Ultrasonic element with linear inclined plane arrangement

Abstract

A transducer for an intrabronchial ultrasound sampling device may include a substrate, a plurality of electrode tracks, and a plurality of ultrasound elements. A plurality of electrode tracks may be disposed on the substrate. Each of the plurality of electrode tracks may be independently electrically connected. The plurality of ultrasound elements may be spaced from the proximal end portion of the transducer to the distal end portion of the transducer. Each of the plurality of ultrasound elements may be coupled to an electrode track of the plurality of electrode tracks and angled relative to the substrate so as to extend a field of view of the transducer distally beyond a distal edge of the transducer.

Description

CLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority under 35 U.S.C. 119 to U.S. Patent Application Serial No. 63 / 503,093, titled “LINEARLY ARRANGED ULTRASOUND ELEMENTS,” filed May 18, 2023, in the name of Christopher Lee (Attorney Docket No. 5409.860 PRV), and U.S. Patent Application Serial No. 63 / 581,814, titled “LINEARLY ARRANGED ULTRASOUND ELEMENTS,” filed September 11, 2023, in the name of Vignesh Mandalapa Bhoopathy et al. (Attorney Docket No. 5409.860 PV2), each of which is hereby incorporated by reference in its entirety. TECHNICAL FIELD

[0002] Examples described herein generally relate to ultrasound devices. More specifically, examples described herein generally relate to linearly arranged ultrasound elements. BACKGROUND

[0003] Conventional endoscopes can be used for various clinical procedures, including, for example, illuminating, imaging, detecting, and diagnosing one or more disease states, providing fluid delivery (e.g., providing saline or other agents via a fluid channel) toward an anatomical region, providing access (e.g., via a working channel) for one or more treatment devices for sampling or treating the anatomical region, and providing a suction channel for collecting fluids (e.g., saline or other agents), among others. Such anatomical regions can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, biliary-pancreatic 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), among others. SUMMARY

[0004] The inventors of the present disclosure have recognized limitations of the field of view of transducers on sampling devices. For example, transducers used for sampling devices typically have a limited field of view, making it difficult for a medical provider to obtain a sample from a target tissue near the insertion limit of the sampling device. Accordingly, the inventors have developed a sampling device that includes a transducer designed to extend the field of view of the transducer beyond the distal edge of the sampling device.

[0005] In an example, a bronchoscopic ultrasound sampling device can include an elongate member extending along a longitudinal axis between a proximal section and a distal section. The elongate member can define a lumen extending from the proximal section into the distal section. The elongate member can include a medical instrument outlet and a transducer. The medical instrument outlet can be configured to direct a medical instrument from the lumen and into tissue of a patient. The transducer can be attached to the distal section of the elongate member and can include a plurality of ultrasound elements. The plurality of ultrasound elements can be spaced apart from a proximal portion of the transducer to a distal portion of the transducer. Each element of the plurality of ultrasound elements can be angled relative to the longitudinal axis of the elongate member so as to extend a field of view of the transducer distally of a distal end of the distal section of the elongate member. In this way, the distal most boundary of the field of view extends distally compared to if the ultrasound elements were arranged perpendicular to the longitudinal axis, enabling the medical instrument to be advanced distally at an acute angle relative to the longitudinal axis and through the field of view of the transducer so as to penetrate more deeply into the tissue before extending beyond the distal most field of view boundary.

[0006] In an example, a transducer for a bronchoscopic ultrasound sampling device can include a substrate, a plurality of electrode tracks, and a plurality of ultrasound elements. The plurality of electrode tracks can be disposed on the substrate. Each electrode track of the plurality of electrode tracks can be independently electrically connected. The plurality of ultrasound elements can be spaced apart from a proximal portion of the transducer to a distal portion of the transducer. Each element of the plurality of ultrasound elements can be coupled to an electrode track of the plurality of electrode tracks and angled relative to the substrate so as to extend a field of view of the transducer distally beyond a distal edge of the transducer.

[0007] In an example, a method for reprocessing a sampling device can include obtaining a sampling device, sterilizing the sampling device, and storing the sampling device. BRIEF DESCRIPTION OF DRAWINGS

[0008] Various examples are illustrated in the figures of the accompanying drawings. These examples are illustrative, and are not intended to be exhaustive or exclusive, as to the subject matter.

[0009] Figure 1 A schematic diagram illustrating an example of a bronchoscopic ultrasound sampling device system.

[0010] Figure 2 A schematic diagram illustrating an example of an imaging and control system of a bronchoscopic ultrasound sampling device.

[0011] Figure 3 A cross-sectional view of a portion of an example bronchoscope is illustrated.

[0012] Figure 4 A portion of an example ultrasound element array is illustrated.

[0013] Figure 5 An example ultrasound element array is illustrated.

[0014] Figure 6 An example of an array of ultrasound elements is illustrated.

[0015] Figure 7 A side view of an example of a sampling device is illustrated.

[0016] Figure 8 A cross-sectional view of a port in an example actuator of an example sampling device is illustrated.

[0017] Figure 9 A block diagram is illustrated that illustrates an example of a method for reprocessing a bronchoscope. DETAILED DESCRIPTION

[0018] The field of view for an endobronchial ultrasound sampling device can be primarily a byproduct of the geometric properties of the array of ultrasound transducer elements in such an ultrasound sampling device. For example, an array in which the ultrasound transducer elements are linearly distributed and oriented parallel can result in a field of view that is approximately rectangular. Such an arrangement is commonly referred to as a linear array. In contrast, an array in which the ultrasound transducer elements are distributed along a convexly curved surface and each oriented perpendicular to the convexly curved surface (e.g., such that the orientation of each element deviates from an adjacent element) will result in a field of view that unfolds to an increased field of view of ultrasound. Such an arrangement is commonly referred to as a curved array (or curvilinear array).

