WO2016145259A1 - Devices and methods for analysis of tissues - Google Patents

Devices and methods for analysis of tissues

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Publication number
WO2016145259A1
WO2016145259A1 PCT/US2016/021880 US2016021880W WO2016145259A1 WO 2016145259 A1 WO2016145259 A1 WO 2016145259A1 US 2016021880 W US2016021880 W US 2016021880W WO 2016145259 A1 WO2016145259 A1 WO 2016145259A1
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WO
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Application
Patent type
Prior art keywords
embodiments
fig
probe
anchoring
device
Prior art date
Application number
PCT/US2016/021880
Other languages
French (fr)
Inventor
RUIJTER Vivian Emily DE
Enci Mary KAN
Michael Laufer
Michael Christopher LEUNG
Garrett Dolejsi LOCKETZ
Qasim MAHMOOD
Matthew Robert NEAL
Nikolaus Paul VOLK
Edward Wood
Original Assignee
Leland Stanford Junior University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147Holding or positioning arrangements
    • A61B1/00154Holding or positioning arrangements using guide tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/085Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4245Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445Details of catheter construction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09066Basic structures of guide wires having a coil without a core possibly combined with a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09125Device for locking a guide wire in a fixed position with respect to the catheter or the human body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09175Guide wires having specific characteristics at the distal tip

Abstract

A device to guide a medical instalment to a desired location in a subject is provided. The device has a first channel with an imaging probe to identify the desired location, and a second channel with the medical instrument. The second channel can be angulated relative to the first channel to reach the desired location. In some embodiments, the medical instrument is a guidewire or an anchoring guidewire.

Description

DEVICES AND METHODS FOR ANALYSIS OF TISSUES

PRIORITY AND CROSS REFERENCE TO RELATED APPLICATIONS

[0001] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. This application claims the benefit of U.S. provisional applications 62/130,627 filed on March 10, 2015, 62/169,557 filed on June 2, 2015 and 62/206,857 filed on August 19, 2015, which are hereby incorporated by reference in their entirety.

BACKGROUND

Field

[0002] The present technology generally relates to devices and methods for obtaining tissue for analysis and/or for treating cancer.

Description of the Related Art

[0003] Lung cancer is the leading cause of cancer death and the second most common cancer among both men and women in the United States. Screening for cancer, for example, with CT scanning, has led to a major increase in the detection of lesions, many of which are not cancerous bit require a biopsy and tissue based diagnosis. In general, tissues for analysis are provided by bronchoscopy, CT-guided procedures and/or surgery . If the proper tissue is not sampled, additional procedures are often necessary increasing cost and patient discomfort and anxiety.

SUMMARY

[0004] In some embodiments, a device configured to guide a medical instrument to a location in a subject is provided, the device comprising a first channel comprising an imaging probe, wherein the imaging probe is configured to identify the location; and a second channel comprising the medical instalment, wherein the second channel is configured to angulate relative to the first channel to reach the location. [0005] In some embodiments of the device, the medical instrument is a guidewire. In some embodiments of the device, the guidewire comprises an anchoring mechanism, comprising deployable anchors, such that upon reaching the location, the guidewire can be anchored at the location by the anchoring mechanism,

[0006] In some embodiments of the device, the medical instrument comprises a diagnostic or therapeutic probe. In some embodiments of the device, the diagnostic probe comprises a biopsy needle. In some embodiments of the device, the medical instrument is a therapeutic probe, and wherein the therapeutic probe is configured to deliver to the location a therapeutic agent or an ablative energy.

[0007] In some embodiments of the device, the imaging probe is at least one of a radial ultrasound probe, convex-shaped ultrasound probe, confocal probe, endoscopic radio frequency ablation probe or cryoablation probe.

[0008] In some embodiments of the device, the imaging probe comprises an internal tracking and registration system attachment, wherein the internal tracking and registration system attachment can communicate with an external tracking and registration system to generate a 3D image of the vicinity of the location, wherein the 3 D image can be used to identify the location.

[00Θ9] In some embodiments of the device, the deployable anchors comprise wires, hooks, spikes, blades, sharp-edged structures, or points. In some embodiments of the device, the second channel further comprises one or more pull-wires configured to manipulate the angle of the second channel relative to the first channel . In some embodiments of the device, the second channel further comprises one or more flexion structures selected from a hinge, a spring, and a flexible polymer, wherein the one or more flexion structures facilitate angulation of the second channel .

[0010] In some embodiments of the device, the second channel is substantially parallel to the first channel in a closed configuration such that the device can be advanced through a body lumen to the vicinity of the location through an endoscope. In some embodiments of the device, the location can be inside a lumen or outside a lumen. In some embodiments of the device, the anchoring mechanism is located along a distal end region of the guidewire.

[0011] In some embodiments, the device further comprises a control mechanism configured to deploy the anchors from a collapsed state to an extended state. In some embodiments of the device, the control mechanism comprises an inner member coaxially engaged within an outer sheath, wherein the inner member and outer sheath are configured to be axially displaced and/or rotated relative to one another.

[0012] In some embodiments, an anchoring guidewire is provided, comprising: an inner member comprising extendible anchors configured to deploy from a collapsed state to an extended state; and an outer sheath coaxially surrounding the inner member and restraining the anchors in their collapsed state; wherein the outer sheath is configured to displace axially and/or rotate with respect to the inner member, such axial displacement and/or rotation causes openings in the outer sheath to align with the anchors, thereby allowing the anchors to deploy through the openings to the extended state. In some embodiments of the anchoring guidewire, the openings in the outer sheath are selected from slits, slots, or holes.

|0013] In some embodiments, a method for guiding a medical instrument to a desired location in a subject, the method comprising: providing a device comprising a first channel comprising an imaging probe, wherein the imaging probe is configured to identify the location; and a second channel comprising a guidewire, wherein the second channel is configured to angulate relative to the first channel to reach the location; identifying the location; retracting the imaging probe and the second channel leaving the guidewire at the location; and advancing the medical instrument along the guidewire to the location.

[0014] In some embodiments of the method, identifying the location is achieved by communicating an internal tracking and registration system of the device with an external tracking and registration system to generate a 3D image of the vicinity of the desired location.

[0015] In some embodiments, the method further comprises angulating the second channel relative to the first channel at flexion structures selected from a hinge, a spring, and a flexible polymer to reach the location. In some embodiments, the method further comprises anchoring the guidewire at the location by deploying one or more anchors disposed along a distal end region of the guidewire from a collapsed state to an extended state.

