Sampling device comprising tapered housing

Abstract

A distal tip for an intrabronchial ultrasound sampling device may include a housing, a transducer, and a side outlet ramp. The housing may extend from the proximal end section to the distal end section along the central axis. The housing may include a mounting feature that tapers toward a central axis of the housing when the housing extends from the proximal end section toward the distal end section. The transducer may be secured to the mounting feature such that a normal vector of a generally planar face of the transducer forms an acute angle with a central axis of the housing. The side exit ramp may be located at a proximal end of the transducer and configured to direct the needle distally through a field of view of the transducer along a trajectory that forms an acute angle with the central axis and intersects a normal vector of the generally planar face.

Description

Priority requirements

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 510,243, filed June 26, 2023, and U.S. Provisional Patent Application No. 63 / 510,234, filed June 26, 2023, and U.S. Provisional Patent Application No. 63 / 510,257, filed June 26, 2023, the entire contents of which are incorporated herein by reference. Technical Field

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

[0003] Conventional endoscopes can be used for a variety of clinical procedures, including, for example, illuminating, imaging, detecting, and diagnosing one or more disease states; delivering fluids toward anatomical regions (e.g., delivering saline or other preparations via a fluid channel); providing access to one or more therapeutic devices (e.g., via a working channel) for sampling or processing anatomical regions; and providing aspiration access for collecting fluids (e.g., saline or other preparations). Such anatomical regions may include the digestive tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary ducts, intestines, colon, etc.), renal regions (e.g., kidneys, ureters, bladder, urethra), other internal organs (e.g., reproductive system, sinus cavities, submucosal regions, respiratory tract), etc. Summary of the Invention

[0004] The sampling device is an endoscope used in various clinical procedures, including, for example, within a patient's lungs, to: illuminate, image, detect, and diagnose one or more disease states; provide fluid delivery toward an anatomical area (e.g., saline or other preparations via a fluid channel); provide access for one or more therapeutic devices (e.g., via a working channel) for sampling or processing the anatomical area; and provide aspiration access for collecting fluids (e.g., saline or other preparations). The sampling device can be used to detect, treat, and sample abnormalities or anomalies within the lungs. The sampling device can be used to capture samples or biopsies of portions of tissue from a patient's airway or lungs. The sampling device is a small device, therefore it can be fitted within the airway and may have a limited field of view of the transducer. Therefore, sampling may be difficult to fall within the transducer's field of view, and assembling such a small component may be difficult. In response, the inventors of this disclosure have developed a unique design for the distal end of an ultrasound sampling device that moves the distal boundary of the transducer's field of view further forward of the distal edge of the sampling device. The inventors have also developed a transducer that includes a flexible substrate, allowing the transducer assembly to be folded into a mounting feature within the housing.

[0005] In the example, the distal end of the endobronchial ultrasound sampling device may include a housing, a transducer, and a side outlet ramp. The housing may extend from a proximal end section along a central axis to a distal end section. The housing may include a mounting feature that tapers toward the central axis of the housing as it extends from the proximal end section toward the distal end section. The transducer may be fixed to the mounting feature such that the normal vector of a generally planar surface of the transducer forms an acute angle with the central axis of the housing. The side outlet ramp may be located at the proximal end of the transducer and configured such that a guide pin travels 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 a generally planar surface. Attached Figure Description

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

[0007] Figure 1 The illustration shows a schematic diagram of an example of an endobronchial ultrasound system.

[0008] Figure 2 The illustration shows a schematic diagram of an example of the imaging and control system of an intrabronchial ultrasound sampling device.

[0009] Figure 3 The illustration shows a perspective view of a portion of the distal tip of an example sampling device with ultrasound imaging capabilities.

[0010] Figure 4The illustration shows a perspective view of a portion of the example distal tip, where the distal shell is drawn with dashed lines.

[0011] Figure 5 The illustration shows a perspective view of an example of the distal end shell at the distal tip.

[0012] Figure 6 An exploded view of an example of the distal shell at the distal tip is shown.

[0013] Figure 7 The illustration shows a perspective view of an example of the distal end shell at the distal tip.

[0014] Figure 8 The illustration shows a front view of the distal end of the distal shell at the distal tip.

[0015] Figure 9 The illustration shows a perspective view of an example two-piece distal end housing.

[0016] Figure 10 The illustration shows a perspective view of the distal end of an example of a distal shell at the distal tip.

[0017] Figure 11 A perspective view of an example transducer for the distal tip is shown.

[0018] Figure 12 The illustration shows a top view of an example of a transducer for deployment at the distal tip.

[0019] Figure 13 The illustration shows a perspective view of an example connector at the distal end.

[0020] Figure 14 The illustration shows a perspective view of an example of the tail of a transducer wound around the side outlet guide ramp of an example connector around the distal end.

[0021] Figure 15 The illustration shows an internal view of an example of a connector from the distal tip, viewed from the proximal end.

[0022] Figure 16 The illustration shows a perspective view of the proximal end of an example connector with a distal tip.

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

[0024] Figure 18 It is a block diagram illustrating an example of a machine on which one or more examples can be implemented. Detailed Implementation

[0025] Endobronchial ultrasound (EBUS) sampling devices can be used to sense ultrasound images at the distal end of the sampling device. The distal end may also include imaging sensors (e.g., cameras, light sources, etc.), a working channel outlet for instruments (e.g., biopsy needles, scalpels, etc.), and, in recent advancements, a position or orientation sensor. Existing EBUS sampling devices can utilize a rigid distal end structure to house these components. Electronics can be arranged within the distal end of the distal end, such that the ultrasound sensor (e.g., a transducer) is located at the distal end of the distal end. The remaining components within the distal end can be located near the distal end.

[0026] Curved ultrasound sensors can be used to achieve a wide field of view (FOV) and typically utilize a saline-filled balloon encapsulating the curved ultrasound transducer to create sufficient contact between the transducer and airway tissue. The saline-filled balloon prevents air gaps from forming between the airway tissue and the transducer, as these air gaps degrade image quality. Linear ultrasound sensors (e.g., linear ultrasound sensors with a generally flat planar surface) can also be used in EBUS endoscopes; however, such sensors with a flat sensing surface generally produce a narrower FOV compared to curved ultrasound sensors. In some cases, the narrow nature of the FOV can limit the depth at which biopsy samples can be captured during real-time imaging (e.g., due to the biopsy needle deviating from the longitudinal axis of the sampling device and leaving the distal end of the FOV before reaching the sample depth). A flat sensing surface can increase the difficulty of maintaining continuous contact between the linear ultrasound transducer and the patient's tissue (e.g., the patient's airway or bronchioles). Wiring of components within the EBUS can also present challenges because the components are very small and the space available for supplying components within the distal end of the distal tip is limited.

[0027] The inventors of this disclosure have envisioned alternative solutions for EBUS sampling devices. An EBUS sampling device may include a flat ultrasonic sensor located at, near, or just beyond the outer radius of the sampling device. The housing of the distal end may include a tapered portion, which may include mounting features for holding a flexible transducer within the tapered portion. The tapering of the housing and the flexibility of the transducer (i.e., the folding capability of the transducer before mounting in the housing, and the folding capability of the transducer tail before, during, and after mounting in the housing) can save space near the distal edge of the distal end, allowing a camera and light source to be positioned at the distal end of the device, for example, directly below the ultrasonic sensor. The EBUS sampling device may include a wiring outlet that allows electrical communication with components within the distal portion of the distal end via wires, strips, etc., that can extend through the wiring outlet. Reference will be made herein to... Figures 1 to 18The EBUS sampling device will be discussed.

[0028] The foregoing discussion is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The following description is included to provide further information regarding this patent application.

[0029] Figure 1 This is a schematic diagram of an endoscope system 100, which may include: an imaging and control system 102; and an intrabronchial ultrasound sampling arrangement, which includes an endoscope 104 and a sampling device 136 that can be attached to the endoscope 104, and the sampling device 136 includes a distal end 144 extending from the distal end of the endoscope 104 via a distal working channel port. Figure 1 The system described herein is an illustrative example of an endoscope system suitable for use with the systems, apparatus and methods described herein, such as a bronchoscope with linearly arranged ultrasound elements.

[0030] Endoscope 104 may be an instrument capable of being inserted into an anatomical region for imaging or (e.g., via tethering) attached to one or more sampling devices for biopsy or for treating a disease condition associated with the anatomical region. Endoscope 104 may be engaged or connected to imaging and control system 102. Endoscope 104 is described in this example as a bronchoscope, but other types of endoscopes for use with the features and teachings of this disclosure are contemplated. Imaging and control system 102 may include control unit 106, display unit 108, input unit 110, light source 112, fluid source 114, and suction pump 116.

[0031] The imaging and control system 102 may include various ports for connection to the endoscope system 100. For example, the control unit 106 may include a data input port for receiving data from the endoscope 104 and a data output port for transmitting data to the endoscope 104. The light source 112 may include an output port for transmitting light, for example, via an optical fiber link, to the endoscope 104. The fluid source 114 may include a port for transmitting fluid to the endoscope 104. The fluid source 114 may include, for example, a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 116 may include a port for creating a vacuum by drawing a vacuum from the endoscope 104 to generate suction, for example, for drawing fluid from an anatomical region into which the endoscope 104 is inserted. The display unit 108 and the input unit 110 may be used by an operator of the endoscope system 100 to control the functions of the endoscope system 100 and view the output of the endoscope 104. The control unit 106 may also generate signals or other outputs by processing the anatomical region into which the endoscope 104 is inserted. In the example, the control unit 106 can generate electrical output, acoustic output, fluid output, etc., for use in treating anatomical areas by means of, for example, cauterization, cutting, freezing, etc.