[0019] In some clinical environments, the geometric properties associated with a linear array can be superior to the geometric properties of a curved array, despite the larger field of view associated with the curved array. For example, some EBUS biopsy sampling devices include a ramp through which a biopsy needle can be extended into the field of view (FOV) of an ultrasound transducer. Typically, the ramp is located at the proximal end of the US transducer and bends and directs the biopsy needle into the FOV along a needle path axis that deviates at an acute angle from the longitudinal axis of the EBUS device. Depending on the depth of the target nodule or target tissue relative to the airway from which a biopsy is to be collected, it can not be possible to collect a sample while the target nodule (e.g., a solitary pulmonary nodule or “SPN”) remains within the FOV because the needle can exit the distal FOV boundary before reaching the target depth. Thus, the FOV associated with a curved array can be superior to the FOV of a linear array— primarily because the curved geometry of the curved array results in a distal-most FOV boundary that is further from the needle exit. However, the geometric properties of a curved array can severely limit the ability of an EBUS biopsy sampling device to reach into the narrow airways of the periphery of the lung. Thus, there is a clinical need for real-time US imaging techniques that mitigate the challenges described above.

[0020] Figure 1is a schematic view of an endoscopic system 100 that can include an imaging and control system 102 and a bronchoscopic ultrasound sampling device that includes an endoscope 104 and a sampling device 136 that is attachable to the endoscope 104 and that includes a distal end 144 that extends from a distal end of the endoscope 104 via a distal working channel port. Figure 1 The system of FIG. 1 is an illustrative example of an endoscopic system, such as a bronchoscope with linearly arranged ultrasound elements, suitable for use with the systems, devices, and methods described herein.

[0021] The endoscope 104 can be inserted into an anatomical region for imaging or can be attached (e.g., via tethering) to one or more sampling devices for biopsy or one or more treatment devices for treating a disease state associated with the anatomical region. The endoscope 104 can be interfaced or connected to the imaging and control system 102. The endoscope 104 is described in this example as a bronchoscope, but other types of endoscopes are contemplated for use with the features and teachings of the present disclosure. The imaging and control system 102 can include a control unit 106, a display unit 108, an input unit 110, a light source 112, a fluid source 114, and an aspiration pump 116.

[0022] The imaging and control system 102 can include various ports for coupling with the endoscopic system 100. For example, the control unit 106 can 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 can include an output port for transmitting light to the endoscope 104, such as via an optical fiber link. The fluid source 114 can include a port for transmitting fluid to the endoscope 104. The fluid source 114 can include, for example, a pump and a fluid tank, or can be connected to an external tank, container, or storage unit. The aspiration pump 116 can include a port for drawing a vacuum from the endoscope 104 to create suction, such as for drawing fluid back from an anatomical region into which the endoscope 104 is inserted. The display unit 108 and the input unit 110 can be used by an operator of the endoscopic system 100 to control the functions of the endoscopic system 100 and to view the output of the endoscope 104. The control unit 106 can additionally be used to generate signals or other outputs by treating an anatomical region into which the endoscope 104 is inserted. In examples, the control unit 106 can generate electrical outputs, acoustic outputs, fluid outputs, etc., for treating the anatomical region with, for example, cauterization, cutting, freezing, etc.

[0023] Endoscope 104 can include an insertion section 118, a functional section 120, and a handle section 122 that can be coupled to a cable section 124 and a coupler section 126. Insertion section 118 can extend distally from handle section 122, and cable section 124 can extend proximally from handle section 122. Insertion section 118 can be elongate and can include a bend section and a distal end to which functional section 120 can be attached. The bend section can be controllable (e.g., by a steering controller 128 on handle section 122) to steer the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lung, etc.). Insertion section 118 can also include one or more working channels (e.g., internal lumens) that can be elongate and can support insertion of one or more therapeutic tools of functional section 120, such as a bronchoscope. The working channels can extend between handle section 122 and functional section 120. Additional functions such as fluid passageways, guide wires, and pull wires can also be provided by insertion section 118 (e.g., via suction or irrigation passageways, etc.).

[0024] Coupler section 126 can connect to control unit 106 to connect endoscope 104 to features of control unit 106 such as input unit 110, light source 112, fluid source 114, and suction pump 116.

[0025] Handle section 122 can include steering controller 128 as well as ports 130. Steering controller 128 can be a knob, lever, or other actuation mechanism, etc., that can be used to navigate endoscope 104 within a patient. Steering controller 128 can be connected to a pull wire or other actuation mechanism that extends through insertion section 118. Ports 130, as well as other ports such as port 132, can be configured to couple various cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, etc., to handle section 122, e.g., for coupling with insertion section 118. Figure 1 and Figure 2 The example shown in FIGS. 1-3 is an example of endoscope 104.

[0026] According to an example, imaging and control system 102 can be disposed on a mobile platform (e.g., cart 134) having shelves for housing light source 112, suction pump 116, image processing unit 202 (e.g., a computer), etc. Figure 2 Alternatively, Figure 1 and Figure 2 The components of imaging and control system 102 shown in FIGS. 1-3 can be disposed directly on endoscope 104 to make the endoscope “self-contained.”

[0027] The functional section 120 can include components for treatment and diagnosis of a patient's anatomy. The functional section 120 can include an imaging device, an illumination device, and an elevator. The functional section 120 can also include an optically enhanced biological matter and tissue collection and retrieval device as described herein. For example, the functional section 120 can include one or more electrodes that are conductively connected to the handle section 122 and functionally connected to the imaging and control system 102 to analyze biological matter in contact with the electrodes based on contrast biological data stored in the imaging and control system 102.

