METHODS AND STORAGE MEDIUMS FOR USE THEREWITH

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application relates, and claims priority, to U.S. Prov. Patent Application Serial No. 62/665,986, filed May 2, 2018, and to U.S. Prov. Patent Application Serial No. 62/798,368, filed January 29, 2019, the entire disclosures of which are incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION

Field of the Disclosure

[0002] The present disclosure relates to one or more embodiments of direct approach needle scopes and/ or endoscope apparatuses, to one or more embodiments of needle tip mechanisms for needle scope and/or endoscope apparatuses, and to one or more embodiments of methods and storage mediums for use with needle scopes and/or endoscope apparatuses ( e.g ., direct approach scopes and/or endoscope apparatuses, scopes and/or endoscope apparatuses using one or more needle tip mechanisms, etc.). Examples of needle scope applications include imaging, evaluating and characterizing/identifying biological objects or tissue, such as, but not limited to, for nasal applications (e.g., treating maxillary sinusitis, irrigating and suctioning the sinus, performing diagnostics (e.g., laparoscopy), etc.). The needle scopes and/or endoscope apparatuses, the needle tip mechanisms, the methods, and the storage mediums discussed herein may be used with Spectrally Encoded Endoscopy (SEE) endoscopes.

Description of the Related Art

[0003] It is often useful and necessary for medical or research reasons to obtain images from within a subject. An endoscope or some other medical probe has the ability to provide images from inside the subject. The subject may be a human patient. Considering the risk to the subject caused by insertion of a foreign object, it is preferable that the probe be as small as possible. Additionally, the ability to image within small pathways such as vessels, ducts, needles, cuts, cracks etc., provides additional advantages to smaller probe sizes. The ideal medical probe provides as much information with the least amount of disturbance.

[0004] Prior attempts to treat maxillary sinusitis have been risky because such attempts did not use direct imaging. As such, attempts sometimes resulted in blinding the patient because without direct imaging, the Ear Nose Throat specialists (ENTs) did not know whether they were irrigating and suctioning the maxillary sinus or the eye.

[0005] In procedures using a direct path to the maxillary sinus, physicians would sometimes go through the nasal cavity, and they would sometimes use the Caldwell-Luc approach. In the Caldwell-Luc approach, the physician gains access to the maxillary sinus through the patient’s mouth, above the teeth and below the lip. However, the Caldwell-Luc approach is not ideal because it involves additional risks of severing nerves, causing tooth damage, and creating healing complications. Additionally, the Caldwell-Luc approach has been associated with recurrent sinusitis and other issues.

[0006] Increasing the difficulty of such procedures, each and every patient has unique sinus anatomy. The sinuses are like fingerprints, with significant variation from one person to another. For example, 4% of the population does not have a frontal sinus and 14% of the population has frontal sinuses that are not fully formed. There are patients who may have had an orbital fracture and half their eye is sitting in the maxillary sinus. To avoid damaging the eye, physicians no longer blindly insert a needle into the maxillary sinus and inject or suction fluid.

[0007] ENTs generally treat maxillary sinusitis with sinus rinses, antibiotics, balloon dilation, and functional endoscopic sinus surgery (FESS). The current treatment regimen is often ineffective and involves multiple visits to the ENT. Diagnosis involves viewing in the nasal cavity with conventional rod-based endoscopes, without being able to see inside the sinuses. Diagnosis often involves a CT scan of the patient as well.

[0008] Sometimes a patient goes through multiple rounds of treatment for sinusitis by an ENT when they should be going to a headache specialist or other specialist, resulting in months of delay before effective treatment is obtained. For example, an ENT gets a new patient who he or she expects to have acute sinusitis, based on the patient’s symptoms and history. The ENT puts a conventional endoscope into the nasal cavity to look for puss, but there is no puss present. The ENT is not sure if the patient has an infection or not, as not all sinus infections result in puss within the nasal cavity. If this is the first time the patient has come in to this ENT, the ENT will typically put the patient on a course of 7, to, or 14 days of antibiotic, and tell the patient to come back. If the patient comes back and still has an issue, then the physician may try a different antibiotic. Typically, on the third visit, the patient gets a CT scan. If there is nothing in the CT scan, then the ENT sends the patient to a headache specialist. The headache specialist may be booking out 3 months. In this hypothetical, months have now elapsed from the time the patient first visited the ENT to the time the patient finally gets to see the headache specialist to diagnose and treat the issue(s). This has been several months of pain, days out of work, and multiple physician visits and associated costs.

[0009] Additional aspects of treatment(s) that are ineffective include: over-prescription of antibiotics and associated side effects on a patient and epidemiological effects on society; radiation exposure to a patient from CT in diagnosis; ballooning can cause recirculation; etc.

[0010] Physicians/ENTs currently have no way to see inside the presurgical maxillary sinuses. Accordingly, it would be desirable to provide at least one direct needle scope technique, storage medium, and/or apparatus to achieve efficient and improved resolution of an image of biological object(s) or tissue, especially in a way that reduces or minimizes cost of manufacture and maintenance and in a way that allows physicians to increase efficiency and more effectively treat maxillary sinusitis and/or other ENT issues with direct imaging. Additionally, it would be desirable to provide one or more needle tip mechanisms for a needle scope or an endoscope to protect a scope, such as, but not limited to, an ultra-miniature endoscope, which may be fragile due to a small or very small diameter. While such a needle scope or endoscope navigates or is navigated through a nasal passage to get the needle to a desired location, one or more needle tip mechanisms would be desirable to reduce or avoid the risk of the needle tip coming in contact with anatomy and causing harm as the ENT/physician inserts the guide in a nose of a patient. SUMMARY

[0011] Accordingly, it is a broad object of the present disclosure to provide needle scope and/or endoscope apparatuses and systems ( e.g ., using a direct approach, using one or more needle tip mechanisms, using a combination of one or more features discussed herein, etc.), and methods and storage mediums for use with same. In one or more embodiments, what may be used is a direct imaging needle scope that is small in size, less complex, has fewer components and is thus more reliable. In one or more situations, scopes or endoscopes with large or larger overall diameters (OD) (e.g., 2-4 mm) may be too large to travel deep within an area, such as a nasal passage, due to tight anatomy, polyps, swelling from sinusitis, etc. In one or more embodiments, a scope or endoscope may be an ultra-miniature endoscope or scope (e.g., OD of about 2 mm, OD of < 2 mm, etc.) to allow physicians/ENTs to travel through such tight spaces and get access to view anatomy that traditional scopes are not able to. In one or more situations, ultra-miniature endoscopes may be fragile due to having a small or very small diameter (e.g., less than 2 mm, about 2 mm, etc.), and may be protected with an outer layer or sheath made from plastic or material. What may also be used is a needle scope that can be used for immediate diagnosis, treatment and symptom relief on a first ENT/physician visit, for reducing physician visits, for reducing usage of antibiotics, for reducing patient exposure to CT radiation, and for eliminating a risk of blinding a patient compared to prior method(s), as the ENT/physician may confirm the location of the needle prior to irrigating, suctioning, and/ or drug delivery (or any other method of treatment that may be administered via the needle scope). A built-in scope may be used for numerous applications, including, but not limited to, treating sinusitis, viewing within the maxillary sinus, creating an artificial ostium (e.g., by needle puncture), etc. A guide may be curved at the tip in one or more embodiments.

[0012] There is a need for reducing the size of an endoscopic probe so as to be usable for various subjects and treatment areas in, for example, medical inspection applications and medical applications. Further, in order to confirm the structures of subjects and the structures of treatment areas by using direct images, there is a need for acquiring information about the subjects. In one or more methods, needle scope methods, apparatuses/devices and storage mediums discussed herein, discussed in U.S. Provisional Patent Application No. 62/665,986, filed on May 2, 2018, the disclosure of which is incorporated by reference herein in its entirety, and/or discussed in U.S. Provisional Patent Application No. 62/798,368, filed January 29, 2019, the disclosure of which is incorporated by reference herein in its entirety, may be used, for example, with a Spectrally Encoded Endoscopy (SEE) endoscope.

[0013] At least one broad feature(s) of the present disclosure is to provide an endoscope, a probe, and an image acquisition apparatus in SEE for acquiring images with a miniaturized probe or with an ultraminiaturized endoscope using the needle scope, for example, including, but not limited to, the direct approach technology discussed herein and/or needle tip mechanism technology discussed herein. Spectrally encoded endoscopy (SEE) is an endoscope technology which uses a broadband light source, a rotating grating and a spectroscopic detector to encode spatial information on a sample. When illuminating light to the sample, the light is spectrally dispersed along one illumination line, such that the dispersed light illuminates a specific position of the illumination line with a specific wavelength. When the reflected light from the sample is detected with the spectrometer, the intensity distribution is analyzed as the reflectance along the line. By rotating or swinging the grating back and forth to scan the illumination line, a two- dimensional image of the sample is obtained.

[0014] At least a further broad feature(s) of the present disclosure to provide apparatuses and systems using direct approach or direct image technology and/or needle tip mechanisms, and methods and storage mediums for use with same. At least one example may be a SEE ultraminiature endoscope. The endoscope may include a first waveguide for guiding light from a light source to an output port of the first waveguide. The endoscope may include an optical apparatus and/or system. The optical apparatus and/or system may comprise at least a first reflecting surface and a second reflecting surface. The endoscope may include a diffraction grating. The first reflecting surface may be arranged to reflect light from the output port of the first waveguide to the second reflecting surface. The second reflecting surface may be arranged to reflect light from the first reflecting surface back through the first reflecting surface to the diffraction grating. The diffraction grating may diffract light from the second reflecting surface in a non-zero diffraction order in a first direction. The apparatus and/or system may be used to obtain a two or three dimensional image in black and white or in color. [0015] In at least one embodiment, a direct view or direct image needle scope device or apparatus may include: a needle or structure operating to be positioned in a predetermined region or area of an object or subject; and an imaging device that: (i) is disposed or housed in the needle or structure, and (ii) operates to confirm whether the needle or structure is located in the predetermined region or area and to one or more of: obtain one or more direct view or direct approach images of the predetermined region or area of the object or the subject, diagnose the predetermined region or area of the object or the subject, and treat the predetermined region or area of the object or the subject.

[0016] In at least one embodiment, a needle scope device or apparatus may include: a needle or structure operating to be positioned in a predetermined region or area of an object or subject, the needle or structure having one or more needle tip mechanisms operating to reduce or prevent contact between a tip or portion of the needle or structure and the object or subject prior to the needle or structure being positioned in the predetermined region or area; and an imaging device that: (i) is disposed or housed in the needle or structure, and (ii) operates to confirm whether the needle or structure is located in the predetermined region or area and to one or more of: obtain one or more images of the predetermined region or area of the object or the subject, diagnose the predetermined region or area of the object or the subject, and treat the predetermined region or area of the object or the subject. One or more embodiments may be a direct view or direct image needle scope or endoscope.

