ultrasonic elements arranged in a straight line

Abstract

A transducer for an intrabronchial ultrasound sampling device may include a substrate, multiple electrode rails, and multiple ultrasound elements. The multiple electrode rails can be arranged on the substrate. Each of the multiple electrode rails can be electrically connected independently. The multiple ultrasound elements can be spaced apart from each other from the proximal portion to the distal portion of the transducer. Each of the multiple ultrasound elements can be coupled to one of the electrode rails and angled relative to the substrate to extend the field of view of the transducer distally beyond the distal edge of the transducer.

Description

[Technical Field]

[0001] Claim of Priority This patent application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 503,093 entitled "LINEARLY ARRANGED ULTRASOUND ELEMENTS" filed by Christopher Lee on May 18, 2023 (Attorney Docket No. 5409.860PRV) and U.S. Provisional Patent Application No. 63 / 581,814 entitled "LINEARLY ARRANGED ULTRASOUND ELEMENTS" filed by Vignesh Mandalapa Bhoopathy et al. on September 11, 2023 (Attorney Docket No. 5409.860PV2). Each of U.S. Patent Application No. 63 / 503,093 and U.S. Patent Application No. 63 / 581,814 is hereby incorporated by reference in its entirety into the present specification.

[0002] Embodiments described herein generally relate to ultrasound devices. More specifically, embodiments described herein generally relate to linearly arranged ultrasound elements. [Background Art]

[0003] Conventional endoscopes can be used in a wide variety of clinical procedures including, for example, illumination, imaging, detection, and diagnosis of one or more pathological conditions, delivery of fluid toward an anatomical site (e.g., saline or other agents via a fluid channel), passage of one or more therapeutic devices (e.g., via a working channel) for sampling or treatment of an anatomical site, formation of a suction passage for collecting fluid (e.g., saline or other agents), and the like. Such anatomical sites may include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary tract, intestine, colon, etc.), renal regions (e.g., kidney, ureter, bladder, urethra), other internal organs (e.g., reproductive system, paranasal sinuses, submucosa, airways), and the like. [Summary of the Invention] [Means for Solving the Problems]

[0004] The inventors of this disclosure recognized the limitations of the field of view of transducers on a sample collection device. For example, transducers for sample collection devices generally have a limited field of view, which makes it difficult for medical personnel to obtain samples from target tissue near the insertion limit of the sample collection device. Therefore, the inventors have developed a sample collection device that includes a transducer designed to extend the field of view of the transducer beyond the distal edge of the sample collection device.

[0005] In the embodiment, the intrabronchial ultrasound sampling device may include an elongated member extending along the longitudinal axis between a proximal and distal portion. The elongated member can define a lumen extending from the proximal portion into the distal portion. The elongated member may include a medical device outlet and a transducer. The medical device outlet may be configured to direct the medical device from the lumen into the patient's tissue. The transducer may be attached to the distal portion of the elongated member and may include multiple ultrasound elements. The multiple ultrasound elements may be spaced apart from each other from the proximal portion to the distal portion of the transducer. Each of the multiple ultrasound elements may be angled with respect to the longitudinal axis of the elongated member to extend the field of view of the transducer distal to the distal portion of the elongated member. In this way, the distal boundary of the field of view is extended distally compared to when the ultrasound element is positioned perpendicular to the longitudinal axis, thereby allowing a medical device advancing distally at an acute angle to the longitudinal axis and through the transducer's field of view to penetrate deeply into the tissue before extending beyond the distal boundary of the field of view.

[0006] In this embodiment, the transducer for the intrabronchial ultrasound sample collection device may include a substrate, a plurality of electrode rails, and a plurality of ultrasonic elements. The plurality of electrode rails may be arranged on the substrate. Each of the plurality of electrode rails may be electrically connected independently. The plurality of ultrasonic elements may be spaced apart from each other from the proximal portion to the distal portion of the transducer. Each of the plurality of ultrasonic elements may be coupled to one of the electrode rails and angled relative to the substrate so as to extend the field of view of the transducer distally beyond the distal edge of the transducer.

[0007] In the embodiment, a method for reprocessing a sample collection device may include the steps of obtaining the sample collection device, sterilizing the sample collection device, and storing the sample collection device.

[0008] Various embodiments are shown in the attached drawings. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of this subject matter. [Brief explanation of the drawing]

[0009] [Figure 1] This is a schematic diagram of an example of a bronchial ultrasound sample collection device system. [Figure 2] This is a schematic diagram of an embodiment of an imaging and control system for an intrabronchial ultrasound sample collection device. [Figure 3] This is an illustrative cross-sectional view of a portion of a bronchoscope. [Figure 4] This figure shows a partial example of an ultrasonic array of elements. [Figure 5] This figure shows an example of an ultrasonic array of elements. [Figure 6] This figure shows an example of an ultrasonic array of elements. [Figure 7] This is a side view of an example of a sample collection device. [Figure 8]This is a cutout diagram of a port in an exemplary actuator of an exemplary sample collection device. [Figure 9] This is a block diagram showing an example of a method for reprocessing a bronchoscope. [Modes for carrying out the invention]

[0010] The field of view of an intrabronchial ultrasound sampling device can be primarily a byproduct of the geometric characteristics of the arrangement of the ultrasonic transducer elements in such an ultrasound sampling device. For example, in an arrangement where the ultrasonic transducer elements are distributed linearly and oriented parallel to each other, a substantially rectangular field of view may be obtained. Such a configuration is generally called a linear arrangement. In contrast, in an arrangement where the ultrasonic transducer elements are distributed along a convex curved surface (for example, so that the orientation of each element is offset from that of adjacent elements), and each ultrasonic transducer element is oriented perpendicular to the convex curved surface, a field of view that widens to increase the field of view of the ultrasound is obtained. Such a configuration is generally called a curved arrangement (or curved arrangement).

