansion of loop 755
(e.g., a glow stick activated by breaking a barrier that keeps a
chemical reaction from occurring).
[0164] In use, the distal end of device 751 may be inserted into a
gynecological cavity, such as a uterus, using an appropriately
dimensioned introducer device. (The proximal end of device 751
preferably remains external to the patient.) While positioned
within the introducer device, loop 755 is compressed to a small
profile. However, once loop 755 passes completely through the
introducer device, loop 755 self-expands to its expanded state,
where it distends the gynecological cavity. Power source 759, which
may be a battery or other source of electricity, may then be
connected to LED's 757. The light from LED's 757 radiates through
side wall 756 and illuminates the cavity. When illumination of the
distended cavity is no longer desired, power source 759 may be
disconnected from LED's 757. When distension of the cavity is no
longer desired, device 751 may be removed from the patient by
withdrawing loop 755 through the introducer device, the introducer
device serving to compress loop 755.
[0165] Referring now to FIG. 25, there is shown a top view, partly
in section, of another embodiment of a multi-purpose device, the
multi-purpose device being constructed according to the teachings
of the present invention and being represented by reference numeral
801.
[0166] Device 801, which may be used both to distend a
gynecological cavity and to provide a conduit for fluid to be
dispensed into the gynecological cavity, may include an elongated,
resilient, tubular member 803 shaped to include a proximal shaft
portion 805 and distal expandable means. In the present embodiment,
said distal expandable means comprises a self-expanding loop 809.
Preferably, when loop 809 expands, loop 809 distends the uterus or
other gynecological cavity to an extent equivalent to that which
would be attained using the above-described conventional fluid
distension technique at a pressure of at least 40 mm Hg but not
greater than 100 mm Hg and preferably at a pressure of
approximately 70 mm Hg.
[0167] Shaft portion 805 may have a proximal opening 806 adapted to
receive a syringe 808. One or more transverse openings 811 may be
located in loop 809 so that fluid introduced into member 803 by
syringe 808 may be dispensed from member 803 through openings 811
into the gynecological cavity. Examples of fluids that may be
suitable for dispensing using device 801 include, but are not
limited to, pain medications (e.g., analgesics, lidocaine), saline
solutions for irrigation, sclerosing agents to stop bleeding,
agents to destroy endometrium (e.g., trichloroacetic acid),
etc.
[0168] In use, the distal end of device 801 may be inserted into a
gynecological cavity, such as a uterus, using an appropriately
dimensioned introducer device. (The proximal end of device 801
preferably remains external to the patient.) While positioned
within the introducer device, loop 809 is compressed to a small
profile. However, once loop 809 passes completely through the
introducer device, loop 809 self-expands to its expanded state,
where it distends the gynecological cavity. A syringe 808 may then
be inserted into opening 806, and a desired fluid may be dispensed
from syringe 808. The fluid dispensed from syringe 808 into member
803 travels through member 803 and empties into the gynecological
cavity at openings 811. When the dispensing of fluid into the
gynecological cavity is no longer desired, syringe 808 may be
disconnected from member 803. When distension of the cavity is no
longer desired, device 801 may be removed from the patient by
withdrawing loop 809 through the introducer device, the introducer
device serving to compress loop 809.
[0169] Referring now to FIG. 26, there is shown a top view, partly
in section, of another embodiment of a multi-purpose device, the
multi-purpose device being constructed according to the teachings
of the present invention and being represented by reference numeral
901.
[0170] Device 901, which may be used both to distend a
gynecological cavity and to perform an electrocautery ablation of
the endometrium of the cavity, may include an elongated, resilient,
electrically-conductive member 903 having a first end 904-1 and a
second end 904-2. First and second ends 904-1 and 904-2 may be
physically coupled together, but electrically separated by an
insulating material 905, to form a unified shaft 906. The
intermediate portion of member 903 may be configured to form
expandable means. In the present embodiment, said expandable means
comprises a self-expanding loop 909. Preferably, when loop 909
expands, loop 909 distends the uterus or other gynecological cavity
to an extent equivalent to that which would be attained using the
above-described conventional fluid distension technique at a
pressure of at least 40 mm Hg but not greater than 100 mm Hg and
preferably at a pressure of approximately 70 mm Hg.
[0171] A plurality of roller cauterizing units 911 are rotatably
and coaxially mounted on member 903 within loop 909. Units 911 may
be conventional roller cauterizing units, such as those disclosed
in U.S. Pat. No. 5,634,924, U.S. Pat. No. 5,549,605 and U.S. Pat.
No. 5,669,700, all of which are incorporated herein by reference. A
plurality of electrically insulating members 913 are fixedly
mounted on member 903 within loop 909, insulating members 913 being
positioned between adjacent cauterizing units 911.
[0172] Device 901 may further include a delivery sheath 921 or
other introducer device. Sheath 921, which may be a unitary tubular
member, may be shaped to include a proximal end 923, a distal end
925, and a longitudinal lumen 927. Lumen 927 may be dimensioned to
slidably receive shaft 906 and to maintain loop 909, when
positioned therein, in a compressed state. Distal end 925 of sheath
921 may be adapted to be inserted into the uterus transcervically,
with proximal end 923 of sheath 921 preferably remaining external
to the patient. To minimize discomfort to the patient, such as by
obviating the need for administration of an anesthetic to the
patient, the outer diameter of that portion of sheath 921 inserted
into the patient is preferably less than about 5.5 mm.
