EP2632329A2

EP2632329A2 - Apparatus, systems, methods and computer-accessible medium for identification of trachea

Info

Publication number: EP2632329A2
Application number: EP11837098.0A
Authority: EP
Inventors: William C. Ii Warger; James L. Hancock; Joseph Gardecki; Melissa Suter; George Velmahos; Brett E. Bouma; Guillermo J. Tearney
Original assignee: General Hospital Corp
Current assignee: General Hospital Corp
Priority date: 2010-10-27
Filing date: 2011-10-27
Publication date: 2013-09-04
Also published as: JP2013541388A; WO2012058441A2; WO2012058441A3

Abstract

Exemplary apparatus and method for determining information regarding at least one anatomical structure can be provided. For example, it is possible to forward at least one first optical electro-magnetic radiation to the at least one structure (e.g., using at least one first arrangement), and detect at least one second electro-magnetic radiation provided from the at least one structure which is based on first electro-magnetic radiation(s) (e.g., using and at least one second arrangement). It is also possible to determine at least one characteristic of the structure(s) inside thereof based on the second electro-magnetic radiation (e.g., using and at least one third arrangement). For example, the characteristic(s) can include an identification of the structure(s) upon a placement of an apparatus performing such procedure(s) at, within or near at least one airway portion of the structure(s).

Description

APPARATUS, SYSTEMS, METHODS AND COMPUTER-ACCESSIBLE MEDIUM

FOR IDENTIFICATION OF TRACHEA

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SSTTAATTEEMMEENNTT OOFF FFEEDDEERRAALL SSUUPPPPOORRTT

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F FIIEELLDD OOFF TTHHEE DDIISSCCLLOOSSUURREE

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BBAACCKKGGRROOUUNNDD IINNFFOORRMMAATTIIOONN

[[00000044]] TTrraannssoorraall aacccceessss ttoo tthhee ttrraacchheeaa ccaann bbee ooff ssiiggnniifificcaanntt iimmppoorrttaannccee iinn ccrriittiiccaall ccaarree mmeeddiicciinnee ttoo eennssuurree rreessppiirraattiioonn.. TTyyppiiccaallllyy,, ssuucchh aacccceessss ccaann bbee oobbttaaiinneedd uussiinngg aa ttrraannssoorraall ddeevviiccee iinnsseerrttiioonn ooff aa ttuubbee ((iinnttuubbaattiioonn)).. AAnn aalltteerrnnaattiivvee ddeevviiccee ccaann bbee aa bboouuggiiee ttuubbee.. FFrreeqquueennttllyy,, iinnsseerrttiioonnss ooff tthheessee ddeevviicceess ccaann aanndd sshhoouulldd ooccccuurr iinn llooccaattiioonnss aanndd eennvviirroonnmmeennttss tthhaatt mmaakkee iitt ddiifffificcuulltt ttoo ddeetteerrmmiinnee rraappiiddllyy iiff tthhee ddeevviiccee hhaass eenntteerreedd tthhee ttrraacchheeaa oorr ootthheerr oorrggaann ssuucchh aass tthhee eessoopphhaagguuss.. AAss aa rreessuulltt,, iitt ccaann bbee ddeessiirraabbllee ttoo hhaavvee rraappiidd ffeeeeddbbaacckk ffoorr mmeeddiiccaall ppeerrssoonnnneell ttoo ccoonnfifirrmm tthhaatt tthhee ddeevviiccee iiss aaccccuurraatteellyy ppoossiittiioonneedd wwiitthhiinn tthhee ttrraacchheeaa..

[[00000055]] TThhee ccuurrrreenntt ssttaannddaarrdd ooff ccaarree ffoorr aa ppeerrccuuttaanneeoouuss ttrraacchheeoossttoommyy lliikkeelly rreeqquuiirreess ttwwoo ttrraaiinneedd cclliinniicciiaannss,, ee..gg..,, oonnee ttoo ppuunnccttuurree tthhee ttrraacchheeaa aanndd iinnsseerrtt tthhee ccaannnnuullaa aanndd aannootthheerr ttoo ccoonnffiirrmm iinnttrraattrraacchheeaall ppllaacceemmeenntt vviiaa bbrroonncchhoossccooppyy.. AAlltteerrnnaattiivveess ccaann iinncclluuddee,, ee..gg..,, ooppttiiccaall tteecchhnniiqquueess wwiitthhiinn aa nneeeeddllee,, ttrraacchheeaall ((bboouuggiiee)) ttuubbee,, aanndd//oorr ccaannnnuullaa ttoo ccrreeaattee aa ssiinnggllee--ooppeerraattoorr pprroocceedduurree.. [0006] The trachea is a cylinder formed by hyaline cartilage rings and connective tissue, and is immediately surrounded by muscle, fat, and the esophagus. The cartilage rings can primarily be made up of collagen (Types II, XI), have limited blood flow, are stiff compared to the surrounding tissue types, and contain a homogeneous refractive index.

