U.S. patent application number 16/509616 was filed with the patent office on 2020-05-07 for apparatus, systems and methods for proper transesophageal echocardiography probe positioning by using camera for ultrasound imag.
This patent application is currently assigned to Visura Technologies, Inc.. The applicant listed for this patent is Visura Technologies, Inc.. Invention is credited to Lance C. BOLING, Morgan CLYBURN, David B. MARMOR.
Application Number | 20200138405 16/509616 |
Document ID | / |
Family ID | 56887232 |
Filed Date | 2020-05-07 |
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United States Patent
Application |
20200138405 |
Kind Code |
A1 |
MARMOR; David B. ; et
al. |
May 7, 2020 |
APPARATUS, SYSTEMS AND METHODS FOR PROPER TRANSESOPHAGEAL
ECHOCARDIOGRAPHY PROBE POSITIONING BY USING CAMERA FOR ULTRASOUND
IMAGING
Abstract
In some embodiments, a method includes releasably attaching an
image capture assembly to a distal portion of a TEE device. Next,
the TEE device coupled to the image capture assembly is inserted
into an oral cavity of the patient. With the image capture assembly
releasably attached to the distal portion of the TEE device, image
data of an esophagus of the patient captured by the image capture
assembly is displayed. While viewing the display of image data, the
TEE device coupled to the image capture assembly can be moved
within the esophagus. With both the TEE device and the image
capture assembly disposed within the esophagus, the image capture
assembly is detached from the TEE device. With the image capture
assembly detached from the TEE device, and with the TEE device
disposed at least in part within the esophagus, the image capture
assembly is removed from the patient.
Inventors: |
MARMOR; David B.; (Evanston,
IL) ; CLYBURN; Morgan; (Naperville, IL) ;
BOLING; Lance C.; (San Jose, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Visura Technologies, Inc. |
Minneapolis |
MN |
US |
|
|
Assignee: |
Visura Technologies, Inc.
Minneapolis
MN
|
Family ID: |
56887232 |
Appl. No.: |
16/509616 |
Filed: |
July 12, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15834878 |
Dec 7, 2017 |
10376237 |
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16509616 |
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15164538 |
May 25, 2016 |
10045758 |
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15834878 |
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14952289 |
Nov 25, 2015 |
10265046 |
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15164538 |
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62084969 |
Nov 26, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 8/445 20130101;
A61B 1/0684 20130101; A61B 1/00018 20130101; A61B 1/00103 20130101;
A61B 8/12 20130101; A61B 8/5207 20130101; A61B 1/00016 20130101;
A61B 1/053 20130101; A61B 8/4483 20130101; A61B 8/0883 20130101;
A61B 8/463 20130101; A61B 8/4416 20130101; A61B 8/4254 20130101;
A61B 1/2733 20130101; A61B 1/0676 20130101 |
International
Class: |
A61B 8/00 20060101
A61B008/00; A61B 8/08 20060101 A61B008/08; A61B 8/12 20060101
A61B008/12; A61B 1/00 20060101 A61B001/00; A61B 1/05 20060101
A61B001/05; A61B 1/06 20060101 A61B001/06; A61B 1/273 20060101
A61B001/273 |
Claims
1-16. (canceled)
17. An apparatus, comprising: an image capture device configured to
be removably coupled to an imager head of a transesophageal
echocardiography (TEE) ultrasound probe device, and inserted into
an esophagus of a patient when removably coupled to the imager head
of the TEE ultrasound probe device; and a retrieval tension member
coupled to and extending from the image capture device and
configured to extend from the image capture device through the
esophagus and out the patient when (1) the image capture device is
removably coupled to the TEE ultrasound probe device, and (2) the
TEE ultrasound probe device is disposed within a target imaging
location of the esophagus in which the TEE ultrasound probe device
can capture ultrasound images of the heart of the patient, the
image capture device configured to be longitudinally withdrawn
relative to the imager head of the TEE ultrasound probe device in
response to a proximal force applied by the retrieval tension
member.
18. The apparatus of claim 17, wherein the image capture device is
communicatively coupled to an image data processing device
configured to process image data captured by the image capture
device when the image capture device is disposed within the
esophagus, the image processing device being located outside the
patient when both the image capture device and TEE ultrasound probe
device are disposed within the target imaging location of the
esophagus.
19. The apparatus of claim 18, further comprising a communication
line, the image capture device being communicatively coupled to the
image data processing device via the communication line.
20. The apparatus of claim 17, wherein a portion of the image
capture device is configured to be transparent to energy
transmitted from and received by an imaging array of the TEE
ultrasound probe device to allow the energy to pass through the
portion of the image capture device when the image capture device
is removably coupled to the imager head of the TEE ultrasound probe
device.
21. The apparatus of claim 17, wherein the image capture device
includes a seal configured to withstand bodily fluid of at least
one of the esophagus or a stomach of the patient.
22. The apparatus of claim 17, wherein the retrieval tension member
defines a lumen therethrough, the apparatus further comprising a
communication line extending from the image capture device through
the lumen of the retrieval tension member to outside the patient
when both the image capture device and the TEE ultrasound probe
device are disposed within the target imaging location of the
esophagus.
23. The apparatus of claim 17, wherein the proximal force is less
than about 15 Newtons.
24. The apparatus of claim 17, wherein the retrieval tension member
is configured such that an exterior surface of the retrieval
tension member extends from the image capture device, at least
partially abutting an exterior surface of the TEE ultrasound probe
device, and through the esophagus and out the patient when (1) the
image capture device is removably coupled to the TEE ultrasound
probe device, and (2) the TEE ultrasound probe device is disposed
within a target imaging location of the esophagus in which the TEE
ultrasound probe device can capture ultrasound images of the heart
of the patient.
25. An apparatus, comprising: an image capture device configured to
be removably coupled to an imager head of a transesophageal
echocardiography (TEE) ultrasound probe device via a coupling
member, and inserted into an esophagus of a patient when removably
coupled to the imager head of the TEE ultrasound probe device, the
image capture device including a distal-facing camera lens
configured to capture image data within the esophagus and distal to
the imager head of the TEE ultrasound probe device when removably
coupled to the imager head of the TEE ultrasound probe device; the
coupling member configured to releasably attach the image capture
device to the imager head of the TEE ultrasound probe device, the
coupling member configured to detach from the imager head of the
TEE ultrasound probe device to allow longitudinal relative movement
between the imager head of the TEE ultrasound probe device and the
image capture device; and a retrieval tension member coupled to the
image capture device and configured to extend from the image
capture device through the esophagus and out the patient when (1)
the image capture device is removably coupled to the TEE ultrasound
probe device via the coupling member, and (2) the TEE ultrasound
probe device is disposed within a target imaging location of the
esophagus in which the TEE ultrasound probe device can capture
ultrasound images of the heart of the patient.
26. The apparatus of claim 25, wherein the image capture device is
communicatively coupled to an image data processing device
configured to process image data captured by the image capture
device when the image capture device is disposed within the
esophagus, the image processing device being located outside the
patient when both the image capture device and TEE ultrasound probe
device are disposed within the target imaging location of the
esophagus.
27. The apparatus of claim 25, further comprising a communication
line, the image capture device being communicatively coupled to the
image data processing device via the communication line.
28. The apparatus of claim 25, wherein the image capture device
includes a seal configured to withstand bodily fluid of at least
one of the esophagus or a stomach of the patient.
29. The apparatus of claim 25, wherein the retrieval tension member
defines a lumen therethrough, the apparatus further comprising a
communication line extending from the image capture device through
the lumen of the retrieval tension member to outside the patient
when both the image capture device and the TEE ultrasound probe
device are disposed within the target imaging location of the
esophagus.
30. The apparatus of claim 25, wherein the retrieval tension member
is configured such that a central axis of the retrieval tension
member is offset from a central axis of the TEE probe device when
the image capture device is removably coupled to the TEE ultrasound
probe device.
31. The apparatus of claim 25, wherein the coupling member includes
a seam configured to allow longitudinal relative movement between
the imager head and the image capture device.
32. An apparatus, comprising: an image capture device configured to
be removably coupled to an imager head of a transesophageal
echocardiography (TEE) ultrasound probe device via a coupling
member, and inserted into an esophagus of a patient when removably
coupled to the imager head of the TEE ultrasound probe device, the
image capture device configured to capture image data within the
esophagus and distal to the imager head of the TEE ultrasound probe
device when removably coupled to the imager head of the TEE
ultrasound probe device and to transfer the image data via a
communication line from the image capture device to outside the
patient; a retrieval tension member coupled to the image capture
device, the retrieval tension member configured to extend from the
image capture device through the esophagus and out the patient such
that the retrieval tension member extends proximally from the image
capture device and entirely external to an exterior surface of a
body portion of the TEE ultrasound probe device when (1) the image
capture device is removably coupled to the TEE ultrasound probe
device via the coupling member, and (2) the TEE ultrasound probe
device is disposed within a target imaging location of the
esophagus in which the TEE ultrasound probe device can capture
ultrasound images of the heart of the patient to enable the
ultrasound images to be received outside of body.