[0017] In at least one embodiment, a method for controlling a direct approach or direct view needle scope device may include: inserting a structure or needle including an imaging device therein of the needle scope device into a predetermined region or area of an object or subject; and viewing or obtaining, via the imaging device, one or more images from a tip or end of the structure or the needle to: (i) confirm whether the structure or the needle is located in the predetermined region or area of an object or subject; and (ii) one or more of: obtain one or more direct view or direct approach images of the predetermined region or area of the object or the subject, diagnose the predetermined region or area of the object or the subject, and treat the predetermined region or area of the object or the subject. [0018] In at least one embodiment, a method for controlling a needle scope device including one or more needle tip mechanisms may include: inserting a structure or needle including an imaging device therein of the needle scope device into a predetermined region or area of an object or subject; and viewing or obtaining, via the imaging device, one or more images from a tip or end of the structure or the needle to: (i) confirm whether the structure or the needle is located in the predetermined region or area of an object or subject; and (ii) one or more of: obtain one or more images of the predetermined region or area of the object or the subject, diagnose the predetermined region or area of the object or the subject, and treat the predetermined region or area of the object or the subject. In one or more embodiments, the images may be direct view or direct approach images.

[0019] In at least one embodiment, a computer-readable storage medium may store at least one program that operates to cause one or more processors to execute a method for controlling a scope or endoscope for imaging, such as, but not limited to a direct approach or direct view needle scope, a scope or endoscope using a needle tip mechanism, a combination thereof, etc. The method may include: inserting a structure or needle including an imaging device therein of the needle scope device into a predetermined region or area of an object or subject; and viewing or obtaining, via the imaging device, one or more images from a tip or end of the structure or the needle to: (i) confirm whether the structure or the needle is located in the predetermined region or area of an object or subject; and (ii) one or more of: obtain one or more images of the predetermined region or area of the object or the subject, diagnose the predetermined region or area of the object or the subject, and treat the predetermined region or area of the object or the subject. In one or more embodiments, the images may be direct view or direct approach images.

[0020] The apparatus may include a light source that operates to transmit the transmitted light to the needle scope via at least one of the one or more optical fibers such that: (i) the at least one diffractive grating or element is irradiated with the transmitted light; (ii) a sample or a target located in the target region is irradiated with the superposed or substantially superposed diffracted light beams; and (iii) reflected scattered light from the sample or the target is detected by the at least one image sensor or detector. The light source may be a supercontinuum (SC) light source having a wavelength band from blue to infrared. [0021] One or more embodiments of a needle scope in accordance with the present disclosure may include a needle with an imager or imaging device inside of the needle. The needle may be curved to obtain access to the maxillary sinus, such as, but not limited to, a direct approach ( e.g ., by creating an artificial ostium, through the posterior fontanelle, etc.).

[0022] In one or more embodiments, the imager or imaging device may be removed from the needle (e.g., via a lumen of the needle), and irrigation, suction, dilation (e.g., balloon dilation), culture and/ or implantation/delivery of a drug/ fluid may be performed through the needle lumen. In one or more embodiments, the lumen may be narrow or wide depending on whether other tubes or connections are made in or through the needle.

[0023] In one or more further embodiments, a needle may include a fluid area for performing fluid delivery using a syringe or another fluid delivery or removal device attached to the needle. The syringe or fluid delivery or removal device may be connected with a flexible connector (e.g., a tube) to reduce the risk of accidental movement of the needle during attachment of the syringe or other fluid injection or removal device.

[0024] In one or more embodiments, a needle may be wide so that the imager or imaging device may be positioned or disposed in the needle while the needle includes a fluid area for performing any treatment, such as, but not limited to, irrigation, suction, dilation (e.g., balloon dilation), culture and/or implantation/deliveiy of a drug/fluid may be performed through a second needle lumen.

[0025] In one or more additional embodiments, a needle may include multiple lumens where:

(i) the imager or imaging device is disposed or positioned in or through a first needle lumen; and

(ii) the irrigation, suction, dilation (e.g., balloon dilation), culture and/or implantation/delivery of a drug/fluid may be performed through a second needle lumen.

[0026] In accordance with an even further aspect of the present disclosure, a method for controlling a direct image needle scope apparatus may include: inserting a needle into a predetermined location of the maxillary sinus, and viewing an image from a tip of the needle to confirm that the needle is located in the maxillary sinus and then perform diagnosis. In one or more embodiments, the needled is positioned in the maxillary sinus to create an artificial ostium, and may be positioned through or via the posterior fontanelle. [0027] At least one embodiment may be an imaging apparatus used in a needle scope. The imaging apparatus may comprise: a light source; a detector; a first waveguide for guiding light from the light source to an output port of the first waveguide; an optical apparatus and/or system; a diffraction grating; and a second waveguide for gathering light and sending the gathered light to the detector. The optical apparatus and/or system may comprise at least a first reflecting surface and a second reflecting surface. The first reflecting surface may be arranged to reflect light from the output port of the first waveguide to the second reflecting surface. The second reflecting surface may be arranged to reflect light from the first reflecting surface back through the first reflecting surface to the diffraction grating.

[0028] At least another embodiment may be a probe used in a needle scope. One or more embodiments of a probe may comprise: a first waveguide for guiding light from a light source to an output port of the first waveguide; an optical apparatus and/or system; and a diffraction grating. The optical apparatus and/or system may comprise at least a first reflecting surface and a second reflecting surface. The first reflecting surface may be arranged to reflect light from the output port of the first waveguide to the second reflecting surface. The second reflecting surface may be arranged to reflect light from the first reflecting surface back through the first reflecting surface to the diffraction grating.

[0029] In one or more embodiments of the present disclosure, it is possible to, in Spectrally encoded endoscopy (SEE), reduce the size of the optical apparatus and/or system at the end of the probe and acquire black and white and/or color images.

[0030] In one or more embodiments, one or more scopes or endoscopes may be used with one or more needle tip mechanisms to shield the needle, or pull a tip of the needle away from anatomy, a target, a specimen, a tube, walls of a path for the scope or endoscope, etc. while the scope or endoscope is being positioned, and once the scope or endoscope has placed the probe and/or the needle in a predetermined or desired location, the needle tip mechanism(s) may be retracted away from a tip of the needle to use the needle for puncture.

[0031] According to other aspects of the present disclosure, one or more additional apparatuses, one or more systems, one or more methods, and one or more storage mediums using needle scope technique(s) are discussed herein. Further features of the present disclosure will become apparent from the following description of exemplary embodiments with reference to the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] For the purposes of illustrating various aspects of the disclosure, wherein like numerals indicate like elements, there are shown in the drawings simplified forms that may be employed, it being understood, however, that the disclosure is not limited by or to the precise arrangements and instrumentalities shown. To assist those of ordinary skill in the relevant art in making and using the subject matter hereof, reference is made to the appended drawings and figures, wherein:

[0033] FIG. tA is an illustration of at least one embodiment of a needle scope system.

[0034] FIG. tB is a schematic diagram of at least another embodiment of a needle scope system.

[0035] FIG. tC is a schematic diagram of at least one other embodiment of a needle scope system.

[0036] FIG. 2 is a flow diagram showing a method of using a needle scope in accordance with one or more aspects of the present disclosure.

[0037] FIG.3 is a diagrammatic cross-sectional overhead view showing a shaped needle going through a predetermined location, such as the posterior fontanelle, and into the maxillary sinus.

[0038] FIG. 4 is a diagram illustrating dimensions, including a size and a shape, of a needle used for at least one embodiment of a needle scope of the present disclosure.

[0039] FIG. 5 is an illustration of at least one further embodiment of a needle scope system using a needle with a fluid port in accordance with one or more aspects of the present disclosure.

[0040] FIG. 6 is a flow diagram showing at least a further method of using a needle scope in accordance with one or more aspects of the present disclosure.

[0041] FIG. 7 is an illustration of configurations during insertion into a sinus and viewing an image (and a cross-section thereof), and during removal of an imaging device from the needle, for at least one embodiment of a needle scope of the present disclosure. [0042] FIG. 8 is an illustration of configurations of a needle scope device during injection, or removal of fluid, showing a fluid delivery or removal device connected and being connected or disconnected in accordance with one or more aspects of the present disclosure.

[0043] FIG. 9 is an illustration of at least one further embodiment of a needle scope system using a needle with a fluid port and a fluid channel located in between an imaging device and the needle in accordance with one or more aspects of the present disclosure.

[0044] FIG. to is a flow diagram showing at least a further method of using a needle scope in accordance with one or more aspects of the present disclosure.

[0045] FIG. 11 is an illustration of a configuration of a needle having an imager and a fluid area or channel disposed therein in accordance with one or more aspects of the present disclosure.

[0046] FIG. 12 is an illustration of at least one further embodiment of a needle scope system using a fluid port and a multi-lumen tube or a needle with multiple lumens therein in accordance with one or more aspects of the present disclosure.

[0047] FIG. 13 is a flow diagram showing yet another method of using a needle scope in accordance with one or more aspects of the present disclosure.

[0048] FIG. 14 is a diagram showing a configuration of at least one embodiment of a multi lumen tube or a needle with multiple lumens therein in accordance with one or more aspects of the present disclosure.

[0049] FIGS. I5(a)-t5(d) are diagrams illustrating different geometric configurations of an end of a needle for a needle scope in accordance with one or more aspects of the present disclosure.

[0050] FIGS. 16(a) and 16(b) are diagrams illustrating further different geometric configurations of an end of a needle using a tip for a needle scope in accordance with one or more aspects of the present disclosure.

[0051] FIG. 17A is a diagram illustrating at least one embodiment of a scope including an atraumatic tip having a retractable needle in accordance with one or more aspects of the present disclosure.

[0052] FIG. 17B is a diagram illustrating at least one embodiment of a scope including a spring ejected needle tip design with a rim on the retractable needle in accordance with one or more aspects of the present disclosure. [0053] FIG. 18 is a diagram illustrating at least one embodiment of a scope including a needle tip comprising multiple fins which protrude upon rotational actuation in accordance with one or more aspects of the present disclosure.

[0054] FIG. 19 is a diagram illustrating at least one embodiment of a scope including a needle tip formed from a thin sheet of a predetermined material that operates to be rolled at an angle in accordance with one or more aspects of the present disclosure.

[0055] FIG. 20 is a diagram illustrating at least one embodiment of a scope including a screw on a shaft of the scope that operates to actuate the needle tip forwards or backwards in accordance with one or more aspects of the present disclosure.

[0056] FIG. 21A is a diagram illustrating at least one embodiment of a scope including a slider that operates to move the needle tip forwards or backwards in accordance with one or more aspects of the present disclosure.

[0057] FIG. 21B is a diagram illustrating at least one embodiment of a scope including a slider with a handle that operates to move the needle tip forwards or backwards in accordance with one or more aspects of the present disclosure.

[0058] FIG. 22 is a diagram illustrating at least one embodiment of a scope including a shutter that operates to act as a needle tip when extended in accordance with one or more aspects of the present disclosure.

[0059] FIGS. 23A-23E are diagrams illustrating one or more embodiments of a scope including a hole or a groove covered with an outer sheath on a main needle and a pin needle or a wire with a needle tip mounted at the tip, or with a knife edge, in accordance with one or more aspects of the present disclosure.

[0060] FIG. 24 is a flow diagram showing a method of performing an imaging technique in accordance with one or more aspects of the present disclosure.

[0061] FIG. 25 shows a schematic diagram of an embodiment of a computer that may be used with one or more embodiments of a needle scope or endoscope apparatus or system or an imaging system or one or more methods discussed herein in accordance with one or more aspects of the present disclosure.