[0028] As Figure 1 The sampling device 136 can extend from a distal end of a functional section (e.g., the insertion section 118 or the cable section 124) of the endoscope 104, as shown in FIG. 1. The sampling device 136 can be configured to attach to the port 132 such that the sampling device 136 extends through a working channel of the endoscope 104 and out of a distal end of the endoscope 104. The sampling device 136 can include an actuator 138, an instrument actuator 142, 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 in order to navigate the sampling device 136 to a target region within a patient. The actuator can slide along a housing 140 of the sampling device 136. The housing 140 can include markings that can indicate an amount of extension of the sampling device 136 beyond the distal end of the endoscope 104. The instrument actuator 142 can be configured to extend an instrument from the sampling device 136 to obtain a tissue sample from a patient. The distal end 144 of the sampling device 136 can include a transducer (or other imaging device) and an instrument configured to obtain a tissue sample from a patient. The sampling device 136 will be discussed in greater detail herein.

[0029] Figure 2 is Figure 1 a schematic view of an endoscope system 100 including an imaging and control system 102 and a bronchoscopic ultrasound device including an endoscope and a sampling device 136 that is extendable via a distal working channel port of the endoscope. Figure 2Components of an imaging and control system 102 coupled to an endoscope 104 are schematically illustrated. The imaging and control system 102 can include a control unit 106, which can include or be coupled to an image processing unit 202, a therapy generator 206, and a drive unit 208, as well as a light source 112, an input unit 110, and a display unit 108. The control unit 106 can include or be in communication with an endoscope, surgical instrument, and endoscope system, which can include a device configured to engage tissue and collect and store a portion of the tissue, and an imaging device (e.g., a camera) through which the target tissue can be viewed via materials and components including optical enhancement. The control unit 106 can be configured to activate the camera to view the target tissue distal of the endoscope system. Likewise, the control unit 106 can be configured to activate the light source 112 to shine light on the surgical instrument, which can include select components configured to reflect light in a particular manner, such as a tissue cutter enhanced with reflective particles.

[0030] The coupler section 126 can connect to the control unit 106 to connect the endoscope 104 to features of the control unit 106, such as the image processing unit 202, the therapy generator 206, etc. In an example, the port 130 can be used to insert another instrument or device into the endoscope 104, such as a sub-scope or auxiliary scope, or a sampling needle, a biopsy needle, an ablation instrument, a scalpel, etc. Such instruments and devices can be independently connected to the control unit 106 via the cable section 124. In an example, the port 132 can be used to connect the coupler section 126 to various inputs and outputs, such as video, air, light, and electricity.

[0031] Image processing unit 202, ultrasound image processing unit 204, and light source 112 can each be coupled to endoscope 104 or sampling device 136 (e.g., at functional section 120) via wired or wireless connections. Therefore, imaging and control system 102 can illuminate the anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display an image 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 can 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 signals from a diagnostic device, and sensor signals, etc.).

[0032] Fluid source 114 (e.g.) Figure 1 The endoscope 104 (as 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 passages (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.

[0033] Figure 3 The illustration shows an endobronchial ultrasound sampling device (e.g., endoscope 14). Figure 1 A cross-sectional view of a portion of an example. For example, Figure 3 An elongated member 300 (e.g., functional segment 30) of an endobronchial ultrasound sampling device is shown. The elongated member 300 can be configured to be inserted into a patient to obtain one or more samples or images or to perform a medical procedure. In an example, the elongated member 300 can be configured to be inserted into an airway within a patient's lung to obtain a sample of nodules within the patient's lung tissue. The elongated member 300 may include a proximal segment 302 and a distal segment 304. The elongated member 300 may extend along a longitudinal axis 306 between the proximal segment 302 and the distal segment 304. The elongated member 300 may define a lumen 308 extending from the proximal segment 302 into the distal segment 304. The elongated member 300 may also include a medical device outlet 310 and a transducer 312.

[0034] The medical instrument outlet 310 can be configured to direct the medical instrument 320 from the lumen 308 and into the tissue 314 of the patient. In an example, the medical instrument outlet 310 can direct the medical instrument 320 from the lumen 308 and out a side of the elongate member 300 at a predetermined angle (angle 311). The angle 311 can be an angle relative to the longitudinal axis 306 of the elongate member 300. In an example, the angle 311 of the medical instrument outlet 310 can change the trajectory 332 of the medical instrument 320 extending out of the elongate member 300 via the medical instrument outlet 310.

[0035] As discussed herein, the transducer 312 can be configured to transmit and capture ultrasound signals to capture ultrasound images of the tissue of the patient as the medical instrument 320 extends into the tissue of the patient. The transducer 312 can be attached to the distal section 304 of the elongate member 300 and can include a plurality of ultrasound elements (e.g., elements 330). The transducer 312 can extend between the proximal portion 316 and the distal portion 318. The transducer 312 can include a field of view 340 that can be configured to capture the medical instrument 320 as the medical instrument 320 extends from the medical instrument outlet 310 along the trajectory 332.

[0036] The transducer 312 can include a plurality of elements (such as elements 330) that can be configured to emit and capture ultrasound signals. The elements 330 can be spaced apart from the proximal portion 316 of the transducer 312 to the distal portion 318 of the transducer 312. Each of the elements 330 can be angled relative to the longitudinal axis 306 of the elongate member 300 so as to extend the field of view 340 of the transducer 312 to the distal end of the distal section 304 of the elongate member 300.

[0037] As shown in Figure 3 The field of view 340 is distally shifted as compared to the field of view 341 of an example sampling device in which the elements 330 are not angled relative to the longitudinal axis 306. As shown in Figure 3 The distally extended field of view 340 allows more of the trajectory 332 of the medical instrument 320 to be within the field of view 340 of the transducer 312 so that the transducer 312 can capture the medical instrument 320 as it extends into the tissue of the patient. This extension of the field of view 340 can increase the distance that a sampling device (such as the endoscope 14) can capture, extract, sample, or remove tissue of the patient within the tissue of the patient.

