Sampling device including a tapered housing

Abstract

A distal tip for an endobronchial ultrasound sampling device can include a housing, a transducer, and a side-exit ramp. The housing can extend along a central axis from a proximal section to a distal section. The housing can include a mount feature tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal section. The transducer can be secured to the mount feature such that a normal vector of a substantially planar face of the transducer forms an acute angle with the central axis of the housing. The side-exit ramp can be located proximal from the transducer and configured to direct a needle distally through a field of view of the transducer along a trajectory that forms an acute angle with the central axis and that intersects with the normal vector of the substantially planar face.

Description

SAMPLING DEVICE INCLUDING ATAPERED HOUSINGPRIORITY CLAIM

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 510,243, filed June 26, 2023, and U.S. Provisional Patent Application Serial No. 63 / 510,234, filed June 26, 2023, and U.S. Provisional Patent Application Serial No. 63 / 510,257, filed June 26, 2023, which the contents of each are are hereby incorporated by reference in their entirety.TECHNICAL FIELD

[0002] Examples described herein generally relate to endobronchial ultrasound sampling devices such as, for example, endobronchial ultrasound sampling devices including a side-exit ramp for collecting a biopsy within a field of view of an ultrasound transducer.BACKGROUND

[0003] Conventional endoscopes can be used in a variety of clinical procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices for sampling or treating an anatomical region, providing suction passageways for collecting fluids (e.g., saline or other preparations), and the like. Such anatomical regions can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like), renal area (e.g., kidney(s), ureter, bladder, urethra), other internal organs (e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract), and the like.SUMMARY

[0004] Sampling devices are endoscopes used for a variety of clinical procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices for sampling or treating an anatomical region, providing suction passageways for collecting fluids (e.g., saline or other preparations), and the like, within the lungs of a patient. Sampling devices can be used to discover, treat, and sample abnormalities or anomalies within the lungs. Sampling devices can be used to capture samples or biopsies of portions of tissue from within the airways or the lungs of a patient. Sampling devices are small devices so they can fit within the airways and can have a limited field of view of their transducers. As such, it can be difficult for the sampling to fall within the field of view of the transducers and it can be difficult to assemble such small components. In response, the inventors of the present disclosure have developed a unique design for a distal end of an ultrasound sampling device that moves the distal boundary of the field of view of the transducer farther in front of the distal edge of the sampling device. The inventors also developed a transducerthat includes a flexible substrate such that the transducer assembly can be folded to fit within the mounting feature of the housing.

[0005] In examples, a distal tip for an endobronchial ultrasound sampling device can include a housing, a transducer, and a side-exit ramp. The housing can extend along a central axis from a proximal section to a distal section. The housing can include a mount feature tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal section. The transducer can be secured to the mount feature such that a normal vector of a substantially planar face of the transducer forms an acute angle with the central axis of the housing. The side-exit ramp can be located proximal from the transducer and configured to direct a needle distally through a field of view of thetransducer along a trajectory that forms an acute angle with the central axis and that intersects with the normal vector of the substantially planar face.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Various examples are illustrated in the figures of the accompanying drawings. Such examples are demonstrative and not intended to be exhaustive or exclusive examples of the present subject matter.

[0007] FIG. 1 illustrates a schematic diagram of an example of an endobronchial ultrasound system.

[0008] FIG. 2 illustrates a schematic diagram of an example of an imaging and control system of an endobronchial ultrasound sampling device.

[0009] FIG. 3 illustrates a perspective view of a portion of an example distal tip of a sampling device having ultrasound imaging capabilities.

[0010] FIG. 4 illustrates a perspective view of a portion of an example distal tip with a distal housing drawn in phantom.

[0011] FIG. 5 illustrates a perspective view of an example of a distal housing of a distal tip.

[0012] FIG. 6 illustrates an exploded view of an example of a distal housing of a distal tip.

[0013] FIG. 7 illustrates a perspective view of an example of a distal housing of a distal tip.

[0014] FIG. 8 illustrates a front view of a distal end of a distal housing of a distal tip.

[0015] FIG. 9 illustrates a perspective view of an example two-piece distal housing of a distal tip.

[0016] FIG. 10 illustrates a perspective view of a distal end of an example of a distal housing of a distal tip.

[0017] FIG. 11 illustrates a perspective view of an example of a transducerfor a distal tip.

[0018] FIG. 12 illustrates a top view of an example of an unfolded transducerfor a distal tip.

[0019] FIG. 13 illustrates a perspective view of an example coupler of a distal tip.

[0020] FIG. 14 illustrates a perspective view of an example of a tail of a transducer wrapping around a side-exit guide ramp of an example coupler of a distal tip.

[0021] FIG. 15 illustrates an internal view from a proximal end of an example of a coupler of a distal tip.

[0022] FIG. 16 illustrates a perspective view of a proximal end of an example coupler of a distal tip.

[0023] FIG. 17 is a block diagram illustrating an example of a method for reprocessing a sampling device.

[0024] FIG. 18 is a block diagram illustrating an example of a machine upon which one or more examples may be implemented.DETAILED DESCRIPTION

[0025] Endobronchial ultrasound (EBUS) sampling devices can be used to sense ultrasound images at a distal tip of the sampling device device. The distal tip can also include an imaging sensor (e.g., video camera, light source, orthe like), a working channel exit for instruments (e.g., biopsy needle, scalpel, or the like), and in more recent advancements, position or orientation sensors. Existing EBUS sampling devices can utilize a rigid distal tip structure to house these components. The electronics can be arranged in a distal tip of the distal tip such that the ultrasound sensor (e.g., transducer) is located at the distal end of the distal tip. The rest of the components within the distal tip can be located proximate to the distal tip.

[0026] Curvilinear ultrasound sensors can be utilized to enable a wide imaging field of view (FOV), and typically utilize a saline-filled balloon encapsulating a curved ultrasound transducer to can create sufficientcontact between the curved ultrasound transducer and the airway tissues. The saline-filled balloon prevents formation of air gaps between the airway tissue and the transducer as such air aps impair image quality. Linear ultrasound sensors (e.g., having a generally flat planar surface) can also be utilized in EBUS scopes; however, such sensors having a flat sensing surface generally produce a more narrow FOV than curvilinear ultrasound sensors. The narrow nature of the FOV can, in some instances, limit the depth at which a biopsy sample can be captured while being imaged in realtime (e.g., due to a biopsy needle diverging away from a longitudinal axis of the sampling device exiting the distal end of the FOV prior to reaching the sample depth). The flat sensing surface can increase difficulty in maintaining continuous contact between the linear ultrasound transducer and the tissue of the patient (e.g., the airways or bronchioles of the patient). Wiring of the components within the EBUS also can present challenges as the components are very small and there is limited space to feed the components within the distal end of the distal tip.

[0027] The inventors of the present disclosure have devised an alternative solution for an EBUS sampling device. The EBUS sampling device can include a flat ultrasound sensor located at, near, or just beyond, an outer radius of the sampling device. A housing of the distal tip can include a tapered portion that can include a mounting feature to hold a flexible transducer there within. The taper of the housing and the flexibility of the transducer (i.e., the folding capability of the transducer before installation in the housing, and the bending capability of the transducer tail before, during, and after installation in the housing) can save space near the distal edge of the distal tip such that the video camera and light source can be placed at the distal end of the device, for example, directly below the ultrasound sensor. The EBUS sampling device can include a wiring egress that permits electrical communication to components within the distal portion of the distal tip via wires, ribbons, or the like, which can extend through the wiring egress. The EBUS sampling device will be discussed herein with reference to FIGS. 1-18.

[0028] The above discussion is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below is included to provide further information about the present patent application.

[0029] FIG. 1 is a schematic diagram of an endoscopy system 100 that can include an imaging and control system 102 and an endobronchial ultrasound sampling arrangement including an endoscope 104 and a sampling device 136 that is attachable to the endoscope 104 and which includes a distal end 144 that extends from the distal end of the endoscope 104 via a distal working channel port. The system of FIG. 1 is an illustrative example of an endoscopy system suitable for use with the systems, devices, and methods described herein, such as a bronchoscope with linearly arranged ultrasound elements.

[0030] The endoscope 104 can be insertable into an anatomical region for imaging or attachment to (e.g., via tethering) one or more sampling devices for biopsies or therapeutic devices for treating a disease state associated with the anatomical region. The endoscope 104 can interface or connect to the imaging and control system 102. The endoscope 104 is described in the present example as a bronchoscope, though other types of endoscopes are contemplated for use with the features and teachings of the present disclosure. The imaging and control system 102 can include a control unit 106, a display unit 108, an input unit 110, a light source 112, a fluid source 114, and a suction pump 116.

[0031] The imaging and control system 102 can include various ports for coupling with the endoscopy system 100. For example, the control unit 106 can include a data input / output port for receiving data from and communicating data to the endoscope 104. The light source 112 can include an output port for transmitting light to the endoscope 104, such as via a fiber optic link. The fluid source 114 can include a port for transmitting fluid to the endoscope 104. The fluid source 114 can include, for example, a pump and a fluid tank or can be connected to an external tank, vessel, orstorage unit. The suction pump 116 can include a port to draw a vacuum from the endoscope 104 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 104 is inserted. The display unit 108 and the input unit 110 can be used by an operator of the endoscopy system 100 to control functions of the endoscopy system 100 and viewthe output of the endoscope 104. The control unit 106 can also generate signals or other outputs from treating the anatomical region into which the endoscope 104 is inserted. In examples, the control unit 106 can generate electrical output, acoustic output, fluid output, or the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.