[0007] Thus, it may be beneficial to address and/or overcome at least some of the deficiencies of the prior approaches, procedures and/or systems that have been described herein above.

OBJECTS AND SUMMARY OF EXEMPLARY EMBODIMENTS

[0008] It is therefore one of the objects of the present disclosure to reduce or address the deficiencies and/or limitations of such prior art approaches, procedures, methods, systems, apparatus and computer-accessible medium.

[0009] Herein, exemplary embodiments of systems, apparatus, methods and computer- accessible medium are described which can utilize optical diagnostic techniques for an identification of the trachea, e.g., either transcutaneously through a needle or other probe, such as a cannula, or transorally/transnasally using a device to guide intubation such as a bougie (intubation) tube. The optical exemplary technique can comprise optical coherence tomography, optical frequency domain imaging, speckle imaging, refractive index measurement, absorption, autofluorescence, diffuse spectroscopy, and/or photoacoustic procedure(s). In one exemplary embodiment of the present disclosure, the device can comprise a light source, such as a laser diode or LED, which is transmitted through an optical fiber or lens and attached to the needle, trocar, bougie tube or the like at its distal end. The light can be received through the same fiber or through additional optical fibers within the device and transmitted to a detector. The exemplary embodiment of the apparatus can be configured to also direct light to the specimen at different wavelengths or by use of a broad- bandwidth light source. In yet another exemplary embodiment, the light returned from the specimen may be detected by one or more point detectors, a one or two dimensional array of detectors, CCD or CMOS camera, or the like.

[0010] According to certain exemplary embodiments of the present disclosure, the detected signal can be processed by a processing apparatus to determine when the exemplary device is placed within the trachea or the trachea is near the distal end of the device. In a particular

- ? exemplary embodiment of the present disclosure, the processing apparatus can then provide an audible and/or visible cue as to whether or not the device is now contained in the trachea. In certain exemplary embodiment of the present disclosure, this cue can be provided by a light based indicator that turns a particular color when the device has entered the trachea. In another exemplary embodiment of the present disclosure, a sound can be heard and analyzed when the device enters the trachea.

[0011] According to a particular exemplary embodiments of the present disclosure, apparatus and method for determining information regarding at least one anatomical structure can be provided. For example, it is possible to forward at least one first optical electro-magnetic radiation to the at least one structure (e.g., using at least one first arrangement), and detect at least one second electro-magnetic radiation provided from the at least one structure which is based on first electro-magnetic radiation(s) (e.g., using and at least one second arrangement). It is also possible to determine at least one characteristic of the structure(s) inside thereof based on the second electro-magnetic radiation (e.g., using and at least one third arrangement). For example, the characteristic(s) can include an identification of the structure(s) upon a placement of an apparatus performing such procedure(s) at, within or near at least one airway portion of the structure(s).

[0012] In another exemplary embodiment of the present disclosure, the first and second arrangements can form (i) low coherence interferometric system, (ii) optical frequency domain imaging system, and/or (iii) spectral domain optical coherence tomography system.

[0013] According to still another exemplary embodiment of the present disclosure, the second electromagnetic radiation(s) can be a plurality of distinct radiation provided from (i) different spatial locations on the structure(s), or (ii) different temporal locations from the structure(s). The characteristic(s) can include a speckle pattern of the portion(s). The characteristic(s) can further include a distribution of a refractive index that is determined based on the speckle pattern. The third arrangement(s) can correlate the speckle pattern with further speckle patterns obtained at different wavelengths or times from the portion(s).

[0014] In a further exemplary embodiment of the present disclosure, the first and second electromagnetic radiations can be wavelength distinct. The second electromagnetic radiation(s) can be a Raman radiation, a scattered light, and/or a fluorescent light. The second arrangement can detects a plurality of the second electromagnetic radiation(s) at different wavelength. The third arrangement(s) can determine the characteristic(s) of the structure(s) that is/are below (i) an epithelium, and/or (ii) mucosa of the airway portion(s).