[0016] In some embodiments of the method, deploying the one or more anchors involves axially displacing and/or rotating an inner member and outer sleeve relative to one another, thereby allowing the one or more anchors to extend through openings in the outer sleeve. BRIEF DESCRIPTION OF THE- DRAWINGS

[0017] The features and aspects of the present disclosure as provided in the detailed description will be more fully appreciated when considered together with the accompanying drawings,

[0018] FIG. 1 is an illustration of a solitary pulmonary nodule (SPN).

[0019] FIG. 2 is a schematic of an embodiment of an interventional channel device for endoscopic procedures in the closed position.

[0020] FIG. 3 is a schematic of an embodiment of an interventional channel device for endoscopic procedures, in the open (angulated) position, targeting an SPN.

[0021] FIG. 4A is a schematic of an embodiment of an interventional channel device in the closed position (mam window) and open position (insert)

[0022] FIG. 4B is a schematic of an embodiment of an interventional channel device in the open position, with the anchoring guidewire not deployed (main window) and deployed (insert)

[0023] FIG. 4C is a schematic of a biopsy needle that is guided by the anchor guidewire to the SPN.

[0024] FIG. 5A demonstrates real-time identification of the location of a lesion under Radial Probe Ultrasound.

[0025] FIG. 5B demonstrates real-time advancement of diagnostic or therapeutic instrument at the location of a lesion.

[0026] FIGS. 6A-6D shows an illustration of an embodiment of an anchoring mechanism comprising radial hooks or spikes.

[0027] FIGS. 7A-7B shows an illustration of another embodiment of an anchoring mechanism comprising radial hooks or spikes.

[0028] FIGS. 8A-8B shows an illustration of another embodiment of an anchoring mechanism comprising radial hooks or spikes.

[0029] FIGS. 9A-9B shows an illustration of an embodiment of an anchoring mechanism comprising a pre-configured wire .

[0030] FIGS. 10A and 10B show a schematic of a localization and 3D- reconstruction of an SPN by CT-imaging.

[0031 ] FIGS. 11A and 11B are schematics that demonstrate the real time visualization of a SPN during bronchoscopy with the use of CT-based 3D reconstruction, a radial probe endobronchial ultrasound (RP-EBUS) and custom made 3D geometrical mapping software.

[0032] FIGS. 12A and 12B are schematics showing two different embodiments of approaches in the angulation of the endobronchial needle for SPN needle aspiration.

[0033] FIG. 13 is a schematic of an embodiment of an intraoperative navigation system workflow during an endobronchial procedure to localize a region of interest.

[0034] FIG. 14 is a schematic showing an embodiment of a set up for external tracking using electromagnetic navigation during an endobronchial procedure.

[0035] FIG. 15A-15C are schematics of an embodiment of an internal tracking device during an endobronchial procedure.

DETAILED DESCRIPTION

[0036] Lung cancer is the leading cause of cancer mortality in the U.S. at a high of 27% and accounts for 25% of all malignant lung cancers with 224,210 new cases in 2014. Those aged >65 with a history of smoking are higher predisposed to lung cancer. Survival depends on the stage of lung cancer (American Cancer Society, 2014). The probability of incidence of a higher frequency of malignant solitary pulmonary nodules (SPNs) ranges from 10 to 68% and rises with age (Toomes et al ., 1983; Trunk et al., 1974; Ost and Fein, 2000).

[0037] An SPN is a single, small (<30 mm), well-circumscribed, radiographic lesion that is surrounded completely by pulmonary parenchyma (Ost et al., 2003; Gould et al, 2013). More than 94.5% of SPNs are benign lesions of which 80% are caused by infectious granulomas, 10% are hamartomas, and the remaining a variety of rare disorders. A malignant SPN (3.7 - 5.5%) usually includes primary lung cancer, lung metastases, and carcinoid tumors (Weinberger et al., 2015).

[0038] About 69% of those who undergo low-dose computed tomography (LDCT) screening are likely to have solitary pulmonary nodules (SPNs). The increase in LDCT screening studies of smokers who are at high risk for malignancy has resulted in a higher number of reports of SPNs. These SPNs require further diagnostic tests, such as tissue sampling, or have to be monitored over time. The benefits of this screening is expected to reduce mortality due to lung cancer by 20%. However, over-diagnosis may result. Hence, it is important to make an accurate diagnoses for the SPN to ensure appropriate follow-up.

[0039] Current tests have poor diagnostic yield with 30% inconclusive outcome resulting in the need for repeat biopsies. While current procedures have significantly increased the diagnostic yield of biopsy of peripheral pulmonary nodules, the diagnostic yield is still low for small lesions (48% for lesions <20mm) (Czameeka et. al. 2013). In addition, the sequence of tissue removal, storage, and processing has a considerable impact on the success and reliability of subsequent tissue analyses.

[0040] The challenge to peripheral lung biopsies is their location in the peripheral areas of the lungs and the airways to access them are quite small . Hence, it is not possible to have both the imaging probe and the biopsy needle at the same time. The mam issue with current biopsies is the lack of direct visualization of the biopsy location and procedure. Currently, to biopsy peripheral lung nodules, puimonologists first locate the nodule using an endoscopic ultrasound imaging probe and place a guide sheath, or guide wire near the target location. As they cannot direct the sheath/wire, it is left in the airway, and not at the lesion location. This is followed by the use of a biopsy tool through the guide sheath. This method assumes that (a) the guide sheath orientation is in the correct plane to biopsy a small peripheral nodule (b) the guide sheath has not moved when biopsy tools are introduced, and (c) the depth of biopsy penetration has been correctly predetermined.

[0Θ41 ] As will be appreciated by one of ordinary skill in the art, these assumptions do not always hold true, and the diagnostic yield would be higher with direct visualization of needle into nodule. The challenge for real time ultrasonic visualization into the target lesion is to navigate the image probe in combination with a biopsy tool into the small airways (by definition, smaller than 3mm) where the peripheral lesions are usually found. Existing solutions addressing SPNs range from imaged-based solutions that address early diagnosis to invasive procedures such as biopsies to determine malignancy. New emerging solutions, such as optical biopsies, aim to provide a more accurate diagnosis and molecular assessment of pulmonary nodules. However, these emerging systems are costly and require dedicated infrastructures, limiting the availability and sibility of the system for use in patients.