[0032] The endoscope 104 can include an insertion section 118, a functional section 120, and a handle section 122, which can be coupled to a cable section 124 and a coupler section 126. The insertion section 118 can extend distally from the handle section 122, and the cable section 124 can extend proximally from the handle section 122. The insertion section 118 can be elongated and include a bending section and a distal end to which the functional section 120 can be attached. The bending section can be controllable (e.g., by a steering control 128 on the handle section 122) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like). The insertion section 118 can also include one or more working channels (e.g., an internal lumen) that can be elongated and can support the insertion of one or more therapeutic tools of the functional section 120, such as a bronchoscope. The working channel can extend between the handle section 122 and the functional section 120. Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 118 (e.g., via suction or irrigation passageways, or the like).

[0033] A coupler section 126 can be connected to the control unit106 to connect to the endoscope 104 to multiple features of the control unit106, such as the input unit 110, the light source 112, the fluid source 114, and the suction pump 116.

[0034] The handle section 122 can include the steering control 128 and the port 130. The steering control 128 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate the endoscope 104 within the patient. The steering control 128 can be connected to a pull wire or other actuation mechanisms, extending through the insertion section 118. The port 130, as well as other ports, such as a port 132 can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle section 122, such as for coupling with the insertion section 118. The examples shown in FIG. 1 and FIG. 2 are examples of endoscopes 104.

[0035] According to examples, the imaging and control system 102 can be provided on a mobile platform (e.g., a cart 134) with shelves for housing the light source 112, the suction pump 116, an image processing unit 202 (FIG. 2), orthe like. Alternatively, components of the imaging and control system 102, shown in FIG. 1 and FIG. 2, can be provided directly on the endoscope 104 to make the endoscope “self-contained.”

[0036] The functional section 120 can include components for treating and diagnosing the anatomy of a patient. The functional section 120 can include an imaging device 146 (e.g., a complementary metal oxide semiconductor (CMOS) based, Chip-on-the-Tip image sensors), an illumination device 148 (e.g., a light emitting diode), and a working channel port 150 at a distal face of the functional section 120.

[0037] As shown in FIG. 1 , a sampling device 136 can extend from the working channel port 150 at the distal face of the functional section 120 of the endoscope 104. The sampling device 136 can be configured to be attached to the port 132 such that the sampling device 136 extends through a working channel of the endoscope 104 and out the distal end of the endoscope 104. The sampling device 136 can include an actuator 138 for advancing or retracting the insertion section 118 within the working channel so as to control how far distally from the working channel port 150 the distalend of the sampling device 136 extends, an instrument actuator 142 (e.g., for actuating a biopsy needle from a side exit port of the sampling device 136), and a distal end 144. The actuator 138 can be configured to extend the sampling device 136 beyond a distal end of the endoscope 104, such as to navigate the sampling device 136 to the target area within the patient. The actuator can slide along a housing 140 of the sampling device 136. The housing 140 can include indicia, which can indicate an amount of extension of the sampling device 136 beyond a distal end of the endoscope 104. The instrument actuator 142 can be configured to extend an instrument from the sampling device 136 to obtain a tissue sample from the patient. A distal end 144 of the sampling device 136 can include a transducer (or other imaging device) and a side exit port located proximal from the transducer for directing an instrument configured to obtain a tissue sample from the patient into the field of view of the transducer. The sampling device 136 will be discussed in more detail herein.

[0038] FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1 includingthe imaging and control system 102 and the endobronchial ultrasound arrangement, which includes an endoscope and a sampling device 136 extendable via a distal working channel port of the endoscope. FIG. 2 schematically illustrates components of the imaging and control system 102 coupled to the endoscope 104. The imaging and control system 102 can include the control unit 106, which can include or be coupled to an image processing unit 202, a treatment generator 206, and a drive unit 208, as well as the light source 112, the input unit 110, and the display unit 108. The control unit 106 can include, or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system, which can include a device configured to engage tissue and collect and store a portion of that tissue and through which imaging equipment (e.g., a camera) can view target tissue via the inclusion of optically enhanced materials and components. The control unit 106 can be configured to activate a camera to view target tissues distal of the endoscopy system. Likewise, the control unit 106 can be configured to activate the light source 112 to shine a lighton the surgical instrument, which can include select components configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.

[0039] The coupler section 126 can be connected to the control unit 106 to connect to the endoscope 104 to multiple features of the control unit 106, such as the image processing unit 202, the treatment generator 206, or the like. In examples, the port 130 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, orthe like, into the endoscope 104. Such instruments and devices can be independently connected to the control unit 106 via the cable section 124. In examples, the port 132 can be used to connect the coupler section 126 to various inputs and outputs, such as video, air, light and electric.

[0040] The image processing unit 202, the ultrasound image processing unit 204, and the light source 112 can each interface with the endoscope 104 (e.g., at the functional section 120) or the sampling device 136 by wired or wireless electrical connections. The imaging and control system 102 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 108. The ultrasound image processing unit 204 can be configured to receive ultrasonic signals from either of the endoscope 104 or the sampling device 136, which can be converted into ultrasonic images and transmitted to the display unit 108 or any other component of the endoscopy system 100. The imaging and control system 102 can include the light source 112 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). The imaging and control system 102 can connect (e.g., via an endoscope connector) to the endoscope 104 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).

[0041] The fluid source 114 (shown in FIG. 1) can be in communication with control unit 106 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels, and the like) and connectors (barb fittings, fluid seals, valves, and the like). The imaging and control system 102 can also include a drive unit 208, which can include a motorized drive for advancing a distal section of endoscope 104.

[0042] FIG. 3 illustrates a perspective view of a portion of an example distal tip 302 of a sampling device 300. The sampling device 300 (e.g., the endoscope 104 shown in FIGS. 1 and 2) can be an example of an endobronchial ultrasound (EBUS) sampling device, which can be inserted into the airways (e.g., bronchial tubes via the trachea) of a patient to take biopsy samples, capture images, remove (e.g., resect) one or more tissues from within the lungs of the patient, or the like. In some examples, the sampling device 300 can be an EBUS sampling device that facilitates performance of real-time ultrasound imaging of a target tissue such as, for example, a solitary pulmonary nodule (SPN) while a procedure is being performed on the target tissue. Exemplary such procedures include obtaining biopsy samples of the target tissue (e.g., for removal and pathology analysis), performing ablation on the target tissue, injecting medicine into the target tissue, and so on. The distal tip 302 can be connected to the insertion section 118 (FIG. 1 and 2) of the sampling device 300 to be inserted within the lungs of the patient. The distal tip 302 can be connected to the insertion section 118 by a rigid connection that helps maintain the distal tip 302 in the direction that the insertion section 118 is being steered within the patient. The distal tip 302 can also be attached to the insertion section 118 by a rotatable connection (which can rotate about one or more axes) that enables a medical professional to influence further or steer the distal tip 302 as it extends into the patient.

[0043] The distal tip 302 (e.g., the functional section 120 (FIGS. 1 and 2)) can perform tasks duringthe bronchoscopy procedure. For example, the distal tip 302 can capture images (e.g., digital images, ultrasound images,or the like) of the lungs of the patient, capture samples (e.g., using a biopsy needle extending from any of the components of the distal tip 302), or remove one or more objects (e.g., using scalpels, forceps, or the like). The distal tip 302 can include a coupler 304 and a housing 312.

[0044] The coupler 304 can extend along a longitudinal axis LA from a proximal portion 306 to a distal portion 308. The distal portion 308 of the coupler 304 can be coupled to the proximal section 314 of the housing 312. The coupler 304 can include a lumen 309 and a side-exit ramp 310. The lumen 309 and the side-exit ramp 310 can extend within the coupler. For example, the lumen 309 can extend from the proximal portion 306 to the side-exit ramp 310, and the side-exit ramp 310 can extend from the lumen 309 through a side of the coupler 304. The lumen 309 can be substantially circular and can mate with a flexible needle lumen embedded within a flexible sheath of the EBUS endoscope. Thus, an instrument (e.g., a biopsy (or sampling) needle, scalpel, forceps, a laser cutTBNA needle, an ablation device, or the like) can be extended via a port on a proximal end of the EBUS endoscope, through the flexible needle lumen, into the lumen 309, into the side-exit ramp 310, and ultimately out of the side-exit ramp 310. Thus, the side-exit ramp 310 can be configured to direct the instrument 311 through the side of the coupler 304 and toward a tissue of a patient.

[0045] The housing 312 can extend along a central axis CA from a proximal section 314 to a distal section 316. The housing 312 can include a mount feature 318, which can be configured to receive a transducer 320. The mount feature 318 can be tapered toward, to, or past, the central axis CA as the housing 312 extends from the proximal section 314 toward the distal section 316. As illustrated, the mount feature 318 can converge toward the CA near the distal-most tip of the distal section 316 and this convergent nature of the mount feature 318 can result in the transducer 320 leaning forward the distal-most tip of the distal section 316. The taper of the mount feature 318 can shift forward a distal most boundary of a field of view 322 of the transducer such that the field of view 322 of the transducer 320 captures the instrument 311 at greater depths as theinstrument 311 extends from the side-exit ramp 310 and into the tissue of the patient. Stated alternatively, the forward leaning nature of the linear transducer results in the field of view that is generated by the linear transducer to lean forward in relation to the side exit port, which increases the depth at which target nodules may be biopsied while remaining within the field of view. This is because the sampling device pierces deeper into the tissue (e.g., farther from the transducer) the further the sampling device progresses from the proximal end of the FOV to the distal end of the FOV. Once the sampling device extends beyond the distal end of the FOV, the distal tip of the sampling device (e.g., biopsy needle) is no longer imaged. As compared to EBUS sampling devices in which the linear transducer is in line with (e.g., parallel to) the longitudinal axis of the device (e.g., such as the device depicted in FIG. 2A of U.S. Pat. Pub. 2022 / 0313208), the forward leaning nature of the linear transducer increases the distance that the needle can be extended distally from the exit ramp while remaining within the FOV - thereby enabling deeper sampling during real-time visualization of the sampling device within the US image.

