Sample collection device including tapered housing

Abstract

A distal tip for an intrabronchial ultrasound sampling device may comprise a housing, a transducer, and a lateral outlet inclined section. The housing may extend along a central axis from a proximal to a distal region. The housing may have a mounting feature that tapers toward the central axis of the housing as the housing extends from the proximal to the distal region. The transducer may be fixed to the mounting feature such that the normal vector of its substantially planar surface forms an acute angle with the central axis of the housing. The lateral outlet inclined section may be positioned proximal to the transducer and configured to direct the needle distally through the transducer's field of view along a trajectory that forms an acute angle with the central axis and intersects the normal vector of its substantially planar surface.

Description

Technical Field

[0001] Claim of Priority This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 510,243 filed on June 26, 2023, U.S. Provisional Patent Application No. 63 / 510,234 filed on June 26, 2023, and U.S. Provisional Patent Application No. 63 / 510,257 filed on June 26, 2023, the contents of each of which are hereby incorporated by reference into this specification in their entireties.

[0002] The examples described herein generally relate to endobronchial ultrasound sampling devices, such as endobronchial ultrasound sampling devices including a lateral exit ramp for collecting biopsies within the field of view of an ultrasound transducer. Background Art

[0003] Conventional endoscopes can be used in various clinical procedures, including, for example, illuminating, imaging, detecting, and diagnosing one or more pathological conditions; providing fluid delivery (e.g., saline or other agents via a fluid channel) to an anatomical region; providing passage of one or more therapeutic devices (e.g., via a working channel) for sampling or treatment of an anatomical region; and providing a suction channel for collecting fluids (e.g., saline or other agents). Such anatomical regions can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreatobiliary tract, intestine, colon, etc.), renal regions (e.g., kidney, ureter, bladder, urethra), and other internal organs (e.g., reproductive system, sinuses, submucosa, respiratory tract, etc.). Prior Art Documents Patent Documents

[0004] Patent Document 1 U.S. Patent Application Publication No. 2022 / 0313208 Patent Document 2 U.S. Patent Application No. 62 / 989,268 [Patent Document 3] U.S. Patent Application No. 16 / 991,745 [Overview of the project] [Means for solving the problem]

[0005] A sampling device is an endoscope used for a variety of clinical procedures within a patient's lung, including, for example, illuminating, imaging, detecting, and diagnosing one or more pathological conditions; providing fluid delivery (e.g., saline or other preparations via a fluid passage) toward an anatomical region; providing passage (e.g., via a working passage) for one or more therapeutic devices for sampling or treatment of an anatomical region; and providing a suction channel for collecting fluid (e.g., saline or other preparations). Sampling devices may be used to detect, treat, and sample abnormalities or malformations of a sample within the lung. Sampling devices may be used to capture a sample or biopsy of a tissue portion from within a patient's airway or lung. Sampling devices are small devices that can fit snugly into the airway and their transducers may have a limited field of view. Therefore, it can be difficult for sampling to be within the transducer's field of view, and it can be difficult to assemble such small components. In response to this, the inventors of this disclosure have developed a specific design for the distal end of an ultrasonic sampling device that moves the distal boundary of the transducer's field of view further ahead of the distal edge of the sampling device. The inventors have also developed a transducer that includes a flexible base material so that the transducer assembly can be folded to fit snugly into the mounting feature of the housing.

[0006] In this example, the distal tip for an intrabronchial ultrasound sampling device may comprise a housing, a transducer, and a lateral outlet inclined section. The housing may extend along a central axis from a proximal to a distal region. The housing may have a mounting feature that tapers toward the central axis of the housing as the housing extends from the proximal to the distal region. The transducer may be fixed to the mounting feature such that the normal vector of its substantially planar surface forms an acute angle with the central axis of the housing. The lateral outlet inclined section may be positioned proximal to the transducer and configured to direct the needle distally through the transducer's field of view along a trajectory that forms an acute angle with the central axis and intersects the normal vector of its substantially planar surface.

[0007] Various examples are shown in the attached drawings. These examples are illustrative and are not intended to be comprehensive or exclusive examples of the subject matter. [Brief explanation of the drawing]

[0008] [Figure 1] This is a schematic diagram of an example of an intrabronchial ultrasound system. [Figure 2] This is a schematic diagram of an example of an imaging and control system for an intrabronchial ultrasound sample collection device. [Figure 3] This is a perspective view of a portion of the distal tip of an example of a sample collection device with ultrasonic imaging capabilities. [Figure 4] This is a perspective view of a portion of the distal tip of an example where the distal casing is drawn with dashed lines. [Figure 5] This is a perspective view of an example of the distal casing at the distal tip. [Figure 6] This is an exploded view of an example of the distal casing at the distal tip. [Figure 7] This is a perspective view of an example of the distal casing at the distal tip. [Figure 8] This is a front view of the distal end of the distal housing at the distal tip. [Figure 9] This is a perspective view of the two-part distal housing of the distal tip example. [Figure 10] This is a perspective view of the distal end of an example of a distal casing at the distal tip. [Figure 11] This is a perspective view of an example transducer for the distal tip. [Figure 12] This is a top view of an example of an unfolded transducer for the distal tip. [Figure 13] This is a perspective view of the coupler at the distal end of the example. [Figure 14] This is a perspective view of an example of the rear end of a transducer that wraps around the lateral exit guide inclined section of a coupler at the distal tip. [Figure 15] This is an internal view from the proximal end of an example of a coupler at the distal end. [Figure 16] This is a perspective view of the proximal end of an example coupler with a distal tip. [Figure 17] This is a block diagram showing an example of a method for reprocessing a sample collection device. [Figure 18] This block diagram shows examples of machines in which one or more examples may be implemented. [Modes for carrying out the invention]

[0009] An intrabronchial ultrasound (EBUS) sampling device may be used to sense an ultrasound image at the distal tip of the sampling device. The distal tip may also include an imaging sensor (e.g., a video camera or light source) and a working passage exit for an instrument (e.g., a biopsy needle or surgical scalpel), and in more recent advances, it may also include a position sensor or orientation sensor. Existing EBUS sampling devices may utilize a rigid distal tip structure to accommodate these components. Electronic equipment may be positioned at the distal tip of the distal tip so that the ultrasound sensor (e.g., a transducer) is positioned at the distal end of the distal tip. The rest of the components within the distal tip may be positioned in close proximity to the distal tip.

[0010] A curved ultrasonic sensor may be used to enable a wide imaging field of view (FOV), and typically, a saline-filled balloon surrounding a curved ultrasonic transducer can be used to create sufficient contact between the curved ultrasonic transducer and airway tissue. Saline-filled balloons prevent the formation of such voids between the airway tissue and the transducer, since voids impair image quality. Linear ultrasonic sensors (e.g., having a generally flat planar surface) may also be used in EBUS scopes, but such sensors with a flat sensing surface generally produce a narrower FOV than curved ultrasonic sensors. The narrow nature of the FOV, in some examples, limits the depth at which a biopsy sample can be captured while being imaged in real time (e.g., because the biopsy needle diverges away from the longitudinal axis of the sampling device before reaching the sample depth and exits the distal end of the FOV). A flat sensing surface can increase the difficulty of maintaining continuous contact between the linear ultrasonic transducer and the patient's tissue (e.g., the patient's airway or bronchioles). Wiring of components within an EBUS can also present challenges because the components are very small and space for powering the components within the distal end of the distal tip is limited.

[0011] The inventor of the present disclosure has devised an alternative solution for an EBUS sampling device. The EBUS sampling device can comprise a flat ultrasonic sensor at, near to, or just beyond the outer diameter of the sampling device. A housing of the distal tip can comprise a tapered portion that can comprise mounting features to retain a flexible transducer therein. The tapering of the housing and the flexibility of the transducer (i.e., the ability of the transducer to fold prior to installation in the housing, and the ability of the trailing portion of the transducer to bend before, during, and after installation in the housing) can save space near the distal edge of the distal tip such that a video camera and a light source can be arranged at the distal end of the device, such as immediately below the ultrasonic sensor. The EBUS sampling device can comprise a wire exit that enables electrical communication to components in the distal portion of the distal tip via, for example, wires or ribbons, and such wires or ribbons can extend through the wire exit. The EBUS sampling device is discussed herein with reference to Figures 1 to 18.

[0012] The above discussion is intended to provide an overview of the subject matter of the present patent application. It is not intended to provide an exclusive or comprehensive description of the present invention. The following description is included to provide further information regarding the present patent application.

[0013] Figure 1 is a schematic diagram of an endoscopic system 100 that can comprise an imaging and control system 102, and an endobronchial ultrasound sampling configuration including an endoscope 104 and a sampling device 136, wherein the sampling device 136 is attachable to the endoscope 104 and comprises a distal end 144 that extends from the distal end of the endoscope 104 via a distal working channel port. The system in Figure 1 is an illustrative example of an endoscopic system suitable for use with the systems, devices, and methods described herein, such as a bronchoscope with linearly arranged ultrasonic elements.

[0014] The endoscope 104 may be insertable into an anatomical region for imaging, or for attachment (e.g., via a tether) to one or more sample collection devices for biopsy, or to therapeutic devices for treating pathological conditions associated with the anatomical region. The endoscope 104 may interface with or connect to the imaging and control system 102. Although the endoscope 104 is described as a bronchoscope in this example, other types of endoscopes have been considered for use with the features and teachings of this disclosure. The imaging and control system 102 may comprise a control unit 106, a display unit 108, an input unit 110, a light source 112, a fluid supply source 114, and a suction pump 116.

[0015] The imaging and control system 102 may have various ports for connection with the endoscope system 100. For example, the control unit 106 may have data input / output ports for receiving data from and communicating data to the endoscope 104. The light source 112 may have output ports for sending light to the endoscope 104, such as via an optical fiber link. The fluid supply source 114 may have ports for supplying fluid to the endoscope 104. The fluid supply source 114 may, for example, have a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 116 may have ports for drawing a vacuum from the endoscope 104 to generate suction, such as drawing fluid from the anatomical region into which the endoscope 104 is inserted. The display unit 108 and input unit 110 may be used by the endoscope system 100 technician to control the functions of the endoscope system 100 and to view the output of the endoscope 104. The control unit 106 can also generate signals or other outputs for treating the anatomical region into which the endoscope 104 is inserted. For example, the control unit 106 may generate electrical, acoustic, or fluid outputs to treat the anatomical region, for example, by cauterizing, cutting, or freezing.

[0016] The endoscope 104 may comprise an insertion section 118, a functional section 120, and a handle section 122 that can be connected to a cable section 124 and a connector section 126. The insertion section 118 may extend distally from the handle section 122, and the cable section 124 may extend proximal to the handle section 122. The insertion section 118 may be elongated and comprise a bending section and a distal end to which the functional section 120 may be attached. The bending section may be controllable (e.g., by a steering control unit 128 in the handle section 122) to maneuver the distal end through a winding anatomical passage (e.g., the stomach, duodenum, kidney, ureter, trachea, or lung). The insertion section 118 may also comprise one or more working passages (e.g., internal lumens) that can support the insertion of one or more therapeutic instruments into the functional section 120, such as a bronchoscope. The work passage may extend between the handle area 122 and the functional area 120. Additional functionality, such as fluid passage, guide wires, and tension wires, may be provided by the insertion area 118 (e.g., via a suction passage or irrigation passage).

