U.S. patent application number 17/674658 was filed with the patent office on 2022-07-14 for surgical visualization and treatment system.
The applicant listed for this patent is 3NT MEDICAL LTD.. Invention is credited to Ehud BENDORY, Eran BENDORY, Gil Hefer, Tal Shchory.
Application Number | 20220218187 17/674658 |
Document ID | / |
Family ID | 1000006153072 |
Filed Date | 2022-07-14 |
United States Patent
Application |
20220218187 |
Kind Code |
A1 |
BENDORY; Eran ; et
al. |
July 14, 2022 |
SURGICAL VISUALIZATION AND TREATMENT SYSTEM
Abstract
A device for visualizing and providing suction for a surgical
procedure in an ear includes a handle, a main shaft extending from
the handle, an imaging sensor at a distal end of the main shaft, a
light source at the distal end of the main shaft, a first suction
tube extending along a proximal portion of a first side of the main
shaft, a second suction tube extending along a proximal portion of
a second side of the main shaft, and a first suction component. The
first suction component includes a first suction shaft, a first
thumb depress member coupled with a proximal end of the first
suction shaft, a first spring disposed over a proximal portion of
the first suction shaft, and a first suction tubing for connecting
the first suction shaft or the first thumb depress member with the
handle.
Inventors: |
BENDORY; Eran;
(Modiin-Maccabim-Reut, IL) ; BENDORY; Ehud;
(Millburn, NJ) ; Shchory; Tal; (Ramot Menashe,
IL) ; Hefer; Gil; (Shimshit, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
3NT MEDICAL LTD. |
Rosh Ha'ayin |
|
IL |
|
|
Family ID: |
1000006153072 |
Appl. No.: |
17/674658 |
Filed: |
February 17, 2022 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
17644980 |
Dec 17, 2021 |
|
|
|
17674658 |
|
|
|
|
63136002 |
Jan 11, 2021 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/015 20130101;
A61B 1/00066 20130101; A61B 1/05 20130101; A61B 1/0676 20130101;
A61B 1/227 20130101; A61B 1/0014 20130101 |
International
Class: |
A61B 1/015 20060101
A61B001/015; A61B 1/00 20060101 A61B001/00; A61B 1/05 20060101
A61B001/05; A61B 1/227 20060101 A61B001/227; A61B 1/06 20060101
A61B001/06 |
Claims
1. A device for visualizing and providing suction during a surgical
procedure, the device comprising: a handle comprising: at least one
suction shaft insertion port on a top surface of the handle; and a
suction connection port; a visualization shaft extending from the
handle at an angle relative to a longitudinal axis of the handle;
at least one tool coupling shaft extending from the handle along a
first side of the visualization shaft and in fluid communication
with the at least one suction shaft insertion port; an imaging
sensor at a distal end of the visualization shaft; a light source;
and a suction shaft removably coupled with the handle and
comprising a distal end sized to slide through the at least one
suction shaft insertion port and the at least one tool coupling
shaft.
2. The device of claim 1, further comprising a spring disposed over
a proximal portion of the suction shaft to automatically retract
the suction shaft when force applied to a proximal end of the
suction shaft is released.
3. The device of claim 2, further comprising a thumb depress member
coupled with the proximal end of the suction shaft, wherein the
spring is disposed over the proximal portion of the suction shaft,
between the top surface of the handle and the thumb depress
member.
4. The device of claim 2, further comprising: at least one side
suction tube port on a side of the handle; and a side suction tube
removably attached at a first end to the at least one side suction
tube port and at a second end to the suction shaft at or near the
proximal end.
5. The device of claim 1, further comprising a console coupled with
the handle via a cable, wherein the console comprises: a monitor;
and a processing unit.
6. The device of claim 1, wherein the at least one suction shaft
insertion port comprises two suction shaft insertion ports, and
wherein the at least one tool coupling shaft comprises two tool
coupling shafts on opposite sides of the visualization shaft.
7. The device of claim 1, further comprising a surgical tool
configured to be advanced through the at least one suction shaft
insertion port and the at least one tool coupling shaft.
8. The device of claim 7, wherein the surgical tool is selected
from the group consisting of a cutting device, a piercing device, a
seeker, tweezers, forceps, a speculum, a grasper, and a
curette.
9. The device of claim 1, wherein the suction shaft has an outer
diameter of no more than 1.1 millimeters, and wherein the
visualization shaft has an outer diameter of no more than 2.5
millimeters.
10. The device of claim 1, further comprising a finger loop on the
handle configured to allow the handle to be held with a single
finger.
11. A method for facilitating a surgical procedure in a patient,
the method comprising: holding a handle of a visualization and
suction device with one hand; using only the one hand, advancing a
distal end of a rigid visualization shaft and a distal end of a
rigid suction shaft of the visualization and suction device into
the patient to a target treatment area, wherein the rigid suction
shaft passes through a first suction shaft guide tube located
parallel with the rigid visualization shaft; viewing an anatomical
structure in the target treatment area with a camera in the rigid
visualization shaft; applying suction in the target treatment area
via the distal end of the rigid suction shaft; advancing the rigid
suction shaft through the first suction shaft guide tube to
position the distal end of the rigid suction shaft beyond the
distal end of the rigid visualization shaft; performing the
surgical procedure in the target treatment area, while continuing
to view and apply suction in the target treatment area with the
visualization and suction device; and removing the visualization
and suction device from the target treatment area.
12. The method of claim 11, wherein the method further comprises,
before advancing the visualization and suction device into the
patient: advancing the proximal end of the rigid suction shaft into
a distal end of the first suction shaft guide tube and then through
an opening in the handle; placing a spring over the proximal end of
the rigid suction shaft; and attaching the proximal end of the
rigid suction shaft to a thumb depress member, wherein advancing
the rigid suction shaft through the first suction shaft guide tube
comprises depressing the thumb depress member.
13. The method of claim 12, wherein the visualization and suction
device further comprises a second suction shaft guide tube on an
opposite side of the rigid visualization shaft from the first
suction shaft guide tube, and wherein the method further comprises
selecting either the first suction shaft guide tube or the second
suction shaft guide tube in which to place the rigid suction
shaft.
14. The method of claim 13, further comprising advancing a surgical
tool through the second suction shaft guide tube, wherein the
surgical tool is selected from the group consisting of a cutting
device, a piercing device, a seeker, tweezers, forceps, a speculum,
a grasper, and a curette.
15. The method of claim 12, further comprising releasing the thumb
depress member to allow the spring to automatically retract, thus
retracting the rigid suction shaft relative to the rigid
visualization shaft.
16. The method of claim 12, wherein the visualization and suction
device further comprises a second suction shaft guide tube on an
opposite side of the rigid visualization shaft from the first
suction shaft guide tube, the method further comprising: removing
the thumb depress member from the proximal end of the rigid suction
shaft; removing the rigid suction shaft from the first suction
shaft guide tube; inserting the rigid suction shaft into the second
suction shaft guide tube; and reattaching the proximal end of the
rigid suction shaft to the thumb depress member.
17. The method of claim 12, wherein the distal end of the rigid
suction shaft comprises a curved distal tip, and wherein the method
further comprises spinning the thumb depress member with a thumb to
spin the curved distal tip inside the patient and thus provide
suction in a different direction.
18. The method of claim 11, further comprising: advancing the
distal end of the rigid visualization shaft and the distal end of
the rigid suction shaft to a different target treatment area in the
patient; and using the visualization and suction device during the
surgical procedure on the different target treatment area.
19. The method of claim 11, further comprising: removing the rigid
suction shaft from the visualization and suction device; and
advancing a surgical tool through the first suction shaft guide
tube, wherein the surgical tool is selected from the group
consisting of a cutting device, a piercing device, a seeker,
tweezers, forceps, a speculum, a grasper, and a curette.
20. The method of claim 11, wherein viewing the anatomical
structure comprises: illuminating the anatomical structure using an
illumination member located at the distal end of the rigid
visualization shaft; and visualizing with a camera located at the
distal end of the rigid visualization shaft.
21. The method of claim 11, further comprising resting the one hand
holding the handle of the visualization and suction device on the
patient to steady the visualization and suction device during at
least part of the surgical procedure.
22. The method of claim 11, wherein holding the handle comprises
holding the handle with one finger of the one hand via a finger
loop on the handle so that all other fingers of the one hand are
free.
Description
BACKGROUND
[0001] Middle ear surgery is performed on patients for a number of
different reasons, most commonly for chronic recurring ear
infections. When performing middle ear surgery, the ear, nose and
throat (ENT) surgeon (or "otolaryngologist") typically visualizes
the middle ear and the surgical procedure in one of two ways. In
some cases, the surgeon uses a microscope, positioned in front of
the surgeon's eyes, and she typically uses her non-dominant hand to
hold a suction device and her dominant hand to hold a surgical
tool. In other cases, the surgeon uses a handheld endoscope to
visualize the middle ear. The use of a handheld endoscope is
problematic in several different ways.
[0002] First, standard endoscopes have long shafts and are not made
for use in the ear. When the ENT surgeon uses an endoscope in the
ear, he has to hold the handle of the scope up in the air, over the
patient's head, with the surgeon's hand suspended in the air,
unsupported. This factor alone is problematic, because if the
surgeon accidentally moves his unsupported hand during surgery, he
could very easily move the distal end of the endoscope in a way
that could damage the tympanic membrane or one or more of the
delicate structures of the middle ear.
[0003] Second, compounding on the first issue, endoscopes are
generally much heavier than the small, thin surgical tools used in
middle ear procedures. The surgeon thus has an ergonomic imbalance
between a relatively heavy endoscope in her non-dominant hand and a
relatively light surgical device in her dominant hand. This
imbalance adds to the difficulty in stabilizing the endoscope.
Additionally, holding a heavy endoscope suspended over the
patient's head during a surgical procedure may quickly lead to arm
and hand fatigue for the surgeon.
[0004] Third, since the surgeon is holding the endoscope in one
hand, that hand is no longer free to hold a suction device or a
surgical tool. Thus, when an endoscope is used for visualization,
the surgeon cannot use a suction device and visualize the inside of
the ear at the same time.
[0005] Fourth, standard endoscopes have straight shafts, so the
surgeon must hold the endoscope in a direct line straight back from
the patient's ear. This straight-line position makes it impossible,
or at least incredibly challenging, to use an endoscope and a
microscope in the same surgical procedure, since the position of
the endoscope is directly in the path of vision of the microscope.
This is a drawback, because in some procedures an ENT surgeon would
like to be able to switch back and forth quickly and easily between
viewing with a microscope and viewing with an endoscope. It is also
challenging for a surgeon to manipulate multiple tools with
straight shafts held in two hands during an ear surgery procedure,
because the hands must be held very close together (due to the
small diameter of the ear canal), and the tools tend to bump into
one another as the surgeon manipulates them to perform the
procedure.
[0006] For at least these reasons, it would be advantageous to have
an improved system and method for ear visualization. Ideally such a
system and method would be easy to use, allow for good
visualization of the ear, and be compatible with use of other ear
surgery devices. At least some of these objectives will be
addressed in this disclosure.