33. The apparatus of claim 32, wherein the coupling member is made
from a flexible material and configured to releasably attach the
image capture device to the imager head of the TEE ultrasound probe
device, the coupling member configured to detach from the imager
head of the TEE ultrasound probe device in response to a proximal
force applied by the retrieval tension member to allow longitudinal
relative movement between the imager head of the TEE ultrasound
probe device and the image capture device.
34. The apparatus of claim 32, wherein a proximal portion of the
retrieval tension member is coupled to a handle, the handle being
removably couplable to the TEE ultrasound probe device outside the
patient when the image capture device is removably coupled to the
TEE ultrasound probe device via the coupling member, and the TEE
ultrasound probe device is disposed within the target imaging
location of the esophagus.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/834,878, filed Dec. 7, 2017, which is a
divisional of U.S. patent application Ser. No. 15/164,538, filed
May 25, 2016, now U.S. Pat. No. 10,045,758, which is a
continuation-in-part of U.S. patent application Ser. No.
14/952,289, filed Nov. 25, 2015, now U.S. Pat. No. 10,265,046 which
claims priority to and the benefit of U.S. Provisional Application
No. 62/084,969, filed Nov. 26, 2014, the contents of each of which
are incorporated by reference herein in their entirety.
BACKGROUND
[0002] The embodiments described herein relate generally to the
field of transesophageal echocardiography (TEE) and more
particularly to apparatus, systems, and methods for assisting TEE
intubation.
[0003] Echocardiography is a common diagnostic procedure that
utilizes a transducer to transmit ultrasound waves to, for example,
a heart, which deflect or rebound off the structures of the heart.
A computer converts the resulting waves and displays them on a
screen to allow an operator (e.g., a cardiologist) to assess
cardiac structure and function. Some known echocardiograms are
obtained from a transthoracic echocardiography (TTE) approach.
Echocardiograms obtained from the TTE approach, however, are
limited to capturing images through the patient's chest wall. Other
known echocardiograms are obtained from a transesophageal
echocardiography (TEE) approach. A TEE approach, similar to the TTE
approach, allows for capturing of images of the heart, however, the
images can be captured from the esophagus rather than through the
chest wall. As such, the TEE approach can provide optimal imaging
(e.g., clearer images), for example, of heart valves, assessing for
left atrial appendage thrombus, examination of intracardiac tumors,
assessment for intracardiac shunting, etc., when compared to the
TTE approach.
[0004] Known TEE probes include a flexible endoscope with an
ultrasound transducer at its tip. During the TEE procedure, the
probe is inserted into a patient's mouth and advanced into the
esophagus. From the esophageal position, the ultrasound beam does
not have to travel through the chest wall (as compared to the TTE
approach) and therefore offers a much clearer image of several key
heart structures, especially the atria and valves, that may not be
seen as clearly with a TTE. During the procedure, the cardiologist
can rotate the endoscope and examine the heart from different
angles.
[0005] Further, in known TEE procedures with known TEE devices, an
operator inserts the flexible endoscope blindly, i.e., without
seeing where the endoscope is moving within the patient. The
procedure is typically accomplished by the operator's feel and
experience. Some procedures, due in part to the blind nature of the
procedure, result in catastrophic complications (e.g.,
oropharyngeal, esophageal, and/or gastric trauma, perforation,
and/or laceration) with high mortality rates. In addition, TEE
related complications result in substantial additional cost and
additional days for the patient in an intensive care unit.
[0006] Thus, a need exists for improved apparatus, systems, and
methods for an image capture device configured to be releasably
attached to existing TEE probes for insertion into and placement of
the TEE probe within a patient's esophagus, and configured to be
released from the TEE probe and removed from the esophagus, leaving
the transducer at the end of the TEE probe in the proper position
(e.g., within the esophagus) for capturing images (e.g., of the
heart). Allowing an operator to view the esophagus while placing
the TEE probe therein helps to solve the problems resulting from
blind intubation. Adding visualization to the TEE procedure can
reduce the rate of complications because the operator can
accurately use imaging to avoid misplacement of the TEE probe and
trauma due in part to varying anatomy. Further, a need exists for
providing such imaging capabilities to existing TEE probe models
without interfering with the echocardiogram image capture, without
requiring significant modifications to existing TEE probe hardware,
and without adding significant size (e.g., cross-sectional area) to
the TEE probe.
SUMMARY
[0007] Apparatus, systems, and methods for assisting
transesophageal echocardiography (TEE) intubation are described
herein. In some embodiments, devices for providing visualization in
real-time of a TEE intubation are described herein. Such a device
includes an image capture assembly. The image capture assembly is
configured to be removably coupled to an imager head of a
transesophageal echocardiography endoscopic (TEE) device, and
inserted into an esophagus of a patient when removably coupled to
the imager head of the TEE device. The apparatus further includes a
retrieval tension member coupled to the image capture assembly. The
retrieval tension member is configured to extend from the image
capture assembly through the esophagus and out the patient when (1)
the image capture assembly is removably coupled to the TEE device,
and (2) the TEE device is disposed within a target imaging location
of the esophagus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a cross-sectional view of an illustration of a
portion of the human digestive system.
[0009] FIG. 2A is a schematic illustration of a transesophageal
echocardiography endoscopic (TEE) device; FIG. 2B is a schematic
illustration of a camera assist device (CAD); and FIG. 2C is a
schematic illustration of the CAD releasably attached to the TEE
device, according to an embodiment.
[0010] FIG. 3 is a flow chart of a method of assisting TEE
intubation, according to an embodiment.
[0011] FIG. 4 is a schematic illustration of a portion of a CAD
releasably attached to a portion of a TEE device, according to an
embodiment.
[0012] FIG. 5 is a perspective view of the CAD of FIG. 4.
[0013] FIG. 6 is a cross-sectional view of a retrieval tension
member of the CAD of FIG. 4, taken along the line A-A.
[0014] FIG. 7 is a cross-sectional view of an image capture
assembly of the CAD of FIG. 4, taken along the line B-B.
[0015] FIGS. 8A-8F are perspective, top, bottom, back, front, and
side views, respectively, of the image capture assembly of FIG.
7.
[0016] FIGS. 9A-9C are perspective, front, and side views,
respectively, of a CAD handle of the CAD of FIG. 4.
[0017] FIGS. 10-13 are schematic illustrations of the CAD of FIG. 4
in various stages of assisting a TEE intubation.
[0018] FIG. 14 is a perspective view of a portion of an image
capture assembly of a CAD releasably attached to a portion of a TEE
device, according to an embodiment.
[0019] FIG. 15 is a schematic illustration of the CAD of FIG. 14
attached to the TEE device of FIG. 14.
[0020] FIGS. 16-19 are schematic illustrations of the CAD of FIG.
14 in various stages of assisting a TEE intubation.
[0021] FIG. 20 is a perspective view of an image capture assembly
of a CAD releasably attached to a portion of a TEE device,
according to an embodiment.
DETAILED DESCRIPTION
[0022] Apparatus, systems, and methods for assisting
transesophaegeal echocardiography intubation are described herein.
In some embodiments, an apparatus includes an image capture
assembly. The image capture assembly is configured to be removably
coupled to an imager head of a transesophageal echocardiography
endoscopic (TEE) device, and inserted into an esophagus of a
patient when removably coupled to the imager head of the TEE
device. The apparatus further includes a retrieval tension member
coupled to the image capture assembly. The retrieval tension member
is configured to extend from the image capture assembly through the
esophagus and out the patient when (1) the image capture assembly
is removably coupled to the TEE device, and (2) the TEE device is
disposed within a target imaging location of the esophagus.
[0023] In some embodiments, a method can include releasably
attaching an image capture assembly to a distal portion of a TEE
device. With the image capture assembly releasably attached to the
distal portion of the TEE device, the TEE device coupled to the
image capture assembly can be inserted into an oral cavity of the
patient. With the image capture assembly releasably attached to the
distal portion of the TEE device, image data of an esophagus of the
patient captured by the image capture assembly can be displayed. In
this manner, an operator of the device can view a real-time
representation of the esophagus of the patient (e.g., to assist in
TEE intubation). While viewing the display of image data, the TEE
device coupled to the image capture assembly can be moved within
the esophagus. With both the TEE device and the image capture
assembly disposed within the esophagus, the image capture assembly
can be detached from the TEE device (e.g., detached from an imager
head of the TEE device). With the image capture assembly detached
from the TEE device, and with the TEE device disposed at least in
part within the esophagus (e.g., the TEE imager head disposed
within the esophagus), the image capture assembly can be removed
from the patient.
[0024] As used herein, the singular forms "a," "an," and "the"
include plural referents unless the context clearly dictates
otherwise. Thus, for example, the term "a member" is intended to
mean a single member or a combination of members, "a material" is
intended to mean one or more materials, or a combination
thereof.
[0025] As used herein, the words "proximal" and "distal" refer to
the direction closer to and away from, respectively, an operator
(e.g., surgeon, physician, nurse, technician, etc.) who would
insert the medical device into the patient, with the tip-end (i.e.,
distal end) of the device inserted inside a patient's body first.
Thus, for example, the end of a TEE device described herein first
inserted inside the patient's body would be the distal end, while
the opposite end of the TEE device (e.g., the end of the medical
device being manipulated by the operator) would be the proximal end
of the device.