[0017] The coupling area 126 may be connected to the control unit 106 to connect the endoscope 104 to several feature parts of the control unit 106, such as the input unit 110, the light source 112, the fluid supply source 114, and the suction pump 116.

[0018] The handle area 122 may include a control unit 128 and a port 130. The control unit 128 may be a knob, lever, or other operating mechanism that can be used to guide the endoscope 104 in the patient. The control unit 128 may be connected to a tension wire or other operating mechanism extending through the insertion area 118. Port 130 and other ports such as port 132 may be configured to connect various electrical cables, guide wires, auxiliary scopes, tissue retrieval devices, and fluid tubes to the handle area 122, such as for connection to the insertion area 118. The example shown in Figures 1 and 2 is an example of an endoscope 104.

[0019] For example, the imaging and control system 102 may be mounted on a movable platform (e.g., cart 134) with shelves for housing a light source 112, a suction pump 116, or an image processing unit 202 (Figure 2), etc. Alternatively, the components of the imaging and control system 102 shown in Figures 1 and 2 may be mounted directly on the endoscope 104 to make the endoscope "integrated".

[0020] The functional region 120 may include components for the treatment and diagnosis of the patient's anatomical structures. The functional region 120 may include, on its distal surface, an imaging device 146 (e.g., a chip-on-the-chip image sensor based on complementary metal-oxide-semiconductor (CMOS) technology), an illumination device 148 (e.g., a light-emitting diode), and a work passage port 150.

[0021] As shown in Figure 1, the sample collection device 136 may extend from the working passage port 150 on the distal surface of the functional area 120 of the endoscope 104. The sample collection device 136 may be configured to be attached to the port 132 so as to extend outside the distal end of the endoscope 104 through the working passage of the endoscope 104. The sample collection device 136 may comprise an actuator 138 for advancing or retracting the insertion area 118 within the working passage to control how far the distal end of the sample collection device 136 extends distally from the working passage port 150, an instrument actuator 142 (for example, to actuate a biopsy needle from the lateral exit port of the sample collection device 136), and a distal end 144. The actuator 138 may be configured to guide the sample collection device 136 beyond the distal end of the endoscope 104, such as to guide the sample collection device 136 to a target area in the patient. The actuator may slide along the housing 140 of the sample collection device 136. The housing 140 may include markings that can indicate the amount of extension of the sampling device 136 beyond the distal end of the endoscope 104. The instrument actuator 142 may be configured to extend the instrument from the sampling device 136 to obtain a tissue sample from the patient. The distal end 144 of the sampling device 136 may comprise a transducer (or other imaging device) and a lateral exit port located proximal to the transducer for directing the instrument configured to obtain a tissue sample from the patient into the field of view of the transducer. The sampling device 136 is described in more detail herein.

[0022] Figure 2 is a schematic diagram of the endoscopic system 100 of Figure 1, which includes an imaging and control system 102 and an intrabronchial ultrasound configuration including an endoscope and a sample collection device 136 extendable through the distal working passage port of the endoscope. Figure 2 schematically shows the components of the imaging and control system 102 connected to the endoscope 104. The imaging and control system 102 may include a control unit 106, which may include, or be connected to, a light source 112, an input unit 110, and a display unit 108, as well as an image processing unit 202, a treatment generator 206, and a drive unit 208. The control unit 106 may include, or be able to communicate with, an endoscope, surgical instruments, and an endoscopic system, which may include devices configured to engage with tissue and collect and store portions of that tissue, and through these endoscopes, surgical instruments, and endoscopic systems, an imaging device (e.g., a camera) may be able to view the target tissue by including optically enhanced materials and components. The control unit 106 may be configured to activate a camera to view distal target tissue of the endoscope system. Similarly, the control unit 106 may be configured to activate a light source 112 to illuminate surgical instruments, which may include selected components configured to reflect light in a specific manner, such as a tissue cutter being enhanced with reflective particles.

[0023] The coupling area 126 may be connected to the control unit 106 to connect the endoscope 104 to several feature units of the control unit 106, such as the image processing unit 202 or the treatment generator 206. In the example, port 130 may be used to insert other instruments or devices such as a dotascope, auxiliary scope, sampling needle, biopsy needle, cauterizing instrument, or surgical scalpel into the endoscope 104. Such instruments and devices can be independently connected to the control unit 106 via the cable area 124. In the example, port 132 may be used to connect the coupling area 126 to various inputs and outputs such as video, air, light, and electricity.

[0024] The image processing unit 202, the ultrasound image processing unit 204, and the light source 112 can interact with the endoscope 104 (e.g., in the functional area 120) or the sample collection device 136, respectively, by wired or wireless electrical connections. Thus, the imaging and control system 102 can illuminate anatomical regions, collect signals representing anatomical regions, process signals representing anatomical regions, and display images representing anatomical regions on the display unit 108. The ultrasound image processing unit 204 can be configured to receive ultrasound signals from either the endoscope 104 or the sample collection device 136, which can be converted into ultrasound images and transmitted to the display unit 108 or any other component of the endoscope system 100. The imaging and control system 102 may include the light source 112 to illuminate anatomical regions using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). The imaging and control system 102 can be connected to the endoscope 104 (for example, via an endoscope connector) for signal transmission (e.g., light output from a light source, video signals from the imaging system at the distal end, diagnostic signals and sensor signals from a diagnostic device).

[0025] The fluid supply source 114 (shown in Figure 1) can communicate with the control unit 106 and may include one or more sources of air, saline solution, or other fluids, as well as associated fluid pathways (e.g., air passages, irrigation passages, and suction passages) and connectors (barb fittings, fluid seals, and valves). The imaging and control system 102 may also include a drive unit 208 which may include a motor drive for advancing the distal section of the endoscope 104.

[0026] Figure 3 shows a perspective view of a portion of the distal tip 302 of an example of a sample collection device 300. A sample collection device 300 (e.g., an endoscope 104 shown in Figures 1 and 2) may be an example of an intrabronchial ultrasound (EBUS) sample collection device that can be inserted into a patient's airway (e.g., through the trachea into the bronchi) to take a biopsy sample, capture an image, or remove (e.g., excise) one or more tissues from the patient's lung. In some examples, the sample collection device 300 may be an EBUS sample collection device that facilitates real-time ultrasound imaging of a target tissue, such as a solitary pulmonary nodule (SPN), while a procedure is being performed on the target tissue. Exemplary procedures include obtaining a biopsy sample of the target tissue (e.g., for removal and pathological analysis), performing cauterization on the target tissue, and injecting drugs into the target tissue. The distal tip 302 may be connected to the insertion area 118 (Figures 1 and 2) of the sample collection device 300 for insertion into the patient's lung. The distal tip 302 may be connected to the insertion area 118 by a rigid connection that helps maintain the distal tip 302 in the direction in which the insertion area 118 is maneuvered within the patient. The distal tip 302 may also be attached to the insertion area 118 by a rotatable connection (which can rotate around one or more axes) that allows a medical professional to further influence or maneuver the distal tip 302 as it extends into the patient.

[0027] The distal tip 302 (e.g., functional region 120 (Figures 1 and 2)) can perform tasks during bronchoscopy. For example, the distal tip 302 can capture images of the patient's lungs (e.g., digital images or ultrasound images), 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 a surgical scalpel or forceps). The distal tip 302 may include a connector 304 and a housing 312.

[0028] The coupler 304 may extend along the longitudinal axis LA from a proximal portion 306 to a distal portion 308. The distal portion 308 of the coupler 304 may be connected to the proximal section 314 of the housing 312. The coupler 304 may include a lumen 309 and a lateral outlet inclined portion 310. The lumen 309 and the lateral outlet inclined portion 310 may extend within the coupler. For example, the lumen 309 may extend from the proximal portion 306 to the lateral outlet inclined portion 310, and the lateral outlet inclined portion 310 may extend from the lumen 309 through the side of the coupler 304. The lumen 309 may be substantially circular and may match a flexible needle lumen embedded in the flexible sheath of the EBUS endoscope. Therefore, instruments (e.g., biopsy (or sample collection) needles, surgical scalpels, forceps, laser-cut TBNA needles, or cauterization devices) can extend through a port at the proximal end of the EBUS endoscope, through a flexible needle lumen, into the lumen 309, then to the lateral outlet inclined section 310, and finally out of the lateral outlet inclined section 310. Thus, the lateral outlet inclined section 310 may be configured to direct the instrument 311 toward the patient's tissue through the side of the connector 304.

[0029] The housing 312 may extend along the central axis CA from the proximal region 314 to the distal region 316. The housing 312 may include a mounting feature 318 which can be configured to receive a transducer 320. The mounting feature 318 may taper toward the central axis CA, toward the central axis CA, or beyond the central axis CA as the housing 312 extends from the proximal region 314 to the distal region 316. As shown, the mounting feature 318 may converge toward CA near the most distal tip of the distal region 316, and this converged nature of the mounting feature 318 may result in the transducer 320 tilting forward toward the most distal tip of the distal region 316. The tapering of the mounted feature section 318 allows the distal boundary of the transducer's field of view 322 to be moved forward, so that the field of view 322 of the transducer 320 captures the instrument 311 at a greater depth as the instrument 311 extends from the lateral exit inclined section 310 into the patient's tissue. In other words, the forward tilting nature of the linear transducer results in the field of view produced by the linear transducer being tilted forward relative to the lateral exit port, which increases the depth to which the target nodule can be biopsied while it remains in the field of view. This is because as the sampling device moves further from the proximal end of the FOV to the distal end of the FOV, the sampling device penetrates deeper into the tissue (e.g., further from the transducer). 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. Compared to EBUS sampling devices where the linear transducer is aligned with the longitudinal axis of the device (e.g., parallel) (e.g., the device depicted in Figure 2A of U.S. Patent Application Publication 2022 / 0313208), the forward-tilting nature of the linear transducer increases the distance the needle can extend distally from the exit inclined section while remaining within the FOV, thereby enabling deeper sampling during real-time visualization of the sampling device in the US image.

[0030] For example, as shown in Figure 3, angle 324 may be the angle along the tapered or mounted feature portion 318 of the housing 312 and the field of view 322 of the transducer 320. As shown in Figure 3, angle 324 may be acute (i.e., less than 90 degrees) so that the field of view 322 extends beyond the distal edge 321 of the transducer 320. Angle 326 may be the angle between the coupler 304 and the tapered or mounted feature portion 318 of the housing 312. As shown in Figure 3, angle 326 may be obtuse (i.e., greater than 90 degrees). This causes the transducer 320 to tilt toward the distal area 316 of the housing 312 so that the field of view 322 of the transducer 320 extends beyond the distal edge 321 of the transducer 320.