[0038] Figure 4 A portion of the transducer 312 mounted on the elongate member 300 is illustrated. As Figure 4As shown, each of the plurality of elements 330 can be angled such that the normal vector 402 of each element 330 can be parallel to the other elements 330. Therefore, each element can transmit an ultrasound signal 404 and can transmit the ultrasound signal 404 from the patient's tissue (e.g., tissue 314). Figure 3 The ultrasound signal 404 is captured during reflection to generate an ultrasound image. The ultrasound signal 404 of each element in element 330 can overlap with the ultrasound signals 404 of other elements in element 330. Therefore, each element in element 330 can generate an ultrasound signal 404 of a different frequency in order to reduce interference between overlapping signals (such as ultrasound signals 404) of other elements in element 330.

[0039] By angulating element 330, the field of view 340 of transducer 312 can be increased. Figure 3 Extending beyond the distal edge 319 of the transducer 312, to capture the medical device 320 extending from the medical device outlet 310 and entering the patient's tissue 314. Figure 3 The trajectory of 332 ( Figure 3 More trajectories. The increased trajectory 332 captured by transducer 312 can increase the distance from medical device outlet 310, where the patient's target tissue can be sampled by a sampling device (e.g., endoscope 14). Figure 1 ))sampling.

[0040] like Figure 4 As shown, each element in element 330 can be positioned relative to the longitudinal axis 306 of the elongated member 300. Figure 3 The elements in element 330 may form an angle of approximately 30 degrees relative to the longitudinal axis 306 of the elongated member 300. In the example, each element in element 330 may form an angle of between 25 and 40 degrees relative to the longitudinal axis 306 of the elongated member 300. In the example, each element in element 330 may form an angle of between 10 and 70 degrees relative to the longitudinal axis 306 of the elongated member 300. In the example, the elements in element 330 may form any angle relative to the longitudinal axis 306 of the elongated member 300 to maximize the quality of the images captured by element 330 when the medical device 320 extends into the patient's tissue.

[0041] The inventors of this disclosure have recognized that an array of configurations for element 330 can achieve varying clarity and quality in ultrasound images. Therefore, various examples of angles that can be included for element 330 are possible. For example, such as... Figure 4As shown in FIG. 3, each of the normal vectors 402 of the elements 330 can be parallel. In an example, the normal vectors 402 can be angled relative to one another. For example, a proximal-most element of the elements 330 can be more upright than an element 330 attached toward a distal portion of the transducer 312, such as the distal portion 318. In an example, the normal vectors 402 of each of the elements 330 can be offset from one another such that none of the normal vectors of the elements 330 are parallel. In an example, the array of elements 330 can include yet another element of the elements 330 that includes a normal vector 402 that is not parallel to the other normal vectors 402 of the elements 330.

[0042] The following will be discussed together Figure 5 and Figure 6 . Figure 5 An example of an array of ultrasound elements 330 is illustrated. Figure 6 Another example of an array of ultrasound elements 330 is illustrated. As Figure 5 and Figure 6 As shown in FIG. 5, the transducer 312 can include a substrate 502, a plurality of electrode tracks (tracks 504), and a plurality of ultrasound elements, such as the elements 330.

[0043] The substrate 502 can be configured to hold the transducer 312 together in a configuration such that the transducer 312 can function as designed. For example, the substrate 502 can be configured to electrically isolate components of the transducer 312 from other components of the transducer 312 and to electronically connect components of the transducer 312 to other components of the transducer 312. The substrate 502 can include lead zirconate titanate (PZT), polyvinylidene fluoride, lead metaniobate, quartz and Rochelle salt, ceramic composites, other piezoelectric composites, other piezoelectric materials, or any combination thereof, among others.

[0044] The tracks 504 can be disposed on the substrate 502 such that each of the tracks 504 is independently electrically connected. Thus, each of the tracks 504 can be energized independently of the other tracks 504. The independent electrical connectivity of the tracks 504 can help control the transducer 312 in order to provide more customized imaging by providing more predictable images with less interference.

[0045] The elements 330 can be spaced apart from a proximal portion 316 of the transducer 312 Figure 3 to a distal portion 318 of the transducer 312 Figure 3 Each of the elements 330 can be coupled to any of the tracks 504. Thus, when each respective track 504 is energized, the elements 330 coupled to the respective track 504 of the tracks 504 can receive power to transmit an ultrasound signal, such as the ultrasound signal 404 Figure 4Endoscopic system 10 ( Figure 1 It can be programmed to excite each of the tracks 504 at different frequencies to control the energization of the elements 330 connected to the corresponding tracks, thereby improving the ultrasound images captured by the transducer 312.

[0046] Each element in element 330 may also be angled relative to substrate 502 in order to increase the field of view 340 of transducer 312. Figure 3 The field of view 340 of the transducer 312 extends distally beyond the distal edge 319 of the transducer 312. As discussed herein, angulating the element 330 can extend the field of view 340 of the transducer 312 beyond the distal edge 319 of the transducer 312 to capture more of the trajectory 332 of the medical device 320 extending from the medical device outlet 310 and entering the patient's tissue. The increased trajectory 332 captured by the transducer 312 can increase the distance from the medical device outlet 310, allowing the target tissue of the patient to be sampled by the sampling device (e.g., endoscope 14). Figure 1 ))sampling.