BRIEF SUMMARY
[0007] This disclosure describes various embodiments of an ear
endoscope device, system and method for visualizing an ear surgery
procedure. In some embodiments, the ear endoscope device includes a
handle, a main visualization shaft that holds a visualization
component (e.g., a camera), and a tool attachment mechanism for
coupling a surgical tool with the ear endoscope. Some embodiments
also include the surgical tool itself. Specifically, several
embodiments include a visualization component and a suction
component, which work together as one device. The suction component
(or other tool in alternative embodiments) may be coupled with the
visualization component in a number of different ways, such as by a
sheath, via one or more tubes or lumens, through the main
visualization shaft, etc.
[0008] The device is configured to be held in, and operated with,
one hand, and it is short enough and thin enough to be advanced
easily into the ear canal and to allow the surgeon to rest her hand
on the patient's head during the ear procedure while holding the
device, which surgeons often do with their tool-holding hand in ear
surgery procedures for stability. In various embodiments, the
camera may be free to roll (or "spin") about its own axis within a
sheath, the camera may be free to rotate around the longitudinal
axis of the suction device within the sheath, and/or the attached
suction device or other surgical tool may be free to spin around
the camera and/or around its own axis.
[0009] In one aspect of the disclosure, a device for visualizing
and providing suction for a surgical procedure in an ear may
include a handle, a main shaft extending from the handle and
defining a longitudinal axis, an imaging sensor at a distal end of
the main shaft, a light source at the distal end of the main shaft,
a suction shaft extending from the handle parallel to the
longitudinal axis of the main shaft, and a spring coupled with the
suction shaft and/or the handle, such that when the suction shaft
is advanced in a distal direction and then released, the suction
shaft retracts automatically. Some embodiments may further include
a thumb depress member coupled with a proximal end of the suction
shaft, where the spring is disposed over a proximal portion of the
suction shaft, between a top of the handle and a bottom of the
thumb depress member.
[0010] In some embodiments, the suction shaft includes a straight
proximal portion that extends parallel to the longitudinal axis of
the main shaft and a distal curved portion, where the suction shaft
is coupled with the handle such that it can spin and thus cause the
distal curved portion to point in different directions. Such an
embodiment may further include a thumb depress member coupled with
a proximal end of the suction shaft. Optionally, a surface feature
may be included on a top surface of the thumb depress member for
facilitating a user spinning the thumb depress member to spin the
suction shaft. In some embodiments, the device may also include a
handle suction port on the handle, a free spin suction member
disposed over a proximal portion of the suction shaft such that the
free spin suction member does not spin when the suction shaft
spins, a suction shaft suction port on the free spin suction
member, and a suction tube connecting the handle suction port with
the suction shaft suction port. In some embodiments, the free spin
suction member houses two O-rings positioned above and below a hole
in the suction shaft that communicates with the suction shaft
suction port on the free spin suction member, and the O-rings and
the free spin suction member form a seal with the suction shaft
over the hole.
[0011] In various embodiments, the suction shaft has an outer
diameter of no more than 1.1 millimeter. Some embodiments further
include a suction shaft guide positioned on one side of the main
shaft, where the suction shaft extends through the suction shaft
guide. In some embodiments, the device includes a first suction
shaft guide positioned on a first side of the main shaft, and a
second suction shaft guide positioned on a second side of the main
shaft, where the suction shaft may be passed through either the
first suction shaft guide or the second suction shaft guide to
provide suction on either side of the main shaft.
[0012] In some embodiments, the suction shaft includes a sharp
distal tip for piercing a tympanic membrane, and the device further
comprises a stop member on the suction shaft for preventing an ear
tube positioned on the suction shaft from sliding proximally past
the stop member along the suction shaft. In some embodiments, the
handle is adjustable from a straight configuration to an angled
configuration. Other embodiments may include a handle angle
adjustment member removably attachable to the handle to adjust an
angle by which the handle is held by a user.
[0013] In some embodiments, the suction shaft extends alongside the
main shaft. Alternatively, the suction shaft may extend through the
main shaft. The handle may include at least one suction tube port
for attaching a suction tube between the handle and the suction
shaft. The handle may also include at least one suction finger
control port, configured to allow a user to control application of
suction by placing a finger over the finger control port and
releasing the finger from the finger control port. Additionally,
the handle may include a finger loop configured to allow the device
to be held by a single finger of the user. In one embodiment, the
finger loop is configured to extend around a middle finger of one
hand of the user, the device further includes a thumb depress
member to be manipulated by the thumb of the same hand, and the
handle further includes a suction control port configured to be
covered by the index finger of the same hand.
[0014] In another aspect of the disclosure, a device for
visualizing a surgical procedure on an ear may include a suction
tube, a camera coupled with the suction tube in a side-by-side
arrangement, and a sheath disposed around an outside of the suction
tube and an outside of the camera to couple the suction tube and
the camera together. In some embodiments, the sheath holds the
camera and the suction tube in such a way that the camera is free
to roll or spin about its own axis within the sheath, and the
camera is also free to rotate about a longitudinal axis of the
suction tube within the sheath. In some embodiments, the suction
tube may have an outer diameter of no more than about 1.1
millimeters, and the camera may have an outer diameter of no more
than about 2.5 millimeters. In some embodiments, for example, the
sheath is disposed around the camera and the suction tube but is
not fixedly attached to either one, so they are free to roll and
rotate within the sheath. For example, the surgeon may want to roll
the camera for image orientation and/or may want to rotate the
camera around the suction tube for ergonomic reasons, such when
moving the device from one hand to the other.
[0015] In some embodiments, the suction tube is rigid and includes
a tubular portion with a distal suction end, a suction device
attachment end opposite the distal suction end, and a bend in the
tubular portion. In some embodiments, for example, the tubular
portion is located about 40-100 millimeters from the distal suction
end. In one embodiment, the bend in the tubular portion forms an
angle of about 45 degrees, although other angles are possible in
alternative embodiments. In some embodiments, the sheath is shorter
than a distance from the distal suction end to the bend in the
tubular portion, and the camera and the sheath are configured to
slide along the tubular portion of the suction tube from a first
position, in which a distal end of the camera is adjacent to the
distal suction end of the tubular portion, and a second position,
in which the distal end of the camera is proximal to the distal
suction end. In some embodiments the suction tube is made of metal.
In some embodiments, at least a portion of the camera may be
flexible. In some embodiments, the sheath is made of a heat-shrink
polymer.
[0016] In another aspect of the disclosure, a method for performing
a surgical procedure on an ear of a patient involves holding a
combined visualization and suction device in one hand and advancing
a distal end of the combined visualization and suction device into
the ear. The combined visualization and suction device may be the
same as or similar to the one described immediately above, and it
may have any or all of the features described above. The method
also involves viewing using the camera to view inside of the ear,
activating the suction tube inside of the ear, and performing the
surgical procedure on the ear, using a surgical tool held in the
hand that is not holding the combined visualization and suction
device. The method may also involve using the activated suction
tube of the device to hold and move one or more structures within
the ear. The activated suction tube may alternatively or
additionally be used to suction fluid from the ear.
[0017] In some embodiments, the method may further involve rolling
the camera about its own longitudinal axis within the sheath. The
method may also involve rotating the camera around a longitudinal
axis of the suction tube within the sheath. In some embodiments,
the method may involve additionally viewing the ear using a
microscope. Optionally, the suction tube may include a bend, and
the method may further involve holding the combined visualization
and suction device outside of a direct line of sight between a
surgeon's eyes and the ear. The method may also involve supporting
the hand that is holding the combined visualization and suction
device on the patient's head during the surgical procedure.
Optionally, the method may involve supporting the hand that is
holding the surgical tool on the patient's head during the surgical
procedure.
[0018] In another aspect of the present disclosure, a device for
visualizing a surgical procedure in an ear may include an ear
endoscope and a coupler. The ear endoscope includes a handle, a
shaft extending from the handle and having a bend with an angle of
90-155 degrees, an outer diameter of no more than 2.5 millimeters,
and a length of 30-80 millimeters, an imaging sensor at a distal
end of the shaft, and a light source. The coupler is attached to a
side of the ear endoscope shaft for attaching a tool to the
endoscope. In various embodiments, the surgical tool and the
overall device may include any of the features described above. The
surgical tool may be a suction device, as previously described, or
alternatively it may be any other suitable tool, such as but not
limited to a cutting device, a piercing device, an ear tube
placement device, a seeker, tweezers or forceps.
[0019] In another aspect of the disclosure, a method for performing
a surgical procedure in an ear of a patient may first involve
attaching a tool to an ear endoscope in a side-by-side arrangement,
using a coupler, where the ear endoscope includes a shaft with a
bend and an outer diameter of no more than 2.5 millimeters. The
method may further involve holding a handle of the ear endoscope in
one hand, advancing a distal end of the ear endoscope into the ear
with the tool attached, viewing an inside of the ear, using the ear
endoscope, and using the tool attached to the ear endoscope to
facilitate or perform at least part of the surgical procedure. The
combined visualization and surgical tool device may be the same as,
or similar to, the embodiment described above, and it may include
any of the features described above.
[0020] In another aspect of the present disclosure, an ear
endoscope device for use in a surgical procedure in an ear may
include a handle, a visualization shaft extending from the handle,
a tool guide extending from the handle parallel to the
visualization shaft and configured to guide a tool into the ear
with the visualization shaft, an imaging sensor at a distal end of
the visualization shaft, and a light source. In one embodiment, the
ear endoscope device may include at least one tool coupler on a
side of the shaft, at least one suction shaft insertion port at or
near a distal end of the handle, two side suction tube connection
ports at or near the distal end of the handle, a rear suction tube
connection port at or near a proximal end of the handle, and a
suction lumen connecting the rear suction tube connection port to
the two side suction tube connection ports. In various embodiments,
the shaft and the handle may form an angle of between about 90
degrees and about 155 degrees. In some embodiments, the shaft may
have an outer diameter of no more than about 2.5 millimeters and a
length of between about 30 millimeters and about 80
millimeters.
[0021] In some embodiments, the ear endoscope further includes a
suction device. The suction device may include a suction shaft for
passing through the at least one suction shaft insertion port and
the at least one tool coupler, a thumb depress member coupled with
the suction shaft for allowing a user to advance the suction shaft,
a side suction tube for attaching the suction shaft, via the thumb
depress portion, to one of the two side suction tube connection
ports, and a rear suction tube for connecting the rear suction tube
connection port to a suction source. The suction device may further
include a spring disposed over a proximal portion of the suction
shaft, between the thumb depress member and the handle of the ear
endoscope. The spring may be configured to automatically retract
the suction shaft relative to the shaft when the thumb depress
portion is released. In some embodiments, an open one of the two
side suction tube connection ports that is not attached to the side
suction tube is configured to act as a finger operated suction
control for controlling the application of suction force with a
user's finger.
[0022] In some embodiments, the handle includes two suction shaft
insertion ports and two tool couplers disposed on opposite sides of
the shaft, where each of the two suction shaft insertion ports
feeds into a corresponding one of the two tool couplers. In some
embodiments, the handle includes a finger loop for facilitating
holding the device with a user's finger under the handle.
Alternatively, the handle may include any other finger hold shape
or other ergonomic shape to facilitate gripping the device with one
hand.
