U.S. patent application number 11/115040 was filed with the patent office on 2005-12-08 for optical transesophageal echocardiography probe.
Invention is credited to Aviv, Jonathan E., Corwin, Steven, DiTullio, Marco R., Homma, Shunichi.
Application Number | 20050273012 11/115040 |
Document ID | / |
Family ID | 23167625 |
Filed Date | 2005-12-08 |
United States Patent
Application |
20050273012 |
Kind Code |
A1 |
Aviv, Jonathan E. ; et
al. |
December 8, 2005 |
Optical transesophageal echocardiography probe
Abstract
The present invention concerns an optical transesophageal
echocardiography probe (OPTEE) having an optical fiber bundle, a
suction channel and light channels for illumination, wherein the
OPTEE has a circumference along its distal tip that allows both
safe insertion and insures the stability of the probe. The probe
tip is generally circular in circumference, but levels off to a
flat surface for a portion of the circumference, and is provided
with beveled edges and corner throughout so that there are no sharp
edges to traumatize the patient. The invention also concerns an
optically-recessed OPTEE comprising an optical transesophageal
probe comprising a longitudinally extending main body having an
outer surface and a substantially circular cross-section and a
distal portion having an outer surface and a distal tip, wherein an
optical bundle having a distal tip is positioned on the outer
surface of the main body and the outer surface of the distal
portion and the distal tip of the optical bundle does not extend as
far as the distal tip of the distal portion.
Inventors: |
Aviv, Jonathan E.; (New
York, NY) ; Homma, Shunichi; (New York, NY) ;
DiTullio, Marco R.; (New York, NY) ; Corwin,
Steven; (New York, NY) |
Correspondence
Address: |
WOLF, BLOCK, SHORR AND SOLIS-COHEN LLP
250 PARK AVENUE
10TH FLOOR
NEW YORK
NY
10177
US
|
Family ID: |
23167625 |
Appl. No.: |
11/115040 |
Filed: |
April 26, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11115040 |
Apr 26, 2005 |
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10188357 |
Jul 1, 2002 |
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6884220 |
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60302410 |
Jun 29, 2001 |
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Current U.S.
Class: |
600/478 |
Current CPC
Class: |
A61B 1/07 20130101; A61B
1/2733 20130101; A61B 8/12 20130101 |
Class at
Publication: |
600/478 |
International
Class: |
A61B 006/00 |
Claims
We claim:
1. An optical transesophageal echocardiography probe comprising a
probe shaft, a transition zone having a generally circular
cross-section and a probe tip reduced in at least one dimension,
wherein said probe tip is provided with a flat surface.
2. The probe of claim 1, wherein the end of said probe tip is
rounded.
3. The probe of claim 1, wherein edges of the probe tip are
beveled.
4. The probe of claim 1, wherein the transition zone has edges that
are beveled.
5. The probe of claim 1, wherein the probe also comprises at least
one viewing channel, at least one suction channel, and at least one
illumination channel.
6. The probe of claim 1, wherein the horizontal dimension of the
cross-section of probe tip is substantially equal to or greater
than the diameter of the probe shaft.
7. The probe of claim 6, where the horizontal dimension of the
cross-section of probe tip is from about 1.2 to about 2.0 times the
diameter of the probe shaft.
8. The probe of claim 1, wherein the vertical dimension of the
cross-section of probe tip is equal to or slightly less than the
diameter of the probe shaft.
9. The probe of claim 8, wherein the vertical dimension of the
cross-section of distal tip is slightly less than the diameter of
the probe shaft.
10. An optical transesophageal probe comprising a longitudinally
extending main body having an outer surface and a substantially
circular cross-section and a distal portion having an outer surface
and a distal tip, wherein an optical bundle having a distal tip is
positioned on the outer surface of the main body and the outer
surface of the distal portion and the distal tip of the optical
bundle does not extend as far as the distal tip of the distal
portion.