[0062] FIG.26 shows a schematic diagram of another embodiment of a computer that may be used with one or more embodiments of a needle scope or endoscope apparatus or system or an imaging system or methods discussed herein in accordance with one or more aspects of the present disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0063] Embodiments will be described below with reference to the attached drawings. Like numbers refer to like elements throughout. It shall be noted that the following description is merely illustrative and exemplary in nature, and is in no way intended to limit the disclosure and its applications or uses. The relative arrangement of components and steps, numerical expressions and numerical values set forth in the embodiments do not limit the scope of the disclosure unless it is otherwise specifically stated. Techniques, methods, and devices which are well known by individuals skilled in the art may not have been discussed in detail since an individual skilled in the art would not need to know these details to enable the embodiments discussed below. Further, an endoscope as disclosed in the following which is used to inspect an inside a human body may also be used to inspect other objects. Examples of specialized endoscopes which are examples of endoscope in which an embodiment may be implemented including: angioscope; anoscope; arthroscope; arterioscope; arthroscope, bronchoscope; capsule endoscope; choledochoscope; colonoscope; colposcope; cystoscope; encephaloscope; esophagogastroduodenoscope; esophagoscope; gastroscope; hysteroscope; laparoscope; laryngoscope; mediastinoscope; nephroscope; neuroendoscope; proctoscope; resectoscope; rhinoscope; sigmoidoscope; sinusoscope; thoracoscope; ureteroscope; uteroscope; borescope; fiberscope; inspection camera; and any specialized endoscope which may be adapted to include an embodiment. The endoscope may be flexible or rigid. An embodiment may also be a probe or an imaging apparatus.

[0064] One or more devices, optical systems, methods, and storage mediums for obtaining a direct image (e.g., black and white, color, etc.) of a subject, such as tissue (e.g., of the maxillary sinus), using a needle scope technique and/or for diagnosing, irrigating, suctioning, dilating (e.g., balloon), culturing, tissue sampling, performing a biopsy, implanting/delivering a drug/fluid and/or performing any other type of diagnosis and/or treatment using a needle scope technique are disclosed herein. In accordance with at least one aspect of the present disclosure, one or more devices, optical systems, methods, and storage mediums discussed herein use a needle scope technique to provide a direct image or a direct view.

[0065] One method of speeding up the gathering of information is to encode a component of the spatial information with spectral information. In the context of endoscopy or a needle scope, one example that may be used is referred to as spectrally encoded endoscopy (SEE), which uses the wavelength of the illumination light to encode spatial information from a sample. Such needle scope and/or SEE endoscope technology increases the speed with which images may be obtained and improves the efficiency of performing diagnosis and treatment through smaller diameter endoscopic probes and/or smaller or minimized needles. SEE is an endoscope technology which uses a broadband light source, a rotating grating and a spectroscopic detector to encode spatial information on a sample. When illuminating light to the sample, an object and/or a patient (or a portion thereof), the light is spectrally dispersed along one illumination line, such that the dispersed light illuminates a specific position of the illumination line with a specific wavelength. When the reflected light from the sample is detected with the spectrometer, the intensity distribution is analyzed as the reflectance along the line. By rotating or swinging the grating back and forth to scan the illumination line, a two-dimensional image of the sample is obtained.

[0066] SEE is a technology that may utilize optical fibers, miniature optics, and a diffraction grating (or prism) for high-speed imaging through small diameter and flexible endoscopic probes. Polychromatic light emanating from the SEE probe is spectrally dispersed and projected in such a way that that each color (wavelength) illuminates a different location on the sample in one line (the dispersive line, spectral line, or illumination line). Reflected (or scattered) light from the sample may be collected and decoded by a spectrometer and/or a detector to form an image line. Each position of the line corresponds with a specific wavelength of the illumination light. Spatial information in another dimension substantially perpendicular to the dispersive line may be obtained by moving the probe. SEE has been used to produce high quality images in two and three dimensions as well as in color. SEE may be accomplished by using a broad bandwidth light input into a single optical fiber. By rotating or swinging the grating back and forth to scan an illumination line along which the light is spectrally dispersed, a two-dimensional image of the sample is obtained. [0067] FIG. lA is an illustration of at least a first embodiment (with a further or alternative embodiment being shown in FIG. tB and an even further or other alternative embodiment being shown in FIG. tC as discussed below), such as a needle scope too in which one or more of the features of the subject embodiment may be implemented. This needle scope system too may include a needle 115, and may be connected ( e.g ., via a cable) to a console or computer 1300, a monitor 1309, a network 1306 (e.g., a hospital network), and a power connection 122. In one or more embodiments, a needle scope too may include a handle 119. At least one advantage of a smaller or minimized needle size is minimized invasiveness, resulting in at least less trauma, less pain, faster healing, less scarring, and less risk of complications (e.g., from avoidance of radiation from imaging, less exposure to radiation from imaging, etc.). This is especially important in“rule out” cases, where an ENT may use one or more features of the present disclosure to discover that a patient does not have (and, therefore,“rule out”) a sinus problem. With low risk of complications from a tiny needle, benefits of a procedure outweigh risks, as a patient may get an immediate referral to a headache specialist and/or other relevant medical professional instead of first enduring weeks or months of ineffective treatments by the ENT. One or more of the features shown in at least FIGS. 1A-4 results in a minimized or smallest needle size. Preferably, in one or more embodiments, an imager or an imaging device 112 (best seen in FIGS. 1B-1C) is housed inside the needle 115. The imager 112 (e.g., an SEE probe, an SEE endoscope, etc.) is used inside the needle 115 during insertion of the needle 115 into the patient (e.g., into a maxillary sinus of the patient) to confirm that the needle 115 is in the maxillary sinus and to diagnose the patient. In one or more embodiments, the dimensions of the curved needle 115 may be set to obtain optimal access to a predetermined location in the patient, such as, but not limited to, the maxillary sinus, the posterior fontanelle of the maxillary sinus, etc. In one or more embodiments, the anatomy of the predetermined area of the patient may be used to define the geometry of the needle 115. For example, to access a maxillary sinus through the posterior fontanelle, the curved needle 115 may have an outer diameter of 3 mm or less. In one or more embodiments, the curved needle 115 is at least or about 60 degrees to make a hole to the maxillary sinus. Preferably, to see one or more predetermined sinus areas (e.g., a floor of the sinus, the ceiling of the sinus, the sides of the sinus, etc.), the curved needle 115 operates to be 90 degrees or more. In one or more embodiments, the curved needle 115 may preferably have a bending angle range of about 60 degrees to about 90 degrees or more. The curved needle 115 may preferably have a bending angle of 90 degrees or more, preferably 110 degrees. The width of the curved needle 115 is preferably less than 16mm. The needle guide 115 may have sharp edge at the tip. One embodiment can be angled tip as shown in Fig. 16 (a) and (b).

[0068] The needle scope too may include or be connected to a broadband light source 102 (best shown in FIGS. 1B-1C for systems too’, too”). The broadband light source 102 may include a plurality of light sources or may be a single light source. The broadband light source 102 may include one or more of a laser, an organic light emitting diode (OLED), a light emitting diode (LED), a halogen lamp, an incandescent lamp, supercontinuum light source pumped by a laser, and/ or a fluorescent lamp. The broadband light source 102 may be any light source that provides light which may then be dispersed to provide light which is then used to for spectral encoding of spatial information. The broadband light source 102 may be fiber coupled or may be free space coupled to the other components of the needle scope too or any other embodiment (including, but not limited to, systems too’ (see FIG. tB), too” (see FIG. tC), too’” (see FIG. 5), too”” (see FIG. 9), too’”” (see FIG. 12), etc.) discussed herein.

[0069] As best seen in FIGS. 1B-1C, the needle scope too, too’ and/or too” (or any other needle scope or apparatus or system discussed herein) may include a rotary junction 106. The connection between the light source 102 and the rotary junction 106 may be a free space coupling or a fiber coupling via fiber 104. The rotary junction 106 may supply just illumination light via the rotary coupling or may supply one or more of illumination light, power, and/ or sensory signal lines.

[0070] The rotary junction 106 couples the light to a first waveguide 108. In one embodiment, the first waveguide 108 is a single mode fiber, a multimode fiber, or a polarization maintaining fiber.

[0071] The first waveguide 108 is coupled to an optical apparatus and/ or system that operates as an imager or imaging device 112. The optical apparatus and/or system (or the imager) 112 may include one or more optical components, that refract, reflect, and disperse the light from the first waveguide 108 to form a line of illumination light 114 on a sample, an object or a patient 116 ( e.g ., a predetermined area in the patient, a predetermined area in a maxillary sinus, through the posterior fontanelle and into the maxillary sinus, etc.)· In an embodiment, the line of illumination light 114 is a line connecting focal points for a wavelength range as the illumination light exits the optical apparatus and/ or system (or the imager or imaging device) 112, the wavelength range being determined by the light source 102. In another embodiment, the spectrometer 120 may further limit the wavelength range by only using information from specified wavelengths of interest. In another embodiment, the line of illumination light 114 is a line formed by the illumination light as the illumination light intersects a surface of the sample 116 for the range of wavelengths that are detected by the spectrometer 120. In another embodiment, the line of illumination light 114 is a line of illumination light in a wavelength range formed on a specific image plane which is determined by the detection optics. In one or more embodiments, only some of the points on the image line may be in focus while other points on the image line may not be in focus. The line of illumination light 114 may be straight or curved.

[0072] In an alternative embodiment, the optical apparatus and/or system (or the imager or imaging device) 112 may partially collimate the light from the waveguide 108 such that the light is focused onto the sample, the object or the patient 116 but the light is substantially collimated at a dispersive optical element such as a grating.

[0073] The apparatus (such as the needle scope, too, too’, too”, too’”, too””, too’””, etc.) may include a detection waveguide 118. The detection waveguide 118 may be a multimode fiber, a plurality of multimode fibers, a fiber bundle, a fiber taper, or some other waveguide. The detection waveguide 118 gathers light from the sample, the object and/or the patient 116 which has been illuminated by light from the optical apparatus and/or system (or the imager or the imaging device) 112. The light gathered by the detection waveguide 118 may be reflected light, scattered light, and/or fluorescent light. In one embodiment, the detection waveguide 118 may be placed before or after a dispersive element of the optical apparatus and/or system 112. In one embodiment, the detection waveguide 118 may be covered by the dispersive element of the optical apparatus and/or system 112, in which case the dispersive element may act as wavelength-angular filter. In another embodiment, the detection waveguide 118 is not covered by the dispersive element of the optical apparatus and/or system, imager or imaging device 112. The detection waveguide 118 guides detection light from the sample, the object and/or the patient 116 to a spectrometer 120.

[0074] The spectrometer 120 may include one or more optical components that disperse light and guide the detection light from the detection waveguide 118 to one or more detectors. The one or more detectors may be a linear array, a charge-coupled device (CCD), a plurality of photodiodes or some other method of converting the light into an electrical signal. The spectrometer 120 may include one or more dispersive components such as a prisms, gratings, or grisms. The spectrometer 120 may include optics and opto-electronic components which allow the spectrometer 120 to measure the intensity and wavelength of the detection light from the sample, the object and/ or the patient 116. The spectrometer 120 may include an analog to digital converter (ADC).