[0011] In some clinical settings, the geometric properties associated with linear alignment may be preferable to those associated with curved alignment, even though the field of view associated with curved alignment is larger than that of linear alignment. For example, some EBUS biopsy sample collection devices include a ramp through which the biopsy needle may extend into the field of view (FOV) of the ultrasound transducer. Generally, the ramp is located proximal to the US transducer, curves, and directs the biopsy needle into the FOV along the needle path axis. The needle path axis is acutely deviated from the longitudinal axis of the EBUS device. Depending on the depth at which the target nodule or target tissue is located relative to the airway from which the biopsy data is collected, the needle may exit the distal FOV boundary before reaching the target depth, making it impossible to collect the sample while leaving the target nodule (e.g., a solitary pulmonary nodule or "SPN") within the FOV. Therefore, the FOV associated with curved alignment may be preferable to the FOV of linear alignment, primarily due to the geometric properties of the curved surface of the curved alignment, resulting in the most distal FOV boundary being more distal compared to the needle exit. However, the geometric properties of the curved surface arrangement significantly limit the capabilities of EBUS biopsy sample collection devices, sometimes preventing them from reaching the narrow airways surrounding the lungs. Therefore, real-time US imaging techniques that mitigate the above challenges are clinically necessary.

[0012] Figure 1 is a schematic diagram of an endoscopic examination system 100, which may include an imaging and control system 102 and an intrabronchial ultrasound sampling configuration, which includes an endoscope 104 and a sampling device 136 that is attachable to the endoscope 104 and includes a distal end 144, the distal end 144 extending from the distal end of the endoscope 104 via a distal working channel port. The system in Figure 1 is an exemplary embodiment of an endoscopic system suitable for use with the systems, devices, and methods described herein, such as a bronchoscope having linearly arranged ultrasonic elements.

[0013] The endoscope 104 can be inserted into an anatomical site for imaging, or attached (e.g., via tethering) to one or more sample collection devices for biopsy, or attached to one or more therapeutic devices for the treatment of a pathological condition associated with an anatomical site. The endoscope 104 can interact with or connect to the imaging and control system 102. In this embodiment, the endoscope 104 is described as a bronchoscope, but other types of endoscopes are intended to be used in the features and teachings of this disclosure. The imaging and control system 102 may include a control unit 106, a display unit 108, an input unit 110, a light source 112, a fluid source 114, and an inhalation pump 116.

[0014] The imaging and control system 102 may include various ports for coupling with the endoscopy system 100. For example, the control unit 106 may include data input / output ports for receiving data from the endoscope 104 and transmitting the data to the endoscope 104. The light source 112 may include an output port for sending light to the endoscope 104, for example, via an optical fiber link. The fluid source 114 may include ports for supplying fluid to the endoscope 104. The fluid source 114 may include, for example, a pump and a fluid tank, or it may be connected to an external tank, container, or storage unit. The suction pump 116 may include a port used to create suction by drawing the endoscope 104 into a vacuum, for example, to draw fluid from the anatomical site into which the endoscope 104 is inserted. The display unit 108 and input unit 110 can be used by the operator of the endoscopy system 100 to control the functions of the endoscopy system 100 and to display the output of the endoscope 104. The control unit 106 may also be used to generate signals or other outputs by treating the anatomical site into which the endoscope 104 is inserted. In the embodiment, the control unit 106 can generate electrical output, acoustic output, fluid output, etc., to treat anatomical sites using methods such as cauterization, cutting, or freezing.

[0015] The endoscope 104 may include an insertion section 118, a functional section 120, and a handle section 122, which can be coupled to a cable section 124 and a coupler section 126. The insertion section 118 may extend distally from the handle section 122, and the cable section 124 may extend proximal to the handle section 122. The insertion section 118 may be elongated and include a bend section and a distal end, to which the functional section 120 can be attached. The bend section may be controllable (for example, by a steering control unit 128 on the handle section 122) to operate the distal end through a tortuous anatomical passage (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 can assist in the insertion of one or more therapeutic tools of the functional section 120, such as a bronchoscope. The working channel may extend between the handle portion 122 and the functional portion 120. Additional functions such as fluid passages, guide wires, and pull wires may be provided by the insertion portion 118 (for example, via suction or irrigation passages).

[0016] The coupler section 126 can be connected to the control unit 106, allowing the endoscope 104 to be connected to multiple functions of the control unit 106, such as the input unit 110, light source 112, fluid source 114, and suction pump 116.

[0017] The handle portion 122 can include a steering control portion 128 and a port 130. The steering control portion 128 can be a knob, a lever, or other actuation mechanism, which can be used to steer the endoscope 104 within a patient. The steering control portion 128 can be connected to a pull wire extending through the insertion portion 118, or another actuation mechanism. The port 130, and other ports such as port 132, can be configured to couple to the handle portion 122 for coupling various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes to the insertion portion 118, for example. The embodiment shown in Figures 1 and 2 is an embodiment of the endoscope 104.

[0018] According to an embodiment, the imaging and control system 102 can be provided on a movable platform (e.g., a cart 134) having a shelf for accommodating a light source 112, a suction pump 116, an image processing unit 202 (Figure 2), and the like. Alternatively, the components of the imaging and control system 102 shown in Figures 1 and 2 can be provided directly on the endoscope 104 to make the endoscope "self-contained".

[0019] The functional portion 120 can include components for treating and diagnosing a patient's anatomy. The functional portion 120 can include an imaging device, an illumination device, and an elevator. The functional portion 120 can further include the optically enhanced biological material and tissue collection and recovery devices described herein. For example, the functional portion 120 can include one or more electrodes conductively connected to the handle portion 122 and operatively connected to the imaging and control system 102, for analyzing biological material in contact with the electrodes based on comparative biological data stored in the imaging and control system 102.

[0020] As shown in Figure 1, the sample collection device 136 may extend from the distal end of the functional section of the endoscope 104 (e.g., the insertion section 118 or the cable section 124). The sample collection device 136 may be configured to be attached to a port 132 such that the sample collection device 136 extends through the working channel of the endoscope 104 and exits from the distal end of the endoscope 104. The sample collection device 136 may include an actuator 138, an instrument actuator 142, and a distal end 144. The actuator 138 may be configured to extend the sample collection device 136 beyond the distal end of the endoscope 104 to guide the sample collection device 136 to a target area in the patient. The actuator may slide along the housing 140 of the sample collection device 136. The housing 140 may include an indicator that can show the amount by which the sample collection device 136 extends beyond the distal end of the endoscope 104. The instrument actuator 142 may be configured to extend an instrument from the sampling device 136 to acquire a tissue sample from the patient. The distal end 144 of the sampling device 136 may include a transducer (or other imaging device) and an instrument configured to acquire a tissue sample from the patient. The sampling device 136 is described in more detail herein.