[0026] The embodiments described herein can be formed or
constructed of one or more biocompatible materials and/or blends
thereof. Examples of suitable biocompatible materials include
metals, glasses, ceramics, or polymers.
[0027] FIG. 1 is an illustration of a portion of a human digestive
system, for example, to provide context to the description of the
devices and methods herein. Said another way, while specific
portions of the human digestive system are shown and described, it
is not meant to be an exhaustive discussion of the human digestive
system. Rather, pertinent anatomical structures, passageways, etc.
are presented by way of example to illustrate a use of the devices
and methods described herein. While the human digestive system is
shown in and described with respect to FIG. 1, the devices and
methods described herein can be used in other portions of a body.
As shown in FIG. 1, an upper region of a patient 5 includes, inter
alia, access to the digestive system via the mouth 21. The
digestive system includes the mouth 21, the oral cavity 22, the
pharynx 23, the esophagus 24, and the stomach 25. As shown, the
mouth 5 is in fluid communication with and provides access to the
oral cavity 22. Distal to and in fluid communication with the oral
cavity 22 is the pharynx 23; distal to and in fluid communication
with the pharynx 23 is the esophagus 24; and distal to and in fluid
communication with the esophagus 24 is the stomach 25. The heart 26
is located adjacent to the esophagus 24 and above the stomach 25,
as shown.
[0028] Because the esophagus 24 is located in close proximity to
the heart (e.g., upper chambers of the heart), the esophagus 24
provides suitable minimally and/or noninvasive access for a
transesophageal echocardiography (TEE) device to be inserted into
the esophagus 24 (through the mouth 21, oral cavity 22 and pharynx
23) to capture clear, detailed, and unique images of the heart 26
(e.g., the heart chambers, valves, tumors, etc.) and/or other
anatomy associated therewith (e.g., blood vessels connected to the
heart), as described in further detail herein. For example, a TEE
device can include a transducer at its distal end that is inserted
into the esophagus 24 and is configured to send sound waves to the
heart 5 and receive the echoes that bounce back from the heart 5.
Such echoes can be converted to a suitable visual representation
and displayed, for example, on a display device outside of the
patient 5. Compared to standard echocardiograms (e.g.,
non-transesophageal, transthoracic), a TEE device can provide
clearer images, for example, of the upper chambers of the heart 26
and the valves between the upper and lower chambers of the heart
26, thereby providing more accurate and effective diagnostic data.
Further, in some instances, for example, in which a patient has an
abnormally thick chest wall, is overweight, is using a ventilator,
or is otherwise affected by something that minimizes the
effectiveness of a standard echocardiogram, a TEE device can
provide the desired images of the heart to assess the heart's
structure and/or function, and diagnose any issues associated
therewith. TEE devices can further be used during and/or in
conjunction with other procedures, e.g., during a procedure to
repair a heart valve.
[0029] As discussed in more detail herein, when passing a TEE probe
through a patient's esophagus, it is desirable to minimize physical
contact with portions of the esophagus and surrounding anatomy to
avoid trauma thereto. In some embodiments, an apparatus (e.g., a
camera assist device (CAD)) can facilitate TEE intubation by
providing to the operator (e.g., a cardiologist) with images in
real-time as the TEE probe is inserted into the patient and/or
passed through the esophagus, and in some instances, the stomach.
For example, a CAD can be removably attached to a TEE probe during
insertion of the TEE probe into a patient and to a desirable
position within the patient to allow an operator to visualize in
real-time various anatomies (e.g., esophagus, stomach, and the
like) of the patient during the intubation. In this manner, the
operator can insert, maneuver, and/or dispose the TEE probe within
the patient while limiting and/or preventing undesirable trauma
(e.g., oropharyngeal trauma, esophageal trauma, gastric trauma,
etc.) and/or related complications due in part to inserting a probe
without visual cues.
[0030] Such a releasably attachable CAD can be configured to be
compatible with various existing TEE probe models without
interfering with the echocardiogram image capture, without
requiring significant modifications to existing TEE probe hardware,
and without adding significant size to the TEE probe.
[0031] FIG. 2C is a schematic illustration of a CAD 1200 removably
attached to a TEE probe 1100 with both the CAD 1200 and the TEE
probe 1100 partially disposed inside a patient (e.g., an esophagus
of the patient during a TEE intubation), according to an
embodiment. FIG. 2A is a schematic illustration of the TEE probe
1100 (separated from the CAD 1200), and FIG. 2B is a schematic
illustration of the CAD 1200 (separated from the TEE probe 1100).
The CAD 1200 can be configured to be removably attached to any TEE
probe (also referred to herein as "TEE device") suitable for TEE
intubation. The TEE probe 1100 can include a TEE body 1120 having a
TEE imager head 1130 coupled to its distal end and a TEE controller
1110 coupled to its, opposite, proximal end. The TEE imager head
1130 can include an ultrasound transducer (or any other suitable
imaging device) configured to capture image data of, for example, a
heart of the patient. For example, with the imager head 1130
disposed within the esophagus of a patient, the imager head 1130
can be configured to transmit ultrasound waves to the heart and
receive waves deflecting and/or rebounding therefrom. An image
processor (not shown) can transform the image data (e.g.,
ultrasound waves) and transmit the transformed data to a visual
display (not shown) outside the patient. In this manner, with the
TEE imager head 1130 disposed within the patient (e.g., within the
esophagus of the patient), an operator (e.g., a cardiologist) can
view from outside the patient a graphical representation of the
heart and surrounding anatomy inside the patient.
[0032] To facilitate such insertion of the TEE imager head 1130,
the CAD 1200 can be removably coupled to the TEE imager head 1130
prior to and during the insertion into and passage through the
esophagus of the patient to provide the operator with real-time
images of the passageway and surrounding anatomy. With access to
such real-time images, the operator can limit or avoid undesirable
and/or inadvertent contact with the esophagus and/or associated
anatomy, thereby limiting and/or preventing complications, and in
extreme circumstances, mortality. Additionally, with such access to
real-time images, the operator can easily and repeatedly locate
various regions of interest within the esophagus in which to
dispose the TEE imager head 1130 for imaging of the heart and other
anatomy. As described in more detail herein, after assistance from
the CAD 1200 in moving the TEE imager head 1130 in the esophagus to
a target region of the esophagus (e.g., a region in which the TEE
imager head 1130 can send signals to and receive signals from
target anatomy, such as the heart), the CAD 1200 can be decoupled
and/or removed from the TEE imager head 1130. With the CAD 1200
decoupled from the TEE imager head 1130, the CAD 1200 can be
withdrawn proximally through the esophagus 24, oral cavity 22, and
out the mouth 21 of the patient, leaving the TEE imager head 1130
disposed within the target region of the esophagus 24.
[0033] As shown in FIG. 2B separated from the TEE probe, the CAD
1200 can include an image capture device 1240 configured to capture
image data within a digestive system of a patient, an illumination
device 1230 configured to illuminate at least a portion of the
digestive system to increase quality of the image data captured by
the image capture device 1240, and a coupling member 1250
configured to releasably attach to the TEE imager head 1130 of the
TEE device 1100 (the illumination device 1230, image capture device
1240, and coupling member 1250 collectively referred to herein as
"image capture assembly 1245"). As discussed in further detail
herein, the image capture device 1240 can be configured to send the
image data it captures across a communication line 1220 (see e.g.,
FIGS. 2B and 2C) extending from the image capture device 1240 to a
graphical display device 1210. The graphical display device 1210
can be configured to display a graphical representation of the
image data, thereby providing an operator of the TEE device 1100
with visual access in real-time to various portions within the
digestive system of the patient.
[0034] The image capture device 1240 can be any suitable component,
subsystem, device and/or combination of devices configured to
capture image data (e.g., a single image and/or a series of images
(a video)). The image capture device 1240 can include a sensor and
a lens, and can be configured to transmit image data captured
within the patient to the graphical display device 1210 disposed
outside the patient via the communication line 1220. In some
instances, the lens can be disposed at a distal end of the image
capture assembly 1245. In this manner, the image capture device
1240 can capture image data immediately distal to and/or
immediately downstream of the image capture assembly 1245. Although
the sensor and lens are shown and described with respect to FIG. 2B
as being collocated, in some instances, the sensor and lens can be
located in any suitable portion of the image capture assembly 1245.
For example, in some embodiments, the lens can be located at a
distal end of the image capture assembly 1245, while the sensor can
be located at a proximal end portion or a medial portion of the
image capture assembly 1245.
[0035] In some instances, the image capture device 1240 can include
an image processor (not shown) configured to process the image data
such that the image data can be graphically displayed on the
graphical display device 1210. In other instances, for example, to
allow for a smaller form factor of the image capture device 1240,
processing of the image data can occur entirely outside the patient
and distinct from the image capture device 1240. In such instances,
the image data can be processed, for example, at an image processor
of the graphical display device 1210. In yet further instances, the
image data can be processed at an image processor separate from
both the graphical display device 1210 and the image capture device
1240, and the sent to the graphical display device 1210 to be
displayed. In some instances, the image capture device 1240 can
include wireless capabilities. For example, in such instances, the
image capture device 1240 can communicate wirelessly with an image
processor and/or the graphical display device 1210. In this manner,
image data can be transmitted from the image capture device 1240
when disposed within the patient to outside the patient without any
physical wires.