[0023] In another aspect of the present disclosure, a method for
performing a surgical procedure in an ear canal of a patient may
involve holding in one hand an ear endoscope with an attached
suction device, advancing a distal end of the ear endoscope with
the attached suction device into the patient's ear canal,
depressing a thumb depress member of the suction device with a
thumb of the hand, to advance a suction shaft of the suction device
relative to a visualization shaft of the ear endoscope, applying
suction in the ear canal with the suction device, and viewing an
inside of the ear canal, using the ear endoscope. In one
embodiment, applying suction in the ear canal involves applying a
finger of the hand to an open suction control opening on the
handle.
[0024] In some embodiments, the method also involves releasing the
thumb depress portion to allow a spring on the suction shaft to
expand to cause the suction shaft to retract relative to the shaft
of the ear endoscope. In some embodiments, depressing the thumb
depress member causes the suction shaft to advance through a
suction shaft insertion port on a handle of the ear endoscope and
through a tool coupler attached to the shaft of the ear endoscope.
The spring may be disposed over the suction shaft, between the
thumb depress member and the handle. The method may optionally also
involve supporting the hand that is holding the ear endoscope on
the patient's head during the surgical procedure.
[0025] These and other aspects and embodiments are described in
further detail below, in relation to the attached drawing
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a perspective view of a surgeon's hands and a
surgical field, including a patient's ear, illustrating how a prior
art endoscope and surgical tool are typically held;
[0027] FIG. 2 is a side view of an ear visualization system, shown
with a suction device, according to one embodiment;
[0028] FIG. 3 is a close-up illustration of a distal portion of the
ear endoscope shown in FIG. 2;
[0029] FIG. 4 is a perspective view of coupler for use with an ear
visualization system, according to one embodiment;
[0030] FIG. 5A is a side view of a combined visualization and
suction device for use in ear surgery procedures, according to one
embodiment;
[0031] FIG. 5B is a side view of the visualization/suction device
of FIG. 5A, with the suction component advanced distally, relative
to the visualization component;
[0032] FIG. 5C is a side, exploded view of the
visualization/suction device of FIGS. 5A and 5B;
[0033] FIG. 5D is a front, end-on view of the shafts of the
combined visualization and suction device of FIGS. 5A-5C;
[0034] FIG. 6 is a perspective view of a surgeon's hands and a
surgical field, including a patient's ear, illustrating how a
combined visualization and suction device, according to one
embodiment, may be held and used during an ear surgery procedure;
and
[0035] FIG. 7 is a side view of a combined visualization and
suction device for use in ear surgery procedures, where the camera
has a bend near its distal end, according to one embodiment;
[0036] FIG. 8 is a side view of a combined visualization and
suction device for use in ear surgery procedures, where the sheath
couples the camera and suction tube together at an angle relative
to one another, according to another embodiment;
[0037] FIGS. 9A-9C are side, front and exploded views,
respectively, of a combination visualization and suction device,
according to an alternative embodiment;
[0038] FIGS. 10A and 10B are side views of a portion of the
combination device of FIGS. 9A-9C, illustrating a method for
advancing and retracting a suction shaft relative to a
visualization shaft, according to one embodiment;
[0039] FIG. 11 is a perspective view of portion of a patient's
head, including the ear, and a physician's hand holding the
combination device of FIGS. 9A-10B;
[0040] FIG. 12 is a perspective view of a visualization component
of the combination device of FIGS. 9A-11, along with a viewing
system, according to one embodiment;
[0041] FIGS. 13A-13C are right/rear perspective, left/rear
perspective and left side views, respectively, of an ear endoscope
device, according to one embodiment;
[0042] FIG. 14A is a side view of the ear endoscope device of FIGS.
13A-13C, with a detached optional suction device for the ear
endoscope, according to one embodiment;
[0043] FIG. 14B is a side view of the ear endoscope and suction
device of FIG. 14A, with the suction device attached to the ear
endoscope;
[0044] FIG. 14C is a perspective view of the ear endoscope with
suction device of FIGS. 14A and 14B, shown in the left hand of a
physician user;
[0045] FIG. 15 is a distal-end view of a shaft of an ear endoscope,
according to an alternative embodiment;
[0046] FIGS. 16A and 16B are side views of an ear endoscope with a
curved tip suction shaft, showing the suction shaft advanced
distally (FIG. 16A) and retracted proximally (FIG. 16B), according
to one embodiment;
[0047] FIG. 17 is a side view of an ear endoscope with a curved tip
suction shaft and a handle with a finger loop, according to an
alternative embodiment;
[0048] FIGS. 18A-18D are perspective views of four different
embodiments of a thumb depress member of an ear endoscope with a
curved tip suction shaft;
[0049] FIG. 19 is a side view of an ear endoscope device with an
adjustable-angle handle, according to one embodiment;
[0050] FIG. 20 is a side view of an ear endoscope device with a
malleable handle, according to one embodiment;
[0051] FIG. 21A is a side view of an ear tube placement,
visualization and suction device, advanced partway into an ear
canal, according to one embodiment;
[0052] FIG. 21B is a side view of the device of FIG. 21A, showing
placement of an ear tube across the tympanic membrane, according to
one embodiment;
[0053] FIG. 22 is a side view of a curved distal end of an ear tube
placement, visualization and suction device, according to one
embodiment; and
[0054] FIGS. 23 and 24 are side views of a portion of an ear
visualization/suction device, illustrating a removable handle
adjustment feature (FIG. 24);
[0055] FIGS. 25 and 26 show the portion of the device from FIGS. 23
and 24 without (FIG. 25) and with (FIG. 26) an optional handle
adjustment feature;
[0056] FIGS. 27A and 27B are diagrammatic illustrations of an ear
visualization/suction device of the present application, shown in
an orientation as if the device were being held in a left hand
while inserted into a right ear (FIG. 27A) and a left ear (FIG.
27B), according to one embodiment;
[0057] FIGS. 28A and 28B are diagrammatic illustrations of an ear
visualization/suction device of the present application, shown in
an orientation as if the device were being held in a left hand
while inserted into a right ear (FIG. 28A) and a left ear (FIG.
28B), according to an alternative embodiment;
[0058] FIGS. 29A and 29B are front perspective and side perspective
views, respectively, of an ear visualization and suction device,
according to an alternative embodiment;
[0059] FIG. 29C is a side view of a suction shaft portion of the
device of FIGS. 29A and 29B;
[0060] FIG. 30 is a side view of two different suction shaft
portions of the device of FIGS. 29A and 29B;
[0061] FIG. 31A is a rear perspective view of the device of FIGS.
29A and 29B, with an alternative suction shaft portion attached and
with part of the handle removed;
[0062] FIGS. 31B and 31C are top views of a portion of the
configuration of the device of FIG. 31A;
[0063] FIG. 32A is a side view of an ear visualization and suction
device with optional irrigation, according to one embodiment;
[0064] FIG. 32B is a side view of the device of FIG. 32A, with the
suction component not shown and the irrigation portion removed from
the handle;
[0065] FIG. 32C is a side view of the device of FIGS. 32A and 32B,
with the suction component not shown and the irrigation portion
inserted into the handle; and
[0066] FIG. 32D is a top view of the device of FIGS. 32A-32C, in
the configuration of FIG. 32C.
DETAILED DESCRIPTION
[0067] In general, the embodiments described herein are directed to
a device, system and method for visualizing an ear surgery
procedure. The ear visualization device generally includes an ear
endoscope (or "camera"), with an attachment mechanism for attaching
an additional tool to the endoscope. Oftentimes, the additional
tool is a suction device, so the device provides for visualization
and suction with one device, held in one hand. In alternative
embodiments, however, any of a number of different tools may be
attached to the endoscope, in addition to or instead of a suction
device. In some embodiments, the attachment mechanism for attaching
the additional tool is built into the endoscope. Alternatively, the
attachment mechanism may be a separate coupler or sheath, which
attaches to the shaft of the ear endoscope and allows any of a
number of different types of surgical tools to be attached to the
endoscope in a side-by-side arrangement. In yet other embodiments,
visualization and suction may be integrated into the device. The
ear visualization system may include the ear endoscope along with a
separate attachment mechanism, a light source for the endoscope, a
video monitor for displaying images captured by the endoscope
and/or any other suitable components. In some embodiments, the
system may also include a suction device or other surgical tool. In
other embodiments, the ear endoscope device or system may be
provided by itself, and may be used with one or more optional,
stand-alone tools.
[0068] As mentioned immediately above, in some embodiments, the
attachment mechanism is a separate piece, which may be removed from
the endoscope shaft. In such embodiments, the endoscope and the
coupler may be referred to as a "system," due to the combination of
two different devices. In alternative embodiments, the coupler may
be integral with, or permanently attached to, the endoscope shaft,
in which case the endoscope with coupler may be referred to as a
"device." In any case, use of the terms "system" and "device"
herein should not be interpreted as limiting the scope of the
invention.
[0069] In some embodiments, the device may include an endoscope and
a suction tube that also operates as an ear tube placement device.
The distal tip of the suction/ear tube placement component may have
a sharp distal tip to pierce the tympanic membrane, and the device
may also include a stop for preventing the ear tube from sliding
proximally up the suction/ear tube placement component. This device
embodiment is described in further detail below.
[0070] The shaft of the ear endoscope and whatever surgical tool it
is used with may have very small diameters, so the distal end of
the combined device fits easily into an ear canal, for helping
visualize and perform an ear surgery procedure. In some
embodiments, the coupler surrounds part of the endoscope shaft and
part of the surgical tool in such a way that the shaft can rotate
about a longitudinal axis of the tool and can also roll (or "spin")
about its own longitudinal axis.
[0071] In one embodiment, described in detail below, the surgical
tool is a suction tube device. In alternative embodiments, however,
the tool may be any suitable, small-diameter tool, such as but not
limited to a cutting device, a piercing device, an ear tube
placement device, a seeker, tweezers, forceps, a speculum, a
grasper, or a curette. In the description below of the suction
embodiment, the fact that any other suitably sized surgical tool
may be substituted for the suction device will not be repeated with
the description of every embodiment. Similarly, the devices and
methods described below for use in an ear surgery procedure may be
used or adapted for use in any other suitable surgical procedure.
This, too, will not be repeated with the description of every
embodiment.
[0072] Although the following description is focused on use of the
devices, systems and methods for visualizing and facilitating ear
surgery procedures, the same embodiments may be used, or adapted
for use, in any other suitable procedures and parts of a human or
animal body. Therefore, the invention is not limited to use in the
ear.
[0073] Referring now to FIG. 1, a prior art method for performing
an ear surgery using a standard endoscope 10 is illustrated. The
figure shows a surgical field, with the patient's ear E exposed for
the procedure. The surgeon is holding the endoscope 10 in his left
hand L and a surgical tool 12 in his right hand. Due to the length
of the endoscope 10, the surgeon has to hold his left hand L up in
the air, suspended over the patient, in order to hold the handle of
the endoscope 10. As mentioned previously, this can be very awkward
and potentially dangerous to the tympanic membrane and/or
structures of the middle ear, especially in longer procedures where
the surgeon's left arm and left hand L get fatigued. Additionally,
the surgeon does not have a free hand to hold a suction device or
other surgical tool, since both of the surgeon's hands are
occupied. To have suction in this scenario, a nurse or other
assistant would have to hold the suction device in the patient's
ear.