[0021] FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1, the endoscopy system 100 includes an imaging and control system 102 and an endobronchial ultrasound arrangement, the endobronchial ultrasound arrangement includes an endoscope and a sampling device 136 extendable through a distal working channel port of the endoscope. FIG. 2 schematically illustrates components of the imaging and control system 102 coupled to an endoscope 104. The imaging and control system 102 can include a control unit 106, and the control unit 106 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 communicate with an endoscope, a surgical instrument, and an endoscopy system, the endoscopy system includes a device configured to engage tissue and collect and store a portion of the tissue, through which device an imaging apparatus (e.g., a camera) can visualize target tissue by including optically enhanced materials and components. The control unit 106 can be configured to activate the camera to visualize target tissue distal to the endoscopy system. Similarly, the control unit 106 can be configured to activate the light source 112 to illuminate a surgical instrument that can include a selected component configured to reflect light in a specific manner, such as a tissue cutter enhanced with reflective particles.

[0022] A coupler unit 126 can be connected to the control unit 106 to connect the endoscope 104 to a plurality of functions of the control unit 106, such as the image processing unit 202 and the therapy generator 206. In an embodiment, the port 130 can be used to insert a daughter scope or auxiliary scope, or another instrument or device such as a sampling needle, a biopsy needle, an ablation instrument, a scalpel into the endoscope 104. Such instruments and devices can be independently connected to the control unit 106 via the cable portion 124. In an embodiment, the port 132 can be used to connect the coupler unit 126 to various inputs and outputs such as video, air, light, and electricity.

[0023] The image processing unit 202, the ultrasound image processing unit 204, and the light source 112 can each interact with the endoscope 104 (for example, in the functional unit 120) or the sample collection device 136 by wired or wireless electrical connection. Thus, the imaging and control system 102 can illuminate anatomical sites, collect signals representing anatomical sites, process signals representing anatomical sites, and display images representing anatomical sites on the display unit 108. The ultrasound image processing unit 204 can be configured to receive ultrasound signals from either the endoscope 104 or the sample collection device 136, and can convert the ultrasound signals into ultrasound images and transmit them to the display unit 108 or any other component of the endoscopy system 100. The imaging and control system 102 may include a light source 112 for illuminating anatomical sites using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). The imaging and control system 102 can be connected to the endoscope 104 (for example, via an endoscope connector) for signal transmission (e.g., light output from a light source, video signals from the imaging system at the distal end, diagnostic and sensor signals from a diagnostic device, etc.).

[0024] The fluid source 114 (shown in Figure 1) can communicate with the control unit 106 and may include one or more sources of air, saline solution, or other fluids, as well as associated fluid passages (e.g., air channels, irrigation channels, suction channels, etc.) and connectors (barb fittings, fluid seals, valves, etc.). The imaging and control system 102 may also include a drive unit 208, which may include an electric drive for advancing the distal end of the endoscope 104.

[0025] Figure 3 shows a partial cross-sectional view of an embodiment of an intrabronchial ultrasound sampling device (e.g., an endoscope 14 (Figure 1)). For example, Figure 3 shows an elongated member 300 (e.g., a functional part 30) of the intrabronchial ultrasound sampling device. The elongated member 300 can be configured to be inserted into a patient to acquire one or more samples or images, or to complete a medical procedure. In an embodiment, the elongated member 300 can be configured to be inserted into the airway in a patient's lung to acquire a sample of a nodule in the patient's lung tissue. The elongated member 300 may include a proximal portion 302 and a distal portion 304. The elongated member 300 may extend along a longitudinal axis 306 between the proximal portion 302 and the distal portion 304. The elongated member 300 may define a lumen 308 extending from the proximal portion 302 into the distal portion 304. The elongated member 300 may also include a medical device outlet 310 and a transducer 312.

[0026] The medical instrument outlet 310 can be configured to direct the medical instrument 320 from the lumen 308 into the patient's tissue 314. In an embodiment, the medical instrument outlet 310 can direct the medical instrument 320 out of the lumen 308 through the side of the elongated member 300 at a predetermined angle (angle 311). The angle 311 can be the angle with respect to the longitudinal axis 306 of the elongated member 300. In an embodiment, the angle 311 of the medical instrument outlet 310 can alter the trajectory 332 of the medical instrument 320 extending from the elongated member 300 through the medical instrument outlet 310.

[0027] As described herein, the transducer 312 may be configured to transmit and capture an ultrasound signal to capture an ultrasound image of the patient's tissue as the medical device 320 extends into the patient's tissue. The transducer 312 may be attached to the distal portion 304 of the elongated member 300 and may include a plurality of ultrasound elements (e.g., element 330). The transducer 312 may extend between the proximal portion 316 and the distal portion 318. The transducer 312 may include a field of view 340, which may be configured to capture the medical device 320 as it extends along the trajectory 332 from the medical device exit 310.

[0028] The transducer 312 may include a plurality of elements (such as elements 330) that can be configured to emit and capture ultrasonic signals. The elements 330 may be spaced apart from each other from the proximal portion 316 to the distal portion 318 of the transducer 312. Each element of the elements 330 may be angled with respect to the longitudinal axis 306 of the elongated member 300 so as to extend the field of view 340 of the transducer 312 distal to the distal portion 304 of the elongated member 300.

[0029] As shown in Figure 3, the field of view 340 is shifted distally compared to the field of view 341 of an exemplary sampling device in which the element 330 is not angled with respect to the longitudinal axis 306. As shown in Figure 3, with the distally extended field of view 340, more of the trajectory 332 of the medical instrument 320 enters the field of view 340 of the transducer 312, thereby allowing the transducer 312 to capture the medical instrument 320 as it extends into the patient's tissue. Extending the field of view 340 in this way increases the distance within the patient's tissue over which a sampling device (such as an endoscope 14) can capture, extract, collect, or remove patient tissue.