[0046] For example, as shown in FIG. 3 angle 324 can be an angle along the taper of the housing 312 or the mount feature 318 and the field of view 322 of the transducer 320. As shown in FIG. 3, the angle 324 can be an acute angle (i.e., less than 90 degrees, such that the field of view 322 extends beyond the distal edge 321 of the transducer 320. Angle 326 can be the angle between the coupler 304 and the taper of the housing 312 or the mount feature 318. As shown in FIG. 3, the angle 326 can be obtuse (i.e., greater than 90 degrees). As such, the transducer 320 leans toward the distal section 316 of the housing 312 such that the field of view 322 of the transducer 320 extends beyond the distal edge 321 of the transducer 320.

[0047] Additionally, the taper of the housing 312 and the mount feature 318 can help the transducer 320 engage with the tissue of the airways of the lungs to help prevent air gaps between the transducer 320 and the inner walls of the airways of the lungs to help improve the ultrasonic images captured by the transducer 320. Moreover, the taper ofthe housing 312 and the mount feature 318 can help the distal tip 302 navigate through the airways and lungs of the patient because the housing 312 has a smaller diameter on the distal portion of the distal tip 302, which can be easier to navigate into new airways and areas of the lungs of the patient than a distal tip with a consistent diameterfrom a proximal end to a distal end.

[0048] The transducer 320 can be a linear array transducer. The transducer 320 can extend from the proximal edge 331 to the distal edge 321 . The transducer 320 can be configured to capture an ultrasonic image of the tissue of the patient duringthe sampling of the target tissue of the patient via the instrument 311 . The transducer 320 will be discussed in more detail herein.

[0049] FIG. 4 illustrates a perspective view of a portion of an example distal tip 302 of a sampling device 300 with the housing 312 (shown in phantom). The housing 312 can include grooves 424 (e.g., a first groove 424A and a second groove 424B in FIG. 9). The first groove 424A and the second groove 424B can be aligned with each other, such as along a common plane. Alternatively, the first groove 424A and the second groove 424B can be offset from each other. The grooves 424 can extend from the proximal section 314 toward the distal section 316 of the housing 312. As shown in FIG. 9, the first groove 424A can be angularly offset from the second groove 424B, and each of the grooves 424 can be configured to receive an electromagnetic coil 426. It will be appreciated that the angular offset nature of the grooves 424 can enable a pair of electromagnetic coils 426 to capture all six degrees of freedom of the motion of the sampling device 300 as it navigates within the patient. The electromagnetic coils 426 and the angular offset of the grooves 424 will be discussed in more detail with reference to FIG. 9.

[0050] As shown in FIG. 4, the distal tip 302 can include an image sensor428 and a light source 430. The image sensor428 and the light source 430 can be connected to the image processing unit (e.g., the image processing unit 202 orthe ultrasound image processing unit 204), see FIG.2) and the light source 112 (FIG. 1 ), respectively. The distal tip 302 can be configured to receive the image sensor 428 and the light source 430 in a distal tip 305 of the distal tip 302 such that the image sensor 428 and the light source 430 define a distal end 303 of the distal tip 302. Thus, the image sensor 428 and the light source 430 can be installed within the housing 312 directly below the transducer 320.

[0051] The image sensor428 and the light source 430 can be installed closer to the distal end 303 of the distal tip 302 than a distal edge 321 of the transducer 320. The image sensor 428 and the light source 430 can be installed at an equal distance from the distal end 303 of the distal tip 302 as the distal edge 321 of the transducer 320. Because the image sensor 428 and the light source 430 can be mounted below or closer to the distal end 303 of the distal tip 302 than the transducer 320, the image sensor 428 and the light source 430 can be mounted at an angle that aligns with (is substantially parallel to or angled with respect to) the central axis CA of the housing 312.

[0052] FIG. 5 illustrates a perspective view of an example of the housing 312 of the distal tip 302. As shown in FIG. 5, the mount feature 318 can include a support surface 532. The support surface 532 can be recessed within a periphery 313 of the housing 312. The transducer 320 (FIG. 3) can be secured to the support surface 532 to hold the transducer 320 within the mount feature 318.

[0053] As shown in FIG. 5, the support surface 532 can begin on the proximal section 314 of the housing 312 and extend toward the distal section 316 of the housing 312 along the taper (e.g., forward leaning and substantially planar face) of the mount feature 318. The support surface 532 can include a transducer tail ramp 534, which can guide the tail of the transducer 320 through the proximal section 314 of the housing 312. The transducer tail ramp 534 can taper toward the central axis CA of the housing 312, which can provide clearance for the tail of the transducer 320 as it extends through the proximal section 314 of the housing 312 and into the coupler 304 (FIG. 3).

[0054] The support surface 532 can terminate before the distal section 316 of the housing 312. As such, the support surface 532, the mount feature 318, and a tray 640 can define a fill-up gap 536. The fill-up gap 536 can be configured to receive a binding agent (e.g., a potting epoxy, polymer, or any other filler that can be used to secure the components of the sampling device 300 within the housing 312, or the like). As such, the binding agent can be injected through the fill-up gap 536 to help secure the components within the housing 312. Binding agent material that extends out of the fill-up gap 536 can help secure the transducer 320 to the mount feature 318 and the support surface 532. In examples, a binding agent, for example, epoxy, can be used to secure the components within the housing 312, then the binding agent can be filled usingthe fill-up gap 536 to hold the secured components in their position duringthe use of the sampling device 300.

[0055] The amount of recess of the support surface 532 relative to the periphery 313 of the housing 312 can be adjusted to adjust the relationship between the transducer 320 and the periphery 313 of the housing 312. For example, the recess of the support surface 532 relative to the periphery 313 of the housing 312 can be increased to secure the transducer 320 so that the transducer 320 is aligned with the periphery 313 of the housing 312. The recess of the support surface 532 relative to the periphery 313 of the housing 312 can be decreased to secure the transducer 320 so that the transducer 320 can extend beyond the periphery 313 of the housing 312. Extending the transducer 320 beyond the periphery 313 of the housing 312 can help the transducer 320 obtain better contact with the tissue of the airways and the lungs of the patient as the transducer 320 captures ultrasonic images of the tissue of the patient. In examples in which the distal end of the EBUS device is steerable, a clinician may manipulate the steering mechanism to cause the transducer face to articulate into direct contact with a tissue surface - thereby substantially removing any airgaps between the transducer and tissue surface. It will be appreciated that removal of airgaps between an ultrasound transducer anda tissue for which imaging is intended can improve image quality since the airgaps can result in high impedance mismatches, which can hinder the transmission of ultrasound energy. Some existing ultrasound systems (e.g., many curvilinear EBUS devices) utilize an expandable balloon that is fillable with saline to provide ultrasonic contact. It is an object of the presently disclosed device to achieve such ultrasonic contact via direct contact between the ultrasound transducer and the tissue wall.

[0056] FIG. 6 illustrates an exploded view of an example of the housing 312 of the distal tip 302 of the sampling device 300. The distal tip 302 can include a tray 640 configured to be installed within the distal section 316 of the housing 312 and defining a distal end 303 of the distal tip 302. When installed in the distal end 303 of the distal tip 302, the tray 640 can at least partially cover the distal edge 321 (FIG. 4) of the transducer 320. The tray 640 can include a distal body 642 and a support 644.

[0057] The support 644 can extend from the distal body 642 and can be configured to couple the tray 640 to the housing 312. For example, the distal body 642 can include a mechanical interface that can be complementary with a mechanical interface within the housing 312 to removably secure the tray 640 within the housing 312. The distal body 642 can include a surface that is configured to be secured to a surface of the housing 312 with epoxy or any other binding agent. For example, the surface can have a rough surface finish, grooves, protrusions, or the like to help the epoxy hold the tray within the housing 312.

[0058] The distal body 642 can have a rectangular profile, as shown in FIG. 6. The distal body 642 can have any other profile that matches or substantially matches the periphery 313 of the housing 312 near the distal section 316 of the housing 312. The distal body 642 can include an image sensor mount 646 and a light source mount 648. The image sensor mount 646 can be adjacent to the light source mount 648. As shown in FIG. 6, the image sensor mount 646 and the light source mount 648 can be apertures formed in the distal body 642. The image sensor mount 646 and the light source mount 648 can be configured to receive at least a portion of theimage sensor 650 and the light source 652 (e.g., light emitting diode of LED), respectively.

[0059] As shown in FIG. 6, an image sensor 650 (e.g., the image sensor 428 (FIG. 4)) and a light source 652 (e.g., the light source 430 (FIG. 4)) can be attached adjacently to each other as a part of an imaging assembly 654. The imaging assembly 654 can be configured to be attached to the support 644 of the tray 640 before the tray 640 is installed into the housing 312. The image sensor 650, the light source 652, and the imaging assembly 654 will be discussed in more detail herein.

[0060] FIGS. 7 and 8 will be discussed together below. FIG. 7 illustrates a perspective view of an example of a housing 312 of a distal tip 302. FIG. 8 illustrates a front view of a distal section 316 of a housing 312 of a distal tip 302.