[0173] In use, loop 909, together with cauterizing units 911 and
insulating members 913 mounted thereon, is inserted into lumen 927
of sheath 921 through proximal end 923. Distal end 925 of sheath
921 is then inserted into a gynecological cavity, such as a uterus.
(Proximal end 923 of sheath 921 preferably remains external to the
patient.) Shaft 906 is pushed distally through lumen 927 until loop
909 passes completely through sheath 921 and into the cavity. No
longer compressed by sheath 921, loop 909 immediately self-expands
to its expanded state, where it distends the gynecological cavity.
A source of electricity may then be connected to the member 903,
causing cauterizing units 911 to become actuated. Shaft 906 is then
rotated about its longitudinal axis. This causes loop 909 to be
correspondingly rotated and causes cauterizing units 911 to be
drawn across the walls of the cavity, where units 911 perform an
electrocautery ablation of the walls. When further electrocautery
ablation of the walls is no longer desired, member 903 may be
disconnected from the power source. When distension of the cavity
is no longer desired, loop 909 may be removed from the patient by
withdrawing loop 909 through sheath 921, sheath 921 serving to
compress loop 909.
[0174] Referring now to FIG. 27, there is shown a top view, partly
in section, of another embodiment of a multi-purpose device, the
multi-purpose device being constructed according to the teachings
of the present invention and being represented by reference numeral
1001.
[0175] Device 1001, which may be used both to distend a
gynecological cavity and to perform a resection, may include a
larger diameter expandable member 1003 and a smaller diameter
expandable member 1005, smaller diameter expandable member 1003
being nested within larger diameter expandable member 1005. In the
present embodiment, each of expandable member 1003 and expandable
member 1005 comprises a self-expanding whisk-like structure. Larger
expandable member 1003, which is preferably used for distension,
may be fixed at its proximal end to a positioning wire 1007, which,
in turn, may be fixed at its proximal end to a handle 1009. Smaller
expandable member 1005, which is preferably used for resection, may
be fixed at its proximal end to a positioning wire 1011, which, in
turn, may be fixed at its proximal end to handle 1009. Wire 1011
may also be electrically connected to a power source 1013 to
provide electricity to expandable member 1003.
[0176] Device 1001 may further include a sheath 1015 or other
introducer device. Sheath 1015, which may be a unitary tubular
member, may be shaped to include a proximal end 1023, a distal end
1025, and a longitudinal lumen 1027. Distal end 1025 may be adapted
to be inserted into the uterus transcervically, with proximal end
1023 preferably remaining external to the patient. To minimize
discomfort to the patient, such as by obviating the need for
administration of an anesthetic to the patient, the outer diameter
of sheath 1015 (or at least that portion of sheath 1015 inserted
into the patient) is preferably less than about 5.5 mm. Wires 1007
and 1011 may be slidably disposed within sheath 1015 so that, by
appropriately positioning wires 1007 and 1011 relative to sheath
1015, expandable members 1003 and 1005 may be positioned within
sheath 1015, where they are maintained in a compressed state by
sheath 1015, or may be positioned distally relative to sheath 1015,
where they are free to expand to their expanded states.
[0177] Referring now to FIG. 28, there is shown a top view, partly
in section, of another embodiment of a multi-purpose device, the
multi-purpose device being constructed according to the teachings
of the present invention and being represented by reference numeral
1101.
[0178] Device 1101, which may be used to distend a gynecological
cavity and to grab or otherwise manipulate tissue, may include a
larger diameter expandable member 1103 and a smaller diameter
expandable member 1105, smaller diameter expandable member 1103
being nested within larger diameter expandable member 1105. In the
present embodiment, each of expandable member 1103 and expandable
member 1105 comprises a self-expanding whisk-like structure. Larger
expandable member 1103, which is preferably used for distension,
may be fixed at its proximal end to a positioning wire 1107, which,
in turn, may be fixed at its proximal end to a handle 1109. Smaller
expandable member 1105, which is preferably used for grabbing or
snaring, may be fixed at its proximal end to a positioning wire
1111, which, in turn, may be fixed at its proximal end to a handle
1113. As can be appreciated, because wires 1107 and 1111 are
attached to different handles, expandable members 1103 and 1105 are
independently operable.
[0179] Device 1101 may further include a sheath 1115 or other
introducer device. Sheath 1115, which may be a unitary tubular
member, may be shaped to include a proximal end 1123, a distal end
1125, and a longitudinal lumen 1127. Distal end 1125 may be adapted
to be inserted into the uterus transcervically, with proximal end
1123 preferably remaining external to the patient. To minimize
discomfort to the patient, such as by obviating the need for
administration of an anesthetic to the patient, the outer diameter
of sheath 1115 (or at least that portion of sheath 1115 inserted
into the patient) is preferably less than about 5.5 mm. Wires 1107
and 1111 may be slidably disposed within sheath 1115 so that, by
appropriately positioning wires 1107 and/or 1111 relative to sheath
1115, one or both of expandable members 1103 and 1105,
respectively, may be positioned within sheath 1115, where they are
maintained in a compressed state by sheath 1115, or one or both of
expandable members 1103 and 1105 may be positioned distally
relative to sheath 1115, where they are free to expand to their
expanded states.
