U.S. patent application number 13/911930 was filed with the patent office on 2014-09-25 for method and apparatus for hysteroscopy and endometrial biopsy.
This patent application is currently assigned to EndoSee Corporation. The applicant listed for this patent is Robert K. Deckman, Paul D. Indman, Xiaolong OUYANG, Shih-Ping Wang. Invention is credited to Robert K. Deckman, Paul D. Indman, Xiaolong OUYANG, Shih-Ping Wang.
Application Number | 20140288460 13/911930 |
Document ID | / |
Family ID | 47108179 |
Filed Date | 2014-09-25 |
United States Patent
Application |
20140288460 |
Kind Code |
A1 |
OUYANG; Xiaolong ; et
al. |
September 25, 2014 |
METHOD AND APPARATUS FOR HYSTEROSCOPY AND ENDOMETRIAL BIOPSY
Abstract
Methods and devices are described for performing a combined
hysteroscopy and endometrial sampling. Techniques for improving
visual images include forward facing fluid ports for clearing
tissue debris and LED positioning and design. Manufacturability is
improved through separately formed tip and shaft pieces. User
interface features are described including user-friendly
handle-mounted buttons as well the use of an interactive integrated
touch screen display. The handle and display can be mated to a
docking station for storage and recharging batteries.
Inventors: |
OUYANG; Xiaolong; (Palo
Alto, CA) ; Indman; Paul D.; (San Jose, CA) ;
Deckman; Robert K.; (San Bruno, CA) ; Wang;
Shih-Ping; (Los Altos, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
OUYANG; Xiaolong
Indman; Paul D.
Deckman; Robert K.
Wang; Shih-Ping |
Palo Alto
San Jose
San Bruno
Los Altos |
CA
CA
CA
CA |
US
US
US
US |
|
|
Assignee: |
EndoSee Corporation
Los Altos
CA
|
Family ID: |
47108179 |
Appl. No.: |
13/911930 |
Filed: |
June 6, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13474429 |
May 17, 2012 |
8460182 |
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13911930 |
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PCT/US2012/034698 |
Apr 23, 2012 |
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13474429 |
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PCT/US2011/051982 |
Sep 16, 2011 |
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PCT/US2012/034698 |
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61623376 |
Apr 12, 2012 |
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61611182 |
Mar 15, 2012 |
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61600593 |
Feb 18, 2012 |
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61599981 |
Feb 17, 2012 |
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61570816 |
Dec 14, 2011 |
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61556167 |
Nov 4, 2011 |
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61555391 |
Nov 3, 2011 |
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61544280 |
Oct 7, 2011 |
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61539736 |
Sep 27, 2011 |
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61515092 |
Aug 4, 2011 |
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61506074 |
Jul 9, 2011 |
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61494400 |
Jun 7, 2011 |
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61490029 |
May 25, 2011 |
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Current U.S.
Class: |
600/570 ;
600/109; 600/562 |
Current CPC
Class: |
A61B 1/053 20130101;
A61B 1/00091 20130101; A61B 1/018 20130101; A61B 1/00124 20130101;
A61B 1/00108 20130101; A61B 1/0676 20130101; A61B 10/04 20130101;
A61B 1/00087 20130101; A61B 1/00101 20130101; A61B 2090/372
20160201; A61B 90/361 20160201; A61B 1/00016 20130101; A61B 1/0005
20130101; A61B 1/0607 20130101; A61B 1/00103 20130101; A61B 1/303
20130101; A61B 1/00066 20130101; A61B 1/05 20130101; A61B 10/0275
20130101; A61B 1/00039 20130101; A61B 1/00094 20130101; A61B 1/0684
20130101; A61B 1/00052 20130101; A61B 1/00179 20130101; A61B
2017/00221 20130101; A61B 1/00105 20130101; A61B 1/015 20130101;
A61B 1/00034 20130101; A61B 1/045 20130101; A61M 2210/1433
20130101; A61B 1/00128 20130101; A61B 10/0291 20130101; A61B
2090/309 20160201; A61B 1/126 20130101; A61B 34/25 20160201 |
Class at
Publication: |
600/570 ;
600/109; 600/562 |
International
Class: |
A61B 10/02 20060101
A61B010/02; A61B 1/303 20060101 A61B001/303 |
Claims
1-71. (canceled)
72. A self-contained, hand-held, low-cost endometrial endoscope
having a single-use, disposable cannula releasably connected by
hand to a multiple-use handle that contains an image display and
detachable by hand from the handle, including: a distal portion of
the cannula configured and dimensioned for insertion into the
patient's uterus and having one or more distal openings configured
to provide fluid outflow, an imaging system configured to image the
uterus and generate video signals in electronic format, and an
illumination system configured to illuminate the uterus; a proximal
portion of the cannula provided with one or more ports configured
to provide passage of fluid into the cannula, and a connector; an
electrical cable extending within the cannula from the imaging
system to the proximal portion and configured to carry video and
control signals; a handle configured for multiple endoscopic
examinations of patients and shaped and dimensioned to be grasped
by a user's hand to manipulate the endoscope while examining a
patient's uterus, the handle including an integral image display
and an interior containing electronic components; a coupling formed
of portions of the handle and the connector and configured to
releasably, by hand, attach to and detach from the handle, by
mating an extension of one of the handle and the connector with a
recess in the other one of the handle and the connector, and to
releasably establish an electrical connection between the cable and
the handle; wherein the connector includes an outer shell and a
barrier fitted inside the outer shell and including a first seal
configured to keep fluid in the cannula from reaching the
electronic components in the handle but to allow passage of the
electrical cable and one or more additional seals between the first
seal and the electronic components, also configured to keep fluid
in the cannula from reaching the electronic components, including a
seal formed by an inner portion of the barrier tightly enveloping a
radial extend of the cable; wherein the electronic components are
configured to receive user commands entered by user operations of
one or more of the handle and the display, the imaging system is
configured to provide an image of the uterus, and the display is
configured to display the image for viewing by the user while the
cannula is inserted in the patient's uterus.
73. The endoscope of claim 72, further including plural
user-operated control elements in at least one of the handle and
the display configured to receive the commands entered by user
operation to selectively energize the illumination and imaging
systems to image the patient's uterus and to display images at said
display.
74. The endoscope of claim 72, further including a tissue sampling
element at the distal portion of the cannula configured to sample
endometrial tissue and deliver samples into the cannula.
75. The endoscope of claim 74, in which the tissue sampling element
includes a side opening with a proximally facing edge configured to
scrape endometrial tissue from the uterus.
76. The endoscope of claim 72, in which the illumination system
includes one or more LED devices at the distal portion of the
cannula.
77. The endoscope of claim 72, in which the imaging system
comprises an electronic imaging device generating a standard video
format image for display.
78. The endoscope of claim 72, in which the cannula includes plural
enclosed channels extending between the distal and proximal
portions.
79. The endoscope of claim 78, in which one of the plural channels
is configured for endometrial tissue sampling.
80. A self-contained endoscope for examining a patient's uterus,
including: a cannula configured for insertion into the patient's
uterus to distend and image the uterus, and a handle including an
integral image display and configured and dimensioned for a user to
hold and manipulate the endoscope; wherein a distal end of the
cannula has one or more openings configured to provide fluid
outflow, an imaging system configured to image the uterus and
provide electronic video images to the display, and an illumination
system configured to illuminate the uterus; a coupling between at
least one of (i) the cannula and the handle and (ii) the handle and
the display, which coupling forms a boundary between a single-use
portion of the endoscope that includes at least the cannula and a
multiple use portion that includes at least the display; wherein
the coupling has an attached state in which the single-use portion
and the multiple-use portion joined by a hand operation into a
single, self-contained endoscope that the user manipulates in space
through the handle, and the imaging system and display are
physically and electrically integrated, and a released state in
which the single-use portion and the multiple-use portion of the
instrument are physically and electrically separated by a hand
operation; one or more ports in a proximal, side surface of the
cannula; computer circuits and control elements in at least one of
the handle and the display that are responsive to operator
manipulation of the control elements to selectively energize the
illumination and imaging systems to image the patient's uterus and
to display images at the display when the coupling is in its
attached state; a fluid barrier configured to keep fluid in the
cannula from entering interior portions of the multiple-use portion
scope; wherein the endoscope is configured for a medical procedure
in which the cannula is inserted into the patient's uterus to
selectively provide, under operator control including through the
control elements, each of (a) uterus distention by introducing
fluid under positive pressure into one or more of the ports, which
fluid passes through the cannula and enters the uterus through one
or more of the openings at the distal end, (b) uterus illumination
with the illumination system; (c) images of the illuminated uterus
taken said imaging system; and (d) display of the images at the
display; and wherein the coupling is hand-changed from the attached
state to the released state to thereby uncouple the single-use
portion so that a new single-use portion can be coupled by a hand
operation with the same multiple-use portion for use for another
uterus examination; and whereby the multiple-use portion is kept
from being contaminated with fluid from the single-use portion and
need not be sterilized between patient but can be simply
disinfected.
81. The self-contained endoscope of claim 80, in which the
multiple-use portion includes the handle and the display.
82. The self-contained endoscope of claim 80, in which the control
elements include buttons on the handle.
83. The self-contained endoscope of claim 80, in which at least
some of the computer circuits are in the handle.
84. The self-contained endoscope of claim 80, further including
another fluid barrier configured to keep fluid flowing in the
cannula from moving in the proximal direction into interior
portions of the handle.
85. The self-contained endoscope of claim 80, further including a
sampling opening at a side surface of the distal end of the cannula
configured to collect tissue samples from the patient's uterus.
86. The self-contained endoscope of claim 85, in which the sampling
opening includes an edge facing in a proximal direction and
configured to scrape tissue from the patient's uterus wall and
direct the scraped tissue into the cannula.
87. The self-contained endoscope of claim 80, in which the
illumination system includes at least one LED device at the distal
end of the cannula.
88. The self-contained endoscope of claim 80, in which the imaging
system includes an integrated circuit at the distal end of the
cannula that generated and transmits to the display a standard
video format image.
89. A method of examining a patient's uterus with a hand-held,
self-contained endoscope, said method including: releasably
attaching by hand a sterile, single-use portion of the endoscope to
a multiple-use portion of the endoscope; introducing a distal end
of the single-use portion into the patient's uterus; distending the
patient's uterus by introducing fluid into one or more channels in
the single-use portion and causing the fluid to flow into the
patient's uterus through one or more openings at the distal end;
illuminating the patient's uterus with an illumination system
emitting light at the distal end; imaging the uterus while
illuminated with an imaging system at the distal end; sending
images of the uterus from the illumination system through a cable
in the single-use portion; selectively displaying the images at a
display that is connected to the cable and is physically and
electrically integrated with, and moves with, the single-use
portion of the instrument during the patient's examination;
controlling the illumination and imaging systems with
operator-manipulated control elements on at least one of the
single-use and multiple-use portions; keeping fluid in the
single-use portion from contaminating interior portions of the
multiple-use portion through the use of one or more fluid barriers
in the endoscope; releasing by hand and removing the single-use
portion from the multiple-use portions; disinfecting the
multiple-use portion without requiring sterilization; and attaching
by hand a new, sterile single-use portion to the multiple-use
portion to prepare the endoscope for another examination of a
uterus.
90. The method of claim 89, in which the controlling comprises
manipulating by hand control elements in a handle that is a part of
the multiple-use portion of the endoscope and that the user grasps
to manipulate the endoscope while examining the patient's
uterus.
91. The method of claim 89, including sampling endometrial tissue
by scraping the patient's uterus with a sampling opening that is on
a side surface of the distal end of the single-use portion and has
an edge facing in a proximal direction, and extracting scraped
tissue through at least one said channels.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation of U.S.
application Ser. No. 13/474,429 filed on May 12, 2012, which in
turn is which in turn is a continuation-in-part of applications
nos. PCT/US12/34698 filed on Apr. 23, 2012 and PCT/US11/051982
filed on Sep. 16, 2011 and U.S. application Ser. No. 12/911,297
filed on Oct. 25, 2010. The parent applications are incorporated by
reference. The following related applications also are incorporated
by reference:
[0002] International Patent Appl. No. PCT/US12/34698 filed Apr. 23,
2012;
[0003] International Patent Appl. No. PCT/US11/051982 filed Sep.
16, 2011;
[0004] U.S. Ser. No. 12/911,297, filed Oct. 25, 2010;
[0005] U.S. Prov. Ser. No. 61/623,376 filed Apr. 12, 2012;
[0006] U.S. Prov. Ser. No. 61/611,182 filed Mar. 15, 2012;
[0007] U.S. Prov. Ser. No. 61/600,593 filed Feb. 18, 2012;
[0008] Prov. Ser. No. 61/599,981 filed Feb. 17, 2012;
[0009] U.S. Prov. Ser. No. 61/570,816 filed Dec. 14, 2011;
[0010] U.S. Prov. Ser. No. 61/556,167 filed Nov. 4, 2011;
[0011] U.S. Prov. Ser. No. 61/555,470 filed Nov. 3, 2011;
[0012] U.S. Prov. Ser. No. 61/550,391 filed Oct. 22, 2011;
[0013] Prov. Ser. No. 61/544,280 filed Oct. 7, 2011;
[0014] U.S. Prov. Ser. No. 61/539,736 filed Sep. 27, 2011;
[0015] Prov. Ser. No. 61/515,092 filed Aug. 4, 2011;
[0016] U.S. Prov. Ser. No. 61/506,074 filed Jul. 9, 2011;
[0017] U.S. Prov. Ser. No. 61/494,400 filed Jun. 7, 2011;
[0018] U.S. Prov. Ser. No. 61/490,029 filed May 25, 2011;
[0019] U.S. Prov. Ser. No. 61/485,601 filed May 12, 2011;
[0020] U.S. Prov. Ser. No. 61/482,309 filed May 4, 2011;
[0021] U.S. Prov. Ser. No. 61/482,200 filed May 3, 2011;
[0022] U.S. Prov. Ser. No. 61/476,754 filed Apr. 18, 2011;
[0023] U.S. Prov. Ser. No. 61/453,533 filed Mar. 16, 2011;
[0024] U.S. Prov. Ser. No. 61/450,115 filed Mar. 7, 2011;
[0025] U.S. Prov. Ser. No. 61/444,098 filed Feb. 17, 2011;
[0026] U.S. Prov. Ser. No. 61/437,687 filed Jan. 30, 2011;
[0027] U.S. Prov. Ser. No. 61/431,316 filed Jan. 10, 2011;
[0028] U.S. Prov. Ser. No. 61/429,093 filed Dec. 31, 2010;
[0029] U.S. Prov. Ser. No. 61/418,248 filed Nov. 30, 2010;
[0030] U.S. Prov. Ser. No. 61/415,771 filed Nov. 19, 2010; and
[0031] U.S. Prov. Ser. No. 61/324,961 filed Apr. 16, 2010.
The above-referenced international and U.S. non-provisional and
provisional patent applications are collectively referenced herein
as "the commonly assigned incorporated applications."
FIELD
[0032] The present invention generally relates to a medical device
for use in hysteroscopic examinations and sampling of the uterus.
More particularly, some embodiments relate to a medical device
having integrated visualization and endometrial sampling
components.
BACKGROUND
[0033] Office-based endometrial biopsy is a standard diagnostic
procedure used by gynecologists. While efficacious in detection of
cancer, endometrial biopsy frequently will not detect endometrial
polyps, submucous myomas, and other endometrial pathology.
Hysteroscopy, or direct vision of the inside of the uterus
(referred to herein as the "uterine cavity" and/or "endometrial
cavity"), has been shown to greatly improve diagnostic accuracy.
Few gynecologists do office hysteroscopy, however, because of the
complexity and expense of the equipment and supplies required.
While it is possible to take tiny biopsies through some
hysteroscopes that have operating channels, the surgeon usually
needs to remove the hysteroscope and then do an endometrial biopsy
with a different instrument. The repeated insertion and removal of
multiple instruments into the patient's uterine cavity can be
uncomfortable for the patient and/or may prolong the time required
to complete the hysteroscopy and endometrial sampling procedures
compared to performing both procedures without the repeated
insertion and removal of different instruments. And, such use of
multiple instruments for the same inspection/biopsy procedure
requires the expense and inconvenience of buying, stocking and
sterilizing such instruments.
[0034] The subject matter claimed herein is not limited to
embodiments that solve any disadvantages or that operate only in
environments such as those described above. Rather, this background
is only provided to illustrate one exemplary technology area where
some embodiments described herein may be practiced.
SUMMARY
[0035] According to some embodiments, an integrated endoscopic
apparatus for examining uterine tissues is described. The apparatus
includes: an elongate member having a proximal end, a distal end,
and being dimensioned so as to facilitate insertion of the distal
end through a patient's cervix and into the uterus; a light
delivery system adapted to illuminate the uterine tissues being
examined; a side-facing sampling opening in the elongate member
located and dimensioned so as to facilitate in collection of
endometrial tissues; an electronic imaging module positioned on the
distal end of the elongate member; and a distal-facing fluid
opening positioned on the distal end of the elongate member so as
to improve visual inspection using the electronic imaging module by
allowing fluid to flow in a distal direction near the lens thereby
reducing debris close to the imaging module. According to some
embodiments the elongate member includes separated fluid paths for
the side-facing opening and the distal-facing opening and/or
internal features to enhance fluid flow from the elongate member
through the distal-facing fluid opening. According to some
embodiments, the electronic imaging module includes a solid-state
CMOS sensor, as well as integrated video processing circuitry
substantially co-planar with the sensor, to output standard video
signals. According to some embodiments, the apparatus includes a
handle and an integrated electronic display monitor.
[0036] According to some embodiments, an integrated endoscopic
apparatus for examining uterine tissues is described that includes:
an elongate member having a proximal end, a distal end, and being
dimensioned so as to facilitate insertion of the distal end through
a patient's cervix and into the uterus; an LED-based light delivery
system positioned near the distal end and adapted so as to emit
light from at least two points greater than 1 mm apart thereby
illuminating uterine tissues being examined; a side-facing sampling
opening in the elongate member located and dimensioned so as to
facilitate in collection of endometrial tissues; an electronic
imaging module positioned on the distal end of the elongate member;
and a fluid opening positioned on the distal end of the elongate
member so as to improve visual inspection using the electronic
imaging module by allowing fluid to flow in a distal direction near
the lens thereby reducing debris close to the imaging module.
According to some embodiments, the electronic imaging module
includes a centrally positioned aperture through which light enters
the imaging module, and the light delivery system includes two LEDs
positioned on the distal end at opposite sides of the aperture from
one another. According to some embodiments, the light delivery
system includes a ring-shaped LED module positioned so as to
surround the aperture.
[0037] According to some embodiments, an integrated endoscopic
apparatus for examining uterine tissues is described that includes:
an elongate member having a proximal end, a distal end, and being
dimensioned so as to facilitate insertion of the distal end through
a patient's cervix and into the uterus, wherein the distal end of
the elongate member comprises an at least partially hollow shaft
member, and a distal tip member wherein the shaft and tip members
are separately formed so as to be mated to one another during
assembly; a light delivery system adapted to illuminate the uterine
tissues being examined; a side-facing sampling opening in the
elongate member located and dimensioned so as to facilitate in
collection of endometrial tissues; and an electronic imaging module
positioned on the distal end of the elongate member. According to
some embodiments, a distal-facing fluid opening is positioned on
the distal end of the elongate member so as to improve visual
inspection using the electronic imaging module by allowing fluid to
flow in a distal direction near the lens thereby reducing debris
close to the imaging module. According to some embodiments, the
shaft and tip members are separately formed for improved assembly
yield. The distal tip uses acrylic and the elongate member uses
nylon.
[0038] According to some embodiments, a method of manufacturing an
integrated endoscopic apparatus for examining uterine tissues is
described which includes: forming a distal end tip body that is
dimensioned to house a light delivery system adapted to illuminate
the uterine tissues being examined, and an electronic imaging
module positioned on the distal end of the elongate member, the
distal end tip body also being formed so as to provide a
side-facing sampling opening in the tip body located and
dimensioned so as to facilitate in collection of endometrial
tissues; forming an elongate shaft member; and securely attaching
the distal tip body to the elongate shaft member thereby forming an
elongate member of an integrated endoscope dimensioned so as to
facilitate insertion of the distal end through a patient's cervix
and into the uterus.