[0032] Endoscope 104 may include an insertion section 118, a functional section 120, and a handle section 122, which may be coupled to a cable section 124 and a connector section 126. The insertion section 118 extends distally from the handle section 122, and the cable section 124 extends proximally from the handle section 122. The insertion section 118 may be elongated and includes a bendable section and a distal end to which the functional section 120 is attached. The bendable section may be controllable (e.g., controllable via a steering controller 128 on the handle section 122) to manipulate the distal end through tortuous anatomical pathways (e.g., stomach, duodenum, kidney, ureter, trachea, lung, etc.). The insertion section 118 may also include one or more working channels (e.g., internal lumens), which may be elongated and may support the insertion of one or more therapeutic instruments, such as a bronchoscope, into the functional section 120. The working channel can extend between the handle section 122 and the functional section 120. Additional functions such as fluid passage, guide wire, and traction wire can also be provided by the insertion section 118 (e.g., via a suction or flushing passage).

[0033] The connector section 126 can be connected to the control unit 106 to connect the endoscope 104 to various features of the control unit 106, such as the input unit 110, the light source 112, the fluid source 114, and the suction pump 116.

[0034] Handle section 122 may include a steering controller 128 and a port 130. Steering controller 128 may be a knob, lever, or other actuation mechanism for navigating the endoscope 104 within the patient's body. Steering controller 128 may be connected to a traction cable or other actuation mechanism extending through insertion section 118. Port 130 and other ports such as port 132 may be configured to connect various cables, guide wires, auxiliary endoscopes, tissue collection devices, fluid tubing, etc., to handle section 122, for example, for connection to insertion section 118. Figure 1 and Figure 2 The example shown is an example of endoscope 104.

[0035] According to the example, the imaging and control system 102 can be mounted on a mobile platform (e.g., a trolley 134) having features for accommodating a light source 112, a suction pump 116, and an image processing unit 202. Figure 2 Shelves such as ) etc. Alternatively, Figure 1 and Figure 2 The components of the imaging and control system 102 shown can be directly mounted on the endoscope 104 to make the endoscope "independent".

[0036] Functional segment 120 may include components for processing and diagnosing a patient's anatomy. Functional segment 120 may include an imaging device 146 (e.g., a tip-on-chip image sensor based on complementary metal-oxide-semiconductor (CMOS), an illumination device 148 (e.g., a light-emitting diode), and a working channel port 150 located at the distal end of functional segment 120.

[0037] like Figure 1As shown, the sampling device 136 can extend from the working channel port 150 at the distal end of the functional segment 120 of the endoscope 104. The sampling device 136 can be configured to attach to port 132 such that it extends through the working channel of the endoscope 104 and extends beyond the distal end of the endoscope 104. The sampling device 136 may include: an actuator 138 for advancing or retracting the insertion segment 118 within the working channel to control how far the distal end of the sampling device 136 extends distally from the working channel port 150; an instrument actuator 142 (e.g., for actuating a biopsy needle from a side exit port of the sampling device 136); and a distal end 144. The actuator 138 can be configured to extend the sampling device 136 beyond the distal end of the endoscope 104, for example, to navigate the sampling device 136 to a target area within the patient's body. The actuator can slide along the housing 140 of the sampling device 136. The housing 140 may include markings indicating the amount of extension of the sampling device 136 beyond the distal end of the endoscope 104. An instrument actuator 142 may be configured to extend an instrument from the sampling device 136 to obtain a tissue sample from the patient. The distal end 144 of the sampling device 136 may include a transducer (or other imaging device) and a lateral exit port located proximal to the transducer for guiding the instrument configured to obtain a tissue sample from the patient into the transducer's field of view. The sampling device 136 will be discussed in more detail herein.

[0038] Figure 2 It includes an imaging and control system 102 and an intrabronchial ultrasound arrangement structure. Figure 1 A schematic diagram of an endoscope system 100, the endobronchial ultrasound arrangement including an endoscope and a sampling device 136 that can extend through the distal working channel port of the endoscope. Figure 2The components of an imaging and control system 102 coupled to an endoscope 104 are schematically illustrated. The imaging and control system 102 may include: a control unit 106, which may include or be coupled to an image processing unit 202, a treatment generator 206, and a drive unit 208; and a light source 112, an input unit 110, and a display unit 108. The control unit 106 may include, or communicate with, an endoscope, surgical instruments, and an endoscopic system, which may include means configured to engage tissue and collect and store a portion of that tissue, and an imaging device (e.g., a camera) may be used to observe target tissue via the endoscope, surgical instruments, and endoscopic system through materials and components including optical enhancements. The control unit 106 may be configured to activate the camera to observe target tissue distal to the endoscopic system. Similarly, control unit 106 can be configured to enable light source 112 to illuminate a surgical instrument, which may include selected components configured to reflect light in a particular manner, such as a tissue cutter enhanced with reflective particles.

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

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

[0041] Fluid source 114 ( Figure 1 The endoscope 104 (shown in the diagram) can communicate with control unit 106 and may include one or more air sources, saline sources, or other fluid sources, as well as associated fluid paths (e.g., air passages, flushing passages, suction passages, etc.) and connectors (barbed fittings, fluid seals, valves, etc.). Imaging and control system 102 may also include drive unit 208, which may include a motorized actuator for advancing the distal segment of endoscope 104.

[0042] Figure 3 The illustration shows a perspective view of a portion of an example distal tip 302 of a sampling device 300. The sampling device 300 (e.g., Figure 1 and Figure 2 The endoscope 104 shown may be an example of an endobronchial ultrasound (EBUS) sampling device that can be inserted into a patient's airway (e.g., a bronchus via the trachea) to obtain a biopsy sample, capture images, remove (e.g., resect) one or more tissues from the patient's lungs, etc. In some examples, the sampling device 300 may be an EBUS sampling device that facilitates real-time ultrasound imaging of a target tissue, such as a solitary pulmonary nodule (SPN), during surgery on the target tissue. Exemplary procedures of this type include obtaining a biopsy sample of the target tissue (e.g., for removal and pathological analysis), performing ablation on the target tissue, and injecting medication into the target tissue, etc. The distal tip 302 may be connected to the insertion segment 118 of the sampling device 300. Figure 1 and Figure 2The distal tip 302 is inserted into the patient's lung. It can be rigidly connected to the insertion segment 118 via a connector that helps maintain the distal tip 302 in the direction in which the insertion segment 118 is turned within the patient. The distal tip 302 can also be attached to the insertion segment 118 via a rotatable connector that allows a medical professional to further influence or turn the distal tip 302 as it extends into the patient.

[0043] Distal tip 302 (e.g., functional segment 120) Figure 1 and Figure 2 The distal end 302 can perform tasks during a bronchoscopy procedure. For example, it can capture images of the patient's lungs (e.g., digital images, ultrasound images, etc.), capture samples (e.g., using a biopsy needle extending from any part of the distal end 302), or remove one or more objects (e.g., using a scalpel, forceps, etc.). The distal end 302 may include a connector 304 and a housing 312.

[0044] The connector 304 may extend from the proximal portion 306 along the longitudinal axis LA to the distal portion 308. The distal portion 308 of the connector 304 may be coupled to the proximal segment 314 of the housing 312. The connector 304 may include a lumen 309 and a side outlet ramp 310. The lumen 309 and the side outlet ramp 310 may extend within the connector. For example, the lumen 309 may extend from the proximal portion 306 to the side outlet ramp 310, and the side outlet ramp 310 may extend from the lumen 309 through a side portion of the connector 304. The lumen 309 may be generally circular and may mate with a flexible needle lumen embedded within the flexible sheath of an EBUS endoscope. Therefore, instruments (e.g., biopsy (or sampling) needles, scalpels, forceps, laser-cut TBNA needles, ablation devices, etc.) can extend through a port on the proximal end of the EBUS endoscope, through the flexible needle lumen, into lumen 309, into the side exit bevel 310, and ultimately out of the side exit bevel 310. Thus, the side exit bevel 310 can be configured to guide the instrument 311 through the side of the connector 304 and toward the patient's tissue.

[0045] The housing 312 may extend from the proximal segment 314 along the central axis CA to the distal segment 316. The housing 312 may include a mounting feature 318 configured to receive the transducer 320. The mounting feature 318 may taper toward or through the central axis CA as the housing 312 extends from the proximal segment 314 toward the distal segment 316. As illustrated, the mounting feature 318 may converge toward CA near the distal tip of the distal segment 316, and this converging nature of the mounting feature 318 may cause the transducer 320 to tilt forward toward the distal tip of the distal segment 316. The taper of the mounting feature 318 may shift the distal boundary of the transducer's field of view 322 forward, such 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 ramp 310 and into the patient's tissue. Alternatively, the forward-tilting nature of the linear transducer causes the field of view generated by the linear transducer to tilt forward relative to the side exit port, which increases the depth at which the target nodule can be biopsied while remaining within the field of view. This is because the deeper the sampling device penetrates into the tissue (e.g., further from the transducer), the farther the sampling device travels from the proximal end of the FOV to the distal end of the FOV. Once the sampling device extends beyond the distal end of the FOV, the distal tip of the sampling device (e.g., a biopsy needle) no longer images. This is similar to the linear transducer and device (e.g., as described in U.S. Patent Publication 2022 / 0313208). Figure 2 Compared to an EBUS sampling device whose longitudinal axis is aligned (e.g., parallel) with the longitudinal axis of the device depicted in A, the forward tilting nature of the linear transducer increases the distance the needle can extend from the exit ramp to the distal end while remaining within the FOV—thus enabling deeper sampling during real-time visualization of the sampling device within the US image.