[0180] In the various embodiments discussed above, non-fluid
mechanical means are used to distend the gynecological cavity.
According to a further aspect of the invention, fluid means are
used initially to distend the cavity, and non-fluid mechanical
means are thereafter used to maintain the cavity in its distended
state. As can be appreciated, this two-part distension technique
may make use of many, if not all, of the devices described above.
An illustration of this two-part technique is shown in FIGS. 29(a)
and 29(b). More specifically, in FIG. 29(a), a distension device
1201 has been inserted into a patient, and a quantity of a
distension medium has been dispensed from a fluid reservoir 1203
through an introducer device 1205 and into the uterus, causing the
uterus to be distended. In FIG. 29(b), a shaft 1207 is moved
distally relative to introducer device 1205, causing a
self-expanding basket 1207 to be ejected from introducer device
1205 into the uterus, where it immediately self-expands to maintain
the uterus in its distended state.
[0181] Referring now to FIG. 30, there is shown a top view of an
alternate device to device 1201 for use in practicing the two-part
distension method illustrated in FIGS. 29(a) and 29(b), the
alternate device being constructed according to the teachings of
the present invention and being represented generally by reference
numeral 1301.
[0182] Device 1301 may comprise a pair of arms 1303 and 1305. A
pressure pad 1307 may be mounted on the outer end of arm 1303, and
a pressure pad 1309 may be mounted on the outer end of arm 1305.
The inner ends of arms 1303 and 1305 may be joined to a spring 1309
that biases arms 1303 and 1305 away from one another. A loop 1311,
whose purpose will become apparent below, may be positioned
adjacent to spring 1309.
[0183] Referring now to FIGS. 31(a) and 31(b), there is shown one
way in which device 1301 may be used to distend a gynecological
cavity. In FIG. 31(a), a pair of devices 1301 are shown loaded into
an introducer device 1321, the introducer device 1321 having been
inserted into a patient. The uterus of the patient is shown
distended with a distension fluid. Devices 1301 may be ejected from
introducer device 1321 by an ejector rod (not shown). In FIG.
31(b), devices 1301 are shown deployed in the uterus to maintain
the uterus in its already distended state. When distension of the
uterus is no longer desired, devices 1301 may be removed from the
uterus by inserting a hook or similar structure into loop 1311 and
then pulling device 1301 into introducer device 1321.
[0184] Referring now to FIGS. 32(a) and 32(b), there are shown top
views, partly in section, of a second alternate device to device
1201 for use in practicing the two-part distension method
illustrated in FIGS. 29(a) and 29(b), the second alternate device
being constructed according to the teachings of the present
invention and being represented generally by reference numeral
1401.
[0185] Device 1401 may comprise a coiled wire 1403 having a loop
1405 at its proximal end and a ball 1406 at its distal end. Device
1401 may be used in a fashion analogous to that described above in
connection with device 1301.
[0186] Referring now to FIGS. 33(a) and 33(b), there are shown top
views, partly in section, illustrating an alternate embodiment for
distending a uterus or gynecological cavity using an inflatable
bladder or balloon cage 3301. The inflatable bladder or balloon
cage 3301 is dimensioned to contact at least a portion of the wall
of a uterus or other gynecological cavity to maintain distension of
the cavity. In the illustrated embodiment, the inflatable bladder
or balloon cage 3301 is delivered to the target or surgical area
through a delivery tube 3303. The inflatable bladder or balloon
cage 3301 is tethered to a fill tube 3305, which is used to fill
the inflatable bladder or balloon cage 3301 with air, liquid, gel,
or the like during the inflation of the bladder or balloon cage
3301. The tether is also used to remove the air, liquid, gel, or
the like during the deflation of the bladder or balloon cage 3301,
and the tether or a separate pull wire or grasper may be used to
draw the bladder or balloon cage 3301 back into the delivery tube
3303.
[0187] As illustrated in FIG. 33(b), the delivery tube 3303 has
been proximally retracted to expose the balloon cage 3301. Balloon
cage 3301 has been inflated, to define a working space. The balloon
cage 3301 comprises at least a first strut 3307 and a second strut
3309 oriented in an arcuate configuration to provide a
hemispherical construct. The first strut 3307 and second strut 3309
are in communication with the fill tube 3305 by way of a third
strut 3311. At least two or three or four or more struts may be
provided, depending upon the desired performance of the cage 3301.
In addition, the inflated configuration of the cage 3301 may be
hemispherical as illustrated, spherical, elliptical, or any of a
variety of three dimensional configurations depending upon the
desired shape of the resulting working space. The struts will
generally define at least one window 3313 there between, through
which tissue will be exposed and potentially prolapsed, to be
treated using the therapeutic or diagnostic devices described
elsewhere herein. The treatment device may be advanced axially
through the delivery tube 3303, or in parallel outside of the
delivery tube 3303 depending upon the desired instrument
configuration.