[0042] Thus, m some embodiments, devices and/or methods of targeting lung lesions under direct vision during endobronchial biopsy procedures is provided. The devices and/or methods can increase the success of one-time biopsy procedure, decrease costs and decrease required resources. In some embodiments, devices and/or methods for targeting and anchoring diagnostic and/or therapeutic instalments in nodules under direct vision during endoscopic procedures are provided. In some embodiments, the nodules comprise currently low-yield lesions. In some embodiments, the diagnostic and/or therapeutic instruments comprise endoscopic instalments, ultrasound instruments and/or other localization instruments. For example, in some embodiments, devices and/or methods for targeting and anchoring diagnostic and/or therapeutic instruments in nodules during endoscopic procedures are provided.

[0043] In some embodiments, devices and/or methods for the localization, analysis and/or treatment of SPNs in a patient are provided. In some embodiments, the devices and/or methods allow for localizing SPNs during an endobronchial procedure. In some embodiments, the devices and/or methods allow for confirming SPNs during an endobronchial procedure. In some embodiments, devices and/or methods for confirming the location of SPNs are provided. In some embodiments, the endobronchial procedure can be a biopsy procedure. In some embodiments, the patients have one or more prior radiographically-diagnosed SPNs. In some embodiments, the devices and/or methods increase success of one-time biopsy procedure, decrease costs, and decrease required resources.

[0044] Any of the devices provided herein can be used with the any of the methods provided herein and vice versa. In some embodiments, the device is referred to with alternative terms such as angulation tool, sleeve or sheath.

INTERVENTIONAL CHANNEL DEVICE FOR ENDOSCOPIC PROCEDURES

[0045] Current peripheral lung biopsies have a poor diagnostic yield, with 30% inconclusive outcomes resulting in the need for repeat biopsies. The main issue with current biopsies is the lack of direct visualization of the biopsy location and procedure. Thus, there is a need to allow for direct visualization of endobronchial diagnostic and therapeutic instruments into an SPN nodule via for example a real time visualization probe. Implementation of real-time optical imaging techniques can aid in SPN biopsy- targeting and microscopically assess a lung nodule before biopsy for morphologic diagnosis and molecular testing. To help guide the endobronchial instruments to increase biopsy accuracy under visualization, there is an additional need to calibrate the manipulation of the biopsy needle based on characteristics of the ultrasound imaging. The same advantages for biopsy can be realized for therapeutic probes, e.g., therapeutic energy delivery or drug delivery, where the therapeutic probe is accurately advanced under visualization .

[0046] Thus, devices and methods are disclosed that provided solutions to the above-mentioned problems. The devices and methods disclosed provide targeting of nodules located in hard to reach areas such as outside the airway and allow diagnostic and therapeutic instruments to reach the exact location of the nodule.

[0047] In some embodiments, devices and methods for obtaining a tissue for analysis are provided. In some embodiments, the tissue can be any tissue, organ, etc. In some embodiments, devices and methods for targeting a lesion in a tissue are provided. In some embodiments, the lesion and/or the tissue can be any lesion and/or tissue requiring a biopsy. In some embodiments, the lesion is an SPN (FIG. I: 100). The lesion is targeted using one or more interventional channel devices according to the present disclosure. The device can be used as a universal add-on device. Embodiments of the device are shown in FIGS. 2-4. In some embodiments, the device has a small size and a compact shape. Thus, in some embodiments, the device can be used in small and hard to reach areas within a body cavity or a lumen, e.g., peripheral airways of the lungs. The device can be used for diagnostic and therapeutic instalments at nodular or suspect lesions.

[0Θ48] In some embodiments, the device comprises an outer sleeve (FIG. 3; 1). The outer sleeve (FIG. 3; 1) may be of any material. For example, in some embodiments, the outer sleeve may be made of a polymer, an elastomer, a polycarbonate material or any other biocompatible and/or durable polymer. The outer sleeve (FIG. 3: 1 ) is flexible and that allows navigation through, for example, the airways of the lung. The outer sleeve may of any shape. For example, the outer sleeve may be cylindrical (FIG. 3; 1). If the outer sleeve is cylindrical, it may have a range of diameter of about 0.5 mm to about 10 mm. In some embodiments, the diameter is about 3 mm (FIGS. 4A-4C). In one of the embodiments, the diameter of the outer sleeve of the device is smaller than the diameter of the channel of an endoscope and allows the device to fit within the working channel of the endoscope. The endoscope can be, for example, a bronchoscope. In another embodiment, the diameter of the outer sleeve is larger than the diameter of the channel of the endoscope and may be attached on the outside of the channel of the endoscope so as to not be limited in usability by the diameter of the channel of the endoscope. In some embodiments, that the diameter of the outer sleeve is larger than the bronchoscope, it can be operated without the endoscope.

[0049] An embodiment of the device is shown in FIG. 3. The device comprises an outer sleeve (FIG. 3: 1). The outer sleeve comprises at least two channels. A first channel (FIG. 3, 300} comprises a channel for an imaging probe (FIG. 3; 4). In some embodiments, the first channel (FIG. 3: 1) comprises an imaging probe (FIG. 3; 4). The imaging probe can be a CT scan probe, an MRJ probe, an ultrasound probe, etc. For example, in some embodiments, the imaging probes may include, but are not limited to, ultrasound (US) probes, such as radial US (R-US) or convex (C-US) shaped US probes, or confocal probes. The imaging probe may be changed at any moment for a different diagnostic or therapeutic instrument, such as an endoscopic radio frequency ablation (RFA) or cryoablation probe. The imaging probe is configured to identify the desired location, for example, an SPN (FIG. 3; 6).

[0050] A second channel (FIG. 3: 2) comprises a channel for an anchoring guidewire (FIG. 3; 5). In some embodiments of the device the first and second channels can angulated relative to each other. Angulation is achieved by a mechanism (FIG. 3: 3) to adjust the angle (FIG. 3; 7) of the second channel relative to the first channel. In some embodiments, the mechanism (FIG. 3; 3) to adjust the angle (FIG. 3; 7) of the second channel relative to the first channel comprises a wire (FIG. 3; 3). Pulling the wire (FIG. 3; 3) allows the angle (FIG. 3; 7) between the first and second channels to be increased. Releasing the wire (FIG. 3: 3) allows the angle (FIG. 3: 7) to be decreased. The wire (FIG. 3; 3) can be pulled manually, by an automated device or both. In some embodiments, in order to pull the second channel to the desired angle a calibration system may be used. In some embodiments, the angle can range from about 5 degrees to about 180 degrees. In some embodiments, the angle is about 45 degrees. In some embodiments, the angle is about 75 degrees. In some embodiments, the angle is about 90 degrees. In some embodiments, the calibration system allows determining the distance pulled with the angle created. Therefore, the radial distance traveled by the second channel relative to the first channel can be determined based on the distance for which the wire is pulled. Thus, in some embodiments, using the distance measurement on the image as a reference, the physician will puil the fiber to the position that corresponds to the radial distance of the lesion. In some embodiments, the calibration system may be automated through, for example, a software program. In some embodiments, the calibration system may be manually calculated through a chart. In some embodiments, the calibration system may be both automated and manual. In some embodiments, other angulation mechanisms are provided. In some embodiments, the angulation mechanism is a spring-based mechanism and comprises one or more springs (FIG. 12A). In some embodiments, the angulation mechanism may be magnet-based or needle shaft-based (FIG. 12B). The angulation mechanisms may consist of stainless-steel, polycarbonate or other biocompatible and durable polymers. In some embodiments, the angulation mechanism may also comprise one or more hinges that allow the second channel to be angulated relative to the first channel.