[0015] According to a still further exemplary embodiment of the present disclosure, a probe arrangement can be provide, whereas at least a portion of the first arrangement(s) can be part of the probe arrangement. The probe arrangement can be associated with or inserted into a needle arrangement. Further, the probe arrangement can be within a needle of the needle arrangement. The probe arrangement can be associated with or inserted into a tubular arrangement. For example, the tube arrangement can be structured to be inserted into the airway portion(s) transorally, transnasally and/or trascutaneously. The tube arrangement can include an intubation tube, a bougie tube, or a tracheostomy tube. The probe arrangement can include a further apparatus which can be configured to provide an audible signal or a visual signal when the probe arrangement is within or near (or not within or near) the airway portion(s). The first arrangement(s) can also direct the first electromagnetic radiation(s) in a direction that is approximately non-parallel or approximately perpendicular to a long axis of the probe arrangement.

[0016] According to yet another exemplary embodiment of the present disclosure, the first electromagnetic radiation(s) can impact the structure(s) at a first location. The second electromagnetic radiation(s) can be provided from a second location of the structure(s). The first and second locations can be different from one another.

[0017] These and other objects, features and advantages of the exemplary embodiments of the present disclosure will become apparent upon reading the following detailed description of the exemplary embodiments of the present disclosure, when taken in conjunction with the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Further objects, features and advantages of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments of the present disclosure, in which:

[0019] Figure 1 is an exemplary cross-sectional optical frequency domain interferometry ("OFDI") image of swine airway using an exemplary embodiment of a system and a method in accordance with the present disclosure; [0020] Figure 2 is a set of exemplary OFDI images of a cartilage ring, fat, muscle, and a cartilage ring with connective tissue using an exemplary embodiment of the system and method in accordance with the present disclosure;

[0021] Figure 3A is an original optical domain frequency interferometry ("OFDI") image of a swine trachea using an exemplary embodiment of the system and method in accordance with the present disclosure;

[0022] Figures 3B and 3B are a set of exemplary spectrally encoded endoscopy ("SEE") image reconstructions of the swine trachea obtained ex vivo with clear visualization of the cartilage rings using an exemplary embodiment of the system and method in accordance with the present disclosure;

[0023] Figure 4 is an exemplary graph of a decorrelation slope of speckle patterns originating from cartilage, fat, muscle, esophagus, and cartilage rings with connective tissue in accordance certain exemplary embodiments of the system and method of the present disclosure;

[0024] Figure 5 is an exemplary graph of data derived from Raman spectra of the trachea ex vivo in accordance with certain exemplary embodiments of the system and method of the present disclosure;

[0025] Figure 6 are exemplary images of excitation-emission matrices for the trachea compared to surrounding tissues obtained using exemplary embodiments of the system and method in accordance with the present disclosure;

[0026] Figure 7A is an exemplary embodiment of the system according to the present disclosure (which can be provided in the form of a needle-based device), and an exemplary application thereof;

[0027] Figure 7B is a detailed illustration of the exemplary device shown in Figure 7A, and components thereof;

[0028] Figure 8 is an exemplary flow diagram for a process according to an exemplary embodiment of the present disclosure to identify the trachea using the exemplary device shown in Figures 7A and 7B; [0029] Figure 9A is another exemplary embodiment of the system according to the present disclosure (which can be provided in the form of a guidewire-based device), and an exemplary application thereof;

[0030] Figure 9B is a detailed illustration of the exemplary device shown in Figure 9A, and components thereof;

[0031] Figure 10 is an exemplary flow diagram for a process according to another exemplary embodiment of the present disclosure to identify the trachea using the exemplary device shown in Figures 9 A and 9B;

[0032] Figure 1 1 A is still another exemplary embodiment of the system according to the present disclosure (which can be provided in the form of a cannula-based device), and an exemplary application thereof;

[0033] Figure 1 IB is a detailed illustration of the exemplary device shown in Figure 1 1 A, and components thereof;

[0034] Figure 12 is an exemplary flow diagram for a process according to another exemplary embodiment of the present disclosure to identify the trachea using the exemplary device shown in Figures 1 1A and 1 I B.