[0030] Figure 4 shows a portion of the transducer 312 mounted on the elongated member 300. As shown in Figure 4, each element of the multiple elements 330 can be angled so that the normal vector 402 of each element 330 is parallel to the normal vector 402 of the other elements of element 330. Thus, each element can transmit an ultrasonic signal 404, and an ultrasonic image can be generated by capturing the ultrasonic signal 404 as it reflects off the patient's tissue (e.g., tissue 314 (Figure 3)). Each ultrasonic signal 404 of element 330 can overlap with the ultrasonic signals 404 of the other elements of element 330. Thus, each element of element 330 can generate an ultrasonic signal 404 at a different frequency to reduce interference between overlapping signals (such as ultrasonic signals 404) of the other elements of element 330.

[0031] By angling element 330, the field of view 340 (Figure 3) of transducer 312 can be extended beyond the distal edge 319 of transducer 312 to capture more of the trajectory 332 (Figure 3) of medical instrument 320 (Figure 3) extending from the medical instrument outlet 310 into the patient's tissue 314. The enlarged trajectory 332 captured by transducer 312 can increase the distance from the medical instrument outlet 310 to which the patient's target tissue can be collected by a sampling device (e.g., endoscope 14 (Figure 1)).

[0032] As shown in Figure 4, each element 330 can be angled at approximately 30 degrees with respect to the longitudinal axis 306 (Figure 3) of the elongated member 300. In the embodiment, each element 330 can be angled at 25 to 40 degrees with respect to the longitudinal axis 306 of the elongated member 300. In the embodiment, each element 330 can be angled at 10 to 70 degrees with respect to the longitudinal axis 306 of the elongated member 300. In the embodiment, each element of the element 330 can be angled at any angle with respect to the longitudinal axis 306 of the elongated member 300 to maximize the image quality captured by the element 330 when the medical device 320 extends into the patient's tissue.

[0033] The inventors of this disclosure have recognized that the arrangement of the elements 330 can achieve variations in the clarity and quality of the ultrasonic image. Therefore, various embodiments of the angles of the elements 330 can be included. For example, as shown in Figure 4, each of the normal vectors 402 of the elements 330 can be parallel. In embodiments, the normal vectors 402 can be angled relative to each other. For example, the nearest element of the elements 330 can be more upright than an element 330 mounted near the distal portion of the transducer 312 (such as the distal portion 318). In embodiments, the normal vectors 402 of each element of the elements 330 can be offset from each other such that none of the normal vectors of the elements 330 are parallel. In embodiments, the arrangement of elements 330 can include one or more elements of the elements 330 that have normal vectors 402 that are not parallel to the other normal vectors 402 of the elements 330.

[0034] Figures 5 and 6 will be described below together. Figure 5 shows an example of an ultrasonic array of element 330. Figure 6 shows another example of an ultrasonic array of element 330. As shown in Figures 5 and 6, the transducer 312 may include a substrate 502, a plurality of electrode rails (rails 504), and a plurality of ultrasonic elements (such as element 330).

[0035] The substrate 502 can be configured to assemble the transducer 312 in a way that allows it to function as designed. For example, the substrate 502 can be configured to electronically 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 may include lead zirconate titanate (PZT), polyvinylidene fluoride, lead metaniobate, quartz and Rochelle salts, ceramic composites, other piezoelectric composites, other piezoelectric materials, or any combination thereof.

[0036] The rails 504 can be arranged on the substrate 502 such that each rail of the rails 504 is electrically connected independently. Thus, each rail of the rails 504 can be charged independently of the other rails of the rails 504. The independent electrical connectivity of the rails 504 can help control the transducer 312 to result in more custom imaging by providing less interference and more predictable images.

[0037] The elements 330 can be spaced apart from each other, from the proximal portion 316 (Figure 3) to the distal portion 318 (Figure 3) of the transducer 312. Each element of the elements 330 can be coupled to any of the rails 504. Therefore, when each of the rails 504 is charged, the elements 330 coupled to each of the rails 504 can receive power and transmit an ultrasonic signal (ultrasonic signal 404 (Figure 4), etc.). The endoscopy system 10 (Figure 1) can be programmed to improve the ultrasonic image captured by the transducer 312 by energizing each of the rails 504 at different frequencies to control the charging of the elements 330 coupled to each rail.

[0038] Each element of element 330 can also be angled relative to the substrate 502 so that the field of view 340 (Figure 3) of the transducer 312 extends distally beyond the distal edge 319 of the transducer 312. As described herein, angling the element 330 allows the field of view 340 of the transducer 312 to extend beyond the distal edge 319 of the transducer 312 so as to capture more of the trajectory 332 of the medical instrument 320 extending from the medical instrument exit 310 into the patient's tissue. The increased trajectory 332 captured by the transducer 312 can increase the distance from the medical instrument exit 310 to which a sampling device (e.g., endoscope 14 (Figure 1)) can collect the patient's target tissue.

[0039] As shown in Figures 5 and 6, each element of the element 330 may include multiple drums (drums 510). Each drum of the drum 510 may be separated laterally from the other drums of the drum 510 (for example, across the medical device 320 and perpendicular to the longitudinal axis 306 of the elongated member 300). Each drum of the drum 510 may have a diameter 512. As shown in Figure 5, the diameter 512 of each drum of the drum 510 may be common, thereby each of the drums 510 having the same diameter 512. As shown in Figure 6, one or more drums of the drum 510 may have various diameters 512, such as multiple variations of the diameter 512 of the drum 510. The diameter 512 of the drum 510 can affect the frequency of the ultrasonic signal 404 transmitted by the element 330. Thus, the ultrasonic signal 404 of the element 330 can be adjusted by changing the diameter 512 of the drum 510. For example, increasing the diameter 512 can lower the frequency of the transmitted ultrasonic signal 404. Therefore, reducing the diameter 512 allows for an increase in the frequency of the ultrasonic signal 404 transmitted by the element 330.

