System to confirm sheath position within lumen

Abstract

A sampling device may include an elongate body, a medical instrument, and a sensor. The elongate body may extend longitudinally between the proximal end section and the distal end section and define a lumen. A medical device may be inserted into the elongate body. At least a portion of the medical device may be configured to be inserted into the lumen. A medical device may include a protective sheath and a sampling portion. The protective sheath may extend longitudinally between the proximal end portion and the distal end portion and define a working lumen. The sampling portion may be slidably mounted within the working lumen and may be extended relative to the protective sheath such that the sampling portion may be retracted within and distally extended from the protective sheath. The sensor may be configured to generate a signal indicating that the protective sheath is adjacent to the outlet of the lumen.

Description

Priority requirements

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 514,382, filed July 19, 2023, the contents of which are incorporated herein by reference. Technical Field

[0002] The examples described in this article generally relate to sampling devices, such as sampling devices that include systems for confirming the location of a protective sheath within a lumen. Background Technology

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

[0004] Sampling devices can be endoscopes used in various clinical procedures, including, for example, within a patient's lungs, for: illuminating, imaging, detecting, and diagnosing one or more disease states; providing fluid delivery toward anatomical areas (e.g., providing saline or other preparations via a fluid channel); providing access to one or more therapeutic devices (e.g., via a working channel) for sampling or processing anatomical areas; providing aspiration access for collecting fluids (e.g., saline or other preparations), etc. Sampling devices can be used to detect, treat, and sample abnormalities or anomalies within the lungs. Sampling devices can be used to capture samples or biopsies of various portions of tissue from a patient's airways or lungs.

[0005] Intraluminal sampling devices may include an outlet port through which a biopsy needle extends to the target tissue requiring a biopsy sample. For example, an endobronchial ultrasound (EBUS) sampling device may include a side outlet port through which a flexible biopsy needle extends to perform transbronchial needle aspiration (TBNA). During TBNA or other types of sampling procedures, clinicians will typically extend the needle sheath at least partially out of the outlet port before extending the biopsy needle, which resides within the needle sheath, from the distal end of the sheath. The primary reason for this sequential extension of the needle sheath from the outlet port and subsequently the biopsy needle from the distal end of the needle sheath (e.g., to the target tissue) is to prevent damage to the EBUS device itself. For example, many EBUS devices include a bevel element that connects the needle lumen, extending the entire length of the flexible EBUS sheath, to the side outlet port. This bevel element may be made of a plastic material and may be configured to deflect the biopsy needle away from the longitudinal axis of the EBUS device. In devices with this configuration, attempts by the operating clinician to allow the extremely sharp distal tip of the biopsy needle, sampling device, cutting device, or any other medical device to extend directly into the bevel element without a needle sheath covering the biopsy needle may result in the distal tip of the needle puncturing or otherwise damaging the bevel element of the EBUS device or the medical device itself. Therefore, the inventors of this disclosure have created an EBUS sampling device comprising a system for detecting the position of a protective sheath within the lumen to verify whether the sampling needle or other medical device can extend from the distal tip of the protective sheath into the patient's tissue.

[0006] In the example, the sampling device may include an elongated body, a medical device, and a sensor. The elongated body may extend longitudinally between a proximal segment and a distal segment and define a lumen. The medical device may be inserted into the elongated body. At least a portion of the medical device may be configured to be inserted into the lumen. The medical device may include a protective sheath and a sampling portion. The protective sheath may extend longitudinally between a proximal segment and a distal segment and define a working lumen. The sampling portion may be slidably mounted within the working lumen and may extend relative to the protective sheath such that the sampling portion can retract within the protective sheath and extend distally from the protective sheath. The sensor may be configured to generate a signal indicating adjacency between the protective sheath and the lumen outlet. Attached Figure Description

[0007] Various examples are illustrated in the accompanying figures. Such examples are illustrative and are not intended to be exhaustive or exclusive examples of the subject matter.

[0008] Figure 1 The illustration shows a schematic diagram of an example of an endobronchial ultrasound system.

[0009] Figure 2The illustration shows a schematic diagram of an example of the imaging and control system of an intrabronchial ultrasound sampling device.

[0010] Figure 3 The illustration shows a perspective view of a portion of the distal tip of an example sampling device with ultrasound imaging capabilities.

[0011] Figure 4 The illustration shows a perspective view of a portion of the distal tip of an example sampling device having a sampling instrument located within a working lumen of a protective sheath and an elongated member.

[0012] Figure 5 The illustration shows a perspective view of a portion of the distal tip of an example sampling device having a protective sheath adjacent to the outlet of the working lumen of an elongated member.

[0013] Figure 6 The illustration shows a perspective view of a sampling device having a protective sheath with an outlet adjacent to the working lumen of an elongated member, and a portion of an example distal tip of the sampling device extending from the protective sheath.

