Patent ID: 12186129

DETAILED DESCRIPTION

Embodiments of the present disclosure include medical devices useful in obtaining ultrasound images within the body, e.g., via one or more ultrasound sensors, and methods of performing medical procedures using such devices.

The term “ultrasound sensor” as used herein includes devices configured to transmit and/or receive ultrasound (≥20 kHz) and other frequency sound waves for producing an image. For example, ultrasound sensors suitable for the present disclosure include transceivers and transducers capable of both transmitting and receiving ultrasound. By measuring the time between sending ultrasound signals and receiving the echoes of those signals reflected by various features in the body, the distance to those features may be determined, e.g., to obtain images. The images may provide information regarding tissue structure (e.g., density, shape, contour, etc.), the presence or absence of tumors, lesions, or other abnormalities, the size and location of any such abnormalities, and/or blood flow or other fluid flow characteristics. The images may be two-dimensional or three-dimensional.

Ultrasound imaging may have advantages over other types of imaging. For example, ultrasound can provide real-time images, avoiding a delay between capturing an image of an area of interest and performing a medical procedure on that area. Further, because ultrasound sensors operate via sound waves, e.g., rather than electromagnetic radiation, they are typically less harmful to the patient.

FIG.1shows an exemplary medical device100according to some embodiments of the present disclosure. The medical device100may comprise a controller104and a shaft102extending from a proximal end122to a distal end124. The controller104may have any suitable shape, including cylindrical and ergonomic shapes for easy or comfortable gripping by one or both hands. The shaft102may include one or more ultrasound sensors150. The ultrasound sensor(s)150may be at or proximate to the distal end124of the shaft102. The controller104may include an electronic cable30, e.g., for providing power to the ultrasound sensor(s)150and/or for communication between the ultrasound sensor(s)150and a processor or graphical interface.

In some embodiments, the medical device100may be steerable, e.g., to allow an operator to navigate the shaft102through tortuous anatomy and/or towards a site of interest. Any suitable steering mechanism may be used. For example, the steering mechanism may comprise a plurality of steering wires coupling the controller104to the shaft102, e.g., to transmit user input from the controller104to the shaft102to articulate or deflect the shaft102along one or more planes.

As shown inFIG.1, for example, the controller104may include one or more actuators, e.g., first and second actuators136,138, each coupled to at least one control member282(e.g., mechanical or electronic steering wire) that extends along the shaft102(seeFIG.2A). In some embodiments, the first actuator136may control deflection of the distal end124of the shaft102in one plane (e.g., xy plane), and the second actuator138may control deflection of the distal end124in a different plane (e.g., yz plane). For example, the first actuator136may be coupled to a first pair of control members282such that rotational and/or translational motion of the first actuator136may deflect the distal end124of the shaft102in one plane. Similarly, the second actuator138may be coupled to a second pair of control members282, such that rotational and/or longitudinal motion of the second actuator138, independent of the first actuator136, may deflect the distal end124in a different plane. Concerted movement of the first and second actuators136,138may achieve deflection in a plurality of other planes, e.g., providing for 360 degree manipulation of the shaft102. In some embodiments, each actuator136,138may be coupled to only one control member282and/or the controller104may include only one actuator.

Other steering mechanisms suitable for manipulating the shaft102may be used, including, but not limited to, other types of mechanical mechanisms and electrical mechanisms. For example, the controller104may be in electrical communication with various portions of the shaft102(e.g., via electronic control members282), such that user input at the actuators136,138may be converted to electrical signals to control deflection of the distal end124of the shaft102. In some embodiments, the medical device100may not include a steering mechanism. For example, the medical device100need not be steerable according to some aspects of the present disclosure.

The shaft102may include one or more working channels230and/or one or more auxiliary channels280. An example is illustrated inFIGS.2A-2C, whereinFIG.2Bshows a cross-sectional view of a distal portion of the shaft102ofFIG.2A, andFIG.2Cshows a cross-sectional view of a proximal portion of the shaft102ofFIG.2A. In some embodiments, for example, the shaft102may include one working channel230and four auxiliary channels280as shown. WhileFIGS.2A-2Cshow the shaft102including one working channel230and four auxiliary channels280, the shaft102may include more than one working channel (e.g., two, three, or more working channels). Further, the shaft102may include fewer or more than four auxiliary channels280(e.g., two, three, five, or six or more auxiliary channels280), or may not include any auxiliary channels280.