[0188] Referring to FIGS. 34(a) and 34(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using dual balloons or a
restricted balloon 3401. In the illustrated embodiment, the
inflatable restricted balloon 3401 is delivered to the target or
surgical area through a delivery tube 3403. The restricted balloon
3401 is tethered to a fill tube 3405, which is used to fill the
restricted balloons 3401 with air, liquid, gel, or the like during
the inflation of the restricted balloon 3401. The tether is also
used to remove the air, liquid, gel, or the like during the
deflation of the restricted balloon 3401, and the tether or a
separate pull wire or grasper is used to draw the restricted
balloon 3401 back into the delivery tube 3403. To localize the
distension of the gynecological cavity, the restriction device 3407
is customizable to adjust the shape and form of the restricted
balloon 3401.
[0189] The balloon 3401 will generally comprise at least a first
lobe spaced apart from a second lobe to create a working space in
between. The first and second lobes may be proximal and distal ends
of a common balloon, having a central portion necked down to the
catheter shaft such as by the use of an external restraining band
or by internal adhesive bonding. Alternatively, two separate
balloons may be provided spaced apart along a shaft, and which may
be inflated through a common inflation lumen or through two
distinct inflation lumens if it is desirable to inflate the lobes
sequentially. Any of a variety of materials may be utilized for any
of the inflatable embodiments disclosed herein, such as materials
well known in the angioplasty balloon arts including Nylon, PET,
and various polyesters and densities of polyethylene.
Alternatively, more elastic materials such as silicone or latex may
be utilized, depending upon the desired functionality.
[0190] Referring to FIGS. 35(a) and 35(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using a conical air bladder 3501
having a pre-shaped structure. In the illustrated embodiments, the
air bladder 3501 is delivered to the target or surgical area
through a delivery tube 3503. The bladder 3501 is tethered to a
fill tube 3505, which is used to fill the balloon 3501 with air,
liquid, gel, or the like during the inflation of the balloon 3501.
The tether may also be used to remove the air, liquid, gel, or the
like during the deflation of the balloon 3501, and the tether is
used to draw the balloon 3501 back into the delivery tube 3503.
[0191] In the illustrated embodiment, the balloon 3501 is
configured in a generally frusto conical shape, having a relatively
small diameter proximal end and a relatively larger diameter distal
end for exposing a working site on the wall of the uterus or other
organ. A single continuous annular balloon chamber 3507 may be
defined within the balloon 3501. Alternatively, a plurality of
discrete chambers may be provided in the wall of the balloon
3501.
[0192] Any of a variety of steering mechanisms such as pull wires
and push wires may extend through the delivery tool 3503 and attach
to the balloon 3501, to allow lateral inclination of the
longitudinal axis of the balloon 3501 to access treatment sites
which are displaced laterally from the longitudinal axis of the
delivery tube 3503.
[0193] In some embodiments, the film utilized to construct balloon
3501 comprises Mylar, or other polyester films, or other materials
disclosed herein or known in the art.
[0194] Referring to FIGS. 36(a) and 36(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using a spring mesh 3601. In the
illustrated embodiments, the spring mesh 3601 is delivered to the
target or surgical area through a delivery tube 3603. Once deployed
in the cavity, the spring mesh 3601 unravels or otherwise enlarges
under spring force. The spring mesh 3601 is tethered to a tether
tube or cable 3605, which is configured to retract the mesh into
the delivery tube 3603 for removal. To localize the distension of
the gynecological cavity, the structure of the spring mesh 3601, in
some embodiments, is customizable so as to adjust the shape and
form of the spring mesh 3601. In some embodiments, the spring mesh
comprises nitinol or other similar materials.
[0195] Referring to FIGS. 37(a) and 37(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using an expandable foam, which
may be delivered in the form of a pill 3701. In the illustrated
embodiments, the foam pill 3701 is delivered to the target or
surgical area through a delivery tube 3703. In other embodiments,
the foam pill 3701 is in the form of two liquids that are injected,
pumped, or inserted into the cavity. After the foam pill 3701 or
the liquids are inserted into the cavity, a chemical reaction
occurs to create a pressurized solidified clear foam or gel that a
probe or morcellator can pass through. In certain embodiment, the
foam or gel is time dissolvable and is either absorbed by the body
or passed out of the cavity over time. In other embodiments, the
foam or gel is aspirated out of the cavity using delivery tube 3703
or other device. The foam or gel comprises any number of chemicals
or materials known to a person of skill in the art.
[0196] Referring to FIG. 38, there is a top view, partly in
section, illustrating an alternate embodiment for distending a
gynecological cavity using magnet blocks 3801. In the illustrated
embodiment, the magnetic building blocks 3801 are delivered to the
target or surgical area through a delivery tube 3803. Each building
block 3801 is configured to bond to opposing poles to build a
structure capable of distending the gynecological cavity. To remove
the structure from the cavity, the structure would be pulled apart
using a grasper and drawn into the delivery tube 3803 one block at
a time.
[0197] Referring to FIG. 39, there is top view, partly in section,
illustrating an alternate embodiment for distending a gynecological
cavity using internal magnets 3901 and/or external magnets 3905. In
the illustrated embodiment, the internal magnets 3901 are delivered
to and are placed at the target or surgical area through a delivery
tube 3903. After the internal magnets 3901 have been positioned,
the external magnet 3905 is positioned outside the cavity or the
body to attract and engage the internal magnets 3901. Once engaged,
the external magnet 3905 is pulled away from the body or increased
in strength such as by increasing the supply voltage to an
electromagnet to distend the cavity. To remove the internal magnets
3901 from the cavity, the internal magnets 3901 are drawn into the
delivery tube 3903, such as by a grasper or by the use of a
magnetic wand.