[0051] Once the desired location, for example, an SPN (FIG. 3; 6) is identified using the imaging probe (FIG. 3: 4), the second channel can be angulated towards the desired location such that the second channel reaches the desired location. When the second channel is angulated towards the desired location, the guidewire (FIG. 3; 5) is brought in the vicinity of the desired location. The anchoring guidewire can be anchored at the desired location by one or more anchoring mechanisms (described below).

[0052] Subsequently, the diagnostic or therapeutic probe or instrument is advanced into the lesion FIG 3B, at which time the diagnostic or therapeutic probe or instrument will be visible on the image. At this point, the protocol is similar to current procedures, for example, trans-bronchial needle aspiration procedures and advance the diagnostic instrument accurately in the core of the lesion, the diagnostic instrument will achieve at the plane of the imaging interface on a screen.

[0053] FIGS. 2-3, show a device thai can be described as an add-on interventional channel device to an imaging probe for endoscopic procedures. The add-on channel allows for angulation of a diagnostic or therapeutic probe or insirument through an extra channel, such as an endoscopic biopsy forceps, needle or guidewire, when targeting and/or entering a suspicious lesion, such as a nodule, under direct visualization.

[0054] In some embodiments, the first channel is fixed in position and the second channel can be angulated relative to the first channel (FIG. 3; 7). The angulation allows the device to be targeted under direct vision. In some embodiments, the device is configured to guide a medical instrument to a desired location in a subject.

[0055] The sleeve may be attached to the imaging probe either at the proximal or distal end, or both, to ensure it is always at the correct location along the probe and allows for a degree of rotation. This may be achieved by simply rotating the sleeve manually, or rotating in an automatized fashion via robotic or similar system.

[0056] The sleeve may contain visible numbers from proximal to distal to indicate the length of the device in centimeters or inches. The sleeve may consist of, but is not limited to, two working channels. The channels may be of any size or shape.

[0057] FIG. 2 demonstrates the mechanism of targeting nodules for diagnostic or therapeutic purposes under an angle with the use of a real time imaging probe. The angulation mechanism for diagnostic or therapeutic instruments may be described as a wire-based fiber tension-like mechanism 3. As the physician pulls the fiber on the proximal end, the distal end which is attached to the diagnostic or therapeutic instrument channel 2 will pull the channel away from the probe to increase the angle. The range of degrees of the angle may be between 0-180 degrees. In some embodiments, the range of degrees of the angle may be between 30-45 degrees. In some embodiments, the range of degrees of the angle may be between 0-75 degrees. In some embodiments, the range of degrees of the angle may be between 0-90 degrees. In some embodiments, the range of degrees of the angle may be between 0-180 degrees. After the physician identifies the location of the lesion FIG 3A via real time imaging, such as radial ultrasound, he can determine how far to pull the fiber on the proximal end such that the needle guide is pointed at the target site. To help guide the endobronchial instalments to accurately target the desired lesion, a calibration method may be applied based on the image of, for example, the ultrasound image using sonometers.

[0Θ58] In some embodiments, the anchoring mechanism of the anchoring guidewire is deployed under image guidance provided by the imaging probe in the first channel of the device described above (such as US, CT, etc) during interventional procedures via endoscope. The tip of instrument may be of various geometrical shapes or material that facilitates piercing, cutting, anchoring or any other mechanism when advancing through tissue, this includes but is not limited to needle, blunt, tapered or threaded shapes. The tip may also have an angulating or rotating component to facilitate distal directional changes when located in the tissue. The shaft or body of the guidewire acts as a guidewire leading to the anchor. Thus, allowing any additional instruments to be passed through, over, or alongside the guidewire and directly to the area of interest for diagnostic or therapeutic purposes. In some embodiments, the guidewire is provided with one or more anchoring mechanisms. In some embodiments, the guidewire is without an anchor,

[0059] Regardless the configuration of the anchoring mechanisms as illustrated in FIGS. 6-9, additional features may include treatment instalments, either directed via angulation to the site, or advanced along the anchored guidewire to the site. Such treatment instruments may include for example, cauterization, coagulation, cutting, and ablation instruments. The device may also include features that enhance the visibility of the treatment instrument during imaging procedures, such as ultrasound. This may be achieved through several mechanisms: passing a liquid, dye, marker, gas bubbles or other substance through or at the tip of the instrument, modifying the surface of the instrument to maximally reflect US waves, using imaging enhancing materials for the instrument, or other imaging enhancing methods.

|0060] The endobronchial procedure can be diagnostic. The endobronchial procedure can be therapeutic. The endobronchial procedure can be diagnostic and therapeutic. In some embodiments, the device is compatible with any type of imaging probe, endoscope or both.

|0061] In some embodiments, the present disclosure describes devices and/or methods for targeting and anchoring endoscopic instruments in a nodular or suspect lesion during endobronchial) diagnostic or therapeutic procedures. The novelty of this device includes i) its anchoring and passage component for diagnostic and therapeutic instruments, ii) the method and enabling device for angulating and targeting diagnostic and therapeutic instruments at a nodular or suspect lesion, and iii) its small size, permitting the use of it in small peripheral airways.