[0061] The image sensor mount 646 can be configured to mount the image sensor 650 adjacent to the transducer 320 and within the distal tip 305 of the distal tip 302. The image sensor mount 646 can be configured to secure the image sensor 650 below a distal edge 321 (shown in FIG. 8) of the transducer 320 (or a distal end of the mount feature 318). The image sensor mount 646 can be configured to mount the image sensor 650 such that a central axis CAI of the image sensor 650 is essentially parallel to the central axis CA of the housing 312. The image sensor mount 646 can mount the image sensor 650 such that a distal edge of the image sensor 650 is aligned with the distal tip 305 of the distal tip 302. The image sensor mount 646 can mount the image sensor 650 such that a distal edge of the image sensor 650 is aligned adjacently with the distal tip 305 of the distal tip 302. Thus, because the distal edge of the image sensor 650 is at or near the distal tip 305 of the distal tip 302, the image sensor 650 can capture video distal to the distal tip 302 without other components of the distal tip 302 (e.g., the mount feature 318 or the transducer 320) blocking or interfering with the field of view of the image sensor 650.

[0062] The light source mount 648 can be configured to mount the light source 652 adjacent to the transducer 320 and within the distal tip 305of the distal tip 302. The light source mount 648 can be configured to secure the light source 652 below a distal edge 321 of the transducer 320 (both in FIG. 8) (or a distal end of the mount feature 318). The light source mount 648 can be configured to mount the light source 652 such that a central axis CAL of the light source 652 is essentially parallel to the central axis CA of the housing 312. The light source mount 648 can mount the light source 652 such that a distal edge of the light source 652 is aligned with the distal tip 305 of the distal tip 302. The light source mount 648 can mount the light source 652 such that a distal edge of the light source 652 is aligned adjacently with the distal tip 305 of the distal tip 302. Thus, because the light source 652 is at or near the distal tip 305 of the distal tip 302, the light source 652 can provide light distal to the distal tip 302 without other components of the distal tip 302 (e.g., the mount feature 318 or the transducer 320) blocking or interfering with the light from the light source 652.

[0063] FIGS. 9 and 10 will be discussed together below. FIG. 9 illustrates a perspective view of an example two-piece housing 912. FIG. 10 illustrates a perspective view of the two-piece housing 912. The two-piece housing 912 can be configured to aid in the assembly of the housing and the distal tip 302 (FIG. 3) by providing more access to the housing and allowing easier placement of the components within the distal tip 302. As shown in FIGS. 9 and 10, the two-piece housing 912 can include a first portion 960 and a second portion 962. The first portion 960 and the second portion 962 can be configured to be attached such that the first portion 960 and the second portion 962 are adjacent to each other when the two-piece housing 912 is assembled.

[0064] As shown in FIGS. 9 and 10, the first portion 960 can include the mount feature 318. The first portion 960 can also include a first attachment interface 964 and a wire cutout 966. The first attachment interface 964 can be recessed within a periphery 913 of the two-piece housing 912. The first attachment interface 964 can be configured to be inserted within the distal portion 308 (FIG. 3) of the coupler 304 (FIG. 3). Thewire cutout 966 can be configured to direct one or more wires of the transducer 320 into the distal portion 308 of the coupler 304 (FIG. 3) to mount the two-piece housing 912 to the coupler 304.

[0065] The second portion 962 can include a mounting interface 968. The mounting interface 968 can be recessed within the periphery 913 of the two-piece housing 912 and can be inserted within the distal portion 308 of the coupler 304 to mount the two-piece housing 912 to the coupler 304. The mounting interface 968 can include a clocking protrusion 974. The clocking protrusion 974 can extend radially outward from the second portion 962 and can be engageable with the coupler 304 (FIG. 3) to ensure proper installation of the two-piece housing 912 and the coupler 304. As shown in FIG. 9, the clocking protrusion 974 can extend from the second portion 962 toward the proximal section 914 of the two-piece housing 912. The clocking protrusion 974 can be generally rectangular, as shown in FIG. 9, or can be round, square, or any other shape that can be complementary to a feature on the coupler 304 to ensure proper alignment of the two-piece housing 912 when the two-piece housing 912 is inserted into the coupler 304, orthe like. Proper alignment of the two-piece housing 912 and the coupler 304 helps to ensure that the field of view of the transducer (e.g., the field of view 322 of the transducer 320 (FIG. 3) captures the medical instrument (e.g., the instrument 311 (FIG. 3)) as it extends from the side-exit ramp of the coupler (e.g., the side-exit ramp 310 of the coupler 304 (FIG. 3)).

[0066] As shown in FIG. 9, the first portion 960 can include alignment protrusions 970, and as shown in FIG 10, the second portion 962 can include alignment grooves 972. The alignment protrusions 970 and the alignment grooves 972 can be complementary to align the first portion 960 with the second portion 962 during the assembly of the two-piece housing 912. In examples, the first portion 960 can include any other alignment characteristics (e.g., surface finishes, shapes, patterns, or the like) or features (e.g., grooves, ridges, protrusions, or the like) that can be complementary to alignment characteristics or features of the second portion 962.

[0067] The first portion 960 of the two-piece housing 912 can also include grooves 424. The first groove 424A can extend from the proximal section 914 of the two-piece housing 912 toward the distal section 916. The second groove 424B can extend from the proximal section 914 of the two- piece housing 912 toward the distal section 916. The first groove 424A and the second groove 424B can be angularly offset from one another. Each of the grooves 424 can be configured to receive an electromagnetic coil 426.

[0068] The electromagnetic coils 426 in the grooves 424 can aid the navigation of the sampling device 300 (FIG. 3) and more particularly, the distal tip 302 (FIG. 3) within the patient. In examples, an external coil array can generate an electromagnetic field such that the position and orientation of the electromagnetic coil 426 can be detected within the electromagnetic field. As the distal tip 302 moves within the body of the patient, changes in the position and orientation of the distal tip 302 can be detected by the electromagnetic coil 426. Such changes to the position and orientation of the distal tip 302 detected by the electromagnetic coil 426 can be sent to a control system (e.g., the imaging and control system 102, see FIG. 1 ).

[0069] In examples, each of the electromagnetic coils 426 can include five degrees of freedom. The angular offset of the grooves 424 can enable the two five-degree of freedom coils (e.g., the electromagnetic coil 426) to obtain 6 degrees of freedom navigation data. As such, pitch, yaw, roll, linear, vertical straightness, and horizontal straightness can be determined for the distal tip 302 (FIG. 3) via the combination of each of the electromagnetic coil 426 installed in the grooves 424. Thus, the precise location and position of the distal tip 302 can be tracked by the control system (e.g., the imaging and control system 102 (FIG. 1 )) throughout the medical procedure. The control system can have alarms, signals, or warnings based on any of the sensed orientations of the distal tip 302 within the patient.

[0070] As discussed herein, and shown in FIG. 10, the imaging assembly 654 can be connected to each of the image sensor 650 and thelight source 652. A proximal end 656 of the imaging assembly 654 can include electrical pads 658. The electrical pads 658 can be configured for wires 660 to be secured thereto such as to electrically connect the image sensor 650 and the light source 652 to the wires 660 via the electrical pads 658. The wires 660 can be configured to connect the electrical pads 658 to a control system (e.g., the imaging and control system 102 (FIG. 1 )) such that the control system is connected to the image sensor 650 and the light source 652 via the wires 660, the imaging assembly 654, and the electrical pads 658. As shown in FIG. 10, the imaging assembly 654 can be connected directly to the second portion 962 of the two-piece housing 912. In examples, the second portion 962 can also receive a tray (e.g., the tray 640 (FIG. 6)) to receive the image sensor 650 and the light source 652.

[0071] FIGS. 11 and 12 will be discussed together. FIG. 11 illustrates a perspective view of an example of the transducer 320. FIG. 12 illustrates a perspective view of an example of the transducer 320 in an unfolded orientation for a distal tip of a sampling device.

[0072] As shown in FIGS. 11 and 12, the transducer 320 can be disposed on a flexible substrate that can be folded as shown in FIG. 11 from a flat configuration, as shown in FIG. 12. The transducer 320 can be a part of an imaging assembly 1100. The imaging assembly 1100 can include the substrate 1102, the application-specific integrated circuits 1104, the capacitors 1106, and the lineartransducer array 1108.

[0073] The flexibility of a substrate 1102 of the transducer 320 can help the transducer 320 fit within the housing (e.g., the housing 312 (FIG. 3)) while decreasing an area (within the housing) required to mount the transducer 320. Thus, the foldable substrate 1102 helps decrease the size of the housing such that the housing can taper from the proximal section (e.g., the proximal section 314 (FIG. 3)) to the distal section (e.g., the distal section 316 (FIG. 3)). As shown in FIG. 12, the transducer 320 can include application-specific integrated circuits 1104, capacitors 1106, and a linear transducer array 1108. The application-specific integrated circuits 1104, the capacitors 1106, and the linear transducer array 1108 can each bemounted to the flexible substrate 1102. As shown in FIG. 11 , the transducer320 can include a ribbon tail 1110.

[0074] The substrate 1102 can be a laminated structure that includes a coverlay, an electrical insulating layer, electrically conductive features, and adhesives. In examples, the coverlay and the electrical insulating layer can be made of polyimide. The electrically conductive layers can be etched, routed, or traced using copper, stainless steel, aluminum, any other electrically conductive material, or the like. The substrate 1102 can also be made using any other process or of materials that permit the flexibility of the substrate 1102 such that the substrate 1102 can be folded to be installed within the housing 312 (FIG. 3).