[0075] The spectrometer 120 may transmit the digital or analog signals to a processor or a computer such as, but not limited to, an image processor, a processor or computer 1300, 1300’ ( see e.g., FIGS. 1A-1C, 5, 9, 12, and 25-26), a combination thereof, etc. The image processor may be a dedicated image processor or a general purpose processor that is configured to process images. In at least one embodiment, the computer 1300, 1300’ may be used in place of, or in addition to, the image processor. In an alternative embodiment, the image processor may include an ADC and receive analog signals from the spectrometer 120. The image processor may include one or more of a CPU, DSP, FPGA, ASIC, or some other processing circuitry. The image processor may include memory for storing image, data, and instructions. The image processor may generate one or more images based on the information provided by the spectrometer 120. A computer or processor discussed herein, such as, but not limited to, the computer 1300, the computer 1300’, the image processor, may also include one or more components further discussed herein below (see e.g., FIGS. 25-26).

[0076] One or more components of the needle scope (such as the needle scope, too, too’, too”, too’”, too””, too’””, etc.) may be rotated via the rotary junction 106, or oscillated so as to scan a line of illumination light 114 so as to create a 2D array of illumination light. A 2D image may be formed by scanning a spectrally encoded line from the optical apparatus and/or system, the imager or imaging device 112 across the sample, the object and/or the patient 116. The needle scope (such as the needle scope, too, too’, too”, too’”, too””, too’””, etc.) may include an additional rotary junction that couples the light from the detection fiber 118 to the spectrometer 120. Alternatively, the spectrometer 120 or a portion of the spectrometer 120 may rotate with the fiber 118. In an alternative embodiment, there is no rotary junction 106 and the light source rotates with the fiber 108. An alternative embodiment may include an optical component (mirror) after a dispersive element in the optical system or imager 112 which rotates or scans the spectrally encoded line of illumination light across the sample, the object and/ or the patient 116 substantially perpendicular to the spectrally encoded line of illumination light 114 in a linear line to produce a 2D image or circumferentially in a circle so as to produce a toroidal image. Substantially, in the context of one or more embodiments of the present disclosure, means within the alignment and/ or detection tolerances of the needle scope (such as the needle scope, too, too’, too”, too’”, too””, too’””, etc.) and/or any other system being discussed herein. In an alternative embodiment, there is no rotary junction 106 and an illumination end of the optical apparatus and/or system or the imager 112 is scanned or oscillated in a direction perpendicular to the illumination line.

[0077] In accordance with one or more aspects of the present disclosure, one or more methods for controlling a needle scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, etc.) are provided herein. FIG. 2 illustrates a flow chart of at least one embodiment of a method for controlling a needle scope and/or performing direct approach imaging using the needle scope. Preferably, the method(s) may include one or more of the following: (i) inserting a needle ( e.g ., the needle 115) into a predetermined location of the maxillary sinus ( see step S2000 in FIG. 2); and (ii) viewing an image from a tip of the needle (e.g., the needle 115) to confirm that the needle (e.g., the needle 115) is located in the maxillary sinus and then performing diagnosis (see step S2001 in FIG. 2). One or more methods may further include using the posterior fontanelle as the predetermined location and using the needle to puncture the posterior fontanelle to gain access to the maxillary sinuses. In one or more embodiments, a SEE probe may be connected to one or more systems (e.g., the needle scope, too, too’, too”, too’”, too””, 100’””, etc.) with a connection member or interface module. For example, when the connection member or interface module is a rotary junction for a SEE probe, the rotary junction may be at least one of: a contact rotary junction, a lenseless rotary junction, a lens-based rotary junction, or other rotary junction known to those skilled in the art. The rotary junction may be a one channel rotary junction or a two channel rotary junction. In one or more embodiments, the illumination portion of the SEE probe may be separate from the detection portion of the SEE probe. For example, in one or more applications, a probe may refer to the illumination assembly, which includes the illumination fiber 108 ( e.g ., single mode fiber, a GRIN lens, a spacer and the grating on the polished surface of the spacer, etc.). In one or more embodiments, a scope may refer to the illumination portion which, for example, may be enclosed and protected by a drive cable, a sheath, and detection fibers (e.g., multimode fibers (MMFs)) around the sheath. Grating coverage is optional on the detection fibers (e.g., MMFs) for one or more applications. The illumination portion may be connected to a rotary joint and may be rotating continuously at video rate. In one or more embodiments, the detection portion may include one or more of: the detection fiber 118, the spectrometer 120, the computer 1300, the computer 1300’, etc. The detection fibers, such as the detection fiber(s) 118, may surround the illumination fiber, such as the IF 108, and the detection fibers may or may not be covered by the grating, such as the grating 107.

[0078] In one or more embodiments, the needle 115 operates to bend and/ or puncture through the posterior fontanelle to enter into the maxillary sinus (best shown in FIG.3 showing the needle 115 or the multi-lumen structure 115’ going through one of the nasal passages 31 and into a maxillary sinus 33 through the posterior fontanelle 32 (e.g., of the patient 116). Also shown are a septum 34 and needle ostium guide 35 as diagrammatic reference points). The imager 112 operates to confirm a location in the maxillary sinus to avoid irrigation and/or suction into an eye of the patient, and also to diagnose the sample, the object and/or the patient 116.

[0079] In one or more alternative embodiments, a dispersive element 107 (i.e., a diffraction grating) may be used in the optical apparatus and/or system 112 as shown, respectively, in FIGS. tB and tC. In one or more embodiments (best seen in FIGS. tB and tC), light that has been emitted from the core of the end portion of the illumination optical fiber or the first waveguide 108 may enter a spacer 111 via a refractive-index distribution lens (hereinafter referred to as“gradient index (GRIN) lens”) 109 (alternatively, in one or more embodiments, the lens 210 of FIG. 2 may be used as the GRIN lens). The diffraction grating 107 is formed at the tip portion of the spacer lit as shown in FIGS. tB and tC, and a spectral sequence 114 is formed on the subject or sample 116 by a light flux of white light entering the diffraction grating 107. FIG. tC illustrates an alternative embodiment of a needle scope system too” including a spectrometer as shown in FIG. tB ( see e.g., system too’), with the exception being that a deflecting or deflected section 117 is incorporated into the system too’ of FIG. tB such that the cable or fiber 104 and/or the cable or fiber 108 connecting the light source 102 to the rotary junction 106 and/or the optical apparatus and/or system 112 and the cable or fiber 118 connecting the spectrometer 120 to the rotary junction 106 and/or the optical apparatus and/or system or imager 112 pass through, and are connected via, the deflected section 117 (discussed further below).

[0080] In at least one embodiment, a console or computer 1300, 1300’ operates to control motions of the RJ 106 via a Motion Control Unit (MCU) 140, acquires intensity data from the detector(s) in the spectrometer 120, and displays the scanned image (e.g., on a monitor or screen such as a display, screen or monitor 1309 as shown in the console or computer 1300 of any of FIGS. lA, 5, 9, 12 and 25 and/ or the console 1300’ of FIG. 26 as further discussed below). In one or more embodiments, the MCU 140 operates to change a speed of a motor of the RJ 106 and/or of the RJ 106. The motor may be a stepping or a DC servo motor to control the speed and increase position accuracy. In one or more embodiments, the deflection or deflected section 117 may be at least one of: a component that operates to deflect the light from the light source to the interference optical system, and then send light received from the interference optical system towards the at least one detector; a deflection or deflected section that includes at least one of: one or more interferometers, a circulator, a beam splitter, an isolator, a coupler, a fusion fiber coupler, a partially severed mirror with holes therein, and a partially severed mirror with a tap; etc. In one or more other embodiments, the rotary junction 106 may be at least one of: a contact rotary junction, a lenseless rotary junction, a lens-based rotary junction, or other rotary junction known to those skilled in the art.

[0081] In an embodiment, the first waveguide 108 may be single mode fiber. In an alternative embodiment, the first waveguide 108 may be a multimode fiber or a double clad fiber. In an embodiment, the second waveguide 118 may be a multi-mode fiber a single mode fiber, or a fiber bundle. [0082] In an alternative embodiment, the first waveguide 108 may be an inner core of a double-clad fiber, while the second waveguide 118 may be between the inner core and the outer cladding of the double clad fiber. If a double clad fiber is used, an alternative embodiment may include an optical coupler for guiding illumination light to the inner core, and the optical coupler may also receive detection light from the outer waveguide which is then guided to the spectrometer 120.

[0083] As best seen in FIG. 4, one or more embodiments of a needle ( e.g ., the needle 115) of a needle scope (e.g., the needle scope, too, too’, too”, too’”, too””, too’””, etc.) may have needle dimensions (e.g., size, shape, angle, etc.) as shown in FIG. 4. In one or more embodiments, a needle gauge may define an inner and outer diameter of the needle 115. Preferably, one or more embodiments of a needle (e.g., the needle 115, the needle 115’, the tube 115’ discussed below, etc.) may be bent to enter the maxillary sinus or other predetermined location of the sample, the object and/or the patient 116. Preferably, the needle 115 includes a bend radius, a needle gauge, a needle length, a straight length at a tip of the needle (as shown diagrammatically in FIG. 4) and a bend angle. One or more embodiments of the needle 115 may include a bend radius, a needle gauge, a needle length, a straight length at a tip of the needle, and a bend angle, for performing a direct approach to the maxillary sinuses through the posterior fontanelle, as follows in Table 1:

TABLE 1

[0084] Modifications to the dimensions shown in Table 1 may be made without departing from the spirit and scope of the present disclosure. For example, as aforementioned, the geometry and dimensions of the needle ( e.g ., the needle 115, the needle 115’, the tube 115’, etc.) may be modified to accommodate the predetermined area or target region for imaging, diagnosis and/ or treatment.

[0085] FIG. 5 illustrates an alternative embodiment of a needle scope system too’” including the needle scope system too as shown in FIG. tA ( see e.g., system too), with the exception being that the needle 115 is sized to be just barely larger than the imager 112, such that the imager 112 may be slid out of the needle 115 during any procedure when desired. The imager 112 may be used inside the needle 115 during insertion to confirm that the needle 115 is in the maxillary sinus and to diagnose the patient 116. The needle 115 may include a fluid port 122 in one or more embodiments. The imager 112 may be removed from the needle 115, and the lumen of the needle 115 may be used for irrigation, suction, dilation, culture, and/or implantation/deliveiy of a drug/fluid. The fluid port 122 is a fluid connector such as a luer lock. The imaging device or the imager 112 may be put back into the needle 115 after removal for confirmatory viewing inside the sinus. In one or more embodiments, the dimensions of the curved needle 115 may be set to obtain optimal access to the posterior fontanelle.

[0086] FIG. 6 illustrates a flow chart of at least one additional embodiment of a method for controlling a needle scope and/or performing direct approach imaging using the needle scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, etc.). Preferably, the method(s) may include one or more of the following: (i) inserting a needle (e.g., the needle 115) into a predetermined location of the maxillary sinus ( see step S2000 in FIG. 6); (ii) viewing an image from a tip of the needle (e.g., the needle 115) to confirm that the needle (e.g., the needle 115) is located in the maxillary sinus and then performing diagnosis (see step S2001 in FIG. 6); (iii) removing the imager or the imaging device (such as the imager 112) from a lumen of the needle (such as the needle 115) (see step S2002 in FIG. 6); and (iv) irrigating, suctioning, dilating (e.g., balloon), culturing, tissue sampling, performing a biopsy, and/or implanting/delivering a drug/fluid (and/or performing any other relevant treatment to the maxillary sinus) through the needle lumen (see step S2002 in FIG. 6). In one or more embodiments, these method(s) may further include the aforementioned additional details of the method(s) discussed in relation to FIG. 2, and, as such, the description of same is being omitted here.