ANCHORING TECHNIQUE FOR ENDOSCOPIC PROCEDURES

|0Θ62] FIGS. 6-9 show different embodiments of anchoring mechanisms. One or more anchoring mechanisms may be used to anchor the anchoring guidewire in a tissue, e.g., pulmonary tissue. In some embodiments, the device is a mechanically- operated device. In some embodiments, the anchoring is achieved by a pushing, pulling, or twisting motion of a proximal end of the anchoring guidewire enabling a change at the distal end of the anchoring guidewire, which allows the anchoring mechanism to be deployed an anchors the anchoring guidewire. After the anchoring mechanism has been deployed, the anchor remains in the area of interest until removal . [0063] The embodiments displayed in FIGS. 6-9 illustrate possible operating mechanisms of the anchoring mechanism. In some embodiments, the anchoring mechanism comprises two sheaths, an inner sheath (FIGS. 6-8; 1) and an outer sheath (FIGS. 6-8; 2). In some embodiments, the inner and outer sheaths may be made of PEEK or other material. The inner sheath (FIGS. 6-8; 1) and the outer sheath (FIGS. 6-8; 2) create the body of the anchoring mechanism and w<ork in concert with each other. In each embodiment of the anchoring mechanism, the inner sheath (FIGS. 6-8; 1) and the outer sheath (FIGS. 6-8; 2) have a specific movement relative to each other. The relative movement activates or inactivates the anchoring mechanism. A first movement activates the anchoring mechanism and a second movement, which is usually in a direction opposite to the first movement, inactivates the anchoring mechanism. Thus, the first movement allows the anchoring mechanism to be anchored at the area of interest and the second mechanism allows the device to be removed from the area of interest.

[0064] FIG. 6 shows an embodiment in which the inner sheath is rotated at a proximal end in order to deploy the anchoring mechanism at the distal end. In some embodiments, the anchoring mechanism is deployed at the distal end when the proximal end is rotated clockwise. In some embodiments, the anchoring mechanism is deployed at the distal end when the proximal end is rotated counter-clockwise. FIGS. 6A and 6B show views before the anchoring mechanism has been deployed. FIG. 6A shows a cross- sectional view and 6B shows a side-on view. FIGS. 6C and 6D show views after the anchoring mechanism has been deployed. FIG. 6C shows a cross-sectional view and 6D shows a side-on view. FIGS. 6C and 6D show after the anchor has been deployed. FIG. 6A shows a cross sectional view of the sheaths before the anchoring mechanism is deployed. FIG. 6C shows a cross sectional view after the other and inner sheaths have been rotated relative to each other, deploying the anchoring mechanism. In some embodiments, the anchoring mechanism comprise anchoring spikes (FIGS. 6C and 6D; 3), which are deployed through the windows (FIGS. 6B and 6D; 4). The windows are present at the distal end of the outer sheatli (FIG. 6D). The anchoring spikes (FIGS. 6C and 6D; 3) are attached to the distal end of the inner sheath and move in and out of the windows (FIGS. 6B and 6D; 4) located at the distal end of the out sheath when the inner sheath is rotated relative to the other sheath. In some embodiments, the anchoring spikes (FIGS. 6C and 6D; 3) are pointed and sharp at the end which allow them to anchor onto the tissue surrounding the region of interest. Thus, any movement of the anchoring guidewire is prevented by the spikes. In some embodiments, the number of spikes (FIGS. 6C and 6D; 3) and windows (FIGS. 6B and 6D; 4) is about 2 to about 100, In some embodiments, the number of spikes and windows is 2, 3, 4, 5 or 6, In some embodiments, the number of spikes and windows is 4,

[0065] FIGS. 7 A and 7B show illustrations of another embodiment of the anchoring mechanism. In contrast to the anchoring mechanism shown in FIGS. 6A-6D, the anchoring mechanism illustrated in FIGS. 7A and 7B are deployed when the inner sheath (FIG. 7 A and 7B; 1} slides relative to the outer sheath (FIGS. 7 A and 7B; 2). In some embodiments the anchoring mechanism is deployed through pulling/pushing (See Fig 7 and Fig 8). Thus, as the inner sheath is pulled out of the outer sheath, the anchoring spikes (FIG. 7B; 3) are deployed through the windows (FIGS. 7A and 7B; 4). The anchoring spikes anchor the anchoring guidewire similarly to the anchoring spikes in FIGS. 6A-6D. In some embodiments, the number of spikes (FIG. 7B; 3) and windows (FIGS. 7 A and 7B: 4) is about 2 to about 6. In some embodiments, the number of spikes and windows is 2, 3, 4, 5 or 6. In some embodiments, the number of spikes and windows is 3.

[0066] FIGS. 8A and 8B show another embodiment of the anchoring mechanism. The inner and outer sheaths have the same relative motion as the inner and out sheaths of FIG. 7. In this case, the anchor is deployed when the inner sheath slides relative to the outer sheath. In some embodiments, the anchor is deployed when the inner sheath is pulled away from the distal end. In some embodiments, the anchor is deployed when the outer sheath is pushed towards the distal end. The anchoring mechanism is deployed through one or more slits (FIG. 8; 5) instead of windows on the outer sheath (FIG. 8, 2). In some embodiments, as the inner and outer sheaths slide along each other, the outer sheath bends and/or folds over to form the anchoring protrusions/spikes expand radially away from a central axis. FIG. 8A shows the anchoring mechanism before deployment. FIG. 8B shows the anchoring mechanism after deployment with the anchor spikes (FIG. 8B; 4). The device may consist of one or more anchoring spikes. In some embodiments, the number of spikes (FIG. 7B: 3) and windows (FIGS. 7 A and 7B: 4) is about 2 to about 6. In some embodiments, the number of spikes and windows is 2, 3, 4, 5 or 6. In some embodiments, the number of spikes and windows is 3.

[0067] In the embodiments above, the anchoring mechanism may be in the form of spikes, hooks, sharp-edged structure, points, blades, wires or other features, to enable the device to embed in tissue. In some embodiments, the anchoring mechanism is as shown in FIG. 4 and is shaped like an anchor. In some embodiments, the anchoring mechanism of FIG. 4 is made of a shape memory alloy. In some embodiments, the shape memory alloy is nitinol.

[0068] In some embodiments, the anchoring mechanism may comprise a wire- based mechanism, for example, as illustrated in FIGS. 9A and 9B. The wire-based anchoring mechanism comprises an outer sheath (FIG. 9A: 7) and a pre-molded wire (FIG. 9B; 6) that is comprised within the outer sheath. In some embodiments, the pre- molded wire is made of a shape memory alloy. In some embodiments, the shape memory alloy is nitinol. FIG. 9A illustrates the anchoring mechanism before deployment, FIG. 9B illustrates the pre-molded wire-based anchoring mechanism after deployment. In some embodiments, the pre-molded wire-based anchoring mechanism is deployed by a rotating or twisting motion of the wire-based anchoring mechanism relative to the outer sheath. In some embodiments, the wire-based anchoring mechanism is deployed by pushing the wire out and/or retracting the outer sheath. In some embodiments, the wire-based anchor is a memory shape alloy. Pushing the wire-based anchor out and/or retracting the outer sheath to release the wire-based anchor enables the wire-based anchor to adopt its memory shape. In some embodiments, the pre-molded wire-based anchoring mechanism is deployed by pushing the wire-based anchoring mechanism out of the outer sheath. In some embodiments, the shape of the wire-based anchoring mechanism can be without limitation flat spiral, conical spiral, coiled, oval, rectangular or hook-l ike. In some embodiments, the wire-based anchoring mechanism, can be made from without limitation nitinol or titanium .

