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Patent 2375168 Summary

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(12) Patent Application: (11) CA 2375168
(54) English Title: AN OPTICAL PROBE ACCESSORY DEVICE FOR USE IN IN VIVO DIAGNOSTIC PROCEDURES
(54) French Title: ACCESSOIRE DE SONDE OPTIQUE POUR DIAGNOSTICS IN VIVO
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 5/00 (2006.01)
  • A61B 1/00 (2006.01)
  • A61B 19/00 (2006.01)
(72) Inventors :
  • NORDSTROM, ROBERT (United States of America)
  • BEE, DAVID (United States of America)
  • MODELL, MARK (United States of America)
  • HED, ZE'EV (United States of America)
  • KWO, JENNIE (United States of America)
  • EMANS, MATTHEW (United States of America)
(73) Owners :
  • MEDISPECTRA, INC. (United States of America)
(71) Applicants :
  • MEDISPECTRA, INC. (United States of America)
(74) Agent: MBM INTELLECTUAL PROPERTY LAW LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2000-06-09
(87) Open to Public Inspection: 2000-12-14
Examination requested: 2001-12-03
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2000/016014
(87) International Publication Number: WO2000/074556
(85) National Entry: 2001-12-03

(30) Application Priority Data:
Application No. Country/Territory Date
60/138,235 United States of America 1999-06-09
09/481,762 United States of America 2000-01-11

Abstracts

English Abstract




The present invention recognizes that optical probes function both as medical
access devices and as instruments which collect complex optical data. The
invention provides an optical probe accessory device which can access luminal
spaces within the body of a patient without sacrificing the quality of optical
data obtained. The accessory device further comprises either, singly, or in
combination, selectable features or options which optimize light transmission,
maximize patient comfort, and provide single-use capabilities.


French Abstract

L'invention, qui part du principe qu'une sonde optique joue à la fois le rôle de dispositif médical d'accès et celui d'instrument de recueil de données optiques complexes, consiste en un accessoire de sonde optique pouvant accéder à des lumières du corps du patient sans sacrifier la qualité des données optiques obtenues. Ledit accessoire présente, seules ou en combinaison, des caractéristiques ou options choisissables optimisant la transmission de lumière, augmentant le confort du patient, et en faisant un produit uniservice.

Claims

Note: Claims are shown in the official language in which they were submitted.



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CLAIMS

1. An accessory device for an optical probe comprising a body and an
attachment element for
attaching the accessory device to the probe, said attachment element detaching
from the body
of the accessory device when the accessory device is removed from the probe,
thereby
preventing re-use of the accessory device.
2. The accessory device of claim 1, wherein said attachment element includes a
grasping
element and wherein grasping said grasping element detaches said attachment
element from
the body of the accessory device.
3. The accessory device of claim 2, wherein the grasping element is a tab or
snap ring.
4. The accessory device of claim 1, wherein the attachment element is
conformable to an end of
the probe bearing illumination optics.
5. The accessory device of claim 4, wherein the attachment element is flexible
and the body of
the accessory device is rigid.
6. The accessory device of claim 1, wherein the attachment element is
separated from the body
of the accessory device by perforations and wherein rupturing said
perforations detaches the
attachment element from the body of the accessory device.
7. The accessory device of claim 1, wherein at least a portion of the device
is made of a shrink-
fitted material.
8. The accessory device of claim 7, wherein the shrink-fitted material is
shrinkable using heat.
9. The accessory device of claim 7, wherein the accessory device can be rolled
up before and
after use with an optical probe.
10. An accessory device for an optical probe, comprising an integral light-
focusing element.


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11. The accessory device of claim 10, wherein said integral light-focusing
element includes
an annular lens.
12. The accessory device of claim 10, wherein the accessory device comprises
an end for
attachment to said optical probe and an end distal to said end for attachment
including an
integral faceted mirror.
13. The accessory device of claim 10, wherein the accessory device is at least
partially
transparent.
14. The accessory device of claim 13, wherein said accessory device comprises
a window.
15. The accessory device of claim 14, wherein the window is at least partially
flat.
16. The accessory device of claim 13, wherein the window functions as an
objective for an
optical probe.
17. The accessory device of claim 13, wherein the window forms a segmented
lens.
18. The accessory device of claim 10, wherein the accessory device further
includes an
illuminating light source.
19. An accessory device for use with an optical probe, comprising a connecting
ring, said
connecting ring comprising a plurality of openings sized to accept a plurality
of light
transmitting fibers from said optical probe.
20. An accessory device for an optical probe, comprising an electrical element
bearing
encoded information.
21. The accessory device of claim 20, wherein said electrical element is
encoded with
identification information.


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22. The accessory device of claim 20, wherein said electrical element enables
certain
operating modes of the device.
23. The accessory device of claim 20, wherein said electrical element is
remotely
programmable.
24. The accessory device of claim 20, wherein said electrical element is an
RFID chip.
25. A system, comprising:
a processor including a memory, said memory comprising identification
information; and
an electrical element reader for accessing information encoded in an
electrical
element and for transmitting a signal to the processor relating to information
carried by
the electrical element,
wherein the processor compares identification information encoded in the
electrical element to identification information within the memory, and
transmits
instructions based on whether or not a match is found between identification
information
encoded in the electrical element and identification information encoded in
the memory.
26. The system of claim 25, wherein if no match is found, the identification
information
encoded in the electrical element is added to the memory.
27. The system of claim 25, wherein the instructions include an instruction
which permits
an optical probe to function if no match is found.
28. The system of claim 25, wherein the instructions include an instruction
which prevents an
optical probe from functioning if a match is found.
29. The system of claim 27 or 28, further comprising:


-22-


an optical probe comprising illumination optics for illuminating a sample
and for receiving light emitted by the sample; and
an accessory device comprising an electrical element bearing
identification information which can be accessed by the electrical element
reader.
30. The system of claim 29, wherein the electrical element is remotely
programmable.
31. The system of claim 29, further comprising a light source in communication
with said
probe, and wherein transmission of light from the light source is controlled
by the
processor.
32. The system of claim 29, wherein the electrical element reader is attached
to the optical
probe.
33. The system of claim 29, wherein the electrical element reader is
integrally attached to the
optical probe.
34. The system of claim 29, wherein the electrical element reader is removably
attached to the optical probe.
35. The system of claim 30, wherein the electrical element is an RFID chip and
the electrical
element reader is a transponder.
36. The system of claim 29, wherein the electrical element further includes
information
relating to a target tissue being analyzed.
37. An accessory device for use with an optical probe and for accessing a body
space,
comprising a flexible portion for conforming to said body space.
38. The accessory device of claim 35, further comprising an electrical element
bearing
identification information.