[0046] For example, such as Figure 3 As shown, angle 324 can be the angle along the tapering of housing 312 or mounting feature 318 and the field of view 322 of transducer 320. Figure 3 As shown, angle 324 can be an acute angle (i.e., less than 90 degrees) such that the field of view 322 extends beyond the distal edge 321 of the transducer 320. Angle 326 can be the angle between the connector 304 and the tapered portion of the housing 312 or mounting feature 318. Figure 3 As shown, angle 326 can be an obtuse angle (i.e., greater than 90 degrees). Therefore, transducer 320 is tilted toward the distal end segment 316 of housing 312 such that the field of view 322 of transducer 320 extends beyond the distal edge 321 of transducer 320.

[0047] Additionally, the tapering of the housing 312 and mounting feature 318 helps the transducer 320 engage with the tissue of the lung's airway, helping to prevent air gaps between the transducer 320 and the inner wall of the lung's airway, thereby helping to improve the ultrasound images captured by the transducer 320. Furthermore, the tapering of the housing 312 and mounting feature 318 helps the distal tip 302 navigate through the patient's airway and lungs because the housing 312 has a smaller diameter at the distal portion of the distal tip 302, which makes it easier to navigate into the patient's new airway and lung regions compared to a distal tip with a uniform diameter from the proximal end to the distal end.

[0048] Transducer 320 may be a linear array transducer. Transducer 320 may extend from a proximal edge 331 to a distal edge 321. Transducer 320 may be configured to capture ultrasound images of a patient's tissue during sampling of a target tissue of the patient via instrument 311. Transducer 320 will be discussed in more detail herein.

[0049] Figure 4 The illustration shows a perspective view of a portion of an example distal tip 302 of a sampling device 300 having a housing 312 (shown in dashed lines). The housing 312 may include a recess 424 (e.g., Figure 9 The first groove 424A and the second groove 424B are located in the housing 312. The first groove 424A and the second groove 424B can be aligned with each other, for example, along a common plane. Alternatively, the first groove 424A and the second groove 424B can be offset from each other. The groove 424 can extend from the proximal end segment 314 of the housing 312 toward the distal end segment 316 of the housing 312. Figure 9 As shown, the first groove 424A can be offset at an angle relative to the second groove 424B, and each groove in the grooves 424 can be configured to receive an electromagnetic coil 426. It will be understood that the angular offset nature of the grooves 424 allows a pair of electromagnetic coils 426 to capture all six degrees of freedom of motion of the sampling device 300 as it navigates within the patient's body. (See reference...) Figure 9 The angular offset of electromagnetic coil 426 and groove 424 will be discussed in more detail.

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

[0051] Image sensor 428 and light source 430 can be mounted closer to the distal end 303 of distal tip 302 than the distal edge 321 of transducer 320. Image sensor 428 and light source 430 can be mounted at a distance equal to the distance from the distal edge 321 of transducer 320 to the distal end 303 of distal tip 302. Because image sensor 428 and light source 430 can be mounted below the distal end 303 of distal tip 302 or mounted closer to the distal end 303 of distal tip 302 than transducer 320, image sensor 428 and light source 430 can be mounted at an angle aligned with (approximately parallel to or at an angle relative to) the central axis CA of housing 312.

[0052] Figure 5 A perspective view of an example of the housing 312 of the distal tip 302 is shown. Figure 5 As shown, mounting feature 318 may include a support surface 532. The support surface 532 may be recessed into the periphery 313 of the housing 312. Transducer 320 ( Figure 3 It can be fixed to the support surface 532 to hold the transducer 320 within the mounting feature 318.

[0053] like Figure 5 As shown, the support surface 532 may begin on the proximal end section 314 of the housing 312 and extend along the tapering of the mounting feature 318 (e.g., a forward-sloping and generally flat surface) toward the distal end section 316 of the housing 312. The support surface 532 may include a transducer tail ramp 534 that may guide the tail of the transducer 320 through the proximal end section 314 of the housing 312. The transducer tail ramp 534 may taper toward the central axis CA of the housing 312, which may extend the tail of the transducer 320 through the proximal end section 314 of the housing 312 and extend to the connector 304. Figure 3 (This provides a gap at the tail of transducer 320.)

[0054] The support surface 532 may terminate before the distal end segment 316 of the housing 312. Therefore, the support surface 532, mounting feature 318, and tray 640 may define a filler gap 536. The filler gap 536 may be configured to receive an adhesive (e.g., potting epoxy, polymer, or any other filler that can be used to secure components of the sampling device 300 within the housing 312). Thus, adhesive can be injected through the filler gap 536 to help secure the components within the housing 312. The adhesive material extending out of the filler gap 536 can help secure the transducer 320 to the mounting feature 318 and the support surface 532. In this example, an adhesive, such as epoxy, may be used to secure the components within the housing 312, and then the filler gap 536 may be used to fill the adhesive to hold the secured components in their position during use of the sampling device 300.

[0055] The amount of recess of the support surface 532 relative to the periphery 313 of the housing 312 can be adjusted to regulate the relationship between the transducer 320 and the periphery 313 of the housing 312. For example, the recess of the support surface 532 relative to the periphery 313 of the housing 312 can be increased to fix the transducer 320 so that the transducer 320 is aligned with the periphery 313 of the housing 312. The recess of the support surface 532 relative to the periphery 313 of the housing 312 can be decreased to fix the transducer 320 so that the transducer 320 can extend beyond the periphery 313 of the housing 312. Extending the transducer 320 beyond the periphery 313 of the housing 312 helps the transducer 320 achieve better contact with the patient's airway and lung tissue when the transducer 320 captures ultrasound images of the patient's tissues. In an example where the distal end of the EBUS device is steerable, the clinician can manipulate the steering mechanism to hinge the transducer facets into direct contact with the tissue surface—thus substantially eliminating any air gap between the transducer and the tissue surface. It will be understood that eliminating the air gap between the ultrasound transducer and the tissue intended for imaging improves image quality, as air gaps can lead to high impedance mismatch, which can impede the transmission of ultrasound energy. Some existing ultrasound systems (e.g., many curved EBUS devices) utilize inflatable balloons that can be filled with saline to provide ultrasound contact. The purpose of the currently disclosed device is to achieve this ultrasound contact via direct contact between the ultrasound transducer and the tissue wall.

[0056] Figure 6An exploded view of an example of the housing 312 of the distal tip 302 of the sampling device 300 is shown. The distal tip 302 may include a tray 640 configured to be mounted within the distal segment 316 of the housing 312 and defining the distal end 303 of the distal tip 302. When mounted in the distal end 303 of the distal tip 302, the tray 640 may at least partially cover the distal edge 321 of the transducer 320. Figure 4 The tray 640 may include a distal body 642 and a support member 644.

[0057] Support 644 may extend from distal body 642 and may be configured to attach tray 640 to housing 312. For example, distal body 642 may include mechanical engagements that may complement mechanical engagements within housing 312 to removably secure tray 640 within housing 312. Distal body 642 may include surfaces configured to be fixed to housing 312 using epoxy resin or any other adhesive. For example, the surface may have a rough surface finish, grooves, protrusions, etc., to help the epoxy resin retain the tray within housing 312.

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

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

[0060] We will discuss this together below. Figure 7 and Figure 8 . Figure 7A perspective view of an example of the housing 312 of the distal tip 302 is shown. Figure 8 The illustration shows a front view of the distal end section 316 of the housing 312 of the distal tip 302.

[0061] The image sensor mounting portion 646 can be configured to mount the image sensor 650 near the transducer 320 and within the distal tip 305 of the distal tip 302. The image sensor mounting portion 646 can also be configured to fix the image sensor 650 to the distal edge 321 of the transducer 320. Figure 8 Below (or the distal end of mounting feature 318). The image sensor mounting portion 646 can be configured to mount the image sensor 650 such that the central axis CAI of the image sensor 650 is substantially parallel to the central axis CA of the housing 312. The image sensor mounting portion 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 portion 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 at or near the distal tip 305 of the distal tip 302, the image sensor 650 can capture video from the distal end of the distal tip 302, while other components of the distal tip 302 (e.g., mounting feature 318 or transducer 320) do not obstruct or interfere with the field of view of the image sensor 650.

[0062] The light source mounting portion 648 can be configured to mount the light source 652 near the transducer 320 and within the distal tip 305 of the distal tip 302. The light source mounting portion 648 can also be configured to fix the light source 652 to the distal edge 321 of the transducer 320 (both the light source 652 and the distal edge 321 of the transducer 320 are...). Figure 8 Below (or at the distal end of mounting feature 318). The light source mounting portion 648 can be configured to mount the light source 652 such that the central axis CAL of the light source 652 is substantially parallel to the central axis CA of the housing 312. The light source mounting portion 648 can mount the light source 652 such that the distal edge of the light source 652 is aligned with the distal tip 305 of the distal tip 302. The light source mounting portion 648 can mount the light source 652 such that the distal edge of the light source 652 is adjacently aligned with the distal tip 305 of the distal tip 302. Therefore, because the light source 652 is located at or near the distal tip 305 of the distal tip 302, the light source 652 can provide light to the distal end of the distal tip 302 without other components of the distal tip 302 (e.g., mounting feature 318 or transducer 320) blocking or interfering with the light from the light source 652.