[0047] like Figure 5 and Figure 6 As shown, each element in component 330 may include a plurality of drum-shaped members (drum-shaped members 510). Each drum-shaped member 510 may be laterally spaced from the other drum-shaped members 510 (e.g., across the medical device 320 and perpendicular to the longitudinal axis 306 of the elongated member 300). Each drum-shaped member 510 may include a diameter 512. Figure 5 As shown, the diameter 512 of each drum in the drum-shaped member 510 can be common, such that each drum in the drum-shaped member 510 has the same diameter 512. Figure 6 As shown, one or more of the drum-shaped members 510 may include varying diameters 512, such as multiple variations in the diameter 512 of the drum-shaped members 510. The diameter 512 of the drum-shaped members 510 can affect the frequency of the ultrasonic signal 404 transmitted by the element 330. Therefore, the ultrasonic signal 404 of the element 330 can be adjusted by changing the diameter 512 of the drum-shaped members 510. For example, increasing the diameter 512 can decrease the frequency of the transmitted ultrasonic signal 404. Therefore, decreasing the diameter 512 can increase the frequency of the ultrasonic signal 404 transmitted by the element 330.

[0048] like Figures 1 to 6 As shown in the example, the endoscopic system (e.g., endoscopic system 10 or elongated member 300) can be directly inserted into the patient's body. In other examples, the elongated member 300 can be inserted into the patient's body using the sampling device 700. Figure 7is a side view of a sampling device 700 according to at least one example of the present disclosure. The sampling device 700 can operate in conjunction with an insertion device 730 (only a portion of which is shown) Figure 7 As previously described, the insertion device 730 can include an insertion catheter that can be inserted into the body via a stoma or other opening. In examples, the insertion device 730 can receive an elongate instrument 702 (e.g., the elongate member 300 (shown in FIG. 3) Figure 3 ) and the elongate instrument 702 can extend through the insertion catheter to a desired location. For example, the elongate instrument 702 can be inserted through a working channel of a bronchoscope and extend out of a port on a distal end of the bronchoscope. In this manner, the elongate instrument 702 can extend into more distal bronchial structures than the bronchoscope because the elongate instrument 702 has a smaller outer diameter than the bronchoscope. The elongate instrument 702 can be a sampling probe that can include an imaging probe (which can be incorporated into a distal tip of the elongate instrument) and a sampling needle within a flexible lumen catheter. The elongate instrument 702 can be inserted via the insertion device 730 to obtain a tissue sample at a desired location within the body. The elongate instrument 702 can also include a stylet that can be removably inserted into or through the needle, as further described below.

[0049] The sampling device 700 described herein can be coupled to the insertion device 730 using a coupler 706 at a distal end 708 of the sampling device 700. An elongate instrument 702 that can be manipulated by the sampling device 700 can extend through the coupler 706 and can be inserted into an insertion catheter of the insertion device 730. The elongate instrument 702 can be secured to an actuator 712 that is movably coupled to a housing 714. The actuator 712 can move along the housing 714 between a proximal end 710 and a distal end 708 of the sampling device 700 (the proximal and distal ends 113 and 111 of the sampling device 700 correspond to the proximal and distal ends of the housing 714) to extend and retract the elongate instrument 702 relative to the insertion device 730. Movement of the actuator 712 along the housing 714 in a distal direction and a proximal direction can cause the elongate instrument 702 to extend distally from or retract into a port at a distal end of the insertion device 730, respectively. An anti-kink device can be received within the housing 714 to provide lateral support to the elongate instrument 702 as the actuator 712 moves the elongate instrument 702 through the housing 714.

[0050] In an example, the flexible lumen catheter of the elongate instrument 702 can be secured to the actuator 712 while the needle can be received into the flexible lumen catheter via the actuator 712. In some embodiments, the proximal port 716 can be configured to receive and secure an imaging probe, such as, for example, a radial endobronchial ultrasound (EBUS) probe, which is configured to generate real-time ultrasound images of tissue surrounding the distal end of the elongate instrument 702. The needle inlet guide tube 718 can be configured to receive and engage the needle actuator 720 to which a sampling needle can be secured. The needle inlet guide tube 718 and the needle actuator 720 can be movably coupled at a directional interface 722. The directional interface 722 can be configured to maintain the orientation of the needle actuator 720 relative to the needle inlet guide tube 718 to control the orientation of the sampling needle, as further described below. The needle actuator 720 can removably receive an end cap 724, which can be coupled with a stylet and used to releasably secure the stylet within the sampling needle. Depending on the location of the target tissue within the patient’s anatomy, the stylet can be used to prevent the sampling needle from collecting non-target tissue. For example, in the case where the operator is targeting tissue that is more than a few millimeters or centimeters beyond the airway wall, the operator can fully insert the stylet into the sampling needle while the sampling needle is advanced through the non-target tissue. Then, when the operator sees on the real-time images generated by the imaging probe that the needle has reached or is close to reaching the target tissue, the stylet can be withdrawn to allow the target tissue to enter the sampling needle core. The needle actuator can also include a release mechanism 726 that the operator can actively engage to allow the sampling needle to be advanced into a sampling position, as further described below.