[0031] Furthermore, the tapering of the housing 312 and the mounting feature 318 can help the transducer 320 engage with the lung airway tissue to prevent a gap between the transducer 320 and the inner wall of the lung airway, thereby helping to improve the ultrasound image captured by the transducer 320. In addition, the tapering of the housing 312 and the mounting feature 318 can help the distal tip 302 to be guided through the patient's airway and lung because the housing 312 has a smaller diameter in the distal portion of the distal tip 302, which may make it easier to guide into new airways and lung areas in the patient's lung than a distal tip with a constant diameter from proximal to distal.

[0032] The transducer 320 may be a linear array transducer. The transducer 320 may extend from the proximal edge 331 to the distal edge 321. The transducer 320 may be configured to capture ultrasound images of the patient's tissue during sampling of the patient's target tissue via the instrument 311. The transducer 320 is discussed in more detail herein.

[0033] Figure 4 shows a perspective view of a portion of the distal tip 302 of an example of a sampling device 300 with a housing 312 (shown by dashed lines). The housing 312 may include grooves 424 (e.g., a first groove 424A and a second groove 424B in Figure 9). The first groove 424A and the second groove 424B may be aligned with each other, for example, along a common plane. Alternatively, the first groove 424A and the second groove 424B may be offset from each other. The grooves 424 may extend from the proximal region 314 toward the distal region 316 of the housing 312. As seen in Figure 9, the first groove 424A may be angularly offset from the second groove 424B, and each of the grooves 424 may be configured to receive an electromagnet coil 426. It is understood that the angular displacement between the grooves 424 allows the pair of electromagnet coils 426 to capture all six degrees of freedom of motion of the sample collection device 300 when the sample collection device 300 is guided within the patient. The relationship between the electromagnet coils 426 and the angular displacement between the grooves 424 is examined in more detail with reference to Figure 9.

[0034] As shown in Figure 4, the distal tip 302 may include an image sensor 428 and a light source 430. The image sensor 428 and light source 430 may be connected to an image processing unit (for example, image processing unit 202 or ultrasonic image processing unit 204, see Figure 2) and a light source 112 (Figure 1), respectively. The distal tip 302 may be configured to receive the image sensor 428 and light source 430 at the distal tip 305 of the distal tip 302, so that the image sensor 428 and light source 430 define the distal end 303 of the distal tip 302. Thus, the image sensor 428 and light source 430 may be installed in the housing 312 immediately below the transducer 320.

[0035] The image sensor 428 and light source 430 may be positioned closer to the distal end 303 of the distal tip 302 than the distal edge 321 of the transducer 320. The image sensor 428 and light source 430 may be positioned at equal distances from the distal edge 321 of the transducer 320 and the distal end 303 of the distal tip 302. Since the image sensor 428 and light source 430 can be mounted below or near the distal end 303 of the distal tip 302 than the transducer 320, they can be mounted at an angle that aligns with the central axis CA of the housing 312 (an angle that is substantially parallel or oblique to the central axis CA).

[0036] Figure 5 shows a perspective view of an example of the housing 312 of the distal tip 302. As shown in Figure 5, the mounting feature 318 may have a support surface 532. The support surface 532 may be recessed into the periphery 313 of the housing 312. The transducer 320 (Figure 3) may be fixed to the support surface 532 in order to hold the transducer 320 within the mounting feature 318.

[0037] As shown in Figure 5, the support surface 532 may begin in the proximal region 314 of the housing 312 and extend toward the distal region 316 of the housing 312 along the tapering (e.g., a forward-sloping and substantially planar surface) of the mounting feature 318. The support surface 532 may include a transducer tail inclined portion 534, which can guide the tail portion of the transducer 320 through the proximal region 314 of the housing 312. The transducer tail inclined portion 534 may taper toward the central axis CA of the housing 312, which can provide space for the tail portion of the transducer 320 as it extends through the proximal region 314 of the housing 312 to the coupler 304 (Figure 3).

[0038] The support surface 532 may be interrupted in front of the distal region 316 of the housing 312. This allows the support surface 532, the mounting feature 318, and the tray 640 to define a fill gap 536. The fill gap 536 may be configured to receive a binder (e.g., an embedding epoxy resin, polymer, or any other filler that can be used to fix the components of the sampling device 300 into the housing 312). This allows the binder to be injected through the fill gap 536 to help fix the components into the housing 312. The binder material extending outward from the fill gap 536 can help fix the transducer 320 to the mounting feature 318 and the support surface 532. In this example, a binder such as epoxy resin may be used to fix the components into the housing 312, so that the binder can be filled using the fill gap 536 to hold the fixed components in place during use of the sampling device 300.

[0039] The degree of recession of the support surface 532 relative to the periphery 313 of the housing 312 may be adjusted to coordinate the relationship between the transducer 320 and the periphery 313 of the housing 312. For example, the recession of the support surface 532 relative to the periphery 313 of the housing 312 can be increased to fix the transducer 320 so that it aligns with the periphery 313 of the housing 312. The recession of the support surface 532 relative to the periphery 313 of the housing 312 can be decreased to fix the transducer 320 so that it 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 patient's airway and lung tissue when the transducer 320 captures ultrasound images of the patient's tissue. In devices where the distal end of the EBUS device is maneuverable, a clinician can operate the maneuvering mechanism to bring the transducer surface into direct contact with the tissue surface, thereby substantially eliminating the gap between the transducer and the tissue surface. It is understood that eliminating the gap between the ultrasound transducer and the tissue intended to be imaged can improve image quality, as the gap can result in high impedance mismatch and interfere with the transmission of ultrasound energy. Some existing ultrasound systems (e.g., many curved EBUS devices) utilize an inflatable balloon that can be inflated with saline to provide ultrasound contact. The objective of the devices disclosed herein is to achieve such ultrasound contact via direct contact between the ultrasound transducer and the tissue wall.

[0040] Figure 6 shows an exploded view of an example of the housing 312 of the distal tip 302 of the sample collection device 300. The distal tip 302 is configured to be installed in the distal area 316 of the housing 312 and may include a tray 640 that defines the distal end 303 of the distal tip 302. When installed on the distal end 303 of the distal tip 302, the tray 640 can at least partially cover the distal edge 321 (Figure 4) of the transducer 320. The tray 640 may include a distal body 642 and a support 644.

[0041] The support 644 extends from the distal body 642 and may be configured to connect the tray 640 to the housing 312. For example, the distal body 642 may have a mechanical interface that may be complementary to the mechanical interface in the housing 312 in order to removably secure the tray 640 within the housing 312. The distal body 642 may have a surface configured to be fixed to the surface of the housing 312 with epoxy resin or any other binder. For example, the surface may have a rough surface finish, grooves, or protrusions, etc., to help the epoxy resin hold the tray within the housing 312.

[0042] The distal body 642 may have a rectangular contour, as shown in Figure 6. The distal body 642 may have any other contour near the distal area 316 of the housing 312 that coincides with or substantially coincides with the periphery 313 of the housing 312. The distal body 642 may comprise an image sensor mounting section 646 and a light source mounting section 648. The image sensor mounting section 646 may be adjacent to the light source mounting section 648. As shown in Figure 6, the image sensor mounting section 646 and the light source mounting section 648 may be openings formed in the distal body 642. The image sensor mounting section 646 and the light source mounting section 648 may be configured to receive at least a portion of an image sensor 650 and a light source 652 (e.g., an LED light-emitting diode), respectively.

[0043] As shown in Figure 6, an image sensor 650 (e.g., image sensor 428 (Figure 4)) and a light source 652 (e.g., light source 430 (Figure 4)) may be mounted adjacent to each other as part of an imaging assembly 654. The imaging assembly 654 may be configured to be mounted on the support 644 of the tray 640 before the tray 640 is installed in the housing 312. The image sensor 650, the light source 652, and the imaging assembly 654 are discussed in more detail herein.

[0044] Figures 7 and 8 are discussed together below. Figure 7 shows a perspective view of an example of the housing 312 of the distal tip 302. Figure 8 is a front view of the distal region 316 of the housing 312 of the distal tip 302.

[0045] The image sensor mounting section 646 may be configured to mount the image sensor 650 adjacent to the transducer 320 within the distal tip 305 of the distal tip 302. The image sensor mounting section 646 may be configured to fix the image sensor 650 below the distal edge 321 of the transducer 320 (shown in Figure 8) (or the distal end of the mounting feature section 318). The image sensor mounting section 646 may be configured to mount the image sensor 650 such that the central axis CAI of the image sensor 650 is essentially parallel to the central axis CA of the housing 312. The image sensor mounting section 646 can mount the image sensor 650 such that the distal edge of the image sensor 650 is aligned with the distal tip 305 of the distal tip 302. The image sensor mounting section 646 can mount the image sensor 650 such that the distal edge of the image sensor 650 is aligned adjacent to the distal tip 305 of the distal tip 302. Therefore, because the distal edge of the image sensor 650 is located near or close to the distal tip 305 of the distal tip 302, the image sensor 650 can capture video of the distal tip 302 without other components of the distal tip 302 (e.g., the mounted feature section 318 or transducer 320) obstructing or interfering with the field of view of the image sensor 650.

[0046] The light source mounting section 648 may be configured to mount the light source 652 adjacent to the transducer 320 and within the distal tip 305 of the distal tip 302. The light source mounting section 648 may be configured to fix the light source 652 below the distal edge 321 of the transducer 320 (both in Figure 8) (or the distal end of the mounting feature section 318). The light source mounting section 648 may be configured to mount the light source 652 such that its central axis CAL is essentially parallel to the central axis CA of the housing 312. The light source mounting section 648 can mount the light source 652 such that its distal edge is aligned with the distal tip 305 of the distal tip 302. The light source mounting section 648 can mount the light source 652 such that its distal edge is aligned adjacent to the distal tip 305 of the distal tip 302. Therefore, because the light source 652 is located near or at the distal tip 305 of the distal tip 302, the light source 652 can provide light to the distal tip 302 without other components of the distal tip 302 (e.g., mounted feature 318 or transducer 320) obstructing or interfering with the light from the light source 652.

[0047] Figures 9 and 10 are discussed together below. Figure 9 shows a perspective view of an example two-part housing 912. Figure 10 shows a perspective view of a two-part housing 912. The two-part housing 912 may be configured to facilitate the assembly of the housing and the distal end 302 (Figure 3) by providing further access to the housing and allowing for easier arrangement of components within the distal end 302. As shown in Figures 9 and 10, the two-part housing 912 may comprise a first part 960 and a second part 962. The first part 960 and the second part 962 may be configured to be mounted adjacent to each other when the two-part housing 912 is assembled.