The working channel230may receive one or more instruments inserted into the working channel230for performing a medical procedure. Suitable instruments may include, but are not limited to, needle devices, forceps, scalpels, snares, biopsy brushes, optical devices, and imaging devices (e.g., in addition to the ultrasound sensor(s)). The working channel230may extend from the proximal end122of the shaft to the distal end124, and may be in communication with a proximal inlet for insertion of the instruments. For example, the medical device100may include a side port144(seeFIG.1) in communication with the working channel230for the insertion of one or more instruments into the working channel230.

In some embodiments, the working channel230may be configured to maintain one or more instruments in a specific orientation with respect to the shaft102. For example, the working channel230may have a cross-sectional shape and/or one or more surface features complementary to the instrument to “key” the instrument to the working channel and limit relative rotation between the instrument and the working channel. The working channel230may have a non-circular cross-sectional shape as shown inFIGS.2B and2C, e.g., having a tapered or narrowed portion231. An instrument having a complementary cross-sectional shape may maintain its orientation as it passes through the working channel230. The distal end of the instrument therefore may have a unique radial location upon exiting the distal end124of the shaft102. By aligning the shaft102with a target site (e.g., positioning the shaft102such that the narrowed portion231of the working channel230points toward the target site), the instrument may have the proper orientation for performing a medical procedure at the target site.

In some embodiments, the shaft102may include an area211having a unique echogenic pattern or signature to assist in directing the instrument(s) towards the target site. Any suitable material, combination of materials, surface features, and/or texture may be used to produce a unique echogenic signature to be identified in an ultrasound image. For example, the area211may include grooves, divots, lattice marks, stepped portions, projections, ridges, and/or other distinguishing surface features or textures. Further, for example, the area211may comprise one or more materials having a different density than other portions of the shaft102, such that the area211may be identified in an ultrasound image.

The area211may be integrated into the shaft102(e.g., integrated into the ultrasound sensor150or other distal portion of the shaft102) in order to have a fixed position with respect to the working channel230. Upon locating a target site in the body via ultrasound imaging, the area211(also visible via ultrasound) may be aligned with the target site to likewise align the working channel230(and, for example, narrowed portion231) with the target site. Instruments inserted into the working channel230and maintaining a specific orientation as they pass through the working channel230therefore may have the proper orientation for performing a medical procedure at the target site.

The auxiliary channels280may accommodate control members282for deflecting the shaft102, as mentioned above, and/or for connecting the ultrasound sensor150to a power source or for electronic communication. In some embodiments, the auxiliary channels280and/or control members282may terminate proximal to the ultrasound sensor150, as shown inFIG.2A. Each auxiliary channel280may house one or more control members282. Further referring toFIGS.2A and2C, for example, two of the auxiliary channels280may accommodate a pair of control members282coupled to the first actuator136, and the remaining two auxiliary channels may accommodate a separate pair of control members282coupled to the second actuator138(only one control member282is shown inFIG.2Afor clarity). One of the auxiliary channels280also may accommodate an electronic control member282to couple the ultrasound sensor150to a power source, a processor for generating images, and/or a graphical interface for displaying images.

Ultrasound Sensors

The ultrasound sensor(s) may be in wired or wireless communication with a processor for analyzing the ultrasound signals to produce an image. In some embodiments, for example, the ultrasound sensor(s) may be configured to communicate with a processor such as a computer via an electronic cable, as mentioned above. In some embodiments, the medical device may include a processor. Referring toFIG.1, for example, the medical device100may include a processor in the controller104, the shaft102, or the ultrasound sensor150. Further, the processor may be in wired or wireless communication with a suitable graphical interface to display the images generated via the ultrasound sensor(s).

In some embodiments, the ultrasound sensor(s) may completely surround the working channel. The ultrasound sensor may include a single sensor partially or completely surrounding the working channel, or a plurality of sensors disposed around the working channel such that the plurality of sensors partially or completely surround the working channel.