[0063] We will discuss this together below. Figure 9 and Figure 10 . Figure 9 The illustration shows a perspective view of the example two-piece housing 912. Figure 10 The illustration shows a perspective view of the two-piece housing 912. The two-piece housing 912 can be configured to assist the housing and the distal end 302 by providing more entry points to the housing and allowing easier placement of components within the distal end 302. Figure 3 Assembly of ). For example Figure 9 and Figure 10 As shown, the two-piece housing 912 may include a first portion 960 and a second portion 962. The first portion 960 and the second portion 962 may be configured to be attached during the assembly of the two-piece housing 912 such that the first portion 960 and the second portion 962 are attached adjacent to each other.

[0064] like Figure 9 and Figure 10 As shown, the first portion 960 may include mounting feature 318. The first portion 960 may also include a first attachment engagement 964 and a wire cutout 966. The first attachment engagement 964 may be recessed within the periphery 913 of the two-piece housing 912. The first attachment engagement 964 may be configured to insert into the connector 304 ( Figure 3 The distal portion 308 () Figure 3 The wire cutout 966 can be configured to guide one or more wires from the transducer 320 to the connector 304. Figure 3 In the distal portion 308, the two-piece housing 912 is mounted to the connector 304.

[0065] The second portion 962 may include a mounting engagement 968. The mounting engagement 968 may be recessed within the periphery 913 of the two-piece housing 912 and may be inserted into the distal portion 308 of the connector 304 to mount the two-piece housing 912 to the connector 304. The mounting engagement 968 may include a synchronizing protrusion 974. The synchronizing protrusion 974 may extend radially outward from the second portion 962 and may engage with the connector 304. Figure 3 The two-piece housing 912 and connector 304 are joined together to ensure proper installation. Figure 9 As shown, the synchronizing protrusion 974 can extend from the second portion 962 toward the proximal end section 914 of the two-piece housing 912. The synchronizing protrusion 974 may be generally rectangular, such as... Figure 9The shape shown, or may be rounded, square, or any other shape that can complement the features on the connector 304 to ensure proper alignment of the two-piece housing 912 when inserted into the connector 304. Proper alignment of the two-piece housing 912 and the connector 304 helps ensure that the transducer is properly aligned at its side outlet ramp from the connector (e.g., connector 304). Figure 3 The field of view when the side exit ramp 310 of the transducer 320 extends (e.g., the field of view when the transducer 320 extends). Figure 3 ) capture medical devices (e.g., device 311 ( Figure 3 The field of view is 322).

[0066] like Figure 9 As shown, the first portion 960 may include an aligned protrusion 970, and as Figure 10 As shown, the second portion 962 may include an alignment groove 972. The alignment protrusion 970 and the alignment groove 972 may be complementary to align the first portion 960 with the second portion 962 during assembly of the two-piece housing 912. In this example, the first portion 960 may include any other alignment characteristics (e.g., surface finish, shape, pattern, etc.) or features (e.g., grooves, ridges, protrusions, etc.) that may be complementary to the alignment characteristics or features of the second portion 962.

[0067] The first portion 960 of the two-piece housing 912 may further include a recess 424. A first recess 424A extends from the proximal end section 914 of the two-piece housing 912 toward the distal end section 916. A second recess 424B extends from the proximal end section 914 of the two-piece housing 912 toward the distal end section 916. The first recess 424A and the second recess 424B may be offset at an angle relative to each other. Each recess in the recess 424 may be configured to receive an electromagnetic coil 426.

[0068] The electromagnetic coil 426 in the groove 424 can help to control the sampling device 300 inside the patient's body. Figure 3 ), and more specifically for the distal tip 302 ( Figure 3 Navigation is performed using an external coil array. In this example, an external coil array can generate an electromagnetic field, allowing the position and orientation of the electromagnetic coil 426 to be detected within that 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 electromagnetic coil 426. This change in the position and orientation of the distal tip 302 detected by the electromagnetic coil 426 can be transmitted to a control system (e.g., imaging and control system 102, see...). Figure 1 ).

[0069] In the example, each electromagnetic coil in electromagnetic coil 426 may include five degrees of freedom. The angular offset of the groove 424 allows the two five-degree-of-freedom coils (e.g., electromagnetic coil 426) to acquire six degrees of freedom navigation data. Therefore, the combination of each electromagnetic coil in electromagnetic coil 426 mounted in the groove 424 can be used to determine the navigation data for the distal tip 302. Figure 3 The pitch, yaw, roll, linearity, vertical straightness, and horizontal straightness of the distal tip 302. Therefore, the precise position and orientation of the distal tip 302 can be controlled throughout the medical process by a control system (e.g., imaging and control system 102). Figure 1 Tracking. The control system may have alarms, signals, or warnings based on any sensed orientation detected by the distal tip 302 within the patient's body.

[0070] As discussed in this article and Figure 10 As shown, imaging assembly 654 can be connected to each of image sensor 650 and light source 652. The proximal end 656 of imaging assembly 654 may include an electrical pad 658. The electrical pad 658 may be configured to secure a wire 660 to the electrical pad 658, for example, to electrically connect the image sensor 650 and light source 652 to the wire 660 via the electrical pad 658. The wire 660 may be configured to connect the electrical pad 658 to a control system (e.g., imaging and control system 102). Figure 1 This allows the control system to be connected to the image sensor 650 and the light source 652 via wires 660, imaging component 654, and solder pads 658. Figure 10 As shown, the imaging component 654 can be directly connected to the second portion 962 of the two-piece housing 912. In this example, the second portion 962 can also receive a tray (e.g., tray 640). Figure 6 (), to accommodate image sensor 650 and light source 652.

[0071] We will discuss this together. Figure 11 and Figure 12 . Figure 11 A perspective view of an example of transducer 320 is shown. Figure 12 A perspective view of an example of a transducer 320 in an unfolded orientation for the distal end of a sampling device is shown.

[0072] like Figure 11 and Figure 12 As shown, the transducer 320 can be disposed on a flexible substrate, which can be mounted on a flexible substrate such as... Figure 12 The flat configuration shown folds into the shape of Figure 11As shown, transducer 320 may be part of imaging assembly 1100. Imaging assembly 1100 may include substrate 1102, application-specific integrated circuit 1104, capacitor 1106, and linear transducer array 1108.

[0073] The flexibility of the substrate 1102 of the transducer 320 can help the transducer 320 be fitted into the housing (e.g., housing 312). Figure 3 This reduces the area required (within the housing) for mounting the transducer 320. Therefore, the foldable substrate 1102 helps reduce the size of the housing, allowing the housing to be mounted from the proximal end section (e.g., proximal end section 314). Figure 3 ()) tapering to the distal segment (e.g., distal segment 316 () Figure 3 )).like Figure 12 As shown, transducer 320 may include application-specific integrated circuit 1104, capacitor 1106, and linear transducer array 1108. The application-specific integrated circuit 1104, capacitor 1106, and linear transducer array 1108 may each be mounted to flexible substrate 1102. Figure 11 As shown, the transducer 320 may include a ribbon tail 1110.

[0074] Substrate 1102 may be a laminated structure comprising a capping layer, an electrically insulating layer, conductive features, and an adhesive. In this example, the capping layer and the electrically insulating layer may be made of polyimide. The conductive layer may be etched, laid out, or traced using copper, stainless steel, aluminum, or any other conductive material. Substrate 1102 may also be made using any other process or a material that allows for flexibility, such that substrate 1102 can be folded to be mounted within housing 312. Figure 3 ).

[0075] Application-specific integrated circuit 1104 can be configured to receive signals from linear transducer array 1108 and can transmit one or more signals in response to signals received from linear transducer array 1108. Capacitor 1106 can help provide geometric and mechanical flexibility to imaging assembly 1100. Linear transducer array 1108 can generate signals based on tissue within the transducer's field of view. Signals from linear transducer array 1108 can be generated by application-specific integrated circuit 1104, capacitor 1106, or imaging assembly 1100, endoscope system 100 ( Figure 1 ) or sampling device 300 ( Figure 3The imaging assembly 1100 may be received by any other component. In some examples, the imaging assembly 1100 may be configured to perform synthetic aperture imaging techniques, thereby achieving array imaging with a reduced number of transmission lines. This reduction in the number of transmission lines provides the benefits of reduced size (e.g., a smaller device diameter due to fewer transmission lines extending from the distal end to the proximal end) and reduced power consumption and / or heat generation. Additional details associated with the exemplary imaging assembly 1100 are described in 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, the entire disclosure of each of which is incorporated herein by reference.

[0076] As discussed herein, substrate 1102 can be secured to a mounting feature (e.g., mounting feature 318). Figure 3 The supporting surface (e.g., supporting surface 532) Figure 5 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 in 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 completely 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 in the periphery of the housing (e.g., periphery 313). Figure 3 ))Inside.