[0074] Referring to FIG. 2, an ear surgery visualization system
100, according to one embodiment, may include an ear endoscope 102
and a coupler 112. Also pictured in FIG. 2 is a suction device 128,
which is not necessarily part of the system 100, but which is shown
in the figure for illustrative purposes. In alternative
embodiments, the suction device 128 may be replaced by any other
suitable surgical tool, such as the ones listed previously.
[0075] The ear endoscope 102 includes a handle 104, a shaft 106 and
a processor 122, which may also act as a light source. The shaft
106 includes a proximal portion 107, a bend 108 and a distal
portion 110, ending in a distal tip 111. The endoscope 102 also
includes a light source 120 in the handle 104, and light fibers 118
that carry the light from the light source 120, through the shaft
106, to the distal tip 111. A camera on a chip (described more
fully below) may be positioned at the distal tip 111, to acquire
images of the ear. The system 100 may also include a video monitor
126, although optionally the video monitor 126 may be a separate
component that is not part of the system 100. In another
embodiment, the processor 122 and video monitor 126 may be combined
in one unit.
[0076] The shaft 106 of the endoscope 102 may have a total length
of about 30 millimeters to about 80 millimeters and an outer
diameter of less than about 2.5 millimeters. In some embodiments,
the outer diameter of the shaft 106 may be continuous along its
length. Alternatively, the outer diameter of the distal portion 110
may be smaller than the outer diameter of the proximal portion 107.
The bend 108 may form an angle between the proximal portion 107 and
the distal portion 110 of between about 90 degrees and about 155
degrees. The handle 104 may be very small and lightweight, compared
to typical endoscope handles. In fact, the handle 104 may be shaped
to have a comfortable pencil grip, so the surgeon may hold and
manipulate the ear endoscope 102 like a pencil. Ear endoscope 102
may also include a cable 124, attaching the handle 104 to the
processor 122.
[0077] The coupler 112 includes an endoscope attachment portion 114
and a tool attachment portion 116. In some embodiments, each of the
two portions 114, 116 is shaped as a tube or a semicircular tube.
In some embodiments, the endoscope attachment portion 114 and the
tool attachment portion 116 may have the same diameter.
Alternatively, they may have different diameters. For example, in
some embodiments the endoscope attachment portion 114 has a larger
diameter than that of the tool attachment portion 116. The coupler
112 may be permanently attached to the shaft 106, or it may be
removable, according to different alternative embodiments. The
coupler 112 may be attached to the distal portion 110 of the shaft
106, as shown. Alternatively, the coupler 112 may be attached to
the proximal portion 107, for example if the shaft 106 is straight,
or of the coupler 112 follows the bend 108 in the shaft 106.
[0078] The weight, size and feel of the ear endoscope 102 may be
similar to that of other ear surgery tools. This makes it more
comfortable for the surgeon to hold and prevents an imbalance
between the ear endoscope 102 and other tools. The surgeon may hold
the handle 104 with a pencil grip and may rest her hand and/or the
handle 104 on the patient's head during the procedure. In order to
achieve this desired weight, size and feel, any suitable materials
may be used for the various parts of the ear visualization system
100. For example, in one embodiment, the handle 104 may be made of
any suitable lightweight plastic, and the shaft 106 may be made of
any suitable metal, such as stainless steel. Alternatively, the
handle 104 may be made of a lightweight metal. The coupler 112 may
be made of plastic or metal, for example. Any suitable, medically
safe materials may be used.
[0079] As mentioned above, a suction device 128 is illustrated in
FIG. 2, attached to the shaft 106 of the endoscope 102 via the
coupler 112, in a side-by-side arrangement. Any other tool may be
substituted for the suction device 128, in alternative embodiments.
The suction device 128 is also shown with a source of suction 130,
which may be a separate component, wall suction, or any suitable
suction source. The suction tube portion of the suction device 128
is flexible, at least along part of its length, and has a distal
portion with an outer diameter that fits within the tool attachment
portion 116 of the coupler. Various embodiments and features of a
suction device 128 are described in further detail below.
[0080] Referring now to FIG. 3, the distal portion 110 of the
endoscope shaft 106 is illustrated in greater detail. At the distal
end 111 of the shaft 106 are positioned an imaging sensor 140 and
two light sources 142. The imaging sensor 140 may be any type of
suitable sensor, such as a complementary metal-oxide semiconductor
(CMOS) camera or any other "camera on a chip" type of device. The
two light sources 142 (or alternatively any other number of light
sources) may be light emitting diode (LED) lights, for example.
These may be in addition to, or as an alternative to, the light
source 120 shown in the handle 104 in FIG. 2. In other words,
according to various embodiments, one or more light sources for the
endoscope device 102 may be located in the handle 104, at the
distal end 111 of the shaft 106, or both.
[0081] FIG. 4 is a magnified view of an alternative embodiment of a
coupler 212 for use with the ear endoscope 102. The coupler 212
includes an endoscope attachment portion 214, a tool attachment
portion 216, a longitudinal top opening 250 in the tool attachment
portion 216, and a longitudinal middle opening 252 between the
endoscope attachment portion 214 and the tool attachment portion
216. In this embodiment the endoscope attachment portion 214 has a
larger diameter than that of the tool attachment portion 216. The
tool (not shown) may be inserted into the tool attachment portion
216 by pushing it down through the top opening 250 or by sliding it
into the proximal end of the tool attachment portion 216 and
advancing it distally. In the case where the tool is pushed through
the top opening 250, the coupler 212 may flex outward slightly, by
expanding at the two openings 250, 252, to accommodate the tool. In
alternative embodiments, the endoscope attachment portion 214
and/or the tool attachment portion 216 may be formed as complete
tubes, with circular cross-sections rather than semi-circular
cross-sections. As mentioned above, the coupler may be made of any
suitable material.
[0082] Referring to FIGS. 5A-5D, one embodiment of an ear surgery
visualization device 20 is illustrated. In this embodiment, the
visualization device 20, which may also be called "a combined
visualization and suction device," includes a suction tube 22, a
camera 30 and a coupler 38 (or "sheath") disposed around the
suction tube 22 and the camera 30. The suction tube 22 has a distal
end 24, a proximal end 26 for connecting with suction tubing
connected to a suction source, and a bend 28 along its length. The
camera 30 includes a distal portion 32, a proximal portion 36 and a
distal end 34.
[0083] The suction tube 22 may be any standard or customized
suction tube device. In various embodiments, the suction tube 22
may be rigid and may be made out of any suitable material, such as
stainless steel or other biocompatible metal or plastic. The
suction tube 22 will have an overall diameter and length to allow
it to be advanced easily into the ear and to allow a surgeon to
hold the visualization device 20 with one hand, resting on the
patient's head, during the procedure. In some embodiments, for
example, the suction tube 22 has an outer diameter, at least along
the portion between the bend 28 and the distal end 24, of about 0.6
millimeter to about 1.1 millimeters. The bend 28 in the suction
tube 22 is optional, and alternative embodiments may be straight.
The bend 28 may be advantageous, however, because it allows the
visualization device 20 to be held at an angle from the ear, so the
hand holding the device 20 is not in the direct line of sight of
the surgeon. This is especially advantageous in cases where the
surgeon wants to use a microscope and the visualization device 20
in the same procedure, but it is also advantageous in keeping the
suction tube 22 and the camera 30 out of the way of any surgical
tools held in the surgeon's other hand. In various embodiments, for
example, the bend 28 may be located about 40 millimeters to about
100 millimeters from the distal end 24 of the suction tube 22. In
one embodiment, the bend may be about 60 millimeters from the
distal end 24. In alternative embodiments of the device 20, where
the camera 30 is combined with a different type of surgical tool
rather than the suction tube 22, that surgical tool may also
include the same or a similar bend.
[0084] The camera 30 may be any suitable, small-diameter camera for
viewing an ear during an ear surgery procedure. In some
embodiments, for example, the camera 30 may be a fiber optic camera
or a complementary metal-oxide-semiconductor (CMOS) camera. As
small-diameter cameras are well known, they will not be described
in detail here. In some embodiments, at least the distal portion 32
of the camera 30 may be relatively rigid, so that the surgeon can
easily roll it about its longitudinal axis and/or rotate it
relative to the suction tube 22. In some embodiments, the camera 30
may include a bend, which may coincide with the bend 28 in the
suction tube. The camera 30 may include CMOS sensors with a lens
array. The sensors may be arrayed in a cube of between 0.6 mm by
0.6 mm and 1.0 mm by 1.0 mm, with overall length of up to 3 mm, in
some examples. Alternative embodiments may include a fiber optic
bundle for image capture, rather than CMOS. The light source for
illumination may be LED at the distal tip 34 or fiber infused with
light from a remote LED.
[0085] The cross-sectional shape of the camera 30 may vary in
different embodiments (round, oval, square, rectangular, etc.), but
in the embodiment shown the camera 30 has a round cross-sectional
shape. This is advantageous for rolling and rotating the camera 30
within the coupler 38 and relative to the suction tube 22. The body
of the camera 30 is made from a relatively rigid or at least
semi-rigid material, such as stainless steel or plastic (e.g.,
thermoplastic). The length of the distal portion 32 may be, for
example, about 5 mm to about 100 mm. In some embodiments, the
distal portion 32 may be as long as the length of the suction tube
22 from its distal end 24 to the bend 28, which in one embodiment
is about 60 mm. In various embodiments, the camera 30 and a light
source may be integrated into a metal tube, over-molded with
plastic, encapsulated in a polymer, or the like.
[0086] The coupler 38 may be any suitable material and have any
suitable length, thickness and size, according to various
embodiments. In one embodiment, the coupler 38 is formed as a tube
of heat-shrink polymer wrap that surrounds distal portions of the
suction tube 22 and the camera 30. The heat-shrink polymer may be
polyethylene terephthalate (PET) in some embodiments, or may
alternatively be any other suitable polymer, such as but not
limited to a polyolefin, a polyimide or nylon. As illustrated in
FIGS. 5A and 5B, in one embodiment, the coupler 38 is disposed
about the suction tube and the camera 30 such that the suction tube
22 can advance (FIG. 5B) and retract (FIG. 5A), relative to the
coupler 38 and the camera 30. For example, in some embodiments, the
suction tube 22 can advance from a position where its distal end 24
is at or near the distal end 34 of the camera 30 (FIG. 5A) to a
position where its distal end 24 is ahead of that of the camera 30
(FIG. 5B). In this embodiment, the camera 30 may also be able to
slide forward and backward. In alternative embodiments, camera 30,
suction tube 22 or both may be fixed to the inner surface of the
coupler 38, such as by adhesive, thus reducing the amount of
mobility of one or both components relative to the coupler 38.
[0087] FIG. 5C is an exploded view of the ear surgery visualization
device 20, showing the suction tube 22, the camera 30 and the
coupler 38 separate from one another. For assembly, the coupler 38
may be wrapped or slid over the suction tube 22 and the camera 30
in some embodiments.
[0088] FIG. 5D illustrates possible directions of movement of the
camera 30, the suction tube 22 and the coupler 38, relative to one
another. In some embodiments, the coupler 38 may be positioned
around but not fixedly attached to the camera 30 and the suction
tube 22, as described above. In addition to allowing the suction
tube 22 and/or the camera 30 to advance longitudinally through the
coupler 38, this configuration also allows the suction tube 22 and
the camera 30 to roll about their own axes within the coupler 38
(two small hollow arrows around perimeter of coupler 38).
