U.S. patent application number 11/018665 was filed with the patent office on 2005-07-21 for optical probe accessory device for use in in vivo diagnostic procedures.
This patent application is currently assigned to MediSpectra, Inc.. Invention is credited to Bee, David, Emans, Matthew, Hed, Ze'ev, Kwo, Jennie, Modell, Mark, Nordstrom, Robert.
Application Number | 20050159646 11/018665 |
Document ID | / |
Family ID | 34069421 |
Filed Date | 2005-07-21 |
United States Patent
Application |
20050159646 |
Kind Code |
A1 |
Nordstrom, Robert ; et
al. |
July 21, 2005 |
Optical probe accessory device for use in in vivo diagnostic
procedures
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.
Inventors: |
Nordstrom, Robert; (Hanover,
MA) ; Bee, David; (Groton, MA) ; Modell,
Mark; (Natick, MA) ; Hed, Ze'ev; (Nashua,
NH) ; Kwo, Jennie; (Cambridge, MA) ; Emans,
Matthew; (Boston, MA) |
Correspondence
Address: |
TESTA, HURWITZ & THIBEAULT, LLP
HIGH STREET TOWER
125 HIGH STREET
BOSTON
MA
02110
US
|
Assignee: |
MediSpectra, Inc.
Lexington
MA
|
Family ID: |
34069421 |
Appl. No.: |
11/018665 |
Filed: |
December 21, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11018665 |
Dec 21, 2004 |
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09591706 |
Jun 9, 2000 |
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6847490 |
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11018665 |
Dec 21, 2004 |
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09481762 |
Jan 11, 2000 |
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6826422 |
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11018665 |
Dec 21, 2004 |
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09241806 |
Feb 2, 1999 |
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6411835 |
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09241806 |
Feb 2, 1999 |
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08782936 |
Jan 13, 1997 |
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6104945 |
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60138235 |
Jun 9, 1999 |
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60115373 |
Jan 11, 1999 |
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Current U.S.
Class: |
600/127 ;
340/573.1; 359/673; 600/473; 600/476 |
Current CPC
Class: |
A61B 5/0075 20130101;
A61B 2562/08 20130101; A61B 1/00096 20130101; A61B 1/00082
20130101; G01N 21/4795 20130101; A61B 1/00059 20130101; A61B
1/00103 20130101; A61B 5/0071 20130101; A61B 5/0084 20130101; A61B
1/00062 20130101; A61B 1/00142 20130101; A61B 2090/0814 20160201;
A61B 1/00135 20130101; A61B 1/043 20130101 |
Class at
Publication: |
600/127 ;
600/473; 600/476; 359/673; 340/573.1 |
International
Class: |
A61B 001/00; A61B
005/00 |
Claims
What is claimed is:
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.
10-41. (canceled)
42. The accessory device of claim 1, wherein the attachment element
is configured to prevent reattachment of the accessory device to
the probe after the accessory device is removed from the probe.
43. An accessory device for an optical diagnostic system having an
associated reader, the accessory device comprising a marker capable
of being read by the reader to thereby prevent re-use of the
accessory device.
44. The accessory device of claim 43, wherein the marker comprises
a bar code.
45. The accessory device of claim 43, wherein the marker comprises
an RFID chip.
46. The accessory device of claim 43, wherein the marker is capable
of being read by an optical sensor.
47. The accessory device of claim 43, wherein the marker comprises
encoded information.
48. The accessory device of claim 47, wherein the encoded
information comprises identification information.
49. The accessory device of claim 43, wherein at least a portion of
the accessory device provides a shield between a contact surface
and an optical probe.
50. The accessory device of claim 49, wherein the optical probe is
a part of the optical diagnostic system.
51. The accessory device of claim 49, wherein the accessory device
is configured to prevent contact between a patient and the optical
probe.
52. The accessory device of claim 49, wherein the contact surface
is a body lumen and wherein at least a portion of the accessory
device is configured to conform to the body lumen.