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39. The accessory device of claim 35, further comprising an integral lens.

40. The accessory device of claim 10, further comprising an electrical element
bearing
identification information.

41. The accessory device of claim 10, further comprising a body and an
attachment element
for attaching the accessory device to the probe, said attachment element
detaching from
the body of the accessory device when the accessory device is removed from the
probe,
thereby preventing re-use of the accessory device.

Description

Note: Descriptions are shown in the official language in which they were submitted.



CA 02375168 2001-12-03
WO 00/74556 PCT/US00/16014
AN OPTICAL PROBE ACCESSORY DEVICE FOR USE IN
IN VIVO DIAGNOSTIC PROCEDURES
Related Applications
The application claims priority to U.S. Provisional Application Serial Number
60/138,235, filed on June 9, 1999 and is also a continuation-in part of U.S.
Patent Application
09/481,762, filed January 11, 2000, which claims priority to U.S. Provisional
Application Serial
Number 60/115,373, filed January 11, 1999, and is a continuation-in-part of
U.S. Patent
Application 09/241,806, filed February 2, 1999, which is a continuation-in-
part of U.S. Patent
Application 08/782,936, filed January 13, 1997. The entirety of these
applications is
incorporated by reference.
Field of the Invention
The invention relates to an accessory device for an optical probe for use in
in vivo
diagnostic procedures. The accessory device provides an optimal optical path
for light from an
optical probe while minimizing patient discomfort. The accessory device
features optional
selectable elements to enhance its versatility in in vivo diagnostic
procedures.
Background of the Invention
The early detection of disease increases the chance for successful therapeutic
intervention. Non-invasive optical diagnostic devices which detect changes in
the biochemical
and structural features of tissues provide tools to detect the early stages of
disease (e.g., cancer).
An optical device for detecting tissue features typically comprises a console
unit which includes
a light source, a detector, electronics, and a computer, in communication with
an optical probe
through which light is transmitted to and from a tissue. The optical probe can
be the end of a
fiber optic cable or can contain complex optical elements intended to shape an
output light beam
from an optical source into a desired geometry.
Optical probes coupled to endoscopic devices have been used to obtain tissue-
specific
information from patients. Representative organs which can be characterized
using an
endoscopic approach include the colon, uterus, bladder, and stomach.
Fluorescence
spectroscopy using endoscopic optical probes can distinguish between cancerous
and
precancerous tissue in these organs. However, the development of optical
probes for clinical use
has been hampered due to the difficulty of miniaturizing the optical elements
necessary for the


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collection of optical data. Additional constraints arise because an optical
probe, like any medical
access device, must be decontaminated and sterilized prior to reuse. The
delicate construction of
30 light directing and focussing elements within the optical probe generally
make it difficult, if not
impossible, to sterilize the probe.
Because it is generally not economical to discard an optical probe after a
single use, it is
desirable to provide an accessory device which acts as a shield between the
illumination optics of
the optical probe and the tissue being analyzed. While it is generally known
in the art to equip a
35 medical device with a protective barrier or sheath to provide a cover for
the device, it is desirable
to provide an accessory device for an optical probe which serves more than a
mere barner
function, but which complements the function of the optical probe.
Accordingly, the present
invention provides an accessory device for an optical probe which comprises
multiple optional
features to enhance the versatility of the device in in vivo diagnostic
procedures.
40 Summary of the Invention
The invention recognizes that optical probes function both as medical access
devices and
as instruments which collect complex optical data. The invention provides an
optical probe
accessory device which accesses luminal spaces within the body of a patient
without sacrificing
the quality of optical data obtained. The accessory device further comprises
either, singly, or in
45 combination, selectable features which optimize light transmission,
maximize patient comfort,
and provide single-use capabilities.
In one aspect of the invention, an accessory device for an optical probe is
provided which
creates an optimal light path between the optical probe and a target tissue.
Optional optical
elements are provided which enhance the light transmitting and light receiving
functions of the
50 probe. In one embodiment, an accessory device comprises optical elements
which create an
optical waveguide to improve optical data collection by the probe. In this
embodiment, the
accessory device includes a window which functions as an objective for the
optical probe's
illumination elements. In other embodiments of the invention, the window is
coated with anti-
fog and/or anti-glare agents to maximize the passage of diagnostic light to
and from the probe.
55 In still other embodiments, the accessory device is adapted to function
with an optical probe
which comprises a plurality of optical fibers and the accessory device
comprises a plurality of
openings sized to accept a plurality of light transmitting fibers from the
optical probe.
By acting as an intermediate between the optical probe and the target tissue
being
analyzed, the accessory device is not subject to the same design constraints
as the optical probe