[0087] As best seen in FIG. 7, a structural configuration of one or more embodiments of a needle scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, etc.) and using same to perform any of the method(s) described herein ( e.g ., the method as shown in FIG. 6) may involve setting up the needle scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, etc.) during insertion into the maxillary sinus and viewing of an image ( see e.g., Steps S2000 and S2001 in FIG. 6). The needle 115, fluid port 122 and the handle 119 may have the configuration shown on the left side of FIG. 7, and may have the cross- section shown where the imager 112 is disposed in and extends through the needle 115. Removal of the imager or the imaging device 112 from a lumen of the needle 115 may be as shown diagrammatically as shown on the right side of FIG. 7. The imager 112 may be removed by pulling the imager 112 and/or the handle 119 down or away from the needle 115 and out of the fluid port 122 (see e.g., Step S2002 in FIG. 6).

[0088] As best seen in FIG. 8, one or more devices may be used during injection or suctioning/removal of a fluid (see e.g., Step S2003 in FIG. 6). As shown in FIG. 8, a syringe is used as a fluid delivery or removal device 80. However, the fluid delivery or removal device 80 may be any device that operates to inject or suction/ remove fluid as desired. For example, another fluid injection/removal device or a vacuum may be used instead of a syringe. As shown on the left side of FIG. 8, the fluid injection/ removal device 80 may be attached to the needle 115 via a fluid port 82 (and/or the fluid port 122 as discussed above), and may have the cross section where the needle 115 includes the fluid area 81 therein (e.g., without the imager 112 being positioned therein). As shown on the right side of FIG. 8, the fluid injection/ removal device 80 may include a flexible connector (e.g., a tube) 83 that operates to connect the fluid injection/removal device 80 to the needle 115 such that a risk of accidental movement of the needle 115 is reduced and/or eliminated during attachment of the syringe or other fluid injection or removal device 80.

[0089] FIG. 9 illustrates an alternative embodiment of a needle scope system too”” including the needle scope system too’” as shown in FIG. 5 (see e.g., system too’”), with the exception being that, in this embodiment, a physician/ENT does not need to remove the imager 112 during fluid injection or suction. In this embodiment, the needle 115 is sized to be a little larger (and/or wider) than the imager 112, such that fluid can flow between the inner lumen of the needle 115 and the outer diameter of the imager 112. This is beneficial for cleaning the lens, as saline or other fluid may be flushed around the imager 112 to clear blood, mucus, puss, condensation, or other material that is clouding or blocking view. The system 100”” includes a fluid port 91, and the fluid port 91 is a fluid connector such as a luer lock. Instruments, such as a balloon for dilation may also be deployed through this fluid port 91 and the space between the imager 112 and needle 115. The needle 115 of this embodiment may be larger/wider than the needle of the prior embodiments.

[0090] FIG. 10 illustrates a flow chart of at least one additional embodiment of a method for controlling a needle scope and/or performing direct approach imaging using the needle scope (such as, but not limited to, the needle scope, 100, 100’, 100”, 100’”, 100””, 100’””, etc.). Preferably, the method(s) may include one or more of the following: (i) inserting a needle ( e.g ., the needle 115) into a predetermined location of the maxillary sinus ( see step S2000 in FIG. 10); (ii) viewing an image from a tip of the needle (e.g., the needle 115) to confirm that the needle (e.g., the needle 115) is located in the maxillary sinus and then performing diagnosis (see step S2001 in FIG. 10); and (iii) irrigating, suctioning, dilating (e.g., balloon), culturing, tissue sampling, performing a biopsy, and/or implanting/delivering a drug/fluid (and/or performing any other relevant treatment to the maxillary sinus) through a gap (see e.g., the fluid area 92 shown in FIG. 11) between an imaging device (such as the imager 112) located in a needle (such as the needle 115) and an inner wall of the needle lumen (see step S2004 in FIG. 10). In one or more embodiments, these method(s) may further include the aforementioned additional details of the method(s) discussed in relation to FIGS. 2 and 6, and, as such, the description(s) of same is/ are being omitted here.

[0091] As shown in FIG. 11, the needle 115 may include the imager 112 therein and have additional space for use as a fluid area 92 such that when fluid is inserted or suctioned/removed using a fluid insertion/removal device 80, the fluid passes between an imaging device (such as the imager 112) located in a needle (such as the needle 115) and an inner wall of the needle lumen in the fluid area 92 (see step S2004 in FIG. 10). [0092] FIG. 12 illustrates an alternative embodiment of a needle scope system 100’”” including the needle scope system 100”” as shown in FIG. 9 ( see e.g., system 100””), with the exception being that, in this embodiment, there is a multi-lumen guide (e.g., a tube, a needle with cavities there through, etc.) instead of a single lumen needle. One lumen is for the imager (e.g., the imager 112) and at least one other lumen is present and operates for irrigation, suction, dilation, culture, and/or implantation/delivery of drug/fluid (and/or any other diagnoses and/or treatment procedure for the patient 116). This guide could be a multi-lumen needle, a multi-lumen tube with a traumatic tip, or another elongated multi-lumen structure (see e.g., the structure 115’ of FIGS. 12 and 14) with dimensions optimized to access a predetermined location (e.g., the posterior fontanelle) of the maxillary sinus from the nostril of the patient 116. The system 100’”” may also include the aforementioned fluid port 91. Instruments, such as a balloon for dilation may also be deployed through this fluid port 91 and in the second lumen or other structure provided for same between the imager 112 and the needle or tube 115’.

[0093] FIG. 13 illustrates a flow chart of at least one further embodiment of a method for controlling a needle scope and/or performing direct approach imaging using the needle scope (such as, but not limited to, the needle scope, 100, 100’, 100”, 100’”, 100””, 100’””, etc.). Preferably, the method(s) may include one or more of the following: (i) inserting a multi-lumen structure (e.g., a multi-lumen needle, a multi-lumen tube with a traumatic tip, or another elongated multi-lumen structure (see e.g., the structure 115’ of FIGS. 12 and 14)) into a predetermined location of the maxillary sinus (see step S2000 in FIG. 13); (ii) viewing an image from a tip of the multi-lumen structure (e.g., a multi-lumen needle, a multi-lumen tube with a traumatic tip, or another elongated multi-lumen structure (see e.g., the structure 115’ of FIGS. 12 and 14)) (for example, via an imaging device or the imager 112 located in a first lumen of the structure 115’) to confirm that the multi-lumen structure (e.g., a multi-lumen needle, a multi lumen tube with a traumatic tip, or another elongated multi-lumen structure (see e.g., the structure 115’ of FIGS. 12 and 14)) is located in the maxillary sinus and then performing diagnosis (see step S2001 in FIG. 13); and (iii) irrigating, suctioning, dilating (e.g., balloon), culturing, tissue sampling, performing a biopsy, and/or implanting/delivering a drug/fluid (and/or performing any other relevant treatment and/or diagnosis step to the maxillary sinus) through a gap (e.g., a second lumen provided for the fluid area 92’ shown in FIG. 14 through which fluid passes) of the multi-lumen structure ( e.g ., a multi-lumen needle, a multi-lumen tube with a traumatic tip, or another elongated multi-lumen structure ( see e.g., the structure 115’ of FIGS. 12 and 14)) ( see step S2005 in FIG. 13). In one or more embodiments, these method(s) may further include the aforementioned additional details of the method(s) discussed in relation to FIGS. 2, 6 and to, and, as such, the description(s) of same is/ are being omitted here.

[0094] As shown in FIG. 14, the multi-lumen structure {e.g., a multi-lumen needle, a multi lumen tube with a traumatic tip, or another elongated multi-lumen structure) 115’ may include the imager 112 in a first lumen thereof and may have a second lumen for use as a fluid area 92’ such that when fluid is inserted or suctioned/removed using a fluid insertion/removal device 80, the fluid passes through the second lumen of the multi-lumen structure ( see step S2005 in FIG. 13)·

[0095] As best seen in FIGS. ts(a)-(d), a position of the imager 112 may be set differently in a needle (such as the needle 115) or in a multi-lumen structure {e.g., a multi-lumen needle, a multi lumen tube with a traumatic tip, or another elongated multi-lumen structure) 115’. For example, as shown in FIG. 15(a), the imager 112 may be positioned closer to the piercing portion {e.g., the top, pointed part of the needle) of the needle 115, and fluid may be flushed (injected/suctioned) via the fluid area 92, which is disposed near the bottom side of the needle 115 or the multi-lumen structure {e.g., a multi-lumen needle, a multi-lumen tube with a traumatic tip, or another elongated multi-lumen structure) 115’. Alternatively, the positions of the imager 112 and the fluid area 92 or 92’ may be switched as shown in FIG. 15(b) such that the imager 112 is positioned on the bottom part of the needle {e.g., disposed away from the piercing portion of the needle 115 or the multi-lumen structure 115’). As further alternatives, the geometry of the needle 115 and/or the multi-lumen structure 115’ may be modified as needed {e.g., based on the anatomy of the patient 116, the desired procedures, etc.). For example, as shown in FIGS. 15(c) and 15(d), the piercing portion of the needle 115 and the multi-lumen structure 115’, respectively, may be differently located {e.g., on the bottom portion of the needle 115 {see FIG. 15(c)), on the bottom portion of the multi-lumen structure 115’ {see FIG. 15(d)). Further modifications {e.g., changes in size, shape, geometry, taper, dimensions, materials, etc.) may be made to the structure of the needle 115 and/or the multi-lumen structure 115’ without departing from the spirit and scope of the present disclosure.

[0096] Additionally or alternatively, as best shown in FIGS. 16(a) and 16(b), further modifications may be made to the needle 115 and/or the multi-lumen structure 115’ without departing from the spirit, for example, by using a differently sloped/tapered needle point, such as point 161 having a sharp point or point 162 having a sharp but rounded point, for a needle 115 and/or multi-lumen structure 115’. As best seen in FIG. 16(a), the opening 167 to permit the imaging may be located on a first side ( e.g ., the underside, on the bottom, etc.) of the needle tip 161, 162. As best seen in FIG. 16(b), the opening 168 to permit the imaging may be located on a second side (e.g., the top side, above, etc.) of the needle tip 161, 162 (see also, the needle tip 163, 164 as best seen in FIG. 16(b)). Preferably, the opening 167, 168 is sloped, tapered and/or otherwise geometrically sized and shaped to permit a user of the needle 115 or multi-lumen structure 115’ to obtain an image of the predetermined region or area (e.g., a target). As shown in FIG. 16(a) the curved portion 165 of the needle 115 or multi-lumen structure 115’ may have a consistent curve, a predetermined radius or other predetermined size and shape. As shown in FIG. 16(b) the curved portion 166 of the needle 115 or multi-lumen structure 115’ may have a consistent curve, a predetermined radius or other predetermined size and shape. The curved portion 165 may be sized and/or shaped differently than the curved portion 166 in one or more embodiments.