Additionally, the camera 30 may be rotated around a longitudinal
axis of the suction tube 22 (larger hollow arrow). The suction tube
22 may also be rotated around a longitudinal axis of the camera 30.
This freedom of movement--rotation and rolling--allow the surgeon
to adjust the orientation of the camera 30 and/or the suction tube
22 easily and quickly, without necessarily changing the orientation
of both components. Again, however, in alternative embodiments the
coupler 38 may be adhered or otherwise fixedly attached to either
or both of the camera 30 and the suction tube 22.
[0089] FIG. 6 shows a surgical field, including a patient's ear E,
and the left hand L and the right hand R of a surgeon, performing a
procedure on the ear E. The surgeon's left hand L is holding the
ear surgery visualization device 20, as described above, which
includes the suction tube 22 and the camera 30. The suction tube 22
is attached proximally to a suction hose 40, which in turn is
attached to a source of suction (not shown). The surgeon's right
hand R holds a surgical tool 12. As indicated by the large arrows
on the figure, the surgeon's hands are approaching the ear E from
two different angles, leaving a line of direct vision open from the
surgeon's eyes to the patient's ear E (depicted by the
middle/upper-right hollow arrow). This arrangement will allow a
surgeon to visualize the surgical field using both a microscope and
the camera 30, if desired. As also illustrated in FIG. 6, the ear
visualization device 20 is sized and shaped such that the surgeon
can rest her hand on the patient's head during the procedure. In
performing the procedure, the surgeon may advance the device 20
into the ear E, suction out the ear E using the suction tube 22,
visualize the ear E using the camera 30, and perform the procedure.
Alternatively or additionally, the suction tube 22 may be used to
hold onto and move one or more small anatomical structures of the
ear, such as but not limited to the bones of the middle ear.
Suction may also be used to hold different devices, such as an ear
tube or ossicular prostheses. The device 20 is generally small
enough that the camera 30 can be used to visualize the middle ear
through a natural hole or incision in the tympanic membrane. These
actions may be performed in any sequence and in any combination. In
some embodiments, it may be possible for the surgeon to separate
the camera 30 from the suction tube 22 during the ear surgery
procedure, so they can be used separately.
[0090] In some embodiments, the ear surgery visualization device 20
may be used with another, different ear surgery visualization
device (not shown). For example, the combined camera/suction tube
device 20 may be held in the surgeon's non-dominant hand, and a
combined camera/surgical tool device may be held in the surgeon's
dominant hand. These two devices 20 may be used at the same time,
thus acquiring two images of the ear. The views from the two
cameras may be displayed on a single, split video screen, for
example, with the right half marked `R` and the left half marked
`L`. In all embodiments, the video screen may be separate and
located above the patient's head and within the field of view of a
microscope, so that the surgeon can view the surgical field through
the microscope and look at the endoscopic view through the
microscope as well, or simply switch from looking through the
microscope to looking at the video screen. In another embodiment,
it may be possible to digitally feed the endoscopic image into the
microscope, so that the surgeon can view both of them through the
microscope, or toggle between them by pressing a button, for
example.
[0091] Referring now to FIG. 7, an alternative embodiment of an ear
surgery visualization/suction device 50 is illustrated. As
mentioned above, in some embodiments, the suction tube 22 may be
advanced, relative to the camera 30, as shown in FIG. 5B, such that
the distal end 24 of the suction tube 22 is ahead of the distal end
34 of the camera 30. In embodiments where the distal portions of
the suction tube 22 and the camera 30 are both straight and are
connected in parallel with one another, the suction tube 22 may
interfere with the field of view of the camera 30 in this
configuration. The embodiment of the device 50 shown in FIG. 7 is
configured to address that issue. In this embodiment, the distal
portion 32 of the camera 30 includes a bend 52. This bend 52
orients the field of view 54 of the camera 30 at an angle, relative
to the longitudinal axes of the suction tube 22 and the camera 30,
so the suction tube 22 does not interfere with or limit the field
of view 54. In various embodiments, the bend 52 may be located
anywhere along the length of the camera 30, although in many
embodiments it will be located near the distal end 34, so that it
is distal to the distal end of the coupler 38.
[0092] Referring now to FIG. 8, another alternative embodiment of
an ear surgery visualization/suction device 60 is illustrated. This
embodiment is alternative way of addressing the issue of the
suction tube 22 cutting off part of the field of view 54 of the
camera. In this embodiment, the sheath 68 has a wider distal end 64
and a narrower proximal end 66. Thus, the sheath 68 couples the
camera 30 and the suction tube 22 together such that they are
oriented at an angle relative to one another. In other words, they
are not parallel with one another. As with the previous embodiment,
this helps prevent the field of view 54 of the camera 30 from being
limited by the suction tube 22.
[0093] Referring now to FIGS. 9A-9C, one embodiment of an ear
visualization system 300 is illustrated. The ear visualization
system 300 includes an ear endoscope 302 and an optional suction
device 310. The ear endoscope 302 includes a handle 304, a shaft
306 extending from one end of the handle 304, two tool couplers
307a, 307b (see FIG. 9B) on either side of the shaft 306, and a
cable 308 extending from the opposite end of the handle 304.
Imaging components pass through the handle 304, the shaft 306 and
the cable 308, which components may be any of those described above
and which are not shown in these figures. The handle 304 includes
two suction shaft apertures 305a, 305b (not visible in these
drawings, because they are on the top surface of the handle 304),
through which the shaft 316 of the suction component 310 is
advanced. The shaft 316 of the suction component 310 advances
through one of the two tool couplers 307a, 307b, after exiting the
distal end of the corresponding aperture 305a, 305b. The handle 304
may have any of a number of suitable sizes, shapes and weights, but
in this embodiment it is configured to be held easily in a pencil
grip by the physician. The handle 304 may be made of lightweight
plastic, in some embodiments.
[0094] The suction component 310 includes a suction tube 312, a
thumb depress portion 314, a suction control aperture 320, a
suction shaft 316 with a distal end 317, and a spring 318 disposed
over the suction shaft 316, between the thumb depress portion 314
and the handle 304. The suction shaft 316 extends through the
suction shaft aperture 305a in the handle 304, through the tool
coupler 307a, and alongside the visualization component shaft 306.
As will be described further below, the user physician may depress
the thumb depress portion 314 to advance the distal end 317 of the
suction shaft 316 out of the distal end of the visualization shaft
306 and thus farther into the ear. When the user releases the thumb
depress portion 314, the spring 318 automatically retracts the
suction shaft 316 back along the visualization shaft 306, through
the tool coupler 307a and the aperture 305a. The physician may use
an index finger (or other finger) to cover the suction control
aperture 320 to apply suction, and she may remove the finger from
the hole to remove or reduce suction at the distal end 317 of the
suction shaft 316.
[0095] FIG. 9B is a front view of the ear visualization system 300,
which illustrates that this embodiment includes two suction tool
couplers 307a, 307b, one on either side of the visualization
component shaft 306. This embodiment thus also includes two suction
shaft apertures 305a, 305b, each feeding into one of the two
suction tool couplers 307a, 307b. The two tool couplers 307a, 307b
facilitate holding and manipulation of the device 300 by either a
right hand or a left hand, and placement of the suction tube/other
tool either below or above the camera sensor. The visualization
component shaft 306, the tool couplers 307a, 307b and the suction
shaft 316, in some embodiments, may be made of metal, such as
stainless steel or other biocompatible metal. In some embodiments,
the visualization component shaft 306 has an outer diameter of
about 2.5 millimeters or less. Similarly, each of the tool couplers
307a, 307b may have an outer diameter of about 2.5 millimeters or
less. The suction shaft 316 has an outer diameter sized to fit
through the inner diameter of the tool couplers 307a, 307b. In some
embodiments, the suction shaft 316 may have an outer diameter of
about 1.1 millimeters or less.
[0096] FIG. 9C is a side view of the ear visualization system 300,
with ear endoscope 302 separated from the suction device 310. In
this embodiment, the ergonomic design of the handle 304 may be
important for facilitating handling of the system 300 by the
physician. For example, the handle 304 includes a finger grip
feature 322, which may allow for easy gripping of the handle 304
with a middle finger (or other finger). The user's index finger may
be used to control the suction control aperture 320, and the user's
thumb may be used to control the thumb depress portion 314 of the
suction component 310. In other embodiments, one of which is
described below, the finger grip feature 322 may include a loop, an
elastic ring or any other suitable shape.
[0097] In various alternative embodiments, one or more variations
may be made to the ear endoscope device 300. For example, in some
embodiments, the couplers 307a, 307b may extend the entire length
(or along a longer portion but not the entire length) of the
endoscope main shaft 306. In some embodiments, there may be only
one coupler and one aperture, rather than two couplers 307a, 307b
and two apertures 305a, 305b.
[0098] Referring to FIG. 15, in yet another alternative embodiment,
an ear endoscope shaft 500 may include an outer shaft body 502, a
tool guide 504 forming a tool lumen 506, two light sources 508a,
508b and an imaging sensor. The tool guide 504 and tool lumen 506,
in this embodiment, are located inside the outer shaft body 502,
unlike the previously described embodiments that place the suction
tube through a coupler on the outside of the main endoscope shaft.
In some embodiments, the tool guide 504 may be used for applying
suction or advancing a suction device through the shaft 500.
Alternatively, the tool guide 504 may be used for advancing any
other suitable tool through the ear endoscope shaft 500, such as
any tool listed in this application. This embodiment of FIG. 15 may
be applied to any of endoscope embodiments described above or below
to generate alternative embodiments.
[0099] FIGS. 10A and 10B illustrate a method for advancing and
retracting the suction shaft 316 in the ear visualization system
300, according to one embodiment. In FIG. 10A, the physician is
depressing the thumb depress portion 314 of the suction component
310 with her thumb T. This advances the suction shaft 316 through
the handle 304 and the tool coupler 307a, thus advancing the
suction shaft 316 along the side of the visualization shaft 306.
Thus, the distal end 317 of the suction shaft 316 would be advanced
farther down into the patient's ear. In this configuration, the
spring 318 is compressed. In FIG. 10B, the physician has released
her thumb T from the thumb depress portion 314, allowing the spring
318 to expand and causing the suction shaft 316 to retract
proximally through the tool coupler 307a and the handle 304. Thus,
the physician can easily adjust the position of the distal end 317
of the suction shaft 316 relative to the visualization shaft
306.
[0100] In various embodiments, the distal end 317 of the suction
shaft 316 may be positioned in a number of different locations
relative to the distal end of the visualization shaft 306. When the
suction shaft 316 is fully advanced, its distal end 317 may be
located at, proximal to or distal to the distal end of the
visualization shaft 306. Similarly, when the suction shaft 316 is
fully retracted, its distal end 317 may be located at, proximal to
or distal to the distal end of the visualization shaft 306. For
example, in one embodiment, the distal end 317 of the suction shaft
316 may be disposed even with the distal end of the visualization
shaft 306 in the fully retracted position and then may be advanced
to a position distally beyond the distal end of the visualization
shaft 306. In another embodiment, the distal end 317 of the suction
shaft 316 may be disposed more proximally than the distal end of
the visualization shaft 306 in the fully retracted position and
then may be advanced to a position even with the distal end of the
visualization shaft 306. Any combination of locations is possible,
according to various alternative embodiments.