[0069] In some embodiments, the anchoring guidewire is as shown in FIG. 4B. In some embodiments, the anchoring guidewire is comprised of at least two wire- shaped hooks (FIG. B, inset). In some embodiments, the number of wire -shaped hooks can be greater than two. In some embodiments, the wire-shaped hooks are made of a memory shape alloy . In some embodiments, the memory shape alloy is Nitinol. In some embodiments, the outer sleeve holds the two wire-shaped hooks together, keeping them straight and parallel to each otlier before deployment. Pushing the wire-based anchor out and/or retracting the outer sheath to release the wire-based anchor allows the wire-based anchor to adopt its memory shape (FIG. 4B, inset). DEVICES AND METHODS FOR LOCALIZATION AND ANALYSIS OF TISSUES

[0070] In some embodiments, devices and methods for localizing and confirming one or more SPNs are provided. It is understood that where SPNs are called out in this description, the disclosed devices and methods may also be used for localization, analysis, and diagnostic and therapeutic applications, related to other other lesions or sites of interest in the lungs or in other tissues and organs. The devices and methods can be used during interventional procedures such endobronchial procedures (e.g., endobronchial biopsy) in patients. In some embodiments, the patients have prior radiographically-diagnosed SPNs. In some embodiments, the invention provides a combined SPN image mapping & ultrasound guided needle aspiration, an intraoperative navigation device for endoscopic procedures, and analysis of retrieved lung tissue via portable Raman spectral device.

Combined SPN image mapping & ultrasound guided needle aspiration system

[0071 j FIG. 10A shows the reconstruction of the patient's airways in 3- dimensions based on previously obtained CT scans, or similar data such as MRl's, in combination with an automated planning of the optimal path to the SPN . This automated planning may include but is not limited to intrabronchial pathways. It may also include routing through any other extrabronchiai or intrabronchial pathway. FIG. 30B shows the virtual 3D reconstruction of the SPN using custom-made software. The custom-made software may include but is not limited to image segmentation software or rendering software. The 3D reconstruction process may be combined with the use of any dye, marker or agent systemicailv or locally administered to the patient or SPN or both. Examples without limitation include fluorescence or indocyanine green.

[0072| FIG. 11 is an illustration of an embodiment of a real time 3D reconstruction of a SPN during bronchoscopy by combining localization data of a previously obtained CT-scan and a real time imaging probe. The real time imaging probe (FIG. 11 A; 1 ) is comprised within the first channel (FIG. 1A; 2) of the device. In some embodiments, the imaging probe may comprise without limitation any type of imaging source such as ultrasound, confocal endomicroscopy, optical coherence tomography or narrow band imaging. In one of the embodiments, the imaging probe may comprise an ultrasound probe (FIG. 11A; 1). The imaging probe may be shaped radial, convex or otherwise. The probe may be advanced manually or using an automated device. The probe may be advanced at a constant or variable speed (FIG. 1 1 A; 3) or both. The speed (FIG. 11 A; 3) can be regulated through one or more accompanying or integrated automated device or system such as motorized engines or software based systems to regulate and/or inform the physician regarding the applied speed. The speed at which the probe is advanced could also be tracked through and software based system that then corrects the differences in speed. While advancing the probe intra-bronchially or through any other anatomical structure, custom made geometrical mapping software may create real time a 3D image of the covered imaging area (FIG. 1 1A; 4) through the probe-based imaging source and the previous obtained CT data and detect a lesion of interest e.g., an SPN (FIG. 11A; 5).

[0073] Real time illustration of the 3D reconstruction and localization of an SPN may be obtained by comparing and analyzing in real time two or more sets of image data obtained using the imaging probe. The 3D reconstruction and localization of an SPN may be achieved by comparing and analyzing data related to the anatomical features in the covered imaging area (FIG. 11A; 4). Information such as the shape, size and/or density of the SPN (FIG. 11 A; 6) may be obtained . The real time 3D reconstruction and localization of the SPN can be displayed to a physician or a health care professional on a monitor or similar display device (FIG. 1 IB).

[0074] FIGS. 12A-12B show two different embodiments to position the endobronchial needle for image-guided needle aspiration or biopsy of SPN. FIG. 12A, an endobronchial imagmg-probe, such as ultrasound, is positioned in a working channel of an endoscope (e.g., a bronchoscope). The imaging probe may have an extra lumen 2, located internally or externally, to pass through an endobronchial needle or similar instrument for tissue sampling. In the case when a SPN is located aligned with the probe, the needle 3 or similar instalments may be advanced and retrieve a tissue sample. In the case when the SPN is not aligned but positioned in an angle or perpendicular with the probe, the probe may have a mechanism to allow the lumen, with the needle or similar instrument, to readjust its locations and align with the SPN. This mechanism may include but is not limited to re-angulating a part of the lumen through a spring-based (e.g. 4), wire-driven, or magnetic-force based mechanism. The angle of the re-angulating part of lumen may be calculated based on the distance d (distance of the re-angulating location of the lumen and the distal end of the probe) and height h (distance between probe and SPN) or may be fixed. The height h may be calculated through the probe-based imaging device. In one embodiment the distance d may be adjusted if required by using a mechanical, eventually wire-driven, sliding mechanism 5 of the lumen shaft outlet relative to the guide sheath that allows stage less adjustment. Materials for the lumen, the casing may include (but should not be limited to) durable polycarbonate tubes that are fully biocompatible,

[0075] FIG. 12B illustrates another embodiment for advancing of the endobronchial needle, or similar instrument, perpendicular to the probe and SPN, This may be applied when the probe is positioned parallel to a SPN, In one embodiment, when advancing the endobronchial needle through the lumen the shaft of the lumen may be retracted exposing an opening in the wall of the imaging probe and allowing the endobronchial needle to advance. In another embodiment the exposed opening in the lumen may have a shaft 6 covering the opening and allowing to perpendicular expand to a SPN using mechanisms such as a spring configuration, a configuration using stacked tubes or a folding mechanism (all 8). An endobronchial needle 7 or similar instrument may advance through an opening in these configurations to reach the SPN. The shaft including its parts of the mechanism enabling a perpendicular configuration may consist of stainless-steel, polycarbonate or other biocompatible and durable polymers.