[0051] Figure 8 is a cross-sectional view of the port 716 in the actuator 712 of the sampling device 700 according to at least one example of the present disclosure. The sampling device 700 can include an imaging probe 748 (e.g., the elongate member 300 (FIG. 1) of the sampling device 100 (FIG. 1) of the present disclosure) that is secured to the proximal port 716 of the actuator 712. The imaging probe 748 can be configured to generate real-time images of tissue surrounding the distal end of the elongate instrument 702. The needle inlet guide tube 718 can be configured to receive and engage the needle actuator 720 to which a sampling needle can be secured. The needle inlet guide tube 718 and the needle actuator 720 can be movably coupled at a directional interface 722. The directional interface 722 can be configured to maintain the orientation of the needle actuator 720 relative to the needle inlet guide tube 718 to control the orientation of the sampling needle, as further described below. The needle actuator 720 can removably receive an end cap 724, which can be coupled with a stylet and used to releasably secure the stylet within the sampling needle. Depending on the location of the target tissue within the patient’s anatomy, the stylet can be used to prevent the sampling needle from collecting non-target tissue. For example, in the case where the operator is targeting tissue that is more than a few millimeters or centimeters beyond the airway wall, the operator can fully insert the stylet into the sampling needle while the sampling needle is advanced through the non-target tissue. Then, when the operator sees on the real-time images generated by the imaging probe that the needle has reached or is close to reaching the target tissue, the stylet can be withdrawn to allow the target tissue to enter the sampling needle core. The needle actuator can also include a release mechanism 726 that the operator can actively engage to allow the sampling needle to be advanced into a sampling position, as further described below. Figure 3The proximal port 716 of the actuator 712 can be configured to receive the imaging probe 748 and direct the imaging probe 748 into the first lumen 744 of the flexible lumen catheter 740. The flexible lumen catheter 740 can include a proximal end 742 that can be coupled to the actuator 712. In examples, the flexible lumen catheter 740 can define a second lumen 746 configured to receive a sampling needle 750. The second lumen flexible lumen catheter 740 can extend into the first lumen 744 and can be configured to hold the sampling needle 750 away from the imaging probe 748. In other examples, the flexible lumen catheter 740 can define only a single lumen configured to receive the sampling needle 750, and the distal end of the elongate instrument 702 can include an imaging element (e.g., a linear ultrasound transducer) incorporated into a distal tip thereof adjacent to a ramp of the side exit port configured to direct the sampling needle 750 into the field of view of the imaging element. As described further below, the sampling needle 750 can be coupled with and controlled by the needle actuator 720.

[0052] The sampling needle 750 can extend between a base 752 Figure 4 ) and a tip 754. The sampling needle 750 can also include a lumen 751. The lumen 751 can be used to extract a sample from a patient. The needle actuator 720 can be slidably mounted on the needle entry guide tube 718 (which can also be described further below). In examples, the sampling needle 750 can extend from the needle actuator 720 through the needle entry guide tube 718 and into the second lumen 746 of the flexible lumen catheter 740 through which it can extend into the body to collect a sample. The needle entry guide tube 718 can also be joined with the actuator 712. Thus, when the needle entry guide tube 718 and the imaging probe 748 are secured to the actuator 712, movement of the actuator 712 along the housing 714 can advance the elongate instrument 702 and the imaging probe 748 and sampling needle 750 contained therein.

[0053] Figure 9 A schematic diagram illustrating an example method 900 is shown. The method 900 can be a method of reprocessing a bronchoscope (e.g., the endoscope 14, the elongate member 300, etc.). More specific examples of the method 900 are discussed below. In particular, for ease and clarity, the steps or operations of the method 900 are illustrated in a particular order; many of the operations discussed can be performed in a different order or in parallel without materially affecting other operations. The method 900 discussed includes operations performed by a number of different actors, devices, and / or systems. It should be understood that a subset of the operations discussed in the method 900 can be attributable to a single actor, device, or system, which can be considered a separate independent process or method.

[0054] Reference will be made toFigure 9 A reprocessing method 900 for the above-described treatment instrument (e.g., the endoscope 14 or another bronchoscope) is described. The above-described treatment instrument (e.g., the endoscope 14 or another bronchoscope) can be discarded after one use, or can be reused, e.g., multiple times. In the case of a configuration that is reused multiple times, for example, Figure 9 The reprocessing method 900 shown in FIG. 9 can be relevant.

[0055] An operator can collect and transport the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) after the used treatment instrument is used for treatment (step S1). At this time, the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) can be transported in a dedicated container to prevent contamination from the treatment instrument (e.g., the endoscope 14 or another bronchoscope).

[0056] Then, the operator can clean and sterilize the collected and transported used treatment instrument (e.g., the endoscope 14 or another bronchoscope) (step S2). Specifically, in cleaning the treatment instrument (e.g., the endoscope 14 or another bronchoscope), deposits adhering to the outside of the functional section 30 can be removed by using a brush or the like. Thereafter, in order to remove pathogenic microorganisms and the like originating from blood, body fluids, and the like, the functional section 30 can be cleaned using a cleaning solution containing isopropyl alcohol, a proteolytic enzyme detergent, and alcohol. The cleaning liquid is not limited to the above-described cleaning liquid, and other cleaning liquids can be used. In addition, in sterilizing the treatment instrument (e.g., the endoscope 14 or another bronchoscope), in order to sterilize pathogenic microorganisms and the like adhering to the functional section 30, any one of high-pressure steam sterilization, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide, and hydrogen peroxide low-temperature sterilization can be used. The functional section 30 can be detached by actuating the clamping piece or the securing feature to decouple the coupler and the housing.

[0057] The operator can perform an acceptance inspection on the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) (step S3). In detail, the operator can check whether the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) has a major defect, or whether the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) exceeds the maximum number of reprocessing times.

[0058] Then, the operator can detach the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) (step S4). The functional section 30 can be detached by removing the housing from the coupler and removing all of the components from within the coupler and the housing.

[0059] After step S4, some parts are replaced (step S5). For example, any of the components of functional section 30 or any of the components within the coupler or housing can be replaced during step S4.

[0060] After step S5, the operator can assemble the newly formed therapeutic instrument (e.g., endoscope 14 or another bronchoscope) (step S6). In some examples, step S6 can 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.

[0061] After step S6, the operator can inspect and test the newly formed therapeutic instrument (e.g., endoscope 14 or another bronchoscope) (step S7). Specifically, the operator of the remanufacturing verifies that the newly formed therapeutic instrument (e.g., endoscope 14 or another bronchoscope) has the same effectiveness and safety as the original product through various functional tests.