[0014] Figure 7 The illustration shows a perspective view of a portion of the distal tip of an example sampling device having a protective sheath adjacent to the outlet of the working lumen of an elongated member.

[0015] Figure 8 The illustration shows a perspective view of a portion of the distal tip of an example sampling device having a protective sheath adjacent to the outlet of the working lumen of an elongated member.

[0016] Figure 9 The illustration shows a graphical representation of an example graphical user interface for an endobronchial ultrasound system.

[0017] Figure 10 This is a block diagram illustrating an example of a method for reprocessing a sampling device.

[0018] Figure 11 It is a block diagram illustrating an example of a machine on which one or more examples can be implemented. Detailed Implementation

[0019] Endobronchial ultrasound (EBUS) sampling devices can be used to sense ultrasound images at the distal end of the sampling device. The distal end may also include imaging sensors (e.g., cameras, light sources, etc.), a working channel outlet for instruments (e.g., biopsy needles, scalpels, etc.), and, in recent advancements, a position or orientation sensor. Existing EBUS sampling devices can utilize a rigid distal end structure to house these components. Electronics can be arranged within the distal end of the distal end, such that the ultrasound sensor (e.g., a transducer) is located at the distal end of the distal end. The remaining components within the distal end can be located near the distal end.

[0020] Existing techniques for extending a biopsy needle from the exit port of an endoluminal sampling device involve first extending the needle sheath into the field of view of an imaging device, such as an endoscope or ultrasound transducer. Then, once the extension of the needle sheath has been visually confirmed in a real-time image stream, the clinician will then advance the biopsy needle from the needle sheath into the target tissue. One drawback of this approach is that, depending on the device configuration (e.g., the position of the imaging device relative to the exit port), extending the needle sheath into the field of view of the imaging device may require significant extension from the device, resulting in contact between the needle sheath and the tissue wall. The force exerted by the needle sheath against the tissue wall can potentially cause trauma to the tissue wall. Therefore, the inventors of this disclosure have developed an EBUS sampling device that includes a system for detecting the position of a protective sheath within the lumen to verify whether a sampling needle or other medical device can be extended from the distal tip of the protective sheath into the patient's tissue. Reference will be made herein to... Figures 1 to 10 The EBUS sampling device will be discussed.

[0021] Figure 1 This is a schematic diagram of an endoscope system 100, which may include: an imaging and control system 102; and an intrabronchial ultrasound sampling arrangement, which includes an endoscope 104 and a sampling device 136 that can be attached to the endoscope 104, and the sampling device 136 includes a distal end 144 extending from the distal end of the endoscope 104 via a distal working channel port. Figure 1 The system described herein is an illustrative example of an endoscope system suitable for use with the systems, apparatus and methods described herein, such as a bronchoscope with linearly arranged ultrasound elements.

[0022] Endoscope 104 may be an instrument capable of being inserted into an anatomical region for imaging or (e.g., via tethering) attached to one or more sampling devices for biopsy or for treating a disease condition associated with the anatomical region. Endoscope 104 may be engaged or connected to imaging and control system 102. Endoscope 104 is described in this example as a bronchoscope, but other types of endoscopes for use with the features and teachings of this disclosure are contemplated. Imaging and control system 102 may include control unit 106, display unit 108, input unit 110, light source 112, fluid source 114, and suction pump 116.

[0023] The imaging and control system 102 may include various ports for connection to the endoscope system 100. For example, the control unit 106 may include a data input port for receiving data from the endoscope 104 and a data output port for transmitting data to the endoscope 104. The light source 112 may include an output port for transmitting light, for example, via an optical fiber link, to the endoscope 104. The fluid source 114 may include a port for transmitting fluid to the endoscope 104. The fluid source 114 may include, for example, a pump and a fluid tank, or may be connected to an external tank, container, or storage unit. The suction pump 116 may include a port for creating a vacuum by drawing a vacuum from the endoscope 104 to generate suction, for example, for drawing fluid from an anatomical region into which the endoscope 104 is inserted. The display unit 108 and the input unit 110 may be used by an operator of the endoscope system 100 to control the functions of the endoscope system 100 and view the output of the endoscope 104. The control unit 106 may also generate signals or other outputs by processing the anatomical region into which the endoscope 104 is inserted. In the example, the control unit 106 can generate electrical output, acoustic output, fluid output, etc., for use in treating anatomical areas by means of, for example, cauterization, cutting, freezing, etc.