The ultrasound sensor(s) may be fixed with respect to the working channel (e.g., incorporated into the wall of the shaft or otherwise immovable relative to the working channel), while instruments may be translatable through the working channel and relative to the ultrasound sensor(s). In some embodiments, the ultrasound sensor(s) may at least partially surround the working channel(s) of the medical device, e.g., to allow a user to view sites of interest in the body while independently and simultaneously manipulating instruments passed through the working channel(s). The ultrasound sensor(s) may be configured to image a single field of view greater than about 90 degrees, greater than about 180 degrees, greater than about 270 degrees, or a single field of view of about 360 degrees (panoramic view) about the shaft. Thus, for example, the ultrasound sensor(s) may provide a relatively wide field of view in a single image (e.g., the entire image captured simultaneously), rather than patching together images captured in sequence with a more narrow field of view. By including a relatively wide field of view in a single image, the ultrasound sensor(s) may help to guide the user in performing a medical procedure.

FIGS.2A-2BandFIG.3Aillustrate examples of medical devices comprising a single ultrasound sensor. For example,FIGS.2A-2Bshow a single ultrasound sensor150that includes a lumen therethrough to define or otherwise accommodate the working channel230, such that the ultrasound sensor150completely surrounds the working channel230. In some embodiments, the shaft may include a wall separating at least part of the lumen of the ultrasound sensor from one or more working channels.FIG.3Aillustrates a cross-sectional view of a shaft302a(which may include any of the features of shaft102discussed above) comprising a single ultrasound sensor350adisposed radially outward of, and completely surrounding, two working channels330a,332a.As shown, a wall portion362aseparates the ultrasound sensor350afrom the working channels330a,332a.At least one of the working channels (e.g., working channel330a) may be configured to maintain instruments in a particular orientation upon exiting the distal end of the shaft302a,as discussed above. In some embodiments, both working channels330a,332amay be configured to maintain the orientation of instruments as they are passed through the respective working channels. The shaft may include only one working channel (e.g.,330a), or include more than two working channels, such as three or more working channels.

WhileFIGS.2A-2CandFIG.3Aillustrate examples of devices comprising a single ultrasound sensor, additional embodiments are encompassed within the present disclosure. For example, a single ultrasound sensor need not completely surround the working channel(s). In some embodiments, the ultrasound sensor may form an arc that only partially surrounds the working channel(s).

In some embodiments, the medical device may comprise a plurality of ultrasound sensors, e.g., two, three, four, five, or six or more sensors. The ultrasound sensors may be configured to produce individual images (e.g., arc-shaped images), and/or may be combined to generate a single field of view. In some embodiments, for example, the plurality of ultrasound sensors may provide for a 360 degree view. The individual images may be captured simultaneously and/or may be combined simultaneously into a single image.

FIG.3Billustrates a cross-sectional view of a shaft302b(which may include any of the features of elongate bodies102or302adiscussed above) comprising four ultrasound sensors350bdisposed radially outward of the working channel330b.The sensors350bmay be disposed within a wall portion362bof the shaft302b.In some embodiments, the plurality of sensors350bmay be regularly spaced (e.g., symmetrically spaced) about the working channel330b.The wall portion362bmay separate each ultrasound sensor350bfrom the working channel330band/or from adjacent ultrasound sensors350b.

Instruments

As mentioned above, the instruments used for performing a medical procedure according to the present disclosure may have a shape complementary to the shape of the working channel. With respect to the shaft102shown inFIGS.2A-2C, for example, the instruments to be inserted into the working channel230may include a shaft that has a complementary non-circular cross-sectional shape, such that once inserted into the working channel230, the instruments cannot rotate relative to the working channel230and maintain their radial orientation.

The instruments may have a preset or predetermined shape, such that the distal end of the instruments curve or bend radially outward upon exiting the working channel of the medical device. For example, the instruments may have a preset curved configuration wherein the distal end of the instrument bends back proximally. In some embodiments, the instrument may comprise a flexible material, e.g., a shape-memory material such as Nitinol, that allows the instrument to have a straight configuration while housed in the working channel, and a curved configuration outside the working channel. When the instrument exits the working channel to adopt the preset curved configuration, the distal end of the instrument may come within the field of view of the ultrasound sensor(s).

FIGS.4A and4Bshow instruments according to some embodiments of the present disclosure, whereinFIG.4Ashows a biopsy brush710, andFIG.4Bshows a needle. Other types of instruments are encompassed by the present disclosure, as mentioned above. Each instrument710,720is shown extending through the working channel430of an exemplary shaft402(which may include any of the features of shafts102,302a,or302bdiscussed above) comprising a working channel430and an ultrasound sensor radially outward of the working channel430. The working channel430has a narrowed portion431, similar to the shape of working channel230shown inFIGS.2A-2C. Further, the shaft402includes an area411with a unique echogenic signature, similar to area211of shaft102shown inFIGS.2A-2C, wherein the area411is radially aligned with the narrowed portion431of the working channel430.