53. A method for limiting re-use of an accessory device with an
optical probe in an optical diagnostic system, the method
comprising the steps of: providing an accessory device comprising a
marker; reading the marker to obtain information about the
accessory device; and at least one of: disabling operation of the
optical probe with the accessory device based at least in part on
the information, where the accessory device has been previously
used; and enabling operation of the optical probe with the
accessory device based at least in part on the information, where
the accessory device has not been previously used.
54. The method of claim 53, wherein at least a portion of the
accessory device provides a shield between a contact surface and
the optical probe.
55. The method of claim 54, wherein the contact surface is a body
lumen and wherein at least a portion of the accessory device
conforms to the body lumen.
56. The method of claim 53, wherein the information comprises
identification information about the accessory device.
57. The method of claim 53, wherein the information comprises usage
history of the accessory device.
58. The method of claim 53, wherein the marker comprises a bar
code.
59. The method of claim 53, wherein the marker comprises an RFID
chip.
60. The method of claim 53, wherein the reading step comprises
scanning the marker.
61. The method of claim 53, wherein the method prevents re-use of
the accessory device with the optical probe.
Description
RELATED APPLICATIONS
[0001] The application claims priority to U.S. Provisional
Application Ser. No. 60/138,235, filed on Jun. 9, 1999 and is also
a continuation-in part of U.S. patent application Ser. No.
09/481,762, filed Jan. 11, 2000, which claims priority to U.S.
Provisional Application Ser. No. 60/115,373, filed Jan. 11, 1999,
and is a continuation-in-part of U.S. patent application Ser. No.
09/241,806, filed Feb. 2, 1999, which is a continuation-in-part of
U.S. patent application Ser. No. 08/782,936, filed Jan. 13, 1997.
The entirety of these applications is incorporated by
reference.
FIELD OF THE INVENTION
[0002] 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
[0003] 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.
[0004] 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 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 light directing and focussing elements
within the optical probe generally make it difficult, if not
impossible, to sterilize the probe.
[0005] 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 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 barrier 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.
SUMMARY OF THE INVENTION
[0006] 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
combination, selectable features which optimize light transmission,
maximize patient comfort, and provide single-use capabilities.
[0007] 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 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. 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.
[0008] 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 (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).
[0009] For example, an optical probe accessory device which
comprises, at least in portion, a 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 another
embodiment, the flexible nature of the accessory device allows it
to be rolled up before and after use with the probe.
[0010] 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 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.
[0011] 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 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 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.
[0012] 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 another patient. In one embodiment, the accessory device
comprises an electrical element bearing encoded information (e.g.,
identification information). In another embodiment, the electrical
element is remotely programmable and the information contained
within the electrical element can be altered by the user.
[0013] In a further aspect of the present invention, a system is
provided which comprises a 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 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.
[0014] The instructions transmitted by the processor control the
actuation of the optical probe. 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 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.
[0015] Any or all of the foregoing optional features (the optical
features to enhance light 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.
[0016] The foregoing and other objects, aspects, features, and
advantages of the invention will become apparent from the following
description and from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] 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 characters generally
refer to the same parts throughout the different views.
[0018] FIG. 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.
[0019] FIGS. 2A and 2B show a schematic representation of an
accessory device according to one embodiment comprising a single
side-looking window. FIG. 2A shows a side view of such a device.
FIG. 2B shows a top view.
[0020] FIG. 3 shows a schematic representation of a single use
accessory probe according to one embodiment comprising a sectional
transparent window.
[0021] FIG. 4 shows a schematic representation of a single-use
accessory device according to one embodiment comprising a flexible
tear-away sheath.
[0022] FIG. 5 shows a single-use accessory device according to one
embodiment of the invention comprising an electrical element for
encoding identification information.
[0023] FIGS. 6A-C show schematic representations of accessory
devices for optical probes marked with identifying information in
the form of a bar code. FIG. 6A shows an accessory device
comprising a bar code on the side of the device. FIGS. 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. FIG. 6A shows a view
of the end of the device bearing the bar code. FIG. 6C shows a view
of the side of the device.
DETAILED DESCRIPTION
[0024] 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 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 be apparent to those of skill in the
art after reading this disclosure that other options can
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 numerous other features may be included in a
device of the invention, either alone or in combination.