[0040] As shown in the embodiments of Figures 1 to 6, an endoscopic examination system (e.g., an endoscopic examination system 10 or an elongated member 300) can be directly inserted into the patient. In other embodiments, the elongated member 300 can be inserted into the patient using a sample collection device 700. Figure 7 is a side view of a sample collection device 700 according to at least one embodiment of the present disclosure. The sample collection device 700 can be used in conjunction with an insertion device 730 (only partially shown in Figure 7), such as an endoscope or bronchoscope. As previously stated, the insertion device 730 may include an insertion conduit that can be inserted into the body through an orifice or other opening. In embodiments, the insertion device 730 may receive an elongated instrument 702 (e.g., an elongated member 300 (Figure 3)), and the elongated instrument 702 can be extended through the insertion conduit to a desired position. For example, the elongated instrument 702 may be inserted through the working channel of a bronchoscope and extended from a port on the distal end of the bronchoscope. In this way, the elongated instrument 702 has a smaller outer diameter than a bronchoscope and can therefore extend into bronchial structures further away than a bronchoscope. The elongated instrument 702 can be a sampling probe that can include an imaging probe (which may be integrated with the distal end of the elongated instrument) and a sampling needle within a flexible lumened catheter. The elongated instrument 702 can be inserted via an insertion device 730 to obtain a tissue sample at a desired location within the body. The elongated instrument 702 may also include a stylet that can be removably inserted into or through the needle, as will be further described below.

[0041] The sampling device 700 described herein can be coupled to the insertion device 730 using a fitting 706 at the distal end 708 of the sampling device 700. The elongated instrument 702 can be operated by the sampling device 700, extend through the fitting 706, and be inserted into the insertion conduit of the insertion device 730. The elongated instrument 702 can be fixed to an actuator 712 that is movably coupled to the housing 714. The actuator 712 can be moved along the housing 714 between the proximal end 710 and the distal end 708 of the sampling device 700 (corresponding to the proximal and distal ends of the housing 714), thereby extending and retracting the elongated instrument 702 toward the insertion device 730. Moving the actuator 712 distally and proximally along the housing 714 allows the elongated instrument 702 to be extended distally from or retracted toward the port at the distal end of the insertion device 730, in each case. A buckling prevention device can be accommodated within the housing 714 to provide lateral support for the elongated instrument 702 as the actuator 712 moves the elongated instrument 702 through the housing 714.

[0042] In some embodiments, a flexible lumened catheter of the elongated instrument 702 can be fixed to an actuator 712, while a needle can be received into the flexible lumened catheter via the actuator 712. In some embodiments, the proximal end 716 can be configured to receive and fix an imaging probe, such as a radial bronchoscopic ultrasound (EBUS) probe, which is configured to generate real-time ultrasound images of the tissue surrounding the distal end of the elongated instrument 702. A needle inlet guide tube 718 can be configured to receive and engage with a needle actuator 720, which can fix a sampling needle. The needle inlet guide tube 718 and the needle actuator 720 can be movably coupled to an orientation determination interface 722. The orientation determination interface 722 can be configured to control the orientation of the sampling needle by maintaining the orientation of the needle actuator 720 relative to the needle inlet guide tube 718, as will be further described below. The needle actuator 720 can be detachably received by an end cap 724. The end cap 724 can be coupled to the stylet, and the stylet can be releasably secured within the sampling needle using the end cap 724. Depending on the location of the target tissue within the patient's biostructure, the stylet can be used to prevent the sampling needle from collecting non-target tissue. For example, in a scenario where the operator is targeting tissue located several millimeters or centimeters beyond the airway wall, the operator may keep the stylet fully inserted within the sampling needle while the sampling needle advances through the non-target tissue. Then, when the operator knows, on the real-time image generated by the imaging probe, that the needle has reached or is about to reach the target tissue, the stylet can be withdrawn, allowing the target tissue to enter the sampling needle core. The needle actuator may also include a release mechanism 726, which the operator can reliably engage with to advance the sampling needle to the sampling position, as also described further below.

[0043] Figure 8 is a cutaway view of a port 716 in an actuator 712 of a sample collection device 700 according to at least one embodiment of the present disclosure. The sample collection device 700 may include an imaging probe 748 (for example, an elongated member 300 (Figure 3)). The proximal port 716 of the actuator 712 may be configured to receive the imaging probe 748 and to orient the imaging probe 748 into a first lumen 744 of a flexible lumened catheter 740. The flexible lumened catheter 740 may include a proximal end 742 that can be coupled to the actuator 712. In an embodiment, the flexible lumened catheter 740 may define a second lumen 746 configured to receive a sample collection needle 750. The second lumen of the flexible lumened catheter 740 may extend into the first lumen 744 and may be configured to keep the sample collection needle 750 away from the imaging probe 748. In other embodiments, the flexible lumened catheter 740 may define only a single lumen configured to receive the sampling needle 750, and the distal end of the elongated instrument 702 may include an image sensor (e.g., a linear ultrasound transducer) integrated within the distal tip of the elongated instrument 702, adjacent to a ramp (of a side exit port) configured to direct the sampling needle 750 into the field of view of the image sensor. As further described below, the sampling needle 750 may be coupled to and controlled by a needle actuator 720.

[0044] The sample collection needle 750 can extend between a base 752 (Figure 4) and a tip 754. The sample collection needle 750 may also include a lumen 751. The lumen 751 can be used to extract a sample from the patient. The needle actuator 720 can be slidably mounted on a needle inlet guide tube 718 (the needle inlet guide tube 718 may be described further below). In this embodiment, the sample collection needle 750 can extend from the needle actuator 720 through the needle inlet guide tube 718 into a second lumen 746 of a flexible lumened catheter 740, through the second lumen 746 to extend the sample collection needle 750 into the body and collect a sample. The needle inlet guide tube 718 can also be joined to an actuator 712. Therefore, when the needle inlet guide tube 718 and the imaging probe 748 are fixed to the actuator 712, moving the actuator 712 along the housing 714 allows the elongated instrument 702, as well as the imaging probe 748 and the sample collection needle 750 contained therein, to be advanced.

[0045] Figure 9 shows a schematic diagram of an exemplary method 900. Method 900 can be a method for reprocessing a bronchoscope (e.g., endoscope 14, elongated member 300, etc.). More specific examples of method 900 are described below. For the sake of clarity and for illustrative purposes, the steps or operations of method 900 are shown in a specific order, and many of the operations described can be performed in different sequences or in parallel without substantially affecting other operations. Method 900 described includes operations performed by multiple different operating entities, devices, or systems. It should be understood that a subset of the operations described in method 900 that can be attributed to a single operating entity, device, or system can be considered a separate standalone process or method.