[0039] According to some embodiments a user-friendly integrated
endoscopic apparatus for examining uterine tissues is described
that includes an elongate member having a proximal end, a distal
end, and being dimensioned so as to facilitate insertion of the
distal end through a patient's cervix and into the uterus; a light
delivery system adapted to illuminate the uterine tissues being
examined; a side-facing sampling opening in the elongate member
located and dimensioned so as to facilitate in collection of
endometrial tissues; an electronic imaging module positioned on the
distal end of the elongate member; a handle having a low overall
off-axis profile so as to facilitate easy rotation and tilting in
use, the handle including a plurality of buttons to control a
plurality of features of the apparatus; and an integrated
touch-sensitive electronic display monitor being in electrical
communication with the electronic imaging module. According to some
embodiments a brightness control button is included with which a
user can make a selection from at least three different
illumination levels from the light delivery system. According to
some embodiments, the plurality of buttons includes a capture
button with which a user can select either capturing a still image,
or capturing video images, which are stored in a storage device
within the apparatus. According to some embodiments a lighted
battery status indicator is provided that indicates battery status
information to a user using two or more colors. According to some
embodiments, a plurality of display screens can be displayed on the
integrated touch-sensitive display monitor including a basic menu
screen from which a plurality of other screens can be accessed, and
one of the plurality of buttons on the handle can be used by a user
to jump directly to the basic menu screen.
[0040] According to some embodiments, a method for interacting with
a user is described including displaying to a user a plurality of
screens on a touch-sensitive electronic display monitor, the
monitoring being integrated with an endoscopic apparatus. According
to some embodiments, user input on the touch sensitive display is
received indicating a selection by he user of a stored captured
image file (e.g. a still or video image) that the user would like
to view. In response to the received user selection, content from
the selected stored image file is displayed on the touch sensitive
display.
[0041] According to some embodiments, an integrated endoscopic
apparatus for examining uterine tissues is described including: an
elongate member having a proximal end, a distal end, the distal end
including a distal face having a rounded edges so as to facilitate
safe insertion of the distal end through a patient's cervix and
into the uterus, wherein the edges are rounded to a radius of at
least 0.25 millimeters; a light delivery system adapted to
illuminate the uterine tissues being examined; an electronic
imaging module positioned on the distal end of the elongate member;
a handle; and an integrated electronic display monitor, the display
monitor being in electrical communication with the electronic
imaging module. According to some embodiments the edges of the
distal face are rounded to a radius of at least 0.35 millimeters,
or at least 0.5 millimeters. According to some embodiments the
distal face is convex, so as to decrease collection of inadvertent
tissue collection on the distal face which could impair visual
examination using the imaging module.
[0042] Other features and other embodiments will become apparent
from the description of drawings and detailed description of
preferred embodiments below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] To further clarify the above and other advantages and
features of the subject matter of this patent specification,
specific examples of embodiments thereof are illustrated in the
appended drawings. It should be appreciated that these drawings
depict only illustrative embodiments and are therefore not to be
considered limiting of the scope of this patent specification or
the appended claims. The subject matter hereof will be described
and explained with additional specificity and detail through the
use of the accompanying drawings in which:
[0044] FIG. 1 is a left side view of a device for combined
hysteroscopy and endometrial biopsy according to some
embodiments;
[0045] FIG. 2 is a top plan view of a device for combined
hysteroscopy and endometrial biopsy according to some
embodiments;
[0046] FIG. 3 is a right side view of a device for combined
hysteroscopy and endometrial biopsy according to some
embodiments;
[0047] FIG. 4 is a distal end view of a device for combined
hysteroscopy and endometrial biopsy according to some
embodiments;
[0048] FIG. 5 is a proximal end view of a device for combined
hysteroscopy and endometrial biopsy according to some
embodiments;
[0049] FIG. 6 is a prospective view of a distal tip of a device for
combined hysteroscopy and endometrial biopsy according to some
embodiments;
[0050] FIG. 7 is a left side view of a distal tip of a device for
combined hysteroscopy and endometrial biopsy according to some
embodiments;
[0051] FIG. 8A is a right side view of a distal tip assembly of a
device for combined hysteroscopy and endometrial biopsy according
to some embodiments;
[0052] FIGS. 8B-8E are further views of the distal tip assembly of
a device for combined hysteroscopy and endometrial biopsy according
to some embodiments;
[0053] FIG. 9 is perspective view of a distal tip of a device for
combined hysteroscopy and endometrial biopsy according to some
embodiments;
[0054] FIGS. 10 and 11 show details of the internal structure of
the shaft having separated fluid channels of a device for combined
hysteroscopy and endometrial biopsy according to some
embodiments;
[0055] FIGS. 12, 13 and 14 show internal structures of a distal tip
of a device for combined hysteroscopy and endometrial biopsy
according to some alternate embodiments;
[0056] FIGS. 15-16 show a distal tip of a device for combined
hysteroscopy and endometrial biopsy according to some alternate
embodiments;
[0057] FIGS. 17A-17B show a distal tip of a device for combined
hysteroscopy and endometrial biopsy having an up-tilted camera
module, according to some embodiments;
[0058] FIGS. 18A-18B illustrate how camera tilting effects
effective field of view for a device for combined hysteroscopy and
endometrial biopsy, according to some embodiments;
[0059] FIG. 19 shows a distal tip of a device for combined
hysteroscopy and endometrial biopsy having a prism-aided tilted
camera view, according to some embodiments;
[0060] FIGS. 20A-20B and 21A-21B show examples of ring-type LEDs
for use with a hysteroscopy device, according to some
embodiments;
[0061] FIG. 22 shows a device for combined hysteroscopy and
endometrial biopsy having malleable shaft, according to some
embodiments;
[0062] FIGS. 23 and 24 show details of the a device for combined
hysteroscopy and endometrial biopsy having separate tip and shaft
assemblies, according to some embodiments;
[0063] FIG. 25 is an exploded view of some internal components of a
distal tip of a device for combined hysteroscopy and endometrial
biopsy, according to some embodiments;
[0064] FIGS. 26-28 are cross sections showing examples of different
internal shaft structures within a cannula for a device for
combined hysteroscopy and endometrial biopsy, according to some
embodiments;
[0065] FIGS. 29 and 30 show further details of a distal tip for a
device for combined hysteroscopy and endometrial biopsy, according
to some embodiments;
[0066] FIGS. 31-33 show a single-use device for combined
hysteroscopy and endometrial biopsy, according to various
embodiments;
[0067] FIGS. 34-39 show a device combined hysteroscopy and
endometrial biopsy having a detachable handle, which can be mated
with a docking station, according to some embodiments;
[0068] FIGS. 36 and 37 are a perspective view and a side view,
respectively, of the handle and display docked to a base station,
according to some embodiments;
[0069] FIG. 40 is a top view of a device for combined hysteroscopy
and endometrial biopsy having additional buttons on the handle,
according to some embodiments;
[0070] FIG. 41 is shows a display screen user interface for a
hysteroscopy device, according to some embodiments;
[0071] FIG. 42 shows details of some elements of a user interface
for a hysteroscopy device, according to some embodiments;
[0072] FIG. 43 is a flow chart showing aspects of a user interface
for a hysteroscopy device relating to entering new patient
information, according to some embodiments;
[0073] FIG. 44 is a flow chart showing aspects of a user interface
for a hysteroscopy device relating to previewing images and video,
according to some embodiments;
[0074] FIGS. 45A-45B are a flow chart showing aspects of a user
interface for a hysteroscopy device relating to playback of saved
images and video, according to some embodiments;
[0075] FIG. 46 is a flow chart showing aspects of a user interface
for a hysteroscopy device relating to settings, according to some
embodiments;
[0076] FIGS. 47-48 are side views showing details of the shapes of
distal tips of a hysteroscopy device, according to some
embodiments.
[0077] FIGS. 49-51 illustrate further details and embodiments; and
FIG. 52 is a flowchart illustrating examples of steps in using
certain embodiments;
[0078] FIG. A1 illustrates an example medical device including an
endoscope and sampling device, according to some embodiments;
[0079] FIG. A2 illustrates an example medical device according to
some embodiments;
[0080] FIG. A3 illustrates an example medical device according to
some embodiments disclosed herein;
[0081] FIG. A4A illustrates an example medical device according to
some embodiments disclosed herein;
[0082] FIG. A4B illustrates an exploded view of a portion of the
example medical device shown in FIG. A4A;
[0083] FIGS. A5A-A5C illustrate an example fluid and connector hub
for use in a medical device according to some embodiments disclosed
herein;
[0084] FIGS. A6A-A6B illustrate an example fluid and connector hub
for use in a medical device according to some embodiments disclosed
herein;
[0085] FIGS. A7A-A7C illustrate an example fluid and connector hub
for use in a medical device according to some embodiments disclosed
herein;
[0086] FIG. A8 illustrates an example medical device according to
some embodiments disclosed herein;
[0087] FIG. A9 illustrates an example medical device according to
some embodiments disclosed herein;
[0088] FIG. A10 illustrates an example medical device according to
some embodiments disclosed herein;
[0089] FIG. A11 illustrates a flowchart of an example method of
operating the medical device according to some embodiments
disclosed herein;
[0090] FIG. A12 illustrates a flowchart of an example method of
operating the medical device according to some embodiments
disclosed herein; and
[0091] FIG. A13 illustrates a flowchart of an example method of
operating the medical device according to some embodiments
disclosed herein;
[0092] FIGS. A14A-A14D illustrate a device for combined
hysteroscopy and endometrial biopsy according to some
embodiments;
[0093] FIGS. A15A-A15D illustrate a device at respective phases of
a method for combined hysteroscopy and endometrial sampling
according to some preferred embodiments;
[0094] FIGS. A16-A17 illustrate further detail of the handle and
display portions of a sampling endoscope, according to some
embodiments;
[0095] FIGS. A18A-A18D illustrate closer views of the distal end of
a device for combined hysteroscopy and endometrial biopsy,
according to some embodiments;
[0096] FIG. A19 illustrates various factors in optimal sensor
design for single use video endoscopes, according to some
embodiments;
[0097] FIGS. A20A-A20C illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0098] FIGS. A21A-A21B illustrate a sampling endoscope having a
pistol grip, according to some embodiments;
[0099] FIGS. A22A-A226 illustrate an endoscope having optical fiber
illumination, according to some embodiments;
[0100] FIGS. A23A-A23D illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0101] FIGS. A24A-A248 illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0102] FIGS. A25A-A258 illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0103] FIGS. A26A-A26B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0104] FIGS. A27A-A27B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0105] FIGS. A28A-A28B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0106] FIGS. A29A-A29B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments;
[0107] FIG. A30 is a cross sectional view illustrating further
detail of a camera module for use with a device having combined
hysteroscopy and endometrial sampling capability, according to some
embodiments;
[0108] FIG. A31 illustrates a device having combined hysteroscopy
and endometrial ablation capability, according to some
embodiments;
[0109] FIGS. A32A-A32C illustrate the distal end of a device having
combined hysteroscopy and endometrial ablation capability,
according to some embodiments; and
[0110] FIGS. A33A-A33C illustrate a device at respective phases of
a method for combined hysteroscopy and endometrial ablation,
according to some embodiments.
DETAILED DESCRIPTION
[0111] A detailed description of examples of preferred embodiments
is provided below. While several embodiments are described, it
should be understood that the new subject matter described in this
patent specification is not limited to any one embodiment or
combination of embodiments described herein, but instead
encompasses numerous alternatives, modifications, and equivalents.
In addition, while numerous specific details are set forth in the
following description in order to provide a thorough understanding
work, some embodiments can be practiced without some or all of
these details. Moreover, for the purpose of clarity, certain
technical material that is known in the related art has not been
described in detail in order to avoid unnecessarily obscuring the
new subject matter described herein. It should be clear that
individual features of one or several of the specific embodiments
described herein can be used in combination with features or other
described embodiments. Further, like reference numbers and
designations in the various drawings indicate like elements.
[0112] FIG. 1 is a left side view of a device for combined
hysteroscopy and endometrial biopsy according to some embodiments.
Many of the elements of the embodiments of hysteroscope 100 shown
in FIG. 1 are the same as or similar to those discussed in the
embodiments described in the commonly assigned incorporated
applications, and such elements may not be described or may only
briefly be described. It will also be appreciated that the aspects
of the embodiments described in the commonly assigned incorporated
applications may also apply to the embodiments described
herein.
[0113] The device 100 is particularly advantageous for enabling a
physician to perform an efficient combined hysteroscopic
examination and an endometrial biopsy, although it is to be
appreciated that other uses for hysteroscope 100 are within the
scope of the present teachings. The hysteroscope 100 can bring
about substantial efficiencies in terms of keeping equipment costs
low and keeping the time required to perform the procedure modest,
while at the same time providing the opportunity for better
endometrial sample quality over conventional "blind" endometrial
sample collection methods. Hysteroscope 100 includes a cannula 102,
fluid hub 104, sliding connector 106, handle body 108, display
mount 112 and display 110. The cannula 102 is made of a distal tip
120 and a shaft 122. The fluid hub includes one or more fluid ports
114 for delivering fluid into the device and thus into the uterus
and/or for applying suction to extract fluid and tissue samples
from the uterus. As shown the shaft 122 is curved near its distal
end, for example having a 25 degree bend as shown. According to
some embodiments, a bend of between 15 and 35 degrees near the
distal end has been found to be suitable for many applications. The
distal tip 120 includes a video camera assembly, lighting elements
and fluid ports for in-flow (i.e. out of the device 100 and into
the patient) and out-flow (i.e. into the device 100 and out of the
patient). A sampling port on the upper side of the distal tip 120
also includes a cutting portion, which aids in tissue sample
collection, as described in more detail below. The tip 120 includes
a housing body that is made from acrylic, according to some
embodiments. The shaft 122 is made from nylon, according to some
embodiments. According to some embodiments the display 110 is a
touch screen display, and is able to tilt upwards and downwards by,
for example, about 45 degrees. According to some embodiments, in
FIG. 1 as in other figures herein, various dimensions are shown
that have been found to be suitable for many applications, but
those skilled in the art may vary those dimensions without
departing from the teachings of this patent specification.
According to some embodiments, the cannula 102 (including the
camera assembly, LED lighting and fluid ports integrated into the
distal tip 120), fluid hub 104 and sliding connector 106 are
designed for a single-use. According to these embodiments the
cannula 102, fluid hub 104 and connector 106 are delivered to the
medical practitioner in pre-sterilized package and are intended to
be disposed of after a single-use, while the handle 108 and display
110 are designed to be re-used many times.
[0114] FIG. 2 is a top plan view of a device for combined
hysteroscopy and endometrial biopsy according to some embodiments.
In this view, three control buttons are shown on the handle body
108. In particular, ON/OFF button 210 is used to toggle the device
100 on or off. According to some embodiments, the power ON/OFF
button 210 is backlit using two differently colored LEDs to
indicate the status of rechargeable battery 220 to the user. For
example, green backlighting can be used to indicate the battery
level is OK and red backlighting can be used to indicate the
battery 220 is low (for example, less than 30% capacity remaining,
such as used for icon 4218 shown in FIG. 42 infra). According to
some embodiments the capacity of battery 220 is about 2500 mAh.
According to some embodiments, the LED lighting of button 210 can
also be used to indicate battery charging status during re-charging
of the battery 220 from an external power source, such as when
docked to a base station such as shown in FIGS. 36-37, infra, or
when connected to a USB powered source using port 312 shown in
FIGS. 3-4 infra. In this case, the backlighting LED shows red while
charging the battery and green when the battery 220 is fully
charged. According to some embodiments, the ON/OFF button 210
doubles as a "home" button, such that a shorter press, such as 1
second or less, of button 210 brings up a home screen menu on the
display 110, as shown in FIG. 41, infra, while a longer press will
turn the unit off.
[0115] LED brightness control button 212 is used to control the
brightness of the LEDs on the distal tip 120. According to some
embodiments a total of four different LED illumination levels has
been found to be suitable and the single button 212 controls the
level by cycling through the levels, changing the illumination
level with each button press. The Snap/Video button 214 is used to
capture still images and/or video from the camera in tip 120.
According to some embodiments, pressing Snap/Video button 214 for
three seconds or less captures a single still photo, while pressing
button 214 for longer than three seconds starts video recording.
When video is being recorded, a single press of button 214 stops
video capture. Further details of the user interface which includes
the buttons 210, 212 and 214 as well as the interactive touch
screen display 110 are described with respect to FIGS. 41-46 infra.
According to some embodiments, an audible acknowledgement signal is
associated with presses of the buttons 210, 212 and 214. For
example, a single "beep" is sounded when any of the buttons
(including software buttons such as shown in FIGS. 41 and 43-46
infra.) except for double beeps when either the Snap/Video button
214 or an OK software button is pressed.
[0116] FIG. 3 is a right side view of a device for combined
hysteroscopy and endometrial biopsy according to some embodiments.
On the side of the display 110 is a rubber flap 310 that covers
mini-USB port 312 and SD card slot 314. Flap 310 forms a fluid seal
around the edge of the opening. Beneath the flap 310, the mini-USB
port 312 serves multiple purposes including video-out to an
external display, connector to an AC adapter for charging the
rechargeable battery 220, and/or as a port to a host PC for
downloading and uploading images, video and/or settings, as well as
for charging the rechargeable battery 220. The SD card slot 314 is
used to accept flash memory cards used to store images, video
and/or settings for the device 100. According to some embodiments a
standard size high-capacity (SDHC or SDXC) slot is provided,
although smaller form factors such as Mini SD or Micro SD cards, or
other types of storage media can be used.
[0117] FIG. 4 is a distal end view of a device for combined
hysteroscopy and endometrial biopsy according to some embodiments.
The tip 120 and shaft 122 can be seen, as well as the fluid hub
104, fluid port 114 and handle body 108. The SD card USB port flap
310 is also shown on the side of the display body. Also shown,
according to some embodiments is photo/video processing circuitry
410 that can be used to enhance or otherwise manipulate standard
video signals and/or images received from the camera module in tip
120.
[0118] FIG. 5 is a proximal end view of a device for combined
hysteroscopy and endometrial biopsy according to some embodiments.
Touch-sensitive screen 110 is preferably 3.5 inches (diagonally) in
size.
[0119] FIG. 6 is a prospective view of a distal tip of a device for
combined hysteroscopy and endometrial biopsy according to some
embodiments. Distal tip 120 includes a tip housing 600 that is made
from acrylic, according to some embodiments. On the tip side of the
tip 120 is the sampling port 610 used to draw fluid out of the
patients uterus as well as collect tissue. The sampling port 610
includes a cutting edge 612, which is sharp and positioned so as to
facilitate collection of the endometrial sample by scraping. On the
distal end of the tip 120 is camera assembly 640. Two LEDs 630 and
632 are positioned above and below the camera to evenly illuminate
the uterine tissue for visual inspection. A light shield 642 acts a
lens hood and shields direct light from the LEDs 630 and 632 from
entering the aperture of the camera 640.
[0120] One problem in performing visual inspections of endometrial
tissues, and particularly in situations where the endometrial
medium, consisting of free tissue, loosely attached tissue and/or
fluid, is relatively thick, is that light reflected from tissue
particles suspended close to the lens can appear overly-bright and
therefore impair imaging of other tissue surfaces. According to
some embodiments, two forward facing fluid ports, 620 and 622 are
provided to allow fluid to exit the tip and tend to push suspended
particulate matter away from the camera so as to enhance image and
video capture by camera 640. In some cases some tissue debris may
collect on the distal surface such that imaging would be impaired
in such cases the forward facing ports are useful in clearing away
such collected tissue. Also it has been found that the forward
facing ports are helpful in aiding insertion of the cannula in many
cases as the fluid provides lubrication as well as a partial
distending of tissues just ahead of the distal tip during
insertion. Since the forward facing ports improve visualization,
the risk of accidental damage to the uterus is greatly reduced.
[0121] FIG. 7 is a left side view of a distal tip of a device for
combined hysteroscopy and endometrial biopsy according to some
embodiments. The acrylic body 600 of the tip 120 preferably
includes one or more ridges 710 to aid in securely fastening the
tip 120 to the shaft 122 (not shown).