[0198] Referring to FIGS. 40(a) and 40(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using an extendible piston 4001.
In the illustrated embodiment, the extendible piston 4001 is a
hydraulic piston that is delivered through the cervix and to the
target or surgical area. In certain embodiments, the extendible
piston 4001 is positioned at a substantially 90.degree. angle with
respect to the longitudinal axis of the uterus. The extendible
piston 4001 is tethered to a fill tube or tether 4005, which is
used to fill the extendible piston 4001 with air, liquid, gel, or
the like to extend the extendible piston 4001 using pressure from
the air, liquid, gel, or the like. The tether is also used to
remove the air, liquid, gel, or the like to reduce the size of the
extendible piston 4001. To remove the extendible piston 4001 from
the cavity, the pressure inside the extendible piston 4001 is
removed to reduce the size of the piston, and the piston is pulled
through the cervix using the tether 4005.
[0199] The extendable piston 4001 may be pivotably connected to a
control wire, and provided with one or two or more pull wires to
manipulate the piston 4001 from an axial orientation as seen in
FIG. 40(a) to a transverse orientation as seen in FIG. 40(b). The
piston 4001 is provided with at least a first surface 4007 and a
second surface 4009 for contacting first and second positions on
adjacent tissue. Actuation of the piston 4001 moves the first
surface 4007 and the second surface 4009 farther apart from each
other, to create a space.
[0200] Referring to FIGS. 41(a) and 41(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using a device with expandable
arms 4101 and 4102. In the illustrated embodiment, the expandable
arms 4101 and 4102 are pivotably connected to an inner delivery
tube 4107 that is axially moveably carried within an outer delivery
tube 4103. In certain embodiments, the expandable arms comprise
flexible atraumatic tips so as to further distend the cavity wall
without causing injury or puncture to the wall. After the
expandable arms 4101 are positioned in the cavity, the expandable
arms 4101 and 4102 are expanded to distend the gynecological cavity
when wedge portion 4109 is proximally retracted until the wedge
portion 4109 is locked in position by drive brake 4111. To remove
the expandable arms 4101 and 4102, the tether 4105 is released and
the brake 4111 is released thereby freeing the wedge portion 4109.
The expandable arms 4101 and 4102 are allowed to compress as the
inner delivery tube 4107 pulls the expandable arms 4101 back into
the outer tube 4103.
[0201] Various embodiments disclosed herein illustrate a first and
a second arm or tine, such as the embodiment illustrated in FIGS.
41(a) and 41(b). In each of these embodiments, a third arm or tine
is preferably also included, so that a first and second arm are
able to open in a first plane, and the third arm is able to advance
laterally with respect to the first plane, to create a three
dimensional working space. A forth or a fifth or additional arms
may also be included, depending upon the specific device design.
The arms are movable throughout a range sufficient to create a
working space having a cross sectional dimension of at least about
2 mm, and preferably at least about 3 mm or 4 mm or more. In
general, the working space will have a transverse dimension of less
than about 15 mm, and usually less than about 8 mm or 10 mm.
[0202] Referring to FIGS. 42(a) and 42(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using expandable hinged bars
4201. In the illustrated embodiment, the expandable hinged bars
4201 are deployed when an inner tube 4207 pushes the expandable
hinged bars 4201 from an outer tube 4203 thereby allowing the
spring loaded hinged bars 4201 to expand and distend the
gynecological cavity. To remove the expandable hinged bars 4201, a
tether 4205 is used to draw the expandable hinged bars 4201 into
the outer tube 4203 thereby collapsing the hinged bars 4201.
[0203] In the embodiment illustrated in FIGS. 42(a) and 42(b),
along with a number of other embodiments disclosed herein, the
mechanical distension structure may be left in place in the
expanded configuration such as illustrated in FIG. 42(b), and the
inner tube 4207 and/or outer tube 4203 may be proximally retracted
from the patient, leaving the tether 4205 in place. This provides
working space for diagnostic or therapeutic instrumentation to be
introduced to the treatment site. Once the procedure has been
completed, a removal tube may be advanced over the tether 4205
until the distal end of the removal tube is in the vicinity of the
expansion structure. The expansion structure may thereafter be
retracted proximally into the removal tube such as by pulling on
the tether 4205 or other removal tool which has been connected to
the expansion device.
[0204] Referring to FIGS. 43(a) and 43(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using an expandable clip 4301. In
the illustrated embodiment, the expandable clip 4301 performs
similarly to the expandable hinged bars illustrated in FIGS. 42(a)
and 42(b) in that the expandable clip 4301 is deployed when an
inner tube 4307 pushes expandable clip 4301 from an outer tube 4303
thereby allowing the spring loaded expandable clip 4301 to expand
and distend the gynecological cavity. To remove the expandable clip
4301, a tether 4305 is used to draw the expandable clip 4301 into
the outer tube 4303 thereby collapsing the expandable clip
4301.
[0205] In the illustrated embodiment, the expandable clip 4301
comprises at least a first strut 4309 carrying at least one tissue
contacting surface 4311. At least a second strut 4313 carries at
least a second tissue contacting surface 4315. Spring bias from the
clip 4301 urges the first tissue contacting surface 4311 away from
the second tissue contacting surface 4315. One or two or more loops
4317 may be provided, to increase the spring force of the clip as
will be understood by those of skill in the art.