[0036] To enhance the quality of image data captured by the image
capture device 1240, the CAD 1200 can optionally include an
illumination device 1230 (as shown in dotted form in FIGS. 2B and
2C). The illumination device 1230 can be configured to illuminate a
target area (e.g., within the esophagus) in which the image capture
device 1240 can capture image data. The illumination device 1230
can include any suitable illumination source or interface. For
example, in some instances, an illumination device 1230 can include
a light emitting diode (LED). In some instances, the illumination
device 1230 can be separate from the image capture device 1240,
while in other instances, the illumination device 1230 can be
collocated with and/or integral to the image capture device 1240.
In some instances, for example, in which the image capture device
1240 includes an infrared sensor, the CAD 1200 may exclude an
illumination device 1230.
[0037] In some instances, the communication line 1220 can include
one or more optical fibers. In such instances, light can be
received at the image capture device 1240, transmitted via the
optical fiber(s) of the communication line 1220, and converted
outside the patient to an electronic signal. In this manner, with
the image processing taking place entirely outside the patient
during the TEE intubation, the image capture assembly 1245 can have
a smaller form factor. In such instances, the illumination device
1230 can include one or more LEDs. Further, in some instances, the
optical fiber can be disposed of after the procedure, while other
components of the CAD 1200 can sterilized and reused in subsequent
procedures.
[0038] In some instances, one or both of the image capture device
1240 and the illumination device 1230 can be controlled remotely
via the communication line 1220. For example, in such instances,
the image capture device 1240 can receive via the communication
line 1220 a signal including instructions to capture one or more
images, and/or the illumination device 1230 can receive power
and/or a signal to illuminate. In some instances, one or both of
the image capture device 1240 and the illumination device 1230 can
receive power via the communication line 1220 from a power source
external to patient. In other instances, one or both of the image
capture device 1240 and the illumination device 1230 can include a
power source (e.g., a battery) configured to store power sufficient
for operation of one or both of the image capture device 1240 and
the illumination device 1230.
[0039] In some instances, the image capture device 1240 can include
a lens filter (e.g., ultraviolet filter, infrared filter, etc.)
(not shown). An image filter can provide an operator of the CAD
1200 visual indicators within the patient's digestive system. For
example, in some instances, when moving the CAD 1200 within the
patient, an operator may want to avoid certain weak portions (or
portions otherwise particularly susceptible to damage and/or
trauma) of the digestive system (e.g., esophagus). In such
instances, a lens filter can provide visual indicators to the
operator when a graphical representation of the image data is
displayed.
[0040] To facilitate insertion of the CAD 1200 removably coupled to
the TEE device 1100 into the patient and through the esophagus, and
similarly, withdrawal of the CAD 1200 from the patient when the CAD
1200 is detached from the TEE device 1100, the image capture
assembly 1245 can be configured to change between a first
configuration, in which the image capture assembly 1245 has a first
cross-sectional area, to a second configuration, in which the image
capture assembly 1245 has a second cross-sectional area smaller
than the first cross-sectional area. In this manner, the image
capture assembly 1245 can be disposed in its first, larger
configuration when the operator desires to view images captured by
the image capture device 1240, and the image capture assembly 1245
can be transitioned to its second, smaller configuration, when the
operator desires to move the image capture assembly 1245 through
one or more relatively narrow portions of the patient (e.g., narrow
portions of the esophagus). For example, an operator can transition
the image capture assembly 1245 between configurations to avoid
portions of the patient (e.g., the esophagus) that are particularly
susceptible to trauma.
[0041] The CAD 1200 can further include a retrieval tension member
1260 that can be operable to decouple the image capture assembly
1245 of the CAD 1200 from the TEE imager head 1130. As shown, for
example, in FIG. 1B, a distal end portion of the retrieval tension
member 1250 can be coupled to the coupling member 1250 of the CAD
1200, and an opposite, proximal end portion of the retrieval
tension member 1260 can be coupled to a CAD handle 1280. The CAD
handle 1280 can include a holding device or member that can be used
to hold and/or control the retrieval tension member 1260 extending
from the CAD handle 1280 during TEE intubation and removal of the
CAD 1200 from the patient. The holding device or member can be
configured to releasably attach to a proximal end portion of the
TEE device 1100 (e.g., a proximal portion of the TEE body 1120).
Further, in some instances, the CAD handle 1280 can include or be
coupled to an actuator or the like that can be operable in
releasing the coupling member 1250 of the CAD 1200 from the TEE
imager head 1130. In this manner, in use, for example, with the TEE
device 1100 (and the image capture assembly 1245 removably attached
thereto) disposed within a target region of the esophagus, an
operator can pull, actuate and/or otherwise manipulate the holding
device or member, handle, actuator or the like of the CAD handle
1280, and in turn, pull, actuate, and/or otherwise manipulate the
retrieval tension member 1250 to release the coupling member 1250
of the image capture assembly 1245 from the TEE imager head 1130
and withdraw the retrieval tension member through the digestive
system and out the patient, leaving the TEE device 1100 disposed
within the esophagus. In some instances, the CAD handle 1280 can be
used by the operator to manipulate movement of the retrieval
tension member 1260 and/or the coupling member 1250, and/or to
actuate the coupling member 1250. In instances in which the image
capture assembly 1245 is reconfigurable between configurations, as
discussed in further detail herein, the CAD handle 1280 can be used
to transition the image capture assembly 1245 between its
configurations.
[0042] As shown in FIG. 2C, the image capture assembly 1245 of the
CAD 1200 is configured to removably or releasably attach to the TEE
imager head 1130 via the coupling member 1250. The coupling member
1250 can be configured to releasably attach to the TEE imager head
1130 in any suitable manner and can include any suitable fastening
feature (e.g., mount(s), notch(es), groove(s), indent(s), slot(s),
shoulder(s), adhesive(s), latch(es), magnetic coupling(s),
electromagnetic coupling(,) threaded coupling(s), a friction fit,
an interference fit, a snap-fit, and/or the like).
[0043] In some instances, the coupling member 1250 can include a
concave portion configured to receive and/or circumscribe at least
in part a portion of the TEE imager head 1130. By receiving a
portion of the TEE imager head 1130 in the concave portion of the
coupling member 1250, the combined cross-sectional area of the TEE
imager head 1130 and the image capture assembly 1245 of the CAD
1200 can be desirably small while providing coupling retention
forces sufficient to maintain coupling between the TEE imager head
1130 and the coupling member 1250 during movement of the TEE device
1100 and CAD device 1200 through the patient's digestive system.
The coupling member 1250 can be configured to resist any suitable
force. For example, in some instances, the coupling member 1250 can
be configured to resist forces up to about 10 Newton (N). In such
instances, the coupling member 1250 can be configured to release
from the TEE imager head 1130 in response to a force above about 10
N (e.g., 11 N). As another example, in some instances, the coupling
member 1250 can be configured to resist forces up to about 15 N. In
such instances, the coupling member 1250 can be configured to
release from the TEE imager head 1130 in response to a force above
about 15 N (e.g., 16 N). In use, for example, an operator can apply
a force (for example, via the tension member 1260) exceeding the
force at which the coupling member 1250 is configured to resist
when releasably attached to the TEE imager head 1130 to decouple
the coupling member 1250 from the TEE imager head 1130. As
discussed in more detail herein, the operator can apply the force
at the CAD handle 1280.
[0044] In some instances, the coupling member 1250 can include a
magnetic mechanism configured to releasably attach to the TEE
imager head 1130 by magnetic force. In use, with the coupling
member 1250 releasably attached to the TEE imager head 1130 by the
magnetic mechanism, an operator can apply a force (e.g., pull the
retrieval tension member 1260) sufficient to overcome the magnetic
force of the magnetic mechanism to release the coupling member 1250
from the TEE imager head 1130.
[0045] In some instances, the coupling member 1250 can include an
electromagnetic mechanism (e.g., one or more electromagnets)
configured to releasably attach to the TEE imager head 1130 by
electromagnetic force when energized. In such instances, the
electromagnetic mechanism can be energized (e.g., receive an
electric current) via the communication line 1220 by an energy
source configured to be located outside the patient during the TEE
intubation. The electromagnetic mechanism of the coupling member
1250, when energized, can produce a magnetic field sufficient to
releasably attach to the TEE imager head 1130. In this manner, in
use for example, the electromagnetic mechanism can be energized and
releasably attached to the TEE imager head 1130 prior to inserting
the TEE device 1100 into the patient. With the TEE device disposed
in a target region (e.g., the esophagus) within the patient, the
electromagnetic mechanism can be deenergized to release the
coupling member 1250 from the TEE imager head 1100. An operator can
control the electric current sent to the coupling member 1250. For
example, in some instances, the energy source can be located at
and/or controlled at the CAD handle 1280. In other instances, the
energy source can be located and/or controlled at a control device
(not shown) separate from the CAD handle 1280 of the CAD 1200.