[0097] Additionally or alternatively, one or more embodiments of a needle scope may involve SEE as aforementioned or any other imaging techniques (even if not using SEE). One or more embodiments of a needle scope may use Chip-on-Tip technology and/or a fiber bundle scope. A multi-lumen structure 115’ may include a window for the first imaging lumen and may include the second lumen without a window. A needle 115 and/or a multi-lumen structure 115’ may include detection fibers that conform to an inner lumen of the needle 115 and/ or the multi-lumen structure 115’ to optimize fluid flow. One or more embodiments of a needle scope may include a hole on the side thereof to turn on and off suction (e.g., the hole may be covered to turn on suction, and the hole may be uncovered to turn off suction). In one or more embodiments, a needle scope may retract an illumination core only (for example, a sheath may be used as a needle (window rotating on can)). Alternatively or additionally, an over-the-scope exchange may be used (which is similar to a rapid exchange port on an interventional cardiology device), and a wider instrument (such as a suction tube or dilation device) may ride over the scope (needle) and into the opening (such a device may completely encircle the scope in one or more embodiments). A clip-in-Exchange may be used where a wider instrument (such as a suction tube or dilation device) snaps onto the side of the needle, and a physician/ENT may push this instrument forward with the needle as a guide such that the wider instrument may easily access the hole in the sinus. Additionally or alternatively, single handed advancement and retraction maybe used where the advancement and retraction of the imager 112 through a needle 115 is done using a slide mechanism or other feature thereon or on the handle (for example, advance and retract instruments (such as balloon or other dilator) may be used). In one or more needle scope, the exchange concept may operate like a punch like biopsy. In one or more embodiments, the aforementioned lens may spin.

[0098] Additionally, one or more embodiments may use needle tip mechanism(s) that operate to position a tip of the needle or structure when it is time to use the tip, and to retract, withdraw, house, or otherwise prevent, the tip of the needle or structure from detrimentally affecting (e.g., puncturing, piercing, scratching, damaging, etc.) the anatomy, structure, target, object, patent, etc. in which the scope or endoscope is being used. In an embodiment, a scope or endoscope with an atraumatic tip for insertion into a predetermined target area, such as, but not limited to, a nasal cavity, may be used for sinus procedures (e.g., using a direct needle approach) by using an extendable needle tip. After the needle tip is used to puncture the predetermined portion of the anatomy, the needle tip may be retracted or otherwise positioned to re-expose the atraumatic tip. Needle tip mechanism(s) may include, but are not limited to, one or more of the following: a scope with a retractable needle tip, a spring loaded needle tip, multiple fins that form a needle tip, a rolled sheet needle with a tip, a screw mechanism needle tip, an axial slide mechanism needle tip, a hinged needle tip, mechanism(s) to actuate the needle tip(s) forward and/or backward, etc.

[0099] Examples of needle tip mechanism(s) are further discussed herein below, and several examples are shown in at least FIGS. 17A-23E.

[0100] In one or more embodiments, a scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof ( _' e.g ., the needle 115, 115’) may include a needle tip ( e.g ., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein, etc.) that is moved forward and backward along the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) using a spring 202 that operates to compress (to move the needle tip back, retract the needle tip, etc.) (as best seen in the top portion of FIG. 17A) and decompress (to move the needle tip forward, to use the needle tip, etc.) (as best seen in the bottom portion of FIG. 17A). For example, the spring 202 may decompress and move forward along a direction, an axis or an arrow 203 as shown in the bottom portion of FIG. 17A, and the spring 202 may operate to compress and return to its original orientation (e.g., by compressing in a direction opposite to the direction of the arrow 203 (see e.g., arrow 203’ as shown in the bottom of FIG. 17B), along an axis of the arrow 203, etc.) as shown in the top portion of FIG. 17A. In an“insertion mode” or a “use mode”, the guide preferably has an atraumatic tip and allows the physician/ENT to insert and navigate the guide through the nasal passage without scraping the anatomy and causing harm to the patient. In a case where the physician/ENT has properly positioned the needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein, etc.) and is ready to puncture a predetermined portion of the anatomy (e.g., a side wall in a sinus to create an artificial ostium; a portion of a sinus as shown in FIG. 3 discussed above; etc.), the physician/ENT may use a mechanism or mechanisms to extend or protrude the tip of the needle (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein, etc.). After the puncture is performed and the guide is within the sinus, the tip of the needle and/or the needle may be retracted to return the guide to an atraumatic tip and to return the tip of the needle to a position that does not cause harm to the patient.

[0101] In one or more embodiments (best seen in FIG. 17A), a spring loaded needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) may be used to achieve an atraumatic tip. A needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) may be positioned at the distal end of a scope or endoscope, and the needle tip ( e.g ., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) may be actuated by a spring mechanism (see e.g., the spring 202 discussed herein). When the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) is guided to a predetermined location such that a physician/ENT is ready to perform puncturing with the needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using aspring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.), the spring mechanism (e.g., the spring 202) operates to eject the needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) forward exposing the sharp edge (see e.g., the edge 204 of the needle tip 201 in FIGS. 17A-17B) of the needle tip (see e.g., the bottom portion of FIG. 17A showing that the needle tip 204 is moving forward as indicated by the arrow 203). After puncture, the spring 202 may be retracted or compressed (see e.g., the top portion of FIG. 17A) to pull back the needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) to an unexposed position and restoring the tip to an atraumatic tip (see e.g., top portion of FIG. 17A, top portion of FIG. 17B, bottom portion of FIG. 17B, etc.). In one or more embodiments, a lancet mechanism design may be used for the puncture and instant retraction of the needle tip.

[0102] As best seen in FIG. 17B, one or more embodiments of a spring loaded needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) may have mechanical features (such as, but not limited to, a rim 205, a tab 205, a flange 205, etc.) to allow the tip of the needle (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) to be embedded into the desired piercing/puncturing site without fully entering through a tissue or target wall during the puncture, and to act as a trocar or introducer for the guide, probe, scope, needle (such as, but not limited to the needle 115, 115’, any other needle discussed herein, etc.), or any other portion of the guide, probe, scope or needle ( e.g ., the imaging portion 112; the needle 115, 115’; the fluid portion 92, 92’; etc.), etc. to enter the cavity (best seen in FIG. 17B where the needle tip (e.g., the needle tip 201) extends into the tissue or target site 206 ( see e.g., the second portion of FIG. 17B) and the guide, probe, scope, needle (such as, but not limited to the needle 115, 115’, any other needle discussed herein, etc.), or any other portion of the guide, probe, scope or needle (e.g., the imaging portion 112; the needle 115, 115’; the fluid portion 92, 92’; etc.), etc. extends through the needle tip 201 and into a cavity to the right of the tissue or target anatomy 206). As shown in the top image of FIG. 17B, the spring 202 may be in a compressed state such that the needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) and scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) are not in touch with the tissue/ anatomy/target 206 yet. In the second image of FIG. 17B, the spring 202 may be decompressed to perform the puncture through the tissue/anatomy/target 206. Upon needle insertion during the puncture, the rim/tab/flange 205 may operate to prevent the needle (see e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) from fully penetrating the tissue/anatomy/target 206. In one or more embodiments, pushing the scope forward (as shown by the arrow 203 in the third image of FIG. 17B) may recompress the spring 202 and the needle tip (e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) may be returned to the retracted position (see e.g., the third image of FIG. 17B). As shown in the bottom image of FIG. 17B, the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof ( e.g ., the needle 115, 115’) may be retracted (as indicated by the arrow 203’ in the bottom image of FIG. 17B) to remove the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) and needle ( see e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) using a spring (e.g., the spring 202 discussed herein), the needle tip 201 of FIGS. 17A-17B, any other needle tip discussed herein used along with a spring, etc.) from the puncture site of the tissue/anatomy/target 206 (e.g., after imaging has been completed).

[0103] In one or more embodiments, a needle tip (see e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) used along with multiple fins, the needle tip 201 of FIG. 18, any other needle tip discussed herein used along with multiple fins, etc.) may be comprised of multiple fins 301 which protrude upon a rotational actuation (e.g., as shown diagrammatically by arrow 303 in FIG. 18). Upon rotation (e.g., as indicated by the rotational arrow 303 in the bottom portion of FIG. 18), the fins 301 move forward (as indicated by the right arrow 203 in the bottom portion of FIG. 18), protrude from the guide or end of the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.), and form the needle tip (see e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) used along with multiple fins, the needle tip 201 of FIG. 18, any other needle tip discussed herein used along with multiple fins, etc.) to perform the puncture. Rotating the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) or a portion of the scope (e.g., a handle attached to the scope - see for example, the handle 704 as shown in FIG. 21B) may actuate the fins 301 at the distal end forward to form the needle tip (see e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) used along with multiple fins, the needle tip 201 of FIG. 18, any other needle tip discussed herein used along with multiple fins, etc.) in one or more embodiments.

[0104] As shown in FIG. 19, one or more needle tip mechanism(s) may comprise a rolled sheet needle 402 where the thin sheet 402 of a predetermined material (e.g., metal) is rolled at an angle to define the needle tip (see e.g., the needle tip 161, 162, 163, 164 of FIGS. 16(a) and/or 16(b) used along with the rolled sheet 402, the needle tip 201 of FIG. 19, any other needle tip discussed herein used along with a rolled sheet ( e.g ., the rolled sheet needle 402), etc.)· At an insertion state, the end of the sheet is flush or retracted from the distal tip of the guide or the probe (e.g., the probe portion (e.g., the element or imager 112, 112’)), the needle 115, 115’, or any other portion of a probe, guide, and/or needle discussed herein, etc.) (see e.g., the top portion of FIG. 19 where the rolled sheet 402 is relaxed). The sheet 402 may be connected to a rotational mechanism on a predetermined portion of the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’), such as, but not limited to, a hand piece, a handle or scope guide 704, a controller, etc. Rotating the mechanism (e.g., the handle or scope guide 704) in one direction (in a direction opposite to the direction 303 shown in the bottom portion of FIG. 19) may rotate the sheet 402 or the sheath the sheet 402 is within, which constricts (see bottom portion of FIG. 19) or relaxes the roll 402 (see top portion of FIG. 19). Tightening (e.g., by rotating the mechanism (e.g., the handle or scope guide 704) in the other direction (e.g., the direction 303 as shown in the bottom portion of FIG. 19)) the rolled sheet 402 preferably actuates the sharp corner or edge 204 forward to expose the needle tip 201 (best seen in the bottom portion of FIG. 19). Relaxing the roll again may retract the sharp corner or edge 204 (e.g., after puncturing is completed). In one or more embodiments, the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) is wrapped with a thin metal sheet as the rolled sheet 402. Tightening or constriction of the wrap or sheet 402 extends the needle tip 201. Unwinding of the sheet/wrap 402 retracts the sharp corner/edge 204 or the needle tip 201.

[0105] As shown in FIG. 20, one or more embodiments of a needle tip mechanism may be a screw mechanism needle where a needle tip 201 may be actuated forward and backward by the screw mechanism 601 on the guide, scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) or probe. A rib or a notch on the needle tip 201 preferably slides along the groove on the outer guide and/or on the screw mechanism 601, which keeps the needle 201 from rotating in one or more embodiments (e.g., to have less interaction with the anatomy/target/object and keeps the needle tip 201 motion forward (such as along arrow 203 in the bottom portion of FIG. 20) or backward. Preferably, in at least one embodiment, a screw 6ot on the shaft of the scope actuates the needle tip forward. Rotating the screw or a sheath on the screw ( e.g ., in the direction of the rotational arrow 303 shown in FIG. 20) pushes the needle tip 201 forward (as indicated in the directional arrow 203 on the right of FIG. 20). Rotating the screw 601 in the opposite direction retracts the needle tip. In one or more embodiments, the screw rotation may be controlled by a rotation mechanism on a predetermined location of the scope, such as, but not limited to, the handle ( see e.g., the handle 704 discussed herein), the hand piece, a controller, etc.