[0101] Referring to FIG. 11, a physician's hand H is shown holding
the combination device 300 over an anatomical model. As shown, the
handle 304 fits comfortably in the hand H, with the middle finger
on the bottom and the index finger on the top. The thumb is
positioned on the thumb depress portion 314, and the visualization
component shaft 306 and the suction shaft 316 are extended into the
model. During an ear procedure, the physician might rest his or her
hand on the patient's head, for support and stability and to
prevent arm fatigue. The very light weight of the handle 304 and
the device 300 in general make it easy to manipulate and hold.
[0102] Referring now to FIG. 12, in some embodiments, the ear
visualization system 300 may include the ear endoscope 302 and a
viewing system 330. The viewing system may include a video monitor
336, a console 332 and a cable 334 connecting the two. The console
332 may include a connector 338, into which a connector 337 on the
visualization component 302 inserts. The various parts of the
viewing system 330 may be any suitable off-the-shelf or custom
components, according to various embodiments. In an alternative
embodiment, the console 332 may include a built-in screen, rather
than having a separate video monitor 336, and the endoscope 300
would connect to the console 332. In various embodiments, the ear
endoscope 302 may be provided with the viewing system 330, with the
suction device 310 or as a stand-alone device.
[0103] Referring now to FIGS. 13A-13C, another embodiment of an ear
endoscope 400 is illustrated. In this embodiment the ear endoscope
400 includes a handle 402 with a finger loop 404, a shaft 406, two
tool coupling shafts 408a, 408b, two side suction tube connection
ports 410a, 410b, two suction tube insertion ports 412a, 412b, a
rear suction tube connection port 414 and a sensor interface cable
416. In this embodiment, the ear endoscope 400 may be provided as a
separate unit and may be used with an add-on suction device, or it
may be provided with the suction device. In either case, a suction
supply may be connected to the rear suction tube connection port
414, which is in fluid communication with a suction lumen running
through the handle 402 and exiting at the two side suction tube
connection ports 410a, 410b. One of the two side suction tube
connection ports 410a, 410b may in turn be connected to a short
suction tube, which is connected to a suction shaft that passes
through one of the suction tube insertion ports 412a, 412b and one
of the tool coupling shafts 408a, 408b, as will be described
further below. Whichever of the two suction tube connection ports
410a, 410b is left open may be used by the physician as a suction
control, by placing a finger over the open port 410a or 410b to
apply suction or releasing the finger from the open port 410a or
410b to turn off suction.
[0104] The finger loop 404 on the handle 402 may be flexible in
some embodiments and rigid in others. In alternative embodiments,
the finger loop 404 may have any other suitable shape or size for
facilitating gripping the endoscope 400. The finger loop 404 allows
the physician user to hold and operate the ear endoscope 400 with
one hand. In fact, the finger loop 404 may allow the physician to
hold the handle 402 with one finger (middle finger, for example)
and operate other functions of the device 400 with other fingers.
For example, the user may pass a middle finger through the finger
loop 404, use the thumb of the same hand to advance the suction
tube, and use the index finger of the same hand to control suction
by covering and uncovering the open port 410a or 410b.
Alternatively, the fingers may be placed and used in a different
configuration on the handle 402. As is evident from FIGS. 13A-13C,
the shaft 406 is straight in this embodiment, but it is angled
relative to the handle 402, so that the overall endoscope device
400 is angled, to allow the physician to place the shaft 406 in the
ear canal without obstructing a direct viewing path into the ear
canal.
[0105] Referring now to FIGS. 14A-14C, the ear endoscope 400 of
FIGS. 13A-13C is now shown with an optional suction device 420.
FIG. 14A shows the suction device 420 detached from the ear
endoscope 400. The suction device 420 includes a suction shaft 422,
connected to a thumb depress member 424, which is connected to a
side suction tube 426. A spring is disposed over a proximal portion
of the suction shaft 422, to provide for automatic retraction of
the suction shaft 422 relative to the main shaft 406 of the ear
endoscope 400, when the user releases pressure off of the thumb
depress member 424. The suction device 420 may also include a rear
suction tube 428. The suction shaft 422 is passed through either of
the two suction tube insertion ports 412a, 412b and thus through
the corresponding tool coupling shaft 408a, 408b. Side suction tube
426 may be connected to either of the two side suction tube
connection ports 410a, 410b, leaving the opposite side port 410a,
410b open for finger control of suction. Additionally, the rear
suction tube 428 is attached to the rear suction tube connection
port 414, to supply suction force from a suction supply (such as
wall suction, canister suction, etc.--not shown in FIG. 14A) to the
suction device 420. As explained above, a suction lumen in the
handle 402 of the endoscope 400 (not visible in the figures)
connects the rear suction tube connection port 414 with the two
side suction tube connection ports 410a, 410b.
[0106] FIG. 14B shows all the components of the suction device 420
attached to the ear endoscope. As shown in this figure, the spring
418 resides over the suction shaft 422 and between a bottom surface
of the thumb depress member 424 and a top surface of the handle
402. When the user presses down on the thumb depress member 424,
the suction shaft 422 advances distally along the main shaft 406,
and the spring 418 compresses. When the user then releases pressure
off of the thumb depress member 424, the suction shaft 422
automatically retracts proximally, relative to the handle 402 and
the main shaft 406.
[0107] FIG. 14C shows a physician's left hand H holding the
combined ear endoscope 400 and suction device. As illustrated here,
the physician's thumb is positioned on the thumb depress member 424
and is used to advance the suction shaft 422. The physician's
middle or ring finger may be placed through the finger loop 404 of
the handle 402, and the physician's index finger may be placed over
or removed from the open side suction tube connection port 410b, to
control the application of suction through the suction shaft 422.
If the physician prefers to hold the ear endoscope 400 in his right
hand, the side suction tube 426 and suction shaft 422 may simply be
shifted to the opposite side of the ear endoscope 400.
[0108] FIG. 15 is a cross-sectional view of a distal/shaft portion
of an ear visualization device 500, according to one embodiment.
The portion of the device 500 illustrated in FIG. 15 may be used
with any of the embodiments described above or below. The
illustrated portion of the device 500 includes an outer shaft 502,
inside of which there is a suction shaft 504 forming a suction
lumen 506. Also located inside the outer shaft 502 are a camera 510
and two sets of light fibers 508a, 508b, which are illustrated as
rectangular but may be bundled in circular, ovoid or any other
suitable shapes. In some embodiments, the inside of the outer shaft
502 may be solid or filled with a material, and the camera 510 and
light fibers 508a, 508b may reside in lumens formed within the
material in the outer shaft 502. The camera 510 may be located at
or near the distal end of the outer shaft 502 and may be any kind
of suitable camera, such as but not limited to a complementary
metal-oxide-semiconductor (CMOS) or charge-coupled device (CCD)
camera. The light source may be any type of suitable light source,
as well, including but not limited to light fibers 508a, 508b, one
or more light emitting diodes (LEDs), etc. Again, this is only one
exemplary embodiment of the shaft portion of a device 500.
[0109] FIGS. 16A and 16B illustrate another embodiment of an ear
visualization/suction device 600. As with previous embodiments,
device 600 includes a handle 602, a main shaft 606 (or "endoscope
shaft," which includes a camera at its distal end), a suction guide
shaft 607 on the side of the main shaft 606, a thumb depress
portion 624 attached to a suction shaft 622 and a suction tube 626,
and a spring 618 disposed over a portion of the suction shaft 622
to automatically retract the suction shaft 622 when the user
releases her thumb from the thumb depress portion 624 (as in FIG.
16B). In this embodiment, the suction shaft 622 of the ear
visualization/suction device 600 further includes a curved distal
tip 623, and the thumb depress portion 624 includes a surface
feature 628. The physician user may apply pressure to the thumb
depress portion 624 (as in FIG. 16A) and use the surface feature
628 (a bump in the present embodiment) to spin the thumb depress
portion 624 and thus the suction shaft 622 and the curved distal
end 623. In this way, the suction distal end 623 may be directed in
multiple different directions to suction different areas within the
ear. The curved distal tip 623 may have different shapes and angles
and the surface feature 628 may also have many different shapes and
configurations, some of which are described in further detail
below. For example, in one alternative embodiment, the extreme end
of the curved distal end 623 may be slanted, rather than the
blunt/flat end illustrated in FIGS. 16A and 16B, which may help
facilitated suctioning over surfaces as the distal end 623 is spun
around.
[0110] FIG. 17 illustrates another embodiment of an ear
visualization/suction device 700. This embodiment also includes a
handle 702, which in this case is attached at its proximal end to
an endoscope cable 730 and a suction tube 732, both of which pass
through the body of the handle 702 to the front/distal end of the
handle 702. Suction tube 732 passes through the body of the handle
702 and terminates at two suction ports 708 (only the left port is
visible in FIG. 17), one on each side of the handle 702. One
suction port 708 is attached to a short suction tube 712, which in
turn attaches to a suction port 710 on a free spin suction member
715 that is disposed over, and spins freely around, the suction
shaft 722. The suction port 710 on the free spin suction member 715
is in fluid communication with the lumen of the suction shaft 722,
so that suction force passes through the port 710 and into the
lumen of the shaft 722. In use, suction travels from the suction
tube 732, through the handle 702, through the suction port 708,
through the short suction tube 712, through the suction port 710,
and down the suction shaft 722 to the distal end of the suction
shaft 722. The physician user will cover an opposite-side, open
suction port (corresponding to 708, but on the side of the handle
702 that is not visible in FIG. 17) with his finger to apply
suction to the suction shaft 722 and will release his finger from
the open suction port to allow suction to flow out of the open port
and thus stop the flow of suction through the suction shaft
722.
[0111] As with the previously described embodiment, the ear
visualization/suction device 700 includes a main shaft 706, which
includes a camera at its distal end for visualizing the ear. It
also includes a suction guide shaft 707, and a suction shaft 722
with a curved distal tip 723. The device 700 may also include a
spring 718 disposed over the proximal portion of the suction shaft
722, between the top of the handle 702 and the bottom of the free
spin suction member 715. The free spin suction member 715 is
disposed over the proximal end portion of the suction shaft 722,
just below the thumb depress member 724, which again includes a
surface feature 728. The free spin suction member 715 houses two
O-rings 714, one of which is positioned above the hole in the
suction tube 722 into which the port 710 leads, and one of which is
below the hole. The free spin suction member 715 and O-rings 714
form a liquid sealed chamber that will pass suction from the short
suction tube 712, through the suction port 710 on the free spin
suction member 715 and finally into the suction shaft 722. At the
same time, the suction shaft 722 can be rotated, while the free
spin suction member 715 stays in one place (does not rotate), thus
preventing the short suction tube 712 from twisting around the
suction shaft 722. Again, in this embodiment, when the user spins
the thumb depress member 724, using the surface feature 728, the
free spin suction member 715 does not rotate with the thumb depress
member 724 or the suction shaft 722, but instead remains in the
same place, by rotating freely over the suction shaft 722 as the
shaft spins. In this way, the suction port 710 does not spin
together with the suction shaft 722 but stays in one place. This is
important, because if the free spin suction member 715, along with
the suction port 710, were to spin around with the thumb depress
member 724 and the suction shaft 722, the short suction tube 712
would twist around the suction shaft 722 and make it difficult for
the user to spin the suction shaft 722. It would also prevent free,
continuous, 360-degree rotation of the suction shaft 722 and could
potentially also result in pulling off of one of the suction ports
708, 710, spinning the suction shaft 722 back to its original
orientation, or even hampering advancement of the suction shaft 722
in and out of the ear. Advantageously, the free spin suction member
715 allows the user to spin the thumb depress member 724 and the
suction shaft 722 continuously, 360 degrees or more, as much as
desired, without twisting the short suction tube 712.