[0046] In some instances, the coupling member 1250 can include a
mechanical latch configured to releasably attach to the TEE imager
head 1130 when the mechanical latch is disposed in its engaged
configuration. The mechanical latch can be configured to transition
to a disengaged position to release the coupling member 1250 from
the TEE imager head 1130. The mechanical latch can be controlled
remotely by the operator. For example, the mechanical latch can be
operably coupled to the CAD handle 1280 via the retrieval tension
member 1260. In this manner, the CAD handle 1280 can be operable to
cause the mechanical latch to transition between its engaged and
disengaged configurations.
[0047] In some instances, the coupling member 1250 can be formed
such that it can be deformed (compressed and/or expanded) and, when
released, return to its original (undeformed) shape. To achieve
this, the coupling member 1250 can include or be formed from
materials, such as metals or plastics, for example, that have shape
memory properties. For example, in some instances, the coupling
member can include or be formed from Nitinol.RTM.. In such
instances, the Nitinol.RTM. can be treated (e.g., heated to a
martensitic temperature, and then quenched) such that it can
readily revert to its memory shape at a calibrated temperature.
With such properties, the coupling member 1250, when heated (and
expanded) can be disposed about the TEE imager head 1130, and then
allowed to cool. When cooled, the coupling member 1250 can be
sufficiently releasably coupled to the TEE imager head for
insertion into and movement through the esophagus of the patient.
With the TEE imager head disposed in a target region within the
esophagus, heat can be conveyed to the coupling member 1250 to
expand and thereby release the coupling member 1250 from the TEE
imager head 1130. With the coupling member 1250 released from the
TEE imager head, the image capture assembly 1245 can be withdrawn
from the patient, leaving the TEE device 1100 disposed within the
patient (e.g., within the target region of the esophagus).
[0048] In some instances, the coupling member 1250 can include
and/or define a sleeve configured to circumscribe at least in part
the TEE imager head 1130. The sleeve can include any suitable
release mechanism. For example, in some instances, the sleeve can
include a threaded seam. In this manner, a portion of the thread
can be configured to extend from the coupling member 1250 when the
coupling member 1250 is disposed within, for example, the target
region of the esophagus, through the esophagus and out the mouth of
the patient such that an operator can pull or otherwise manipulate
the thread to open the threaded seam. In some instances, the thread
can be coupled to the retrieval tension member 1260, and the
retrieval tension member 1260 can be pulled and/or otherwise
manipulated to pull the thread a distance sufficient to open the
threaded seam. With the threaded seam opened, the sleeve of the
coupling member 1250 is allowed to release from the TEE imager head
1130. With the coupling member 1250 released from the TEE imager
head 1130, the image capture assembly 1245 can be withdrawn from
the patient, leaving the TEE device 1100 disposed within the
patient (e.g., within the target region of the esophagus).
[0049] In yet further instances, in addition to or instead of the
threaded seam, the sleeve of the coupling member 1250 can include a
sliding mechanical fastener, such as a zipper. In such instances,
the coupling member 1250 can be releasably coupled to the TEE
imager head 1130 by sliding the sleeve about the TEE imager head
1130 and sliding or otherwise manipulating a slider of the zipper
to transition the zipper to its engaged configuration. The slider
of the sleeve can be operably coupled to the distal end portion of
the retrieval tension member 1260. In use, for example, with the
sleeve of the coupling member 1250 disposed about the TEE imager
head, the zipper engaged, and the TEE imager head 1130 disposed in
a target region with the patient, an operator can pull or otherwise
manipulate the retrieval tension member 1260 (and/or the CAD handle
1280) to slide the slider a distance sufficient to release the
sleeve from the TEE imager head 1130. With the sleeve disengaged
from the TEE imager head 1130, the image capture assembly 1245 can
be withdrawn from the patient, as described in more detail
herein.
[0050] In some instances, the coupling member 1250 can be
configured to not obstruct an imaging array of the TEE device 1100
when the coupling member 1250 is coupled to the TEE imager head
1130. In this manner, the coupling member 1250 can be configured to
not compromise image data to be captured by the TEE device 1100. In
other instances, for example, the coupling member 1250 can include
an imaging window defined such that the imaging window does not
obstruct the imaging array of the TEE device 1100 when the coupling
member 1250 is coupled to the TEE imager head 1130. In yet further
instances, for example, a portion of the coupling member 1250 can
be transparent to energy (e.g., ultrasound) transmitted from and
received by the imaging array to allow the energy to pass through
the portion of the coupling member 1250 when the coupling member
1250 is releasably attached to the TEE imager head 1130. In this
manner, the coupling member 1250 can be coupled to the TEE imager
head 1130 without interfering with imaging operations of the TEE
imager head 1130.
[0051] In some embodiments, for example, in which a coupling member
is configured to be coupled to a TEE imager head without
interfering with imaging operations of the TEE imager head, in use,
the coupling member can remain coupled to the TEE imager head
throughout the intubation procedure, including during removal of
the TEE probe from the patient. In such instances, the image
capture device can provide image data captured within the patient's
digestive system during insertion of the TEE probe, and/or during
removal of the TEE probe, with the image capture device attached to
the TEE imager head.
[0052] In some instances, the image capture assembly 1245, or any
portions thereof (e.g., the illumination device 12340, the image
capture device 1240, the coupling member 1250), can be
monolithically constructed, while in other instances, one or more
of the portions of the image capture assembly 1245 can be formed
separately and then joined together. Further, the image capture
assembly 1245, or any portions thereof, can include one or more
seals configured to withstand bodily fluid. For example, in some
instances, it is important to seal the electronics of the image
capture assembly 1245 (e.g., the image capture device 1240 and the
illumination device 1230) from any potentially compromising bodily
fluids (e.g., bodily fluids of the esophagus and/or the stomach of
the patient). In this manner, the electronic components can be
protected from such fluids.
[0053] During retrieval and removal of the CAD 1200 from the
digestive system of the patient, it is desirable to limit and/or
prevent excessive contact with the esophagus (e.g., trauma to the
wall of the esophagus, esophageal and/or pharyngeal perforation)
and associated anatomy by the CAD 1200. Said another way, with the
coupling member 1250 decoupled from the TEE imager head, it is
desirable to control and/or define at least in part a removal
profile of the CAD 1200 from patient. To that end, the CAD 1200 can
include a tension coupler 1270, as shown for example in FIGS. 2B
and 2C, configured to slidably engage with the TEE body 1120 of the
TEE device 1100. With the tension coupler 1270 slidably coupled to
and/or engaged with the TEE body 1120, and with the TEE device 1100
and the CAD 1200 disposed in the esophagus and the coupling member
1250 of the CAD 1200 released from the TEE imager head 1130, the
retrieval tension member 1260 can be controlled and/or retained
close to the TEE body 1120 as the retrieval tension member 1260 is
withdrawn proximally through the esophagus and out the mouth of the
patient. In this manner, the CAD 1200 can be withdrawn through the
esophagus in a controlled manner to limit and/or avoid undesirable
contact with surrounding anatomy. Said another way, the tension
coupler 1270 can define at least in part a removal profile of the
CAD 1200 through the digestive system of the patient.
[0054] The tension coupler 1270 can include any suitable mechanism
configured to slidably engage with the TEE body 1120 to control
and/or define the removal profile of the CAD 1200 from the TEE
device 1100 and the patient. For example, in some instances, the
tension coupler 1270 can include one or more rings and/or straps
configured to wrap around or otherwise be disposed about the TEE
body 1120. In such instances, for example, as an operator pulls or
otherwise manipulates the CAD handle 1280 and/or the retrieval
tension member 1260 to withdraw the CAD 1200 from the patient, a
distance between the retrieval tension member 1260 and the TEE body
1120 is defined and/or limited by a size (e.g., a diameter or
perimeter) of the rings and/or straps.
[0055] In some instances, the tension coupler 1270 can include a
magnetic mechanism configured to releasably attach to the TEE body
1120 by magnetic force. For example, the tension coupler 1270 can
include one or more electromagnets configured to releasably attach
to the TEE body by electromagnetic force when the one or more
electromagnets are energized. Similar to the discussion with
respect to the coupling member 1250 having an electromagnetic
mechanism, the electromagnets of the tension coupler 1270 can be
deenergized to release the tension coupler 1270 (and in turn at
least a portion of the retrieval tension member 1260) from the TEE
body 1120.
[0056] As described above, the image data captured by the image
capture device 1240 can be conveyed to the graphical display device
1210 of the CAD 1200 via the communication line 1220, e.g., during
TEE intubation. In some instances, the graphical display device
1210 can be the same device at which image data captured by the TEE
device 1100 is displayed. In this manner, an operator can view both
image data captured by the TEE device 1100 and the image capture
device 1240 at a single graphical display device 1210. In other
instances, the image data captured by the image capture device 1240
and the image data captured by the TEE device 1100 can be displayed
at separate graphical display devices. For example, in such
instances, the image data captured by the image capture device 1240
can be displayed at the graphical display device 1210, and the
image data captured by the TEE device 1100 can be displayed at an
echocardiography machine distinct and/or separate from the
graphical display device 1210. In some instances, the graphical
display device 1210 can be wearable by the operator. For example,
in such instances, the graphical display device 1210 can include an
eyepiece in which an operator can view in real-time (e.g., during
the TEE intubation) the image data captured by the image capture
device 1240 of the CAD 1200.