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60 (i.e., does not have to be a certain minimum size to accommodate a
plurality of optical
elements). Accordingly, in one aspect of the invention, the accessory device
can be tailored to
conform to a particular body lumen being accessed (e.g., in one embodiment,
the cervix, in
another embodiment, an ear canal).
For example, an optical probe accessory device which comprises, at least in
portion, a
65 flexible material which conforms to the shape of a body space being
accessed is contemplated by
the present invention. The flexible portion provides a shield between the
tissue being assayed by
the optical probe and the probe itself. In another embodiment, a segment of
the flexible portion
conforms to an end of the optical probe bearing illumination optics,
protecting the illumination
optics of the probe from bodily fluids while shielding the patient from,
contaminants. In still
70 another embodiment, the flexible nature of the accessory device allows it
to be rolled up before
and after use with the probe.
In another aspect of the invention, the attachment device is a single-use,
disposable
device, allowing the optical probe to be used multiple times without
transmitting disease from
one patient to another. In this embodiment, to maximize the attachment
device's capacity to
75 protect patients from contamination, the attachment device is crippled,
either mechanically, or
electronically, after a single use, so that an optical probe will not function
with an attachment
device which has been previously used.
For example, the accessory device comprises a body and an attachment element
and is
mechanically prevented from re-use. In this embodiment, the attachment element
attaches the
80 accessory device to the probe and detaches from the body of the accessory
device when the
accessory device is removed from the probe. The accessory device is unable to
function without
the attachment element and so detachment of the accessory device from the
probe prevents its
reuse. In one embodiment, the attachment element comprises a grasping element,
such as a tab
or a snap ring which detaches the attachment element from the body of the
accessory device. In
85 a further embodiment, the attachment element is separated from the body of
the accessory device
by perforations and rupturing the perforations detaches the attachment element
from the body of
the accessory device.
In yet another embodiment, a disposable, single-use accessory device for an
optical probe
comprises an electrical element rather than a mechanical element which
prevents its re-use in
90 another patient. In one embodiment, the accessory device comprises an
electrical element
bearing encoded information (e.g., identification information). In another
embodiment, the


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electrical element is remotely programmable and the information contained
within the electrical
element can be altered by the user.
In a further aspect of the present invention, a system is provided which
comprises a
95 processor and an electrical element reader. The electrical element reader
accesses information
encoded in the electrical element carried by the accessory device and
transmits a signal to the
processor relating to identification information carried by the electrical
element. The processor
includes a memory which stores identification information and which compares
the stored
information with identification information encoded by the electrical element.
The processor
100 transmits instructions based on whether or not a match is found between
identification
information encoded in the electrical element and identification information
stored within the
memory. If no match is found, the identification information encoded in the
electrical element is
added to the memory.
The instructions transmitted by the processor control the actuation of the
optical probe.
105 For example, in one embodiment, the system includes a light source in
communication with both
the processor and the optical probe. Transmission of light from the light
source to the probe
relies upon instructions received from the processor. In another embodiment,
instructions from
the processor can include particular operating parameters relating to a tissue-
specific diagnostic
procedure (for example, but not limited to the diagnosis of cervical cancer).
Use of an accessory
110 device with an electrical element which identifies the device as one which
is suited for accessing
the cervix triggers the processor to implement operating parameters suited to
the diagnosis of
cervical cancer. Thus, the system provides flexibility that allows the optical
probe to be used
with a variety of accessory devices in a variety of diagnostic procedures.
Any or all of the foregoing optional features (the optical features to enhance
light
115 transmission, minimally invasive, tissue-conforming structural features,
mechanical or electrical
disabling elements conferring single-use capabilities) can be combined to meet
the needs of a
particular diagnostic procedure. Because of the modular nature of the optical
probe accessory
device, the optical probe itself is not limited for use in a single diagnostic
application but can be
adapted for a variety of diagnostic applications.
120 The foregoing and other objects, aspects, features, and advantages of the
invention will
become apparent from the following description and from the claims.


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Brief Description of the Drawings
The objects and features of the invention can be better understood with
reference
to the following detailed description and accompanying drawings, in which like
reference
125 characters generally refer to the same parts throughout the different
views.
Figure 1 shows a schematic representation of an accessory device for an
optical probe
according to one embodiment comprising an optical window located at an end of
the
device distal from the illumination optics of an optical probe.
130 Figure 2A and 2B show a schematic representation of an accessory device
according to one embodiment comprising a single side-looking window. Figure 2A
shows a side view of such a device. Figure 2B shows a top view.
Figure 3 shows a schematic representation of a single use accessory probe
according to one embodiment comprising a sectional transparent window.
135 Figure 4 shows a schematic representation of a single-use accessory device
according to one embodiment comprising a flexible tear-away sheath.
Figure 5 shows a single-use accessory device according to one embodiment of
the
invention comprising an electrical element for encoding identification
information.
Figures 6A-C show schematic representations of accessory devices for optical
140 probes marked with identifying information in the form of a bar code.
Figure 6A shows
an accessory device comprising a bar code on the side of the device. Figures
6B and C
show an embodiment of the invention in which the bar code is placed on an
optical
window which forms the end of the device distal to the illumination optics of
the optical
probe. Figure 6 A shows a view of the end of the device bearing the bar code.
Figure 6C
145 shows a view of the side of the device.
Detailed Description
Because an accessory device according to the invention complements the
function of an
optical probe such accessory devices provide more than merely a sheath for an
optical probe. An
accessory device of the invention comprises a number of optional features
which a user can
150 select in optimizing the accessory device to suit a particular
application. Any or all of these
options can be present in an accessory device according to the invention.
Because of the many
permutations of accessory devices which can be designed according to the
invention, the optical
probe itself acquires more versatility and can be used in a variety of
diagnostic settings. It will