[0206] Referring to FIGS. 44(a) and 44(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using a plurality of wires 4401,
carried by the distal end of a support structure such as an inner
tube 4407. The wires have a first collapsed state and second
expanded state wherein the wires form a wisp or other laterally
enlarged configuration. In the illustrated embodiment, the wires
4401 are deployed when an outer tube 4403 is proximally retracted
thereby exposing the wires 4401 and allowing the wires 4401 to
self-expand and distend the gynecological cavity. To remove the
wires 4401, a tether 4405 is used to draw the wires 4401 into the
outer tube 4403 thereby collapsing the wires 4401. In some
embodiments, the wires 4401 comprises nitinol or other similar
materials.
[0207] The wires 4401 may be in the form of two or three or four or
six or more loops such as illustrated in FIG. 44(b). This allows
the wire loops, when in the expanded configuration, to form a three
dimensional cage structure to enable sites specific distension at a
desired treatment site.
[0208] Referring to FIGS. 45(a) and 45(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using expandable bands 4501. In
the illustrated embodiment, the expandable bands 4501 perform
similarly to the wires 4401 illustrated in FIGS. 44(a) and 44(b) in
that the expandable bands 4501 are deployed when an outer tube 4503
is proximally retracted relative to an inner tube 4507 thereby
allowing the bands 4501 to self-expand to an unstressed state
thereby distending the gynecological cavity. To remove the bands
4501, a tether 4505 or other pull element is used to draw the bands
4501 into the outer tube 4503 thereby collapsing the wires
4501.
[0209] Referring to FIGS. 46(a) and 46(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using bands 4601 having a central
drive shaft 4609. In the illustrated embodiment, the bands 4601 are
deployed using outer delivery tube 4603. After the bands 4601 are
positioned at the target site, a threaded rod 4607 within the drive
shaft 4609 is rotated by an inner tube 4611, thereby axially
shortening the distension element and causing the bands 4601 to
expand laterally and distend the gynecological cavity. To remove
the bands 4601, the inner tube 4611 rotates the drive shaft 4609 in
the opposite direction to axially lengthen the distension element
and laterally collapse the bands 4601. A tether 4605 may then be
used to draw the bands 4601 into the outer delivery tube 4603.
[0210] Referring to FIGS. 47(a) and 47(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using an expandable over center
arm 4709. In the illustrated embodiment, the arms 4701 are deployed
when an inner tube 4707 pushes the arms 4701 from an outer tube
4703 thereby allowing the self-expanding arms 4701 to expand and
distend the gynecological cavity. To remove the expandable arms
4701, a tether 4705 is connected to at least one over center arm
4709 configured to collapse the arms 4701 when the tether 4705 is
drawn proximally into the outer tube 4703. After the arms 4701 are
collapsed, the tether 4705 is used to pull the arms 4701 into the
outer tube 4703 for removal.
[0211] Referring to FIGS. 48(a) and 48(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using helical ribbon 4801. In the
illustrated embodiment, the helical ribbon 4801 is exposed by
proximally retracting outer delivery tube 4803. After the helical
ribbon 4801 is positioned at the target site, a threaded rod within
the drive shaft 4809 is rotated to cause the helical ribbon 4801 to
twist and expand, thereby distending the gynecological cavity. To
remove the ribbon 4801, the drive shaft 4809 is rotated in the
opposite direction to collapse the helical ribbon 4801, and a
tether 4805 is used to draw the collapsed helical ribbon 4801 into
the outer delivery tube 4803 for removal. Two or three or four or
more helical ribbons may be provided on the distension device.
[0212] Referring to FIGS. 49(a) and 49(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using expandable arms 4901 and
4902 having an over center linkage 4909. In the illustrated
embodiment, the expandable arms 4901 and 4902 are deployed using
outer delivery tube 4803. After the expandable arms are positioned
at the target site, an over center linkage 4909 is configured to
laterally pivot the expandable arms 4901 and 4902 to distend the
gynecological cavity. This may be accomplished by spring bias, or
by axial proximal retraction or distal advance of a central pivot
point 4911 on linkage 4909 using a pull wire or push wire as will
be understood by those of skill in the art. To remove the
expandable arms 4901, a tether 4905 or push wire may be connected
to the over center linkage 4909. When the tether 4905 is drawn into
outer delivery tube 4803 the over center linkage 4909 causes the
expandable arms 4901 to collapse.
[0213] Referring to FIGS. 50(a), 50(b), and 50(c), there are top
views, partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using expandable T-bar 5001. In
the illustrated embodiment, the expandable T-bar 5001 is deployed
using outer delivery tube 5003. After the expandable T-bar 5001 is
positioned at the target site, the T-bar 5001 is rotated 90.degree.
degrees to engage the walls of the gynecological cavity. Wires 5009
are connected to ends 5007. When wires 5009 are actuated, the ends
5009 are ratcheted outward to distend the gynecological cavity
wall. To remove the T-bar 5001, an inner delivery tube comprises an
actuator to release the ratcheted ends 5007 and rotate the T-bar
5001 back 90.degree. degrees so as to withdraw the T-bar 5001 from
the gynecological cavity.