[0048] As shown in Figures 9 and 10, the first portion 960 may include a mounting feature 318. The first portion 960 may also include a first mounting interface 964 and a wire cutout 966. The first mounting interface 964 may be recessed into the periphery 913 of the two-part housing 912. The first mounting interface 964 may be configured to be inserted into the distal portion 308 (Figure 3) of the coupler 304 (Figure 3). The wire cutout 966 may be configured to direct one or more wires of the transducer 320 toward the distal portion 308 (Figure 3) of the coupler 304 in order to mount the two-part housing 912 onto the coupler 304.

[0049] The second portion 962 may include a mounting interface 968. The mounting interface 968 can be retracted into the periphery 913 of the two-part housing 912 and inserted into the distal portion 308 of the coupler 304 for mounting the two-part housing 912 onto the coupler 304. The mounting interface 968 may include a clocking projection 974. The clocking projection 974 may extend radially outward from the second portion 962 and may be engageable with the coupler 304 to ensure proper mounting of the two-part housing 912 to the coupler 304 (Figure 3). As shown in Figure 9, the clocking projection 974 may extend from the second portion 962 toward the proximal portion 914 of the two-part housing 912. The clocking projection 974 can be generally rectangular, as shown in Figure 9, or it can be circular, square, or any other shape that may be complementary to the features on the coupler 304 in order to ensure proper alignment of the two-part housing 912 when the two-part housing 912 is inserted into the coupler 304, etc. Proper alignment of the two-part housing 912 and the coupler 304 helps ensure that the field of view of the transducer (e.g., the field of view 322 of transducer 320 (Figure 3)) captures the medical instrument (e.g., instrument 311 (Figure 3)) when the medical instrument extends from the lateral exit inclined portion of the coupler (e.g., the lateral exit inclined portion 310 of coupler 304 (Figure 3)).

[0050] As shown in Figure 9, the first portion 960 may be provided with alignment projections 970, and as shown in Figure 10, the second portion 962 may be provided with alignment grooves 972. The alignment projections 970 and the alignment grooves 972 may be complementary to align the first portion 960 with the second portion 962 during the assembly of the two-part housing 912. In the example, the first portion 960 may include any other alignment characteristics (e.g., surface finish, shape, or pattern) or features (e.g., grooves, ridges, or projections) that may be complementary to align the characteristics or features of the second portion 962.

[0051] The first portion 960 of the two-part housing 912 may also include grooves 424. The first groove 424A may extend from the proximal region 914 to the distal region 916 of the two-part housing 912. The second groove 424B may extend from the proximal region 914 to the distal region 916 of the two-part housing 912. The first groove 424A and the second groove 424B may be angularly offset from each other. Each of the grooves 424 may be configured to receive an electromagnet coil 426.

[0052] The electromagnet coil 426 in groove 424 can assist in guiding the sample collection device 300 (Figure 3), more specifically, in guiding the distal tip 302 (Figure 3) within the patient. In this example, an external coil array can generate an electromagnetic field so that the position and orientation of the electromagnet coil 426 can be detected within the electromagnetic field. As the distal tip 302 moves within the patient's body, changes in the position and orientation of the distal tip 302 can be detected by the electromagnet coil 426. Such changes in the position and orientation of the distal tip 302 detected by the electromagnet coil 426 can be transmitted to a control system (e.g., imaging and control system 102, see Figure 1).

[0053] In the example, each of the electromagnet coils 426 may have five degrees of freedom. The angular displacement of the groove 424 allows two five-degree-of-freedom coils (e.g., electromagnet coils 426) to obtain six-degree-of-freedom induction data. Thereafter, pitch, yaw, roll, anterior-posterior direction, vertical straightness, and horizontal straightness can be determined for the distal tip 302 (Figure 3) through each combination of the electromagnet coils 426 installed in the groove 424. Thus, the precise location and position of the distal tip 302 can be tracked throughout the medical procedure by a control system (e.g., imaging and control system 102 (Figure 1)). The control system may have warnings, signals, or attention based on any of the sensed orientations of the distal tip 302 in the patient.

[0054] As described herein and shown in Figure 10, the imaging assembly 654 may be connected to the image sensor 650 and the light source 652, respectively. The proximal end 656 of the imaging assembly 654 may include an electrical pad 658. The electrical pad 658 may be configured such that the wire 660 is fixed to the electrical pad 658 so that the image sensor 650 and the light source 652 are electrically connected to the wire 660. The wire 660 may be configured to connect to a control system (e.g., imaging and control system 102 (Figure 1)) so that the control system is connected to the image sensor 650 and the light source 652 via the wire 660, the imaging assembly 654, and the electrical pad 658. As shown in Figure 10, the imaging assembly 654 may be directly connected to the second part 962 of the two-part housing 912. In the example, the second part 962 may also accept a tray (e.g., tray 640 (Figure 6)) to accept the image sensor 650 and the light source 652.

[0055] Figures 11 and 12 are considered together. Figure 11 shows a perspective view of an example of transducer 320. Figure 12 shows a perspective view of an example of transducer 320 in an unfolded orientation for the distal tip of a sample collection device.

[0056] As shown in Figures 11 and 12, the transducer 320 may be placed on a flexible substrate that can be folded from a flat configuration as shown in Figure 12, as shown in Figure 11. The transducer 320 may be part of an imaging assembly 1100. The imaging assembly 1100 may comprise a substrate 1102, an application-specific integrated circuit 1104, a capacitor 1106, and a linear transducer array 1108.

[0057] The flexibility of the substrate 1102 of the transducer 320 can help the transducer 320 fit into a housing (e.g., housing 312 (Figure 3)) while reducing the area (within the housing) required to mount the transducer 320. Thus, the foldable substrate 1102 helps reduce the size of the housing so that it can taper from the proximal area (e.g., proximal area 314 (Figure 3)) to the distal area (e.g., distal area 316 (Figure 3)). As shown in Figure 12, the transducer 320 may comprise an application-specific integrated circuit 1104, a capacitor 1106, and a linear transducer array 1108. The application-specific integrated circuit 1104, the capacitor 1106, and the linear transducer array 1108 can each be mounted on the flexible substrate 1102. As shown in Figure 11, the transducer 320 may comprise a ribbon tail 1110.

[0058] The substrate 1102 may be a laminated structure comprising a coverlay, an electrical insulating layer, a conductive feature portion, and an adhesive. In the example, the coverlay and the electrical insulating layer may be made from polyimide. The conductive layer may be etched, pathed, or traced using copper, stainless steel, aluminum, or any other conductive material. The substrate 1102 may be made using any other process that enables the flexibility of the substrate 1102, or from a material that enables the flexibility of the substrate 1102, so that it can be folded to be installed in the housing 312 (Figure 3).

[0059] The application-specific integrated circuit 1104 can be configured to receive signals from the linear transducer array 1108 and to transmit one or more signals in response to signals received from the linear transducer array 1108. The capacitor 1106 can help provide geometric and mechanical flexibility to the imaging assembly 1100. The linear transducer array 1108 can generate signals based on tissue within the field of view of the transducers. Signals from the linear transducer array 1108 can be received by the application-specific integrated circuit 1104, the capacitor 1106, or any other component of the imaging assembly 1100, such as the endoscope system 100 (Figure 1) or the sample collection device 300 (Figure 3). In some examples, the imaging assembly 1100 may be configured to implement synthetic aperture imaging techniques to enable array imaging with a reduced number of transmit lines. This reduced number of transmit lines provides the benefits of smaller dimensions (e.g., a smaller device diameter due to fewer transmit lines extending from the distal end to the proximal end), as well as reduced power consumption and / or heat generation. Additional details associated with the exemplary imaging assembly 1100 are described in both U.S. Patent Application No. 62 / 989,268 filed March 13, 2020, and U.S. Patent Application No. 16 / 991,745 filed August 12, 2020, each of which is incorporated herein by reference in their whole.

[0060] As described herein, the substrate 1102 can be fixed to a support surface (e.g., support surface 532 (Figure 5)) of a mounting feature (e.g., mounting feature 318 (Figure 3)). The substrate 1102 can be fixed to the support surface such that the application-specific integrated circuit 1104, capacitor 1106, and linear transducer array 1108 are at least partially recessed into the periphery of the housing (e.g., periphery 313 (Figure 3)). The substrate 1102 can be fixed to the support surface such that the application-specific integrated circuit 1104, capacitor 1106, and linear transducer array 1108 are fully recessed into the periphery of the housing (e.g., periphery 313 (Figure 3)). The substrate 1102 can be fixed to the support surface such that at least one of the application-specific integrated circuit 1104, capacitor 1106, or linear transducer array 1108 is at least partially recessed into the periphery of the housing (e.g., periphery 313 (Figure 3)).

[0061] As discussed herein, epoxy resin or any other curing agent may be used to fix the transducer 320 within the mounting feature. The substrate 1102 of the transducer 320 is foldable and can be cured with epoxy resin or any other curing agent so that the application-specific integrated circuit 1104 is directly beneath the linear transducer array 1108. The substrate 1102 of the transducer 320 is foldable and can be cured with epoxy resin or any other curing agent so that the application-specific integrated circuit 1104 is between the linear transducer array 1108 and the image sensor or light source (e.g., image sensor 428 or light source 430 (Figure 4)).

[0062] The substrate 1102 of the transducer 320 is foldable and can be compacted within the mounting feature area so that the linear transducer array 1108 faces away from the housing (e.g., housing 312 (Figure 3)). The substrate 1102 of the transducer 320 is foldable and can be compacted within the mounting feature area so that the linear transducer array 1108 extends beyond the periphery of the housing (e.g., the periphery 313 of housing 312 (Figure 3)). The substrate 1102 of the transducer 320 is foldable and can be compacted within the mounting feature area so that the linear transducer array 1108 aligns with the periphery of the housing (e.g., the periphery 313 of housing 312 (Figure 3)).

[0063] The ribbon tail 1110 is flexible and can extend from the proximal edge 331 of the transducer 320. For example, the ribbon tail 1110 can extend to a coupler (e.g., coupler 304 (Figure 3)). The ribbon tail 1110 can communicate with the transducer 320. The ribbon tail 1110 may be equipped with an electrical pad 1114 at its proximal end 1113. The electrical pad 1114 can communicate with the transducer 320 and may be configured to which a wire 1116 can be attached. For example, the electrical pad 1114 can electrically connect the ribbon tail 1110 to the wire 1116. The wire 1116 may be configured to connect the electrical pad 1114 to a control system (e.g., an imaging and control system 102 (Figure 1)) so that the control system is connected to the transducer 320 via the wire 1116 and the electrical pad 1114.