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be apparent to those of skill in the art after reading this disclosure that
other options can
155 additionally be provided, and such options are encompassed within the
scope of the invention.
All that is required to practice the present invention, is that the accessory
device permit optical
data collection by an optical probe without obstruction. A number of preferred
features of a
device of the invention is discussed below. These may be used singly or in
combination with
each other or with other probe features known in the art. The skilled artisan
appreciates that
160 numerous other features may be included in a device of the invention,
either alone or in
combination.
Option 1. Maximal Light Transmission
In one aspect of the invention, the accessory device provides additional
optical features to
enhance the transmission of light from the optical probe to the tissue and
from the tissue to the
165 optical probe. According to this aspect of the invention, the user selects
optical features that are
for the accessory device that are compatible with the operation parameters of
the optical probe.
In practice, the accessory device is fabricated using material which has a
high optical
transmission over the spectral bandwidth of operation of the probe. For
example, for some
probes, obtaining an image by the probe is not as important as obtaining a
very high signal-to-
170 noise ratio from an optical response in spectral regions that do not
overlap, or only partially
overlap, the visible region of the spectrum. That is, the inclusion of
features to ensure adequate
performance of the optics to create a visual image of the sample may degrade
the performance of
the device in collecting acceptable optical signals such as fluorescence,
Raman, or reflectance
spectra.. In embodiments where image quality is not an issue, the portion of
the accessory
175 device actually transmitting an ultraviolet (UV) excitation beam (e.g.,
the end of the device distal
to the probe) can be made of a very thin Teflon~ or can comprise other
fluoroplastics such as
THV-200P~ (a TFE/HPF/VDF terfluoropolymer from the 3M~ corporation). These
plastics do
not demonstrate a significant fluorescent response when irradiated with UV.
In some embodiments, the accessory device is used with an optical probe which
functions
180 by directing light to a tissue and receiving at least fluorescent light re-
emitted from the tissue
after absorption of the excitation light, while in other embodiments, the
accessory device
receives scattered light from a target tissue, such as elastic scattered light
(e.g. reflectance
spectroscopy) or inelastic scattered light (e.g., as in Raman spectroscopy
applications). In these
embodiments, the light being directed back to the probe provides diagnostic
information relating
185 to the chemical/structural features of a tissue being analyzed rather than
its morphological


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features. An accessory device used in these applications is made of materials
which provide
minimal interference with the light being directed back towards the probe. In
a preferred
embodiment, the accessory device comprises a low-fluorescing plastic and has
high optical
transmission through the ultraviolet and visible spectral regions from 300 nm
to 750 nm.
190 In other embodiments, where imaging is a function of the probe, an
accessory device is
provided which does not fluoresce when illuminated by a laser or other light
source and has a
sufficiently large aperture or opening to collect low levels of light emitted
during fluorescence of
some samples such as tissue, good modulation transfer function for good image
transmission,
and/or a lack of color tint to preserve spectral accuracy. The accessory
device can be fabricated
195 from material including, but not limited to, UVT acrylic or amorphous
polyolefin (e.g., Zeonex~
Nippon Zeon CO., Ltd.) and the like. The skilled artisan can recognize and
identify equivalent
materials using routine experimentation and routine testing.
The type of optical probe, and hence the type of accessory device used, will
depend upon
the particular diagnostic application required. For example, in diagnosing
cervical tissue
200 pathologies, in some instances it is desirable to obtain both imaging and
non-imaging optical
information. This combination of modalities is important when spatial location
of biopsy sites is
the output of the optical device. In this embodiment, an accessory device
should be selected
which creates minimal interference with the spectroscopic functions of the
device, and has good
imaging capability to locate specific tissue sites. . However, when the
application is ASCUS
205 Triage (Atypical Squamous Cells of Undetermined Significance Triage), non-
imaging
information is more important, because determining the location of the
abnormal tissue is not
necessary. Here, an accessory device can be used which is not suited for
imaging purposes. In a
third instance, the optical probe can be used as an adjunct to a standard pap
smear test. In this
embodiment, a non-imaging device is suitable. .
210 The present invention also contemplates that the optical features of the
accessory device
include optical elements which complement the function of the optical probe.
In one
embodiment, the accessory device includes a flat window which permits passage
of diagnostic
light to and from the optical probe without distortion. Window materials
include, but are not
limited to, cast or molded polymethylmetacrylate (PMMA) and other materials
which provide no
215 significant fluorescence in response to an excitation beam. By way on non-
limiting examples,
polystyrene or polycarbonate are two such materials. The placement of the
window on the
accessory device is selected to optimize the collection of light from a tissue
being analyzed. In
one embodiment, shown in Figure 1, the window 11 is at the end of the
accessory body 10 most


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_g_
distal from the probe. In another preferred embodiment, shown in Figures 2A-B
and Figure 3,
220 the window is provided on the side of the accessory device, giving the
opportunity to gather
optical information from the side as the device is moved along or through a
sample. The
window can be configured in a variety of shapes. In the embodiment shown in
Figures 2A and
2, the accessory device comprises a circular window 13. In the embodiment
shown in Figure 3,
the window is a transparent section 15 of the accessory device.
225 In another preferred device, the window is fastened onto the end of a
cylindrical- or
toroidal-shaped ring segment that is press-fitted onto the accessory device,
forming an annular
lens which functions as an objective for the optical probe's illumination
elements. The wall
thickness of the ring segment on which the window/lens sits is designed to
allow the accessory
device to act as an optical waveguide to direct light onto target tissues for
better visualization or
230 data collection. In one embodiment of the invention, the wall thickness of
the ring segment is
between about 0.5 mm and 2.0 mm . The window itself can form a lens, or
alternatively, a lens
can be added to the window as a separate element. For example, the window can
be segmented
so that a portion of the structure is flat (i.e., optically passive), while
other portions are curved
(i.e., forming lens segments).
235 In another accessory device contemplated by the invention, a delivery
apparatus is
operably connected to the window for dispensing a fluid which has an index of
refraction
matching the window or other exposed optical elements in the accessory device
and/or optical
probe. Delivery devices encompassed within the scope of the invention include
a bead or other
container residing in a space defined by the ring segment which can be caused
to break and
240 discharge its fluid. Fluid from the delivery device spreads downward by
capillary force to fill
the space between optical elements in the accessory device (e.g., such as the
window itself) and
the optical probe. In another embodiment, the window is coated with an anti-
fog agent or an
anti-glare agent. In still a further embodiment, the accessory device is
provided with a flexible
sleeve which covers the window and serves a protective function.
245 The accessory device of the present invention can also be adapted to
include other optical
elements to facilitate the acquisition of diagnostic data, such as filters,
polarizers, or light
reflecting elements. For example, in one embodiment of the invention, the
distal end of the
accessory device includes a reflecting element such as an integral faceted
mirror. In a further
embodiment, the reflecting element is in the shape of a cone which has a half
angle of 45 degrees
250 . A light beam impinging on one of the facets of the reflecting element
will be reflected at a 90
degree angle to the incident light causing it to be emitted laterally from the
distal end of the