[0106] As shown in FIGS. 21A-21B, one or more needle tip mechanism(s) may be a slider (also referred to as an axial slide mechanism) 702 that moves the needle tip 201 along the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) as the slider 702 is slid in the same, corresponding direction. For example, as the slider 702 is moved in the direction of the arrow 203 shown in FIGS. 21A-21B, the needle tip 201 is also moved in that direction. The needle tip 201 may be actuated forward by a slide mechanism (such as, but not limited to, the slider 702) on the guide, probe or scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’). In one or more embodiments, the sliding mechanism 702 may be attached to a flexible sheath with a metal tip attached to the needle tip 201. Sliding the mechanism 702 forward on a predetermined location on the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’), such as, but not limited to, a handle (see e.g., the handle 702), a hand piece, a controller, etc., may slide the sheath along the guide, probe or scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’), protruding the needle tip 201 beyond the distal end of the scope (such as, but not limited to, the needle scope, too, too’, too”, too”’, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) (see e.g., bottom portions of FIGS. 21A and 21B). Retracting the slider retracts the needle tip (see e.g., top portions of FIGS. 2iA and 2tB). [0107] As shown in FIG. 22, one or more embodiments of a needle tip mechanism 201 may be a hinge needle. A shutter 801 at the guide, probe or scope tip may act as a needle tip 201 in the open position ( see bottom portion of FIG. 22). Opening the shutter 801 may involve moving the shutter 801 backward in the direction of the arrow 203’ shown in the bottom part of FIG. 22 to have the needle tip 201 formed and extending beyond the distal end of the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof ( e.g ., the needle 115, 115’). The scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) may have a shutter or cap 801 with a hinged top. Moving the cap or shutter 801 forward may move the needle tip 201 to the closed position (see top portion of FIG. 22).

[0108] As shown in FIGS. 23A-23E, embodiments may involve a smaller needle and/ or a knife edge 901. One or more embodiments may integrate a smaller needle 901 to open a hole in a tissue/anatomy/target (see e.g., the tissue/anatomy/target 206 discussed above) for the main tube (e.g., the needle 115, the needle 115’, any portion of a probe, needle or scope discussed herein, etc.) to advance and widen the small hole made by the smaller needle 901. This configuration allows the whole needle tip 201 to maintain the small diameter of the main guide or tube (e.g., the needle 115, the needle 115’, any portion of a probe, needle or scope discussed herein, etc.) with an advancing sharp needle integrated, such as the smaller needle 901. There may be a hole 902 (see e.g., FIGS. 23A, 23C) or a groove 903 covered with an outer sheath (see e.g., FIG. 23D) on the main needle (see e.g., the needle 115, the needle 115’, etc.) and a pin needle or a wire (see e.g., the pin needle or wire 904) with a needle tip (see e.g., the needle 901) is mounted at the tip or distal end of the probe, scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’), or guide. The pin or the wire (see e.g., the pin/wire 904) as well as the hole or groove 902, 903 to house the pin or wire (see e.g., the pin/wire 904) may be connected back to a predetermined location on the scope (such as, but not limited to, the needle scope, too, too’, too”, too’”, too””, too’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’), such as, but not limited to, a proximal handle, a handle (see e.g., the handle 704 discussed herein), a hand section, a controller, etc. By pushing the wire 904 as shown in FIG. 23B, the pin end or the smaller needle 904 advances to open a small opening in the tissue ( see e.g., the tissue/anatomy/target 206 discussed above), where it will be an opening, which will be widened by pushing the main tube, guide, or probe of the scope (such as, but not limited to, the needle scope, 100, 100’, 100”, 100’”, 100””, 100’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’)· FIG. 23E is another embodiment with a wider sharp flat knife 905 to extend out (the black piece). The groove 903 may cover an arc of less than 90 degrees of the outer diameter to minimize the diameter of the whole device. As shown in FIGS. 23D and 23E, the groove 903 may be carved on the main tube ( see e.g., a tube of the needle 115, the needle 115’, a tube of the needle 115’, the needle 115’, etc.) and then an outer tube or sheath may be fitted to create a hole from the tip or distal end of the scope (such as, but not limited to, the needle scope, 100, 100’, 100”, 100’”, 100””, 100’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’), probe or guide to the back of the main tube.

[0109] As aforementioned, there are various configurations that may use predetermined portions of the scope (such as, but not limited to, the needle scope, 100, 100’, 100”, 100’”, 100””, 100’””, any other scope discussed herein, etc.) or a portion thereof (e.g., the needle 115, 115’) to control the needle tip mechanisms 201, such as, but not limited to, handle mechanisms or handle (see e.g., the handle 704 discussed herein) portions for actuation. For example, a handle may include a button release to activate a spring release mechanism. By way of another example, a rotational mechanism on the handle may rotate a coil or screw on the scope to actuate the needle tip forward or for retraction. By way of a further example, a slide with a track mechanism on the handle may control the location of the needle tip along the body of the scope by sliding or pulling the needle tip as desired.

[0110] In accordance with one or more aspects of the present disclosure, one or more methods for performing imaging are provided herein. FIG. 24 illustrates a flow chart of at least one embodiment of a method for performing imaging. Preferably, the method(s) may include one or more of the following: (i) defining a spectrum of wavelength ranges to use for acquiring the image such that the spectrum bands overlap or substantially overlap on a sample or target (see step S4000 in FIG. 24); (ii) detecting light reflected from the target region (see step S4001 in FIG. 24); (iii) separating the detected light into two or more light fluxes having different wavelengths ( see step S4002 in FIG. 24); and imaging the light fluxes separated from the detected light to acquire or generate the black and white and/or color image ( see step S4003 in FIG. 24). One or more methods may further include at least one of: using a probe grating to generate the spectrum bands that overlap or substantially overlap on the target region; and optimizing the probe grating so that a diffraction efficiency is high within the wavelength ranges. In one or more embodiments, a SEE probe may be connected to one or more systems {e.g., the system too, the system too’, the system too”, the system too’”, the system too””, the system too’””, etc.) with a connection member or interface module. For example, when the connection member or interface module is a rotary junction for a SEE probe, the rotary junction may be at least one of: a contact rotary junction, a lenseless rotary junction, a lens-based rotary junction, or other rotary junction known to those skilled in the art. The rotary junction maybe a one channel rotary junction or a two channel rotary junction. In one or more embodiments, the illumination portion of the SEE probe may be separate from the detection portion of the SEE probe. For example, in one or more applications, a probe may refer to the illumination assembly, which includes the illumination fiber 108 {e.g., single mode fiber, a GRIN lens, a spacer and the grating on the polished surface of the spacer, etc.). In one or more embodiments, a scope may refer to the illumination portion which, for example, may be enclosed and protected by a drive cable, a sheath, and detection fibers {e.g., multimode fibers (MMFs)) around the sheath. Grating coverage is optional on the detection fibers {e.g., MMFs) for one or more applications. The illumination portion may be connected to a rotary joint and may be rotating continuously at video rate. In one or more embodiments, the detection portion may include one or more of: the detection fiber 118, the spectrometer 120, the computer 1300, the computer 1300’, etc. The detection fibers, such as the detection fiber(s) 118, may surround the illumination fiber, such as the IF 108, and the detection fibers may or may not be covered by the grating, such as the grating 107.

[0111] Unless otherwise discussed herein, like numerals indicate like elements. For example, while variations or differences exist between the systems, such as, but not limited to, the system too, the system too’, the system too”, the system too’”, the system too””, the system too’””, etc., one or more features thereof may be the same or similar to each other, such as, but not limited to, the light source 102 or other component(s) thereof ( e.g ., the console 1300, the console 1300’, the RJ 106, etc.)· Those skilled in the art will appreciate that the light source 102, the RJ 106, the MCU 140, the spectrometer 120 (one or more components thereof) and/or one or more other elements of the system too, may operate in the same or similar fashion to those like-numbered elements of one or more other systems, such as, but not limited to, the system too’, the system too”, the system too’”, the system too””, the system too’””, etc. as discussed herein. Those skilled in the art will appreciate that alternative embodiments of the system too, the system too’, the system too”, the system too’”, the system too””, the system too’””, etc., and/or one or more like- numbered elements of one of such systems, while having other variations as discussed herein, may operate in the same or similar fashion to the like-numbered elements of any of the other systems (or components thereof) discussed herein. Indeed, while certain differences exist between the system too, the system too’, the system too”, the system too’”, the system too””, the system too’””, and the other system(s) as discussed herein, there are similarities. Likewise, while the console or computer 1300 may be used in one or more systems (e.g., the system too, the system too’, the system too”, the system too’”, the system too””, the system too’””, etc.), one or more other consoles or computers, such as the console or computer 1300’, etc., maybe used additionally or alternatively.

[0112] Light emitted by a white light source may be transmitted by an illumination light transmission fiber and may be incident on a probe portion via the RJ 106. Additionally or alternatively, the light emitted by the white light source may be transmitted by the illumination light transmission fiber and may be incident on the probe portion (e.g., the optical apparatus and/or system or the imager 112) via a deflecting or deflected section 117 and via the RJ 106. Reflected light from the spectral sequence (e.g., light from the spectral sequence that is formed on, and is reflected by, the subject or sample; light that is reflected by the subject or sample; etc.) is taken in by a detection fiber or cable, such as the cable or fiber 118. Although one detection fiber may be used in one or more embodiments, a plurality of detection fibers may be used additionally or alternatively. In one or more embodiments, the detection fiber may extend to and/or near the end of the probe section. For example, the detection fiber 118 may have a detection fiber portion (e.g., a fiber extending through the probe portion) that extends from or through the RJ 106 through, and to and/or near ( e.g ., adjacent to the end of the probe section, about the end of the probe portion, near the end of the probe portion closest to the sample, etc.) the end of, the probe section (e.g., the optical apparatus and/or system 112). The light taken in by the detection fiber 118 is separated into spectral components and detected by at least one detector, such as, but not limited to, a spectrometer 120 (and/or one or more components thereof as discussed herein), provided at the exit side of the detection fiber 118. In one or more embodiments, the end of the detection fiber 118 that takes in the reflected light may be disposed on or located near at least one of: the diffraction grating 107, the end of the spacer lit, the end of the probe portion or the imager 112, etc. Additionally or alternatively, the reflected light may be passed at least one of: through the probe portion, through the GRIN lens, through the rotary junction, etc., and the reflected light may be passed, via a deflecting or deflected section 117 (discussed above and below), to the spectrometer 120. As the portion extending from the RJ 106 to the probe portion 112 is rotated about the rotational axis extending in the longitudinal direction of the probe portion 112, the spectral sequence moves in a direction orthogonal to the spectral sequence, and reflectance information in two-dimensional directions may be obtained. Arraying these pieces (e.g., the reflectance information in two-dimensional directions) of information makes it possible to obtain a two-dimensional image.