[0046] A reprocessing method 900 for the above-mentioned treatment instruments (e.g., endoscope 14 or another bronchoscope) will be described with reference to Figure 9. The above-mentioned treatment instruments (e.g., endoscope 14 or another bronchoscope) can be disposed of after a single use, or can be reused multiple times, for example. In the case of a configuration that is reused multiple times, a reprocessing method 900, for example, as shown in Figure 9, may be appropriate.

[0047] The operator can collect used treatment instruments (e.g., endoscope 14 or another bronchoscope) after they have been used for treatment and transport them to a factory or other location (step S1). At this time, used treatment instruments (e.g., endoscope 14 or another bronchoscope) can be transported in a dedicated container to prevent contamination of the instruments.

[0048] Next, the operator can clean and sterilize the collected and transported used treatment instruments (e.g., the endoscope 14 or another bronchoscope) (step S2). Specifically, when cleaning the treatment instruments (e.g., the endoscope 14 or another bronchoscope), deposits adhering to the outside of the functional unit 30 can be removed by using a brush or the like. Subsequently, the functional unit 30 can be cleaned using an isopropanol cleaning solution containing a cleaning agent, a proteolytic enzyme detergent, and alcohol to remove pathogenic microorganisms derived from blood, body fluids, etc. The cleaning liquid is not limited to the cleaning liquid described above, and other cleaning liquids may be used. Furthermore, in sterilizing the treatment instruments (e.g., the endoscope 14 or another bronchoscope), any of the following can be used to sterilize pathogenic microorganisms adhering to the functional unit 30: autoclaving, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide, and hydrogen peroxide low-temperature sterilization. The functional unit 30 can be disassembled by activating a clip or fixing mechanism to separate the coupler and housing.

[0049] The operator may perform an acceptance inspection of used treatment instruments (e.g., endoscope 14 or another bronchoscope) (step S3). Specifically, the operator may inspect whether the used treatment instruments (e.g., endoscope 14 or another bronchoscope) have significant defects or whether the number of used treatment instruments (e.g., endoscope 14 or another bronchoscope) exceeds the maximum number for reprocessing.

[0050] Next, the operator can disassemble the used treatment instrument (for example, the endoscope 14 or another bronchoscope) (step S4). The functional unit 30 can be disassembled by removing the housing from the coupler and removing all components from within the coupler and housing.

[0051] After step S4, some parts are replaced (step S5). For example, during step S4, any of the components of the functional unit 30, or any of the components within the coupler or housing, may be replaced.

[0052] After step S5, the operator can assemble a new treatment instrument (e.g., endoscope 14 or another bronchoscope) (step S6). In some embodiments, step S6 may include adding an identifier to indicate that the device has been modified from its original state, such as adding a label or other mark to specify that the device has been reprocessed, modified, or remanufactured.

[0053] 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 remanufacturing operator verifies through various functional tests that the newly formed therapeutic instrument (e.g., endoscope 14 or another bronchoscope) has the same efficacy and safety as the original product.

[0054] Following step S7, the operator sequentially performs sterilization and storage (step S8) and shipment of the new treatment instrument (e.g., endoscope 14 or another bronchoscope) (step S9). In step S8, a sterilization process using a sterilizing gas such as ethylene oxide gas or propylene oxide gas is applied to the new treatment instrument (e.g., endoscope 14 or another bronchoscope), and the device is stored in a storage container until use.

[0055] Steps S1-S9 described above are performed to achieve reprocessing of a medical instrument (e.g., endoscope 14 or another bronchoscope). Any of steps S1-S9 can be completed by one or more parties in any order of the steps. Furthermore, steps S1-S9 are exemplary steps and do not constitute a comprehensive list of steps that an operator may perform to modify, remanufacture, or replace a medical instrument (e.g., endoscope 14 or another bronchoscope).

[0056] The above description is intended to provide an overview of the subject matter of this patent application. This description is not intended to provide an exclusive or exhaustive description of the invention. The following description is included to provide further information relating to this patent application.

[0057] The following non-limiting embodiments will detail, in particular, some aspects of the subject matter that solve the problems described herein and provide the benefits described herein.

[0058] Example 1 is an intrabronchial ultrasound sampling device comprising an elongated member extending along a longitudinal axis between a proximal and distal portion, the elongated member defining a lumen extending from the proximal to the distal portion, the elongated member including a medical instrument outlet configured to direct a medical instrument out of the lumen into the patient's tissue, and a transducer attached to the distal portion of the elongated member, the transducer including a plurality of ultrasonic elements spaced apart from each other from the proximal portion of the transducer to the distal portion of the transducer, each of the plurality of ultrasonic elements being angled with respect to the longitudinal axis of the elongated member to extend the field of view of the transducer distal to the distal portion of the elongated member, thus forming an intrabronchial ultrasound sampling device.

[0059] In Example 2, the subject of Example 1 optionally includes the condition that the normal vector of each element among the multiple ultrasonic elements is parallel to the normal vector of the other elements among the multiple ultrasonic elements.

[0060] In Example 3, the subject matter of Example 2 is optionally configured such that each of the multiple ultrasonic elements is angled at 25° to 40° with respect to the longitudinal axis of the elongated member.

[0061] In Example 4, one or more themes from Examples 2 to 3 are optionally selected to include the arrangement in which each of the multiple ultrasonic elements is angled at 30° with respect to the longitudinal axis of the elongated member.

[0062] In Example 5, one or more of the themes from Examples 1 to 4 are optionally configured such that the medical instrument exit guides the medical instrument out of the lumen through the side of the elongated member at a predetermined angle.

[0063] In Example 6, one or more subjects from Examples 1 to 5 are optionally included, in which the medical device is a sampling needle configured to capture a sample of at least a portion of a patient's tissue.

[0064] In Example 7, one or more themes from Examples 1 to 6 are optionally selected to include a configuration in which each of the multiple ultrasonic elements comprises multiple drums, and each of the multiple drums is positioned laterally apart from the other drums.

[0065] In Example 8, the subject of Example 7 is optionally extended to include each of the drums among the multiple drums having a common diameter.

[0066] In Example 9, one or more themes from Examples 7-8 are optionally included, in which multiple drums include various diameters.

[0067] Example 10 is a transducer for an intrabronchial ultrasound sample collection device, wherein the transducer comprises a substrate, a plurality of electrode rails disposed on the substrate, each of which electrode rails is independently electrically connected, and a plurality of ultrasonic elements spaced apart from each other from the proximal portion to the distal portion of the transducer, each of which ultrasonic elements is coupled to one of the electrode rails, and the transducer is angled relative to the substrate so as to extend the field of view distally beyond the distal edge of the transducer.