[0075] The application-specific integrated circuits 1104 can be configured to receive signals from the lineartransducer array 1108 and can transmit one or more signals in response to the signals received from the linear transducer array 1108. The capacitors 1106 can help provide geometrical and mechanical flexibility of the imaging assembly 1100. The linear transducer array 1108 can generate signals based on the tissue within the field of view of the transducer. The signal from the linear transducer array 1108 can be received by the application-specific integrated circuits 1104, the capacitors 1106, or any other component of the imaging assembly 1100, the endoscopy system 100 (FIG. 1 ), or the sampling device 300 (FIG. 3). In some examples, the imaging assembly 1100 can be configured to perform synthetic aperture imaging techniques to enable array imaging with a reduced number of transmission lines. This reduction in the number of transmission lines provides the benefits of reduced size (e.g., smaller device diameter due to less transmission lines extendingfrom the distal end to the proximal end) and reduced power consumption and / or heat generation. Additional details associated with an exemplary imaging assembly 1100 are described in both U.S. Patent Application No. 62 / 989,268 filed on Mar. 13, 2020, and U.S. Patent Application No. 16 / 991 ,745 filed on Aug. 12, 2020, each of which are hereby incorporated herein by reference in their entirety.

[0076] As discussed herein, the substrate 1102 can be secured to a support surface (e.g., the support surface 532 (FIG. 5)) of the mount feature (e.g., the mount feature 318 (FIG. 3)). The substrate 1102 can be secured to the support surface such that the application-specific integrated circuits 1104, the capacitors 1106, and the linear transducer array 1108 are at least partially recessed within the periphery (e.g., the periphery 313 (FIG. 3)) of the housing. The substrate 1102 can be secured to the support surface such that the application-specific integrated circuits 1104, the capacitors 1106, and the linear transducer array 1108 are completely recessed within the periphery (e.g., the periphery 313 (FIG. 3)) of the housing. The substrate 1102 can be secured to the support surface such that at least one of the application-specific integrated circuits 1104, the capacitors 1106, or the linear transducer array 1108 is at least partially recessed within the periphery (e.g., the periphery 313 (FIG. 3)) of the housing.

[0077] As discussed herein, epoxy, or any other setting agent can be used to secure the transducer 320 within the mounting feature. The substrate 1102 of the transducer 320 can be folded and set in epoxy, or any other setting agent, such that the application-specific integrated circuits 1104 are directly below the linear transducer array 1108. The substrate 1102 of the transducer 320 can be folded and set in epoxy, or any other setting agent, such that the application-specific integrated circuits 1104 are between the linear transducer array 1108 and the image sensor or the light source (e.g., the image sensor 428 or the light source 430 (FIG. 4)).

[0078] The substrate 1102 of the transducer 320 can be folded and set within the mount feature such that the linear transducer array 1108 is facing away from the housing (e.g., the housing 312 (FIG. 3)). The substrate 1102 of the transducer 320 can be folded and setwithin the mount feature such that the linear transducer array 1108 extends beyond the periphery of the housing (e.g., the periphery 313 of the housing 312 (FIG. 3)). The substrate 1102 of the transducer 320 can be folded and set within the mount feature such that the linear transducer array 1108 aligns with the periphery of the housing (e.g., the periphery 313 of the housing 312 (FIG. 3)).

[0079] The ribbon tail 1110 can be flexible and can extend from a proximal edge 331 of the transducer 320. For example, the ribbon tail 1110 can extend into the coupler (e.g., the coupler 304 (FIG. 3)). The ribbon tail 1110 can be in communication with the transducer 320. The ribbon tail 1110 can include electrical pads 1114 on a proximal end 1113 of the ribbon tail 1110. The electrical pads 1114 can be in communication with the transducer 320 and can be configured for the wires 1116 to be attached thereto. For example, the electrical pads 1114 can electrically connect the ribbon tail 1110 to the wires 1116. The wires 1116 can be configured to connect the electrical pads 1114 to a control system (e.g., the imaging and control system 102 (FIG. 1 )) such that the control system is connected to the transducer 320 via the wires 1116 and the electrical pads 1114.

[0080] The ribbon tail 1110 can include a first bent portion 1111 that can be routed beyond and downward from the proximal section of the housing (e.g., the proximal section 314 of the housing 312) in a profile that remains substantially orthogonal to a longitudinal axis LA of the coupler 304. The ribbon tail 1110 can include a second bent portion 1112 that can wrap generally upward around the longitudinal axis LA (FIG. 3) of the coupler 304. The second bent portion 1112 can include electrical pads 1114. The electrical pads 1114 can be configured to connect wires 1116 to the second bent portion 1112 of the ribbon tail 1110. The combination of the first bent portion 1111 and second bent portion 1112 allows for the ribbon tail 1 110 to move proximally away from the transducer while moving downward (e.g., away from the side of the device having the side exit port from the ramp) to provide clearance from the ramp (from which a biopsy needle can protrude into a patient’s tissue within the FOV of the US transducer) and then to wrap around the ramp (e.g., needle lumen) as shown in FIG. 16. The flared or splayed-out nature of the second bent portion 1112 provides increased spacing between electrical soldering points. As illustrated in FIG. 11 , the first bent portion 1111 includes bending characteristics that are substantially limited to bending in a first plane and the second bent portion 1112 includes bending characteristics that aresubstantially limited to bending in a second plane, that is different than the first plane. This configuration with first and second bent portions allows for bending in the first plane to lower or drop the ribbon tail 1110 underneath the ramp of the coupler (shown in FIGS. 13 and 14), and then to transition (e.g., at a portion in between the first and second bent portions) to bending in the second plane which wraps the 1110 around the ramp within the wiring egress channel 1410.

[0081] FIGS. 13-16 will be discussed together. FIG. 13 illustrates a perspective view of an example coupler (e.g., the coupler 304 (FIG. 3)) of a distal tip (e.g., the distal tip 302) of a sampling device (e.g., the sampling device 300 (FIG. 3)). FIG. 14 illustrates a perspective view of an example of a ribbon tail 1110 of a transducer 320 wrapping around a side-exit ramp 310 of an example coupler 304 of a distal tip 302. FIG. 15 illustrates an internal view from a proximal end (e.g., from the proximal portion 306) of an example of a coupler 304 of a distal tip 302. FIG. 16 illustrates a perspective view of a proximal end (e.g., of the proximal portion 306) of an example coupler 304 of a distal tip 302.

[0082] As discussed herein, the coupler 304 can extend from a proximal portion 306 to a distal portion 308. The coupler 304 can include a side-exit ramp 310 extendingfrom the proximal portion 306 and through a side 1302 of the coupler 304. The side-exit ramp 310 can direct an instrument (e.g., instrument 311 (FIG. 3)) through the side 1302 of the coupler 304 and toward a tissue of the patient. As shown in FIGS. 14-16, the coupler 304 can include a wiring egress channel 1410.

[0083] The wiring egress channel 1410 can be disposed belowthe side-exit ramp 310 and wrapped at least partially around the side-exit ramp 310. Moreover, the wiring egress channel 1410 can be located directly under the pair of the electromagnetic coils 426 (FIG. 9). The wiring egress channel 1410 can be generally U-shaped with an inner profile that is substantially concentric with the side-exit ramp 310 and an outer profile that is substantially concentric with an outer profile of the coupler 304. As discussed herein, the ribbon tail 1110 can extend from the transducer 320and into the coupler 304. For example, the ribbon tail 1110 can extend from the transducer 320 into the wiring egress channel 1410 of the coupler 304. As discussed herein, the second bent portion 1112 can include the electrical pads 1114 (FIG. 11). The electrical pads 1114 can be distal of the wiring egress channel 1410. The electrical pads 1114 can be within the wiring egress channel 1410.

[0084] As shown in FIG. 15, the ribbon tail 1110 can split into a first part 1502 and a second part 1504. The first part 1502 and the second part 1504 can splay around the side-exit ramp within the coupler (e.g., the sideexit ramp 310 of the coupler 304).

[0085] As shown in FIGS. 13 and 14, the coupler 304 can include a locking groove 1304. As shown in FIG. 14, the housing 312 can include a locking tab 1412. The locking tab 1412 can be complementary with the locking groove 1304 to hold the coupler 304 and the housing 312 together after installation, assembly, or the like of the coupler 304 and the housing 312. The coupler 304 and the housing 312 can include any other complementary locking mechanism, for example, threads, pins, grooves, ridges, protrusions, orthe like, or any other mechanism that can hold the coupler 304 and the housing 312 together during the operation of the sampling device 300.

[0086] As discussed in FIG. 9, the clocking protrusion 974 can extend radially outward from the second portion 962 (FIG. 9) and can be engageable with the coupler 304 to ensure proper installation of the housing (e.g., the housing 312 or the two-piece housing 912) and the coupler 304. As shown in FIG. 14, the coupler 304 can include a clocking feature (e.g., a clocking groove 1414). The clocking groove 1414 can be formed in the proximal section 314 of the housing 312. The clocking groove 1414 can be complementary to the clocking protrusion 974 to ensure proper alignment of the coupler 304 and the housing (e.g., the housing 312 (FIG. 3) or the two-piece housing 912 (FIG. 9)) during assembly, installation, or the like of the coupler 304 and the housing. The second portion 962 and the clocking groove 1414 are just example alignment indicators that can beused to ensure the coupler 304 and the housing 312 are aligned. The inventors of the present application appreciate that there are many other alignment tools, mechanisms, aids, guides, orthe like, that can be used to ensure the coupler 304 and the housing 312 are properly aligned when the coupler 304 and the housing 312 are assembled such that the instrument 311 extends into the field of view 322 of the transducer 320 as it extends from the side-exit ramp 310 of the coupler 304.

[0087] FIG. 17 illustrates a schematic view of an example method 1700. The method 1700 can be a method of reprocessing a sampling device (e.g., the endoscope 104, the sampling device 300, or the like). More specific examples of the method 1700 are discussed below. The steps or operations of the method 1700 are illustrated in a particular orderfor convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations. The method 1700 as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that subsets of the operations discussed in the method 1700 can be attributable to a single actor, device, or system could be considered a separate standalone process or method.