[0122] FIG. 8A is a right side view of a distal tip assembly of a
device for combined hysteroscopy and endometrial biopsy according
to some embodiments. In these embodiments, the forward facing
in-flow (out of the device) fluid ports are connected to a separate
fluid channel to enhance control over the fluid flowing into and
out of the device 100. The tip 120 in this case includes separated
fluid channels for fluid in-flow and out-flow. In particular a
separate fluid channel 810, which runs along the upper right side,
is connected to the front-facing fluid port 620, and another fluid
channel, not shown, is connected to the other front-facing fluid
port 622, not shown. A central fluid channel 820 is connected to
the side sampling port 610.
[0123] FIGS. 8B-8E are further views of the distal tip assembly of
a device for combined hysteroscopy and endometrial biopsy according
to some embodiments. FIG. 8B is a proximal end view of the tip 120
shown in FIG. 8A. The tip body or housing 600 includes two in-flow
(out of the device and into the patient) channels 810 and 812 that
are fluidly connected to the two in-flow front-facing ports, and a
central channel 820 that is fluidly connected to the sampling port
610. The central channel 820 is also used to run a video and
control cable from the camera assembly towards the handle and the
display. FIG. 8C is a sectional view of the distal tip along the
line A-A' shown in FIG. 8A. Note that the tip housing 600 is made
of an outer sleeve 830 and a core 832, according to some
embodiments. FIG. 8D is a sectional view of the distal tip along
the line B-B' shown in FIG. 8A, and shows the connection between
the central fluid channel 820 and the sampling port 610. FIG. 8E is
a distal end view of the tip assembly 120 shown in FIG. 8A.
According to some embodiments, the tip 120 outer dimensions are
slightly larger toward the distal end. For example, the tip body
600 measures 3.8 mm.times.4.6 mm at the proximal end, shown in FIG.
8B, and measures 4.2 mm.times.4.8 mm at the distal end, shown in
FIG. 8E.
[0124] FIG. 9 is perspective view of a distal tip of a device for
combined hysteroscopy and endometrial biopsy according to some
embodiments. This view of the distal tip assembly 120 shows fluid
direction arrows such as arrows 910, 912 and 914 for fluid flowing
through channel 810 and out of front-facing port 620. The arrows
916 and 918, similarly, show the direction of fluid flowing in
channel 812. The arrows 920, 922 and 924 show the direction of
fluid from sampling port 610 and through the central channel
820.
[0125] FIGS. 10 and 11 show details of the internal structure of
the shaft having separated fluid channels of a device for combined
hysteroscopy and endometrial biopsy according to some embodiments.
FIG. 10 is a perspective view of the distal end of the shaft 122.
The distal end 1030 of the shaft 122 has the internal structure
removed so as to be able to mate with the proximate end of the tip
120. The shaft 122 has separate channels 1010 and 1012 that are
aligned so as to fluidly mate with channels 810 and 812
respectively on tip 120. The upper central channel 1020 is used for
the out-flow fluid (i.e. into the device) for removing fluid from
the uterus and/or to provide negative pressure for tissue sample
collection. The channel 1020 is thus positioned to fluidly mate
with central channel 820. Also included is a separate channel 1022
that is used to house the video and camera control cable, which
also passes through the central channel 820 of tip 120. FIG. 11 is
a cross section of the shaft 122. According to some embodiments,
the shaft 122 is made from extruded nylon.
[0126] FIGS. 12, 13 and 14 show internal structures of a distal tip
of a device for combined hysteroscopy and endometrial biopsy
according to some alternate embodiments. FIGS. 12-14 show two
embodiments wherein the in-flow and out-flow paths are not
separated as in the case of the embodiments of FIGS. 8A-E and 9. In
the case where the flow paths are not separated, the tip 120, shaft
122 and fluid hub 104 can be more structurally simplified. However,
due to the relative sizes of the forward facing fluid ports 610 and
612 on the one hand and the side-facing port 620 on the other,
certain structural elements may be included to ensure adequate
fluid flow out of the front facing ports 610 and 612 during times
when useful to improve visual inspection. In the case of FIGS. 12
and 13, an element 1210 is included just behind the sampling port
610 to direct the fluid towards the forward-facing ports as shown
by arrow 1310 in FIG. 13. In the case of FIG. 14, the upper section
1410 is filled in solid so as to aid in directing the fluid towards
the forward-facing ports as shown by arrow 1412.
[0127] FIGS. 15-16 show a distal tip of a device for combined
hysteroscopy and endometrial biopsy according to some alternate
embodiments. FIGS. 15-16 show a further embodiment wherein the
in-flow and out-flow paths are not separated as in the case of the
embodiments of FIGS. 8A-E and 9. In this case, the two
forward-facing fluid ports 1520 and 1522 are positioned lower on
the distal tip 120 such that the camera module 1540 and the video
cable 1612 tend to force the in-flow direction fluid (i.e. out of
the tip 120) under the cable 1612 and toward the ports 1520 and
1522 rather than out of the side-facing sampling port 610. The
arrows 1610 show example fluid flow paths in the in-flow direction
(out of the device). According to other embodiments other internal
structures can be provided in addition to or in place of those
shown in shown in FIGS. 12-16 to enhance flow through the forward
facing ports.
[0128] FIGS. 17A-17B show a distal tip of a device for combined
hysteroscopy and endometrial biopsy having an up-tilted camera
module, according to some embodiments. In FIG. 17A, it can be seen
that camera 1710 is tilted up at an angle of, e.g., 12 degrees from
the longitudinal axis of the tip body or housing 600. The upwards
tilting of the camera increases the effective field of view of the
device. Also shown in FIGS. 17A and 17B is a glass cover 1712 of
camera module 1710. A light guide 1720 is also used to diffuse
light from one or more LEDs, such as LED 1722. The light guide
1720, as shown in FIG. 17B surrounds the camera module 1710. The
light guide 1720 can be made of glass or a polymer, for example.
Also shown in this example is a forward facing fluid port 1740
which is useful in directing fluid in a forward direction so as to
enhance visual inspection.
[0129] FIGS. 18A-18B illustrate how camera tilting provides a
larger effective field of view for a device for combined
hysteroscopy and endometrial biopsy, according to some embodiments.
During visual inspection of the uterine tissues, the device 100 is
rotated about its longitudinal axis by the doctor or medical
professional. The position of the cannula 102 when rotated 180
degrees, is shown by the dotted outline 1810. The field of view
(FOV) of the camera module in this example is shown which combined
with the bending of the shaft 122 by and angle .alpha., results in
an effective field of view in the case of FIG. 18A of .beta..sub.1.
In the case of FIG. 18B, the camera is tilted upwards by an angle
of .gamma., which results in an increase in effective field of view
by twice .gamma., due to the rotation of the device. The effective
field of view of the device 100 in FIG. 18B is shown as
.beta..sub.2.
[0130] FIG. 19 shows a distal tip of a device for combined
hysteroscopy and endometrial biopsy having a prism-aided tilted
camera view, according to some embodiments. In this case a prism
1910 is used to modify the angle of the camera module 1920 to
provide an effective upwards tilting of the field of view of the
camera module 1920 by an angle .gamma., which will result in an
increased effective field of view of the device during use by two
times .gamma..
[0131] FIGS. 20A-20B and 21A-21B show examples of ring-type LEDs
for use with a hysteroscopy device, according to some embodiments.
In FIGS. 20A and 20B, a ring-type LED 2020 is shown surrounding a
camera module 2010 that is used on the distal tip of a hysteroscopy
device, such as device 100 described herein. In FIG. 20A, the
illumination intensity distribution curve 2030 represents
illumination from a single LED sector 2022 from ring LED 2020. In
FIG. 20B, the overall illumination distribution curve 2032
represents the illumination from the entire ring LED 2020. Note
that the center is much brighter than the edges, which may be
problematic for imaging under some circumstances. According to some
embodiments, a more evenly distributed intensity is achieved using
an ring-type LED as shown in FIGS. 21A and 21B. In FIG. 21A, the
ring type LED 2120 is shown surrounding a camera module 2010 that
is used on the distal tip of a hysteroscopy device, such as device
100 described herein. The illumination intensity distribution curve
2130 represents illumination from a single LED sector 2122 from
ring LED 2120. Note that the intensity is unevenly distributed
towards the outer edge of the ring. The intensity profile is
adjusted, for example, by using different thicknesses or
orientations of the LED. FIG. 21B shows the resulting overall
intensity distribution 2132 from ring LED 2120 where the center is
more even with the edges, which results in enhanced imaging
quality.
[0132] FIG. 22 shows a device for combined hysteroscopy and
endometrial biopsy having malleable shaft, according to some
embodiments. In this example, cannula 102 includes a malleable
shaft 2200. The shaft 2200 is malleable at the time of usage to aid
reaching and visualizing recessed portions of the uterine cavity.
The shaft 2200 can be made malleable, for example, by using a
flexible nylon that includes one or more bendable metal wires
running along the inside length of the shaft housing.
[0133] FIGS. 23 and 24 show details of a device for combined
hysteroscopy and endometrial biopsy having separate tip and shaft
assemblies, according to some embodiments. The cannula 102 of
device 100 is made up of a tip 120 and a shaft 122. The tip 120
includes a molded acrylic tip housing 600 that houses the camera
module, LEDs and other elements as described herein. The shaft 122
is made from extruded nylon, such as nylon 6, and may have internal
structure such a shown in FIGS. 10, 26-28. According to some
embodiments, shaft 122 can be made of another suitable material,
such as Provista Copolymer. In FIG. 23 a video cable 2310 is also
shown running along the inside of shaft 122 which carries video
signals as well as control signals for the camera module and/or the
LEDs in the tip 120. FIG. 24 shows how the tip assembly 120 is
attached to the shaft 122. According to some embodiments, about 5
mm or more of the tip 120 is inserted into the shaft 122. If there
are internal structures such as shown in FIGS. 10, and 26-28, they
are spaced inwardly from the distal end of the shaft 122 so that
proper mating can be achieved. Through the implementation of
separately manufactured tip and shaft pieces, as shown, it has been
found that the manufacturing cost can be decreased, and yield can
be increased because the shaft is extruded while the acrylic tube
is molded to provide sophisticated structure. Furthermore, the
separate tip and shaft design allows for greater flexibility in
forming the internal structures within both the tip and shaft.
[0134] FIG. 25 is an exploded view of some internal components of a
distal tip of a device for combined hysteroscopy and endometrial
biopsy, according to some embodiments. In this example, tip
assembly 120 is shown with various parts of the camera module
separated for ease of viewing. The camera module includes CMOS
sensor module 2510, lens 2512, iris 2514, shield 2516 and glass
cover 2518. The CMOS sensor module 2510 includes a low voltage
color CMOS image sensor core, image sensor processing and image
output interface circuitry on a single chip such as the OmniVision
7675. By providing integrated digital video processing within
sensor module 2510, all video processing can be performed directly
on the same PCB as the CMOS sensor, or on the same substrate in
which the CMOS is formed such that the imaging plane of the CMOS
and the plane along which the video processing circuits extend
substantially coincide. In this example, the video signal from
sensor module 2510 can be in any suitable video format, such as
NTSC, PAL, or another common video format, so that no further video
processing would be required to drive widely available displays for
common video formats such as TV displays, tablets, computers and
hospital workstations. Also shown in FIG. 25 are one or more LEDs
2530. According to some embodiments another LED can be used mounted
above the camera module. The holder 2520 retains the camera module
and LEDs. According to some embodiments, the holder 2520 holds the
camera module at an up-tilted angle of for example 12 degrees from
the longitudinal axis of the tip housing 600.
[0135] FIGS. 26-28 are cross sections showing examples of different
internal shaft structures within a cannula for a device for
combined hysteroscopy and endometrial biopsy, according to some
embodiments. In FIG. 26, shaft 2610 includes a separate channel
2612 for the cable used for video and control signals as well as
LED power. The upper channel 2614 is used for as the fluid channel
for both in-flow and out-flow directions. Similarly, in FIG. 27,
shaft 2710 includes a separate channel 2712 for the cable, while an
upper channel 2714 is used for as the fluid channel for both
in-flow and out-flow directions. In the example of FIG. 28, a
partially separated internal structure is used. The shaft 2810
includes an upper lobe 2814 used for fluid flow and a lower lobe
2812 that primarily holds the cable 2820 used for LED power, video
signals and control signals for the camera. The structure of FIG.
28 allows for simplified assembly since it is easier to position
the cable 2810 in the lower lobe than to thread or fish it through
a separate channel.
[0136] FIGS. 29 and 30 show further details of a distal tip for a
device for combined hysteroscopy and endometrial biopsy, according
to some embodiments. FIG. 29 is a perspective view of the distal
tip 120 and distal end of shaft 122, according to some embodiments.
As in some other described embodiments, the tip 120 includes a tip
housing body 600 that is made from molded acrylic, for example a
single molded piece of transparent acrylic. The tip 120 includes a
side facing sampling port 610 and front facing fluid port 2940. A
forward facing camera module includes a glass cover 1712 and in
this case an acrylic camera module housing shell 2910. Two forward
facing LEDs 2920 and 2922 are positioned just below the glass cover
1712. The cable 1612 used for LED power, video signals and control
signals for the camera is also shown running down the shaft 122.
FIG. 30 is a cross section of the tip and shaft shown in FIG.
29.
[0137] Conventional endoscopes are typically tethered and
cumbersome to use. They require skilled staff to operate and
maintain. This makes it especially difficult in time critical
locations such as an emergency room, operating room, and other
areas of a medical facility where multiple devices and instruments
are being used simultaneously. According to some embodiments, the
device 100 shown for example in FIGS. 1-5 is a hand-held, compact
single use endoscope. In these cases, endoscope 100 is provided in
a sterile package, so is ready for immediate use without requiring
any preparation for diagnostic or therapeutic procedures. According
to some embodiments the single use device 100 needs no
sophisticated connectors such that the entire endoscope is supplied
in a sterile package ready for use.
[0138] FIGS. 31-33 show a single-use device for combined
hysteroscopy and endometrial biopsy, according to various
embodiments. In the case of FIG. 31, device 100 includes an
external monitor 3110 for viewing the images and/or video. A
sterile cord 3112, which transmit the images and video to the
external monitor, is attached to and is packaged with the device
100.
[0139] In the case of device 100 of FIG. 32, the images and video
are transmitted by a wireless connection. The handle 100 includes a
wireless transmitter 3212 and the eternal monitor 3210 includes a
wireless receiver. According to some embodiments Wi-Fi technology
is used. According to some embodiments, a device such as a smart
phone 3220, a tablet computer 3222, a mobile computer, or other
mobile device having wireless and display capabilities are used to
view the images and/or video.
[0140] In the case of FIG. 33, the device 100 includes a gyroscopic
module 3310 embedded to provide constant reference of orientation.
A video processor is used to register the displayed images upright
on the devices such as devices 3210, 3110, 3220 and 3222.
[0141] FIGS. 34-39 show a device for combined hysteroscopy and
endometrial biopsy having a detachable handle, which can be mated
with a docking station, according to some embodiments. FIGS. 34 and
35 show details of the handle and display detached from the fluid
hub and cannula, according to some embodiments. FIG. 34 is a
perspective view wherein handle 108 and display 110 are detached
from the sliding connector 106 of the fluid hub 104 such as shown
in FIG. 1. The distal end of the handle body 108 includes connector
3410 that has pin sockets that are used both for communicating and
supplying power to the cannula when connected as well as to
transmit video and control signals and settings to and from a base
station or docking station when docked. The handle 108 also
includes a recessed DC connector 3412 that is used to supplying
power to the handle 108 when docked, for example to recharge the
battery 220 and/or to prevent battery drain when downloading or
viewing images and video and/or uploading settings to the unit.
FIG. 35 is a distal end view of the handle 108, and shows the
rubber flap 3510 that seals the DC power connector 3412 when not
being used such as during docking with a docking station.
[0142] FIGS. 36 and 37 are a perspective view and a side view,
respectively, of the handle and display docked to a base station,
according to some embodiments. The handle 108 and display 110 are
shown mated, or docked with base station 3610. The distal portion
of the handle 108 is inserted into the opening, lined with a rubber
liner 3612. When inserted in the base station 3610, the handle and
display are well supported protected as shown. In addition to
providing a stable base for the handle and display, the base
station 3610 can also be used to supply power to handle and
display, such as for recharging the battery and/or for viewing
images and video on the display 110. For this purpose, an external
power supply can be connected to the base station 3610 via the DC
power connector 3712. The base station can also be used to
communicate with the handle and display, such as to view and or
download images or video, as well as to view and modify settings.
The mini-USB connector 3710 can be used for this purpose, as well
as to supply power to the base station (as well as to the handle
and display when docked). According to some embodiments, the base
station 3612 includes wireless communication circuitry, such as
Wi-Fi, for communicating with devices such as a smart phone 3220, a
tablet computer 3222 (as shown in FIG. 32), a mobile computer, or
other mobile device having wireless and display capabilities are
used to view the images and/or video. FIGS. 38 and 39 are a plan
view and perspective view of the base station 3610 without the
handle inserted. As can be seen a mating connector 3810 is provided
which mates with the connector 3410 as shown in FIGS. 34 and 35.
Also provided is a DC power connector 3812 that mates with the DC
power connector 3412 as shown in FIG. 34. Additional storage and/or
processing can be provided for still or video images from the
device 100, such as storage in PACS or other archival storage
systems of the type commonly used in hospitals and clinics for
patient records and medical images and/or processing in work
stations commonly used for processing and viewing of medical images
in hospitals and clinics. The still and/or video images from the
device 100 can be formatted as needed for a commonly used format,
such as DICOM in one example, in the base station 3610, or one or
more of the devices 3220 and 3222, or a mobile computer, or a
computing device connected to the base station 3610. The formatted
still and/or video images then can be transmitted in accordance
with the selected format to a PACS or other storage system, and/or
to a workstation where they can be further processed as is known in
the art, e.g., to enhance certain aspects of images or to carry out
CAD (computer aided detection) processes, and can be displayed
alone or together with images from other modalities or prior images
of the same patient for diagnostic or other purposes. According to
some embodiments the base station as shown in FIGS. 36-39 are
particularly useful when the cannula 102, fluid hub 104 and
connector 106 are intended to be disposed of after a single-use,
while the handle 108 and display 110 are designed to be re-used
many times. In this case the handle and display are conveniently
stored on the base station while a supply of single-use cannula/hub
assemblies are kept in pre-sterilized packages ready for use.
[0143] FIG. 40 is a top view of a device for combined hysteroscopy
and endometrial biopsy having additional buttons on the handle,
according to some embodiments. As shown, in addition to the ON/OFF
button 210, LED brightness control button 212, and Snap/Video
button 214 as described in FIG. 2, the handle 108 includes a
playback button 4010 and a manual white balance button 4012. The
playback button 4010 is used to re-play snapshots and/or video
taken during the procedure such that medical personnel can later
review the images or video on the display 110. The manual white
balance button 4012 is used to cycle through several pre-set white
balance levels so that the user can quickly and easily select a
suitable white balance for the particular case.
[0144] FIG. 41 shows a display screen user interface for a device
for combined hysteroscopy and endometrial biopsy, according to some
embodiments. The touch-screen display 110 of hysteroscopy device
100 is shown with home screen 4110. According to some embodiments,
the display is 3.5 inches in size. The home screen 4110 includes
four options that can be selected by a user by touching the screen.
A battery status icon 4120 is shown in the upper left corner. The
home screen 4110 includes four user-selectable menu options (or
soft-buttons) that are labeled as shown: new patient, preview,
playback and setup. According to some embodiments, pressing the
power ON/OFF button 210 for 1 second or less is used as a "home
button" on the device 100 such that the home screen 4110 is
displayed.
[0145] FIG. 42 shows details of some elements of a user interface
for a device for combined hysteroscopy and endometrial biopsy,
according to some embodiments. Five levels of battery status can be
displayed to the user in these examples on a display associated
with the device, such as display 110. Icons 4210, 4212, 4214, 4216
and 4218 are used for 100%, 80%, 60%, 40% and 30% capacity
remaining in rechargeable battery 220 respectively. According to
some embodiments, a red color and/or flashing is used for the icon
4218 to further draw the attention of the user.