[0035] Figure 13A is a further exemplary embodiment of the system according to the present disclosure (which can be provided in the form of a transnasal or transoral intubation-tube- based device) , and an exemplary application thereof;

[0036] Figure 13B is a detailed illustration of the exemplary device shown in Figure 13A, and components thereof; and

[0037] Figure 14 is an exemplary flow diagram for a process according to another exemplary embodiment of the present disclosure to identify the trachea using the exemplary device shown in Figures 13A and 13B.

[0038] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. Moreover, while the subject disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described exemplary embodiments without departing from the true scope and spirit of the subject disclosure as defined by the appended claims.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0039] Figure 1 shows an exemplary image of a cross section of an ex vivo swine airway, where the cartilage ring (c), epithelium (e), lamina propria (lp), submucosa (sm), and perichondrium (p) using an exemplary embodiment of a system in accordance with the present disclosure can be visualized. A variety of exemplary imaging techniques that can include optical coherence tomography, optical frequency domain imaging, spectral encoding confocal microscopy, and/or spectral encoding endoscopy can be used with a variety of scanning patterns that include linear, raster, circular, spiral, and rosette so as to generate the exemplary image. An exemplary embodiment of such imaging technique can be configured to include a scanning technique such as a microelectromechanical (MEMS) mirror, rotating ( isley) prisms, rotating angle-cleaved lenses, resonant fiber, and rotary fiber.

Refractive index variation

[0040] Figure 2 shows a set of exemplary OFDI images of a cartilage ring, fat, muscle, and a cartilage ring (with a connective tissue) which illustrate a variation of a refractive index through the tissue types using an exemplary embodiment of the system, method and apparatus in accordance with an exemplary embodiment of the present disclosure. In Figure 2, the exemplary cartilage ring is shown to contain a homogeneous band of intensity, followed by a discontinuity and then a lower homogeneous intensity, which compares to a heterogeneous intensity within the fat and muscle. A variety of refractive index depth profiling techniques, such as optical coherence tomography, optical frequency domain imaging, low-coherence interferometry, spectral encoding endoscopy, and/or spectral encoding confocal microscopy, can be used in the scanning and non-scanning configurations.

[0041] Figure 3A shows an original optical domain frequency interferometry ("OFDI") image 310 of a swine trachea using an exemplary embodiment of the system and method in accordance with the present disclosure. Figures 3B and 3B illustrate a set of exemplary spectrally encoded endoscopy ("SEE") image reconstructions 320, 325 of the swine trachea obtained ex vivo with clear visualization of the cartilage rings using an exemplary embodiment of the system and method in accordance with the present disclosure which can indicate the potential for a similar identification with the exemplary SEE device.

Exemplary Biomechamcat [ Results

[0042] The hyaline cartilage within the cartilage rings can result in a mechanically stiffer tissue compared to the surrounding tissue types. This stiffness can be assessed by analyzing exemplary correlation techniques, such as laser speckle imaging, that compare the diffusion of the particles within tissue. Figure 4 shows an exemplary scatter graph of the slope of the speckle pattern decorrelation for cartilage 410, fat 450, muscle 440, esophagus 430, and cartilage rings 420 with connective tissue. Using such exemplary patterns 410-450, the cartilage rings can be differentiated from the other tissue types generated according to an exemplary embodiment of the present disclosure. For example, the decorrelation of the speckle pattern 410 can be much slower in cartilage due to the higher biomechanical stiffness compared to the speckle patterns 420-450 of other tissue types.

Exemplary Biochemical Results

[0043] Each of the tissue types within and surrounding the trachea are made up of various biochemical signatures that can be probed by techniques that measure inelastic scattering, such as Raman spectroscopy. Figure 5 shows an exemplary graph of a fit coefficient of protein 510 and triglycerides 520 along a scan between two cartilage rings generated using the system, method and/or apparatus according to an exemplary embodiment of the present disclosure. For example, as shown in Figure 5, a strong protein signal exists from the rings and a strong triglycerides signal exists from the connective tissue between the rings. An exemplary embodiment of an inelastic scattering technique can fit a library of biochemical signatures within the tissue types.