Referring toFIG.4A, the brush710may have a body714with a narrowed portion715complementary to the narrowed portion of the working channel430, such that, once inserted into the working channel430, the brush710cannot rotate about an axis of working channel430to change its orientation. The distal end712of the brush710may be preshaped into a curved configuration, such that the distal end712bends back proximally, aligned with the narrowed portion715. The brush710may comprise a flexible material that allows the distal end712to adopt a linear configuration for insertion into the working channel430until exiting the working channel430as shown. While in the curved configuration, the distal end712of the brush410may point towards the echogenic area411of the shaft402. The curvature may allow the distal end712of the brush710to bend back and into the field of view of the ultrasound sensor450. The distal end712of the brush may extend radially outward and include bristles for collecting tissue samples from within a patient's body, e.g., from a tissue surface adjacent to the shaft402.

FIG.4Bshows a needle720extending through the working channel430, wherein the needle has a pointed distal end722for sampling tissue. The body724of the needle720also may have a shape complementary to the working channel430, e.g., in order to “key” the needle720to the working channel430to maintain its orientation relative to the shaft402. Similar to the brush710ofFIG.4A, the needle720may have a preset curved configuration, such that upon exiting the working channel430, the distal end722of the needle720may point towards the echogenic area411of the shaft402, and may bend back within view of the ultrasonic sensor450.

The medical devices and instruments disclosed herein may be used to image and/or conduct medical procedures on any suitable passageway, channel, structure, or surface within the body, including, but not limited to, features of the respiratory system, the gastrointestinal system, and/or the cardiovascular system. In some embodiments, for example, the medical device may be used in endobronchial ultrasound (EBUS) procedures to view various features of the respiratory system. In this procedure, an endoscopic ultrasound probe is introduced into the trachea and advanced into the bronchus and bronchial passageways for analysis, e.g., to locate and/or identify abnormalities such as lesions or enlarged lymph nodes, which may be located beyond the inner bronchial wall. EBUS may be used to image tracheobronchial lymph nodes to screen for lung cancer, for example, wherein ultrasound allows visualization of diseased or otherwise abnormal tissues outside of the bronchial airways.

FIGS.5A and5Billustrate an exemplary EBUS procedure using the devices and instruments of the present disclosure.FIG.5Ashows the bronchus of a patient, including various bronchial passageways502. The shaft802of a medical device (which may include any of the features of shafts102,302a,302b,and/or402, or medical device100discussed above) may be inserted into the bronchus500and advanced into a bronchial passageway502as shown inFIG.5B. The shaft802may include an ultrasound sensor850(which may include any of the features of ultrasound sensors150,350a,350b,and/or450discussed above), such that the ultrasound sensor850partially or completely contacts the walls of the bronchial passageway502to facilitate imaging. The ultrasound sensor850may be used to generate images of the passageway502, and/or of anatomical features deeper in the anatomy (beyond the walls of passageway502) in real time as the shaft802is moved along the passageway502. The shaft802may include an area811with a specific echogenic signature visible in the images.

Upon locating a site of interest, e.g., lesion565, along the surface of the passageway502or even deeper than the surface of passageway502, the shaft802may be positioned (e.g., translated and/or rotated) such that the lesion565is radially aligned with the area811on the shaft802. An instrument820(which may include any of the features of instruments710and/or720discussed above) such as a biopsy needle may be inserted into the shaft802via a working channel of the shaft802, wherein upon exiting the working channel, the distal end of the instrument820may bend back proximally to come within the field of view of the ultrasound sensor850. The distal end of the instrument820also may be aligned with the lesion565to collect a tissue sample for analysis. Upon collecting the sample, the instrument820may be withdrawn into the working channel (e.g., by bending the distal end of the instrument820into a linear configuration for passage through the working channel), and withdrawn from the patient's body.

Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the embodiments disclosed herein. While certain features of the present disclosure are discussed within the context of exemplary procedures (e.g., EBUS and biopsy procedures), the devices, instruments, and methods are not so limited and may be used in other areas of the body, and for other medical procedures according to the general principles disclosed. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the present disclosure being indicated by the following claims.