[0146] FIG. 43 is a flow chart showing aspects of a user interface
for a device for combined hysteroscopy and endometrial biopsy
relating to entering new patient information, according to some
embodiments. From home screen 4110 on a display such as 110, when
the user selects "new patient" screen 4310 is displayed, allowing
the user to enter a new patient ID number. After entering the new
number using the number buttons provided (e.g., a soft button),
pressing "OK" confirms the user's entry. If the ID already exists,
the message "ID already exists" is displayed prompting the user to
enter a different number. A "go-back" button is also provided in
the lower right corner, and in many other screens shown herein,
that allows the user to return to the previous screen. According to
some embodiments, the camera module on the distal tip of the device
100 can be used to enter patient information as a barcode scanner
for barcodes and/or matrix barcodes such as a QR Code, which may
already be on the patient's file or paperwork, to quickly and
accurately enter a patient ID number. In this case a "scan" button
4320 is included on screen 4310. After successfully entering a new
patient ID number, the confirmation screen 4312 is displayed for a
fixed duration, for example 3 seconds, after which a transition is
automatically made to the preview screen 4412 in FIG. 44 infra,
such that live video from the camera module of device 100 is
displayed.
[0147] FIG. 44 is a flow chart showing aspects of a user interface
for a device for combined hysteroscopy and endometrial biopsy
relating to previewing images and video, according to some
embodiments. From home screen 4110 on a display such as 110, when
the user selects "preview" screen 4410 is displayed, allowing the
user to select from among a list of cases, or patients, to use.
Touching directly on one of the numbers highlights the number, such
with yellow highlighting. Touching the up and down arrows on the
scroll bar on the right side scrolls through the list (or scrolls
the colored highlight field through the list). According to some
embodiments touch and drag gestures such as is known with
smartphone and tablet computer interfaces can be used for scrolling
through lists of numbers or images. When a highlighted number is
pressed again, then screen 4412 is displayed, in which live video
from the distal mounted camera of device 100 is shown to the user.
The live preview screen 4412 also includes the patient ID number on
the left side as well as a green disk icon in the upper right
corner to indicate to the user that live preview is being
displayed. Pressing the go-back button returns to the previous
screen. A playback button on the right side allows the user to
re-play a predetermined length of video, such as 3-5 seconds.
Pressing the snap button 214 for 3 seconds or less causes capture
of a single photo, as shown in screen 4412. A solid red disk icon
is displayed in the upper right corner. The single capture image is
displayed for 1 second (or other fixed length of time) after which
the live preview screen 4412 is returned to. Additionally, or in
addition to displaying the image, an audible photo shutter sound
can be played and/or a brief transition to white or black can be
used to indicate to the user that a still image has been captured,
according to some embodiments. If the snap button 214 is pressed
for longer than 3 seconds, video is captured, as shown in screen
4416. In this case the video being captured is displayed while the
red disk icon in the upper right corner blinks to indicate that
video is being captured. Video capture begins and continues until
the snap button is pressed again. According to some embodiments a
timer 4430 can also be provided showing the length of video
captured.
[0148] FIGS. 45A-45B are a flow chart showing aspects of a user
interface for a device for combined hysteroscopy and endometrial
biopsy relating to playback of saved images and video, according to
some embodiments. In FIG. 45A, from home screen 4110 on a display
such as 110, when the user selects "playback" screen 4510 is
displayed, allowing the user to select from among a list of cases,
or patients, to playback. As in screen 4410, yellow highlighting is
used to first select a case. If the user selects "delete case" then
the highlighted case will be deleted after a confirmation screen
4512. If a case is highlighted and then selected, screen 4514 in
FIG. 45B is displayed. Screen 4514 includes thumbnail images of all
of the captured still images and video, which can be scrolled
through (using the scroll bar, or using a swipe gesture). A
particular image or video is highlighted, such as will yellow, as
indicated by the dashed line 4520. The thumbnail images include the
file number, as well as a movie icon 4522 when the file is video
rather than a still image. Screen 4514 also shows the patient ID on
the left margin, as well as a delete icon and go back button on the
right margin. The delete icon can be used to delete an individual
highlighted file, after user confirmation. Selecting a highlighted
video file, such as image "20120308.sub.--001" caused playback
screen 4516 to be displayed. The user can control the video
playback using the play/pause, rewind and fast forward buttons. The
user can also move to the next or previous file using the arrow
buttons in the right margin. Screen 4518 shows an example of
displaying a still image.
[0149] FIG. 46 is a flow chart showing aspects of a user interface
for a device for combined hysteroscopy and endometrial biopsy
relating to settings, according to some embodiments. From home
screen 4110 on a display such as 110, when the user selects "setup"
screen 4610 is displayed, allowing the user to view and modify
various device settings. Examples of such settings are the system
clock, which can be modified using the screen 4612, as well as the
TV out format and formatting the internal flash memory card.
According to some embodiments, many other settings can be
programmed by the user using the interface shown.
[0150] FIGS. 47-48 are side views showing details of the shapes of
distal tips of a device for combined hysteroscopy and endometrial
biopsy, according to some embodiments. It has been found that the
distal tip of the device preferably should be rounded for several
reasons. First, the tip roundness greatly lowers the risk of
accidental damage to the uterus, such as piercing or puncturing
delicate uterine tissues during use. Secondly, the distal tip
roundness affects the resistance of the distal tip to collecting
matter that can clog the tip and blocking the view of the camera.
It has been found that the edges of the tip should preferably be
rounded by at least a radius of 0.25 mm. In the example shown in
tip 120 of FIG. 47, the edges of the distal tip such as shown in
region 4702 are rounded to a radius of 0.5 mm. Additionally, it has
been found that there is benefit to the front face of the distal
tip to be rounded as well. By making the front face 4710 convex the
tip is much less likely to collect tissue debris or other matter
that might occlude the field of view or make it more difficult to
obtain clear images from the camera module. In the example of FIG.
47, the front face 4710 is preferably rounded to a radius of about
10 mm. In the example of FIG. 48, the distal tip 120 preferably has
a substantially flat central portion 4810, surrounded by an outer
region 4812 that is rounded to a radius of about 2.5 mm. The edge
portion 4802 is rounded to a radius of about 0.44 mm. It has been
found that making substantially flat the central portion 4810
(which is less than about 30% of the total frontal area in this
example) can be useful in reducing distortion in the images
captured by the camera module while the substantial curved portions
4812 and 4802 provide enough rounding to avoid tissue collection
and reduce tissue damage risks. According to some embodiments, it
has been found that the outer region making up at least 50% of the
frontal area should be substantially rounded.
[0151] FIG. 49 is a cross section showing details of a sealed
sliding connector for a device for combined hysteroscopy and
endometrial biopsy, according to some embodiments. The sliding
connector 106 is shown here with an outer shell 4910 that includes
a lip 4912 that fits over an o-ring seal 4920 and a portion of the
handle assembly 108 so as to provide a suitable seal between the
fluid hub 104 and the handle assembly 108. Multiple similar seals
can be provided along the length of connector 106 to further
isolate handle 108 from patient matter when the cannula assembly of
the device is disposable but handle 108 is reusable. An additional
connector (not shown) can be inserted between connector 106 and
handle 108 for further insulation, and can be made in a way to
allow the additional connector to be sterilized before used for
another patient (as it only has to provide an electrical connection
between the cannula and the handle). Fluid hub 104 comprises a
sealed sliding connector 106 that fits inside an outer shell 4910
of hub 104. Sliding connector 106 envelopes a cable 2310 that has
an enlarged cross-section at its proximal end, from which from
which cable 2310 extends distally to the camera module and the LEDs
at distal tip 120 to carry video signals and control signals.
Sealed sliding connector 106 comprises a barrier 4914 fitted
tightly inside outer shell 4910. Barrier 4914 terminates at its
proximal end in an extension 4914a that fits into a closed channel
108a in handle 108 such that an outwardly facing bump 4914a1
releasably fits into an inwardly facing depression 108a1 in channel
108a. Barrier 4914 further includes a distal portion that
terminates in a first seal 4914b having an opening 4914c through
which cable 2310 passes An intermediate portion of barrier 4914
provides an additional seal by including an inner indentation 4914e
tightly enveloping a radial projection 2310a1 of the proximal
portion of cable 2310. Barrier 4914 further includes at its
proximal portion a lip 4914d that helps form another additional
seal by bearing against o-ring 4920 to further help ensure that
fluid and tissue samples will not reach interior portions of handle
108 when the instrument is in use.
[0152] FIG. 50 shows a hysteroscope, according to some embodiments.
The hysteroscope 5000 can be identical or similar to the device 100
described herein (including, for example, the user-interface
described in FIGS. 41-46), except that it is intended only for
hysteroscopy and not endometrial biopsy. As such the distal tip
assembly 5020 does not have a side-facing sampling port and does
not make use a separate fluid channel for sampling (as shown in
FIGS. 8A-E and 9). However, a separate channel coupled to a side
port or another forward facing port can be provided if desired to
both deliver fluid to the uterus and withdraw fluid (and other
matter) from the uterus, for example distend and relax the uterus
or to flush the uterus. The assembly 5020 includes a tip body 5022,
camera assembly 640 and LEDs 630 and 632. According to some
embodiment, as with the device 100, the cannula 102 (including
distal tip 5020), fluid hub 104 and sliding connector 106 are
designed for a single-use, while the handle 108 and display 110 are
designed to be re-used many times. Thus, the hysteroscope 5000
includes many of the same features and benefits from many of the
same advantages as the combined hysteroscopy and biopsy device
100.
[0153] FIG. 51 shows details of a distal tip for a hysteroscope
such as shown in FIG. 50. The distal tip assembly 5020 is shown
with the tip body 5022 including two forward facing fluid ports 620
and 622, two LEDs 630 and 632, as well as camera assembly 640.
[0154] FIG. 52 is a flow chart illustrating an example use of a
hysteroscopy device having the disposable cannula and re-usable
handle and display, according to some embodiments. In step 5210, an
unused cannula assembly, which for example includes cannula 102,
fluid hub 104 and connector 106 as shown in FIG. 1 or in FIG. 50,
is removed from a sterile package and in step 5212 the connector is
attached to a previously used handle assembly, which for example
includes a handle 108 and a display 110 as shown in FIG. 1 or in
FIG. 50. Although the handle assembly has been previously used, it
is cleaned and disinfected according to known standard practices,
such as with rubbing alcohol or other disinfectant such as Cidex.
Note that the example shown in FIG. 52 is for a previously used
handle assembly, but the same steps would also apply to the case of
a brand new handle assembly. In step 5214, the cannula is inserted
through the cervix into the uterus, while flowing fluid from
forward facing ports, such as ports 620 and 622 shown and described
supra. Note that according to some embodiments, the sterile package
is opened but not removed from the cannula assembly in step 5210.
In this case the package is only opened the proximal end of the
cannula, namely the end with the connector such that the connector
can be attached to the handle. Then just prior to use, the
remainder of the packaging is removed from the cannula. In step
5216 the user visually examines the endometrial tissue by viewing
live images on the display 110. Lighting can be adjusted, for
example using a control button on the handle. If the user wishes,
still and/or video images can be captured using a control button on
the handle. In step 5220, in the case where the device is for
combined hysteroscopy and endometrial biopsy, tissues can be
gathered using the side facing sampling port (such as port 610)
without having to withdraw the cannula. In some cases steps 5216,
5218 and/or 5220 may be repeated as needed. Note that fluid induced
distending and un-distending as described in some of the commonly
assigned incorporated applications also is carried out to aid in
examination and tissue collection, according to some embodiments.
In step 5224 the cannula is withdrawn. In step 5226 the cannula
assembly is disconnected, by detaching the connector from the
handle, and the entire cannula assembly is disposed of. In step
5228 stored images are played back on the display, for example
using a touch-screen interface as described supra. In step 5230 the
handle assembly is docked to a base station for battery recharging
and/or for transferring images and patient information out of the
handle to other storage/processing facilities. According to some
embodiments, a standard cleaning procedure is performed on the
handle prior to docking on the base station. Note that the step
5228 of playing back the images can happen at any time after
capturing in step 5218. For example, play back can be done before
gathering samples, in step 5220, after withdrawal but prior to
detaching the cannula in step 5226, or while the handle assembly is
docked in the base station such that steps 5228 and 5230 are
performed in parallel. In the case of viewing playback images while
docked in a base station, tilting of display 110, as described with
respect to FIG. 1, has been found to be useful in some
situations.
[0155] Recent advances have enabled small, miniature and disposable
endoscopes. Some embodiments disclosed herein innovatively combine
a miniature endoscope with a modified endometrial sampling device
in an integrated medical device. The integrated medical device
combines a hysteroscope sheath with an endometrial sampling device,
allowing the gynecologist or other healthcare provider to perform
the dual function of hysteroscopy and endometrial sampling without
the need of conventional cumbersome hysteroscope device such that
hysteroscopy and the endometrial sampling may be done in a single
procedure without the need for a separate medical device
[0156] FIG. A1 illustrates a medical device combining an endoscope
and endometrial sampling device, according to some embodiments.
Medical device A100 includes a processor module A102, a sampling
portion A104, a balloon A106 and imaging module A108. In some
embodiments, the processor module A102 has a battery A110 or is
otherwise connected to a power source, and further includes various
video processing electronics A112 that control the operation of
various components of the medical device A100.
[0157] The processor module a102 further includes a first connector
A114 that is complementary to and configured to receive a second
connector A116 on a proximal end A118 of a semi-rigid endoscope
A120 included in the sampling portion A104. The first and second
connectors A114, A116 provide a mechanical and electrical interface
between the processor module A102 and the endoscope A120. According
to some embodiments, the endoscope A120 is substantially
cylindrical with an outer diameter of less than about 2.8
millimeters ("mm").
[0158] The imaging module A108 is attached to a distal end A122 of
the endoscope A120. In some embodiments, the imaging module A108
may include at least one of each of a lens A108A, illumination
device A108B and imaging device A108C (illustrated in FIG. A8,
infra). According to some embodiments, the imaging or
photon-sensing device is positioned directly behind the lens and
contained within the housing. The illumination device A108B may be
a light emitting diode ("LED") or other suitable optical
illumination delivered by optical fiber from light sources inside
the endoscope A120 or processor module A102. That is, the
illumination device A108B may be LEDs located at the distal end
A126 or it may LEDs in the proximal end A118 or the processor
module A102 whose light is transmitted to the distal end A126 of a
sampling sheath A124 via optic media or fibers that are embedded in
the walls of the sampling sheath A124 or embedded in the endoscope
A120. The imaging device may be a complementary
metal-oxide-semiconductor ("CMOS") image sensor, a charge-coupled
device ("CCD"), or other suitable image sensor.
[0159] The sampling portion A104 further includes the sampling
sheath A124. In the illustrated embodiment, the sampling sheath
A124 has a substantially hollow cylindrical shape open on both ends
for receiving the endoscope A120. An outer diameter of the sampling
sheath A124 is less than about 4.6 mm in some embodiments and an
inner diameter of the sampling sheath A124 is sufficiently large to
accommodate the endoscope A120. The distal end A126 of the sampling
sheath A124 and/or the distal end A122 of the endoscope A120 that
contact tissue within the patient are smooth or blunt shaped in
some embodiments and/or may be hydrophilically coated. Optionally,
one or both of the endoscope A120 or sampling sheath A124 is a
single-use device intended for use on a single patient during a
single procedure, after which the endoscope A120 or sampling sheath
A124 is intended to be discarded.
[0160] The balloon A106 is secured near a distal end A126 of the
sampling sheath A124. Although not required in all embodiments, in
the illustrated embodiment the sampling sheath A124 includes one or
more holes A127 formed near its distal end A126 which can be used
to obtain endometrial samples as explained in greater detail
below.
[0161] The sampling sheath A124 includes a first fluid line A128 in
communication with the balloon A106. A port A130 attached to the
first fluid line A128 provides an interface for connecting the
first fluid line A128 to a syringe or other suitable
inflating/deflating device. In operation, the syringe is filled
with a fluid that is forced into or out of the balloon A106 through
the first fluid line A128 to inflate or deflate the balloon
A106.
[0162] The sampling sheath A124 also includes a second fluid line
A132 in communication with the hollow interior of the sampling
sheath A124. The second fluid line A132 permits fluid such as a
saline solution or other suitable fluid to be delivered, e.g., from
a syringe A134, through the second fluid line A132 to the sampling
sheath A124 and out of the distal end A126 of the sampling sheath
A124 for distention or other purpose at the site of the procedure.
A fluid stopper A136, such as a rubber nipple or O-ring, is
positioned in a proximal end A138 of the sampling sheath A124. The
fluid stopper A136 forms a seal around the endoscope A120 at the
proximal end A138 of the sampling sheath A124 to prevent the fluid
from exiting the sampling sheath A124 through the proximal end
A138. It will be appreciated that the various fluid stoppers A136
described herein, which may include O-rings and duckbill valves as
will be discussed in more detail to follow prevent fluid leakage.
In addition, the fluid stoppers A136 prevent air intrusion during
sample gathering. Excess air getting pulled in proximally may
reduce the suction at the distal end of the medical device
A100.
[0163] According to some embodiments, the medical device A100
permits a hysteroscope and endometrial sampling to be performed
during a single procedure without removing the sampling sheath A124
and/or endoscope A120 from within the patient between the
hysteroscope and endometrial sampling. According to these and other
embodiments, and in operation, the endoscope A120 is inserted from
the proximal end A138 of the sampling sheath A124 through the
sampling sheath A124 to its distal end A126. According to some
preferred embodiments, the endoscope A120 is pre-assembled with the
sampling sheath A124 in one single piece. The fluid stopper A136
forms a seal around the endoscope A120 to prevent fluid from
exiting through the proximal end A138 of the sampling sheath A124.
A healthcare provider inserts the distal end A122/A126 of the
medical device A100 through the vagina and cervix of a patient and
into the patient's uterus. The term "healthcare provider" as used
herein should be construed broadly and includes physicians, nurses,
technicians and other users of the medical device A100.
[0164] The patient's uterus is distended by filling the uterus with
fluid via the second fluid line A132 and sampling sheath A124. The
balloon A106 is inflated via the first fluid line A128 to occlude
the patient's cervix should leakage of fluid prevent adequate
uterine distention.
[0165] The healthcare provider performs the hysteroscopy by
operating and manipulating the medical device A100 to obtain images
of the interior of the patient's uterus (and/or cervix and vagina)
via, e.g., the imaging module A108. As indicated in FIG. A1, data
representing the images thereby obtained is output to a video
display (not shown in FIG. A1) separate from the medical device
A100.
[0166] After performing the hysteroscopy, in some embodiments the
endoscope A120 is removed from the sampling sheath A124 while the
sampling sheath A124 remains in place within the patient. In other
embodiments, the endoscope A120 need not be removed. The fluid
stopper A136 at the proximal end A138 of the sampling sheath A124
is sealed. The syringe A134 is removed from the second fluid line
A132 and suction is applied, e.g., via an empty syringe, to the
second fluid line A132, to collect an endometrial sample via the
sampling sheath A124. In more detail, suction applied to the second
fluid line A132 creates suction at the distal end A126 and at the
holes A127 of the sampling sheath A124. When the distal end A126
and/or holes A127 of the sampling sheath A124 are sufficiently
close to the endometrium of the patient's uterus, the suction
removes a sample of the endometrium. The sampling sheath A124 can
then be removed from the patient.
[0167] FIG. A2 illustrates a medical device combining an endoscope,
endometrial sampling device and integrated display, according to
some embodiments. The medical device A100 of FIG. A2 is identical
in many respects to the medical device A100 of FIG. A1 and
reference can be made above for a description of the identical
components. In contrast to the medical device A100 of FIG. A1,
however, the medical device A100 of FIG. A2 includes an integrated
display A140 attached to the processor module A102. The integrated
display A140 is configured to receive data representing the images
obtained during operation of the medical device A100 and to
generate and display the images to the healthcare provider or other
user of the medical device A100. Optionally, the data representing
the images can additionally be output to an external display as
indicated in FIG. A2. In some embodiments, the data representing
the images can be output and displayed on both the integrated
display A140 and an external display. In this way, the healthcare
provider performing the procedure may view the displayed images at
the same time that a person such as another healthcare provider or
a family member of the patient may also view the images even if
they are not close to where the procedure is taking place.