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accessory device, allowing light to be efficiently directed to the target
tissue within the lumen the
accessory device is accessing. A light-focusing element can additionally be
provided in optical
communication with the reflecting element in order to focus light beams
appropriately on the
255 target tissue. In still further embodiments of the invention, reflecting
elements are provided
within the body of the accessory device in optical communication with a
window. In the
embodiment of the invention shown in Figure 2B, the reflective element is a
reflective planar
surface 14. In the embodiment of the invention shown in Figure 3, the
reflecting element is a
conical surface which directs light from the optical probe towards the
transparent sectional
260 window 15. It should be apparent to those a skill in the art that a
variety of shapes of reflecting
surfaces can be provided and positioned to optimize the light path from the
optical probe to the
window of the accessory device.
In embodiments of the invention where the optical probe being used with the
accessory
device comprises a plurality of optical fibers, a reflecting element can be
provided whose
265 number of facets correspond to the number of excitation fibers in the
probe, creating an optimal
light path between the target tissue and light from the optical probe through
the accessory device.
In this embodiment, the accessory device can also be configured to attach to
the probe in way
that further optimizes this light path. For example, in one preferred
embodiment, the accessory
device is fitted onto the probe via a connecting ring which comprises openings
designed to adapt
270 to a particular configuration of optical fibers (e.g., bundled or spaced).
Attachment of the probe
to the accessory device can only be achieved by correctly aligning optical
fibers with appropriate
regions in the accessory device. In one instance, the optical probe comprises
a plurality of pins
which fit into holes in the connecting ring of the accessory device only when
the accessory
device is positioned in a specific orientation, ensuring the proper
orientation of the optical probe
275 with respect to the accessory device.
Additionally, the accessory device can be adapted to provide a light source
for evenly
illuminating a tissue being visualized. In one embodiment, the accessory
device includes an
illuminating light source positioned around the circumference of the accessory
device. The
illuminating light source can be an integral part of the device or can be
snapped on by a ring
280 mechanism.
In applications where visible marking or tagging specific regions of the
sample is
necessary or important, the accessory device is provided with a dispenser
capable of directing a
marking fluid toward the sample. The fluid can be applied to localized regions
of the sample for
identifying selected regions, or it can be dispensed over a broad region of
the sample, as a bath


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285 or wash. The purpose of the bath or wash may be to affect chemical changes
in the sample to aid
in the identification of substances in or characteristics of the sample. For
example, in optical
detection of pre-cancerous lesions of the cervix, the application of a mild
acetic acid wash
increases the contrast and visibility of the regions of suspicious lesions.
Other types of fluids that can be used to enhance visualization of the sample,
include
290 hypertonic, hypotonic, hyperosmotic, and hypo-osmotic solutions. Hyper- or
hypo-osmotic
solutions can be generated in a number of ways, such as by using distilled
water, either alone, or
in combination with ionic or nonionic molecular constituents. Varying the
hydrogen ion
concentration of a fluid (e.g., pH) can generate additional visualization-
enhancing agents. Dye
solutions can also be applied such as, for example, Lugol's iodine, toluidine
blue or methylene
295 blue, and others.
Option 2. Minimal Invasiveness, Tissue-Conforming Structure
The accessory device can be designed to conform to a particular lumen being
accessed,
thus minimizing the invasive effect of the accessory device. In one
embodiment, the accessory
device comprises a flexible portion which provides a shield between the tissue
being assayed and
300 the optical probe while at the same time maximizing patient comfort by
adapting itself to any
space being accessed by the device. In one embodiment, the flexible accessory
device can be in
the form of an inflatable balloon into which a fluid (e.g., an index-matching
fluid)is inserted to
partially inflate the structure. Balloons can be made from compliant
materials, such as
polyethylene, latex (natural or synthetic), polyurethane, and silicone, or non-
compliant materials,
305 such as polyethylene terephthalate (PET).
When brought into contact with the tissue, the flexible accessory device
distributes the
contact pressure of the device evenly over the entire contact surface (such as
a body lumen),
while the index-matching fluid provides good optical communication with the
tissue. In another
embodiment, the flexible portion also conforms to the end of the optical probe
bearing
310 illumination optics, shielding the illumination optics of the probe from
body fluids, while
simultaneously shielding the patient from contamination by the probe. In this
embodiment of the
invention, the accessory device comprises, at least in portion, a shrink-
fitted material (e.g., which
can be shrunk using heat). A heating element (such as, but not limited to, a
resister) can be
included-in the shrink-fitted material such that shrinkage is triggered when a
voltage is applied to
315 the resistor. Alternatively, the material can be shrunk using a heating
device such as a hand-held
hairdryer. Because of the flexible nature of the accessory device, it can be
packaged in a rolled