[0064] The ribbon tail 1110 may include a first bend 1111 that can be routed downward beyond the proximal area of ​​the housing (e.g., the proximal area 314 of the housing 312) in a contour that remains substantially perpendicular to the longitudinal axis LA of the coupler 304. The ribbon tail 1110 may include a second bend 1112 that can generally wrap upward around the longitudinal axis LA of the coupler 304 (Figure 3). The second bend 1112 may include an electrical pad 1114. The electrical pad 1114 may be configured to connect a wire 1116 to the second bend 1112 of the ribbon tail 1110. The combination of the first bent portion 1111 and the second bent portion 1112 allows the ribbon posterior portion 1110 to move proximal away from the transducer (e.g., away from the side of the device having a lateral exit port) while moving downward, in order to provide space from the inclined portion (from which the biopsy needle can protrude into the patient's tissue within the FOV of the US transducer) and consequently wrap around the inclined portion (e.g., the needle lumen) as shown in Figure 16. The trumpet-shaped or flared nature of the second bent portion 1112 provides increased spacing between electrical solder points. As shown in Figure 11, the first bent portion 1111 includes bending properties substantially limited to bending in a first plane, and the second bent portion 1112 includes bending properties substantially limited to bending in a second plane different from the first plane. This configuration, with a first bend and a second bend, allows the first bend in the plane to lower or move the ribbon tail portion 1110 below the inclined portion of the coupler (as shown in Figures 13 and 14), and then transition to a second bend in the plane (for example, in the portion between the first and second bends) that wraps the ribbon tail portion 1110 around the inclined portion in the wiring exit passage 1410.

[0065] Figures 13 to 16 are considered together. Figure 13 shows a perspective view of a coupler (e.g., coupler 304 (Figure 3)) in an example of a distal tip (e.g., distal tip 302) of a sample collection device (e.g., sample collection device 300 (Figure 3)). Figure 14 shows a perspective view of an example of the ribbon tail portion 1110 of a transducer 320 that wraps around the lateral outlet inclined portion 310 of coupler 304 in an example of a distal tip 302. Figure 15 shows an internal view of an example of coupler 304 of a distal tip 302 from the proximal end (e.g., from the proximal portion 306). Figure 16 shows a perspective view of the proximal end (e.g., proximal portion 306) of coupler 304 in an example of a distal tip 302.

[0066] As described herein, the coupler 304 may extend from a proximal portion 306 to a distal portion 308. The coupler 304 may include a lateral outlet inclined portion 310 extending from the proximal portion 306 through a side portion 1302 of the coupler 304. The lateral outlet inclined portion 310 can direct an instrument (e.g., instrument 311 (Figure 3)) toward patient tissue through the side portion 1302 of the coupler 304. As shown in Figures 14 to 16, the coupler 304 may include a wiring exit passage 1410.

[0067] The wiring exit passage 1410 can be positioned below the lateral exit inclined section 310 and can wrap around the lateral exit inclined section 310 at least partially. Furthermore, the wiring exit passage 1410 can be positioned directly below the pair of electromagnet coils 426 (Figure 9). The wiring exit passage 1410 may be generally U-shaped, with an inner contour substantially concentric with the lateral exit inclined section 310 and an outer contour substantially concentric with the outer contour of the coupler 304. As discussed herein, the ribbon tail section 1110 can extend from the transducer 320 to the coupler 304. For example, the ribbon tail section 1110 can extend from the transducer 320 to the wiring exit passage 1410 of the coupler 304. As discussed herein, the second bent section 1112 may comprise an electrical pad 1114 (Figure 11). The electrical pad 1114 may be distal to the wiring exit passage 1410. The electrical pad 1114 may be located within the wiring exit passage 1410.

[0068] As shown in Figure 15, the ribbon tail portion 1110 can be divided into a first portion 1502 and a second portion 1504. The first portion 1502 and the second portion 1504 may extend around the lateral outlet inclined portion within the coupler (for example, the lateral outlet inclined portion 310 of the coupler 304).

[0069] As shown in Figures 13 and 14, the coupler 304 may be provided with a locking groove 1304. As shown in Figure 14, the housing 312 may be provided with a locking tab 1412. The locking tab 1412 may be complementary to the locking groove 1304 in order to hold the coupler 304 and the housing 312 together after installation or assembly of the coupler 304 and the housing 312. The coupler 304 and the housing 312 may be provided with any other complementary locking mechanisms, such as threads, pins, grooves, ridges, projections, or any other mechanism that can hold the coupler 304 and the housing 312 together during the operation of the sampling device 300.

[0070] As discussed in Figure 9, the clocking projection 974 may extend radially outward from the second portion 962 (Figure 9) and may be engageable with the coupler 304 to ensure proper alignment of the housing (e.g., housing 312 or two-part housing 912) with the coupler 304. As shown in Figure 14, the coupler 304 may be equipped with a clocking feature (e.g., a clocking groove 1414). The clocking groove 1414 may be formed in the proximal area 314 of the housing 312. The clocking groove 1414 may be complementary to the clocking projection 974 to ensure proper alignment of the coupler 304 and the housing (e.g., housing 312 (Figure 3) or two-part housing 912 (Figure 9)) during assembly or installation of the coupler 304 and the housing. The second portion 962 and the clocking groove 1414 are merely example alignment indicators that may be used to ensure that the coupler 304 and the housing 312 are aligned. The inventors of this application understand that there are many other alignment tools, mechanisms, aids, or guides that can be used to ensure that the coupler 304 and the housing 312 are properly aligned when the coupler 304 and housing 312 are assembled such that the device 311 extends into the field of view 322 of the transducer 320 as the transducer 320 extends from the lateral outlet inclined portion 310 of the coupler 304.

[0071] Figure 17 is a schematic diagram of an example of Method 1700. Method 1700 may be a method for reprocessing a sample collection device (e.g., endoscope 104 or sample collection device 300). A clearer example of Method 1700 is discussed below. Although the steps or operations of Method 1700 are shown in a specific order for convenience and clarity, many of the operations discussed can be performed in a different order or in parallel without substantially affecting other operations. Method 1700 as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that a subset of the operations discussed in Method 1700 may be attributable to a single actor, device, or system and may be considered a separate, independent process or method.

[0072] A reprocessing method 1700 for the above-mentioned treatment instruments (e.g., endoscope 104 or sample collection device 300) will be described with reference to Figure 17. The above-mentioned treatment instruments (e.g., endoscope 104 or sample collection device 300) may be discarded after a single use or may be reused multiple times. In the case of a configuration for reuse multiple times, for example, the reprocessing method 1700 shown in Figure 17 may be relevant.

[0073] After a used treatment instrument (e.g., endoscope 104 or sample collection device 300) has been used for treatment, the technician can collect the used instrument and transport it to a factory or other location (step S1). At this time, the used treatment instrument (e.g., endoscope 104 or sample collection device 300) may be transported in a dedicated container to prevent contamination from the treatment instrument (e.g., endoscope 104 or sample collection device 300).

[0074] At that time, the technician can clean and sterilize the used treatment instruments (e.g., endoscope 104 or sample collection device 300) that are to be collected and transported (step S2). Specifically, when cleaning the treatment instruments (e.g., endoscope 104 or sample collection device 300), any deposits adhering to the outside of the distal tip 302 (e.g., connector 304 or housing 312) may be removed using a brush or the like. Subsequently, to remove pathogenic microorganisms derived from blood, body fluids, etc., the distal tip 302 may be cleaned using an isopropanol-containing cleaning agent, a proteolytic enzyme detergent, and an alcohol cleaning solution. The cleaning liquid is not limited to the cleaning liquid described above, and other cleaning liquids may be used. Furthermore, in sterilizing the treatment instruments (e.g., endoscope 104 or sample collection device 300), any of the following methods can be used to sterilize pathogenic microorganisms adhering to the distal tip 302: autoclaving, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide, and hydrogen peroxide pasteurization. The distal tip 302 components, specifically the coupler 304 and the housing 312, can be disassembled by a clip or fixing feature (e.g., a first mounting interface 964 or a locking tab 1412) to disconnect the coupler 304 and the housing 312.

[0075] The technician may perform an acceptance check of the used treatment instrument (e.g., endoscope 104 or sample collection device 300) (step S3). Specifically, the technician may check whether the used treatment instrument (e.g., endoscope 104 or sample collection device 300) has a significant malfunction or whether the used treatment instrument (e.g., endoscope 104 or sample collection device 300) has exceeded the maximum number of reprocessing cycles.

[0076] Next, the technician can disassemble the used treatment instrument (e.g., the endoscope 104 or the sample collection device 300) (step S4). The technician can disassemble the distal tip 302 by removing the housing 312 from the connector 304 and removing all components from the connector 304 and housing 312.

[0077] After step S4, several parts are replaced (step S5). For example, one of the components of the distal tip 302, or one of the components in the coupler 304 or the housing 312 may be replaced during step S4.

[0078] After step S5, the technician can assemble a new treatment instrument (e.g., an endoscope 104 or a sample collection device 300) (step S6). In some examples, step S6 may include adding an identifier to indicate that the device has been modified from its original state, such as adding a label or other mark to designate the device as having been reprocessed, refurbished, or remanufactured.

[0079] After step S6, the technician can inspect and test the newly formed treatment instrument (e.g., endoscope 104 or sample collection device 300) (step S7). Specifically, the remanufacturing technician verifies that the newly formed treatment instrument (e.g., endoscope 104 or sample collection device 300) has the same effectiveness and safety as the original product through various functional tests.

[0080] Following step S7, the technician then proceeds to sterilize and store (step S8) and ship (step S9) the new treatment instrument (e.g., endoscope 104 or sample collection device 300). In step S8, the sterilization procedure may involve using a sterilizing gas such as ethylene oxide gas, or propylene oxide gas may be applied to the new treatment instrument (e.g., endoscope 104 or sample collection device 300), and the device may be stored in a storage container until use.

[0081] Steps S1 to S9 described above are performed to achieve reprocessing of a medical instrument (e.g., endoscope 104 or sample collection device 300). Any of steps S1 to S9 can be completed by one or more parties in any order. Furthermore, steps S1 to S9 are illustrative steps, not list, encompassing all steps that may be performed by a technician to refurbish, remanufacture, or replenish a medical instrument (e.g., endoscope 104 or sample collection device 300).