11. The probe of claim 10, wherein the probe distal portion has a
flat surface.
12. The probe of claim 11, where the flat surface is a lateral flat
surface that comprises one or more ultrasound transducers.
13. The probe of claim 10, wherein the optical bundle comprises an
illumination source and a viewing means.
14. The probe of claim 13, where the optical bundle comprises fiber
optic fibers that deliver illumination and transmit an image to a
viewer or viewing means.
15. The probe of claim 10, wherein there is more than one optical
bundle.
16. The probe of claim 10 wherein one optical bundle is positioned
opposite to a lateral flat surface.
17. The probe of claim 10, wherein all or a portion of the optical
bundle is partly received in a groove or channel in the outer
surface of the main body and/or the distal portion.
18. The probe of claim 10, wherein all or a portion of each optical
bundle is affixed or adhered to the outer surface of the main body
and/or distal portion.
19. The probe of claim 18, wherein a sheath encircles at least a
portion of the outer surface of the main body and/or the distal
portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/188,357, filed Jul. 1, 2002, which in turn
is based upon commonly assigned U.S. provisional patent application
Ser. No. 60/302,410, filed Jun. 29, 2001, both of which are
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to an optical transesophageal
echocardiography probe (OPTEE). More particularly, the present
invention relates to an optical transesophageal echocardiography
probe having an optical fiber bundle to allow real-time
visualization of the structures that are transversed as the OPTEE
is passed via the mouth into the esophagus, wherein the probe has a
unique profile which allows passage into the esophagus with a
minimum amount of trauma to the patient.
BACKGROUND OF THE INVENTION
[0003] Clinical experience with traditional transesophageal
echocardiography (TEE) has shown that a number of patients have
experienced significant complications as a result of the standard
blind passage of the probe via the mouth into the esophagus. By
"blind", it is meant that the traditional TEE probe never had a way
for the physician passing the probe to actually see where he or she
was going as the probe was passed via the mouth into the throat and
then into the esophagus. The delicate voice box and throat
structures sit directly between the mouth and the esophagus. All
other medical and surgical specialties passing instruments in this
area do so under direct, real-time visualization. Since
approximately 30% of patients undergoing TEE are completely
anti-coagulated, the risk of significant injury to the vocal cords
and throat when a patient's blood is thin is great. As the standard
TEE probe is quite large in diameter--approximately 15 mm (as
opposed to most GI and ENT endoscopes, which are around 3-8
mm)--passing such a large instrument without seeing precisely where
it is going can, and often does, results in considerable untoward
complications for the patient. These complications have included
perforation of the hypopharynx and esophagus, tearing of the throat
tissues, and vocal cord injury. The solution to this problem is to
develop a TEE probe that provides the probe passer, i.e., the
physician, with the ability to actually see what structures he or
she is traversing on the way from the mouth to the esophagus.
[0004] A number of prior art references are known:
[0005] U.S. Pat. No. 5,749,833, which issued to Hakki et al. on May
12, 1998, discloses an esophageal probe with a rounded tip for ease
of insertion;
[0006] U.S. Pat. No. 4,567,882, which issued to Heller on Feb. 4,
1986, discloses an endotracheal tube with a fiberoptic light
conducting means;
[0007] U.S. Pat. No. 5,382,231, which issued to Shlain on Jan. 17,
1995, discloses a transesophageal probe with light conducting and
suction means;
[0008] U.S. Pat. No. 5,105,819, which issued to Wollschlager et al.
on Apr. 21, 1992, discloses a probe for use in transesophageal
echocardiography;
[0009] U.S. Pat. No. 4,327,738, which issued to Green et al. on May
4, 1982, discloses an endoscope for use in esophageal probes
utilizing optical means to aid the user by direct viewing of the
area being intubated;
[0010] U.S. Pat. No. 4,605,009, which issued to Pourcelot et al. on
Aug. 12, 1986, discloses an optical viewing endoscope having
utility in the esophagus. An ultrasonic imaging means for internal
organs is employed with the optical means;
[0011] U.S. Pat. No. 5,505,584, which issued to Matsuura on Sep.