[0057] FIG. 3 shows a schematic flow diagram of a method of using a
camera assist device (CAD) to assist an intubation procedure using
a transesophageal echocardiography endoscopic (TEE) device,
according to an embodiment. The method 100 includes releasably
attaching an image capture assembly (the image capture assembly
1245 of the CAD 1200, or any other image capture assembly described
herein) to a distal portion of a TEE device, at 102.
[0058] With the TEE device coupled to the image capture assembly,
the method 100 further includes inserting, after the releasably
attaching, the TEE device coupled to the image capture assembly
into an oral cavity of a patient, at 104. The method 100 further
includes viewing, after the releasably attaching, a display of
image data (e.g., a graphical representation) of an esophagus of
the patient captured by the image capture assembly, at 106. The
method 100 further includes moving, while viewing the display of
image data, the TEE device coupled to the image capture assembly
within the esophagus, at 108. In this manner, an operator can
visualize insertion of TEE device into the patient to avoid, for
example, undesirable perforations of tissue therein. The method 100
further includes detaching, with both the TEE device and the image
capture assembly disposed within the esophagus of the patient, the
image capture assembly from the TEE device (e.g., the TEE imager
head of the device), at 110. The method 100 further includes
removing, after the detaching the image capture assembly from the
TEE device, via the esophagus, and with the TEE device disposed at
least in part within the esophagus, the image capture assembly from
the patient, at 112.
[0059] FIGS. 4-13 illustrate an embodiment of a CAD 2200 that can
be used to assist intubation of a TEE probe (also referred to
herein as "TEE device"). As shown schematically in side view in
FIG. 4, the CAD 2200 is removably attached to the TEE probe 2100.
The TEE probe 2100 includes a TEE body 2120 having a TEE imager
head 2130 coupled to its distal end and a TEE controller (not
shown) coupled to its, opposite, proximal end. The TEE imager head
2130 includes an imaging array 2132 configured to capture image
data of, for example, a heart of the patient. For example, with the
imager head 2130 disposed within the esophagus of a patient, the
imager head 2130 can be configured to transmit ultrasound waves to
the heart and receive waves deflecting and/or rebounding therefrom.
An image processor (not shown) can transform the image data (e.g.,
ultrasound waves) and transmit the transformed data to a visual
display (not shown) outside the patient. In this manner, with the
TEE imager head 2130 disposed within the patient (e.g., within the
esophagus of the patient), an operator (e.g., a cardiologist) can
view from outside the patient a graphical representation of the
heart and surrounding anatomy inside the patient.
[0060] To facilitate such insertion of the TEE imager head 2130,
the CAD 2200 can be removably coupled to the TEE imager head 2130
(as shown by FIG. 4) prior to and during the insertion into and
passage through the esophagus of the patient to provide the
operator with real-time images of the passageway and surrounding
anatomy. With access to such real-time images, the operator can
limit or avoid undesirable and/or inadvertent contact with the
esophagus and/or associated anatomy, thereby limiting and/or
preventing complications, and in extreme circumstances, mortality.
Additionally, with such access to real-time images, the operator
can easily and repeatedly locate various regions of interest within
the esophagus in which to dispose the TEE imager head 2130 for
imaging of the heart and other anatomy. After assistance from the
CAD 2200 in moving the TEE imager head 2130 in the esophagus to a
target region of the esophagus (e.g., a region in which the TEE
imager head 2130 can send signals to and receive signals from
target anatomy, such as the heart), the CAD 2200 can be decoupled
and/or removed from the TEE imager head 2130. With the CAD 2200
decoupled from the TEE imager head 2130, the CAD 2200 can be
withdrawn proximally through the esophagus 24, oral cavity 22, and
out the mouth 21 of the patient, leaving the TEE imager head 2130
disposed within the target region of the esophagus 24.
[0061] In this embodiment, the CAD 2200 includes an image capture
device 2240 configured to capture image data within a digestive
system of a patient, and a coupling member 2250 configured to
releasably attach to the TEE imager head 2130 of the TEE device
2100 (the image capture device 2240 and the coupling member 2250
collectively referred to herein as "image capture assembly 2245").
FIGS. 8A-8F illustrate various detailed views of the image capture
assembly 2245. As discussed in further detail herein, the image
capture device 2240 can be configured to send the image data it
captures across a communication line 2220 extending from the image
capture device 2240 to a graphical display device 2210. The
graphical display device 2210 can be configured to display a
graphical representation of the image data, thereby providing an
operator of the TEE device 2100 with visual access in real-time to
various portions within the digestive system of the patient.
[0062] The image capture device 2240 includes a sensor 2242 and a
lens 2244, and is configured to transmit image data captured within
the patient to the graphical display device 2210 disposed outside
the patient via the communication line 2220, as shown in FIG. 5. As
shown, the lens 2244 is disposed at a distal end portion of the
image capture assembly 2245. In this manner, the image capture
device 2240 can capture image data immediately distal to and/or
immediately downstream of the image capture assembly 2245. FIG. 7
shows the cross-sectional view identified as B-B in FIG. 5 of the
image capture device 2240. As shown in FIG. 7, the image capture
device 2240 defines an aperture 2246 through in which the lens 2244
is disposed, and the lens defines a pathway through which the
sensor 2242 can communicate with a target area to capture image
data. Also as shown, the image capture device defines an
illumination aperture 2232 through which the illumination device
2230 can communicate to illuminate at least a portion of the target
area.
[0063] In some instances, the image capture device 2240 can include
an image processor (not shown) configured to process the image data
such that the image data can be graphically displayed on the
graphical display device 2210. In other instances, for example, to
allow for a smaller form factor of the image capture device 2240,
processing of the image data can occur entirely outside the patient
and distinct from the image capture device 2240. In such instances,
the image data can be processed, for example, at an image processor
of the graphical display device 2210. In yet further instances, the
image data can be processed at an image processor separate from
both the graphical display device 2210 and the image capture device
2240, and the sent to the graphical display device 2210 to be
displayed. In some instances, the image capture device 2240 can
include wireless capabilities. For example, in such instances, the
image capture device 2240 can communicate wirelessly with an image
processor and/or the graphical display device 2210. In this manner,
image data can be transmitted from the image capture device 2240
when disposed within the patient to outside the patient without any
physical wires.
[0064] In some instances, the image capture device 2240 can be
controlled remotely via the communication line 2220. For example,
in such instances, the image capture device 1240 can receive via
the communication line 2220 a signal including instructions to
capture one or more images. In some instances, the image capture
device 2240 can receive power via the communication line 2220 from
a power source external to patient. In other instances, the image
capture device 2240 can include a power source (e.g., a battery)
configured to store power sufficient for operation of the image
capture device 2240. As shown best by FIG. 8F in cross-sectional
side view, the image capture assembly 2245 defines a communication
lumen 2225 through which the electronics of the image capture
device 2240 can communicate with the communication line 2220.
[0065] In some instances, the image capture device 2240 can include
a lens filter (e.g., ultraviolet filter, infrared filter, etc.)
(not shown). An image filter can provide an operator of the CAD
2200 visual indicators within the patient's digestive system. For
example, in some instances, when moving the CAD 2200 within the
patient, an operator may want to avoid certain weak portions (or
portions otherwise particularly susceptible to damage and/or
trauma) of the digestive system (e.g., esophagus). In such
instances, a lens filter can provide visual indicators to the
operator when a graphical representation of the image data is
displayed.
[0066] The CAD 2200 further includes a retrieval tension member
2260 that is operable to decouple the image capture assembly 2245
of the CAD 2200 from the TEE imager head 2230. As shown, a distal
end portion of the retrieval tension member 2250 is coupled to the
coupling member 2250 of the CAD 2200, and an opposite, proximal end
portion of the retrieval tension member 2260 can be coupled to a
CAD handle 2280. FIG. 6 shows the cross-sectional view identified
as A-A in FIG. 5 of the retrieval tension member 2260. As shown in
FIG. 6, the retrieval tension member 2260 defines multiple tension
member lumens through which the communication line 2220 is routed.
In this embodiment, the retrieval tension member 2260 defines three
tension member lumens, i.e., 2262A, 2262B, and 2262C, however, in
alternative embodiments, the retrieval tension member 2260 can
define any suitable number of lumens. In this embodiment, for
example, the communication line 2220 can include an image data
wire, a power wire, and an illumination wire, each of which can be
routed through one of the tension member lumens 2262A, 2262B,
2262C. In embodiments in which a retrieval tension member includes
one or more electromagnetic tension couplers, the communication
line can include one or more electromagnetic actuation wires that
can be routed through one or more of the tension member lumens
2262A, 2262B, 2262C.
[0067] As shown in FIG. 5, a portion (e.g., an image data wire) of
the communication line 2220 can be routed through a communication
lumen 2285 of the CAD handle 2280 and communicatively coupled to
the graphical display device 2210. Further, a portion (e.g., a
power wire, an illumination wire, etc.) of the communication line
2220 can be routed through communication lumen 2285 of the CAD
handle 2280 and communicatively coupled to a CAD controller 2290.