[0112] One additional feature of this embodiment of the ear
visualization/suction device 700 is an adjustable finger loop 704
on the handle 702. In this embodiment, the user may place her
finger (for example her middle or index finger) through the looped
portion of the finger loop 704 and pull the free end of the finger
loop 704 to tighten the looped portion. The looped portion may also
be pulled, to make it larger. This is but one example of a finger
hold member that may be included on the handle 702 to facilitate
holding of the handle 702 using one finger. In one embodiment, the
user may hold the device 700 with her middle finger, via the finger
loop 704, and operate the device 700 with other fingers of the same
hand (index finger and thumb, for example).
[0113] FIGS. 18A-18D are perspective views of a portion of an ear
visualization/suction device, according to four different
embodiments, where each embodiment includes a differently
configured thumb depress member for rotating a suction shaft with a
curved distal tip. Referring to FIG. 18A, one embodiment of an ear
visualization/suction device 800 includes a generally circular
thumb depress member 802 with an elliptical, off-center, raised
surface feature 804. The thumb depress member 802 also includes a
slightly concave upper surface for receiving the thumb. Having an
off-center surface feature 804 allows the user to rest a finger
(typically the thumb) against the surface feature 804 and
ergonomically easy spinning of the suction shaft. Also pictured in
this and the following embodiments are a handle 801, a handle
suction port 808, a suction shaft 810, and a suction shaft suction
port 806.
[0114] In the embodiment of FIG. 18B, the ear visualization/suction
device 810 includes a similarly circular, slightly concave thumb
depress member 812, with a more round shaped (or oval) surface
feature 814. In the embodiment of FIG. 18C, the ear
visualization/suction device 820 includes an asymmetrical,
bean-shaped thumb depress member 822 with a round-shaped (or oval)
raised surface feature 824 on a lateral portion of the thumb
depress member 822. In the embodiment of FIG. 18D, the ear
visualization/suction device 830 includes another asymmetrical
thumb depress member 832 with a raised, upwardly curving edge at
one side. As FIGS. 18A-18D illustrate, in any given embodiment, the
thumb depress member and the surface feature may have any suitable
shape, size and configuration.
[0115] Referring now to FIG. 19, another embodiment of an ear
visualization/suction device 900 is illustrated. This embodiment
includes many of the features of previous embodiments, which will
not be explained again here. In addition, this embodiment of the
device 900 includes an adjustable handle 902, which may make
holding the handle 902 more comfortable for a given user. The
handle 902 has a distal portion 904, a proximal portion 906, and an
adjustment member 908 between the two. The adjustment member 908
acts as an axis, to allow the proximal portion 906 to rotate down
(and back up as desired), so that the proximal portion 906 can be
angled, relative to the distal portion 904. Thus, the user can
direct the tip of device 900 in the direction of the ear canal
(typically superiorly-posteriorly), regardless of whether the
device 900 is being used in a left ear or a right ear, without
changing the orientation of the user's entire hand. In various
embodiments, the adjustment member 908 may have specific adjustment
angles that the proximal portion 906 clicks into and/or may have a
locking feature to allow the user to lock the proximal portion 906
in a desired angle. In alternative embodiments, the adjustment
member 908 may be positioned farther distally or farther proximally
along the body of the handle.
[0116] Referring now to FIG. 20, in another embodiment, an ear
visualization/suction device 1000 may include a handle 1002 that is
malleable or includes a malleable section 1004. As with the similar
embodiment, the malleable section 1004 allows the user to create an
angle in the handle 1002, which may enhance ergonomics and
comfort.
[0117] Referring now to FIGS. 21A and 21B, one embodiment of an ear
tube placement device 1100 is illustrated. In this embodiment, the
ear tube placement device 1100 also functions as an ear
visualization/suction device. Ear tubes are often placed in
tympanic membranes TM (or "ear drums") that lie between the outer
ear (or "ear canal," labeled in the figures as EC) and the middle
ear, primarily in children but also adults with frequent ear
infections or other problems involving the middle ear. Although one
handle/suction tube configuration is illustrated in FIGS. 21A and
21B, alternative embodiments may include any of the handle/suction
configurations described in this disclosure. As with previously
described embodiments, the device 1100 includes a handle 1102, a
thumb depress portion 1104, a suction tube 1106, a main shaft 1114,
a suction guide tube 1112, a suction shaft 1110, and a spring 1108
positioned over a proximal portion of the suction shaft 1110. This
embodiment further includes a stop member 1120 located near the
distal end of the suction shaft 1110 and a sharp distal tip 1116 on
the suction shaft 1110. An ear tube 1118 may be part of the device
1100 or, more likely, the ear tube 1118 may be any currently
available or to-be-developed ear tube, which is placed over the
distal end 1116 of the suction shaft.
[0118] FIG. 21A illustrates the ear tube placement device 1100 in a
pre-deployment position, with the ear tube 1118 mounted on the
suction shaft 1110 and the distal end of the device 1100 being
advanced into the ear canal EC. The thumb depress member 1104 is
not yet depressed. FIG. 21B shows the device 1100 in position to
deploy the ear tube 1118 in the tympanic membrane TM. In use, the
suction shaft 1110 will typically be advanced toward the TM, until
the sharp distal tip 1116 of the suction shaft 1110 pushes against
the tympanic membrane TM to pierce the membrane. Next, the suction
shaft 1110 will be further advanced, to push the ear tube 1118
through the new hole in the tympanic membrane TM, as illustrated in
FIG. 21B. While 1118 is pushed through the hole, the stop member
1120 prevents 1118 from being pushed back by the TM and sliding
back over suction shaft 1110, as the suction shaft 1110 advances
through the TM. The stop member 1120 may be any suitable piece or
surface feature on (or of) the suction shaft 1110, such as but not
limited to a washer-like member, a raised ring on the suction shaft
1110, another tube disposed over the suction shaft 1110 or the
like. In general, any piece or feature that will prevent the ear
tube 1118 from sliding proximally during deployment will be
suitable. After the ear tube 1118 is placed in the tympanic
membrane TM, the suction shaft 1110 and/or the entire device 1100
may be retracted/pulled back, to slide the suction shaft 1110 out
of the ear tube and the device 1100 out of the ear canal.
[0119] FIG. 22 illustrates a distal end of an alternative
embodiment of an ear tube placement device 1200. In this
embodiment, the main shaft 1202 includes a camera (not visible), as
with previously described embodiments. The suction shaft 1204 is
curved and ends in a sharp distal tip 1208. A stop member 1210 is
disposed over the suction tube, and an ear tube 1206 is shown in
position. In some embodiments, it may be advantageous to have a
curved suction shaft 1204 with the ear tube placement device 1200,
as this will allow it to reach different areas of the TM with
slight spins of the suction shaft 1204.
[0120] Referring now to FIGS. 23-26, in one embodiment of an ear
visualization/suction device 1300, an optional handle angle
adjustment member 1310 may be provided. FIG. 23 shows a portion of
the device 1300 without the handle angle adjustment member 1310,
illustrating a handle 1302, with a finger loop 1306, and a main
shaft 1304. FIG. 24 shows the removable handle angle adjustment
member 1310, which has a straight hand rest portion 1312, a curved
portion 1314 and an attachment portion 1316 that attaches to the
handle 1302. The attachment portion 1316 may be slid over the
handle 1302 into place, such that the diameter of the handle 1302
and/or a stop member along the handle 1302 helps position the
attachment portion 1316. In some embodiments, the attachment
portion 1316 may be moved along the handle 1302 by the user, to any
suitable location on the handle 1302. In various embodiments, the
optional handle angle adjustment member 1310 may have any number of
different sizes, shapes and angles. The curved portion 1314, for
example, may have any suitable angle. In some embodiments, the
curvature of the curved portion 1314 may be adjustable by the
user--for example, it may be malleable. In some embodiments, the
device 1300 may be provided with multiple, differently shaped
handle angle adjustment members 1310, each having a different
angle, shape and/or size.
[0121] FIG. 25 shows a user holding the portion of the device 1300
without the handle angle adjustment member 1310. This figure
illustrates a first relative angle between the user's hand and the
handle 1302, as well as a first orientation of the main shaft 1304
of the device 1300, relative to the hand. FIG. 26 shows the same
user's hand holding the device 1300 with the handle angle
adjustment member 1310 attached. As seen here, the handle 1302 is
now angled in a more upward direction, relative to the user's hand,
and the main shaft 1304 of the device 1300 is angled toward the
hand more than it was in FIG. 24. At the same time, however, the
overall position of the user's hand is almost exactly the same in
FIGS. 25 and 26. This illustrates that the handle angle adjustment
member 1310 (or alternate embodiments thereof) may help a user
access and visualize different parts of an ear without needing to
assume awkward or uncomfortable hand positions.
[0122] FIGS. 27A and 27B are diagrammatic illustrations of one
embodiment of a combined ear visualization/suction device 1400,
shown in an orientation as if the device 1400 were being held in a
left hand while inserted into a right ear (FIG. 27A) and a left ear
(FIG. 27B). These two figures are simple representations of the
device 1400, to illustrate how a working area in an ear canal might
be limited in some scenarios. For example, FIG. 27B shows a
representation of a left ear canal LEC and an area of interest in
the left ear LE. The "area of interest" may refer to an area in the
ear and/or one or more structures in the ear, such as but not
limited to the tympanic membrane, an area just beyond the tympanic
membrane in the middle ear, an area just before the tympanic
membrane, or any other suitable area and/or structure in the ear.
The device 1400 is being held in the left hand of the user (hand
not shown), and the angle of view is represented in the figure by
an eye symbol at the distal tip 1412 of the device 1400. The device
1400 includes a proximal bend 1410, which allows for a working area
1420 within the left ear canal LEC. The working area 1420 can be
used for passing one or more tools for performing a procedure on
the left ear LE area of interest. As FIG. 27B illustrates, when a
user holds the device 1400 in his left hand and accesses the left
ear canal LEC with the device 1400, the working area 1420 is
sufficient for passing one or more tools, because it has a
relatively large entry opening (the opening into the ear canal from
outside the patient).
[0123] In contrast, referring to FIG. 27A, when the left handed
user uses the device 1400 to access a right ear canal REC to view
an area of interest in the right ear RE, this embodiment of the
device 1400 may cut off the entry opening of a working area 1414,
which may make it more difficult for the user to insert working
tools into the ear canal REC. Although the overall size of the
working area 1414 in FIG. 27A is approximately the same as the size
of the working area 1420 in FIG. 27B, the configuration of the
working area 1414 for a left handed user in a right ear canal REC
may be problematic for passage of tools. This may require the user
to position his/her hand in an awkward position or insert tools
through the ear canal REC in an awkward way. The same problem may
occur if a person holds the device 1400 in the right hand and uses
the device 1400 in the left ear canal LEC.