[0077] As discussed herein, epoxy resin or any other curing agent may be used to secure the transducer 320 within the mounting feature. The substrate 1102 of the transducer 320 may be folded and disposed within the epoxy resin or any other curing agent such that the application-specific integrated circuit 1104 is positioned directly beneath the linear transducer array 1108. The substrate 1102 of the transducer 320 may be folded and disposed within the epoxy resin or any other curing agent such that the application-specific integrated circuit 1104 is positioned between the linear transducer array 1108 and the image sensor or light source (e.g., image sensor 428 or light source 430). Figure 4 ))between.

[0078] The substrate 1102 of the transducer 320 can be folded and positioned within a mounting feature, such that the linear transducer array 1108 is positioned away from the housing (e.g., housing 312). Figure 3The substrate 1102 of the transducer 320 can be folded and positioned within the mounting feature, such that the linear transducer array 1108 extends beyond the periphery of the housing (e.g., housing 312). Figure 3 The periphery 313 of the housing. The substrate 1102 of the transducer 320 can be folded and disposed within the mounting feature, such that the linear transducer array 1108 is aligned with the periphery of the housing (e.g., housing 312). Figure 3 Align the perimeter of 313) with the perimeter of ).

[0079] The ribbon tail 1110 can be flexible and can extend from the proximal edge 331 of the transducer 320. For example, the ribbon tail 1110 can extend to a connector (e.g., connector 304). Figure 3 The ribbon tail 1110 may communicate with the transducer 320. The ribbon tail 1110 may include an electrical pad 1114 located on the proximal end 1113 of the ribbon tail 1110. The electrical pad 1114 may communicate with the transducer 320 and may be configured to attach a wire 1116 to the electrical pad 1114. For example, the electrical pad 1114 may 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., imaging and control system 102). Figure 1 This allows the control system to be connected to the transducer 320 via wires 1116 and solder pads 1114.

[0080] The ribbon tail 1110 may include a first bend 1111, which may be arranged with a profile that remains substantially orthogonal to the longitudinal axis LA of the connector 304, extending beyond the proximal end section of the housing (e.g., the proximal end section 314 of the housing 312) and extending downward from the proximal end section of the housing. The ribbon tail 1110 may include a second bend 1112, which may be arranged around the longitudinal axis LA of the connector 304 (… Figure 3 The first bend 1111 and the second bend 1112 may include a solder pad 1114. The solder pad 1114 may be configured to connect the wire 1116 to the second bend 1112 of the ribbon tail 1110. The combination of the first bend 1111 and the second bend 1112 allows the ribbon tail 1110 to move proximally away from the transducer while moving downward (e.g., away from the side of the device having a side exit port from the bevel) to provide a gap relative to the bevel (where the biopsy needle can protrude from the bevel into the patient's tissue within the FOV of the US transducer), and then be wound around the bevel (e.g., the needle lumen), as shown. Figure 16 As shown, the expanding or opening nature of the second bend 1112 provides an increased spacing between the weld points. (As illustrated...) Figure 11As illustrated, the first bend 1111 includes a bending characteristic that is generally limited to bending in a first plane, and the second bend 1112 includes a bending characteristic that is generally limited to bending in a second plane different from the first plane. This configuration having the first bend and the second bend allows bending in the first plane so that the ribbon tail 1110 is lowered or descended below the ramp of the connector. Figure 13 and Figure 14 (as shown), and then (for example, at the portion between the first bend and the second bend) transitions to a bend in a second plane that causes 1110 to wrap around a ramp within the wiring exit channel 1410.

[0081] We will discuss this together. Figures 13 to 16 . Figure 13 The illustration shows a sampling device (e.g., sampling device 300). Figure 3 Example connectors (e.g., connector 304) include the distal end (e.g., distal end 302). Figure 3 A three-dimensional image of )). Figure 14 The illustration shows a perspective view of an example of a ribbon-like tail 1110 wound around the side outlet ramp 310 of an example connector 304 for a transducer 320 around the distal end 302. Figure 15 The illustration shows the interior as seen from the proximal end (e.g., proximal portion 306) of an example of a connector 304 from the distal tip 302. Figure 16 A perspective view of the proximal end (e.g., proximal portion 306) of an example connector 304 with distal tip 302 is shown.

[0082] As discussed herein, connector 304 may extend from proximal portion 306 to distal portion 308. Connector 304 may include a side outlet ramp 310 extending from proximal portion 306 and through side portion 1302 of connector 304. Side outlet ramp 310 may guide an instrument (e.g., instrument 311). Figure 3 It passes through the side 1302 of the connector 304 and faces the patient's tissue. (As shown) Figures 14 to 16 As shown, connector 304 may include wiring exit channel 1410.

[0083] The wiring exit channel 1410 may be located below the side exit ramp 310 and at least partially wound around the side exit ramp 310. Furthermore, the wiring exit channel 1410 may be located within a pair of electromagnetic coils 426 ( Figure 9Directly below. The wiring exit channel 1410 may be generally U-shaped, having an inner contour generally concentric with the side exit ramp 310 and an outer contour generally concentric with the outer contour of the connector 304. As discussed herein, a ribbon tail 1110 may extend from the transducer 320 and into the connector 304. For example, the ribbon tail 1110 may extend from the transducer 320 into the wiring exit channel 1410 of the connector 304. As discussed herein, the second bend 1112 may include an electrical pad 1114 ( Figure 11 The solder pad 1114 may be located at the far end of the wiring exit channel 1410. The solder pad 1114 may be located within the wiring exit channel 1410.

[0084] like Figure 15 As shown, the ribbon-like tail 1110 can be divided into a first segment 1502 and a second segment 1504. The first segment 1502 and the second segment 1504 can be extended around the side outlet ramp within the connector (e.g., the side outlet ramp 310 of the connector 304).

[0085] like Figure 13 and Figure 14 As shown, the connector 304 may include a locking recess 1304. Figure 14 As shown, housing 312 may include a locking protrusion 1412. The locking protrusion 1412 may complement the locking recess 1304 to retain the connector 304 and housing 312 together after installation, assembly, etc. The connector 304 and housing 312 may include any other complementary locking mechanism, such as threads, pins, grooves, ridges, protrusions, etc., or any other mechanism that may retain the connector 304 and housing 312 together during operation of the sampling device 300.

[0086] like Figure 9 As discussed herein, the synchronous protrusion 974 can be derived from the second part 962 ( Figure 9 Extending radially outward, it can engage with connector 304 to ensure proper mounting of the housing (e.g., housing 312 or two-piece housing 912) and connector 304. Figure 14 As shown, the connector 304 may include a synchronization feature (e.g., a synchronization groove 1414). The synchronization groove 1414 may be formed in the proximal end segment 314 of the housing 312. The synchronization groove 1414 may complement the synchronization protrusion 974 to ensure that the connector 304 and the housing (e.g., housing 312) are aligned. Figure 3 ) or two-piece housing 912 ( Figure 9Proper alignment during the assembly, installation, etc., of the connector 304 and the housing. Part 962 and the synchronization groove 1414 are merely example alignment indicators that can be used to ensure alignment of the connector 304 and the housing 312. The inventors of this application understand that many other alignment tools, mechanisms, aids, guides, etc., exist that can be used to ensure proper alignment of the connector 304 and the housing 312 during assembly, such that the instrument 311 extends into the field of view 322 of the transducer 320 as it extends from the side outlet ramp 310 of the connector 304.

[0087] Figure 17 A schematic diagram of example method 1700 is illustrated. Method 1700 can be a method for reprocessing a sampling device (e.g., endoscope 104, sampling device 300, etc.). More specific examples of method 1700 are discussed below. For convenience and clarity, the steps or operations of method 1700 are illustrated in a specific order; many of the operations discussed may be performed in different orders or in parallel without substantially affecting other operations. As discussed, method 1700 includes operations performed by multiple different actors, devices, or systems. It should be understood that a subset of the operations discussed in method 1700 may be attributed to a single actor, device, or system and may be considered as a separate, independent process or method.

[0088] Reference Figure 17 A reprocessing method 1700 for the therapeutic instrument (e.g., endoscope 104 or sampling device 300) described above is described. The therapeutic instrument (e.g., endoscope 104 or sampling device 300) described above can be discarded after a single use, or it can be reused, for example, multiple times. In the case of a configuration that can be reused multiple times, for example... Figure 17 The reprocessing method 1700 shown may be relevant.

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

[0090] Then, the operator can clean and sterilize the collected and transported used treatment instruments (e.g., endoscope 104 or sampling device 300) (step S2). Specifically, when cleaning the treatment instruments (e.g., endoscope 104 or sampling device 300), deposits adhering to the exterior of the distal tip 302 (e.g., connector 304 or housing 312) can be removed using a brush or the like. After this, to remove pathogenic microorganisms from blood, body fluids, etc., the distal tip 302 can be cleaned using a cleaning solution containing isopropanol, proteolytic enzyme detergent, and alcohol. The cleaning solution is not limited to the cleaning solution described above, and other cleaning solutions can be used. Furthermore, in the sterilization of the treatment instruments (e.g., endoscope 104 or sampling device 300), to sterilize pathogenic microorganisms adhering to the distal tip 302, any of the following can be used: autoclaving, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide, and hydrogen peroxide low-temperature sterilization. Partial distal tip 302, and specifically the connector 304 and housing 312, can be disassembled by actuating a clamping or fixing feature (e.g., the first attachment engagement 964 or the locking protrusion 1412) to disconnect the connector 304 and housing 312.