[0062] After step S7, the operator proceeds with sterilization, storage (step S8), and shipping (step S9) of the newly formed therapeutic instrument (e.g., endoscope 14 or another bronchoscope) in sequence. In step S8, a sterilization process can be applied to the newly formed therapeutic instrument (e.g., endoscope 14 or another bronchoscope) using a sterilization gas such as ethylene oxide gas or propylene oxide gas, and the device is stored in a storage container until use.

[0063] The above-described steps S1 through S9 are performed to achieve reprocessing of the therapeutic instrument (e.g., endoscope 14 or another bronchoscope). Any of the steps S1 through S9 can be completed by one or more parties in any order of the steps. Furthermore, steps S1 through S9 are exemplary steps, which are not an exhaustive list of steps that can be performed by an operator to refurbish, remanufacture, or replenish a medical instrument (e.g., endoscope 14 or another bronchoscope).

[0064] The above discussion is meant to provide an overview of the subject of the present patent application. It is not meant to provide an exclusive or exhaustive explanation of the application. The following description is included to provide further information about the present patent application.

[0065] The following non-limiting examples detail certain aspects of the subject matter to address challenges and provide the benefits discussed herein, among others.

[0066] Example 1 is an endobronchial ultrasound sampling device comprising: an elongated member extending along a longitudinal axis between a proximal section and a distal section, the elongated member defining a lumen extending from the proximal section into the distal section, the elongated member including: a medical instrument outlet configured to direct a medical instrument from the lumen and into tissue of a patient; and a transducer attached to the distal section of the elongated member, the transducer including: a plurality of ultrasound elements spaced apart from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements angled relative to the longitudinal axis of the elongated member so as to extend a field of view of the transducer distal of the distal section of the elongated member.

[0067] In Example 2, the subject matter of Example 1 optionally includes, wherein a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

[0068] In Example 3, the subject matter of Example 2 optionally includes, wherein each element of the plurality of ultrasound elements is angled relative to the longitudinal axis of the elongated member between twenty-five degrees and forty degrees.

[0069] In Example 4, the subject matter of any one or more of Examples 2-3 optionally includes, wherein each element of the plurality of ultrasound elements is angled relative to the longitudinal axis of the elongated member by thirty degrees.

[0070] In Example 5, the subject matter of any one or more of Examples 1-4 optionally includes, wherein the medical instrument outlet is configured to direct the medical instrument from the lumen at a predetermined angle and out a side of the elongated member.

[0071] In Example 6, the subject matter of any one or more of Examples 1-5 optionally includes, wherein the medical instrument is a sampling needle configured to capture a sample of at least a portion of the tissue of the patient.

[0072] In Example 7, the subject matter of any one or more of Examples 1-6 optionally includes, wherein each element of the plurality of ultrasound elements includes a plurality of drums, each drum of the plurality of drums laterally spaced apart from other drums of the plurality of drums.

[0073] In Example 8, the subject matter of Example 7 optionally includes, wherein each drum of the plurality of drums includes a common diameter.

[0074] In Example 9, the subject matter of any one or more of Examples 7-8 can optionally include, wherein the plurality of drums comprises varying diameters.

[0075] Example 10 is a transducer for an endobronchial ultrasound sampling device, the transducer comprising: a substrate; a plurality of electrode tracks disposed on the substrate, each of the plurality of electrode tracks independently electrically connected; a plurality of ultrasound elements spaced apart from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements coupled to an electrode track of the plurality of electrode tracks and angled relative to the substrate so as to extend a field of view of the transducer distally beyond a distal edge of the transducer.

[0076] In Example 11, the subject matter of Example 10 can optionally include, wherein a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

[0077] In Example 12, the subject matter of Example 11 can optionally include, wherein each element of the plurality of ultrasound elements is angled between twenty-five degrees and forty degrees relative to a longitudinal axis of the transducer.

[0078] In Example 13, the subject matter of any one or more of Examples 11-12 can optionally include, wherein each element of the plurality of ultrasound elements is angled thirty degrees relative to a longitudinal axis of the transducer.

[0079] In Example 14, the subject matter of any one or more of Examples 10-13 can optionally include, wherein each element of the plurality of ultrasound elements comprises a plurality of drums, each drum of the plurality of drums laterally spaced apart from other drums of the plurality of drums.

[0080] In Example 15, the subject matter of Example 14 can optionally include, wherein each drum of the plurality of drums comprises a common diameter.

[0081] In Example 16, the subject matter of any one or more of Examples 14-15 can optionally include, wherein the plurality of drums comprises varying diameters.

[0082] Example 17 is a method for reprocessing a sampling device, the method comprising: obtaining the sampling device of Example 1; sterilizing the sampling device; and storing the sampling device.

[0083] In Example 18, the subject matter of Example 17 optionally includes removing the medical instrument from the lumen of the elongated member; removing the transducer; sterilizing the medical instrument, the elongated member, and the transducer; and packaging the medical instrument, the elongated member, and the transducer.

[0084] In Example 19, the subject matter of Example 18 optionally includes testing the transducer to ensure that the transducer outputs ultrasound signals within an expected range; and reinstalling the transducer onto the elongated member on a condition that the transducer outputs ultrasound signals within the expected range.

[0085] In Example 20, the subject matter of any one or more of Examples 18-19 optionally includes marking the elongated member to indicate that the elongated member has been reprocessed; logging the elongated member to track a number of times that the elongated member has been reprocessed; and disposing or recycling one or more components of the elongated member after the elongated member has been reprocessed more than a set limit.

[0086] Example 21 is an apparatus, system or method including any elements of any of Examples 1-20.