[0168] FIG. A3 illustrates additional aspects of a medical device
combining an endoscope and endometrial sampling device, according
to some embodiments. As previously described, the medical device
A100 includes a processor module A102 and a sampling portion A104
that include the various elements previously discussed. In some
embodiments, the processor module A102 is configured to be reusable
while the sampling portion A104 is configured to be used only once.
As will be appreciated, since most of the electronics involved with
the medical device A100 are located in the processor module A102,
the processor module A102 is the most expensive part of this
example of the medical device A100. Accordingly, configuring the
processor module A102 to be reusable advantageously saves on the
cost of the medical device A100. It will be appreciated that the
processor module A102 may include the integrated display A140,
although this is not required.
[0169] As will also be appreciated that since the sampling portion
A104 is inserted into the patient's uterus, it will generally not
be sanitary to reuse in another procedure. However, since the
sampling portion may be primarily made of relatively inexpensive
plastics, it is generally economical to use a different sampling
portion A104 for each patient.
[0170] In operation, the healthcare provider or other medical
device 100 user may connect and disconnect the processor module 102
and the sampling portion 104 using connectors 114 and 116 as
previously described when a hysteroscopy or other medical procedure
is to be performed.
[0171] FIGS. A4A-A4B illustrate a medical device combining an
endoscope and endometrial sampling device, according to some
embodiments. Many of the elements of the embodiment shown in FIGS.
A4A-A4B are the same as or similar to those discussed in the
previously described embodiments, such elements will not be
described or only briefly described. It will also be appreciated
that the aspects of the embodiments previously described may also
apply to the present embodiment. For example, although FIG. A4A
does not show the balloon A106, the fluid line A128, and the port
A130, it will be understood that these elements may be included in
the embodiment of FIG. A4A if desired.
[0172] As illustrated, the present embodiment includes a processor
module A102 that includes the battery A100 and the endoscope
electronics A112. The processor module A102 may also include the
connector A114 for connecting to the sampling portion A104. In this
embodiment, the processor module A102 may be about 4 inches long
and have an inner diameter of about 3/4 inches. Of course, other
dimensions for the processor module A102 are also contemplated. The
processor module A102 may also include an integrated display A140,
although this is not required. In the present embodiment, the
integrated display A140 may be an LCD display with a thickness of
about 1/2 inch or less and a diagonal dimension of less than about
4 inches. It will be appreciated that other dimensions are also
contemplated for the integrated display A140.
[0173] As also illustrated, the medical device A100 of the present
embodiment includes the sampling portion A104 including the
endoscope A120 and the sampling sheath A124. In this embodiment,
the sampling sheath A124 may have a length of around 61/2 inches,
an outer diameter of less than about 4.6 mm, and an inner diameter
of greater than about 3.4 mm. As with the above embodiments, the
inner dimension is sufficiently large to accommodate the endoscope
A120. Of course, other dimensions may also be used. As also
illustrated, in this embodiment the sampling sheath A124 has an
angle or curvature A129 at the distal end A126, which in turn
causes the endoscope A120 to also be slightly curved at the distal
end A122. In the present embodiment, the angle or curvature A129 is
greater than about 15 degrees, although other angles or curvatures
are also contemplated. Having the sampling sheath A124 angled or
curved at the distal end along with the sampling sheath being only
moderately stiff allows for easier insertion into the uterus of the
patient.
[0174] As illustrated, the medical device A100 includes one or more
ports A127 for endometrial sampling. Referring to FIG. A4B, an
example embodiment of the ports A127 is shown. In FIG. A4B, two
ports A127A and A127B are included for endometrial sampling. As
shown, these ports are near the distal end A126 and are included in
the angled portion A129 of the sampling sheath A124.
[0175] Returning again to FIG. A4A, the medical device A100
includes a fluid and connector hub A105. As shown, the fluid and
connector hub A105 includes the connector A116 that connects the
sampling portion A104 to the processor module A102. In addition,
the fluid and connector hub A105 includes a connector or opening
A103 that connects the fluid line A132 to the sampling portion
A104. Further, the fluid and connector hub A105 includes a
connector or opening A106 for connecting the sampling sheath A124
to the fluid and connector hub A105, includes the fluid stoppers
A136, and fluid flow channels or chambers. Specific embodiments of
the fluid and connector hub A105 will now be explained.
[0176] FIGS. A5A-A5C illustrate portions of a fluid and connector
hub A105 for use in a medical device combining an endoscope and
endometrial sampling device, according to some embodiments. The one
piece embodiment A200 of the fluid and connector hub A105 may be a
single molded piece of plastic or metal, although any reasonable
material and production method may be used to create the one piece
embodiment A200.
[0177] As illustrated in FIG. A5A, which shows an exterior view of
the one piece embodiment A200, the one piece embodiment A200
includes the connector A116 that connects the sampling portion A104
to the processor module A102. In embodiment A200, the connector
A116 includes retention features A201 that act to align the
connector A116 when connecting with matching features on the
connector A114 of the processor module A102. In addition, the
connector A116 includes an electric plug A202 for connecting with
the endoscope electronics A112 of the processor module A102. The
electric plug A202 allows for electric and/or optic signals to be
sent from the endoscope electronics A112 to the imaging module A108
in the distal end of the endoscope A120.
[0178] FIG. A5B shows various pieces of the medical device A100
that are either included in the one piece embodiment A200 or that
attach to the one piece embodiment A200. For example, FIG. A5B
shows that a fluid stopper A136, which in this embodiment is an
O-ring, although other fluid stoppers may be used, is inserted into
the one piece embodiment A200. Further, a cylindrical connector
piece A213 is used to connect the one piece embodiment A200 at
connection A106 with the sampling sheath A124. Finally, the fluid
line A132 includes a connector A211 that connects with a connector
piece A212 for connecting the fluid line A132 to the one piece
embodiment at the connector A103. It will be appreciated that the
pieces A211, A212, and A213 may be made of a plastic or metal and
may be molded or machined in any reasonable manner.
[0179] FIG. A5C shows an interior view of the one piece embodiment
A200. As shown, the one piece embodiment includes a hollow
cylindrical chamber that is large enough to hold the endoscope A120
and the sampling sheath A124. As shown, the endoscope A120, may be
inserted into connector opening 106 and may connect with the
electric connector A202. In some embodiments, the electrical
connector 202 may be part of the endoscope A120.
[0180] The sampling sheath A124 may also be connected to the one
piece embodiment A200 by the connector A213. Further, as shown, the
fluid stopper A136 may be inserted to prevent fluid from reaching
the processor module A102 when the module is connected to the one
piece embodiment A200. As further shown, the connector A212 is
inserted into the connector or opening A103 to connect the fluid
line A132 to the one piece embodiment A200.
[0181] FIGS. A6A-A6B illustrates portions of a fluid and connector
hub for use in a medical device combining an endoscope and
endometrial sampling device, according to some other embodiments.
In particular, FIGS. A6A and A6B illustrate a two piece embodiment
A300 of the fluid and connector hub A105. The two piece embodiment
A300 of the fluid and connector hub A105 includes a first piece
A301 that connects to a second piece A302. The first and second
pieces A301 and A302 may both be a single molded piece of plastic
or metal, although any reasonable material and production method
may be used to create the first and second pieces A301 and A302.
Please note that some of the elements shown in FIGS. A6A and A6B
have previously been described in relation to other embodiments
disclosed herein and may not be described for the present
embodiment.
[0182] As shown in FIGS. A6A and A6B, the first piece A301 and the
second piece A302 are connected together to form the two piece
fluid and connector hub A300. The pieces A301 and A302 may be
attached with any reasonable attaching means such as, but not
limited to, an epoxy or glue. In one embodiment, the first piece
A301 and the second piece A302 are attached to one another during
an assembly process that is done prior to the two piece fluid and
connector hub A300 being shipped to the healthcare provider or
other user of medical device A100. In other embodiments, the first
piece A301 and the second piece A302 may be attached together by
the healthcare provider or other user of medical device A100.
[0183] As shown in the figures, first piece A301 includes a first
chamber A311, a second chamber A312 and an third intervening
chamber A313. The first chamber A311 has a larger diameter than the
other two chambers. Inside this chamber A311 is placed a duckbill
valve A310. The duckbill valve A310 provides fluid stoppage while
allowing the endoscope A120 to pass through and may therefore be
considered a fluid stopper. In those embodiments where the first
piece A301 and the second piece A302 are attached to one another
during an assembly process that is done prior to the two piece
fluid and connector hub A300 being shipped, the duckbill valve is
placed in chamber A311 during the assembly process. The chamber
A312 typically has a larger diameter than the chamber A313 and has
a counter bore that helps trap the imaging module A108 distally but
allows the imaging module A108 to be removed from the sampling
sheath A124 proximally.
[0184] The second piece A302 includes a chamber A315 that connects
with the chamber A311 upon assembly of the two pieces. The chamber
A315 (as well as the chambers A311, A312, and A313) has at least a
diameter large enough to hold the endoscope A120 and the sampling
sheath A124. As shown, the sampling sheath A124 connects with the
second piece A302 at the connection or opening A106. As with the
one piece embodiment A200, a cylindrical piece A213 is inserted
into the chamber A315 to help connect the sampling sheath A124 with
the second piece A302.
[0185] Since the chamber A315 includes the fluid path from the
fluid line A132, a fluid stopper A136, which in the present
embodiment may be an O-ring, is placed in the chamber A315 to
prevent liquid from reaching the endoscope electronics A112. As
with the one piece embodiment A200, the connector A212 is used to
connect the second piece A302 with the fluid line A132 at the
connector or opening A103.
[0186] FIGS. A7A-A7C illustrate portions of a fluid and connector
hub for use in a medical device combining an endoscope and
endometrial sampling device, according to some other embodiments.
In particular, FIGS. A7A-A7C illustrate a three piece embodiment
A400 of the fluid and connector hub A105. The three piece
embodiment A400 of the fluid and connector hub A105 includes a
first piece A401 that connects to a second piece A402. The second
piece A402 in turn connects to a third piece A403. The first,
second and third pieces A401, A402, and A403 may be single molded
pieces of plastic or metal, although any reasonable material and
production method may be used to create the first, second and third
pieces A401, A402, and A403. The three piece embodiment A400 allows
the imaging module A108 to remain in the sampling sheath A124 for
the entire medical procedure. In other words, there is no need to
remove the imaging module A108 when the endometrial samples are
collected. Of course, the imaging module A108 can be removed during
the procedure if more space is needed for fluid flow. Please note
that some of the elements shown in FIGS. A7A-A7C have previously
been described in relation to other embodiments disclosed herein
and may not be described for the present embodiment.
[0187] As shown, the first piece A401 includes a Touhy Borst seal
A420 as part of the connector A116. The Touhy Borst seal A420 is
used to attach the fluid and connector hub A400 with the processor
module A102 when in use and provides both fluid and air sealing and
helps to fix the position of the optics module A108 in the distal
end. As further shown, the first piece A401 includes a chamber A421
that includes a threaded end A422. The chamber A421 will typically
be large enough to hold the endoscope A120 and/or any electrical or
optical connection between the imaging module A108 and the
processor hub A102.
[0188] The second piece A402 includes a chamber A411 that is sized
to receive the threaded end A422 of the first piece A401. The
chamber A411 includes grooves A413 that mate with threaded end A422
to connect the first and second pieces A401 and A402 together. In
some embodiments, an additional adhesive such as an epoxy or glue
may also be used to help connect the first and second pieces A401
and A402 together.
[0189] Inside the chamber A411 is placed a duckbill valve A410. The
duckbill valve A410 provides fluid stoppage while allowing the
endoscope A120 to pass through. In those embodiments where the
first piece A401 and the second piece A402 are attached to one
another during an assembly process that is done prior to the three
piece fluid and connector hub A400 being shipped, the duckbill
valve is placed in chamber A411 during the assembly process.
[0190] The third piece A403 includes a chamber A426 that receives
an end A412 of the second piece A402 when the pieces A402 and A403
are connected during the assembly process. The chamber A426 will be
large enough to receive the end A412. The second and third pieces
may be secured using an epoxy, a glue, or any other reasonable
means.
[0191] The third piece A403 also includes a chamber A425 that has
at least a diameter large enough to hold the endoscope A120 and the
sampling sheath A124. As shown, the sampling sheath connects with
the third piece A403 at the connection or opening A106. In some
embodiments, the cylindrical piece A213 (not shown) is inserted
into the chamber A425 to help connect the sampling sheath A124 with
the third piece A403. Since the chamber A425 includes the fluid
path from the fluid line A132, the connector A212 is used to
connect the third piece A403 with the fluid line A132 at the
connector or opening A103.
[0192] FIG. A8 illustrates portions near the distal end of a
medical device combining an endoscope and endometrial sampling
device, according to some embodiments. Note that the embodiment
shown in FIG. A8 may be practiced in the embodiments of medical
device A100 previously described, therefore the elements previously
described may not be described in relation to the present
embodiment. FIG. A8 shows a close-up view of the distal end A126 of
the sampling sheath A124. As previously described, the distal end
A26 includes the imaging module A108, which may include a lens set
A108A, illumination device A108B and imaging device A108C.
[0193] As wilt be appreciated, during a medical procedure, the lens
A108A may become dirty due to body fluids and the like. In
addition, the illumination device A108B, which may be one or more
LEDs, may become hot during use. Accordingly, the embodiment of
FIG. A8 includes a curved protrusion A810 that is created on one
side of the sampling sheath A106 at the distal end opening A126.
During use of the medical device A100, the curved protrusion A810
forces at least some the saline fluid or other suitable fluid from
the fluid line A132 to wash over the lens A108A and/or the
illumination device A108B. In this way, the saline fluid or other
suitable fluid is able to wash the surface of the lens A108A. In
addition, the fluid is able to cool the illumination device A108B
in case it gets overheated.
[0194] The curved protrusion A810 may be created during the
manufacturing process of the sampling sheath A124 and may be
created using plastic molding techniques, although other techniques
may also be used. As will be appreciated, the curved protrusion
A810 will typically be large enough and curved enough to force the
saline fluid to wash over the lens the A108A and/or the
illumination device A108B while not blocking the field of view by
lens A108A and illumination A1086.
[0195] FIG. A9 illustrates a medical device combining an endoscope
and endometrial sampling device, according to an additional
embodiment. The embodiment shown in FIG. A9 may be practiced in the
embodiments of medical device A100 previously described. The
embodiment of FIG. A9 shows that the fluid line A132 is connected
to a second fluid line A133. The fluid lines A132 and A133 may be
connected to the medical device A100 at the fluid and connector hub
A105 or may be connected to the sampling sheath A124 as shown in
FIG. A1. In some embodiments, the fluid lines A132 and A133 connect
with the fluid and connector hub A105 at different opening of the
fluid and connector hub A105. The fluid line A132 may be connected
to the distal end opening A126 and the one or more side sampling
holes A127 while the fluid line A133 may be connected to the one or
more side sampling holes A127.
[0196] During a medical procedure, the saline solution or other
suitable solution may be injected into the fluid line A132 by the
syringe A134. A valve or clamp A910 may be placed in or over the
portion of the fluid line A133 that connects with the fluid line
A132 to prevent any in-flow of the saline solution to the fluid
line A133.
[0197] During the out-flow process, when suction is applied to the
tube A132 to collect endometrial samples as previously described,
the valve or clap A910 may be opened or removed to allow out-flow
from both the fluid line A132 and the fluid line A133. In this way,
a greater amount of endometrial samples may be collected. It will
be appreciated that separate syringes A134 may be used for the
in-flow and out-flow process or the same syringe A134 may be used
for both.
[0198] FIG. A10 illustrates a medical device combining an endoscope
and endometrial sampling device, according to an additional
embodiment. The embodiment shown in FIG. A10 may be practiced in
the embodiments of medical device A100 previously described. As
shown, the medical device in this embodiment includes the fluid
line A132 and a second fluid line A133. The fluid lines A132 and
A133 may be connected to the medical device A100 at the fluid and
connector hub A105 or may be connected to the sampling sheath A124
as shown in FIG. A1. In some embodiments, the fluid lines A132 and
A133 connect with the fluid and connector hub A105 at different
opening of the fluid and connector hub A105. The fluid line A132
may be connected to the distal end opening A126 while the fluid
line A133 is connected to the one or more side sampling holes
A127.
[0199] During a medical procedure, the saline solution or other
suitable solution may be injected into the fluid line A132 by the
syringe A134 to create an in-flow. Suction may then be applied to
the tube A133 by a syringe A134 to collect endometrial samples as
previously described. In this way, a flow through process is
created that may result in collected continuous flow of fluid
through the uteral cavity. It will be appreciated that the same
syringe may be used for both fluid lines 132 and 133 if
circumstances warrant. A fluid bag that hanged over the patient may
also be used for fluid inflow.
[0200] As previously described in the various embodiments
disclosed, the medical device A100 may include the sampling portion
A104 that includes the sampling sheath A124, the fluid and
connector hub A105, and the optics module A108. As previously
discussed, these separate parts may be connected in the various
manner previously described. However, according to some embodiments
the sampling portion A104, the fluid and connector hub A105, and
the optics module A108 may all be integrated as a single piece at
manufacturing time. This may remove the need for the various
O-rings, duckbill valves, and Touhy Borst connections previously
described. Thus, according to these embodiments, there is just one
electro/mechanical connection with the processor module A102 and
one single fluid channel and connector to the syringe A134.
Advantageously, this embodiment provides for a minimum of attaching
and detaching parts during a medical procedure and reduces
manufacturing costs.
[0201] FIG. A11 is a flow chart showing a method of operating a
device having a combined endoscope and endometrial sampling device,
according to some embodiments. The method A1100 begins at step
A1105 after the patient is suitably positioned for the procedure,
e.g., the patient may be situated on an exam room table.
[0202] At step A1110, a sterile package including the endoscope
A120 and/or a sterile package including the sampling sheath A124
are opened. Alternately, the endoscope A120 and sampling sheath
A124 are both included in a single package that is opened at step
A1110. In some embodiments, at step A1110 the endoscope A120 may be
inserted into the sampling sheath A124, while in other embodiments
the endoscope A120 is inserted into the sampling sheath A124 prior
to being placed in the single sterile package.
[0203] At step A1115, the endoscope A120 is connected to the
processor module A102. At step A1120, the processor module A102 is
turned on and a manual white balancing procedure is undertaken. At
step A1125, the second fluid line A132 is connected to the syringe
A134 or other supply of saline or other suitable fluid.
[0204] At step A1130, the patient's cervix is disinfected, local
anesthetic is optionally applied, and the distal end A122/A126 of
the medical device A100 is inserted through the patient's vagina
and cervix and into the patient's uterus. During step A1130, the
imaging module A108 may be relaying images to the processor module
A102 for display on the integrated display A140 and/or an external
display to provide direct vision during insertion. Further, saline
or other fluid is infused during step A1130 via the second fluid
line A132 and sampling sheath A124 to distend the patient's
uterus.
[0205] In those embodiments that include the balloon A106, at step
A1135, after the distal end A122/A126 of the medical device A100
has been received within the patient's uterine cavity, the balloon
A106 is inflated via first fluid line A128 to occlude the patient's
cervix should leakage of fluid prevent adequate uterine distention.
As shown by the dashed line, in those embodiments that do not
include the balloon A106, step A1135 is skipped.
[0206] At step A1140, the patient's uterine/endometrial cavity is
inspected using the endoscope A120. At step A1145, the endoscope
A120 is removed while the sampling sheath A124 remains within the
patient. In those embodiments that include the balloon A106, the
balloon A106 is also deflated during step A1145.
[0207] At step A1150, the fluid stopper A136 at the proximal end
A138 of the sampling sheath A124 is occluded and suction is created
at the distal end A126 and/or at the holes A127 of the sampling
sheath A124 by applying suction on the second fluid line A132
using, e.g., an empty syringe. Alternately, the second fluid line
A132 is occluded and suction is applied at the proximal end A138 of
the sampling sheath A124 to create suction at the distal end A126
and/or holes A127 of the sampling sheath A124.
[0208] At step A1155, the sampling sheath A124 is moved in and out
while being rotated and while the suction is applied to the second
fluid line A132 to obtain an endometrial sample.