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up state (e.g., in a sterile wrapper) to be unrolled over the optical probe
when it is ready to be
used.
In one embodiment, the accessory device comprises both a flexible portion and
a rigid tip
320 portion. The length and diameter of the tip portion is selected to be
optimal for accessing a
particular body lumen and to provide for the effective transmission of
diagnostic light from the
optical probe, while the flexible portion of the accessory device is conformed
like a skirt and is
proximal to the end of the optical probe bearing illumination optics. The
flared and flexible
nature of the flexible portion minimizes patient discomfort from the entry of
any portion of the
325 optical probe itself into the body cavity being accessed. The flexible
material and the rigid
portion of the accessory device can be molded as a single unit or can be
molded separately and
connected together
The optical probe accessory device according to the present invention can also
be
designed for a particular anatomic application, e.g., for obtaining
information relating to tissue
330 features of the gastrointestinal tract, the urinary tract, the peritoneal
cavity, the thorax, ear canal,
and the female reproductive tract. Other organs suitable for endoscopic or
percutaneous access
will be apparent to those of ordinary skill in the art. In each of these
cases, the accessory device
is designed as a probe with a particular geometry adapted for the body region
towards which it is
directed. In one embodiment of the invention, an accessory device is provided
for use with an
335 optical probe used in the cervix. In this embodiment, the accessory device
covers the sides of the
probe that encounters the vaginal walls and additionally covers the end of the
optical probe
comprising illumination optics. In a further embodiment, the accessory device
is designed to at
least partially cover an optical probe and is capable of passing, with the
probe, through a distal
aperture of an endoscope. In this embodiment, the accessory device is
accordingly limited in
340 sized to conform to the dimensions of the body cavity being accessed and
the dimensions of the
endoscope.
In still other embodiments of the invention, the accessory device is designed
to transmit
light from an optical probe to the surface of a tissue which is not accessed
through a lumen, for
example, the skin, or breast tissue, or tissue within an open surgical field.
345 Option 3. Single-Use Device
In accordance with the present invention, a single-use accessory device is
provided for at
least partially covering an optical probe. In one embodiment, the accessory
device entirely
covers the probe, while in another embodiment, the accessory device covers or
shield those parts


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of the probe adapted for contact with a body tissue of a patient. As defined
herein, the term
350 "single-use" is understood to mean that the use of the accessory device is
restricted to use with a
single patient. However, in some embodiments, use can be confined to a single
diagnostic
measurement.
In one preferred embodiment according to this aspect of the invention, the
accessory
device comprises both a body and an attachment element for attaching the
accessory device to
355 the probe wherein the device is mechanically prevented from re-use. For
example, the accessory
device comprises a breakable element to allow for physical breakage of at
least a portion of the
device upon removal from the optical probe. The attachment element according
to this
embodiment includes at least one breakable portion which must be broken in
order to remove the
accessory device from the probe. Breaking the breakable portion cripples the
accessory device,
360 preventing its reattachment and re-use. In another embodiment, the
breakable portion includes a
grasping element, such as a tab or snap ring, and grasping the grasping
element results in
breaking the body of the accessory device from the attachment element. In
still another
embodiment, as shown in Figure 4, the attachment element comprises a flexible
material 12 and
the accessory device can only be detached from the probe by tearing the
flexible material 12,
365 separating the attachment element portion of the accessory device from the
body portion.
Alternatively, the flexible element can comprise a weakened material, or
breakpoint, where it
joins to the body of the device (e.g., perforations) to facilitate tearing.
The breakpoint is more
susceptible to mechanical stress than the remaining portions of the device.
The attachment element can be mechanically attached to optical probe by a
variety of
370 mechanisms, including, but not limited, to a tab/slot mechanism (such as a
tab on the attachment
element fits into a slot on the outside of the optical probe or visa versa), a
magnetic attachment
means, a lock and pin mechanism, a band-latching mechanism, or a string. Other
types of
attachment mechanisms (such as fasteners, elastic bands, strings within the
accessory device
which can hook onto the probe, Velcro, adhesive, tapes, glues), including
those which rely on
375 mating a protruding element (on the accessory device or the probe) to a
recessed element (on the
probe or the accessory device) will doubtless be apparent to those of skill in
the art, and are
included within the scope of the invention.
In another embodiment, the actual means of attachment of the attachment
element is the
breakable element in the device. For example, in one embodiment, where the
attachment
380 element attaches to the probe by a tab/slot mechanism, removal of the
accessory device can only
be performed by breaking the tab off, thereby preventing the accessory device
from being


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reattached. In another embodiment, where a protruding mating element is
provided on the
accessory device to allow it to mate with a recessed element in the optical
probe, the protruding
mating element is designed to tear along a tear line, or perforation, in the
accessory device upon
385 mechanical stress (e.g., when the protruding element on the attachment
element is disengaged
from recessed element on the surface of the optical probe), preventing the
protruding mating
element from functioning in future.
In yet another embodiment of the invention, at least the attachment element of
the device
is made of a flexible material and a "cinch purse" string is provided to both
secure the
390 attachment element to the device and to provide a grasping element. In
this embodiment, the
string is attached to a breakable element so that pulling the string breaks
the breakable element
and permits the flexible portion of the accessory device to be rolled over,
away from the optical
probe. Once the breakable element is broken, the accessory device is unable to
be reattached to
the optical probe.
395 While the attachment element can attach directly to the optical probe, it
can also attach
through an intermediate interfacing element which itself attaches to the probe
(e.g., via a ring or
a plastic connecting sleeve). In a further embodiment of the invention, the
attachment element
and the body of the accessory device are modules which can be fitted together.
Different types
of interfacing elements can be used to interface different types of attachment
elements and
400 bodies to different optical probes, allowing the user to select and
combine different desired
features of the accessory device with a particular kind of optical probe.
In another embodiment of the single-use option, the accessory device is
prevented from
reuse by degrading the optical quality of the accessory device after use. For
example, coatings
susceptible to ultraviolet radiation, can be placed on the light-transmitting
portion of the
405 accessory device. During proper use of the device, the coating is
subjected to a sufficient
quantity of ultraviolet radiation so that it becomes at least partially
opaque, preventing its reuse.
The invention also provides an accessory device which can be disabled after
use without
physically altering the device, that is, electronically, for example. . In one
embodiment, an
electrical contact between the accessory and the optical probe is provided. In
this embodiment,
410 an electrical element is embedded within the accessory device which is
capable of making
electrical contact with the optical probe when the accessory device is
properly affixed to the
probe. As defined herein, the term "electrical element" encompasses both
passive electrical
elements (e.g., resistors, capacitors, inductors, diodes, and others) and
active electrical elements
(e.g., transistors, integrated circuits, such as microchips, and others). In
one embodiment, after