Exemplar}, Autofiuorescence Results

[0044] Each of the tissue types surrounding and within the trachea can made of various biological components containing unique autofiuorescence signatures. Figure 6 illustrates a set of exemplary images of excitation-emission matrices for the exterior of the trachea, the lumen of the esophagus, and within fat and muscle from a swine generated using the system, method and/or apparatus according to an exemplary embodiment of the present disclosure. The exemplary trachea images of Figure 6 indicate different excitation and emission patterns compared to the other tissue types and can be used to define specific combinations of excitation and emission patterns to differentiate between the trachea and the other tissue types.

Exemplary Absorption Results

[0045] The biological components within the tissue also provide unique absorption bands that may be probed with techniques such as diffuse spectroscopy and photoacoustics. One exemplary approach can be to analyze the presence of blood within the region of interest because there is no blood flow within the cartilage rings.

[0046] Figure 7 A shows an exemplary embodiment of a device 701 according to the present disclosure, which is provided in the form of a needle-based device in this exemplary embodiment, and Figure 7B illustrates a detailed illustration of the exemplary device shown in Figure 7A, and components thereof. For example, the device 701 can include a light source 702 (e.g., a light emitting diode, laser diode, laser, light bulb, or similar) which can transmit electro-magnetic radiation (e.g., light) along an optical fiber, optical fiber bundle, lens, etc. 703 that runs along the length of the needle 704 to illuminate tissue near a tip 715 of the needle 704. A lens 705 positioned at the tip of the fiber 703 can focus the electromagnetic radiation in a forward direction through a lumen of the needle 704 or at an angle to illuminate the tissue along the side of the needle 704 through an optical window 706 within a shaft of the needle 704. The returning electro -magnetic radiation from the tissue is converted into an electrical signal with a single detector or series/array of detectors 707. The converted electrical signal can be amplified, digitized, and/or processed using a processing arrangement 708 (e.g., a field-programmable gate array, a graphics processing hardware arrangement, a logic circuit, etc.). The exemplary processing arrangement can transmit an electrical signal produced thereby to, e.g., a visual or audio indicator 709 (e.g., red/green/infrared light, speaker, or the like) when the tip 715 of the needle 704 is outside and/or within the trachea.

[0047] Figure 8 shows an exemplary flow diagram of an exemplary procedure to identify the trachea with the exemplary embodiment of the device shown in Figures 7A and 7B according to an exemplary embodiment of the present disclosure. For example, the needle 704 can be inserted into the neck traveling through the skin, muscle, fat, and thyroid in 810. Then, in 820, the needle approaches/enters the trachea, and the visual or audio indicator 709 is activated upon sensing the appropriate tissue in 830.

[0048] In one exemplary embodiment, a signal can be created using the visual or audio indicator 709 when the tip 715 of the needle 704 is located just outside the trachea. In another exemplary embodiment, a signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 is within the tracheal tissue. In still another exemplary embodiment, the signal can be created with the visual or audio indicator 709 to differentiate when the tip 715 of the needle 704 is between two cartilage rings or going through a cartilage ring. In a further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 enters the trachea lumen. In still further exemplary embodiment, the signal can be generated the visual or audio indicator 709 when the tip 715 of the needle 704 is located at the back of the trachea. In according to yet another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 is located along the outside of the esophagus. According to a further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 enters the esophagus lumen. In another embodiment, a signal will be created with the visual or audio indicator 109 when the needle goes completely through the trachea. In another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the needle 704 misses the trachea. In a still further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 is located just outside a blood vessel. In another embodiment, a signal will be created with the visual or audio indicator 109 when the needle is within a blood vessel.

[0049] Figure 9A shows an exemplary embodiment of a device 901 according to the present disclosure, which is provided in the form of a guidewire-based device in this exemplary embodiment, and Figure 9B illustrates a detailed illustration of the exemplary device shown in Figure 9A, and components thereof. This exemplary embodiment is similar to the needle- based exemplary device with the optical fiber, optical fiber bundle, lens, or similar housed within a removable guide-wire 902 that fits within the needle 704. A lens positioned at a tip 915 of the fiber 705 can focuses the electro-magnetic radiation (e.g., light) in the forward direction through the lumen of the needle 704 or at an angle to illuminate the tissue along a side of the needle 704 through the optical window 706 within the needle shaft 706. The returning electro-magnetic radiation from the tissue is converted into an electrical signal with a single detector or series/array of detectors 707. The converted electrical signal can be amplified, digitized, and/or processed using a processing arrangement 708 (e.g., a field- programmable gate array, a graphics processing hardware arrangement, a logic circuit, etc.). The exemplary processing arrangement can transmit an electrical signal produced thereby to, e.g., a visual or audio indicator 709 (e.g., red/green/infrared light, speaker, or the like) when the tip 715 of the needle 704 is outside and/or within the trachea.