The CAD controller 2290 is operable (e.g., by an operator) to
control the electronic components of the CAD 2200. For example, a
user can manipulate the CAD controller 2290 to instruct the image
capture device 2240 to capture one or more images. As another
example, the CAD controller 2290 is operable to send power to the
image capture device 2240 and/or the illumination device 2230. In
alternative embodiments in which the retrieval tension member 2260
includes electromagnetic tension couplers, the CAD controller can
be operable to energize and/or deenergize the electromagnetic
tension couplers.
[0068] The CAD handle 2280 is removably coupled to a proximal
portion of the TEE body 2120, and can be used to hold and/or
control the retrieval tension member 2260 extending from the CAD
controller 2280 during TEE intubation and removal of the CAD 2200
from the patient. In some instances, for example, in use, the CAD
handle 2280 can be removably coupled to the TEE device 2100 (as
shown in FIG. 4) during TEE intubation and until the operator is
ready to withdraw the CAD 2200 from the patient. In this manner,
undesirable slack in the retrieval tension member 2260 and/or in
the communication line 2220 can be limited and/or avoided. Said
another way, with the coupling member 2250 removably coupled to the
TEE imager head 2130, the CAD handle 2280 can be pulled such that
the retrieval tension member 2260 is substantially taught. With the
retrieval tension member 2260 substantially taught, the CAD handle
2280 can be removably coupled to the proximal portion of the TEE
body 2120, as shown in FIG. 4.
[0069] Further, as shown in FIG. 4, the communication line 2220 is
routed through a lumen of the retrieval tension member 2260. In
this manner, the communication line 2220 extending from the image
capture assembly 2245 to the CAD handle 2280 can be shielded or
otherwise protected by the retrieval tension member 2260. Although
not shown, the CAD handle 2280 can include an aperture through
which the communication line 2220 can be routed. From the CAD
handle 2280, the communication line 2220 can be routed to any
suitable device (e.g., an image processor, the graphical display
device 2210, a power source, etc.).
[0070] As shown, the image capture assembly 2245 of the CAD 2200 is
configured to removably attach to the TEE imager head 2130 via the
coupling member 2250. The coupling member 2250 includes a concave
portion configured to receive and/or circumscribe at least in part
a portion of the TEE imager head 2130. By receiving a portion of
the TEE imager head 2130 in the concave portion of the coupling
member 2250, the combined cross-sectional area of the TEE imager
head 2130 and the image capture assembly 2245 of the CAD 2200 can
be desirably small while providing coupling retention forces
sufficient to maintain coupling between the TEE imager head 2130
and the coupling member 2250 during movement of the TEE device 2100
and CAD device 2200 through the patient's digestive system. In this
embodiment, the coupling member 2250 is configured to releasably
attach to the TEE imager head 2130 by an interference fit. In this
manner, with the coupling member 2250 releasably attached to the
TEE imager head 2130, the coupling member 1250, due to the
interference fit, is configured to resist release from the TEE
imager 2130 in response to forces falling short of a threshold
force. As such, the coupling member 2250 can be configured to
remain attached to the TEE imager head 2130 during insertion into
and movement through the patient. For example, from insertion
through the mouth through the larynx and to the esophagus of a
patient, in some instances, the coupling member 2250 may experience
its greatest forces as it moves through the larynx, as the larynx
often includes the smallest diameter lumen and sharpest turn in TEE
intubation procedures (e.g., in a normally functioning digestive
tract). With such design considerations, the coupling member 2250
can be configured to withstand such forces without undesirably
releasing from the TEE imager head 2230.
[0071] Further, in response to forces exceeding the threshold
force, the coupling member 2250 can be configured to release from
the TEE imager head 2230. For example, in use, a user can pull,
withdraw, or otherwise manipulate the CAD handle 2280 to apply a
longitudinal proximal force (via the retrieval tension member 2260)
to the coupling member 2250 exceeding the threshold force, thereby
causing the coupling member 2250 to decouple from the TEE imager
head 2130. In some instances, the coupling member 2250 can be
configured resist a threshold force up to about 10 N. In other
instances, the coupling member 2250 can be configured to resist a
threshold force up to about 15 N.
[0072] Further, as shown in FIG. 4, the coupling member 2250 is
configured to releasably attach to the TEE imager head 2230 without
obstructing the imaging array 2132 of the TEE device 2100. In this
manner, the TEE device 2100 and the CAD 2200 can capture image data
simultaneously when the coupling member 2250 is releasably attached
to the TEE imager head 2130.
[0073] As described with respect to other embodiments herein, the
image data captured by the image capture device 2240 can be
conveyed to the graphical display device 2210 of the CAD 2200 via
the communication line 2220, e.g., in real-time during TEE
intubation. In some instances, the graphical display device 2210
can be the same device at which image data captured by the TEE
device 2100 is displayed. In this manner, an operator can view both
image data captured by the TEE device 2100 and the image capture
device 2240 at a single graphical display device. In other
instances, the image data captured by the image capture device 2240
and the image data captured by the TEE device 2100 can be displayed
at separate graphical display devices. For example, in such
instances, the image data captured by the image capture device 2240
can be displayed at a first graphical display device (e.g., the
graphical display device 2210), and the image data captured by the
TEE device 2100 can be displayed at a second graphical display
device (e.g., an echocardiography machine) distinct and/or separate
from the first graphical display device. In some instances, the
first and/or second graphical display device can be wearable by the
operator. For example, in such instances, the first and/or second
graphical display device can include an eyepiece in which an
operator can view in real-time (e.g., during the TEE intubation)
the image data captured by the image capture device 2240 of the CAD
2200 and/or the image data captured by the TEE imager head 2130 of
the TEE device 2100.
[0074] In use, to assist intubation of the TEE probe 2100, the
image capture assembly 2245 of the CAD 2200 is removably attached
to the TEE imager head 2130 of the TEE device 2100, and inserted
with the TEE imager head 2130 into the mouth 21 of the patient, as
shown in FIG. 10. As described in further detail herein, the image
capture device 2240 of the image capture assembly 2245 is
configured to capture and send image data in real-time (i.e.,
during the intubation procedure) to the graphical display device
2210 disposed outside the patient. With access to a graphical
illustration of such image data, and with the image capture
assembly 2245 inserted through the mouth 22, the operator can move
(in the direction illustrated by arrow A) the TEE imager head 2130
and the image capture assembly 2245 toward and through the oral
cavity 22 of the patient. Further, while viewing a real-time
graphical representation of the patient's anatomy surrounding
and/or downstream of the image capture assembly 2250 and the TEE
imager head 2230, the operator can move the TEE imager head 2130
distally towards and into the esophagus 24 of the patient until the
TEE imager head 2130 reaches a target region (as evidenced by the
graphical representation of the image data captured by the image
capture device 2240), as shown in FIG. 11. Although not shown in
FIG. 11, the operator can move the TEE imager head 2130 further
distally and dispose the TEE imager head 2130 in the patient's
stomach 25.
[0075] With the TEE imager head 2130 located within the target
region of the esophagus, the operator can decouple the CAD handle
2280 from the TEE body 2220, and pull the CAD handle 2280
proximally to release the coupling member 2250 from the TEE device
2100, as described in further detail above. As shown in FIG. 12,
with the coupling member 2250 released from the TEE device 2100,
the operator can further pull the CAD handle 2280 proximally (in
the direction illustrated by arrow B) such that the retrieval
tension member 2260 and the image capture assembly 2245 are
withdrawn proximally through the esophagus 24 of the patient,
leaving the TEE imager head 2130 disposed within the target region
of the esophagus 24, as shown in FIG. 12. As shown in FIG. 13, the
operator can further pull the CAD handle 1280 proximally to remove
the CAD 2200 entirely from the patient.
[0076] FIGS. 14-19 illustrate an embodiment of a CAD 3200 that can
be used to assist intubation of a TEE probe (also referred to
herein as "TEE device"). The CAD 3200 can be constructed and
function similar to any of the CADs described herein, e.g., the CAD
1200, the CAD 2200, etc.). Thus, some details regarding the CAD
3200 are not described below. It should be understood that for
features and functions not specifically discussed, those features
and functions can be the same as or similar to any of the CADs
described herein.
[0077] As shown in FIG. 14, the CAD 3200 includes an image capture
assembly 3245 configured to be removably coupled to a TEE imager
head 3130 of a TEE device 3100. Similar to previous embodiments,
the image capture assembly 3245 includes an illumination device
3230, an image capture device 3240 having a lens 3244, and a
coupling member 3250. As shown, the image capture assembly 3245 is
disposed about the TEE imager head 3130 such that the lens 3244 is
aligned with the distal end of the TEE imager head 3130. In this
manner, the image capture device 3240 can capture image data
immediately distal and/or adjacent to the distal end of the TEE
imager head 3130. In alternative embodiments, an image capture
assembly can be disposed about a TEE imager head such that a lens
of the image capture assembly is aligned distal to the distal end
of the TEE imager head. In this embodiment, the coupling member
3250 defines a sleeve configured to entirely circumscribe a portion
of the TEE imager head 3130, as shown in FIG. 14.