[0082] Figure 18 shows a block diagram of an example machine 1800 that can be implemented by any one or more of the techniques (e.g., methodologies) discussed herein. The example may include, or be operated by, logic or several components or mechanisms in machine 1800, as described herein. A circuit mechanism (e.g., a processing circuit mechanism) is a set of circuits implemented in a tangible entity of machine 1800, including hardware (e.g., simple circuits, gates, logic, etc.). The constituent units of a circuit mechanism may be flexible over time. A circuit mechanism includes constituent units that can perform specific operations individually or in combination when operating. In the example, the hardware of the circuit mechanism may be designed to be immutable to perform a specific operation (e.g., connected by wiring). In the example, the hardware of the circuit mechanism may include variable-connected physical components (e.g., execution units, transistors, simple circuits, etc.) that include a machine-readable medium that is physically modified (e.g., magnetically, electrically, movable locations of invariant mass particles, etc.) to code instructions for a specific operation. When connected to a physical component, the potential electrical properties of the hardware component are changed, for example, from an insulator to a conductor, or vice versa. Instructions can cause embedded hardware (e.g., an execution unit or loading mechanism) to create a component of a circuit mechanism in the hardware via a variable connection to perform a particular part of an operation when in operation. Thus, in the example, a machine-readable medium element is part of a circuit mechanism or communicates with other components of a circuit mechanism when the device is in operation. In the example, any of the physical components can be used in two or more members of two or more circuit mechanisms. For example, under operation, an execution unit can be used in a first circuit of a first circuit mechanism at some point in time, and then again at different times by a second circuit in the first circuit mechanism, or by a third circuit in the second circuit mechanism. Additional examples of these components relating to machine 1800 are as follows:

[0083] In alternative examples, machine 1800 can operate as a standalone device or can be connected to other machines (e.g., over a network). In a networked deployment, machine 1800 can operate as a server machine, a client machine, or both in a server-client network environment. In the example, machine 1800 can act as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. Machine 1800 may be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, web appliance, network router, switch or bridge, or any machine capable of executing (sequentially or otherwise) instructions that specify the actions to be taken by that machine. Furthermore, although only a single machine is shown, the term “machine” should be interpreted to include any set of machines that individually or collectively execute a set (or more sets) of instructions to implement one or more of the methodologies considered herein, such as cloud computing, software as a service (SaaS), and other computer cluster configurations.

[0084] The machine (e.g., a computer system) 1800 may comprise hardware processing units 1802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof) that can communicate with each other, in part or in whole, via an interlink (e.g., a bus) 1830; main memory 1804; static memory (e.g., memory or storage for firmware, microcode, basic input / output (BIOS), unified expansion firmware interface (UEFI), etc.) 1806; and mass storage 1808 (e.g., a hard drive, tape drive, flash storage, or other block device). The machine 1800 may further comprise a display unit 1810; an alphanumeric input device 1812 (e.g., a keyboard); and a user interface (UI) guidance device 1814 (e.g., a mouse). In the example, the display unit 1810, the input device 1812, and the UI guidance device 1814 may be touchscreen displays. The machine 1800 may further include a large-capacity storage (e.g., a drive unit) 1808, a signal generating 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, a compass, an accelerometer, or other sensors. The machine 1800 may also include an output control device 1828 for communicating with or controlling one or more peripheral devices (e.g., a printer, a card reader, etc.) via a serial (e.g., Universal Serial Bus (USB)), parallel, or other wired or wireless (e.g., infrared (IR), near-field communication (NFC)) connection.

[0085] The registers of the processing unit 1802, main memory 1804, static memory 1806, or mass storage 1808 may be, or may comprise, a machine-readable medium 1822 on which one or more sets of data structures or instructions 1824 (e.g., software) that embody or are utilized by any one or more of the technologies or functions described herein are stored. The instructions 1824 may also reside entirely or at least partially in the registers of the processing unit 1802, main memory 1804, static memory 1806, or mass storage 1808 during execution by the machine 1800. In the example, one or any combination of the hardware processing unit 1802, main memory 1804, static memory 1806, or mass storage 1808 may constitute the machine-readable medium 1822. Although machine-readable medium 1822 is shown as a single medium, the term “machine-readable medium” may include a single or multiple mediums configured to store one or more instructions 1824 (e.g., a centralized or distributed database, and / or associated caches and servers).

[0086] The term “machine-readable medium” may include any medium on which instructions for execution by machine 1800 can be stored, encoded, or carried, causing machine 1800 to perform one or more of the technologies of the present disclosure, or any medium on which data structures used by such instructions, or data structures associated with such instructions, can be stored, encoded, or carried. Examples of non-limiting machine-readable mediums may include solid memory, optical media, magnetic media, and signals (e.g., radio frequency signals, signals based on other photons, audio signals, etc.). In the example, a non-transient machine-readable medium comprises a machine-readable medium with a plurality of particles having an invariant (e.g., stationary) mass, and is therefore a composition of a material. Thus, a non-transient machine-readable medium is a machine-readable medium that does not contain signals that propagate transiently. Specific examples of non-temporary machine-readable media include non-volatile 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, magneto-optical disks, CD-ROM disks, and DVD-ROM disks.

[0087] In the example, the information stored or otherwise provided in the machine-readable medium 1822 may represent the instruction 1824, such as the instruction 1824 itself or a format from which the instruction 1824 can be derived. This format from which the instruction 1824 can be derived may be source code, an encoded instruction (e.g., in a compressed or encrypted form), or a packaged instruction (e.g., divided into multiple packages). The information representing the instruction 1824 in the machine-readable medium 1822 may be processed into an instruction by a processing circuit mechanism to perform any of the operations considered herein. For example, deriving the instruction 1824 from the information (e.g., processing by a processing circuit mechanism) may include compiling (e.g., from source code, object code, etc.), interpreting, reading, structuring (e.g., dynamically or statically linking), encoding, decrypting, encrypting, decrypting, packaging, unpackaging, or otherwise manipulating the information into the instruction 1824.

[0088] In the example, the derivation of instruction 1824 may involve assembling, compiling, or interpreting information (e.g., by a processing circuit mechanism) to produce instruction 1824 from some intermediate or pre-processed format provided by a machine-readable medium 1822. When the information is provided in multiple parts, it may be mixed, decompressed, and modified to produce instruction 1824. For example, the information may be multiple compressed source code packages (or object code or binary executable code, etc.) on one or more remote servers. The source code packages may be encrypted as they pass through the network, and if necessary, they may be decrypted, decompressed, assembled (e.g., linked), compiled or interpreted on a local machine (e.g., into a library, a standalone executable, etc.), and executed by the local machine.

[0089] Instruction 1824 can be further transmitted or received through a communication network 1826 using a transmission medium via a network interface device 1820 that utilizes one of several transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP)). Examples of communication networks may include, among many, a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), LoRa® / LoRa®WAN, or satellite communication network, a cellular network (e.g., a cellular network such as one conforming to 3G, 4G LTE / LTE-A, or 5G standards), an analog telephone service (POTS) network, and a wireless data network (e.g., the IEEE 502.11 family of standards known as Wi-Fi®), the IEEE 502.15.4 family of standards, and a peer-to-peer (P2P) network. In the example, the network interface device 1820 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connecting to the communication network 1826. In the example, the network interface device 1820 may include multiple antennas for wireless communication using at least one of the following technologies: single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO). The term “transmission medium” should be interpreted to include any intangible medium on which instructions for execution by machine 1800 can be stored, encoded, or carried, including digital or analog communication signals or other intangible mediums to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0090] The following non-limiting examples illustrate in detail certain aspects of the subject matter to address the challenges and provide the benefits discussed herein.

[0091] Example 1 is a distal tip for an intrabronchial ultrasound sample collection device, comprising a connector extending from a proximal to a distal portion along a longitudinal axis, the connector having a lateral outlet inclined portion extending from the proximal portion through the side of the connector, the lateral outlet inclined portion directing the device toward patient tissue through the side of the connector; and a housing extending from a proximal to a distal portion along a central axis, the housing having a mounting feature in the proximal portion of the housing which is connected to the distal portion of the connector and configured to receive a transducer, the housing having a first portion which tapers toward the central axis of the housing as the housing extends from the proximal to the distal portion, and a second portion which is configured to be attached to the first portion adjacent to the first portion.

[0092] In Example 2, the subject of Example 1 is modified so that the mounted feature section tapers out so that the device extends into the field of view of the transducer.

[0093] In Example 3, the subject of Example 2 includes a mounting feature that comprises a support surface that is recessed into the periphery of the housing, and on which the transducer is fixed in order to hold the transducer within the mounting feature.

[0094] In Example 4, the subject of Example 3 includes the fact that when the transducer is installed within the mounting feature, the support surface is recessed into the periphery of the housing so that the transducer is aligned with the periphery of the housing.

[0095] In Example 5, the subject matter of Examples 3-4 includes the fact that when the transducer is installed within the mounting feature, the support surface is recessed into the periphery of the housing so that the transducer extends outward from the periphery of the housing.

[0096] In Example 6, the subject matter of Examples 1-5 is further described by the configuration in which the first part comprises a first mounting interface that is retracted into the periphery of the housing, and the first mounting interface is inserted into the distal portion of the coupler.

[0097] In Example 7, the subject of Example 6 includes a first part comprising wire cutouts configured to direct one or more wires of a transducer toward the distal portion of a connector.

[0098] In Example 8, the subject matter of Examples 1-7 is further expanded to include a second portion comprising a mounting interface that is retracted into the periphery of the housing, the mounting interface being insertable into the distal portion of the coupler for mounting the housing onto the coupler.

[0099] In Example 9, the subject matter of Examples 1-8 includes a first part comprising an alignment projection and a second part comprising an alignment groove, wherein the alignment projection and the alignment groove are complementary in order to align the first part with the second part.

[0100] In Example 10, the subject matter of Examples 1-9 includes a first part comprising a first groove extending from the proximal area to the distal area of ​​the housing and a second groove extending from the proximal area to the distal area, wherein the first groove is angularly offset from the second groove.

[0101] In Example 11, the subject of Example 10 is extended to include the configuration in which the first groove and the second groove are each configured to receive an electromagnet coil.

[0102] In Example 12, the subject matter of Examples 1 to 11 is further expanded to include a second mounting interface that is recessed into the periphery of the housing, and the second mounting interface is configured to be inserted into the distal portion of the coupler.

[0103] In Example 13, the subject of Example 12 is extended to include a second mounting interface comprising a clocking projection extending radially outward from the second mounting interface and being engageable with the coupler to ensure proper mounting of the housing and coupler.

[0104] In Example 14, the subject matter of Examples 1 to 13 is further described by a first part comprising an image sensor mounting section extending from the distal region to the proximal region, and a light source mounting section adjacent to the image sensor mounting section and extending from the distal region to the proximal region.

[0105] In Example 15, the subject of Example 14 is configured such that the image sensor mounting section is fixed below the distal end of the mounting feature section, and the light source mounting section is fixed below the distal end of the mounting feature section.

[0106] In Example 16, the subject of Examples 14-15 includes the fact that the first part includes a rectangular contour at the distal tip of the first part.

[0107] In Example 17, the subject matter of Examples 14-16 is further extended to include the configuration in which the light source mounting section is equipped with a light source that is aligned with the distal tip of the first portion.

[0108] In Example 18, the subject matter of Examples 14-17 is extended to include the configuration in which the image sensor mounting section fixes an image sensor that is aligned with the distal tip of the first portion.

[0109] In Example 19, the subject matter of Examples 14-18 is extended to include the configuration in which the image sensor mounting section fixes an image sensor that is aligned with the central axis of the housing.

[0110] Example 20 is a distal tip for an intrabronchial ultrasound sample collection device, comprising a housing extending from a proximal to a distal region along a central axis, configured to receive a transducer and having a mounting feature section extending from the proximal to the distal region, and a tray configured to be installed within the distal region of the housing and defining the distal end of the distal tip, having an image sensor mounting section configured to mount an image sensor adjacent to the transducer and within the distal tip of the distal tip.