[0124] FIGS. 28A and 28B are diagrammatic illustrations of an
alternative embodiment of a combined ear visualization/suction
device 1500, shown in an orientation as if the device 1500 were
being held in a left hand while inserted into a right ear (FIG.
28A) and a left ear (FIG. 28B). In this embodiment, the device 1500
includes a proximal bend 1510 and a distal bend 1520, closer to the
distal end 1522 of the device 1500. Thus, when held in the user's
left hand and inserted into the right ear canal REC, the resulting
working area 1524 has a sufficiently large opening and overall
width to allow for tool passage. The distal bend 1520 may be formed
in any of a number of ways and may be either fixed or adjustable in
various embodiments. For example, in some embodiments, a distal
portion of the device 1500 may be malleable, so the user can form
and adjust the distal bend 1520. In other embodiments, the distal
bend 1520 or a distal portion of the device 1500 may be rotatable.
Alternatively, the view of the camera at the distal end 1522 of the
device 1500 may be rotated or otherwise adjusted, for example by
electronic adjustment, to allow for the desired viewing angle.
[0125] FIG. 28B shows the device 1500 with the distal bend 1520
adjusted to have a different angle, designed to access the left ear
canal LEC and view the left ear area of interest LE. In this
scenario, the working area 1530 is also sufficiently wide to allow
for tool passage. Various alternative embodiments may have any
number, location and angle of bends. In one embodiment, a
left-handed device and a right-handed device may be provided.
[0126] Referring now to FIGS. 29A and 29B, an alternative
embodiment of an ear visualization and suction device 1600 is
illustrated. In various embodiments, the suction tube of an ear
visualization/suction device (the side tube through which the
suction device passes) may have an inner diameter ranging from
about 0.6 mm to about 2.5 mm, with some embodiments having an inner
diameter of about 1.1 mm or less. The main shaft (or visualization
shaft) may have an outer diameter of about 2.5 mm or less. These
dimensions may differ in some embodiments. In the embodiments
described above, the suction shaft (i.e., the part of the device
that transmits suction force to the distal end of the device)
passes through the suction tube and slides up and down through the
tube as it is advanced and retracted. The size of the outer
diameter of the suction shaft is thus limited by the size of the
inner diameter of the suction tube. In various embodiments, for
example, the suction shaft may have an outer diameter ranging from
about 0.6 mm to about 2.5 mm, depending on the inner diameter of
the suction tube. In some embodiments, the suction shaft of the ear
visualization/suction device may have an outer diameter measuring
about 3 French (i.e., about 1 mm). For some ear surgery procedures,
this diameter works well. In other cases, however, it might be
advantageous to have a larger suction shaft diameter, to provide
more suction force and/or prevent clogging of the suction device.
For example, in some embodiments it might be advantageous to have a
suction shaft with an outer diameter of about 5 French (i.e., about
1.67 mm). Any number of suitable sizes of suction shafts may be
used in a given embodiment, again ranging from as small as about
0.6 mm outer diameter to as large as about 2.5 mm outer diameter or
more.
[0127] If the suction shaft must pass through the suction tube,
then a larger suction shaft will require a larger suction tube.
Therefore, one way to provide ear visualization/suction devices
with different suction diameters is to provide separate devices
with suction tubes and suction shafts having different diameters,
allowing the user to choose between devices for a given procedure
or even to swap out devices during a procedure. Another way to
allow for suction size variation is to provide one device with
multiple, differently sized suction shaft components that may be
swapped out on the same device. The ear visualization and suction
device 1600, shown in FIGS. 29A and 29B is one embodiment of an
adjustable suction size device.
[0128] In the embodiment of FIGS. 29A and 29B, the device 1600
includes a handle 1602, a main shaft 1606 (or "visualization
shaft"), two suction tubes 1604 extending along either side of a
proximal portion of the main shaft 1606, suction ports 1608 on
either side of the handle 1602, a suction shaft 1612, suction
tubing 1610, a suction push rod 1616, and a thumb depress 1614
attached to the proximal end of the suction push rod 1616. In FIG.
29A, solid-tipped arrows show the path of suction into the distal
end of the suction shaft 1612, into the suction tubing 1610, which
is attached to the handle 1602 via one of the ports 1608, and then
into and through the handle 1602. In some embodiments, for example,
the handle 1602 houses additional suction tubing (shown in later
figures) that connects to further tubing to couple with a source of
suction. In operation, the user presses the thumb depress 1614 to
advance the suction push rod 1616, which extends through one of the
two suction tubes 1604. The suction push rod 1616 advances the
suction shaft 1612. When suction is activated, as illustrated in
FIG. 29A, suction passes through the suction shaft 1612, the
suction tubing 1610, and the handle 1602. The suction push rod 1616
serves merely to advance and retract the suction shaft 1612.
(Retraction occurs automatically via a spring positioned over the
proximal portion of the suction push rod 1616, between the top of
the handle 1602 and the bottom of the thumb depress 1614, as
described in further detail above, in regard to other
embodiments.)
[0129] FIG. 29C shows the suction component 1618 of the device
1600. When coupled with the handle 1602, the suction push rod 1616
extends from a proximal end attached to the thumb depress 1614 to a
distal end attached to the suction shaft 1612 via a junction 1617.
The suction shaft 1612 includes a proximal curve, and its proximal
end fits within the suction tubing 1610. As is evident from FIG.
29C, the outer diameter of the suction push rod 1616 is smaller
than the outer diameter of the suction shaft 1612. For example, the
suction shaft 1612 may have a 5 French outer diameter in one
embodiment. In alternative embodiments, the suction shaft 1612 may
have any suitable diameter. As long as the suction tube push rod
1616 is sized to fit through the suction tube 1604, the suction
shaft 1612 may have any desired inner and outer diameter, according
to different embodiments. In this way, the suction component 1618
and various sizes thereof may allow for the same ear
visualization/suction device 1600 to be adjusted to provide
multiple different sizes of suction shafts 1612. The thumb depress
1614 may be easily removable from the proximal end of the suction
push rod 1616, for example via threaded connection or friction fit.
In this way, the device 1600 facilitates changing of the suction
component 1618 for a different suction component with a differently
sized suction shaft 1612.
[0130] FIG. 30 shows the suction component 1618 on the right and an
alternative suction component 1622 on the left. The suction
component 1618 was already described in reference to FIG. 29C, but
it is shown here with an alternative thumb depress 1620 and with
the spring 1621. The alternative suction component 1622 includes a
suction shaft 1624, a second alternative thumb depress 1628 with a
suction port 1627, suction tubing 1626 and a spring 1629. The
suction shaft 1624 of the alternative suction component 1622
extends through the suction tube 1604 of the device 1600, as
described in relation to other embodiments herein. In one
embodiment, the suction shaft 1624 may have an outer diameter of
about 3 French, while the suction shaft 1612 may have an outer
diameter of about 5 French. In one embodiment, the device 1600 may
be provided with both suction components 1618, 1622, to allow a
user to choose between the two for a procedure or to swap between
the two during a procedure. One method for swapping out the suction
components 1618, 1622 is to remove the thumb depress 1620, 1628
(along with the spring 1621, 1629) and slide either the suction
push rod 1616 or the suction shaft 1624 distally out of the suction
tube 1604. The other suction component 1618, 1622 may then be
loaded into the device 1600 by reversing the process.
[0131] Referring now to FIGS. 31A-31C, the ear visualization and
suction device 1600 is illustrated with the alternative suction
component 1622 attached. FIG. 31A shows a proximal suction tube
1630 extending through the handle 1602. FIGS. 31B and 31C are top
cross-sectional views, with the handle 1602 not illustrated. As
illustrated by solid-tipped arrows in FIG. 31B, in this
configuration, suction travels up the suction shaft 1624, through
the thumb depress 1628, through the suction tubing 1626, and then
into and through the proximal suction tubing 1630 in the handle
1602. FIG. 31C shows how the suction shaft 1624 extends through the
suction tube 1604 and attaches to a distal shaft portion 1632 of
the thumb depress 1628. The distal shaft portion 1632 travels back
and forth within a bore 1634 of the handle, with proximal movement
assisted by the spring 1629.
[0132] The embodiments and features illustrated in FIGS. 29A-31C
represent merely one example of an ear visualization and suction
device 1600 that provides two different suction shaft diameters.
Alternative embodiments may achieve the same objective using
different techniques and features. For example, in one embodiment,
an ear visualization and suction device may have a larger diameter
suction tube, for example allowing for passage of a 5 French (outer
diameter) suction shaft. That device may also be provided with an
alternative suction component having a suction shaft with a smaller
outer diameter, such as 3 French. The smaller suction shaft may
have a wider proximal portion that fits in the suction tube, to
prevent the shaft from wiggling or jostling within the suction
tube. Thus, any number of different embodiments and sizes of
suction shafts may be provided as part of an ear
visualization/suction device.
[0133] Referring now to FIGS. 32A-32D, in one embodiment, an ear
visualization and suction device 1700 may also include an
irrigation component. FIG. 32A shows an assembled side view of the
device 1700, which includes a handle 1702, with a finger hold 1704,
a electric cable 1706, a proximal suction tube 1708, an irrigation
tube 1710, a distal suction tube 1714, a thumb depress 1712 and a
suction shaft 1716. (The main shaft is hidden behind the suction
shaft 1716 in this view.) The electric cable 1706 may contain, for
example, image sensor wires and LED power lines. The device 1700
includes other parts and features described in relation to other
embodiments above, but these will not be described again here. In
this embodiment, the suction shaft 1716, extends through a first
bore in the top of the handle 1702, and an irrigation shaft (not
visible in FIG. 32A) extends through a second bore. Irrigation
fluid, such as saline solution, is passed through the irrigation
tube 1710 and irrigation shaft so that it flows down the side of
the main shaft into the patient's ear. Suction from the suction
shaft 1716 may be used to evacuate the irrigation fluid.
[0134] FIG. 32B shows the ear visualization and suction device 1700
with the irrigation shaft 1722 removed from the handle. As
mentioned above, to use the irrigation portion of the device 1700,
the irrigation shaft 1722 is passed down into one of two bores 1720
on the top of the handle 1702, and thus into one of the two suction
tubes 1718 that extend along either side of a proximal portion of
the main shaft 1717. Either bore 1720 may be used, and the suction
shaft 1716 (not shown in FIG. 32B) is inserted into the other bore
1720. As evident from FIG. 32B, the irrigation shaft 1722 is
shorter than the main shaft 1717, and it may also be shorter than
the length of the two suction tubes 1718. Thus, when irrigation
fluid passes out of the distal end of the irrigation shaft 1722, it
passes along the side of the main shaft 1717 and into the ear. In
alternative embodiments, the irrigation shaft 1722 may be longer or
shorter than the one shown. Also visible in FIG. 32B is one of two
handle suction ports 1724, on either side of the handle 1702,
configured for coupling with the suction tube 1714 (FIG. 32A).
[0135] FIG. 32C is the same side view as in FIG. 32B, but with the
irrigation shaft inserted into one of the bores 1720. FIG. 32D is a
top view of the same configuration of the ear visualization and
suction device 1700.
[0136] The above description of embodiments and features of various
devices and methods is believed to be complete. The embodiments are
meant to exemplary in nature, however, and not exhaustive. Thus,
their description should not be interpreted as limiting the scope
of the invention.
* * * * *