[0091] The operator can perform an acceptance inspection (step S3) on the used treatment instrument (e.g., endoscope 104 or sampling device 300). Specifically, the operator can check whether the used treatment instrument (e.g., endoscope 104 or sampling device 300) has obvious defects or whether the used treatment instrument (e.g., endoscope 104 or sampling device 300) has exceeded the maximum number of reprocessing cycles.

[0092] Next, the operator can disassemble the used treatment instrument (e.g., endoscope 104 or sampling device 300) (step S4). The distal tip 302 can be disassembled by removing the housing 312 from the connector 304 and removing all components from the connector 304 and housing 312.

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

[0094] Following step S5, the operator may assemble the new treatment instrument (e.g., endoscope 104 or sampling 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 marking to designate the device as reprocessed, refurbished, or remanufactured.

[0095] Following step S6, the operator can inspect and test the newly formed therapeutic device (e.g., endoscope 104 or sampling device 300) (step S7). Specifically, the remanufacturing operator verifies that the newly formed therapeutic device (e.g., endoscope 104 or sampling device 300) has the same effectiveness and safety as the original product through various functional tests.

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

[0097] Perform steps S1 through S9 as described above to reprocess the therapeutic device (e.g., endoscope 104 or sampling device 300). Any of steps S1 through S9 may be performed by one or more participants in any order. Furthermore, steps S1 through S9 are exemplary steps and are not an exhaustive list of steps that can be performed by an operator to refurbish, remanufacture, or supplement the medical device (e.g., endoscope 104 or sampling device 300).

[0098] Figure 18A block diagram of an example machine 1800 on which any or more of the techniques (e.g., methods) discussed herein may be performed. As described herein, the example may include, or be operable by, logic or components or mechanisms in the machine 1800. A circuit system (e.g., a processing circuit system) is a collection of circuits implemented in a tangible entity of the machine 1800, including hardware (e.g., simple circuits, gates, logic, etc.). The relationships between circuit system components can be flexible over time. A circuit system includes components that can perform specific operations individually or in combination during operation. In the example, the hardware of the circuit system may be designed in an immutable manner to perform specific operations (e.g., hardwired). In the example, the hardware of the circuit system may include physical components (e.g., execution units, transistors, simple circuits, etc.) connected in a variable manner to encode instructions for specific operations, and the variablely connected physical components include machine-readable media that are physically modified (e.g., magnetically grounded, electrically grounded, movable placement of immutable aggregate particles, etc.). When physical components are connected, the underlying electrical characteristics of the hardware composition are altered, for example, from an insulator to a conductor or vice versa. Instructions enable embedded hardware (e.g., an execution unit or loading mechanism) to create components of a circuit system within the hardware via variable connections to perform parts of a specific operation during operation. Thus, in the example, a machine-readable medium element is part of the circuit system, or communicatively coupled to other components of the circuit system during device operation. In the example, any physical component can be used in more than one component of more than one circuit system. For example, during operation, an execution unit can be used at one point in time in a first circuit of a first circuit system and reused by a second circuit of the first circuit system, or reused at different times by a third circuit of the second circuit system. Additional examples of these components of machine 1000 are provided below.

[0099] In alternative examples, machine 1800 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, machine 1800 may operate as a server machine, a client machine, or both in a server-client network environment. In the examples, machine 1800 may be used as 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, network device, network router, switch, or bridge, or any machine capable of executing instructions (sequentially or otherwise) specifying actions to be taken by that machine. Furthermore, although only a single machine is illustrated, the term "machine" should also be understood to include any set of machines that individually or collectively execute a set (or more) of instructions to perform any or more of the methods discussed herein, such as cloud computing, Software as a Service (SaaS), or other computer cluster configurations.

[0100] Machine (e.g., computer system) 1800 may include a hardware processor 1802 (e.g., a central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 1804, static memory (e.g., memory or storage device for firmware, microcode, basic input / output (BIOS), unified extensible firmware interface (UEFI), etc.) 1806, and mass storage device 1808 (e.g., hard disk drive, tape drive, flash memory, or other block device), some or all of which may communicate with each other via an interconnect link (e.g., bus) 1830. Machine 1800 may also include a display unit 1810, an alphanumeric input device 1812 (e.g., keyboard), and a user interface (UI) navigation device 1814 (e.g., mouse). In this example, the display unit 1810, the input device 1812, and the UI navigation device 1814 may be a touchscreen display. Machine 1800 may additionally include a storage device (e.g., a drive unit) 1808, a signal generation device 1818 (e.g., a speaker), a network interface device 1820, and one or more sensors 1816, such as a Global Positioning System (GPS) sensor, a compass, an accelerometer, or other sensors. Machine 1800 may include an output controller 1828, connected, for example, serially (e.g., Universal Serial Bus (USB), parallelly, or other wired or wirelessly (e.g., infrared (IR), near field communication (NFC), etc.)), to communicate with or control one or more peripheral devices (e.g., printers, card readers, etc.).

[0101] The registers of processor 1802, main memory 1804, static memory 1806, or mass storage device 1808 may be or include machine-readable medium 1822 on which one or more sets of data structures or instructions 1824 (e.g., software) are stored, said set of one or more sets of data structures or instructions 1824 embodying or being utilized by any or more of the techniques or functions described herein. Instructions 1824 may also reside wholly or at least partially within any of the registers of processor 1802, main memory 1804, static memory 1806, or mass storage device 1808 during execution by machine 1800. In this example, one or any combination of hardware processor 1802, main memory 1804, static memory 1806, or mass storage device 1808 may constitute machine-readable medium 1822. Although machine-readable medium 1822 is illustrated as a single medium, the term "machine-readable medium" can include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store one or more instructions 1824.

[0102] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions for use by machine 1800 and to cause machine 1800 to perform any or more of the techniques of this disclosure, or capable of storing, encoding, or carrying data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, non-transitory machine-readable media includes machine-readable media having a plurality of particles with invariant (e.g., stationary) mass and thus being a composition of matter. Therefore, a non-transitory machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transitory machine-readable media can 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 hard disks; magneto-optical disks; and CD-ROM and DVD-ROM discs.

[0103] In the example, information stored on or otherwise provided on machine-readable medium 1822 may represent instruction 1824, such as instruction 1824 itself or a format from which instruction 1824 can be derived. Such a format from which instruction 1824 can be derived may include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., divided into multiple packages), etc. The information representing instruction 1824 in machine-readable medium 1822 may be processed by a processing circuitry system into instructions to implement any of the operations discussed herein. For example, deriving instruction 1824 from information (e.g., processed by a processing circuitry system) may include: (e.g., from source code, object code, etc.) compiling, interpreting, loading, organizing (e.g., dynamic or static linking), encoding, decoding, encrypting, decrypting, packaging, unpacking, or otherwise manipulating the information into instruction 1824.

[0104] In the example, the derivation of instruction 1824 may include the assembly, compilation, or interpretation of information (e.g., by processing a circuit system) to create instruction 1824 according to some intermediate or preprocessed format provided by machine-readable medium 1822. Information provided in multiple parts can be combined, unpacked, and modified to create instruction 1824. For example, the information may be in 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 during transmission over a network and, if necessary, decrypted, decompressed, assembled (e.g., linked), and compiled or interpreted at the local machine (e.g., compiled or interpreted into libraries, standalone executables, etc.), and executed by the local machine.

[0105] Commands 1824 can also be transmitted or received via a communication network 1826 using a transmission medium via network interface device 1820, utilizing any of several transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Example communication networks may include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), LoRa / LoRaWAN or satellite communication networks, mobile phone networks (e.g., cellular networks, such as cellular networks compliant with 3G, 4G LTE / LTE-A, or 5G standards), conventional telephone (POTS) networks, and wireless data networks (e.g., the IEEE 502.11 family of standards known as Wi-Fi®, the IEEE 502.15.4 family of standards, peer-to-peer (P2P) networks, etc.). In the example, network interface device 1820 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connection to communication network 1826. In the example, network interface device 1820 may include multiple antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technology. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions for execution by machine 1800, and the term "transmission medium" includes digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0106] The following non-limiting examples detail certain aspects of this topic to address challenges and provide the benefits discussed herein.

[0107] Example 1 is a distal tip of an endobronchial ultrasound sampling device, the distal tip comprising: a connector extending from a proximal portion along a longitudinal axis to a distal portion, the connector including a side outlet ramp extending within the connector from the proximal portion and extending through a side portion of the connector, the side outlet ramp guiding an instrument through the side portion of the connector toward the patient's tissue; and a housing extending from a proximal segment along a central axis to a distal segment, the proximal segment of the housing being coupled to the distal portion of the connector, the housing including: a first portion including a mounting feature configured to receive a transducer, the mounting feature tapering toward the central axis of the housing as the housing extends from the proximal segment toward the distal segment; and a second portion configured to attach to the first portion such that the second portion is adjacent to the first portion.

[0108] In Example 2, the subject of Example 1 includes, wherein the mounting feature tapers to such that the instrument extends into the field of view of the transducer.

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

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

[0111] In Example 5, the subject matter of Examples 3 to 4 includes a support surface recessed within the periphery of the housing such that the transducer extends beyond the periphery of the housing when the transducer is mounted within the mounting feature.

[0112] In Example 6, the subject matter of Examples 1 to 5 includes, wherein the first part includes: a first attachment engagement recessed within the periphery of the housing, the first attachment engagement being configured to be inserted into the distal portion of the connector.