[0050] Figure 10 shows an exemplary flow diagram of an exemplary procedure to identify the trachea with the exemplary embodiment of the device shown in Figures 9A and 9B according to an exemplary embodiment of the present disclosure. For example, the needle 704 can be inserted into the neck traveling through the skin, muscle, fat, and thyroid in 1010. Then, in 1020, the needle approaches/enters the trachea, and the visual or audio indicator 709 is activated upon sensing the appropriate tissue in 1030.

[0051] In one exemplary embodiment, a signal can be created using the visual or audio indicator 709 when the tip 715 of the needle 704 is located just outside the trachea. In another exemplary embodiment, a signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 is within the tracheal tissue. In still another exemplary embodiment, the signal can be created with the visual or audio indicator 709 to differentiate when the tip 715 of the needle 704 is between two cartilage rings or going through a cartilage ring. In a further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 enters the trachea lumen. In still further exemplary embodiment, the signal can be generated the visual or audio indicator 709 when the tip 715 of the needle 704 is located at the back of the trachea. In according to yet another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 is located along the outside of the esophagus. According to a further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 enters the esophagus lumen. In another embodiment, a signal will be created with the visual or audio indicator 109 when the needle goes completely through the trachea. In another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the needle 704 misses the trachea. In a still further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip 715 of the needle 704 is located just outside a blood vessel. In another embodiment, a signal will be created with the visual or audio indicator 109 when the needle is within a blood vessel.

[0052] Further, as shown in Figure 10, when the exemplary device indicates the tip 715 of the needle 704 is within the proper location, the guide-wire 902 can be provided through the needle into the trachea. In one exemplary embodiment, the guide-wire 902 can then be detached from a housing of the needle 704 in 1040, thus leaving the guide-wire 902 in place such that a cannula can slide over the guide-wire 902 into the trachea in 1050.

[0053] Figure 11A shows an exemplary embodiment of a device 1 101 according to the present disclosure, which is provided in the form of a cannula-based device in this exemplary embodiment, and Figure 1 IB illustrates a detailed illustration of the exemplary device shown in Figure 1 1 A, and components thereof. For example, the device 1 102 can include a light source 702 (e.g., a light emitting diode, laser diode, laser, light bulb, or similar) which can transmit an electro-magnetic radiation (e.g., light) down an optical fiber, optical fiber bundle, lens, etc. 703 that extends along the length of the cannula 1 102 through a needle 1 103 positioned at a tip of the cannula 1 102. A lens positioned at a tip of the fiber 705 can focus the electro-magnetic radiation in the forward direction through a lumen of the needle 1 103 and/or at an angle thereto so as to illuminate the tissue along the side of the needle 1 103 through an optical window within the needle shaft 706. The returning electro-magnetic radiation from the tissue can be converted into an electrical signal using a single detector or a series/array of detectors 707. The converted electrical signal can be amplified, digitized, and/or processed using a processing arrangement 708 (e.g., a field-programmable gate array, a graphics processing hardware arrangement, a logic circuit, etc.). The exemplary processing arrangement can transmit an electrical signal produced thereby to, e.g., a visual or audio indicator 709 (e.g., red/green/infrared light, speaker, or the like) when the tip of the needle 1 103 is outside and/or within the trachea.

[0054] Figure 12 shows an exemplary flow diagram of an exemplary procedure to identify the trachea with the exemplary embodiment of the device shown in Figures 1 1A and 1 IB according to an exemplary embodiment of the present disclosure. For example, the needle 704 can be inserted into the neck traveling through the skin, muscle, fat, and thyroid in 1210. Then, in 1220, the needle approaches/enters the trachea, and the visual or audio indicator 709 is activated upon sensing the appropriate tissue in 1230. [0055] In one exemplary embodiment, a signal can be created using the visual or audio indicator 709 when the tip of the needle 1 104 is located just outside the trachea. In another exemplary embodiment, a signal can be generated using the visual or audio indicator 709 when the tip of the needle 1 104 is within the tracheal tissue. In still another exemplary embodiment, the signal can be created with the visual or audio indicator 709 to differentiate when the tip of the needle 1 104 is between two cartilage rings or going through a cartilage ring. In a further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip of the needle 1 104 enters the trachea lumen. In still further exemplary embodiment, the signal can be generated the visual or audio indicator 709 when the tip of the needle 1 104 is located at the back of the trachea. In according to yet another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip of the needle 1 104 is located along the outside of the esophagus. According to a further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip of the needle 1 104 enters the esophagus lumen. In another embodiment, a signal will be created with the visual or audio indicator 109 when the needle goes completely through the trachea. In another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the needle 704 misses the trachea. In a still further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tip of the needle 1 104 is located just outside a blood vessel. In another embodiment, a signal will be created with the visual or audio indicator 109 when the needle is within a blood vessel.