[0113] Preferably, in one or more embodiments including the deflecting or deflected section 117, the deflected section 117 operates to deflect the light from the light source 102 to the probe portion (e.g., element or the imager 112), and then send light received from the probe portion towards at least one detector (e.g., the spectrometer 120, one or more components of the spectrometer 120, etc.). In one or more embodiments, the deflected section 117 may include or may comprise one or more interferometers or optical interference systems that operate as described herein, including, but not limited to, a circulator, a beam splitter, an isolator, a coupler (e.g., fusion fiber coupler), a partially severed mirror with holes therein, a partially severed mirror with a tap, etc. In one or more embodiments, the interferometer or the optical interference system may include one or more components of the system or of the system, such as, but not limited to, one or more of the light source 102, the deflected section 117, the rotary junction 106, and/or the probe portion (e.g., element 112) (and/or one or more components thereof). [0114] The rotary junction 106 may be a one channel rotary junction or a two channel rotary junction. In one or more embodiments, the illumination portion of the probe may be separate from the detection portion of the probe. For example, in one or more applications, a probe may refer to the illumination assembly, which includes an illumination fiber ( e.g ., single mode fiber, a GRIN lens, a spacer and the grating on the polished surface of the spacer, etc.). In one or more embodiments, a scope may refer to the illumination portion which, for example, may be enclosed and protected by a drive cable, a sheath, and detection fibers (e.g., multimode fibers (MMFs)) around the sheath. Grating coverage is optional on the detection fibers (e.g., MMFs) for one or more applications. The illumination portion may be connected to a rotary joint and may be rotating continuously at video rate. In one or more embodiments, the detection portion operating to obtain the image data may include one or more of: the detection fiber 118, the spectrometer 120, a computer 1300, the computer 1300’ (as discussed further below), etc.

[0115] There are many ways to compute intensity, viscosity, resolution (including increasing resolution of one or more images), creation of black and white and/or color images or any other measurement discussed herein, digital as well as analog. In at least one embodiment, a computer, such as the console or computer 1300, 1300’, may be dedicated to control and monitor the needle scope and/or SEE devices, systems, methods and/or storage mediums described herein.

[0116] The electric signals used for imaging may be sent to one or more processors, such as, but not limited to, a computer 1300 (see e.g., FIGS. 1A-1C and 25), a computer 1300’ (see e.g., FIG. 26), etc. as discussed further below, via cable(s) or wire(s), such as, but not limited to, the cable(s) or wire(s) 113 (see FIG. 25).

[0117] Various components of a computer system 1300 (see e.g., the console or computer 1300 as shown in FIGS. 1A-1C) are provided in FIG. 25. A computer system 1300 may include a central processing unit (“CPU”) 1301, a ROM 1302, a RAM 1303, a communication interface 1305, a hard disk (and/or other storage device) 1304, a screen (or monitor interface) 1309, a keyboard (or input interface; may also include a mouse or other input device in addition to the keyboard) 1310 and a BUS or other connection lines (e.g., connection line 1313) between one or more of the aforementioned components (e.g., including but not limited to, being connected to the console, the probe, any motor discussed herein, a light source, etc.). In addition, the computer system 1300 may comprise one or more of the aforementioned components. For example, a computer system 1300 may include a CPU 1301, a RAM 1303, an input/output (I/O) interface (such as the communication interface 1305) and a bus (which may include one or more lines 1313 as a communication system between components of the computer system 1300; in one or more embodiments, the computer system 1300 and at least the CPU 1301 thereof may communicate with the one or more aforementioned components of a device or system, such as, but not limited to, a system using a motor, a rotary junction, etc.), and one or more other computer systems 1300 may include one or more combinations of the other aforementioned components ( e.g ., the one or more lines 1313 of the computer 1300 may connect to other components via line 113). The CPU

1301 is configured to read and perform computer-executable instructions stored in a storage medium. The computer-executable instructions may include those for the performance of the methods and/or calculations described herein. The system 1300 may include one or more additional processors in addition to CPU 1301, and such processors, including the CPU 1301, may be used for tissue or sample characterization, diagnosis, evaluation, treatment and/or imaging (and/or any other process discussed herein). The system 1300 may further include one or more processors connected via a network connection (e.g., via network 1306). The CPU 1301 and any additional processor being used by the system 1300 may be located in the same telecom network or in different telecom networks (e.g., performing technique(s) discussed herein may be controlled remotely).

[0118] The I/O or communication interface 1305 provides communication interfaces to input and output devices, which may include a light source, a spectrometer, a needle scope, the communication interface of the computer 1300 may connect to other components discussed herein via line 113 (as diagrammatically shown in FIG. 25), a microphone, a communication cable and a network (either wired or wireless), a keyboard 1310, a mouse (see e.g., the mouse 1311 as shown in FIG. 26), a touch screen or screen 1309, a light pen and so on. The Monitor interface or screen 1309 provides communication interfaces thereto.

[0119] Any methods and/or data of the present disclosure, such as the methods for performing tissue or sample characterization, diagnosis, examination, treatment and/or imaging (including, but not limited to, increasing image resolution) and/ or any other process as discussed herein, may be stored on a computer-readable storage medium. A computer-readable and/or writable storage medium used commonly, such as, but not limited to, one or more of a hard disk ( _' e.g ., the hard disk 1304, a magnetic disk, etc.), a flash memory, a CD, an optical disc (e.g., a compact disc (“CD”) a digital versatile disc (“DVD”), a Blu-ray™ disc, etc.), a magneto-optical disk, a random-access memory (“RAM”) (such as the RAM 1303), a DRAM, a read only memory (“ROM”), a storage of distributed computing systems, a memory card, or the like (e.g., other semiconductor memory, such as, but not limited to, a non-volatile memory card, a solid state drive (SSD) (see SSD 1307 in FIG. 26), SRAM, etc.), an optional combination thereof, a server/ database, etc. may be used to cause a processor, such as, the processor or CPU 1301 of the aforementioned computer system 1300 to perform the steps of the methods disclosed herein. The computer- readable storage medium may be a non-transitory computer-readable medium, and/or the computer-readable medium may comprise all computer-readable media, with the sole exception being a transitory, propagating signal in one or more embodiments. The computer-readable storage medium may include media that store information for predetermined, limited and/or short period(s) of time and/or only in the presence of power, such as, but not limited to Random Access Memory (RAM), register memory, processor cache(s), etc. Embodiment(s) of the present disclosure may also be realized by a computer of a system or apparatus that reads out and executes computer executable instructions (e.g., one or more programs) recorded on a storage medium (which may also be referred to more fully as a“non-transitory computer-readable storage medium”) to perform the functions of one or more of the above-described embodiment(s) and/or that includes one or more circuits (e.g., application specific integrated circuit (ASIC)) for performing the functions of one or more of the above-described embodiment(s), and by a method performed by the computer of the system or apparatus by, for example, reading out and executing the computer executable instructions from the storage medium to perform the functions of one or more of the above-described embodiment(s) and/or controlling the one or more circuits to perform the functions of one or more of the above-described embodiment(s).

[0120] In accordance with at least one aspect of the present disclosure, the methods, systems, and computer-readable storage mediums related to the processors, such as, but not limited to, the processor of the aforementioned computer 1300, etc., as described above may be achieved utilizing suitable hardware, such as that illustrated in the figures. Functionality of one or more aspects of the present disclosure may be achieved utilizing suitable hardware, such as that illustrated in Figure 25. Such hardware may be implemented utilizing any of the known technologies, such as standard digital circuitry, any of the known processors that are operable to execute software and/or firmware programs, one or more programmable digital devices or systems, such as programmable read only memories (PROMs), programmable array logic devices (PALs), etc. The CPU 1301 (as shown in Figure 25) may also include and/or be made of one or more microprocessors, nanoprocessors, one or more graphics processing units (“GPUs”; also called a visual processing unit (“VPU”)), one or more Field Programmable Gate Arrays (“FPGAs”), or other types of processing components ( e.g ., application specific integrated circuit(s) (ASIC)). Still further, the various aspects of the present disclosure may be implemented by way of software and/or firmware program(s) that may be stored on suitable storage medium (e.g., computer- readable storage medium, hard drive, etc.) or media (such as floppy disk(s), memory chip(s), etc.) for transportability and/or distribution. The computer may include a network of separate computers or separate processors to read out and execute the computer executable instructions. The computer executable instructions may be provided to the computer, for example, from a network or the storage medium.

[0121] As aforementioned, hardware structure of an alternative embodiment of a computer or console 1300’ is shown in FIG.26. The computer 1300’ includes a central processing unit (CPU) 1301, a graphical processing unit (GPU) 1315, a random access memory (RAM) 1303, a network interface device 1312, an operation interface 1314 such as a universal serial bus (USB) and a memory such as a hard disk drive or a solid state drive (SSD) 1307. Preferably, the computer or console 1300’ includes a display 1309. The computer 1300’ may connect with a motor, a console, and/or any other component of the device(s) or system(s) discussed herein via the operation interface 1314 or the network interface 1312 (e.g., via a cable or fiber, such as the cable or fiber 113 as similarly shown in FIG. 25). A computer, such as the computer 1300’, may include a motor or motion control unit (MCU) in one or more embodiments. The operation interface 1314 is connected with an operation unit such as a mouse device 1311, a keyboard 1310 or a touch panel device. The computer 1300’ may include two or more of each component. [0122] At least one computer program is stored in the SSD 1307, and the CPU 1301 loads the at least one program onto the RAM 1303, and executes the instructions in the at least one program to perform one or more processes described herein, as well as the basic input, output, calculation, memory writing and memory reading processes.

[0123] The computer, such as the computer 1300, 1300’, may communicate with an MCU, a rotary junction, a needle, etc. to perform imaging, diagnosis, treatment and/or any other process discussed herein, and reconstructs an image from the acquired intensity data. The monitor or display 1309 displays the reconstructed image, and may display other information about the imaging condition or about an object to be imaged. The monitor 1309 also provides a graphical user interface for a user to operate any system discussed herein. An operation signal is input from the operation unit (e.g., such as, but not limited to, a mouse device 1311, a keyboard 1310, a touch panel device, etc.) into the operation interface 1314 in the computer 1300’, and corresponding to the operation signal the computer 1300’ instructs any system discussed herein to set or change the imaging condition (e.g., improving resolution of an image or images), and to start or end the imaging. A light or laser source and a spectrometer and/or detector may have interfaces to communicate with the computers 1300, 1300’ to send and receive the status information and the control signals.

[0124] The present disclosure and/or one or more components of devices, systems and storage mediums, and/or methods, thereof also may be used in conjunction with any suitable optical assembly including, but not limited to, SEE probe technology, such as in U.S. Patent Nos. 6,341,036; 7,447,408; 7,551,293; 7,796,270; 7,859,679; 8,045,177; 8,145,018; 8,838,213; 9,254,089; 9,295,391; 9415550; and 9,557,154 and arrangements and methods of facilitating photoluminescence imaging, such as those disclosed in U.S. Pat. No. 7,889,348 to Tearney et al. Other exemplary SEE systems are described, for example, in U.S. Pat. Pubs. 2016/0341951, 2016/0349417, 2017/0035281, 2017/167861, 2017/0168232, 2017/0176736, 2017/0290492, 2017/0322079, 2012/0101374 and 2018/0017778; and WO2015/116951; WO2015/116939; WO2017/117203; WO2017/024145; WO2017/165511; and WO2017/139657, each of which patents, patent publications and patent application(s) are incorporated by reference herein in their entireties. As aforementioned, other imaging techniques may be alternatively or additionally used with the needle scope apparatuses, systems, methods and storage mediums discussed herein. The needle scope, endoscope, or other imaging technology discussed in U.S. Provisional Patent Application No. 62/665,986, filed on May 2, 2018, is incorporated by reference herein in its entirety, and discussed in U.S. Provisional Patent Application No. 62/798,368, filed January 29, 2019, is incorporated by reference herein in its entirety.

[0125] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure (and are not limited thereto), and the invention is not limited to the disclosed embodiments. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present disclosure. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.