[0113] In Example 7, the subject of Example 6 includes, wherein the first part includes: a wire cut-out configured to guide one or more wires of the transducer to a distal portion of the connector.

[0114] In Example 8, the subject matter of Examples 1 to 7 includes, wherein the second part includes: a mounting engagement recessed within the periphery of the housing, the mounting engagement being insertable into the distal portion of the connector to mount the housing to the connector.

[0115] In Example 9, the subject matter of Examples 1 through 8 includes, wherein a first portion includes an alignment protrusion, and wherein a second portion includes an alignment groove, wherein the alignment protrusion and the alignment groove are complementary to align the first portion with the second portion.

[0116] In Example 10, the subject matter of Examples 1 to 9 includes, wherein the first part includes: a first groove extending from a proximal end segment of the housing toward a distal end segment of the housing; and a second groove extending from the proximal end segment toward the distal end segment, the first groove being offset at an angle relative to the second groove.

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

[0118] In Example 12, the subject matter of Examples 1 to 11 includes, wherein the second part includes: a second attachment engagement recessed within the periphery of the housing, the second attachment engagement being configured to insert into the distal portion of the connector.

[0119] In Example 13, the subject matter of Example 12 includes, wherein the second attachment joint includes: a synchronizing protrusion that extends radially outward from the second attachment joint and is capable of engaging with the connector to ensure proper installation of the housing and the connector.

[0120] In Example 14, the subject matter of Examples 1 to 13 includes, wherein the first part includes: an image sensor mounting portion extending from a distal end portion toward a proximal end portion; and a light source mounting portion adjacent to the image sensor mounting portion and extending from the distal end portion toward the proximal end portion.

[0121] In Example 15, the subject matter of Example 14 includes an image sensor mounting portion configured to fix an image sensor below the distal end of a mounting feature, and a light source mounting portion configured to fix a light source below the distal end of a mounting feature.

[0122] In Example 16, the subject matter of Examples 14 to 15 includes, wherein the first part comprises a rectangular outline at the distal tip of the first part.

[0123] In Example 17, the subject matter of Examples 14 to 16 includes a light source mounting portion configured to mount the light source in alignment with the distal tip of the first portion.

[0124] In Example 18, the subject matter of Examples 14 to 17 includes an image sensor mounting portion configured to fix an image sensor to be aligned with the distal tip of a first portion.

[0125] In Example 19, the subject matter of Examples 14 to 18 includes an image sensor mounting portion configured to fix the image sensor in alignment with the central axis of the housing.

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

[0127] In Example 21, the subject of Example 20 includes a tray that at least partially covers the farthest portion of the transducer.

[0128] In Example 22, the subject matter of Examples 20 to 21 includes a connector that extends from a proximal portion to a distal portion, the distal portion of which is coupled to the proximal segment of the housing.

[0129] In Example 23, the subject matter of Example 22 includes, wherein the connector includes: a side outlet bevel extending from a proximal portion within the connector and extending through the side portion of the connector, the side outlet bevel guiding an instrument through the side portion of the connector toward the patient's tissue.

[0130] In Example 24, the subject matter of Example 23 includes, wherein the mounting features taper toward the central axis of the housing as the housing extends from the proximal end segment toward the distal end tip.

[0131] In Example 25, the subject of Example 24 includes, wherein the mounting feature tapers to such that the instrument extends into the field of view of the transducer.

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

[0133] In Example 27, the subject of Example 26 includes, where the remote body includes a rectangular outline.

[0134] In Example 28, the subject matter of Examples 26 to 27 includes, wherein the distal body includes: an image sensor mounting portion extending from the distal end segment toward the proximal end segment; and a light source mounting portion adjacent to the image sensor mounting portion and extending from the distal end segment toward the proximal end segment.

[0135] In Example 29, the subject matter of Example 28 includes an image sensor mounting portion configured to fix an image sensor below the distal end of a mounting feature, and a light source mounting portion configured to fix a light source below the distal end of a mounting feature.

[0136] In Example 30, the subject of Example 29 includes an image sensor mounting section that fixes the image sensor such that the central axis of the image sensor is substantially parallel to the central axis of the housing.

[0137] In Example 31, the subject of Example 30 includes an image sensor mounting portion configured to fix the image sensor such that the distal edge of the image sensor is aligned with the distal tip of the distal end portion.

[0138] In Example 32, the subject matter of Examples 29 to 31 includes an imaging assembly connected to each of an image sensor and a light source, the proximal end of the imaging assembly including an electrical pad configured to secure wires to the electrical pad, the electrical pad being in communication with the image sensor and the light source.

[0139] In Example 33, the subject of Example 32 includes a wire configured to connect an electrical pad to a control system, such that the control system is connected to an image sensor and a light source via the wire and an imaging component.

[0140] In Example 34, the subject matter of Examples 32 to 33 includes an imaging component mounted to a support of a tray.

[0141] In Example 35, the subject matter of Examples 20 to 34 includes, wherein the housing includes: a first groove extending from a proximal end segment toward a distal end segment; and a second groove extending from the proximal end segment toward the distal end segment, the first groove being offset at an angle relative to the second groove.

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

[0143] In Example 37, the subject matter of Examples 20 to 36 includes a transducer whose surface normal vector forms an acute angle with the central axis of the tray.

[0144] Example 38 is a distal tip of an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending from a proximal segment along a central axis to a distal segment, the housing including a mounting feature configured to receive a transducer, the mounting feature tapering toward the central axis of the housing as the housing extends from the proximal segment toward the distal segment; and a connector extending from the proximal portion to the distal portion, the connector including: a side outlet ramp extending within the connector from the proximal portion and extending through a side portion of the connector, the side outlet ramp guiding an instrument through the side portion of the connector toward the patient's tissue; and a wiring outlet channel disposed below the side outlet ramp and at least partially wound around the side outlet ramp.

[0145] In Example 39, the subject of Example 38 includes a transducer comprising: a flexible tail extending from a proximal edge of the transducer into a connector, the flexible tail being in communication with the transducer.

[0146] In Example 40, the subject of Example 39 includes, wherein the flexible tail includes: an electrical pad located on the proximal end of the flexible tail, the electrical pad being in communication with a transducer and configured to attach wires to the electrical pad.

[0147] In Example 41, the subject of Example 40 includes a wire configured to connect an electrical pad to a control system, such that the control system is connected to a transducer via the wire and the electrical pad.

[0148] In Example 42, the subject of Example 41 includes a flexible tail that is arranged to extend beyond the proximal end section of the housing and downward from the proximal end section of the housing, maintaining a profile that is generally orthogonal to the longitudinal axis of the connector.

[0149] In Example 43, the subject of Example 42 includes a flexible tail that transitions into a bent portion that is generally rolled upward around the longitudinal axis of the connector.

[0150] In Example 44, the subject of Example 43 includes, where the bent portion includes an electrical pad.

[0151] In Example 45, the subject matter of Examples 40 to 44 includes an electrical pad located at the far end of the wiring exit channel.

[0152] In Example 46, the subject matter of Examples 40 to 45 includes an electrical pad located within a wiring exit channel.

[0153] In Example 47, the subject matter of Examples 39 to 46 includes a flexible tail divided into a first segment and a second segment, wherein the first segment and the second segment are deployed around a side outlet ramp within the connector.

[0154] In Example 48, the subject matter of Examples 38 to 47 includes, wherein the housing includes a first synchronization feature formed in the proximal end segment of the housing.

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

[0156] In Example 50, the subject of Example 49 includes a second synchronization feature that is complementary to the first synchronization feature to ensure proper alignment of the connector and housing during installation.

[0157] In Example 51, the subject of Example 50 includes a locking protrusion in the housing and a locking recess in the connector, wherein the locking protrusion and the locking recess are complementary to retain the connector and the housing together after installation.

[0158] In Example 52, the subject matter of Examples 38 to 51 includes a wiring exit channel comprising a generally U-shaped profile having an inner surface defined by a wall between the wiring exit channel and a side exit ramp and an outer surface defined by a wall between the wiring exit channel and the outer profile of the connector.

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

[0160] In Example 54, the subject of Example 53 includes an intrabronchial ultrasound sampling device comprising a housing, a tray configured to be mounted within the housing, and a connector.

[0161] In Example 55, the subject matter of Example 54 includes removing the tray from the housing; disconnecting the housing from the connector; sterilizing the housing, tray, and connector; and encapsulating the housing, tray, and connector.

[0162] Example 56 is a distal tip of an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending from a proximal segment along a central axis to a distal segment, the housing including a mounting feature configured to receive a transducer, the mounting feature tapering toward the central axis of the housing as the housing extends from the proximal segment toward the distal segment; and a connector extending from the proximal portion to the distal portion, the connector including: a side outlet ramp extending from the proximal portion and through a side portion of the connector within the connector, the side outlet ramp guiding an instrument through the side portion of the connector toward the patient's tissue; and a wiring outlet channel disposed below the side outlet ramp and at least partially wound around the side outlet ramp; and a transducer including a flexible tail extending from a proximal edge of the transducer into the connector, the flexible tail communicating with the transducer.

[0163] In Example 57, the subject of Example 56 includes, where the bent portion includes solder pads.