[0214] Referring to FIGS. 51(a) and 51(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using a segmented spine linkage
5101. In the illustrated embodiment, the spine linkage 5101 is
deployed from the distal end of outer delivery tube 5103. After the
spine linkage 5101 is positioned at the target site, an actuation
cable 5103 is actuated such as by releasing tension so as to cause
the spine linkage 5101 to form into a substantially rigid spiral or
hoop shape configured to distend the gynecological cavity walls. To
remove the spine linkage 5101, the actuation cable 5103 is actuated
such as by proximal retraction to cause the spine linkage 5101 to
be flexible and not rigid. The flexible spine linkage 5101 is then
proximally withdrawn into outer delivery tube 5103. In other
embodiments, the spine linkage 5101 is actuated by proximal
retraction on the actuation cable 5103 to form a substantially
rigid spiral or hoop, and the actuation cable 5103 is released to
allow the spine linkage 5101 to be flexible.
[0215] Referring to FIGS. 52(a) and 52(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using linked bars 5201 having
springs 5207 and an actuation rod 5203. In the illustrated
embodiment, the linked bars 5201 are deployed using a delivery
tube. After the linked bars are positioned at the target site, an
actuation rod 5203 pulled into the delivery tube to cause the
linked bars to enter into a laterally expanded state capable of
distending the gynecological cavity wall. To collapse and remove
the linked bars 5201, the actuation rod 5203 is released or pushed
out of the delivery tube. Springs 5207 bias the linked bars 5201
toward the collapsed state. In certain embodiments, the linked bars
5201 also comprise expansion arms 5205 that expand to further
distend the gynecological cavity wall. Springs 5207 bias the
expansion arms 5205 toward the expanded state.
[0216] Referring to FIGS. 53(a) and 53(b), there are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using nitinol wire 5301 having
one or two or more pivots 5303. In the illustrated embodiment, the
nitinol wire 5301 is deployed through a delivery tube. After the
nitinol wire 5301 is positioned at the target site, an actuation
rod 5305 is released and may be pulled into the delivery tube to
cause the nitinol wire 5301 to enter into an expanded state
configured to distend the gynecological cavity wall. To collapse
and remove the nitinol wire 5301, the actuation rod 5305 is
released and/or pushed through the delivery tube to cause the
nitinol wire 5301 to enter into a collapsed state. The collapsed
nitinol wire 5301 is then drawn into the delivery tube to be
removed.
[0217] Referring to FIGS. 54(a), 54(b), 54(c), and 54(d), there are
top views, partly in section, illustrating an alternate embodiment
for distending a gynecological cavity using a bellows device 5401,
which comprises bellows 5409 and an elastomeric restraint 5411 that
provides tension as the bellows expands axially. In the illustrated
embodiment, the bellows device 5401 is deployed through a delivery
tube 5403 and is pushed out of the delivery tube 5403 and into the
gynecological cavity by inner push tube 5407. After the bellows
device 5401 is positioned at the target site, a fluid, gel, gas, or
the like is introduced into the bellows 5409 by way of a supply
tube 5405, thereby causing the bellows to expand along an axis
transverse to the longitudinal axis of the delivery tube and
distend the gynecological cavity wall. During the expansion of the
bellows, the restraint 5411 provides tension on the bellows 5409 so
as to prevent the bellows 5409 from shifting or falling over during
expansion.
[0218] To collapse and remove the bellows device 5401, a negative
pressure is applied to the supply tube 5405 to remove the fluid,
gel, gas, or the like from the bellows 5409, thereby allowing the
bellows 5409 to collapse due to the tension provided by restraint
5411. In the collapsed state, the bellows device 5401 is drawn into
the delivery tube 5403 by pulling the supply tube 5405. In certain
embodiments, multiple bellows devices 5401 can be used
simultaneously to distend the gynecological cavity.
[0219] Referring to FIGS. 55(a), 55(b), 55(c), 55(d), and 55(e) are
top views, partly in section, illustrating an alternate embodiment
for distending a gynecological cavity using an umbrella device. In
the illustrated embodiment, the collapsed umbrella device 5501
comprises at least two or three or four or more arms 5515 which may
be biased to be in a collapsed state. The umbrella device 5501 is
deployed through a delivery tube 5503 and is pushed out of the
delivery tube 5503 using a central support 5505. Tension cables
5507 are connected to the proximal ends 5512 of the umbrella device
5501 and are wrapped around pulley hubs 5509 and are positioned
along central support 5505 into the delivery tube 5503 wherein a
user can pull or release the tension cables 5507.
[0220] After the distal end 5513 of the collapsed umbrella device
5501 is positioned in the fundus of the uterus, tension cables 5507
are pulled proximally into the delivery tube 5503 thereby causing
the arms 5515 of the umbrella device 5501 to expand and distend the
gynecological cavity wall. In the expanded state, the tension
cables 5507 are locked into position to maintain distension of the
gynecological cavity wall. In certain embodiments, the tension
cables 5507 are locked into position by a locking means near the
proximal end of umbrella device 5501. In other embodiments, the
tension cables 5507 are locked into position by a locking means
positioned outside the patient's body. It will be understood by
those skilled in the art that various locking means could be
employed to secure the position of the tension cables.