24, 1991, discloses an endoscope with a reduced size distal tip to
mitigate pain during insertion;
[0012] U.S. Pat. No. 5,217,456, which issued to Narciso on Jun. 8,
1993, discloses an intra-vascular optical imaging system;
[0013] U.S. Pat. No. 5,213,093, which issued to Swindle on May 25,
1993 discloses an intravascular optical imaging system; and
[0014] U.S. Pat. No. 4,319,563, Kubota on Mar. 16, 1982, discloses
an endoscopic device having a distal end face formed into a smooth,
spherical convexity.
OBJECTS OF THE INVENTION
[0015] It is therefore an object of the present invention to
provide a transesophageal echocardiography probe which allows
real-time visualization of the structures that are traversed as the
probe is passed via the mouth into the esophagus.
[0016] It is also an object of the invention to provide a
transesophageal echocardiography probe which allows for the direct
suctioning of secretions and debris that may obscure direct passage
of the probe into the esophagus.
[0017] It is a further object of the present invention to provide a
transesophageal echocardiography probe which reduces the trauma
experienced by the patient upon insertion and passage of the TEE
probe through the mouth to the esophagus.
[0018] It is yet another object of the present invention to provide
a transesophageal echocardiography probe which possesses a
cross-sectional configuration such that the TEE probe more easily
and smoothly passes into a patient's esophagus.
[0019] It is a yet further object of the present invention to
provide a transesophageal echocardiography probe which has an
optically-recessed fiber bundle.
[0020] These and other objects of the invention will become more
apparent from the discussion below.
SUMMARY OF THE INVENTION
[0021] The present invention provides for an optical
transesophageal echocardiography probe having an optical fiber
bundle to allow real-time visualizations of the structures that are
transversed as the OPTEE is passed via the mouth into the
esophagus. The probe has a unique profile which allows passage into
the esophagus with a minimum amount of trauma to the patient.
[0022] In one embodiment the transesophageal echocardiography probe
of the present invention is provided with a specially designed
circumference along its distal tip that allows both safe insertion
for the patient and insures stability of the ultrasound portion of
the probe tip. Patient safety is enhanced by making most of the
probe tip circumference a circular shape. The stability of the
ultrasound transducer is enhanced by having the round shape level
off to a flat surface. The transition from a round profile to a
flat profile is made by beveling the edges of the endoscope along
its distal tip. Beveling the edges of the probe tip also decreases
the chance of a probe edge lacerating tissue surfaces in the
patient's passageway.
[0023] In another embodiment of the invention the TEE probe has an
optically-recessed fiber bundle. This configuration facilitates
visualization of the actual tip of the TEE probe while allowing
real-time visualization of the structures that are traversed as the
TEE probe is passed via the mouth into the esophagus. Preferably
this embodiment has a small suction channel for directly suctioning
secretions and debris that may obscure direct passage of the probe
into the esophagus.
[0024] The construction and obvious advantages of the system
provided for by the present invention will become more clearly
understood from the following description of the various specific
embodiments when read in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 is a schematic representation of a side elevational
view of the distal end of one embodiment of an optical
transesophageal echocardiography probe according to the
invention;
[0026] FIG. 1A is a top view of the embodiment of an optical
transesophageal echocardiography probe shown in FIG. 1;
[0027] FIG. 2 is a schematic representation of a cross-sectional
view across line 2-2 of the end sectional view of the optical
transesophageal echocardiography probe shown in FIG. 1;
[0028] FIG. 3 is a schematic representation of a cross-sectional
view across line 3-3 of the main section of the embodiment of an
optical transesophageal echocardiography probe shown in FIG. 1;
[0029] FIG. 4 is a schematic representation of a bottom view
showing the undersurface of the distal end of the embodiment of an
optical transesophageal echocardiography probe shown in FIG. 1;
[0030] FIG. 5 is a schematic representation of an end longitudinal
view of the embodiment of an optical transesophageal
echocardiography probe shown in FIG. 1 showing the various
fiberoptic, suction and light channels located therein;
[0031] FIG. 6 is a schematic representation of the distal end of
the dorsal surface of another embodiment of an optical
transesophageal echocardiography probe according to the
invention;
[0032] FIG. 7 is a schematic representation of a lateral view of
the distal end of the probe shown in FIG. 6; and
[0033] FIG. 8 is a schematic representation of a lateral view of
the embodiment of FIGS. 6 and 7 with a sheath.