[0056] When the tip of the cannula 1 102 is within a proper and/or predetermined location, the needle 1103 can be retracted within the cannula or completely removed at 1240, and the cannula 1 102 can be inserted deeper within trachea at 1250. The cannula 1 102 can then be removed, and the tracheostomy tube can be inserted into the trachea.

[0057] Figure 13A shows an exemplary embodiment of a device 1301 according to the present disclosure, which is provided in the form of a transnasal or transoral intubation-tube- based device in this exemplary embodiment, and Figure 13B illustrates a detailed illustration of the exemplary device shown in Figure 13 A, and components thereof. This exemplary device 1301 is similar to the cannula-based device 1301 of Figures 1 1A and 1 1B with the optical fiber, optical fiber bundle, lens, or similar housed within an intubation tube 1302 that fits within the oral or nasal cavity. A lens positioned at the tip of the fiber 705 focuses the electro-magnetic radiation in the forward direction through the lumen of the intubation tube or at an angle thereto to illuminate the tissue along the side of the intubation tube 1302 through the a window 1304 within the intubation tube 1302.

[0058] Figure 14 shows an exemplary flow diagram of an exemplary procedure to identify the trachea with the exemplary embodiment of the device shown in Figures 13A and 13B according to an exemplary embodiment of the present disclosure. For example, the intubation (or Bougie) tube 1302 can be inserted into the mouth or nose in 1410. Then, in 1420, a tip of the intubation tube 1302 approaches/enters in the larynx, and the visual or audio indicator 709 is activated upon sensing the appropriate tissue in 1430.

[0059] In one embodiment, a signal can be generate with the visual or audio indicator 709 when the tube is located within the trachea lumen. In another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tube 1 102 is located within the esophagus. In yet another embodiment, the signal can be generated using the visual or audio indicator 709 when the tube 1 102 is located within the thyroid cartilage. In still another exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tube 1 102 is within the cricoid cartilage. In a further exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tube 1 102 reaches the carina. In yet farther exemplary embodiment, the signal can be generated using the visual or audio indicator 709 when the tube 1 102 is located within the primary bronchi.

[0060] When the exemplary device 1301 indicates the tip of the intubation tube 1302 is within the proper location, the exemplary device 1301 can be removed in 1440. A balloon 1303 of the intubation tube 1303 can then be inflated to secure the tubing location within the trachea in 1450. According to another exemplary embodiment, the balloon 1303 can be inflated before the exemplary device 1301 is removed.

[0061] The foregoing merely illustrates the principles of the disclosure. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. Indeed, the arrangements, systems and methods according to the exemplary embodiments of the present disclosure can be used with and/or implement any OCT system, OFDI system, SD-OCT system or other imaging systems, and for example with those described in International Patent Application PCT/US2004/029148, filed September 8, 2004 which published as International Patent Publication No. WO 2005/047813 on May 26, 2005, U.S. Patent Application No. 1 1/266,779, filed November 2, 2005 which published as U.S. Patent Publication No. 2006/0093276 on May 4, 2006, and U.S. Patent Application No. 10/501,276, filed July 9, 2004 which published as U.S. Patent Publication No. 2005/0018201 on January 27, 2005, and U.S. Patent Publication No. 2002/0122246, published on May 9, 2002, the disclosures of which are incorporated by reference herein in their entireties. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the disclosure and are thus within the spirit and scope of the present disclosure. In addition, to the extent that the prior art knowledge has not been explicitly incorporated by reference herein above, it is explicitly being incorporated herein in its entirety. Further, the exemplary embodiments described herein can operate together with one another and interchangeably therewith. All publications referenced herein above are incorporated herein by reference in their entireties.