[0111] In Example 21, the subject of Example 20 is extended to include the tray at least partially covering the most distal portion of the transducer.

[0112] In Example 22, the subject of Examples 20-21 includes a coupler that extends from a proximal portion to a distal portion, the distal portion of which is connected to the proximal area of ​​the housing.

[0113] In Example 23, the subject of Example 22 is further described by the coupler, which includes a lateral outlet inclined portion extending from a proximal portion within the coupler through the side of the coupler, which directs the instrument toward the patient's tissue through the side of the coupler.

[0114] In Example 24, the subject of Example 23 includes the fact that the mounted feature tapers toward the central axis of the housing as the housing extends from the proximal region toward the distal tip.

[0115] In Example 25, the subject of Example 24 is modified to include the fact that the mounted feature is tapered so that the device extends into the field of view of the transducer.

[0116] In Example 26, the subject matter of Examples 20-25 is expanded to include a tray comprising a distal body and a support extending from the distal body and configured to connect the tray to a housing.

[0117] In Example 27, the subject of Example 26 includes the fact that the distal body has a rectangular contour.

[0118] In Example 28, the subject matter of Examples 26-27 is further described by the distal body comprising an image sensor mounting section extending from the distal region toward the proximal region, and a light source mounting section adjacent to the image sensor mounting section and extending from the distal region toward the proximal region.

[0119] In Example 29, the subject of Example 28 is configured such that the image sensor mounting section is fixed below the distal end of the mounting feature section, and the light source mounting section is fixed below the distal end of the mounting feature section.

[0120] In Example 30, the subject of Example 29 includes fixing the image sensor in the image sensor mounting section such that the central axis of the image sensor is essentially parallel to the central axis of the housing.

[0121] In Example 31, the subject of Example 30 is further configured such that the image sensor mounting unit is fixed in such a way that the distal edge of the image sensor aligns with the distal tip of the distal tip.

[0122] In Example 32, the subject matter of Examples 29-31 is further expanded to include an imaging assembly connected to an image sensor and a light source, wherein the proximal end of the imaging assembly comprises an electrical pad configured to hold a wire, and the electrical pad communicates with the image sensor and the light source.

[0123] In Example 33, the subject of Example 32 is configured such that the wires connect the electrical pads to the control system, so that the control system is connected to the image sensor and light source via the wires and imaging assembly.

[0124] In Example 34, the subject matter of Examples 32-33 is expanded to include the mounting of the imaging assembly on a tray support.

[0125] In Example 35, the subject matter of Examples 20-34 is further expanded to include a housing comprising a first groove extending from a proximal region to a distal region and a second groove extending from a proximal region to a distal region, wherein the first groove is angularly offset from the second groove.

[0126] In Example 36, the subject of Example 35 is extended to include the configuration in which the first groove and the second groove are each configured to receive an electromagnet coil.

[0127] In Example 37, the subject matter of Examples 20–36 includes the fact that the normal vector of the substantially planar surface of the transducer forms an acute angle with the central axis of the tray.

[0128] Example 38 is a distal tip for an intrabronchial ultrasound sample collection device, comprising a housing extending from a proximal to a distal portion along a central axis, configured to receive a transducer, and having a mounting feature that tapers toward the central axis of the housing as the housing extends from a proximal to a distal portion; and a coupler extending from a proximal to a distal portion, having a lateral outlet inclined portion extending from the proximal portion through the side of the coupler, which directs the instrument toward patient tissue through the side of the coupler, and a wiring exit passage located below the lateral outlet inclined portion and at least partially wrapping around the lateral outlet inclined portion.

[0129] In Example 39, the subject of Example 38 is provided with a transducer, the transducer having a flexible tail section that extends from the proximal edge of the transducer to a coupler and communicates with the transducer.

[0130] In Example 40, the subject of Example 39 is extended to include a flexible tail section having an electrical pad at the proximal end of the flexible tail section, the electrical pad communicating with a transducer and configured to allow for the attachment of an electric wire.

[0131] In Example 41, the subject of Example 40 is extended to include the configuration such that the wires connect the electrical pads to the control system, so that the control system is connected to the transducer via the wires and electrical pads.

[0132] In Example 42, the subject of Example 41 is defined such that the flexible rear section remains substantially perpendicular to the longitudinal axis of the coupler, and the path is defined beyond the proximal section of the housing and downward from the proximal section.

[0133] In Example 43, the subject of Example 42 is extended to include the transition of the flexible rear section into a bent section that generally wraps upward around the longitudinal axis of the coupler.

[0134] In Example 44, the subject of Example 43 is extended to include the presence of an electrical pad in the bent portion.

[0135] In Example 45, the subject matter of Examples 40-44 includes the fact that the electrical pad is distal to the wiring exit passage.

[0136] In Example 46, the subject matter of Examples 40-45 includes the fact that the electrical pad is located within the wiring exit passage.

[0137] In Example 47, the subject matter of Examples 39–46 is expanded to include a flexible tail section that divides into a first part and a second part, with the first and second parts spreading out around a lateral exit inclined section within the coupler.

[0138] In Example 48, the subject matter of Examples 38-47 is further described by the fact that the enclosure includes a first clocking feature formed in the proximal area of ​​the enclosure.

[0139] In Example 49, the subject of Example 48 is further expanded to include a housing that includes a second clocking feature formed on the distal portion of the coupler.

[0140] In Example 50, the subject of Example 49 is further expanded to include the second clocking feature being complementary to the first clocking feature in order to ensure proper alignment between the coupler and the housing during installation.

[0141] In Example 51, the subject of Example 50 is extended to include the fact that the housing has locking tabs and the coupler has locking grooves, and the locking tabs are complementary to the locking grooves in order to hold the coupler and housing together after installation.

[0142] In Example 52, the subject matter of Examples 38-51 is further expanded to include a wiring exit passage having a substantially U-shaped contour having an inner surface defined by the wall between the wiring exit passage and the lateral exit inclined section, and an outer surface defined by the wall between the wiring exit passage and the outer contour of the coupler.

[0143] Example 53 is a method for reprocessing an intrabronchial ultrasound sampling device, comprising the steps of obtaining the intrabronchial ultrasound sampling device of Example 38, sterilizing the intrabronchial ultrasound sampling device, and storing the intrabronchial ultrasound sampling device.

[0144] In Example 54, the subject of Example 53 includes a bronchial ultrasound sample collection device comprising a housing, a tray configured to be installed inside the housing, and a connector.

[0145] In Example 55, the subject of Example 54 includes the steps of removing the tray from the housing, uncoupling the housing from the coupler, disinfecting the housing, tray, and coupler, and packaging the housing, tray, and coupler.

[0146] Example 56 is a distal tip for an intrabronchial ultrasound sample collection device, comprising a housing extending from a proximal to a distal portion along a central axis, configured to receive a transducer, and having a mounting feature that tapers toward the central axis of the housing as the housing extends from a proximal to a distal portion; a coupler extending from a proximal to a distal portion, having a lateral outlet inclined portion extending from the proximal portion through the side of the coupler, which directs the instrument toward patient tissue through the side of the coupler, and a wiring exit passage located below the lateral outlet inclined portion and at least partially wrapping around the lateral outlet inclined portion; and a transducer having a flexible tail portion extending from the proximal edge of the transducer to the coupler and communicating with the transducer.

[0147] In Example 57, the subject of Example 56 is extended to include the presence of an electrical pad in the bent portion.

[0148] Example 58 is a distal tip for an intrabronchial ultrasound sample collection device, comprising a housing extending from a proximal to a distal region along a central axis, having a mounting feature section that tapers toward the central axis of the housing as the housing extends from the proximal to the distal region, a transducer fixed to the mounting feature section such that the normal vector of its substantially planar surface forms an acute angle with the central axis of the housing, and a lateral outlet inclined section located proximal to the transducer, configured to direct the needle distally through the field of view of the transducer along a trajectory that forms an acute angle with the central axis and intersects the normal vector of its substantially planar surface.

[0149] In Example 59, the subject of Example 58 is extended to include a transducer comprising a foldable, flexible substrate.

[0150] In Example 60, the subject of Example 59 is further expanded to include a transducer comprising an application-specific integrated circuit mounted on a flexible substrate, a capacitor mounted on the flexible substrate, and a linear transducer array mounted on the flexible substrate.

[0151] In Example 61, the subject of Example 60 is further expanded to include a support surface that is recessed into the periphery of the housing, the support surface on which the transducer is fixed in order to hold the transducer within the mounting feature.

[0152] In Example 62, the subject of Example 61 is extended to include the transducer being fixed to a support surface such that the application-specific integrated circuit, capacitor, and linear transducer array are at least partially recessed into the periphery of the enclosure.

[0153] In Example 63, the subject matter of Examples 61-62 is extended to include the transducer being fixed to a support surface such that the application-specific integrated circuit, capacitor, and linear transducer array are completely recessed within the periphery of the enclosure.

[0154] In Example 64, the subject matter of Examples 61–63 is further expanded by the fact that the transducer is fixed to a support surface such that at least one of the application-specific integrated circuit, capacitor, or linear transducer array is at least partially recessed into the periphery of the enclosure.

[0155] In Example 65, the subject of Example 64 is expanded to include the folding of transducers and their curing with epoxy resin so that the application-specific integrated circuit is located directly beneath a linear transducer array.

[0156] In Example 66, the subject of Example 65 is extended to include the linear transducer array being oriented away from the housing.

[0157] In Example 67, the subject of Example 66 is expanded to include the linear transducer array extending beyond the perimeter of the enclosure.

[0158] In Example 68, the subject of Example 67 is expanded to include the alignment of the linear transducer array with the periphery of the enclosure.

[0159] In Example 69, the subject matter of Examples 58-68 comprises an image sensor mounting section extending from the distal region to the proximal region, and a light source mounting section adjacent to the image sensor mounting section and extending from the distal region to the proximal region.

[0160] In Example 70, the subject of Example 69 is extended to include the configuration in which the image sensor mounting section fixes the image sensor within the distal area of ​​the housing, and the light source mounting section fixes the light source within the distal area of ​​the housing.

[0161] In Example 71, the subject of Example 70 is expanded to include the position of the image sensor and light source directly below the transducer at the distal edge of the housing.

[0162] Example 72 is a method for reprocessing an intrabronchial ultrasound sampling device, comprising the steps of obtaining the intrabronchial ultrasound sampling device of Example 58, sterilizing the intrabronchial ultrasound sampling device, and storing the intrabronchial ultrasound sampling device.

[0163] In Example 73, the subject of Example 72 is extended to include an intrabronchial ultrasound sample collection device comprising a housing, a tray configured to be installed inside the housing, and a connector.

[0164] In Example 74, the subject of Example 73 includes the steps of removing the tray from the housing, uncoupling the housing from the coupler, disinfecting the housing, tray, and coupler, and packaging the housing, tray, and coupler.

[0165] Example 75 is an apparatus that includes means for carrying out any of Examples 1 to 74.