[0209] At step A1160, the sampling sheath A124 is withdrawn from
the patient and the endometrial sample is collected. The procedure
is completed at step A1165.
[0210] FIG. A12 is a flow chart showing a method of operating a
device having a combined endoscope and endometrial sampling device,
according to some embodiments. The method A1200 begins at step
A1205 after the patient is suitably positioned for the procedure,
e.g., the patient may be situated on an exam room table.
[0211] At step A1210, a sterile package including the endoscope
A120 and/or a sterile package including the sampling sheath A124
are opened. Alternately, the endoscope A120 and sampling sheath
A124 are both included in a single sterile package that is opened
at step A1210. In some embodiments, at step A1210 the endoscope
A120 may be inserted into the sampling sheath A124, while in other
embodiments the endoscope A120 is inserted into the sampling sheath
A124 prior to being placed in the single sterile package.
[0212] At step A1215, the endoscope A120 is connected to the
processor module A102. At step A1220, the processor module A102 is
turned on and a manual white balancing procedure is undertaken. At
step A1225, the fluid line A132 is connected to the syringe A134 or
other supply of saline or other suitable fluid.
[0213] At step A1230, the patient's cervix is disinfected, local
anesthetic is optionally applied, and the distal end A122/A126 of
the medical device A100 is inserted through the patient's vagina
and cervix and into the patient's uterus. During step A1230, the
imaging module A108 may be relaying images to the processor module
A102 for display on the integrated display A140 and/or an external
display to provide direct vision during insertion. Further, saline
or other fluid is infused during step A1230 via the fluid line A132
and sampling sheath A124 to distend the patient's uterus.
[0214] At step A1235, the patient's uterine/endometrial cavity is
inspected using the endoscope A120. At step A1240, the fluid
stopper A136 at the proximal end A138 of the sampling sheath A124
is occluded and suction is created at the distal end A126 and/or at
the holes A127 of the sampling sheath A124 by applying suction on
the fluid line A132 using, e.g., an empty syringe. Alternately, the
fluid line A132 is occluded and suction is applied at the proximal
end A138 of the sampling sheath A124 to create suction at the
distal end A126 and/or holes A127 of the sampling sheath A124.
According to some preferred embodiments, the sheath and endoscope
are preassembled as one piece, and the endoscope does not need to
be withdrawn, and there is no opening at the proximal end that
needs to be plugged.
[0215] At step A1245, the sampling sheath A124 is moved in and out
while being rotated and while the suction is applied to the fluid
line A132 to obtain an endometrial sample. At step A1250, the
sampling sheath A124 is withdrawn from the patient and the
endometrial sample is collected. The procedure is completed at step
A1255.
[0216] FIG. A13 is a flow chart showing a method of operating a
device having a combined endoscope and endometrial sampling device,
according to some embodiments. The method A1300 begins at step
A1305 after the patient is suitably positioned for the procedure,
e.g., the patient may be situated on an exam room table.
[0217] At step A1310, a sterile package including the endoscope
A120 and/or a sterile package including the sampling sheath A124
are opened. Alternately, the endoscope A120 and sampling sheath
A124 are both included in a single sterile package that is opened
at step A1310. In some embodiments, at step A1310 the endoscope
A120 may be inserted into the sampling sheath A124, while in other
embodiments the endoscope A120 is inserted into the sampling sheath
A124 prior to being placed in the single sterile package.
[0218] At step A1315, the endoscope A120 is connected to the
processor module A102. At step A1320, the processor module A102 is
turned on, and a manual white balance procedure is carried out. At
step A1325, the fluid line A132 is connected to the syringe A134 or
other supply of saline or other suitable fluid.
[0219] At step A1330, the patient's cervix is disinfected, local
anesthetic is optionally applied, and the distal end A122/A126 of
the medical device A100 is inserted through the patient's vagina
and cervix and into the patient's uterus. During step A1330, the
imaging module 1A08 may be relaying images to the processor module
A102 for display on the integrated display A140 and/or an external
display to provide direct vision during insertion. Further, saline
or other fluid is infused during step A1330 via the fluid line A132
and sampling sheath A124 to distend the patient's uterus.
[0220] At step A1335, the patient's uterine/endometrial cavity is
inspected using the endoscope A120. In those embodiments
implemented using the medical device A100 described above in
relation to FIG. A9, at step A1340, the clamp or valve A910 is
opened to unlock the fluid line A133. Suction is created at the
distal end A126 and/or at the holes A127 of the sampling sheath
A124 by applying suction on the fluid line A132 using, e.g., an
empty syringe to create outflow in both fluid lines A132 and A133.
The method may then proceed to step A1350 as shown in FIG. A13.
[0221] In those embodiments implemented using the medical device
A100 described above in relation to FIG. A10, the method may skip
step A1340 and go to step A1345. At step A1345, suction is applied
to fluid line A133 using syringes A134A. This creates a
flow-through of the saline liquid and rinses our blood and debris.
The method may then proceed to step A1350 as shown in FIG. A13.
[0222] At step A1350, the sampling sheath A124 is moved in and out
while being rotated and while the suction is applied to the fluid
line A132 or fluid line A133 to obtain an endometrial sample.
[0223] At decision block A1355, it is determined if an option
exists to withdraw the endoscope A120. If yes, then at step A1360,
the endoscope A120 is removed while the sampling sheath A124
remains within the patient. At step A1365, the fluid stopper A136
at the proximal end A138 of the sampling sheath A124 is occluded
and at step A1370 suction is created at the distal end A126 and/or
at the holes A127 of the sampling sheath A124 by applying suction
on the fluid line A132 or fluid line A133 using, e.g., an empty
syringe.
[0224] At step A1375, the sampling sheath A124 is withdrawn from
the patient and the endometrial sample is collected. The procedure
is completed at step A1380.
[0225] If it is determined at decision block A1355 that the
endoscope is not to be withdrawn or the option to withdraw the
endoscope does not exist, the method goes to step A1375 and A1380
where the sampling sheath A124 is withdrawn from the patient, the
endometrial sample is collected and the procedure is completed.
[0226] FIGS. A14A-A14D illustrate a device A1400 for combined
hysteroscopy and endometrial biopsy according to some embodiments.
Many of the elements of the embodiment shown in FIGS. A14A-A14D are
the same as or similar to those discussed in the previously
described embodiments, and such elements may not be described or
may only briefly be described. It will also be appreciated that the
aspects of the embodiments previously described may also apply to
the present embodiments. FIG. A14A is a left-side view; FIG. A14B
is a right side view; FIG. A14C is a top view; and FIG. A14D is a
bottom view of the device A1400, according to some embodiments. The
device A1400 is particularly advantageous for enabling a physician
to perform an efficient diagnostic outpatient office or clinic
procedure for a female patient who is reporting abnormal uterine
bleeding, the procedure combining a hysteroscopic examination with
an endometrial biopsy, although it is to be appreciated that other
uses for the device A1400 are within the scope of the present
teachings. The device A1400 can bring about substantial
efficiencies in terms of keeping equipment costs low and keeping
the time required to perform the procedure modest, while at the
same time providing the opportunity for better endometrial sample
quality over conventional "blind" endometrial sample collection
methods.
[0227] Device A1400 comprises a handle portion A1401 and a sampling
portion A1404 that detachably couples to the handle portion A1401.
Preferably, the sampling portion A1404 is a single-use-only
disposable item, whereas the handle portion A1401 is reusable. The
handle portion A1401 comprises a handle body A1402 that houses a
rechargeable battery and the various electrical components
discussed supra, as well as a video display A1440 that is
integrally formed therewith. According to one embodiment, the
handle body may have a longitudinal dimension "b" of about 4 inches
and a diameter of about three-fourths of an inch, while the video
display A1440 can be a 3-inch diagonal LCD screen having a
thickness "a" of about one inch in the longitudinal direction. The
video display A1440 is generally oriented in a plane that is
transverse to the longitudinal direction such that it can be viewed
by the physician who is performing the procedure while the sampling
portion is extended into the patient's vagina and uterus. According
to some embodiments display A1440 is tiltable upwards and downwards
so as to improve ergonomic performance under some circumstances.
FIG. A14A shows an example of an upward tilt angle a of display
A1440. According to some embodiments the display A1440 is tiltable
upwards by about 45 degrees and downwards by about 45 degrees.
[0228] Sampling portion A1404 comprises a sampling sheath A1424, an
imaging head A1408, and a fluid and connector hub A1405 configured
as illustrated in FIGS. A14A-A14D. Sampling sheath A1424 forms a
single hollow lumen extending along its length, within which lumen
is contained a narrow electrical cable A1499 (shown dotted-line)
that provides the required electrical connectivity between the
handle portion A1401 and the imaging head A1408. By way of example
and not by way of limitation, the sampling sheath A1424 may have an
outer diameter of 3.1 mm, an inner diameter of 2.6 mm, and a length
"d" of at least 6.5 inches, and has a firm yet partially flexible
mechanical nature. The sampling sheath A1424 is preferably made of
an optically clear material so that the fluid(s) therein, including
the endometrial sample itself near end of the procedure, can be
easily viewed by the physician. The electrical cable A1499
preferably has a diameter that is about 1 mm or less if needed.
[0229] According to one example embodiment, sheath A1424 has a
total length of about 233 mm, made up of a straight portion which
is about 172 mm long, and an upwardly curved portion which is about
20.7 degrees at having a radius of about 174 mm. The curved portion
raises the tip 15.6 mm as shown in FIG. A14A. According to some
embodiments, the connector hub A1405 can have a length "c" of 1.25
inches. Preferably, the imaging head A1408 comprises camera optics
having an angular field of view of at least 100 degrees.
[0230] A sampling port A1427 is formed in the sampling sheath A1424
near the distal end and according to some embodiments, has a penny
whistle-type shape configured to facilitate endometrial sample
collection when moved along a tissue surface in a scraping
motion.
[0231] FIGS. A18A-A18D illustrates closer views of the distal end
of the sampling portion A1404 including the sampling port A1427,
according to some embodiments. In particular, FIG. A18A is an end
view; FIG. A18B is a cross section; and FIG. A18C is a perspective
view. For one embodiment, the general dimensions (e.g., length,
inner and outer diameter), the material type, the general
mechanical characteristics (e.g., stiffness, smoothness), and the
nature and dimensions of the sampling port A1427 of the sampling
sheath A1424 may be similar to corresponding components of the
MedGyn Endosampler Model 22720 (3 mm) available from MedGyn
Products, Inc. of Lombard, Ill., with the exception that there is
the imaging module A1408 integrated into its distal tip, and the
thin electrical wiring cable A1499 running down its length.
[0232] According to some embodiments, the sheath A1427 has an
oblong cross section so as to allow room for a forward facing port
A1824 which allows fluids flowing into the uterine cavity (in-flow
fluids) to pass out of the distal end near the camera A1830. The
camera block A1830 includes an aperture A1838 through which the
video images are obtained. By providing an in-flow port on the
distal end of sheath A1427 the video quality can be increased. In
addition to providing room for the in-flow port A1824, the oblong
cross section allows the sampling port A1427 to be positioned
closer to the distal end of the sheath A1427. According to one
embodiment, the outer dimension of the sheath A1424 is about 4.6 mm
by 3.8 mm, and the inner dimension is about 3.8 mm by 3.0 mm. Also
shown are LEDs used for illumination, such as LED A1834. The space
surrounding camera A1830 that is not used for the in-flow port
A1824 is filled in using a suitable glue filler A1814. As shown in
FIG. A18B, the distal end A1816 of the sheath A1824 is preferably
beveled.
[0233] Talon shaped opening A1427 allows for more efficient
collection of endometrial tissue samples. Sharp tip A1820 of
opening A1427 allows for scraping of endometrium. According to one
embodiment, suitable dimensions for the opening A1427 for a sheath
having the dimensions shown in FIG. A18A are shown in FIG. A18B.
Shown in FIG. A18C are dashed arrows illustrating fluid flowing
between the multi-purpose fluid channel A1812 within the sampling
sheath A1424 and the ports A1427 and A1824.
[0234] FIG. A18D shows a front view of the distal end having a
ring-shaped LED A1836, according to some embodiments. The LED A1836
is formed in a recessed ring-shaped area surrounding the aperture
A1838 as shown. In general the LED or LEDs can be placed as close a
possible to the aperture of the camera so long as the LED or LEDs
do not block the field of view of the camera. According to some
embodiments, a ring-shaped LED mounting ring is used such as shown
and described with respect to FIGS. A29A and A29B.
[0235] Referring again to FIG. A14A-A14D, according to some
embodiments, the handle portion A1401 is provided with a relatively
minimal set of external controls buttons or knobs. In particular, a
hardware button A1456 is used for power control (on/off button), an
two hardware buttons A1452 and A1454 are used for manual gain
control of the LCD screen A1440. According to some embodiments
third and fourth hardware buttons A1453 and A1455 are used for
manual white balance and to capture still images from the video
camera for later viewing, respectively. According to some
embodiments, programmable buttons can be provided in place of some
or all of the hardware buttons, and hardware or programmable
buttons can be provided to control other video features such as
zoom-in, zoom-out and manual white balance.
[0236] In addition to providing the required electrical connections
between the handle portion A1401 and the electrical cable A1499,
the fluid and connector hub A1405 is configured to provide a
multi-purpose fluid channel between a fluid coupling opening A1403
and the port or ports at the distal end (such as sampling port
A1427 and the in-flow port). During a hysteroscopic phase of the
procedure, the multi-purpose fluid channel between the opening
A1403 and the distal ports is used to carry a fluid (such as saline
solution) that is infused under positive pressure from an external
source, such as a syringe A1435a coupled to the opening A1403,
toward and outward from the distal end ports (such as in-flow port
A1824 shown in FIGS. A18A and 18C, and sampling port A1427) to
distend the uterus. Other examples of distending fluids that may be
suitable according to some embodiments include: carbon dioxide gas,
electrolyte-poor fluid, and electrolyte-containing fluid. The
multi-purpose fluid channel (channel A1812 shown in FIG. A18C) is
then used to drain the uterus upon application of a negative
pressure (suction), such as can be provided by the external
syringe, to the opening A1403. Subsequently, during a sample
collection portion of the procedure, the multi-purpose fluid
channel continues to provide suction to the sampling portal A1427
such that sample tissue is sucked thereinto and stored. The use of
the same fluid channel to perform these different functions during
different phases of the combined procedure provides an advantageous
balance of device functionality and simplicity of device
manufacturing.
[0237] Notably, the presence of the narrow electrical cable A1499
within the sampling sheath A1424 does not substantially disturb the
operation of the multi-purpose fluid channel nor does it negatively
affect the quality of the acquired endometrial sample. At the same
time, placement of the narrow electrical cable A1499 within the
multi-purpose fluid channel serves to enhance the simplicity of the
device and lower the manufacturing costs. However, it is to be
appreciated that it is not outside the scope of the present
teachings for the electrical cable A1499 to be disposed within a
separate second lumen formed in the sampling sheath A1424, or
alternatively to be adhered along its length to the outside surface
of the sampling sheath A1424, although these configurations are not
believed to be quite as advantageous as the embodiment of FIGS.
A14A-A14D in which the narrow electrical cable A1499 shares the
hollow lumen of the sampling sheath A1424 with the multi-purpose
fluid channel.
[0238] According to some embodiments a data-transfer port A1433, in
the form of a USB port is provided on the exterior of handle A1402.
The USB port A1433 can be used to transfer data such as video or
still captures stored in memory A1437 from the device A1400 to a
computer or other system. The USB port A1433 can also be used to
calibrate, setup and/or change settings on the device A1400 or
otherwise communicate with processor A1439. According to some
embodiments, the USB port can be used to supply power to the device
A1400 either for operation or for charging of rechargeable battery
A1435.
[0239] FIGS. A15A-A15D illustrate the device A1400 at respective
phases of a method for combined hysteroscopy and endometrial
sampling according to some preferred embodiments. For clarity of
presentation, the fluid and connector hub A1405 is illustrated in
FIG. A15A as a dotted line, such that a fluid stopper A1536 is
visible that is configured to prevent fluid from flowing further
toward the handle portion A1401, while at the same time allowing
the electrical cable A1499 to pass onward toward the handle portion
A1401. Also shown in FIG. A15A is an external syringe A1534
including a plunger A1535 for manipulation by an assistant during
the combined hysteroscopy and endometrial sampling procedure, the
syringe A1534 being in fluid communication with the opening A1403
(through a fluid tube A1532) that establishes a multi-purpose fluid
channel with the sampling port A1427 at the distal end. The
physician, whose eye is shown by the graphical symbol "E" in FIG.
A15A, directs the distal tip of the device toward the cervix under
the full or partial guidance provided on the video display A1440.
Advantageously, the physician does not need to turn his/her head
away in order to look at the video display.
[0240] As illustrated in FIG. A15B, once the distal end has been
inserted into the uterus, positive pressure is placed on the
plunger A1535 to cause distention fluid "F" to flow into the uterus
through the sampling portal A1427, which causes a positive pressure
to distend the uterus. The physician then performs a hysteroscopy
by looking at the video display A1440 while manipulating the device
to look around the uterus at different locations and viewing
angles.
[0241] Depending on patient-specific factors, there might be very
little leakage of the fluid "F" from the uterus during the
hysteroscopy (a relatively tight seal of the cervix around the
sampling sheath A1424), or alternatively there might be substantial
leakage of the fluid "F" from the uterus during the hysteroscopy (a
relatively loose seal or space between the cervix and the sampling
sheath A1424). For the latter case (i.e., loose seal or no seal),
uterine distention can be maintained for the necessary viewing time
interval (usually between one minute and several minutes) by
maintaining an inflow of replacement fluid from the sampling portal
A1427 into the uterus as the fluid "F" leaks out from the cervix.
If necessary, the assistant can refill the syringe with fluid if it
runs out. Alternatively or in conjunction with a manually
controlled syringe, any of a variety of automated external fluid
pumping systems can be used to introduce, maintain, and/or evacuate
the uterine distention fluid "F" including, but not limited to, the
handle-mounted fluid pumping scheme that is included in FIGS.
A21A-A21B infra.
[0242] As illustrated in FIG. A15C, upon completion of the
hysteroscopy phase of the procedure, a negative pressure is applied
to the multi-purpose fluid channel within the sampling sheath
A1424, such as by an outward pulling on the plunger A1535 of
syringe A1534, thereby causing a drainage of the fluid "F" outward
from the uterine cavity and back into the syringe (which can be
accompanied by leakage-type drainage of the fluid "F" out of the
cervix, depending on patient-specific factors as described above).
By virtue of the drainage of the distention fluid "F", the uterus
collapses around the sampling sheath A1424.
[0243] As illustrated in FIG. A15D, an endoscopic biopsy phase of
the procedure is then carried out by moving the sampling sheath
A1424 in an inward and outward motion several times, with the
assistance of further negative pressure maintained by continued
pulling of the plunger A1535 of the syringe A1534, an endometrial
sample "S" thereby being scraped off the internal uterine surface
by virtue of the shape of the sampling portal A1427 and sucked into
the multi-purpose fluid channel within the sampling sheath A1424 by
virtue of the negative sucking pressure. Advantageously, the
endoscopic biopsy phase of the combined procedure can be carried
out immediately subsequent to the hysteroscopy phase without
requiring the retraction and reinsertion of any instruments,
thereby streamlining the procedure from a time and complexity
standpoint. Advantageously, the device A1400 brings about the
ability for only a single insertion to be required in achieving the
dual goals of hysteroscopy and endometrial biopsy. The simplicity
of the device allows for use in a regular office setting (rather
than a surgical setting) and decreased physician time. The device
allows for the ability to perform a hysteroscopy in the doctor's
office in addition to an endometrial biopsy, with only very modest
additional time and equipment required in comparison to a
non-hysteroscopic "blind" endometrial biopsy that would be
performed in that same setting, but being much more effective than
the simple "blind" biopsy because much common pathology is
diagnosed by visual appearance, such as submucous fibroids and
polyps, which would be missed by blind biopsy.
[0244] An additional advantage provided by the device A1400 and the
method of FIGS. A15A-A15D is that the physician's observations made
during the hysteroscopy portion of the procedure can be used in
providing a more directed endoscopic biopsy procedure, which can
yield better sample quality in comparison to "blind" endoscopic
biopsy procedures. More particularly, according to an embodiment,
the physician may notice a particular area of interest on the
interior uterine surface during the hysteroscopy phase, whereupon
the physician may then "steer" the sampling port A1427 toward that
particular area of interest during the endoscopic sampling phase.