[0088] The reprocessing method 1700 for the above-described treatment instrument (e.g., the endoscope 104 or the sampling device 300) will be described with reference to FIG. 17. The treatment instrument (e.g., the endoscope 104 or the sampling device 300) described above can be disposed of after one use, or can be repeatedly used, for example, a plurality of times. In the case of a configuration that is repeatedly used a plurality of times, for example, the reprocessing method 1700 shown in FIG. 17 can be relevant.

[0089] An operator can collect the used treatment instrument (e.g., the endoscope 104 or the sampling device 300) after it has been used for treatment and transport it to a factory or the like (Step S1 ). At this time, the used treatment instrument (e.g., the endoscope 104 or the sampling device 300) can be transported in a dedicated container to prevent contaminationfrom the treatment instrument (e.g., the endoscope 104 or the sampling device 300).

[0090] Then, the operator can clean and sterilize the collected and transported used treatment instrument (e.g., the endoscope 104 orthe sampling device 300) (Step S2). Specifically, in cleaning the treatment instrument (e.g., the endoscope 104 or the sampling device 300), deposits adhering to the exterior of the distal tip 302 (e.g., the coupler 304 or the housing 312) can be removed by using a brush or the like. After that, to remove pathogenic microorganisms and the like derived from blood, body fluid, etc., the distal tip 302 can be cleaned using a cleaning solution of isopropanol-containing cleaning agent, proteolytic enzyme detergent, and alcohol. The cleaning liquid is not limited to the cleaning liquid described above, and other cleaning liquids may be used. Further, in the sterilization of the treatment instrument (e.g., the endoscope 104 or the sampling device 300), to sterilize the pathogenic microorganisms and the like adhering to the distal tip 302, any of high-pressure steam sterilization, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide and hydrogen peroxide low-temperature sterilization can be used. The part distal tip 302, and specifically the coupler 304 and the housing 312 can be disassembled by actuating the clips or securing features (e.g., the first attachment interface 964 or the locking tab 1412) to decouple the coupler 304 and the housing 312.

[0091] The operator can perform an acceptance check of the used treatment instrument (e.g., the endoscope 104 or the sampling device 300) (Step S3). In detail, the operator can check whether the used treatment instrument (e.g., the endoscope 104 or the sampling device 300) has significant defects or whether the used treatment instrument (e.g., the endoscope 104 orthe sampling device 300) exceeds a maximum number of reprocessing.

[0092] Next, the operator can disassemble the used treatment instrument (e.g., the endoscope 104 or the sampling device 300) (Step S4). Can disassemble the distal tip 302 by removing the housing 312 fromthe coupler 304 and removing all of the components from within the coupler 304 and the housing 312.

[0093] After the step S4, some parts are replaced (Step S5). For example, any of the components of the distal tip 302, or any of the components within the coupler 304 or the housing 312 can be replaced during step S4.

[0094] After step S5, the operator can assemble a new treatment instrument (e.g., the endoscope 104 or the sampling device 300) (Step S6). In some examples, Step S6 can include adding an identifier to indicate the device has been modified from its original condition, such as a adding a label or other marking to designate the device as reprocessed, refurbished or remanufactured.

[0095] After step S6, the operator can inspect and test the newly formed treatment instrument (e.g., the endoscope 104 or the sampling device 300) (step S7). Specifically, the operator who remanufactures verifies that the newly formed treatment instrument (e.g., the endoscope 104 or the sampling device 300) has the same effectiveness and safety as the original product by various functional tests.

[0096] After Step S7, the operator sequentially performs a sterilization and storage (Step S8), and shipping (Step S9) of the new treatment instrument (e.g., the endoscope 104 or the sampling device 300). In the Step S8, a sterilization treatment can use a sterilizing gas such as ethylene oxide gas or propylene oxide gas is applied to the new treatment instrument (e.g., the endoscope 104 or the sampling device 300), and the device is stored in a storage container until use.

[0097] Steps S1 to S9 described above are executed to achieve reprocessing of the treatment instrument (e.g., the endoscope 104 or the sampling device 300). Any of steps S1-S9 can be completed by one or more parties in any order of the steps. Moreover, steps S1-S9 are exemplary steps, which are not an all-inclusive list of steps that can be performed by an operator to refurbish, remanufacture, or replenish the medical instrument (e.g., the endoscope 104 or the sampling device 300).

[0098] FIG. 18 illustrates a block diagram of an example machine 1800 upon which any one or more of the techniques (e.g., methodologies) discussed herein may perform. Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms in the machine 1800. Circuitry (e.g., processing circuitry) is a collection of circuits implemented in tangible entities of the machine 1800 that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership may be flexible overtime. Circuitries include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuitry may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuitry may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a machine-readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuitry in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, in an example, the machine-readable medium elements are part of the circuitry or are communicatively coupled to the other components of the circuitry when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuitry. For example, under operation, execution units may be used in a first circuit of a first circuitry at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time. Additional examples of these components with respect to the machine1800 follow.

[0099] In alternative examples, the machine 1800 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine 1800 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1800 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1800 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. Further, while only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations.

[0100] The machine (e.g., computer system) 1800 may include a hardware processor 1802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1804, a static memory (e.g., memory or storage for firmware, microcode, a basic-input-output (BIOS), unified extensible firmware interface (UEFI), etc.) 1806, and mass storage 1808 (e.g., hard drives, tape drives, flash storage, or other block devices) some or all of which may communicate with each other via an interlink (e.g., bus) 1830. The machine 1800 may further include a display unit 1810, an alphanumeric input device 1812 (e.g., a keyboard), and a user interface (Ul) navigation device 1814 (e.g., a mouse). In an example, the display unit 1810, input device 1812 and Ul navigation device 1814 may be a touch screen display. The machine 1800 may additionally include a storage device (e.g., drive unit) 1808, a signal generation device 1818 (e.g., a speaker), a network interface device 1820, and one or more sensors 1816, such as a global positioning system (GPS) sensor, compass,accelerometer, or other sensors. The machine 1800 may include an output controller 1828, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[0101] Registers of the processor 1802, the main memory 1804, the static memory 1806, or the mass storage 1808 may be, or include, a machine-readable medium 1822 on which is stored one or more sets of data structures or instructions 1824 (e.g., software) embodying or utilized by any one or more of the techniques orfunctions described herein. The instructions 1824 may also reside, completely or at least partially, within any of registers of the processor 1802, the main memory 1804, the static memory 1806, or the mass storage 1808 during execution thereof by the machine 1800. In examples, one or any combination of the hardware processor 1802, the main memory 1804, the static memory 1806, or the mass storage 1808 may constitute the machine-readable media 1822. While the machine-readable medium 1822 is illustrated as a single medium, the term “machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store the one or more instructions 1824.

[0102] The term “machine-readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1800 and that cause the machine 1800 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine-readable medium examples may include solid-state memories, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, a non-transitory machine- readable medium comprises a machine-readable medium with a plurality of particles having invariant (e.g., rest) mass, and thus are compositions ofmatter. Accordingly, non-transitory machine-readable media are machine- readable media that do not include transitory propagating signals. Specific examples of non-transitory machine-readable media may include: nonvolatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magnetooptical disks; and CD-ROM and DVD-ROM disks.

[0103] In examples, information stored or otherwise provided on the machine-readable medium 1822 may be representative of the instructions 1824, such as instructions 1824 themselves or a format from which the instructions 1824 may be derived. This format from which the instructions 1824 may be derived may include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., split into multiple packages), or the like. The information representative of the instructions 1824 in the machine-readable medium 1822 may be processed by processing circuitry into the instructions to implement any of the operations discussed herein. For example, deriving the instructions 1824 from the information (e.g., processing by the processing circuitry) may include: compiling (e.g., from source code, object code, etc.), interpreting, loading, organizing (e.g., dynamically or statically linking), encoding, decoding, encrypting, unencrypting, packaging, unpackaging, or otherwise manipulating the information into the instructions 1824.

[0104] In examples, the derivation of the instructions 1824 may include assembly, compilation, or interpretation of the information (e.g., by the processing circuitry) to create the instructions 1824 from some intermediate or preprocessed format provided by the machine-readable medium 1822. The information, when provided in multiple parts, may be combined, unpacked, and modified to create the instructions 1824. For example, the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or several remote servers. The source code packages may be encrypted when intransit over a network and decrypted, uncompressed, assembled (e.g., linked) if necessary, and compiled or interpreted (e.g., into a library, standalone executable etc.) at a local machine, and executed by the local machine.

[0105] The instructions 1824 may be further transmitted or received over a communications network 1826 using a transmission medium via the network interface device 1820 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), LoRa / LoRaWAN, or satellite communication networks, mobile telephone networks (e.g., cellular networks such as those complying with 3G, 4G LTE / LTE-A, or 5G standards), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 502.11 family of standards known as Wi-Fi®, IEEE 502.15.4 family of standards, peer-to-peer (P2P) networks, among others. In examples, the network interface device 1820 may include one or more physical jacks (e.g., Ethernet, coaxial, or phonejacks) or one or more antennas to connect to the communications network 1826. In examples, the network interface device 1820 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input singleoutput (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 1800, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software. A transmission medium is a machine-readable medium.

[0106] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0107] Example 1 is a distal tip for an endobronchial ultrasound sampling device, the distal tip comprising: a coupler extending along a longitudinal axis from a proximal portion to a distal portion, the coupler comprising: a side-exit ramp extending within the couplerfrom the proximal portion and through a side of the coupler, the side-exit ramp directs an instrument through the side of the coupler and toward a tissue of a patient; and a housing extending along a central axis from a proximal section to a distal section, the proximal section of the housing coupled to the distal portion of the coupler, the housing including: a first portion including: a mount feature configured to receive a transducer, the mount feature tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal section; and a second portion configured to be attached to the first portion such that the second portion is adjacent to the first portion.