DETAILED DESCRIPTION OF THE INVENTION
[0034] The present invention is directed to an optical
transesophageal echocardiography probe having an optical fiber
bundle to allow real-time visualizations of the structures that are
transversed as the OPTEE is passed via the mouth into the
esophagus. The probe has a unique profile which allows passage
thereof into the esophagus with a minimum amount of trauma to the
patient.
[0035] In one embodiment the probe of the invention has at least
the following distinguishing features:
[0036] The present invention provides for the first
echocardiography probe to have channels for optics and for
suction.
[0037] The OPTEE probe tip has a flat inferior surface that tapers
from a circular profile, thus slightly narrowing its diameter and
shape towards its tip. This allows for smoother insertion into the
esophagus while still permitting flat contact between the
ultrasound sensor and the esophageal wall.
[0038] The point where the probe shifts from circular to a
circle-with-flat-inferior-aspect contains beveled edges so as to
minimize trauma.
[0039] The present invention solves the problem of blindly passing
a large caliber probe over some of the most delicate structures
that exist in the head and neck. In addition, direct visualization
of TEE probe passing will necessarily reduce some of the most
severe, life-threatening complications of this procedure such as
perforation of the throat and esophagus, tearing of the throat
tissues, vocal cord damage and traumatic airway obstruction.
[0040] The transesophageal echocardiography probe of the present
invention in a first embodiment is provided with a specially
designed configuration along its distal tip that allows both safe
insertion for the patient and insures stability of the ultrasound
portion of the probe tip. The stability of the ultrasound
transducer is enhanced by having the round shape level off to a
flat surface. The transition from a round profile to a flat profile
is made by beveling the edges of the endoscope along its distal tip
and lateral edges. Beveling the edges of the probe tip also
diminishes the chance of a probe edge lacerating tissue surfaces in
the patient's passageway.
[0041] In another embodiment of the invention the probe has an
optically recessed tip. More particularly, the distal tip of a
longitudinally extending optical fiber bundle ends a set distance
short of the actual distal end of the distal tip. In addition,
there is a suction channel to remove debris and help keep the
viewing field clear.
[0042] The invention can perhaps be better appreciated from the
drawings. FIGS. 1 to 3 are schematic representations of side
elevational, top, and cross-sectional views of the distal portion
of an optical transesophageal echocardiography probe according to
the invention. A distal portion 10 of a probe shaft 12 is a
transition zone between substantially circular cross-section 12 and
flat-bottomed, bevel edged tip 14, which has a lower flat surface
16. A distal end 18 of tip 14 has beveled edges 20, as are
transition portions 22 from portion 10 to tip 14 and, optionally,
edges of flat surface 16.