This can be particularly advantageous in for cases in which the
uterus contains relatively small lesions or polyps whose cancerous
tissue might otherwise be missed or diluted in a "blind" procedure.
By way of example, the longitudinal axis of the device A1400 may be
thought of as the center of a clockface coordinate system when
viewed from an axial direction by the physician, and the uterus can
be conceptually divided into quarter sections in that clockface
coordinate system. For a patient in a conventional supine position,
an anterior portion of the uterus on the patient's left side would
correspond to clockface positions between 12 o'clock and 3 o'clock.
A posterior portion of the uterus on the patient's left side would
correspond to clockface positions between 3 o'clock and 6 o'clock.
A posterior portion of the uterus on the patient's right side would
correspond to clockface positions between 6 o'clock and 9 o'clock,
and, finally, an anterior portion of the uterus on the patient's
right side would correspond to clockface positions between 9
o'clock and 12 o'clock. In one example scenario, the physician may
notice during the hysteroscopy that there is a particular area of
interest between 6 o'clock and 9 o'clock in the above-described
coordinate system, such as a small polyp. Advantageously, the
physician may then turn the device 1400 to the appropriate angle
(using, for example, a fiducial marker system provided on the
exterior of the device, or an intrinsic fiducial marker system
provided by virtue of the shape of the device) to perform most or
all of the endometrial sampling phase with the sampling port A1427
facing angles between 6 o'clock and 9 o'clock. In this manner, it
is more likely that the endometrial sample will contain the
potentially cancerous tissue than if a "blind" endometrial biopsy
were taken,
[0245] FIGS. A16-A17 illustrate further detail of the handle and
display portions of a sampling endoscope, according to some
embodiments. As can be seen the dimensions of the handle A1402 and
display A1440 are provided according to a sample embodiment. The
various buttons A1452, A1452, A1455 and A1456 are also shown as
described with respect to FIGS. A14A-A14D.
[0246] Thus, according to some embodiments, a handheld video
endoscope integrates endoscope, video processing electronics A1439,
data storage A1437, compact display A1440 and embedded power supply
A1435 for efficient and convenient clinical procedures. The design
should be adapted to be suitable for each specific type of
procedure to minimize patient discomfort while maximizing clinical
efficacy.
[0247] According to some embodiments, an ergonomically designed
handheld hysteroscope is provided. In particular, the display A1440
is mounted on the back end of the device and relatively centered
with respect to the shaft of the endoscope. The screen of display
A1440 is situated at the center of the physician's field of view
while performing the procedure. The design shown advantageously
provides a low off-axis profile, which allows the physician to move
the device freely including rotation and longitudinal motion
without bumping into the patient's legs or into the table.
[0248] The screw driver type handle body A1402 is preferably about
1.0 inches in width. Display screen A1440 is about 3 to 5 inches
measured diagonally. The design provides for easy longitudinal
translation as well as easy rotation. Slim design facilitates easy
hand grip and longitudinal movement. Video display screen A1440 is
mounted with low overall off-axis profile for easy rotation or
tilting.
[0249] FIGS. A21A-A21B illustrate a sampling endoscope having a
pistol grip, according to some embodiments. Many of the elements of
the embodiment shown in FIGS. A21A-A21B are the same as or similar
to those discussed in the previously described embodiments, and
such elements may not be described or may only briefly described.
It will also be appreciated that the aspects of the embodiments
previously described may also apply to the present embodiments.
Sampling endoscope A2100 is similar to endoscope A1400 depicted in
FIGS. A14A-A14D, A16 and A17 except that a pistol handle A2100 is
provided. According to some embodiments, the endoscope probe sheath
A1424 and video display A1440 can rotate while the pistol handle
A2110 remains stationary. Zooming and capture buttons A2160 can be
provided on pistol grip A2110 as shown. According to some
embodiments, the handle body A1402 rotates along with the probe
A1610 and display assembly A1640, and according to other
embodiments the handle body A1632 remains stationary relative to
pistol grip A2110. According to some embodiments, the fluid
connector A1622 and hub assembly A1626 rotate along with the probe
A1610 and display assembly A1640, and according to other
embodiments the fluid connector A1622 and hub assembly A1626 remain
stationary relative to pistol grip A2110. According to some
embodiments, the pistol grip A2110 is disposable and according to
other embodiments the grip A2110 is re-usable. By allowing the
pistol grip A2110 to remain stationary while the sheath A1424 and
display A1440 rotate, the physician is able to move the device
freely including rotation and longitudinal motion without bumping
the pistol grip A2110 into the patient's legs or into other
equipment such as a table.
[0250] According to some embodiments, the sheath A1424 and hub
assembly A1405 are detachable and disposable, while the handle
A1402, pistol grip A2110 and display A1440 are re-usable. According
to some embodiments, the rotation of the sheath and video assembly
is motor driven. According to some embodiments the rotation angle
is registered by the control system and can be used for rotating
the image back in software. Where software rotation is implemented,
according to some embodiments, only the sheath A1424 and hub
assembly A1405 rotate and the image on the display A1440 is rotated
in real time to compensate.
[0251] According to some embodiments, as an alternative, the
manually controlled syringe of FIGS. A15A-A15D is replaced by a
dedicated fluid container A2152 and trigger-actuated bidirectional
pump A2150 that is affixed to or located within the handle portion
A1402 or pistol grip A2110 of the device A2100, which can
facilitate the ability for a physician to perform the combined
hysteroscopy and endometrial sampling procedure without the need
for an assistant to operate the syringe. Included in FIGS.
A21A-A21B is one or more embodiments in which the device A2100 is
outfitted with an enhanced pistol-grip type handle A2110, wherein
the physician may apply positive or negative fluid pressure by
squeezing a trigger-type button A2166. A switch A2164 is provided
that allows the physician to select between positive pumping
pressure and negative suction pressure. For one embodiment, the
fluid pumping and suction pressure may result solely from manual
squeezing of the trigger A2166, with operation being analogous that
of a fellable household spray bottle having a squeeze-trigger. For
another embodiment, motorized operation can be provided using
electrical energy from the rechargeable battery A1435 of the handle
portion or an external source. As described, for some embodiments
in which a pistol-grip type handle A2100 is used, the handle
portion A1402 may be configured so as to allow the trigger A2166
and handle-grip A2100 to remain at a fixed angle in one hand, while
the video display A1440 and sampling sheath A1424 can be rotated in
unison to different clockface angles relative to the longitudinal
axis of the device. The physician may alter the angle of the video
display A1440 and sampling sheath A1424 by directly manipulating
the angle of the video display A1440 with their second hand. The
mechanical fit between the components should be reasonably tight or
resistive so that the video display A1440 and sampling sheath A1424
do not rotate loosely on their own, but will only rotate when so
affirmatively manipulated by the physician's second hand.
[0252] Another variation that is also within the scope of the
present teachings is to leave the video display A1440 upright and
fixed in angular relation to the pistol-grip style handle A2110,
while the sampling sheath A1424 is independently rotatable around
the longitudinal axis. For this embodiment, the angle of the
sampling sheath can be electronically or electromechanically
measured, and then the angle of the image as it appears on the
video display A1440 can be rotated using software or firmware
running on processor A1439 to correspond to the angle of the
sampling sheath.
[0253] By way of still further example, another variation that is
also within the scope of the present teachings is to use a
pistol-grip A2110 that is not triggered, but into which can be
placed a single-use fluid syringe A1435a. The physician can use
their second hand to work the syringe A1435a while holding the
pistol-grip steady with their first hand. By way of even further
example, another variation that is also within the scope of the
present teachings is to incorporate a low-cost rotary fluid pump
directly into the fluid and connector hub A1405, or to build the
low-cost rotary fluid pump into the fluid tube that leads to the
fluid and connector hub from an external reservoir, and to make all
of the sampling portion, the reservoir, the fluid tube, and fluid
pump be single-use disposable items. One example of a suitable
low-cost fluid pump that could be adapted for use into the
described embodiments is the WPM Ultra-Compact Peristaltic Pump
available from Welco, Ltd., of Tokyo, Japan. Therefore, references
to the details of the preferred embodiments are not intended to
limit their scope.
[0254] Further details with respect to imaging sensors and related
technology will now be provided, according to some embodiments.
CMOS (Complementary metal-oxide-semiconductor) sensor technologies
have advanced greatly. Pixel signal to noise is improving while
pixel size is reduced, making it possible to achieve high
resolution with very small sensor area. CMOS sensor requires low
power and voltage. CMOS requires fewer connection wires and the
wires can transmit distance up to several meters. These
characteristics make CMOS sensors ideal for miniature video
endoscopes for in vivo direct visualization of many different
tissues of interest in human body. Because of the miniaturization,
it is possible to embed video cameras in catheters, sheath and
other tools and provide in vivo and sometime concurrent direct
visualization.
[0255] Higher resolution and high photon flux will render higher
image quality. However, there is a physics limit to the size of
pixel. As the individual pixel size become smaller, the signal to
noise, dynamic range decrease and circuitry complexity increases.
The basic tradeoffs between image resolution, clinical value
including invasiveness and the economics of single use cameras,
have not been obvious and a systematic will now be provided.
[0256] FIG. A19 illustrates various factors in optimal sensor
design for single use video endoscopes, according to some
embodiments. Major factors in optimal sensor design for single use
video endoscopes include the following. (1) Sensor Area
(SA)--larger sensor area allows imaging of larger area. However,
cost (C) and invasiveness (INV) increases with sensor size. (2)
Adequate image quality (AIQ)--refers to image quality that provides
adequate visualization. AIQ for three targeted groups of imaging
applications are plotted in curves A1910, A1912 and A1914. For
certain sizes of targeted area to be visualized, AIQ increases with
sensor size but levels off after certain point (the level-off
points A1920, A1922 and A1924), beyond which AIQ changes very
slowly with SA, i.e. the quality of visualization does not change
significantly. (3) Invasiveness (INV), plotted in curve A1930--as
sensor area increases the invasiveness to tissue increases quickly
because the video endoscope size is directly proportional to the
sensor area. (4) Cost (C), plotted in curve A1932--cost of video
endoscope increases as chip area increases because of chip
fabrication cost. Cost also increases as size approaches very small
because of assembly and packaging. Cost is very critical in making
single-use feasible.
[0257] As shown in FIG. A19, an optimal area A1940 of operation is
highlighted. Table 1 lists the range of sensor resolution for the 3
application groups.
TABLE-US-00001 TABLE 1 Endoscope OD Targeted (not including Group
Pixel Size Number of Pixels illumination) G1 1.75~3.0 mm 1~2
Millions <5 mm Such as 3.6 mm G2 1.4~2.5 mm 50K~270K <3 mm
Such as 1.6 mm G3 1.1~1.75 mm 8K~40K <1.5 mm.sup. Such as 1.2
mm
[0258] Thus, in applying CMOS (Complementary
metal-oxide-semiconductor) sensor technologies for medical
endoscopes, optimal sensor specification is achieved based on the
following major factors: Adequate quality for intended use;
invasiveness to the tissue; and cost of manufacturing and assembly.
The current teachings, according to some embodiments, relate to
single-use video endoscopes or video probes for several common
diagnostic and therapeutic procedures including single-use,
flexible and miniature endoscope is inserted through, or fixed
within, the working channel of sheath or catheter to assist the
deployment and verification of biopsy and ablation with RF or
Microwave. With single-use, flexible and miniature endoscope
built-in the sheath or catheter, the targeted tissue sites and can
be visualized concurrent to the RF or Microwave ablation or tissue
biopsy, according to some embodiments. With single-use, flexible
and miniature endoscope built-in the sheath, contraceptive
sterilization procedure can be visualized and verified, according
to some embodiments. Ultra-slim, single-use endoscope on a curved
or angled tip for assisting deployment and verification of implant
devices including IUD (Intra-Uterine Device), and for diagnosis or
treatment of body joints and spines, according to some embodiments.
Ultra-slim, single-use video probes that can be placed inside a
cardiac catheter sheath together or in place of the usual guide
wire, which enables continuous visualization of the catheterization
process inside the cardiovascular vessels and enhance the procedure
which reduce X-ray doses by fluoroscopy, according to some
embodiments.
[0259] According to some embodiments the techniques described
herein can be used for other types of direct optical visualization
of the human body including for example, encephaloscopy,
esophagoscopy, thoracoscopy, angioscopy, nephroscopy, proctoscopy,
colonoscopy, arthroscopy, rhinoscopy, laryngoscopy, bronchoscopy,
mediastinsocopy, gastroscopy, laparoscopy, amnioscopy, and
cystoscopy.
[0260] Many of the embodiments described herein are directed to
"single use", and this provides a significant advantage in many
applications since sterilization is tedious and requires expensive
materials and construction of the scopes. Additionally,
sterilization can be never be perfect. "Single use" means
disposability. The teachings provided herein provide a "sweet spot"
or a good compromise in balancing of the invasiveness, acceptable
image quality and cost.
[0261] Referring again to FIGS. A14A-A14D, A16 and A17, according
to some embodiments, the handset including probe A1424, connector
hub A1405 and handle A1402 is a single disposable piece. The
display assembly A1440 is designed to be re-used many times. A
highly durable design for the connector between the handset A1402
and the display A1440 is provided so that the display A1440 can be
re-used many times.
[0262] One example of the procedure is described as follows: (1)
clean and disinfect the display A1440; (2) take the handset out of
sterile package and connect it to the display A1440; (3) perform
the entire hysteroscopy and biopsy procedure; (4) detach handset
and dispose of it; (5a) clean and disinfect display A1440; or (5b)
peel a protective sheath used to cover the display A1440 and
replace with a new sheath; and (6) the display A1440 is now ready
to use for new procedure.
[0263] According to some embodiments, the display A1440 and handle
A1402 is a single piece that is reusable. A highly durable design
for a connector between the handle A1402 and hub A1405 allows for
the display and handle to be reused many times.
[0264] According to some embodiments, the endoscopic system is
formed of three main parts. Display A1440 is designed to be reused
many times. Handle A1402 is designed to be reused fewer times, and
sheath A1424 and hub A1405 are designed for single use.
[0265] Conventional video endoscopes use a sheath containing
channels for multiple purposes, including instilling distending
media and or collecting tissue samples. According to some
embodiments, the design of the distal tip of an endoscope that
includes a video camera and illumination, combined with a channel
for instillation of distending fluid or gas. Specifically,
structures for fluid inflow allow a solid rounded distal end of the
device to enter the uterus, urethra, or other hollow organ while
maintaining forward flow of distending medium to provide excellent
visualization. According to some embodiments, the use of this
principle is combined with a built-in endometrial biopsy port to
allow directed biopsy without the need to insert other
instruments.
[0266] FIGS. A20A-A20C illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A15D, A16, A17, A18A-A18D and/or
A21A-A21B. In this example embodiments, the sheath A1424 having OD
less than about 4 mm. A backward facing side port A2022 is angled
backward such that the in-flow fluid is naturally directed toward
the forward facing side port A2024. The forward facing side port
A2024 is preferably angled at less than 30 degrees from the central
axis of sheath A1424 near its distal end,
[0267] Multi-purpose fluid channel A1812 is used to carry fluids
under positive pressure outward from the device, for example to
distend the uterus, as well as to carry fluids under negative
pressure inward into the device, for example for sample collection.
A flex cable or wire A1499 is also shown and can be embedded within
the wall of sheath A1424, or more preferably, positioned within the
channel A1812. The camera head A1830 in this example has an OD of
between 1 and 2.62 mm, and an aperture A2038. Illumination is
provided by LEDs, such as LEDs A2034 and A2036.
[0268] According to some embodiments an optional soft flap A2026 is
provided for gating in-flow fluid (i.e. fluid flowing into the
uterus) through forward facing port A2024 instead of backward
facing port A2022. The optional soft flap A2026 is designed to at
least partially occlude the backward port A2022 in the in-flow
phase, thereby forcing most or all of the fluid under positive
pressure through the forward port A2024.
[0269] By providing the two ports as shown the design
advantageously provides for efficient and effective bi-directional
sampling. Backward facing port A2022 captures more samples when
sheath moves backwards, while forward facing port A2024 captures
more samples when sheath moves forwards. FIG. A20C shows further
details of the shape of the forward facing port A2024 and backward
facing port A2022, and dimensions, according to one embodiment.
[0270] Thus, by providing more than one port at or near the distal
end, in-flow of fluids as well as sample collection is facilitated.
As shown the lateral forward port A2024 is provided with angled
ramp that allows the inflow fluid to be injected with a trajectory
at an angle equal or less than 30 degrees from the forward
direction. With the design shown in FIGS. A20A-A20C, there is no
need for an opening at the very distal tip surface. This frees up
more room for camera, as well as for LEDs or other illumination
means. This also allows a solid rounded distal end to facilitate
entry into the uterus, urethra, or other hollow organ while
maintaining forward flow of distending medium to provide excellent
visualization. Thus by providing dual ports or multiple ports,
samples can be captured whether the device move forward or backward
or rolling.
[0271] FIGS. A22A-A226 illustrate an endoscope having optical fiber
illumination, according to some embodiments. Endoscope A2200 is
similar to device A1400 or device A2100 as shown in and described
with respect to FIGS. A14A-A140, A15A-A15D, A16, A17, A18A-A18D
and/or A21A-A21B. In this example, however, illumination is
provided by a high brightness LED module A2228 that is embedded
inside the hub body A2226 as shown. The LED light couples into
optical fibers embedded within the wall of sheath A1424. The
population of optical fibers, such as fiber A2214 shown in FIG.
A22B, is embedded into the sheath material A2212 of sheath A1424.
The optical fibers can be glass (or plastic) light guiding fibers
as is well known, which carry illumination light from the LED
source A2228 to the distal tip A1408. At the distal tip A1408 the
optical fibers are terminated and sealed or covered with light
translucent materials. According to some embodiments, the optical
fibers each have a diameter of about 30 Microns and a numerical
aperture of >0.7. The fibers are preferably held together with
epoxy and polished at the end for coupling with the LED source
A2228. The top section A2230 of sheath A1424, which also
corresponds to the same sector as the irrigation and sample
retrieval port A2208, contains no fibers and remains optically
clear so as to allow the user to see specimen sample fluid as the
fluid is being drawn through the central opening A1812 of sheath
A1424. This "clear sector" A2230, according to some embodiments,
takes up between 25-50% (i.e. 90-180 degrees) of the sheath wall
circumference. According to one embodiment, the clear sector A2230
is spiraled along the length of the sheath A1424 so that the user
can view the specimen fluid from any viewing angle.
[0272] FIGS. A23A-A23D illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A15D, A16, A17, A18A-A18D and/or
A21A-A21B. In this example, the wall of sheath A1424 has OD of less
than about 4 mm. The backward facing side port A2322 is tilted
backward so as to direct the in-flow fluid (i.e. fluid flowing into
the uterus) in multi-purpose fluid channel A1812 toward the forward
port A2324. Forward facing side port A2324 is preferably angled at
less than 30 degrees. A flex cable or wire A1499 is connected to
camera head A1830, which preferably has an OD of between 1 mm and
2.62 mm, and an aperture A2338. Illumination is provided by LEDs
such as LEDs A2334 and A2336. Forward facing port A2324 preferably
has a blunt edge A2328 to facilitate ease of insertion of the
endoscope by lessening risk that the edge A2328 catches on tissue
during insertion. According to some embodiments, an optional soft
flap A2326 is provided for gating in-flow fluid through forward
facing port A2324 instead of backward facing port A2322.
[0273] FIGS. A23C and A23D shows further details of the shape and
dimensions of the backward facing port A2322 and forward facing
port A2324 respectively, according to some embodiments. As in the
case of the design shown in FIGS. A20A-A20C, the design shown in
FIGS. A23A-A23D provide for bi-directional sampling. Backward
facing port A2322 captures more samples when sheath moves
backwards; while forward facing port A2324 captures more samples
when sheath moves forwards.