[0164] Example 58 is a distal tip of an endobronchial ultrasound sampling device, the distal tip comprising: a housing extending from a proximal end segment along a central axis to a distal end segment, the housing including a mounting feature that tapers toward the central axis of the housing as it extends from the proximal end segment toward the distal end segment; a transducer fixed to the mounting feature such that the normal vector of a generally planar surface of the transducer forms an acute angle with the central axis of the housing; and a side outlet ramp located at the proximal end of the transducer and configured such that a guide needle travels 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 the generally planar surface.

[0165] In Example 59, the subject of Example 58 includes a transducer comprising a foldable flexible substrate.

[0166] In Example 60, the subject of Example 59 includes a transducer comprising: an application-specific integrated circuit (ASIC) mounted to a flexible substrate; a capacitor mounted to the flexible substrate; and a linear transducer array mounted to the flexible substrate.

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

[0168] In Example 62, the subject of Example 61 includes a transducer fixed to a support surface such that the application-specific integrated circuit, capacitor, and linear transducer array are at least partially recessed within the periphery of the housing.

[0169] In Example 63, the subject matter of Examples 61 to 62 includes a transducer 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 housing.

[0170] In Example 64, the subject matter of Examples 61 to 63 includes a transducer fixed to a support surface such that at least one of an application-specific integrated circuit, a capacitor, or a linear transducer array is at least partially recessed within the periphery of the housing.

[0171] In Example 65, the subject of Example 64 includes a transducer folded and disposed in epoxy resin such that an application-specific integrated circuit is located directly beneath the linear transducer array.

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

[0173] In Example 67, the subject of Example 66 includes a linear transducer array extending beyond the periphery of the housing.

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

[0175] In Example 69, the subject matter of Examples 58 to 68 includes: an image sensor mounting portion that extends from a distal end portion toward a proximal end portion; and a light source mounting portion that is adjacent to the image sensor mounting portion and extends from the distal end portion toward the proximal end portion.

[0176] In Example 70, the subject matter of Example 69 includes an image sensor mounting portion configured to fix an image sensor within a distal end section of a housing, and a light source mounting portion configured to fix a light source within a distal end section of a housing.

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

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

[0179] In Example 73, the subject matter of Example 72 includes, wherein the intrabronchial ultrasound sampling device comprises: a housing; a tray configured to be mounted within the housing; and a connector.

[0180] In Example 74, the subject matter of Example 73 includes: removing the tray from the housing; disconnecting the housing from the connector; sterilizing the housing, tray, and connector; and encapsulating the housing, tray, and connector.

[0181] Example 75 is a device that includes means for implementing any one of Examples 1 through 74.

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

[0183] Example 77 is a method used to implement any one of Examples 1 through 74.

[0184] Example 78 is a device, system, method, or apparatus that includes any element of any of Examples 1 through 74.

[0185] The above detailed description includes reference to the accompanying drawings, which form a part of the detailed description. The drawings illustrate specific embodiments that can be practiced by way of illustration. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors also contemplate examples (or one or more aspects thereof) using any combination or arrangement of those elements shown or described relative to a particular example (or one or more aspects thereof) shown or described herein, or relative to other examples (or one or more aspects thereof).

[0186] All publications, patents, and patent documents mentioned in this document are incorporated herein by reference in their entirety, as if they were individually incorporated by reference. In the event of any inconsistency between the usage in this document and those documents incorporated by reference, the usage in the incorporated reference shall be considered supplementary to the usage in this document; in the case of irreconcilable inconsistencies, the usage in this document shall prevail.

[0187] In this document, as is common in patent documents, the term "a" or "one" is used to include one or more, independent of any other instance or use of "at least one" or "one or more." In this document, unless otherwise indicated, the term "or" is used to mean a non-exclusive "or," such that "A or B" includes "A but not B," "B but not A," and "A and B." In the appended claims, the terms "comprising" and "in..." are used as concise English equivalents to the corresponding terms "including" and "wherein." Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, or process that includes elements other than those listed after such terms in the claim is still considered to fall within the scope of that claim. Additionally, in the appended claims, the terms "first," "second," and "third," etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0188] As used herein, the term “about” means approximately, within a certain range, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies the range by extending the upper and lower boundaries of the stated value. Typically, the term “about” is used herein to modify numerical values ​​above and below the stated value by a change of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number to which the term is used. Thus, about 50% means a range of 45% to 55%. The numerical ranges listed in this document by endpoints include all numbers and fractions contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, the numerical ranges listed by endpoints in this document include subranges contained within those ranges (e.g., 1 to 5 includes 1 to 1.5, 1.5 to 2, 2 to 2.75, 2.75 to 3, 3 to 3.90, 3.90 to 4, 4 to 4.24, 4.24 to 5, 2 to 5, 3 to 5, 1 to 4, and 2 to 4). It is also understood that all numbers and their fractions are assumed to be modified by the term “about”.

[0189] The foregoing description is intended to be illustrative and not restrictive. For example, the examples described above (or one or more aspects thereof) can be used in combination with each other. Other examples may be used by one of ordinary skill in the art upon reading the foregoing description. The abstract is intended to allow the reader to quickly determine the nature of the technical disclosure, and it should be understood that the abstract is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the detailed description above, various features may be combined to simplify this disclosure. This should not be construed as implying that any unclaimed feature is necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are incorporated herein by reference to the detailed description, wherein each claim exists independently as a separate embodiment. The scope of the examples should be determined by reference to the full scope of the appended claims together with their equivalents.

[0190] The devices disclosed herein may be designed for single-use post-treatment or for multiple-use applications. However, in either case, the device may be repaired for reuse after at least one use. Repair may include a combination of the following steps: disassembly of the device, subsequent cleaning or replacement of specific parts, and subsequent reassembly. Specifically, the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. After cleaning and / or replacement of specific parts, the device may be reassembled at a repair facility or immediately before a surgical procedure by a surgical team for subsequent use. Those skilled in the art will understand that the repair of the device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. The use of these techniques and the resulting repair devices are within the scope of this application.

[0191] Preferably, the invention described herein is performed prior to surgical procedures. First, new or used instruments are obtained and, if necessary, cleaned. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a closed, sealed container, such as a plastic bag or a TYVEK® bag. The container and instruments are then placed in a radiation field, such as gamma radiation, X-rays, or high-energy electrons, that can penetrate the container. The radiation kills bacteria on the instruments and in the container. The sterile instruments can then be stored in a sterile container. The sealed container keeps the instruments sterile until they are opened in a medical facility. Any other techniques known in the art can also be used to sterilize the devices, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

Claims

1. A distal tip for an endobronchial ultrasonic sampling device, the distal tip comprising: A housing extending from a proximal end segment along a central axis to a distal end segment, the housing comprising: Mounting features that taper toward the central axis of the housing as the housing extends from the proximal end section toward the distal end section; A transducer, the transducer being fixed to the mounting feature such that the normal vector of the generally planar surface of the transducer forms an acute angle with the central axis of the housing; and A side exit ramp is located at the proximal end of the transducer and is configured to guide a pin through the field of view of the transducer distally along a trajectory that forms an acute angle with the central axis and intersects the normal vector of the generally planar surface.

2. The distal tip according to claim 1, wherein, The transducer includes a foldable flexible substrate.

3. The distal tip according to claim 2, wherein, The transducer includes: An application-specific integrated circuit (ASIC) is mounted to the flexible substrate. A capacitor, said capacitor being mounted to the flexible substrate; and A linear transducer array, the linear transducer array being mounted to the flexible substrate; and wherein the mounting features include: A support surface recessed within the periphery of the housing, to which the transducer is fixed to hold the transducer within the mounting feature.

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 within the periphery of the housing.

5. The distal tip according to any one of claims 3 to 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 within the periphery of the housing.

7. The distal tip according to claim 6, wherein, The transducer is folded and disposed in epoxy resin such that the application-specific integrated circuit is located directly below the linear transducer array, and wherein the linear transducer array is opposite to the housing.

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

9. The distal tip according to any one of claims 1 to 8, comprising: An image sensor mounting portion, the image sensor mounting portion extending from the distal end section toward the proximal end section; as well as A light source mounting portion, which is adjacent to the image sensor mounting portion and extends from the distal end portion toward the proximal end portion.

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

11. The distal tip according to any one of claims 1 to 10, comprising: A tray configured to be mounted within the distal segment of the housing and defining the distal end of the distal tip, the tray comprising: An image sensor mounting section is configured to mount an image sensor adjacent to the transducer and within the distal end portion of the distal end portion.

12. The distal tip according to claim 11, wherein, The tray includes: Remote body; and A support member that extends from the distal body and is configured to connect the tray to the housing.

13. The distal tip according to claim 12, wherein, The remote body includes a rectangular outline.

14. The distal tip according to any one of claims 12 to 13, wherein, The remote body includes: Image sensor mounting portion, the image sensor mounting portion extending from the distal end section toward the proximal end section; and A light source mounting portion, which is adjacent to the image sensor mounting portion and extends from the distal end portion toward the proximal end portion.

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, and the light source mounting portion is configured to fix the light source below the distal end of the mounting feature.

16. The distal tip according to any one of claims 14 to 15, wherein, The image sensor mounting section fixes the image sensor in such a way that the central axis of the image sensor is substantially 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 is aligned with the distal tip of the distal end portion.

18. The distal tip according to any one of claims 1 to 17, wherein, The housing includes: The first part includes the mounting features; and The second part is configured to be attached to the first part such that the second part is adjacent to the first part.

Images