[0108] In Example 2, the subject matter of Example 1 includes, wherein the mount feature is tapered such that the instrument extends into a field of view of the transducer.

[0109] In Example 3, the subject matter of Example 2 includes, wherein the mount feature comprises: a support surface recessed within a periphery of the housing, the transducer is secured to the support surface to hold the transducer within the mount feature.

[0110] In Example 4, the subject matter of Example 3 includes, wherein the support surface is recessed within the periphery of the housing such that the transducer is aligned with the periphery of the housing when the transducer is installed within the mount feature.

[0111] In Example 5, the subject matter of Examples 3-4 includes, wherein the support surface is recessed within the periphery of the housing such that the transducer extends outside the periphery of the housing when the transducer is installed within the mount feature.

[0112] In Example 6, the subject matter of Examples 1 -5 includes, wherein the first portion comprises: a first attachment interface recessedwithin a periphery of the housing, the first attachment interface configured to be inserted within the distal portion of the coupler.

[0113] In Example 7, the subject matter of Example 6 includes, wherein the first portion comprises: a wire cutout configured to direct one or more wires of the transducer to the distal portion of the coupler.

[0114] In Example 8, the subject matter of Examples 1-7 includes, wherein the second portion comprises: a mounting interface recessed within a periphery of the housing, the mounting interface insertable within the distal portion of the coupler to mount the housingto the coupler.

[0115] In Example 9, the subject matter of Examples 1 -8 includes, wherein the first portion comprises alignment protrusions, and wherein the second portion comprises alignment grooves, wherein the alignment protrusions and the alignment grooves are complementary to align the first portion with the second portion.

[0116] In Example 10, the subject matter of Examples 1-9 includes, wherein the first portion comprises: a first groove extending from the proximal section toward the distal section of the housing; and a second groove extending from the proximal section toward the distal section, the first groove angularly offset from the second groove.

[0117] In Example 11 , the subject matter of Example 10 includes, wherein the first groove and the second groove are each configured to receive an electromagnetic coil.

[0118] In Example 12, the subject matter of Examples 1-11 includes, wherein the second portion comprises: a second attachment interface recessed within a periphery of the housing, the second attachment interface configured to be inserted within the distal portion of the coupler.

[0119] In Example 13, the subject matter of Example 12 includes, wherein the second attachment interface comprises: a clocking protrusion, the clocking protrusion extending radially outward from the second attachment interface and is engageable with the couplerto ensure proper installation of the housing and the coupler.

[0120] In Example 14, the subject matter of Examples 1-13 includes, wherein the first portion comprises: an image sensor mount extendingfrom the distal section toward the proximal section; and a light source mount adjacent to the image sensor mount and extendingfrom the distal section toward the proximal section.

[0121] In Example 15, the subject matter of Example 14 includes, wherein the image sensor mount is configured to secure an image sensor below a distal end of the mount feature, and wherein the light source mount is configured to secure a light source below the distal end of the mount feature.

[0122] In Example 16, the subject matter of Examples 14-15 includes, wherein the first portion includes a rectangular profile at a distal tip of the first portion.

[0123] In Example 17, the subject matter of Examples 14-16 includes, wherein the light source mount is configured to mount a light source aligned with a distal tip of the first portion.

[0124] In Example 18, the subject matter of Examples 14-17 includes, wherein the image sensor mount is configured to secure an image sensor aligned with a distal tip of the first portion.

[0125] In Example 19, the subject matter of Examples 14-18 includes, wherein the image sensor mount is configured to secure an image sensor aligned with the central axis of the housing.

[0126] Example 20 is a distal tip for an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending along a central axis from a proximal section to a distal section, the housing including: a mount feature configured to receive a transducer, the mount feature extending from the proximal section toward the distal section; and a tray configured to be installed within the distal section of the housing and defining a distal end of the distal tip, the tray including: an image sensor mount configured to mount an image sensor adjacent to the transducer and within a distal tip of the distal tip.

[0127] In Example 21 , the subject matter of Example 20 includes, wherein the tray at least partially covers a distal most portion of the transducer.

[0128] In Example 22, the subject matter of Examples 20-21 includes, a coupler extending from a proximal portion to a distal portion, the distal portion of the coupler coupled to the proximal section of the housing.

[0129] In Example 23, the subject matter of Example 22 includes, wherein the coupler comprises: a side-exit ramp extending within the coupler from the proximal portion and through a side of the coupler, the side-exit ramp directs an instrument through the side of the coupler and toward a tissue of a patient.

[0130] In Example 24, the subject matter of Example 23 includes, wherein the mount feature is tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal tip of the distal tip.

[0131] In Example 25, the subject matter of Example 24 includes, wherein the mount feature is tapered such that the instrument extends into a field of view of the transducer.

[0132] In Example 26, the subject matter of Examples 20-25 includes, wherein the tray comprises: a distal body; and a support extending from the distal body and configured to couple the tray to the housing.

[0133] In Example 27, the subject matter of Example 26 includes, wherein the distal body includes a rectangular profile.

[0134] In Example 28, the subject matter of Examples 26-27 includes, wherein the distal body comprises: the image sensor mount extending from the distal section toward the proximal section; and a light source mount adjacent to the image sensor mount and extendingfrom the distal section toward the proximal section.

[0135] In Example 29, the subject matter of Example 28 includes, wherein the image sensor mount is configured to secure the image sensorbelow a distal end of the mount feature, and wherein the light source mount is configured to secure a light source below the distal end of the mount feature.

[0136] In Example 30, the subject matter of Example 29 includes, wherein the image sensor mount secures the image sensor such that a central axis of the image sensor is essentially parallel to the central axis of the housing.

[0137] In Example 31 , the subject matter of Example 30 includes, wherein the image sensor mount is configured to secure the image sensor such that a distal edge of the image sensor aligns with the distal tip of the distal tip.

[0138] In Example 32, the subject matter of Examples 29-31 includes, an imaging assembly connected to each of the image sensor and the light source, a proximal end of the imaging assembly including: electrical pads configured for wires to be secured thereto, the electrical pads in communication with the image sensor and the light source.

[0139] In Example 33, the subject matter of Example 32 includes, wherein the wires are configured to connect the electrical pads to a control system such that the control system is connected to the image sensor and the light source via the wires and the imaging assembly.

[0140] In Example 34, the subject matter of Examples 32-33 includes, wherein the imaging assembly is mounted to the support of the tray.

[0141] In Example 35, the subject matter of Examples 20-34 includes, wherein the housing comprises: a first groove extendingfrom the proximal section toward the distal section; and a second groove extending from the proximal section toward the distal section, the first groove angularly offset from the second groove.

[0142] In Example 36, the subject matter of Example 35 includes, wherein the first groove and the second groove are each configured to receive an electromagnetic coil.

[0143] In Example 37, the subject matter of Examples 20-36 includes, wherein a normal vector of a substantially planar face of the transducer forms an acute angle with a central axis of the tray.

[0144] Example 38 is a distal tip for an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending along a central axis from a proximal section to a distal section, the housing comprising: a mount feature configured to receive a transducer, the mount feature tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal section; and a coupler extendingfrom a proximal portion to a distal portion, the coupler comprising: a side-exit ramp extendingwithin the couplerfrom the proximal portion and through a side of the coupler, the side-exit ramp directs an instrument through the side of the coupler and toward a tissue of a patient; and a wiring egress channel disposed belowthe side-exit ramp and wrapping at least partially around the side-exit ramp.

[0145] In Example 39, the subject matter of Example 38 includes, a transducer including: a flexible tail extendingfrom a proximal edge of the transducer into the coupler, the flexible tail in communication with the transducer.

[0146] In Example 40, the subject matter of Example 39 includes, wherein the flexible tail comprises: electrical pads on a proximal end of the flexible tail, the electrical pads are in communication with the transducer and are configured for wires to be attached thereto.

[0147] In Example 41 , the subject matter of Example 40 includes, wherein the wires are configured to connect the electrical pads to a control system such that the control system is connected to the transducer via the wires and the electrical pads.

[0148] In Example 42, the subject matter of Example 41 includes, wherein the flexible tail is routed beyond and downward from the proximal section of the housing in a profile that remains substantially orthogonal to a longitudinal axis of the coupler.

[0149] In Example 43, the subject matter of Example 42 includes, wherein the flexible tail transitions to a bent portion that wraps generally upward around the longitudinal axis of the coupler.

[0150] In Example 44, the subject matter of Example 43 includes, wherein the bent portion includes the electrical pads.

[0151] In Example 45, the subject matter of Examples 40-44 includes, wherein the electrical pads are distal of the wiring egress channel.

[0152] In Example 46, the subject matter of Examples 40-45 includes, wherein the electrical pads are within the wiring egress channel.

[0153] In Example 47, the subject matter of Examples 39-46 includes, wherein the flexible tail splits into a first part and a second part, wherein the first part and the second part splay around the side-exit ramp within the coupler.

[0154] In Example 48, the subject matter of Examples 38-47 includes, wherein the housing includes a first clocking feature formed in the proximal section of the housing.

[0155] In Example 49, the subject matter of Example 48 includes, wherein the coupler includes a second clocking feature formed in the distal portion of the coupler.

[0156] In Example 50, the subject matter of Example 49 includes, wherein the second clocking feature is complementary to the first clocking feature to ensure proper alignment of the coupler and the housing during installation.