[0274] FIGS. A24A-A24B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A150, A16, A17, A18A-A18D and/or
A21A-A21B. In this example forward facing port A2424 and backward
facing port A2422 are on the opposite side of the sheath tube A1424
to allow in-flow fluid to be more uniform on all sides of sheath
A1424. Forward facing port A2424 is more proximal relative to the
backward port to allow the backward facing port A2422 to be closer
to the distal end of sheath A1424. Forward facing port A2424 has an
edge A2428 that is preferably rounded to avoid catching up tissue.
In one embodiment camera wire A1499 and is pushed up within
multi-channel fluid channel A1812 so as to be closer the upper wall
of sheath A1424, such as by gluing, etc. This has been found to
allow greater in-flow fluid to the forward port A2424.
[0275] Block or stuffing A2426 behind the camera module A1830 is
shaped so at to direct the in-flow fluid to the forward port A2424.
According to some embodiments, sheath A1424 including its distal
end can be made of a single piece of suitable plastic material.
Alternatively, distal tip can be made of metal while the portions
of the sheath A1424 other than the tip are made of plastic
material. The structures shown allow for fluid inflow, while the
solid rounded distal end facilitates entry into the uterus,
urethra, or other hollow organ while maintaining forward flow of
distending medium to provide excellent visualization.
[0276] FIGS. A25A-A25B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A150, A16, A17, A18A-A18D and/or
A21A-A21B. In this example, a backward facing side port A2522 is
angled backward such that the in-flow fluid is naturally directed
toward the forward facing port A2524. The forward facing port A2524
is formed in the very distal end of sheath A1424 as shown.
[0277] Multi-purpose fluid channel A1812 is used to carry fluids
under positive pressure outward from the device, for example to
distend the uterus, as well as to carry fluids under negative
pressure inward into the device, for example for sample collection.
A flex cable or wire A1499 is also shown and can be embedded within
the wall of sheath A1424, or more preferably, positioned within the
channel 1812. The camera head A1830 has an aperture A2538.
Illumination is provided by LEDs, such as LEDs A2534 and A2536. A
filling A2514 such as glue is used to hold the camera A1830 and to
fix the position and orientation of the LEDs as shown. By providing
the in-flow port A2524 on the tip of the device as shown, clear
fluid such as saline can wash over the aperture of camera A1830 and
illumination LEDs so as to enhance imaging quality. Additionally,
the design allows for the backward facing side port A2522 to be
positioned closer to the distal end of sheath A1424 which enhances
the ability to efficiently collect tissue samples.
[0278] FIGS. A26A-A26B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A15D, A16, A17, A18A-A18D and/or
A21A-A21B. In this example, the sheath A1424 has an oblong cross
section. A backward facing side port A2622 is angled backward such
that the in-flow fluid is naturally directed toward the forward
facing port A2624. Forward facing port A2424 is more proximal
relative to the backward port to allow the backward facing port
A2422 to be closer to the distal end of sheath A1424. Forward
facing port A2624 has an edge A2628 that is preferably rounded to
avoid catching up tissue.
[0279] Multi-purpose fluid channel A1812 is used to carry fluids
under positive pressure outward from the device, for example to
distend the uterus, as well as to carry fluids under negative
pressure inward into the device, for example for sample collection.
A flex cable or wire A1499 is also shown positioned within the
channel A1812. The camera head A1830 has an aperture A2638.
Illumination is provided by LEDs, such as LEDs A2634 and A2636. A
filler A2614 such as glue is used to hold the camera A1830 and to
fix the position and orientation of the LEDs as shown. The oblong
cross section of sheath A1424 has been found to allow the sampling
port to be placed closer to the distal tip while also creating room
for in-flow fluid port A2624 and sampling port A2622 to be placed
on opposite sides of the sheath A1424 as shown.
[0280] FIGS. A27A-A27B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A15D, A16, A17, A18A-A18D and/or
A21A-A21B. In this example, the sheath A1424 has an oblong cross
section. A backward facing side port A2722 is angled backward such
that the in-flow fluid is naturally directed toward the forward
facing port A2724. The forward facing port A2724 is formed in the
very distal end of sheath A1424 as shown.
[0281] Multi-purpose fluid channel A1812 is used to carry fluids
under positive pressure outward from the device, for example to
distend the uterus, as well as to carry fluids under negative
pressure inward into the device, for example for sample collection.
A flex cable or wire A1499 is also shown positioned within the
channel A1812. The camera head A1830 has an aperture A2738.
Illumination is provided by LEDs, such as LEDs A2734 and A2736. A
filler A2714 such as glue is used to hold the camera A1830 and to
fix the position and orientation of the LEDs as shown. The oblong
cross section of sheath A1424 has been found to allow the sampling
port A2722 to be placed closer to the distal tip while also
creating room for in-flow fluid port A2724 on the tip of the device
as shown. By providing the port A2724 on the tip, clear fluid such
as saline can wash over the aperture of camera A1830 and
illumination LEDs so as to enhance imaging quality.
[0282] FIGS. A28A-A28B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A15D, A16, A17, A18A-A18D and/or
A21A-A21B. In this example, the sheath A1424 has an oblong cross
section and front facing port A2824 is positioned on the distal tip
and above the camera A1830. This design allows for the backward
facing side port A2822 to be placed even more closely to the distal
end of sheath A1424. The multi-purpose fluid channel A1812 carries
fluids under positive pressure outward from the device, for example
to distend the uterus, as well as to carry fluids under negative
pressure inward into the device, for example for sample collection.
Flex cable or wire A1499 is positioned within lower part of the
channel A1812, preferably opposite to the sampling port A2822 and
in-flow port A2824. The camera head A1830 has an aperture A2838.
Illumination is provided by LEDs, such as LEDs A2834 and A2836. A
filler A2814 such as glue is used to hold the camera A1830 and to
fix the position and orientation of the LEDs as shown.
[0283] FIGS. A29A-A29B illustrate details near the distal end of a
device having combined hysteroscopy and endometrial sampling
capability, according to some embodiments. The device can be such
as device A1400 or device A2100 as shown in and described with
respect to FIGS. A14A-A14D, A15A-A15D, A16, A17, A18A-A18D and/or
A21A-A21B. In this example, the sheath A1424 has an oblong cross
section and front facing port/lumen A2924 is positioned on the
distal tip and above the camera block A1830. The sheath A1424 is
also molded into a multi-lumen tip structure. The sheath material
A1424 is used to separate the camera housing A1830 from the in-flow
lumen A2924. It has been found that this design prevents adhesives
used for mounting the camera block A1830 from seeping into the
in-flow lumen A2924. The multi-purpose fluid channel A1812 carries
fluids under positive pressure outward from the device, for example
to distend the uterus, as well as to carry fluids under negative
pressure inward into the device, for example for sample collection.
Flex cable A1499 is positioned within lower part of the channel
A1812, preferably opposite to the sampling port A2922 and in-flow
port A2924. In this design, the camera block A1830 is partially
housed by the sheath material such that forward fluid pressure is
not applied directly to the camera module directly, thereby
reducing the risk of the camera module being dislodged by the
in-flow fluid. Also preferably included is a wrapper or sleeve
A2914 for the camera block A1830. In FIG. A296, further detail of
the camera block A1830 can be seen, as will be shown in described
in even greater detail herein below. Six LEDs, such as LEDs A1934
and A1936 are mounted on a ring-shaped LED housing A3034. The
camera centrally located and has an aperture A1938. Alight shield
A3076 acts a lens hood and shields direct light from the LEDs from
entering the aperture. Portion A2940 is part of the sheath A1424
located further away from the distal tip, near to the sampling port
A1922 in longitudinal position.
[0284] FIG. A30 is a cross sectional view illustrating further
detail of a camera module for use with a device having combined
hysteroscopy and endometrial sampling capability, according to some
embodiments. The CMOS sensor A3080 and glass lens A3070 are housed
within a stainless steel lens holder A3056 such that there is an
air gap A3054 in between. The CMOS sensor A3080 electronically
communicates via conducting wires such as wires A3052 that pass
through cable A1499. The same or similar wires can provide power to
LEDs near sensor A3080. The cable A1499 is supported by a grommet
A3050. The entire camera module A1830 is housed and protected by a
stainless steel outer housing A3060. A metallic aperture plate
A3074 has a small aperture A3038 through which light is allowed to
pass. The aperture plate A3074 is covered by a glass plate A3072
which is mounted slightly recessed from the most distal end of the
camera module A1830. A number of LEDs, such as LEDs A3036 and A3037
are mounted on ring-shaped LED housing A3034. A light shield A3076
is positioned between the LEDs and the aperture A3038 so as to
block light from the LEDs from directly entering the aperture
thereby enhancing the video images captured by CMOS sensor
A3080.
[0285] FIG. A31 illustrates a device having combined hysteroscopy
and endometrial ablation capability, according to some embodiments.
Global endometrial ablation (GEA) is being used widely for treating
women with abnormal uterine bleeding conditions. Many different
technologies and platforms have been developed, such as the
NovaSure.RTM. system, ThermaChoice.RTM. system and also systems
that employ microwave, or other sources of thermal, laser,
radiofrequency, microwave energy as well as other energy sources.
However, none of these systems (other than those which circulate
heated free fluid under hysteroscopic vision) or procedures have
been integrated with direct visualization. An endoscope or
ultrasound may be used prior to the application of the GEA device,
but not in the same insertion. The device A3100 integrates
visualization for visually guided GEA procedures. In particular,
the device A3100, in addition to the features of a conventional GEA
system such as the NovaSure.RTM. system, includes a miniature
camera unit A1830, which can be as described in FIG. 30 and/or
elsewhere herein. The camera unit A1830 electronically communicates
via cable A1499. The distal tip of sheath A1424 also preferably
includes an illumination source (not shown). An integrated display
A1440 is preferably mounted on the end of handle portion A2110 so
as to aid in visualization during the GEA procedure. According to
some embodiments, the integrated visualization components are
mostly single use or disposable with the GEA components.
[0286] FIGS. A32A-A32C illustrate the distal end of a device having
combined hysteroscopy and endometrial ablation capability,
according to some embodiments. The distal tip of the sheath A1424
includes two tapered end pieces A3220 and A3222 that are shaped so
as to facilitate insertion of the device through the cervix and
into the uterus of the patient. Also shown is the folded electrode
structure A3210 that includes an expandable conductive mesh as is
known. In the embodiment shown in FIG. A32A, and LED A3234 is
mounted near the tip of piece A3222 and LED A3236 is mounted near
the tip of piece A3220. The LEDs and the camera module A1830 are
electrically connected to the system via cable A1499. The mounting
location of the LEDs A3234 and A3236 are preferably slightly away
from the central axis of sheath A1424 so as to reduce the amount of
light from LEDs directly entering the camera module A1830.
According to some embodiments, the camera module A1830 is 2 mm or
less in diameter. FIG. A32B illustrates an embodiment where the two
pieces A3222 and A3220 are made from a translucent material, and
LEDs A3244 and A3246 are mounted within the pieces A3222 and A3220
respectively. FIG. A32C illustrates an embodiment where the LEDs
are mounted in a small ring-shaped holder A3254 surrounding the
camera module A1830, such as shown and described with respect to
FIGS. A29A-A29B and A30. The embodiments of FIGS. A32A-A32B have an
advantage over the embodiment of FIG. A32C in that the overall size
of the combination of the ng-shaped LED holder A3254 and camera
module A1830 is larger than the camera module alone.
[0287] According to some embodiments, the illumination is provided
by a source in the handle of the device A3100 and optical fiber(s)
are used to carry the light to the distal tip, such as shown and
described with respect to FIGS. A22A and A22B herein. For example,
high brightness LEDs can be used within the handle structure A2110
of device A3100, and light-guiding optical fibers can either be
mounted on the inner surface of sheath A1424 or embedded into the
wall of sheath A1424. At the distal tip of device A3100, the
optical fibers are terminated and sealed or covered with light
translucent materials.
[0288] FIGS. A33A-A33C illustrates the device A3100 at respective
phases of a method for combined hysteroscopy and endometrial
ablation according to some embodiments. In FIG. A33A, the distal
end of sheath A1424 is inserted through the cervix A3310. Fluid is
infused through sheath A1424 so as to distend the uterine cavity
A3320. The camera module A1830 has a field of view A3330 and
provides visual images to the medical practitioner(s) of the inner
surfaces of uterine cavity A3320 such as endometrium A3322. In FIG.
A33B, the visual images from camera module A1830 are used to guide
the ablation sheath A1424 to the top of the uterus (fundus).
Through the aid of visual images, the integrated hysteroscopy and
endometrial ablation device has the advantages of (1) reducing the
risk of perforation of the uterine tissues; and (2) helps to ensure
a central positioning of the sheath within the uterine cavity A3320
so as to enhance an even distribution of the electrode
structure.
[0289] In FIG. A33C, the sheath A1424 is pulled back together with
the camera, allowing the electrode mesh structure A3340 to expand
and conform to the shape of the uterine cavity for ablation.
According to some embodiments, the camera is designed to remain
near the distal tip of the electrode mesh structure A3340. After
deployment of the mesh structure 3340, the ablation procedure is
carried out.
[0290] Although the embodiments described in FIGS. A31, A32A-A32C
and A33A-A33C are for a device having combined hysteroscopy and GEA
capability with a systems such as the Novasure.RTM. system,
according to other embodiments, the same or similar components are
combined with GEA systems having other types of ablation sheaths
and/or use other types of GEA technology. In general, visualization
provided by the described embodiments ensures that the GEA device
is correctly inserted into the uterine cavity and minimizes the
risk of a perforation. Without the integrated visualization
provided by these embodiments, cavity integrity tests are indirect
and not always accurate.
[0291] Certain embodiments described above can be used as a
low-cost medical instrument that is disposable at least in part and
in a single insertion distends, images and biopsies a patient's
uterus. The device comprises an elongated conduit having a distal
portion configured and dimensioned for insertion into the patient's
uterus, and a proximal portion, Non-limiting examples of such a
conduit are sampling portion A104, A1404, and probe A1424, without
or together with connection or hub A200, A300, A400, and A1405, The
conduit comprises (a) one or more proximal ports at the proximal
portion of the conduit, configured to provide passage of fluid into
the conduit and of fluid and biopsy samples out of the conduit; (b)
one or more distal openings at the distal portion of the sampling
conduit configured to provide fluid outflow from the conduit and
the inflow of fluid and biopsy samples into the conduit; and (c)
one or more biopsy implements at the distal end of the conduit,
configured and shaped to transfer biopsy samples from the uterus
into the conduit Non-limiting examples are: (a) for proximal ports,
the opening into sheath A124 from fluid line A132 (FIG. A3),
openings A103, the opening for fluid line A133 into hub A105 (FIG.
A9), and opening A1403; (b) for distal openings, hole A127 and
ports A127A, A127B, A1427, A2322, A2324, A2522, A2622, A2722,
A2822, and A2922; and, for biopsy implements, the shaped edges and
sides of the distal openings. The medical instrument further
comprises a handle secured to the conduit at the proximal portion
thereof and configured and dimensioned to be grasped by a user's
hand and manipulated by a user to introduce the distal portion of
the conduit into the patient's uterus, move the conduit's distal
portion within the patient's uterus, and withdraw the conduit from
the patient's uterus. Non-limiting examples of the handle are
module A102, and handle A1401, A1402 (and/or pistol grip A2110).
The instrument includes an imaging system at the distal portion of
the sampling device. Non-limiting examples of an imaging system are
imaging module 108, imaging head A1408, and camera head A1830. The
instrument further includes an illumination system configured to
illuminate the uterus at an illumination field viewed by said
imaging system. Examples of an illumination system are illustrated
at A108B, A1834, A1836, A1934, A1936, A2034, A2036, A2228 and
A2214, A2334, A2336, A2436, A2534, A2536, A2634, A2636, A2734,
A2736, A2834, A2836, A2934, A2936, A3036, A3037, A3234 and A3236.
An image display can be secured to said handle, such as image
display A140 and A1440. A control system can be secured to the
handle and coupled with the imaging system, the illumination system
and the image display and is configured to selectively cause, in
response to user commands, the illumination system to illuminate
the uterus, the imaging system to provide an image of the uterus,
and the display system to display the image for viewing by the
user. Examples of control systems are seen at A112, A1439 (with or
without control buttons A1452-A1456 and/or the control buttons
and/or trigger illustrated in FIGS. A21A-A21B). At least the
conduit is configured to be disposable after a single use in a
patient, but the handle may also be disposable it desired. Further,
all three of the conduit, handle and display can be disposable if
desired, as can the control system. The instrument is configured
for a medical procedure in which the distal portion is inserted
only once into the patient's uterus to provide each of (a) uterus
distention by introducing fluid under positive pressure into one or
more of the proximal ports, which fluid passes through the conduit
and enters the uterus through one or more of the distal openings,
(b) an image of the uterus by illuminating the uterus with the
illumination system and imaging the illuminated uterus with the
imaging system, and (c) taking biopsy samples from the uterus by
engaging the uterus with the biopsy implements and drawing fluid
and biopsy samples from the uterus into the conduit through one or
more of the more distal openings and out of one or more of the
proximal ports by applying negative pressure to one or more of the
proximal ports. Preferably, the conduit is releasably coupled with
the handle so that a new conduit can be secured to the handle for
use with a new patient, and the used conduit can be uncoupled
thereafter, preferably by hand and without requiring the use of
tools, and disposed of in preparation for use with another patient.
In addition, or alternatively, the handle and the display can be
releasably secured to each other so that a new handle and a new
conduit can be secured to the display before use with a new
patient, and thereafter the handle and the conduit can be uncoupled
from the display, preferably by hand and without requiring tools,
and disposed of. An inflatable balloon can be secured to the
conduit, such as balloon 106, and selectively inflated when the
distal end of the conduit is in the uterus, to resist fluid flow
out of the uterus. The instrument can be provided with an ablation
device at the distal portion of the conduit to selectively ablate
at least a selected portion of the uterus under user control.
Examples of ablation devices are electrode mesh structure 3340,
although other types of ablation structures using heat or other
means to ablate can be used instead or in addition (for example,
laser light).
[0292] The medical instrument that is at least party disposable can
be used in a method of distending, imaging and taking biopsy
samples of a patient's uterus in a single insertion of the
instrument into the uterus. The method includes: (a) inserting the
distal portion of the conduit into the patient's uterus by manually
manipulating the handle; (b) distending the uterus by introducing
fluid under pressure into the conduit through one or more proximal
ports at the proximal portion of the conduit and out of the conduit
and into the uterus through one or more of the distal openings at
the distal portion of the conduit; (c) while the distal portion
remains inserted in the uterus, illuminating a portion of the
uterus with an illumination system emitting light from the distal
portion of the conduit; (d) while the distal portion remains
inserted in the uterus, imaging the illuminated portion of the
uterus with an imaging system secured at the distal portion of the
conduit; (e) still while the distal portion remains inserted in the
uterus, displaying, on a display secured to said handle, images
provided by the imaging system; (f) while the distal portion
remains inserted in the uterus, manipulating the distal portion of
the conduit in the patient's uterus and causing the transfer of
fluid and biopsy samples from the uterus into at least one of the
distal openings and out of at least one of said one or more
proximal ports; (g) withdrawing the conduit from the patient's
uterus; and (h) disposing of at least the conduit before using at
least the display for another patient. Only the conduit can be
disposed of and replaced with a new one for a new patient, or both
the handle and the conduit can be disposed of and replaced with a
new conduit and handle for a new patient, or the entire instrument
cab be disposed of and replaced with a new one for a new patient.
If ablation is indicated or desired, an instrument that
additionally includes an ablation structure at the distal portion
can be used to ablate at least a selected portion of the
uterus.
[0293] Although the foregoing has been described in some detail for
purposes of clarity, it will be apparent that certain changes and
modifications may be made without departing from the principles
thereof. It should be noted that there are many alternative ways of
implementing both the processes and apparatuses described herein,
including for using the described devices or certain aspects
thereof for hysteroscopy but not for endometrial biopsy, or for
endometrial biopsy but not for hysteroscopy, or for endoscopy
and/or biopsy other than of the uterus. For example, in some
applications the device shown in FIGS. A50-A51 could also be used
for taking fluid and/or fluid/tissue endometrial samples through
the forward facing fluid parts. Accordingly, the present
embodiments are to be considered as illustrative and not
restrictive, and the body of work described herein is not to be
limited to the details given herein, which may be modified within
the scope and equivalents of the appended claims.
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