[0166] Example 76 is a system for implementing any of Examples 1 through 74.

[0167] Example 77 is a method for carrying out any of Examples 1 through 74.

[0168] Example 78 is an apparatus, system, method, or device that includes any element from any of Examples 1 through 74.

[0169] The above detailed description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments that may be carried out. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described. However, the inventors also consider examples in which only those elements shown or described are provided. Furthermore, the inventors also consider examples using any combination or arrangement of those elements shown or described (or one or more embodiments thereof) with respect to any specific example (or one or more embodiments thereof) or any other example (or one or more embodiments thereof) shown or described herein.

[0170] All documents, patents, and patent documents referenced herein are incorporated by reference in their entirety as if they were incorporated individually by reference. In the event of any inconsistent use between this document and those documents incorporated by reference, the use in the incorporated references should be considered supplementary to the use in this document, and the use in this document shall govern any irreconcilable inconsistencies.

[0171] In this document, the term “one” ("a" or "an") is used to include one or more, independently of any other examples or uses of “at least one” or “one or more,” as is common in patent literature. In this document, the term “or” is used non-exclusively, unless otherwise indicated, to refer to “A or B” including “A but not B,” “B but not A,” and “A and B.” In the appended claims, the terms “including” and “in which” are used as the plain English equivalents of the terms “comprising” and “wherein.” Furthermore, in the following claims, the terms “including” and “comprising” are open-ended, meaning that any system, device, article, or process that includes elements in addition to those listed after such terms in a claim is still considered to be within the scope of that claim. Furthermore, in the following claims, terms such as “first ~,” “second ~,” and “third ~” are used merely as labels and are not intended to impose numerical requirements on those objects.

[0172] The term “approximately” as used herein means roughly, around, about, or about. When the term “approximately” is used in conjunction with a range of numbers, it changes the range by extending the upper and lower boundaries of the numerical value being stated. Generally, the term “approximately” is used herein to change the numerical values ​​above and below the stated value by a difference of 10%. In one aspect, the term “approximately” means plus or minus 10% of the numerical value of the number in which it is used. Thus, approximately 50% means the range of 45% to 55%. The ranges of numbers proposed by endpoints herein include all numbers and fractions that fall within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, the ranges of numbers proposed by the endpoints herein include the partial ranges that are included within that range (for example, 1–5 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 understood that all numbers and their fractions are assumed to be changeable by the term “approximately”.

[0173] The preceding descriptions are intended to be illustrative and not restrictive. For example, the examples (or one or more embodiments thereof) described herein may be used in combination with each other. Other examples may be used by those skilled in the art when considering the preceding descriptions. The abstract is submitted with the understanding that it is intended to give the reader a quick grasp of the essence of the technical disclosure and is not to be used to interpret or limit the scope or meaning of the claims. Also, in the modes for carrying out the invention described above, various features may be grouped together to simplify the disclosure. This should not be interpreted as meaning that any disclosed feature not claimed is essential to any claim. Rather, the subject matter of the invention may lie less than all the features of the specific disclosed embodiments. Accordingly, the following claims are incorporated into the modes for carrying out the invention described herein, such that each claim stands on its own as a separate embodiment. The scope of the examples should be determined by reference to the appended claims, along with the equivalent full scope given to such claims.

[0174] The devices disclosed herein may be designed to be discarded after a single use or to be designed for multiple uses. However, in either case, the devices may be refurbished for reuse after at least one use. Refurbishment may include a combination of the steps of disassembling the device, cleaning or rearranging certain elements, and reassembling. Specifically, the device is disassemblable, and any number of certain elements or parts of the device are selectively replaceable or removable in any combination. After cleaning and / or rearranging certain parts, the device may be reassembled for subsequent use either in a refurbishment facility or by a surgical team immediately before a surgical procedure. Those skilled in the art will understand that refurbishment of a device may utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting use of the refurbished device, is all within the scope of this application.

[0175] Preferably, the present invention as described herein is processed before surgery. First, new or used instruments are obtained and cleaned if necessary. Next, the instruments may be sterilized. In one sterilization technique, the instruments are placed in a closed and sealed container, such as a plastic or TYVEK® bag. Next, the container and instruments are placed in a field of radiation that can penetrate the container, such as gamma rays, X-rays, or higher-energy electrons. The radiation kills bacteria in the instruments and container. The sterilized instruments can then be stored in a sterile container. The sealed container keeps the instruments sterile until opened in a medical facility. The devices may also be sterilized using any other technique known in the art, including but not limited to beta or gamma rays, ethylene oxide, or vapor. [Explanation of symbols]

[0176] 100 Endoscopy Systems 102 Imaging and control systems 104 Endoscope 106 Control Unit 108 Display Units 110 Input Unit 112 Light source 114 Fluid supply source 116 Suction pump 118 Insertion area 120 Functional Area 122 Handle area 124 Cable Area 126 Coupler area 128 Control Unit Ports 130 and 132 134 Cart 136 Sample Collection Devices 138 Actuators 140 cabinets 142 Fixture Actuator 144 Distal end 146 Imaging devices 148 Lighting Devices 150 Work Passage Ports 202 Image Processing Unit 204 Ultrasonic Image Processing Unit 206 Treatment Generator 208 Drive Unit 300 sample collection devices 302 Distal tip 303 Distal end 304 Coupler 305 Distal tip 306 Proximal portion 308 Distal portion 309 Lumen 310 Side exit ramp 311 Equipment 312 cabinets 313 surrounding area 314 Proximal Area 316 Distal Segment 318 Feature section 320 transducers 321 Distal edge 322 Field of view 324, 326 angle 331 Proximal margin 424 Groove 424A First groove 424B Second groove 426 Electromagnet coil 428 Image Sensors 430 Light source 532 Support surface 534 Transducer rear inclined section 536 Filling gap 640 trays 642 Distal main unit 644 Support 646 Image sensor mounting section 648 Light source mounting section 650 Image Sensor 652 Light source 654 Imaging Assembly 656 Proximal end 658 Electric Pad 660 Electric wire 912 Two-part enclosure 913 surrounding area 914 Proximal area 916 Distal Segment 960 Part 1 962 Part 2 964 First mounting interface 966 Wire cutout 968 Mounted interface 970 Alignment protrusion 972 Alignment groove 974 Crocking protrusions 1100 Imaging Assembly 1102 Base material 1104 Application-Specific Integrated Circuits 1106 Capacitor 1108 Linear transducer array 1110 Ribbon rear section 1111 First bend 1112 Second bend 1113 Proximal end 1114 Electric Pad 1116 Electric wire 1302 Side 1304 Locking groove 1410 Wiring exit passage 1412 Locking tab 1414 Crocking groove 1502 Part 1 1504 Part 2 1800 machines 1802 Hardware Processing Unit 1804 Main memory 1806 Static Memory 1808 Large Capacity Storage 1810 Display Unit 1812 Alphanumeric input device 1814 User Interface (UI) Guidance Devices 1816 Sensor 1818 Signal Generating Devices 1820 Network Interface Device 1822 Machine-readable media 1824 command 1826 Communication Network 1828 Output control device 1830 Interlink CA center axis LA Longitudinal axis

Claims

1. A distal tip for an intrabronchial ultrasound sample collection device, A housing that extends along the central axis from the proximal region to the distal region, The housing has a mounting feature portion that tapers towards the central axis of the housing as it extends from the proximal region to the distal region, A transducer fixed to the mounting feature portion such that the normal vector of its substantially planar surface forms an acute angle with the central axis of the housing, A lateral outlet inclined portion located proximal to the transducer, which forms an acute angle with the central axis and is configured to direct the needle distally through the field of view of the transducer along a trajectory that intersects the normal vector of the substantially planar surface. Equipped with a housing The distal tip, which is equipped with this feature.

2. The distal tip of the transducer according to claim 1, comprising a foldable, flexible substrate.

3. The transducer is, An application-specific integrated circuit mounted on the aforementioned flexible substrate, A capacitor mounted on the aforementioned flexible substrate, A linear transducer array mounted on the aforementioned flexible substrate and Equipped with, The aforementioned mounting feature is, A support surface that is recessed into the periphery of the housing, wherein the transducer is fixed to hold the transducer within the mounting feature portion. The distal tip according to claim 2, comprising:

4. The distal tip according to claim 3, wherein the transducer is fixed to the support surface such that the application-specific integrated circuit, the capacitor, and the linear transducer array are at least partially recessed into the periphery of the housing.

5. The distal tip according to claim 3 or 4, wherein the transducer is fixed to the support surface such that the application-specific integrated circuit, the capacitor, and the linear transducer array are completely recessed within the periphery of the housing.

6. The distal tip according to any one of claims 3 to 5, wherein the transducer is fixed to the support surface such that at least one of the application-specific integrated circuit, the capacitor, or the linear transducer array is at least partially recessed into the periphery of the housing.

7. The distal tip according to claim 6, wherein the transducer is folded and fixed with epoxy resin so that the application-specific integrated circuit is directly below the linear transducer array, and the linear transducer array is oriented away from the housing.

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

9. An image sensor mounting section extending from the distal region toward the proximal region, Adjacent to the image sensor mounting section is a light source mounting section extending from the distal area toward the proximal area. The distal tip according to any one of claims 1 to 8, comprising:

10. The distal tip according to claim 9, wherein the image sensor mounting section is configured to fix the image sensor within the distal region of the housing, and the light source mounting section is configured to fix the light source within the distal region of the housing, and the image sensor and the light source are located at the distal edge of the housing, immediately below the transducer.

11. A tray configured to be installed within the distal area of ​​the housing, which defines the distal end of the distal tip, An image sensor mounting section configured to mount an image sensor within the distal tip of the distal tip, adjacent to the transducer. A distal tip according to any one of claims 1 to 10, comprising a tray.

12. The aforementioned tray is The distal main body and A support extending from the distal body and configured to connect the tray to the housing, The distal tip according to claim 11, comprising:

13. The distal tip according to claim 12, wherein the distal body includes a rectangular contour.

14. The distal body is, The image sensor mounting section extends from the distal area toward the proximal area, Adjacent to the image sensor mounting section is a light source mounting section extending from the distal area toward the proximal area. The distal tip according to claim 12 or 13, comprising:

15. The distal tip according to claim 14, wherein the image sensor mounting portion is configured to fix the image sensor below the distal end of the mounting feature portion, and the light source mounting portion is configured to fix the light source below the distal end of the mounting feature portion.

16. The distal tip according to claim 14 or 15, wherein the image sensor mounting portion fixes the image sensor such that the central axis of the image sensor is essentially parallel to the central axis of the housing.

17. The distal tip according to any one of claims 14 to 16, wherein the image sensor mounting portion is configured to fix the image sensor such that the distal edge of the image sensor aligns with the distal tip of the distal tip.

18. The aforementioned enclosure is The first portion includes the aforementioned mounting feature, A second part configured to be attached to the first part so as to be adjacent to the first part, A distal tip according to any one of claims 1 to 17, comprising:

Images