Intraoperative navigation device for endoscopic procedures

[0076] In some embodiments, devices and method workflows for localizing and tracking the movement of a surgical device during a procedure. In some embodiments, the procedure can be without limitation a surgical procedure or an endoscopic procedure (e.g., bronchoscopy). FIG. 13 is a schematic of an intraoperative navigation method workflow to localize a region of interest during a surgical procedure, endoscopic procedure (e.g., bronchoscopy), interventional endoscopic procedure (e.g., a biopsy). In some embodiments, the region of interest may be without limitation a tumor or an SPN . In some embodiments, prior to the endoscopic procedure or interventional endoscopic procedure, a preoperative imaging 32 is obtained. In some embodiments, the preoperative imaging 32 is obtained by, for example, one or more of CT scan, MRI, 3D ultrasound, etc. In some embodiments, an area of interest exposed on preoperative imaging 32 may be analyzed or reviewed further. In some embodiments, the area of interest, for example, an SPN may be highlighted or marked. The area of interest may be highlighted or marked using novel or pre-existing segmentation software as may be understood by one of ordinary skill in the art.

[0077] In some embodiments, the subject/patient may be positioned within an external tracking and registration apparatus. An embodiment of an external tracking and registration apparatus is shown in FIG. 14. Such an apparatus may receive and transmit waves as described in FIG. 14, or the apparatus may be positioned after the patient lays, sits or stands 34. The location of the external tracking and registration apparatus may be fixed, dynamic or moving. Next, the preoperative imaging is fused with the patient's XYZ position coordinates (fiducial registration) in order to create an overlay with the pre- operative!.}' obtained images. The internal tracking and registration apparatus is introduced into the electromagnetic field. Its position is superimposed onto the preoperative imaging dataset. This may be, but not limited to, internal placement of the apparatus in the patient. The device's superimposed position can be compared to the region of interest identified. This information may be displayed in a 3D image or similar on a monitor or other output display device. Based on this information the physician may plan a pathway for the endoscope to reach the area of interest and will provide feedback regarding the device's proximity to the area of interest. The software may also guide the physician in regard to the most efficient pathway to reach the region. In the case of having an internal imaging source present in the patient, position tracking can be coupled with this device, thus enabling real-time 3D image reconstruction and analysis 33 as described in FIGS. 10, 1 1 and 13.

|0078] FIG. 14 demonstrates the positioning and components of an external tracking and registration apparatus. The external tracking and registration apparatus 9, 10, 11 may receive or transmit signals from or to the surface and/or the internal tracking and registration apparatus 15 (also shown in FIG. 15). In one embodiment, the external tracking and registration apparatus may be of any shape, size, orientation, or material that accommodates the ability to send and receive signals, such as electromagnetic or sound waves, from a device positioned within the patient 14. For the sending of signals a magnet, piezoelectric element, or sound producing mechanism may be used. The size and shape of the external tracking and registration apparatus can also accommodate for the variation in sizes, features, and positions of the patient, operating room, or any other equipment present in the operating room. The external and internal embodiment transmitting-receiving apparatus may be manufactured from a combination of materials such as silicone, polymers or copper. The surface tracking and registration components 13 consist of similar elements that may be placed on the patient's chest or any other location internally or externally. The surface tracking and registration apparatus components allow for real time registration of the patient within the field created or received by the external tracking and registration apparatus elements, which in turn allows for registration and tracking of patient movements, such as breathing. The surface tracking and registration components can be of any shape, size or material that accommodates the ability to send and receive signals, such as electromagnetic or sound waves, from a device positioned within the patient.

[0079] FIGS. 15A-15C show- illustrations of an internal tracking and registration apparatus. In some embodiments, the general design of the internal tracking and registration apparatus may be ring shaped. Two embodiments of a ring shaped internal tracking and registration apparatus, 18 and 15, are shown in FIG. 15A and 15C, 15 to allow penetration of other endoscopic instruments. The internal tracking and registration apparatus hereby afterwards referred to as the internal tracking and registration ring, may be placed or slided over an endoscopic, or similar, probe with imaging capabilities such as an ultrasound transducer 17, 19. In one embodiment, the internal tracking and registration apparatus may be circular shaped with a lumen in the center to allow endoscopic instruments to slide through the lumen. In another embodiment the ring is not limited to a ring or circular structure and may be of any shape, size or material that accommodates the ability to interact, connect or be assembled with current minimally invasive imaging instalments such as an endoscopic probe. In one embodiment, when being used during an endoscopic procedure such as bronchoscopy, the ring itself may have the dimensions to fit into the working channel of an endoscope or positioned on top of the probe or endoscope when introducing it into the patient. This coul d be achieved through variations in geometry of the ring or it could require additional structures or materials. The internal tracking and registration ring consists of a transmitting and/or receiving element. These elements may use for example electromagnetic or sound waves. FIG. 15B describes a locking mechanism for attaching and fixing the ring, for example using magnets, adhesives, clasping, clipping or any other type of locking mechanisms 21. The ring may be positioned on a fixed position on a certain distance from the tip of the endoscopic probe to determine the length and location of the probe on the visualized image on the physician's monitor or other display device. FIG. 15C demonstrates a possible method for determining and fixing the position of the ring on the probe. In one embodiment, before sliding the ring over an endoscopic probe, a sheath may be attached to the ring 14, 17. This attachment and locking mechanism may include magnets, adhesives, clasping, clipping or any other type of locking mechanisms. The sheath can be placed over the probe and may have the shape and dimensions of the probe and a fixed length 16, When the ring is fixed at the required position, the sheet could be removed 13, 16 before inserting the probe and the ring in an endoscope and into the patient. This may be done through an unlocking mechanism, such as a twisting, screwing, unclipping or other type of mechanism 18, In another embodiment, after attaching the sheet to the ring, the sheet may be fixed to the ring for the entire procedure and removed after completion of the procedure. Other mechanisms for determining the length of the location on the probe may be physical measurements or markings on the probe or other mechanisms.

[0080] Although this invention has been disclosed in the context of certain embodiments and examples, those skilled in the art will understand that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while several variations of the invention have been shown and described in detail, other modifi cations, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. It should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another in order to form varying modes or embodiments of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above.