Claims

WHAT IS CLAIMED IS:

1. An apparatus for determining information regarding at least one anatomical structure, comprising:

at least one first arrangement configured to forward at least one first optical electro-magnetic radiation to the at least one structure;

at least one second arrangement configured to detect at least one second electro-magnetic radiation provided from the at least one structure which is based on the at least one first electro-magnetic radiation; and

at least one third arrangement configured to determine at least one characteristic of the at least one structure inside thereof based on the at least one second electro-magnetic radiation, wherein the at least one characteristic includes an identification of the at least one structure upon a placement of the at least one apparatus at, within or near at least one airway portion of the at least one structure.

2. The apparatus according to claim 1, wherein the first and second arrangements form at least one of (i) low coherence interferometric system, (ii) optical frequency domain imaging system, or (iii) spectral domain optical coherence tomography system.

3. The apparatus according to claim 1 , wherein the at least one second electromagnetic radiation is a plurality of distinct radiation provided from (i) different spatial locations on the at least one structure, or (ii) different temporal locations from the at least one structure.

4. The apparatus according to claim 3, wherein the at least one characteristic is a speckle pattern of the at least one portion.

5. The apparatus according to claim 4, wherein the at least one characteristic further includes a distribution of a refractive index that is determined based on the speckle pattern.

6. The apparatus according to claim 5, wherein the at least one third arrangement correlates the speckle pattern with further speckle patterns obtained at different wavelengths or times from the at least one portion.

7. The apparatus according to claim 1 , wherein the first and second electromagnetic radiations are wavelength distinct.

8. The apparatus according to claim 7, wherein the at least one second electromagnetic radiation is at least one a Raman radiation, a scattered light, or a fluorescent light.

9. The apparatus according to claim 1, wherein the at least one second arrangement detects a plurality of the at least one second electromagnetic radiation at different wavelength.

10. The apparatus according to claim 1 , wherein the at least third arrangement determines the at least one characteristic of the at least one structure that is below at least one of (i) an epithelium, or (ii) mucosa of the at least one airway portion.

1 1. The apparatus according to claim 1 , further comprising a probe arrangement, wherein at least a portion of the at least one first arrangement is part of the probe arrangement.

12. The apparatus according to claim 1 1 , wherein the probe arrangement is associated with or inserted into a needle arrangement.

13. The apparatus according to claim 12, wherein the probe arrangement is within a needle of the needle arrangement.

14. The apparatus according to claim 1 1, wherein the probe arrangement is associated with or inserted into a tubular arrangement.

15. The apparatus according to claim 14, wherein the tube arrangement is structured to be inserted into the at least one airway portion at least one of transorally, transnasally or trascutaneously.

16. The apparatus according to claim 14, wherein the tube arrangement includes an intubation tube, a bougie tube, or a tracheostomy tube.

17. The apparatus according to claim 1 1, wherein the probe arrangement includes a further apparatus which is configured to provide an audible signal or a visual signal when the probe arrangement is within or near the at least one airway portion.

18. The apparatus according to claim 1 1 , wherein the probe arrangement includes a further apparatus which is configured to provide an audible signal or a visual signal when the probe arrangement is not within or near the at least one airway portion.

19. The apparatus according to claim 1 1, wherein the at least one first arrangement directs the at least one first electromagnetic radiation in a direction that is non-parallel to a long axis of the probe arrangement.

20. The apparatus according to claim 1 1 , wherein the at least one first arrangement directs the at least one first electromagnetic radiation in a direction that is approximately

perpendicular to a long axis of the probe arrangement.

21. The apparatus according to claim 1 , wherein the at least one first electromagnetic radiation impacts the at least one structure at a first location, and the at least one second electromagnetic radiation is provided from the at least one structure from a second location, and wherein the first and second locations are different from one another.

22. A method for determining information regarding at least one anatomical structure, comprising:

forwarding at least one first optical electro-magnetic radiation to the at least one structure;

detecting at least one second electro-magnetic radiation provided from the at least one structure which is based on the at least one first electro-magnetic radiation; and determining at least one characteristic of the at least one structure inside thereof based on the at least one second electro-magnetic radiation, wherein the at least one characteristic includes an identification of the at least one structure upon a placement of at least one portion of an apparatus configured to perform procedures (a)-(c) at, within or near at least one airway portion of the at least one structure.