[0068] In Example 11, the subject of Example 10 optionally includes the condition that the normal vector of each element among the multiple ultrasonic elements is parallel to that of the other elements among the multiple ultrasonic elements.

[0069] In Example 12, the subject matter of Example 11 is optionally configured such that each of the multiple ultrasonic elements is angled between 25° and 40° with respect to the longitudinal axis of the transducer.

[0070] In Example 13, one or more themes from Examples 11 to 12 optionally include each of the multiple ultrasonic elements being angled at 30° with respect to the longitudinal axis of the transducer.

[0071] In Example 14, one or more themes from Examples 10 to 13 are optionally selected to include a configuration in which each of the multiple ultrasonic elements comprises multiple drums, and each of the multiple drums is positioned laterally apart from the other drums.

[0072] In Example 15, the subject of Example 14 is optionally extended to include each of the drums among the multiple drums having a common diameter.

[0073] In Example 16, one or more themes from Examples 14-15 are optionally included, in which multiple drums include a variety of diameters.

[0074] Example 17 is a method for reprocessing a sample collection device, the method comprising the steps of obtaining the sample collection device of Example 1, sterilizing the sample collection device, and storing the sample collection device.

[0075] In Example 18, the subject of Example 17 optionally includes the steps of removing a medical device from the lumen of the elongated member, removing a transducer, sterilizing the medical device, the elongated member, and the transducer, and packaging the medical device, the elongated member, and the transducer.

[0076] In Example 19, the subject of Example 18 optionally includes the steps of testing the transducer to confirm that the transducer outputs an ultrasonic signal within the expected range, and reinstalling the transducer on an elongated member under the condition that the transducer outputs an ultrasonic signal within the expected range.

[0077] Example 20 includes, optionally, one or more subjects from Examples 18 to 19, the steps of marking an elongated member to indicate that the elongated member has been reprocessed, recording the elongated member to track the number of times the elongated member has been reprocessed, and disposing of or reusing one or more components of the elongated member after the elongated member has been reprocessed beyond a set limit.

[0078] Example 21 is an apparatus, system, or method that includes any element from Examples 1 to 20.

[0079] The above description includes references to the accompanying drawings, which form part of the detailed description. The drawings illustrate, as examples, specific embodiments that may be carried out. These embodiments are also referred to herein as “Examples.” Such embodiments may include elements other than those shown or described. However, the inventors also intend to describe embodiments in which only the shown or described elements are provided. Furthermore, the inventors also intend to describe embodiments (or one or more embodiments thereof) using any combination or modification of the shown or described elements relating to any specific embodiment (or one or more embodiments thereof) or other embodiment (or one or more embodiments thereof).

[0080] All publications, patents, and patent documents referenced herein are incorporated herein by reference in whole, as are the individual documents. In the event of any conflict between use herein and a document thus incorporated by reference, the use in the incorporated document should be considered supplementary to the use herein, and in the event of an inconsistent conflict, the use herein shall prevail.

[0081] In this specification, the terms “a” or “an” are used to include one or more, independently of any other instances or uses of “at least one” or “one or more,” as is commonly seen in patent literature. In this specification, the term “or” is used to refer non-exclusively, or unless otherwise indicated, “A or B” is used to include “A but not B,” “B but not A,” and “A and B.” In the appended claims, the terms “including” and “in which” are used as clear English equivalents to the terms “comprising” and “wherein.” Furthermore, in the following claims, the terms “including” and “comprising” are unrestricted, meaning that any system, device, article, or process that includes elements other than those enumerated after such terms in a claim is still considered within the scope of that claim. Furthermore, in the following claims, terms such as “first,” “second,” and “third” are used merely as labels and are not intended to impose any numerical requirements on the subject matter.

[0082] The term “approximately” in this specification means approximately, nearly, roughly, or roughly. When the term “approximately” is used with a numerical range, it modifies the numerical range by extending the boundaries above and below the stated numerical value. Generally, the term “approximately” is used in this specification to modify a numerical value by only 10% above and below the stated value. In one aspect, the term “approximately” means ±10% of the numerical value of the number used with “approximately.” Thus, approximately 50% means 45% to 55%. Numerical ranges described by endpoints in this specification include all numbers and decimals contained within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges specified herein by endpoints include subranges that are contained within that range (for example, 1–5 includes 1–1.5, 1.5–2, 2–2.75, 2.75–3, 3–3.90, 3.90–4, 4–4.24, 4.24–5, 2–5, 3–5, 1–4, and 2–4). It should also be understood that all numbers and their decimals are assumed to be modified by the term “approximately”.

[0083] The above description is intended to be illustrative and not restrictive. For example, the above embodiments (or one or more embodiments thereof) may be used in combination with each other. For example, other embodiments may be used when a person skilled in the art reconsiders the above description. The abstract is presented with the understanding that it will allow the reader to quickly identify the characteristics of the technical disclosure and will not be used to interpret or limit the scope and meaning of the claims. Also, in the above detailed description, various features may be grouped together to streamline the disclosure. This should not be interpreted as meaning that any disclosed features not included in the claims are essential to any claim. Rather, the subject matter of the invention may lie in fewer features than all the features of a particular disclosed embodiment. Accordingly, the following claims are incorporated into the detailed description herein, and each claim stands independently as a separate embodiment. The scope of an embodiment should be determined by referring to such claims, along with the entire scope of equivalents entitled to those included in the appended claims.

[0084] The devices disclosed herein may be designed to be disposed of after a single use or to be designed to be used multiple times. However, in either case, the devices may be repaired so that they can be reused after at least one use. Repair may include a combination of steps of disassembling the device, cleaning or replacing specific components, and then reassembling it. In particular, the device may be disassembled and any number of specific components or parts of the device may be selectively replaced or removed in any combination. After cleaning and / or replacing specific components, the device may be reassembled for use in a repair facility or by a surgical team immediately before a surgical procedure. Those skilled in the art will understand that a wide variety of different techniques may be used for disassembly, cleaning / replacement, and reassembly in the repair of the device. All use of such techniques and the resulting repaired devices are within the scope of this application.