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415 use, the optical probe delivers a current to the accessory device
sufficient to destroy the electrical
element, thus preventing reuse of the accessory device.
In another embodiment, as shown in Figure 5, the accessory device is provided
with an
electrical element 17 bearing encoded information. The electrical element can
be secured to the
accessory device by insertion at a notch on the surface of the device, or
alternatively, can be held
420 in place by a biocompatible adhesive (e.g., a cyanoacrylic adhesive) and
can additionally include
electrical contact elements for making contact with the probe.
In one embodiment of the invention, the electrical element 17 bears encoded
information
relating to the identification of the accessory device. For example, the
encoded information
identifies the device as one which has already been used with the optical
probe. In a further
425 embodiment, the electrical element 17 includes encoded information
relating a target tissue
which is being analyzed. Additional information encoded by the electrical
element 17 includes,
but is not limited to, time, present date, date of manufacture, materials used
in construction, and
the condition of the optical probe or the processing system used with the
optical probe.
Additionally, the electrical element 17 can include information regarding the
intended use of the
430 optical probe, and can enable only,certain modes of operation of the
probe. As defined herein,
an "operating mode" refers to either, or both, the input or output of the
optical probe. In one
embodiment, the operating mode is a functioning or non-functioning state of
the optical probe.
In another embodiment, the operating mode is any of a plurality of input or
output states of the
device. For example, in one operating mode, the optical probe is directed to
provide optical
435 information relating to the location of a sample (e.g., a cancerous
tissue) while in another
operating mode, the optical probe is directed to provide information relating
only to a
biochemical feature of a sample (e.g., the presence or absence of fluorescence
relating to a
cancerous or precancerous state), while in still another operating mode, both
types of information
are provided.
440 Different types of electrical elements can be used. The electrical element
can be a
programmable read-only memory chip (PROM). The electrical element can be
remotely
programmable. In another embodiment of the invention, the electrical element
is an RFID
(radiofrequency identification device) or another active seminconductor
device.
Information within the electrical element can be passed on to a processor in
445 communication with the optical probe through a electrical element reader
which accesses stored
information in the electrical element in a non-contacting manner. In one
embodiment, the
electrical element reader is capable of receiving electromagnetic signals. In
another


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embodiment, the electrical element reader is capable of receiving radiosignals
from the electrical
element.
450 When the electrical element reader is placed in a location in which it can
access stored
identification information encoded in the electrical element, the electrical
element reader
transfers this information to a processor to which the optical probe is
operatively connected. For
example, the electrical element reader can be either attachable to the optical
probe or an integral
part of the optical probe itself, such that the reader has access to the
electrical element as soon as
455 the accessory device is attached to the optical probe. Information from
the electrical element is
thus immediately transferred to the processor which provides instructions to
the probe to either
enable it or prevent it from functioning. In one embodiment, where the
electrical element is an
RFID chip, the "reader" is a transponder for receiving radiosignals from the
electrical element.
In some applications, it is desirable to re-use the accessory device if
another diagnostic
460 test needs to be done with the same patient within a short time of the
first diagnostic test (e.g.,
where the probe has not been removed from the patient). In this embodiment,
the electrical
element can be re-programmed or programmed with additional information,
allowing the optical
probe to function with the same accessory device. In certain embodiments of
the invention, the
electrical element reader is configured as an encoding device to conveniently
change or add
465 information stored within the electrical element.
As contemplated herein, processor includes a memory which comprises
identification
information identifying accessory devices that have been used with the optical
probe. If a match
is found between the identification information obtained by the electrical
element reader and the
identification information within the memory, the processor transmits
instructions to the optical
470 probe which prevents it from functioning. The instructions are then
relayed to components) of
an optical diagnostic system of which the optical probe is a part. For
example, the optical
diagnostic system comprises a light source which is in optical communication
with the optical
probe. The presence of a match between identification information encoded by
the electrical
element and identification information within the memory of the processor
prevents light from
475 being transmitted from the light source to the optical probe. In another
embodiment of the
invention, the optical diagnostic system comprises an optical probe-locking
device which
prevents the probe from being moved (e.g., to position it within a patient) if
a match is found
thus effectively preventing the probe from being used with the "wrong"
accessory device. When
no match is found between the information stored within the electrical element
and information
480 stored within the memory, the identification information relating to the
electrical element is


CA 02375168 2001-12-03
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added to the memory. In this way, subsequent use of the accessory device will
result in
instructions being sent to the probe which prevents it from operating.
In an alternative embodiment, the processor can transmit instructions to the
optical probe
which allow it to function if a "correct" accessory device is used with the
probe. In this
485 embodiment, the processor transmits instructions to either the probe
itself and/or to other
components of the optical diagnostic system when no match is found between
identification
information encoded in the electrical element and the identification
information stored in the
memory. The instructions then trigger the optical probe or other component of
the optical
diagnostic system to function (for example, light can be transmitted through
the optical probe or
490 a specific diagnostic application can be run in response to the
instructions).
In another embodiment, the electrical element is encoded with identification
information
which can only be read if the accessory device is positioned in a correct
orientation with respect
to the optical probe (for example, in an orientation which maximizes light
transmission from the
probe to the accessory device). In this embodiment, the processor will only
transmit instructions
495 to the optical probe to allow the probe to function if the accessory
device is positioned correctly.
Information other than identifying information can also be transmitted to the
processor
via the electrical element. For example, information relating to the
"readiness" of the optical
probe/accessory device can be provided to the electrical element by sensors on
the accessory
device or the optical probe which are responsive to the environment in which
the accessory
500 device/and or probe is placed. The electrical element in turn transmits
the information to the
processor which can alter the functioning of the probe as appropriate.
The electrical element can further include information relating to the target
tissue being
analyzed. In this embodiment of the invention, information read by the
electrical element reader
triggers the processor to activate diagnostic programs unique to the analysis
of that particular
SOS tissue. For example, the accessory device comprises a electrical element
identifying it as an
accessory device used to access the cervix. When the processor receives this
information from
the electrical element reader, the processor will access specific computer
program products)
(e.g., software applications) relating to the diagnosis of cervical tissue
pathologies (e.g., cervical
cancer) and will activate particular data input or data display screens that
relate to diagnosing
510 these pathologies. In other embodiments, the electrical element can
include patient identifying
information, including information relating to a history of a particular
disease (e.g., whether the
patient has a family history of cervical cancer).