[0087] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments that can be practiced. These embodiments are also referred to as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) described herein.

[0088] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as if each were individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document prevails.

[0089] In the present document, like in any patent document, the article "a" or "an" is used as the equivalent of "at least one" or "one or more" unless otherwise indicated. In the present document, the term "or" is used in its inclusive sense (i.e., at least one of A or B is true in this case if either A or B individually is true, which means A without B, B without A, and both A and B are both true), unless otherwise indicated. In the appended claims, the terms "including" and "comprising" are used as the plain English equivalents of the respective terms "including" and "comprising." Also, in the following claims, the terms "including" and "comprising" are open-ended, that is, a system, device, article, composition, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0090] The term "about" as used herein means approximately, in the range of, roughly, or around. When the term "about" is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the stated numerical values. In general, the term "about" is used herein to modify numerical values above and below the stated value by a variance of 10%. In one aspect, the term "about" means plus or minus 10% of the numerical value of the number to which the term is applied. Thus, about 50% means a range of 45% to 55%. Numerical ranges as enumerated throughout this document include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges as enumerated throughout this document include sub-ranges of all numbers and fractions subsumed therein (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 are assumed to be modified by the term "about" even if the term "about" is not expressly stated.

[0091] The above 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 can be used in addition to those described above, such as one would have appreciated from the foregoing description, which is intended to be illustrative, not limiting. This Abstract is provided to allow a reader to quickly ascertain the nature of the technical disclosure. It is not intended to be used to interpret or limit the scope or meaning of the claims. Furthermore, in the above Detailed Description, various features can be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This should not be interpreted as intending that the claimed subject matter requires more features than are expressly identified in the claim. Rather, the inventive subject matter can lie in less than all features of a particular disclosed embodiment. The following claims are hereby expressly incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of the inventive subject matter. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the drawings, which are not necessarily drawn to scale, like elements are depicted by like reference numerals.

[0092] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, a device can be reconditioned for reuse after at least one use. Reconditioning can include an combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, a device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. Use of these techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0093] Preferably, the applications described herein will be processed before surgery. First, a new or used instrument can be obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. Any other technique known in the art can be used for sterilizing a device, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

Claims

1. A bronchoscopic ultrasound sampling device, comprising: an elongate member extending along a longitudinal axis between a proximal section and a distal section, the elongate member defining a lumen extending from the proximal section into the distal section, the elongate member including: a medical instrument outlet configured to direct a medical instrument from the lumen and into tissue of a patient; and a transducer attached to the distal section of the elongate member, the transducer including: a plurality of ultrasound elements spaced from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements angled relative to the longitudinal axis of the elongate member so as to extend a field of view of the transducer distal of the distal section of the elongate member.

2. The sampling device of claim 1, wherein, a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

3. The sampling device of claim 2, wherein, each element of the plurality of ultrasound elements is angled relative to the longitudinal axis of the elongate member between 25 degrees and 40 degrees.

4. The sampling device of claim 2, wherein, each element of the plurality of ultrasound elements is angled relative to the longitudinal axis of the elongate member 30 degrees.

5. The sampling device of claim 1, wherein, the medical instrument outlet is configured to direct the medical instrument from the lumen and out a side of the elongate member at a predetermined angle.

6. The sampling device of claim 1, wherein, the medical instrument is a sampling needle configured to capture a sample of at least a portion of the tissue of the patient.

7. The sampling device of claim 1, wherein, each element of the plurality of ultrasound elements includes a plurality of drums, each drum of the plurality of drums laterally spaced from other drums of the plurality of drums.

8. The sampling device of claim 7, wherein, each drum of the plurality of drums includes a common diameter.

9. The sampling device of claim 7, wherein, the plurality of drums includes varying diameters.

10. A transducer for a bronchoscopic ultrasound sampling device, the transducer comprising: a substrate; a plurality of electrode tracks disposed on the substrate, each electrode track of the plurality of electrode tracks independently electrically connected; a plurality of ultrasound elements spaced from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements coupled to an electrode track of the plurality of electrode tracks and angled relative to the substrate so as to extend a field of view of the transducer distal of a distal edge of the transducer.

11. The transducer of claim 10, wherein, a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

12. The transducer of claim 11, wherein, each element of the plurality of ultrasound elements is angled relative to a longitudinal axis of the transducer between 25 degrees and 40 degrees.

13. The transducer of claim 11, wherein, each element of the plurality of ultrasound elements is angled relative to a longitudinal axis of the transducer 30 degrees.

14. The transducer of claim 10, wherein, each element of the plurality of ultrasound elements includes a plurality of drums, each drum of the plurality of drums laterally spaced from other drums of the plurality of drums.

15. The transducer of claim 14, wherein, each drum of the plurality of drums includes a common diameter.

16. The transducer of claim 14, wherein, the plurality of drums includes varying diameters.

17. A method for reprocessing a sampling device, the method comprising: obtaining the sampling device of claim 1; sterilizing the sampling device; and storing the sampling device.

18. The method of claim 17, comprising: removing the medical instrument from the lumen of the elongate member; removing the transducer; sterilizing the medical instrument, the elongate member, and the transducer; and packaging the medical instrument, the elongate member, and the transducer.

19. The method of claim 18, comprising: testing the transducer to ensure that the transducer outputs ultrasound signals within an expected range; and reinstalling the transducer onto the elongate member on the condition that the transducer outputs ultrasound signals within the expected range.

20. The method of claim 18, comprising: marking the elongate member to indicate that the elongate member has been reprocessed; logging the elongate member to track a number of times that the elongate member has been reprocessed; and disposing or recycling one or more components of the elongate member after the elongate member has been reprocessed beyond a set limit.

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