[0085] Preferably, the inventions described herein are processed before surgery. First, new or used instruments are taken and cleaned as necessary. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a sealed container, such as a plastic or TYVEK® bag. The container and instruments are then placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation kills bacteria on the instruments and inside the container. The sterilized instruments can then be stored in a sterilization container. The sealed container maintains the instruments in a sterile state until they are opened in a medical facility. The devices can also be sterilized using any other technique known in the art, including but not limited to beta or gamma rays, ethylene oxide, or vapor. [Explanation of symbols]

[0086] 14 Endoscopy 30 Functional Sections 100 Endoscopy System 102 Imaging and control systems 104 Endoscope 106 Control Unit 108 Display Units 110 Input Unit 112 Light source 114 Fluid Source 116 Suction pump 118 Insertion section 120 Functional Section 122 Handle section 124 Cable section 126 Coupler section 128 Control Unit 130 ports 132 ports 134 Cart 136 Sample Collection Devices 138 Actuators 140 Housing 142 Fixture Actuator 144 Distal end 202 Image Processing Unit 204 Ultrasonic Image Processing Unit 206 Therapy Generator 208 Drive Unit 300 slender member 302 Proximal part 304 Distal part 306 Longitudinal axis 308 lumens 310 Medical device exit 311 angle 312 Transducer 314 Organization 316 Proximal portion 318 Distal portion 319 Distal margin 320 Medical Devices 330 elements 332 Trajectory 340 field of view 341 Field of view 402 Normal vector 404 Ultrasonic signal 502 circuit board 504 Rail 510 Drums 512 diameter 700 sample collection devices 702 Elongated instrument 706 Joint 708 Distal end 712 Actuator 714 Housing 716 Proximal Port 718 Needle Inlet Guide Tube 720 Needle Actuator 722 Orientation Determination Interface 724 End Cap 726 Release mechanism 730 Insertion Devices 740 Flexible lumen catheter 742 Proximal end 744 First Lumen 748 Imaging probe 750 sample collection needles 751 lumens 752 base 900 ways

Claims

1. A bronchial ultrasound sample collection device, It is equipped with an elongated member that extends along the longitudinal axis between the proximal and distal parts. The elongated member defines a lumen extending from the proximal portion to the distal portion. The elongated member is, A medical instrument outlet configured to direct the medical instrument from the lumen into the patient's tissue, A transducer attached to the distal end of the elongated member, Includes, The transducer is, An intrabronchial ultrasound sampling device comprising a plurality of ultrasonic elements arranged at intervals from each other from the proximal portion to the distal portion of the transducer, wherein each of the plurality of ultrasonic elements is angled with respect to the longitudinal axis of the elongated member so as to extend the field of view of the transducer distal to the distal portion of the elongated member.

2. The sample collection device according to claim 1, wherein the normal vector of each of the plurality of ultrasonic elements is parallel to that of the other elements of the plurality of ultrasonic elements.

3. The sample collection device according to claim 2, wherein each of the plurality of ultrasonic elements is angled at 25° to 40° with respect to the longitudinal axis of the elongated member.

4. The sample collection device according to claim 2, wherein each of the plurality of ultrasonic elements is angled at 30° with respect to the longitudinal axis of the elongated member.

5. The sample collection device according to claim 1, wherein the medical device outlet is configured to guide the medical device out of the lumen, through the side of the elongated member, at a predetermined angle.

6. The sample collection device according to claim 1, wherein the medical device is a sample collection needle configured to capture a sample of at least a portion of the patient's tissue.

7. The sample collection device according to claim 1, wherein each of the plurality of ultrasonic elements comprises a plurality of drums, and each of the plurality of drums is arranged at a lateral distance from the other drums of the plurality of drums.

8. The sampling device according to claim 7, wherein each of the plurality of drums has a common diameter.

9. The sample collection device according to claim 7, wherein the plurality of drums include various diameters.

10. A transducer for an intrabronchial ultrasound sample collection device, wherein the transducer is circuit board and A plurality of electrode rails arranged on the substrate, wherein each of the plurality of electrode rails is electrically connected independently to a plurality of electrode rails, A plurality of ultrasonic elements are arranged at intervals from each other, from the proximal portion to the distal portion of the transducer, Equipped with, A transducer in which each of the plurality of ultrasonic elements is coupled to one of the plurality of electrode rails and is angled with respect to the substrate so as to extend the field of view of the transducer distally beyond the distal edge of the transducer.

11. The transducer according to claim 10, wherein the normal vector of each of the plurality of ultrasonic elements is parallel to the normal vector of the other elements among the plurality of ultrasonic elements.

12. The transducer according to claim 11, wherein each of the plurality of ultrasonic elements is angled at 25° to 40° with respect to the longitudinal axis of the transducer.

13. The transducer according to claim 11, wherein each of the plurality of ultrasonic elements is angled at 30° with respect to the longitudinal axis of the transducer.

14. The transducer according to claim 10, wherein each of the plurality of ultrasonic elements comprises a plurality of drums, and each of the plurality of drums is arranged at a lateral distance from the other drums of the plurality of drums.

15. The transducer according to claim 14, wherein each of the plurality of drums has a common diameter.

16. The transducer according to claim 14, wherein the plurality of drums include various diameters.

17. A method for reprocessing a sample collection device, wherein the method is A step of obtaining the sample collection device according to claim 1, The steps include sterilizing the sample collection device, The steps include storing the sample collection device, Methods that include...

18. The steps include removing the medical device from the lumen of the elongated member, The steps include removing the transducer and A step of sterilizing the medical device, the elongated member, and the transducer, The steps include packaging the medical device, the elongated member, and the transducer, The method according to claim 17, including the method described in claim 17.

19. The steps include: testing the transducer to confirm that the transducer outputs an ultrasonic signal within the expected range; The steps include: reinstalling the transducer on the elongated member, provided that the transducer outputs an ultrasonic signal within the expected range; The method according to claim 18, including the method described in claim 18.

20. The steps include marking the elongated member to indicate that it has been reprocessed, A step of recording the elongated member and tracking the number of times the elongated member has been reprocessed, The steps include: after the elongated member has been reprocessed beyond a set limit, disposing of or reusing one or more components of the elongated member; The method according to claim 18, including the method described in claim 18.

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