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In certain embodiments, a particular type of accessory device is preferred for
a particular
diagnostic application. In these embodiments, it is desirable to prevent an
optical diagnostic
515 system from functioning unless it is used with a suitable accessory
device. In order to ensure
that the proper accessory device is used in its appropriate diagnostic
application, the electrical
element in the accessory device is encoded with information indicating that it
is suited for a
particular use(s). When the processor accesses this information through the
electrical element
reader, only a proper match between the use and the device will permit the
optical probe or other
520 components of the optical system to function.
Although, non-physical means of crippling the accessory device after a single
use have
been disclosed with reference to an electrical element, it should be apparent
to those of skill in
the art that a number of different types of feedback mechanisms can be
incorporated into an
optical diagnostic system. In one embodiment, an optical probe is provided
which is equipped
525 with a light emitting diode and an infrared sensor, while the accessory
device is marked with a
series of lines on one of its surfaces providing identification information.
In this embodiment, the
optical probe sensor obtains information relating to the accessory device's
identification
information and transfers this information to the processor which sends
instructions to the probe
or other components of the system to enable or prevent the probe from
functioning with that
530 particular accessory device.
Optical methods for communicating the usage history of the accessory device to
the
optical probe can also include bar codes. In one embodiment as shown in Figure
6A, a bar code
18 designed to be read by reflectance or fluorescence is fixed to the body of
the accessory
device. If it is placed on the side of the accessory device, a separate reader
may be needed to
535 scan the code. The lot number, intended use, and other pertinent
information is contained in the
code and interpreted by the optical scanner. In another embodiment, shown in
Figure 6B, the
code 19 is fixed to a transparent part 20 of the accessory device. This
permits the optical system
itself to read the contents of the code 19 prior to performing its measurement
of the sample (e.g.,
tissue). Other accessory device marker and reader combinations will be
apparent to those of skill
540 in the art, and are encompassed within the scope of the invention.
As discussed above, any or all of the foregoing options can be combined to
create
accessory devices suitable for particular diagnostic purposes. For example, an
accessory device
including optical elements can also include electrical and/or mechanical
elements to disable the
devise so that it can only be used a single time. Devices with optical
elements and/or single-use
545 devices can include the structural features that make an accessory device
minimally invasive


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and/or tissue-conforming. Any and all of these combinations are encompassed
within the scope
of the invention.
Variations, modifications, and other implementations of what is described
herein will
occur to those of ordinary skill in the art without departing from the spirit
and scope of the
550 invention as claimed. Accordingly, the invention is to be defined not by
the preceding
illustrative description but instead by the spirit and scope of the following
claims.
What is claimed is:

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

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Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 2000-06-09
(87) PCT Publication Date 2000-12-14
(85) National Entry 2001-12-03
Examination Requested 2001-12-03
Dead Application 2009-06-09

Abandonment History

Abandonment Date Reason Reinstatement Date
2008-05-15 R30(2) - Failure to Respond
2008-06-09 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Request for Examination $400.00 2001-12-03
Application Fee $300.00 2001-12-03
Maintenance Fee - Application - New Act 2 2002-06-10 $100.00 2002-05-24
Registration of a document - section 124 $100.00 2002-11-28
Registration of a document - section 124 $100.00 2002-11-28
Registration of a document - section 124 $100.00 2002-11-28
Registration of a document - section 124 $100.00 2002-11-28
Registration of a document - section 124 $100.00 2002-11-28
Registration of a document - section 124 $100.00 2002-11-28
Maintenance Fee - Application - New Act 3 2003-06-09 $100.00 2003-06-09
Maintenance Fee - Application - New Act 4 2004-06-09 $100.00 2004-05-26
Maintenance Fee - Application - New Act 5 2005-06-09 $200.00 2005-06-07
Maintenance Fee - Application - New Act 6 2006-06-09 $200.00 2006-06-06
Maintenance Fee - Application - New Act 7 2007-06-11 $200.00 2007-06-04
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
MEDISPECTRA, INC.
Past Owners on Record
BEE, DAVID
EMANS, MATTHEW
HED, ZE'EV
KWO, JENNIE
MODELL, MARK
NORDSTROM, ROBERT
PRODUCT GENESIS, INC.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 2001-12-03 18 1,113
Abstract 2001-12-03 1 56
Claims 2001-12-03 5 149
Drawings 2001-12-03 3 22
Cover Page 2002-05-17 1 32
Representative Drawing 2004-01-23 1 2
Description 2004-07-09 18 1,103
Claims 2004-07-09 2 77
PCT 2001-12-03 13 454
Assignment 2001-12-03 3 97
Correspondence 2002-05-15 1 24
Assignment 2002-11-28 17 692
Prosecution-Amendment 2004-01-20 4 135
Prosecution-Amendment 2004-07-09 9 422
Prosecution-Amendment 2007-11-15 3 103