[0221] To collapse and remove the umbrella device 5501, the user
releases the tension cables 5507, thereby allowing the arms 5515 to
enter into the collapsed state for removal through the delivery
tube 5503. In certain embodiments, the umbrella device 5501
comprises at least two arms 5515, and in other embodiments the
umbrella device 5501 comprises at least four arms 5515 for
distending the gynecological cavity wall.
[0222] Alternatively, the umbrella 5501 may be radially expanded
under a distal compression force rather than a proximal tension.
This may be accomplished by providing an axially moveable push wire
within or concentrically around the central support 5505. A distal
end of the push wire is mechanically linked such as by a strut to
each of the proximal ends 5512 of the arms 5515. Distal axial
advance of the push wire will cause the struts and thus arms 5515
to advance radially outwardly to create a working space.
[0223] Referring to FIGS. 56(a), 56(b), and 56(c) are top views,
partly in section, illustrating an alternate embodiment for
distending a gynecological cavity using a non-elastic balloon 5601.
In the illustrated embodiment, the collapsed balloon 5601 is
deployed through a delivery tube 5603 and is pushed out of the
delivery tube 5603 by push tube 5607. After the collapsed balloon
5601 is positioned at the target site, a fluid gel, gas, or the
like is introduced into the balloon 5601 by way of a supply tube
5605, thereby causing the balloon to expand to the given shape of
the balloon. The expansion of the balloon, which comprises
semi-rigid walls, provides sufficient force to distend the
gynecological cavity wall.
[0224] To collapse and remove the balloon 5601, a negative pressure
is applied to supply tube 5605 to remove the fluid, gel, gas, or
the like from the balloon 5601, thereby allowing the balloon 5601
to collapse. In the collapsed state, the balloon 5601 is removed
from the gynecological cavity by pulling the supply tube 5605 into
the delivery tube 5603. In certain embodiments, the balloon
comprises polyetheretherketones (PEEK), polyethylene terephthalates
(PET), or other like composite materials that have minimal stretch
characteristics.
[0225] In general, the mechanical distension device is thus any of
a wide variety of structures which are capable of transluminal
introduction through the working channel in a first, reduced cross
sectional profile and transformation to a second, enlarged cross
sectional profile once in the vicinity of the treatment site. The
second, enlarged cross sectional profile creates a sufficient space
at the site to allow manipulation of diagnostic or therapeutic
tools necessary for the intended procedure. This may be, for
example, equivalent to at least the volume of the cavity created by
70 to 80 mm Hg of fluid distension.
[0226] Typically, the distension provided by a fluid or gas is
diffuse in nature. Rather than creating a discrete working space at
the desired treatment site, the media expands the associated cavity
without preference. In the case of uterine distension, a fluid
pressure of 35 to 60 mm Hg typically produces a cavity of 10 to 50
cc in total volume. But the volume of the distension media is
distributed evenly throughout the entire uterus, so that the
effective working space provided in the immediate vicinity of any
particular treatment site is relatively small compared to the total
volume of the cavity. The addition of additional pressure that can
reach 100 to 120 mm Hg does provide additional cavity volume but at
the risk of fluid intravasation and greater pain for the
patient.
[0227] One particular advantage of the mechanical distension
structures in accordance with the present invention is the ability
to create a specific working space at a desired site, while leaving
other parts of the cavity in its collapsed configuration. By
localizing the distension to the desired site, the size of the
working cavity at that site can be optimized while minimizing the
total volume of the distension and the associated pain for the
patient.
[0228] For example, it may be desirable to provide a working space
in the immediate vicinity of a treatment site having dimensions
that would approximate a 10 cc sphere. To create that same working
space by infusion of distension media, the infused volume may need
to be at least about 40 cc or 50 cc or more. Thus, in accordance
with the present invention, the working space created at the
desired site is at least about 50%, often at least about 70% and
preferably at least about 85% of the enclosed volume of the
expandable portion of the distension device. The working space may
be approximately equal to the volume of the expanded device, which
may be less than about 50%, often less than about 35% and
preferably less than about 25% of the volume of distension media
which would be necessary to achieve a similar working volume at the
treatment site.
[0229] The expansion device may be permanently attached to the
distal end of an operating shaft, permanently attached to the
distal end of a tether, or detachable at the treatment site. Any of
a wide variety of detachable expansion structures may be
subsequently removed by advancing a grasper down the working
channel and grasping the device under endoscopic visualization. The
device may be thereafter be proximally retracted into the working
channel and reduced in cross section for removal.
[0230] In general, the tissue distension structure will have at
least a first surface for contacting a first tissue zone and a
second surface for contacting a second tissue zone. Activation of
the distension structure advances the first and second surfaces
away from each other, to enlarge the distance between the first and
second tissue zones. In some embodiments, for example, the tissue
distension structure opens such that it resides substantially
within a single plane which contains the longitudinal axis of the
device. In alternative embodiments, the tissue distension structure
may open in two transverse planes having an intersection along the
longitudinal axis of the device, or such that the distension
structure opens into a more complex three dimensional
configuration, including spherical, elliptical, and other geometric
forms of rotation about an axis. In each instance, the tissue
distension device preferably includes at least one opening in a
side or end wall thereof, to permit access to the target
tissue.
[0231] 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.
* * * * *