[0025] Option 1. Maximal Light Transmission
[0026] 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 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.
[0027] 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-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 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.RTM. or can comprise other fluoroplastics such as
THV-200P.RTM. (a TFE/HPF/VDF terfluoropolymer from the 3M.RTM.
corporation). These plastics do not demonstrate a significant
fluorescent response when irradiated with UV.
[0028] In some embodiments, the accessory device is used with an
optical probe which functions 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
to the chemical/structural features of a tissue being analyzed
rather than its morphological 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.
[0029] 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 from material including, but not
limited to, UVT acrylic or amorphous polyolefin (e.g., Zeonex.RTM.,
Nippon Zeon CO., Ltd.) and the like. The skilled artisan can
recognize and identify equivalent materials using routine
experimentation and routine testing.
[0030] 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 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 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.
[0031] 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 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 FIG. 1,
the window 11 is at the end of the accessory body 10 most distal
from the probe. In another preferred embodiment, shown in FIGS.
2A-B and FIG. 3, 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 FIGS. 2A and 2, the accessory device comprises
a circular window 13. In the embodiment shown in FIG. 3, the window
is a transparent section 15 of the accessory device.
[0032] 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 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).
[0033] 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
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.
[0034] 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. 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 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 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 FIG. 2B, the reflective element is a
reflective planar surface 14. In the embodiment of the invention
shown in FIG. 3, the reflecting element is a conical surface which
directs light from the optical probe towards the transparent
sectional 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.
[0035] 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 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 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 with respect
to the accessory device.
[0036] 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 mechanism.
[0037] 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 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.
[0038] Other types of fluids that can be used to enhance
visualization of the sample, include 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
blue, and others.
[0039] Option 2. Minimal Invasiveness, Tissue-Conforming
Structure
[0040] 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 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,
such as polyethylene terephthalate (PET).
[0041] 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 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 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-up state (e.g., in
a sterile wrapper) to be unrolled over the optical probe when it is
ready to be used.
[0042] In one embodiment, the accessory device comprises both a
flexible portion and a rigid tip 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
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.
[0043] 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
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 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 sized to conform to the dimensions of the body cavity
being accessed and the dimensions of the endoscope.
[0044] 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.
[0045] Option 3. Single-Use Device
[0046] 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 of the probe adapted for contact with
a body tissue of a patient. As defined herein, the term
"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.
[0047] 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 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, 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
FIG. 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, 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.
[0048] The attachment element can be mechanically attached to
optical probe by a variety of 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 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.
[0049] 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 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 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
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.
[0050] 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 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.
[0051] 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 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.
[0052] 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 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.
[0053] 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, 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 use, the optical
probe delivers a current to the accessory device sufficient to
destroy the electrical element, thus preventing reuse of the
accessory device.
[0054] In another embodiment, as shown in FIG. 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 in place by a biocompatible adhesive
(e.g., a cyanoacrylic adhesive) and can additionally include
electrical contact elements for making contact with the probe.
[0055] 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 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 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 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.
[0056] 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.
[0057] Information within the electrical element can be passed on
to a processor in 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 embodiment, the electrical
element reader is capable of receiving radiosignals from the
electrical element.
[0058] 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 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.
[0059] In some applications, it is desirable to re-use the
accessory device if another diagnostic 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 information stored
within the electrical element.
[0060] 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 probe
which prevents it from functioning. The instructions are then
relayed to component(s) 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 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 stored within the memory, the identification
information relating to the electrical element is 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.
[0061] 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
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 a specific diagnostic application can be run in
response to the instructions).
[0062] 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 to the optical probe to allow the probe to function if
the accessory device is positioned correctly.
[0063] 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 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.
[0064] 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 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 product(s) (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 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).
[0065] 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
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 components of the optical system to function.
[0066] 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 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 particular accessory device.
[0067] 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 FIG. 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 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 FIG. 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
in the art, and are encompassed within the scope of the
invention.
[0068] 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 devices can
include the structural features that make an accessory device
minimally invasive and/or tissue-conforming. Any and all of these
combinations are encompassed within the scope of the invention.
[0069] 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 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.
* * * * *