[0157] In Example 51 , the subject matter of Example 50 includes, wherein the housing includes a locking tab, and wherein the coupler includes a locking groove, wherein the locking tab is complementary with the locking groove to hold the coupler and the housing together after installation.

[0158] In Example 52, the subject matter of Examples 38-51 includes, wherein the wiring egress channel comprises a substantially U- shaped profile having an inner surface defined by a wall between the wiringegress channel and the side-exit ramp and an outer surface defined by a wall between the wiring egress channel and an outer profile of the coupler.

[0159] Example 53 is a method for reprocessing an endobronchial ultrasound sampling device, the method comprising: obtainingthe endobronchial ultrasound sampling device of Example 38; sterilizing the endobronchial ultrasound sampling device; and storing the endobronchial ultrasound sampling device.

[0160] In Example 54, the subject matter of Example 53 includes, wherein the endobronchial ultrasound sampling device comprises a housing, a tray configured to be installed within the housing, and a coupler.

[0161] In Example 55, the subject matter of Example 54 includes, removing the tray from the housing; decoupling the housingfrom the coupler; sanitizing the housing, the tray, and the coupler; and packagingthe housing, the tray, and the coupler.

[0162] Example 56 is a distal tip for an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending along a central axis from a proximal section to a distal section, the housing comprising: a mount feature configured to receive a transducer, the mount feature tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal section; and a coupler extendingfrom a proximal portion to a distal portion, the coupler comprising: a side-exit ramp extending within the couplerfrom the proximal portion and through a side of the coupler, the side-exit ramp directs an instrument through the side of the coupler and toward a tissue of a patient; and a wiring egress channel disposed belowthe side-exit ramp and wrapping at least partially around the side-exit ramp; a transducer including: a flexible tail extendingfrom a proximal edge of the transducer into the coupler, the flexible tail in communication with the transducer.

[0163] In Example 57, the subject matter of Example 56 includes, wherein the bent portion includes electrical pads.

[0164] Example 58 is a distal tip for an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending along acentral axis from a proximal section to a distal section, the housing including: a mount feature tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal section; a transducerthat is secured to the mount feature such that a normal vector of a substantially planar face of the transducer forms an acute angle with the central axis of the housing; and a side-exit ramp located proximal from the transducer and configured to direct a needle distally through a field of view of the transducer along a trajectory that forms an acute angle with the central axis and that intersects with the normal vector of the substantially planarface.

[0165] In Example 59, the subject matter of Example 58 includes, wherein the transducer includes a flexible substrate that is foldable.

[0166] In Example 60, the subject matter of Example 59 includes, wherein the transducer comprises: application-specific integrated circuits mounted to the flexible substrate; capacitors mounted to the flexible substrate; and a linear transducer array mounted to the flexible substrate.

[0167] In Example 61 , the subject matter of Example 60 includes, wherein the mount feature comprises: a support surface recessed within a periphery of the housing, the transducer is secured to the support surface to hold the transducer within the mount feature.

[0168] In Example 62, the subject matter of Example 61 includes, wherein the transducer is secured to the support surface such that the application-specific integrated circuits, the capacitors, and the linear transducer array are at least partially recessed within the periphery of the housing.

[0169] In Example 63, the subject matter of Examples 61-62 includes, wherein the transducer is secured to the support surface such that the application-specific integrated circuits, the capacitors, and the linear transducer array are completely recessed within the periphery of the housing.

[0170] In Example 64, the subject matter of Examples 61-63 includes, wherein the transducer is secured to the support surface suchthat at least one of the application-specific integrated circuits, the capacitors, or the linear transducer array is at least partially recessed within the periphery of the housing.

[0171] In Example 65, the subject matter of Example 64 includes, wherein the transducer is folded and set in epoxy such that the applicationspecific integrated circuits are directly below the linear transducer array.

[0172] In Example 66, the subject matter of Example 65 includes, wherein the linear transducer array is facing away from the housing.

[0173] In Example 67, the subject matter of Example 66 includes, wherein the linear transducer array extends beyond the periphery of the housing.

[0174] In Example 68, the subject matter of Example 67 includes, wherein the linear transducer array is aligned with the periphery of the housing.

[0175] In Example 69, the subject matter of Examples 58-68 includes, an image sensor mount extending from the distal section toward the proximal section; and a light source mount adjacent to the image sensor mount and extendingfrom the distal section toward the proximal section.

[0176] In Example 70, the subject matter of Example 69 includes, wherein the image sensor mount is configured to secure an image sensor within the distal section of the housing, and wherein the light source mount is configured to secure a light source within the distal section of the housing.

[0177] In Example 71 , the subject matter of Example 70 includes, wherein the image sensor and the light source are directly below the transducer at a distal edge of the housing.

[0178] Example 72 is a method for reprocessing an endobronchial ultrasound sampling device, the method comprising: obtainingthe endobronchial ultrasound sampling device of Example 58; sterilizing the endobronchial ultrasound sampling device; and storing the endobronchial ultrasound sampling device.

[0179] In Example 73, the subject matter of Example 72 includes, wherein the endobronchial ultrasound sampling device comprises a housing, a tray configured to be installed within the housing, and a coupler.

[0180] In Example 74, the subject matter of Example 73 includes, removing the tray from the housing; decouplingthe housingfrom the coupler; sanitizing the housing, the tray, and the coupler; and packagingthe housing, the tray, and the coupler.

[0181] Example 75 is an apparatus comprising means to implement of any of Examples 1-74.

[0182] Example 76 is a system to implement of any of Examples 1- 74.

[0183] Example 1~t is a method to implement of any of Examples 1- 74.

[0184] Example 78 is an apparatus, system, method, or device including any element of any of Examples 1-74.

[0185] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments that may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0186] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be consideredsupplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

[0187] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0188] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and belowthe numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1 , 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1 -1 .5, 1 .5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1 -4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”

[0189] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples may be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0190] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0191] Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic orTYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. The device may also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.

Claims

CLAIMSClaims:1 . A distal tip for an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending along a central axis from a proximal section to a distal section, the housing including: a mount feature tapered toward the central axis of the housing as the housing extends from the proximal section toward the distal section; a transducer that is secured to the mount feature such that a normal vector of a substantially planar face of the transducer forms an acute angle with the central axis of the housing; and a side-exit ramp located proximal from the transducer and configured to direct a needle distally through a field of view of the transducer along a trajectory that forms an acute angle with the central axis and that intersects with the normal vector of the substantially planarface.

2. The distal tip of claim 1 , wherein the transducer includes a flexible substrate that is foldable.

3. The distal tip of claim 2, wherein the transducer comprises: application-specific integrated circuits mounted to the flexible substrate; capacitors mounted to the flexible substrate; and a lineartransducer array mounted to the flexible substrate; and wherein the mount feature comprises: a support surface recessed within a periphery of the housing, the transducer is secured to the support surface to hold the transducer within the mount feature.

4. The distal tip of claim 3, wherein the transducer is secured to the support surface such that the application-specific integrated circuits, the capacitors, and the lineartransducer array are at least partially recessed within the periphery of the housing.

5. The distal tip of any of claims 3-4, wherein the transducer is secured to the support surface such that the application-specific integratedcircuits, the capacitors, and the lineartransducer array are completely recessed within the periphery of the housing.

6. The distal tip of any of claims 3-5, wherein the transducer is secured to the support surface such that at least one of the applicationspecific integrated circuits, the capacitors, orthe linear transducer array is at least partially recessed within the periphery of the housing.

7. The distal tip of claim 6, wherein the transducer is folded and set in epoxy such that the application-specific integrated circuits are directly belowthe lineartransducer array, and wherein the linear transducer array is facing away from the housing.

8. The distal tip of claim 7, wherein the linear transducer array extends beyond the periphery of the housing, and wherein the linear transducer array is aligned with the periphery of the housing.

9. The distal tip of any of claims 1-8, comprising: an image sensor mount extendingfrom the distal section toward the proximal section; and a light source mount adjacent to the image sensor mount and extending from the distal section toward the proximal section.

10. The distal tip of claim 9, wherein the image sensor mount is configured to secure an image sensor within the distal section of the housing, and wherein the light source mount is configured to secure a light source within the distal section of the housing, and wherein the image sensor and the light source are directly below the transducer at a distal edge of the housing.11 . The distal tip of any of claims 1-10, comprising: a tray configured to be installed within the distal section of the housing and defining a distal end of the distal tip, the tray including:an image sensor mount configured to mount an image sensor adjacent to the transducer and within a distal tip of the distal tip.

12. The distal tip of claim 11 , wherein the tray comprises: a distal body; and a support extendingfrom the distal body and configured to couple the tray to the housing.

13. The distal tip of claim 12, wherein the distal body includes a rectangular profile.

14. The distal tip of any of claims 12-13, wherein the distal body comprises: the image sensor mount extendingfrom the distal section toward the proximal section; and a light source mount adjacent to the image sensor mount and extending from the distal section toward the proximal section.

15. The distal tip of claim 14, wherein the image sensor mount is configured to secure the image sensor below a distal end of the mount feature, and wherein the light source mount is configured to secure a light source below the distal end of the mount feature.

16. The distal tip of any of claims 14-15, wherein the image sensor mount secures the image sensor such that a central axis of the image sensor is essentially parallel to the central axis of the housing.

17. The distal tip of any of claims 14-16, wherein the image sensor mount is configured to secure the image sensor such that a distal edge of the image sensor aligns with the distal tip of the distal tip.

18. The distal tip of any of claims 1-17, wherein the housing comprises: a first portion includingthe mount feature; and a second portion configured to be attached to the first portion such that the second portion is adjacent to the first portion.

Images