[0043] A probe according to the invention will typically be about
100 cm long and be flexible and steerable, preferably in the up and
down directions. Also, typically the diameter of the probe shaft
will be about 10-12 mm and the diameter of the probe distal portion
will be about 1-2 mm greater in the first embodiment and about 6-8
mm greater in the second embodiment described below. The probes
will also have construction elements, e.g., proximal control units,
similar to TEE probes sold by Agilent/Philips and Siemens, as would
be appreciated by those skilled in the art. With regard to the
embodiment set forth in FIGS. 1 to 3, the effective vertical
dimension of the cross-section of tip 14 will be preferably about
the same as the diameter of probe shaft 12, and the effective
horizontal dimension of the cross-section of tip 14 will be from
about 1.2 to about 2.0, preferably from about 1.3 to about 1.7,
times the diameter of probe shaft 12 or distal portion 10. The
diameter of distal portion 10 will be substantially equal to, or
preferably slightly greater than, the diameter of probe shaft 12.
It is within the scope of the invention that the horizontal
dimension of the cross-section of tip 14 and/or the cross-section
of distal tip 18 can be less than described before, even less than
the diameter of shaft 12, so long as the vertical dimension of the
cross-sectional area is no greater than substantially equal to or
less than the effective diameter of distal portion 10 or the
diameter of probe shaft 12.
[0044] FIG. 4 is a schematic representation of a bottom view of the
distal portion 10 of the optical transesophageal echocardiography
probe 12 of FIGS. 1 to 3. Flat surface 16 of tip 14 has viewing
window or windows 24. Optionally surface 16 can comprise one or
more ultrasound transducers as element 24. Also shown are beveled
edges 20.
[0045] FIG. 5 is a schematic representation of an end cordinal view
of the transesophageal echocardiography probe according to FIGS. 1
to 3. Shown are flat surface 16 of tip 14. Also shown are optional
fiberoptic cable channel 26, suction channel 28, and illumination
channels 30.
[0046] In the embodiment of the invention shown in FIG. 6 in a
dorsal view, a TEE probe 40 has a longitudinally extending optical
bundle 42 arranged opposite to an ultrasound transducer site (not
shown). Optical bundle 42, which preferably comprises a fiber optic
bundle of illumination and viewing fibers, terminates in distal end
44 on probe distal portion 48. Channel distal end 44 is not
coexistensive with distal end 50 of TEE probe 40 and terminates
short of distal end 50 a sufficient distance 52 to facilitate
visualization of distal end 50. The site of distal end 44 can be
adjusted or varied. However, distal end 44 is intended to provide a
viewing field that preferably partly includes a portion of distal
end 50 so that the physician can visualize distal end 50 with
regard to the structures being traversed. Preferably the distance
52 between distal end 44 and distal end 50 is from about 5 mm to
about 10 mm, more preferably from about 1 to 8 mm.
[0047] As shown in FIG. 7, optical bundle 42 of TEE probe 40 is
slightly recessed in the outer surface of probe 40. Preferably
bundle 42 is sufficiently recessed that the working profile of
probe 40 is substantially the same as it would be without bundle
42.
[0048] As shown in FIGS. 6 and 7, optical bundle 42 can be
positioned opposite the flat transducer surface 58, and optical
bundle 52 can be slightly recessed in a groove or channel in the
outer surface of probe 40. It is also within the scope of the
invention that there could be more than on optical bundle 42 and
that each bundle 42 could be positioned other than directly
opposite transducer surface 56. Also, each optical bundle 42 need
not be recessed but could be affixed or adhered to the outer
surface of probe 40 with glue, bands, or the like. In one
embodiment, as shown in FIG. 8, a sheath 60 arranged around a probe
62 holds an optical bundle 64 (shown in dotted lines) in position
between sheath 60 and probe 62, where the distal end 66 of bundle
64 is at or slightly distal to the distal end 68 of sheath 60.
Sheath 60 may have a cutout section (not shown) so that it does not
cover any transducer in transducer surface 70. Alternatively, a
combination of a less extending sheath and other means to keep the
optical bundle in place, may be used.
[0049] It will be further apparent to one skilled in this art that
the improvements provided for in the present invention, while
described with relation to certain specific physical embodiments
also lend themselves to being applied in other physical
arrangements not specifically provided for herein, which are
nonetheless within the spirit and scope of the invention taught
here.
* * * * *