[0078] In some instances, the sleeve of the coupling member 3250
can be configured to not obstruct an imaging array (not shown) of
the TEE device 3100 when the coupling member 3250 is coupled to the
TEE imager head 3130, as shown in FIG. 14. In this manner, the
coupling member 3250 can be configured to not compromise image data
to be captured by the TEE device 3100. In other instances, for
example, the sleeve of the coupling member 3250 can define an
imaging window such that the imaging window does not obstruct the
imaging array of the TEE device 3100 when the coupling member 3250
is coupled to the TEE imager head 3130. In this manner, the TEE
imager head 3130 can capture image data conveyed through the
imaging window of the coupling member 3250 when the coupling member
3250 is releasably attached to the TEE imager head 3130. In yet
further instances, for example, a portion of the coupling member
1250 can be transparent to energy (e.g., ultrasound) transmitted
from and received by the imaging array to allow the energy to pass
through the portion of the coupling member 1250 when the coupling
member 1250 is releasably attached to the TEE imager head 1130.
[0079] With the coupling member 3250 releasably attached to the TEE
imager head 3130, the coupling member 3250 can provide a friction
fit with the TEE imager head 3130 such that the coupling member
3250 can resist longitudinal movement relative to the TEE imager
head 3120 in response to a force below a threshold force, similarly
as described with respect to previous embodiments. For example, the
coupling member 3250 can be configured to remain releasably
attached to the TEE imager head 3130 during insertion into and
movement through the patient. For example, from insertion through
the mouth through the larynx and to the esophagus of the patient,
in some instances, the coupling member 3250 may experience its
greatest forces as it moves through the larynx, as the larynx often
includes the smallest diameter lumen and sharpest turn in such TEE
intubation procedures (e.g., in a normally functioning digestive
tract). With such design considerations, the coupling member 3250
can be configured to withstand such forces without undesirably
releasing from the TEE imager head 3230.
[0080] Further, in response to a force (e.g., a longitudinal force
in the proximal direction) exceeding the threshold force, the
coupling member 3250 can be configured to release from the TEE
imager head 3230. For example, in use, a user can pull, withdraw,
or otherwise manipulate the CAD handle 3280 to apply a longitudinal
proximal force (via the retrieval tension member 3260) to the
coupling member 3250 exceeding the threshold force, thereby causing
the sleeve of the coupling member 3250 to overcome the frictional
forces between the sleeve and the TEE imager head 3130 such that
the coupling member slides proximally relative to the TEE imager
head 3130. In some instances, the coupling member 3250 can be
configured to resist a threshold force up to about 10 N. In other
instances, the coupling member 3250 can be configured to resist a
threshold force up to about 15 N.
[0081] In some instances, the sleeve of the coupling member 3250
can be formed of a flexible material. In such instances, when
decoupling the coupling member 3250 from the TEE imager head 3130
(e.g., causing the coupling member 3250 to slide proximally about
and relative to the TEE imager head 3130), the sleeve can radially
expand about the TEE imager head 3130 in response to the
longitudinal proximal force applied by the retrieval tension member
3260. As the sleeve radially expands, the longitudinal proximal
forces to overcome the friction fit decrease.
[0082] In some instances, the sleeve of the coupling member 3250
can allow for a softer and thinner material to be used, thereby
reducing potential complications due to contact with, for example,
the esophagus of the patient. For example, with the sleeve
configured to circumscribe and slide about and/or along the TEE
device 3100, the sleeve can be formed of soft and relatively thin
material.
[0083] In use, to assist intubation of the TEE probe 3100, the
image capture assembly 3245 of the CAD 3200 is removably attached
to the TEE imager head 3130 of the TEE device 3100, and inserted
with the TEE imager head 3130 into the mouth 21 of the patient, as
shown in FIG. 16. As described with respect to previous
embodiments, the image capture device 3240 of the image capture
assembly 3245 is configured to capture and send image data in
real-time (i.e., during the intubation procedure) to the graphical
display device 3210 disposed outside the patient. With access to a
graphical illustration of such image data, and with the image
capture assembly 3245 inserted through the mouth 22, the operator
can move (in the direction illustrated by arrow A) the TEE imager
head 3130 and the image capture assembly 3245 toward and through
the oral cavity 22 of the patient. Further, while viewing a
real-time graphical representation of the patient's anatomy
surrounding and/or downstream of the image capture assembly 3250
and the TEE imager head 3230, the operator can move the TEE imager
head 3130 distally towards and into the esophagus 24 of the patient
until the TEE imager head 3130 reaches a target region (as
evidenced by the graphical representation of the image data
captured by the image capture device 3240), as shown in FIG.
17.
[0084] With the TEE imager head 3130 located within the target
region of the esophagus, the operator can decouple the CAD handle
3280 from the TEE body 3220, and pull the CAD handle 3280
proximally to slidably release the coupling member 3250 from the
TEE device 3100, as described in further detail above. As shown in
FIG. 18, with the coupling member 3250 slidably released from the
TEE device 3100, the operator can further pull the CAD handle 3280
proximally (in the direction illustrated by arrow B) such that the
retrieval tension member 3260 and the image capture assembly 3245
are withdrawn proximally through the esophagus 24 of the patient,
leaving the TEE imager head 3130 disposed within the target region
of the esophagus 24, as shown in FIG. 18. More specifically, as
shown, the operator can pull the CAD handle 3280 proximally such
that the image capture assembly 3245 slides proximally about and
along the TEE body 3120 of the TEE device 3100 through the
esophagus 24 of the patient. As shown in FIG. 19, the operator can
further pull the CAD handle 3280 proximally to slide the image
capture assembly 3245 along the TEE body 3120 and out the mouth 21
of the patient. Further as shown in FIG. 19, with the image capture
assembly 3250 removed from the patient, the coupling member 3250
can be detached completely (e.g., cut) from the TEE body 3120 (and
in turn the TEE device 3100).
[0085] FIG. 20 illustrates an embodiment of a CAD 4200 that can be
used to assist intubation of a TEE probe (also referred to herein
as "TEE device"). The CAD 4200 can be constructed and function
similar to any of the CADs described herein, e.g., the CAD 1200,
the CAD 2200, the CAD 3200, etc.). Thus, some details regarding the
CAD 4200 are not described below. It should be understood that for
features and functions not specifically discussed, those features
and functions can be the same as or similar to any of the CADs
described herein.
[0086] As described with respect to previous embodiments, during
retrieval and removal of a CAD from the digestive system of the
patient, it is desirable to limit and/or prevent excessive contact
with the esophagus (e.g., trauma to the wall of the esophagus,
esophageal and/or pharyngeal performation) and associated anatomy
by the CAD. Said another way, with the coupling member decoupled
from the TEE imager head, it is desirable to control and/or define
at least in part a removal profile of the CAD from patient. To that
end, in this embodiment, the CAD 4200 includes includes multiple
tension couplers 4270, configured to slidably engage with the TEE
body (not shown) of the TEE device (not shown). With the tension
coupler 4270 slidably coupled to and/or engaged with the TEE body,
and with the TEE device and the CAD 4200 disposed in the esophagus
and the coupling member 4250 of the CAD 4200 released from the TEE
imager head, the retrieval tension member 4260 can be controlled
and/or retained close to the TEE body as the retrieval tension
member 4260 is withdrawn proximally through the esophagus and out
the mouth of the patient. In this manner, the CAD 4200 can be
withdrawn through the esophagus in a controlled manner to limit
and/or avoid undesirable contact with surrounding anatomy. Said
another way, the tension coupler 4270 can define at least in part a
removal profile of the CAD 4200 through the digestive system of the
patient.
[0087] In this embodiment, each of the tension couplers 4270
includes a magnetic mechanism configured to releasably attach to
the TEE body by magnetic force, or to couple the opposite ends of
each tension coupler 4270 to each other. In some instances, the
magnetic mechanism can include permanent magnets, while in other
instances, the magnetic mechanism can include an electromagnetic
mechanism. In some instances, the tension couplers 4270 can include
a combination of permanent magnets and electromagnetic mechanisms.
In either case, for example, as an operator pulls or otherwise
manipulates the CAD handle 4280 and/or the retrieval tension member
4260 to withdraw the CAD 4200 from the patient, a distance between
the retrieval tension member 4260 and the TEE body is defined
and/or limited by the length of each tension coupler 427, with the
ends held together by one or both of the permanent magnet or the
electromagnetic mechanism when energized. In instances in which the
tension coupler 4270 includes an electromagnetic mechanism, the
electromagnetic mechanism can be controlled (i.e., energized and/or
deenergized) from the CAD controller 4290 to release the tension
coupler 4270 (and in turn at least a portion of the retrieval
tension member 4260) from the TEE body.
[0088] While various embodiments have been described above, it
should be understood that they have been presented by way of
example only, and not limitation. Where methods described above
indicate certain events occurring in certain order, the ordering of
certain events may be modified. Additionally, certain of the events
may be performed concurrently in a parallel process when possible,
as well as performed sequentially as described above.
[0089] Where schematics and/or embodiments described above indicate
certain components arranged in certain orientations or positions,
the arrangement of components may be modified. While the
embodiments have been particularly shown and described, it will be
understood that various changes in form and details may be made.
Any portion of the apparatus and/or methods described herein may be
combined in any combination, except mutually exclusive
combinations. The embodiments described herein can include various
combinations and/or sub-combinations of the functions, components
and/or features of the different embodiments described.
* * * * *