EXAMPLES

[0081] The present disclosure is further illustrated by reference to the following examples. These examples are provided for illustrative purposes, and are in no way intended to limit the scope of the invention. Example 1

[0082] In some embodiments, the proposed workflow comprises sedating a patient and advancing an endoscope into a patient. The endoscope can, for example, be advanced into the respiratory lumen of the patient. The endoscope is advanced as far as the endoscope can fit. The endoscope is advanced under a white light camera located on the endoscope which provides a visual feedback of the advancement of the endoscope. In some embodiments, a device of the present disclosure (FIG. 4A) in a closed position is advanced through the working channel of the endoscope. The device is advanced under ultrasoimd guidance using, for example, a radial probe ultrasound (FIG. 3; 4). An SPN, if present is identified and localized using the radial probe ultrasound. Based on the XYZ coordinates generated using the internal and external tracking and registration apparatuses and the 3D reconstruction based on collating the information obtained preoperative image data and XYZ coordinates, the location of the SPN is accurately determined.

|0083] After the SPN has been identified under visualization, the second channel (FIG. 3; 2) comprising the anchoring guidewire (FIG. 3; 5) is anguiated towards the SPN (FIG. 3: 6). FIG. 4A shows an anguiated channel 400. Angulation is performed by pulling at the wire that is attached to the second channel and is at the control of the user and can be used to pull at the second channel. Once anguiated the anchoring guidewire (FIG. 3; 5) is advanced into the lesion e.g., an SPN (FIG. 3; 6). When the anchoring guidewire is the desired location e.g., a biopsy location, one or more anchoring mechanisms (FIG. 4B; 405) are deployed that allow the anchoring guidewire to be anchored at the desired location. The presence of a endoscopic probe (FIG. 3; 4) e.g., a radial probe ultrasound, in the first channel allows the anchoring to be performed while still under visualization. FIG. 4B shows deployment of the anchor 405.

|0Θ84] Once the anchoring guidewire is anchored, the first channel comprising the ultrasound imaging probe as well as the second channel are removed, leaving behind only the anchoring guidewire anchored in the desired location. The anchoring guidewire is then used as the guide to direct and advance another device, e.g., a biopsy instrument to the precise location where the anchoring guidewire was anchored. FIG. 4C shows an example of a biopsy instrument 410.

Claims

WHAT IS CLAIMED IS:
1. A device configured to guide a medical instrument to a location in a subject, the device comprising:
a first channel comprising an imaging probe, wherein the imaging probe is configured to identify the location; and
a second channel comprising the medical instalment, wherein the second channel is configured to angulate relative to the first channel to reach the location.
2. The device of claim 1 , wherein the medical instalment is a guidewire.
3. The device of claim 2, wherein the guidewire comprises an anchoring mechanism, comprising deployable anchors, such that upon reaching the location, the guidewire can be anchored at the location by the anchoring mechanism ,
4. The device of claim i, wherein the medical instrument comprises a diagnostic or therapeutic probe.
5. The device of claim 4, wherein the medical instrument comprises a diagnostic probe, and wherein the diagnostic probe comprises a biopsy needle.
6. The device of claim 4, wherein the medical instalment is a therapeutic probe, and wherein the therapeutic probe is configured to deliver to the location a therapeutic agent or an ablative energy.
7. The device of claim I, wherein the imaging probe is at least one of a radial ultrasound probe, convex-shaped ultrasound probe, confocal probe, endoscopic radio frequency ablation probe or cryoabiation probe.
8. The device of claim 1 , wherein the imaging probe comprises an internal tracking and registration system attachment, wherein the internal tracking and registration system, attachment can communicate with an external tracking and registration system to generate a 3D image of the vicinity of the location, wherein, the 3D image can be used to identify the location.
9. The device of claim 3, wherein the deployable anchors comprise wires, hooks, spikes, blades, sharp-edged structures, or points.
10. The device of claim 1, wherein the second channel, further comprises one or more pull-wires configured to manipulate the angle of the second channel, relative to the first channel. 1 ί . The device of claim 1 , wherein the second channel further comprises one or more flexion structures selected from a hinge, a spring, and a flexible polymer, wherem the one or more flexion structures facilitate angulation of the second channel,
12. The device of claim 1, wherein the second channel is substantially parallel to the first channel in a closed configuration such that the device can be advanced through a body lumen to the vicinity of the location through an endoscope.
13. The device of claim 1 , wherein the location can be inside a lumen or outside a lumen.
14. The device of claim 3, wherein the anchoring mechanism is located along a distal end region of the guidewire.
15. The device of claim 3, further comprising a control mechanism configured to deploy the anchors from a collapsed state to an extended state.
16. The device of claim 15, wherein the control mechanism comprises an inner member coaxially engaged within an outer sheath, wherein the inner member and outer sheath are configured to be axially displaced and/or rotated relative to one another.
17. An anchoring guidewire, comprising:
an inner member comprising extendible anchors configured to deploy from a collapsed state to an extended state; and
an outer sheath coaxially surrounding the inner member and restraining the anchors in their collapsed state;
wherein the outer sheath is configured to displace axially and/or rotate with respect to the inner member, such axial displacement and/or rotation causes openings in the outer sheath to align with the anchors, thereby allowing the anchors to deploy through the openings to the extended state.
18. The anchoring guidewire of claim 17, wherein the openings in the outer sheath are selected from slits, slots, or holes.
19. A method for guiding a medical instrument to a desired location in a subject, the method comprising:
providing a device comprising:
a first channel comprising an imaging probe, wherein the imaging probe is configured to identify the location; and a second channel comprising a guidewire, wherein the second channel is configured to angulate relative to the first channel to reach the location;
identifying the location;
retracting the imaging probe and the second channel leaving the guidewire at the location; and
advancing the medical instrument along the guidewire to the location.
20. The method of claim 19, wherein identifying the location is achieved by communicating an internal tracking and registration system of the device with an external tracking and registration system to generate a 3D image of the vicinity of the desired location.
21. The method of claim 20, further comprising angulating the second channel relative to the first channel at flexion structures selected from a hinge, a spring, and a flexible polymer to reach the location.
22. The method of claim 19, further comprising anchoring the guidewire at the location by deploying one or more anchors disposed along a distal end region of the guidewire from a collapsed state to an extended state.
23. The method of claim 22, wherein deploying the one or more anchors involves axially displacing and/or rotating an inner member and outer sleeve relative to one another, thereby allowing the one or more anchors to extend through openings in the outer sleeve.
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