[0024] Endoscope 104 may include an insertion section 118, a functional section 120, and a handle section 122, which may be coupled to a cable section 124 and a connector section 126. The insertion section 118 extends distally from the handle section 122, and the cable section 124 extends proximally from the handle section 122. The insertion section 118 may be elongated and includes a bendable section and a distal end to which the functional section 120 is attached. The bendable section may be controllable (e.g., controllable via a steering controller 128 on the handle section 122) to manipulate the distal end through tortuous anatomical pathways (e.g., stomach, duodenum, kidney, ureter, trachea, lung, etc.). The insertion section 118 may also include one or more working channels (e.g., internal lumens), which may be elongated and may support the insertion of one or more therapeutic instruments, such as a bronchoscope, into the functional section 120. The working channel can extend between the handle section 122 and the functional section 120. Additional functions such as fluid passage, guide wire, and traction wire can also be provided by the insertion section 118 (e.g., via a suction or flushing passage).

[0025] The connector section 126 can be connected to the control unit 106 to connect the endoscope 104 to various features of the control unit 106, such as the input unit 110, the light source 112, the fluid source 114, and the suction pump 116.

[0026] Handle section 122 may include a steering controller 128 and a port 130. Steering controller 128 may be a knob, lever, or other actuation mechanism for navigating endoscope 104 within the patient's body. Steering controller 128 may be connected to a traction cable or other actuation mechanism extending through insertion section 118. Port 130 and other ports such as port 132 may be configured to connect various cables, guide wires, auxiliary endoscopes, tissue collection devices, fluid tubing, etc., to handle section 122, for example, for connection to insertion section 118. Figure 1 and Figure 2 The example shown is an example of endoscope 104.

[0027] According to the example, the imaging and control system 102 can be mounted on a mobile platform (e.g., a trolley 134) having features for accommodating a light source 112, a suction pump 116, and an image processing unit 202. Figure 2 Shelves such as ) etc. Alternatively, Figure 1 and Figure 2 The components of the imaging and control system 102 shown can be directly mounted on the endoscope 104 to make the endoscope "independent".

[0028] Functional segment 120 may include components for processing and diagnosing a patient's anatomy. Functional segment 120 may include an imaging device 146 (e.g., a tip-on-chip image sensor based on complementary metal-oxide-semiconductor (CMOS), an illumination device 148 (e.g., a light-emitting diode), and a working channel port 150 located at the distal end of functional segment 120.

[0029] like Figure 1 As shown, the sampling device 136 can extend from the working channel port 150 at the distal end of the functional segment 120 of the endoscope 104. The sampling device 136 can be configured to attach to port 132 such that it extends through the working channel of the endoscope 104 and extends beyond the distal end of the endoscope 104. The sampling device 136 may include: an actuator 138 for advancing or retracting the insertion segment 118 within the working channel to control how far the distal end of the sampling device 136 extends distally from the working channel port 150; an instrument actuator 142 (e.g., for actuating a biopsy needle from a side exit port of the sampling device 136); and a distal end 144. The actuator 138 can be configured to extend the sampling device 136 beyond the distal end of the endoscope 104, for example, to navigate the sampling device 136 to a target area within the patient's body. The actuator can slide along the housing 140 of the sampling device 136. The housing 140 may include markings indicating the amount of extension of the sampling device 136 beyond the distal end of the endoscope 104. An instrument actuator 142 may be configured to extend an instrument from the sampling device 136 to obtain a tissue sample from the patient. The distal end 144 of the sampling device 136 may include a transducer (or other imaging device) and a lateral exit port located proximal to the transducer for guiding the instrument configured to obtain a tissue sample from the patient into the transducer's field of view. The sampling device 136 will be discussed in more detail herein.

[0030] Figure 2 It includes an imaging and control system 102 and an intrabronchial ultrasound arrangement structure. Figure 1 A schematic diagram of an endoscope system 100, the endobronchial ultrasound arrangement including an endoscope and a sampling device 136 that can extend through the distal working channel port of the endoscope. Figure 2The components of an imaging and control system 102 coupled to an endoscope 104 are schematically illustrated. The imaging and control system 102 may include: a control unit 106, which may include or be coupled to an image processing unit 202, a treatment generator 206, and a drive unit 208; and a light source 112, an input unit 110, and a display unit 108. The control unit 106 may include, or communicate with, an endoscope, surgical instruments, and an endoscopic system, which may include means configured to engage tissue and collect and store a portion of that tissue, and an imaging device (e.g., a camera) may be used to observe target tissue via the endoscope, surgical instruments, and endoscopic system through materials and components including optical enhancements. The control unit 106 may be configured to activate the camera to observe target tissue distal to the endoscopic system. Similarly, control unit 106 can be configured to enable light source 112 to illuminate a surgical instrument, which may include selected components configured to reflect light in a particular manner, such as a tissue cutter enhanced with reflective particles.

[0031] The connector section 126 can be connected to the control unit 106 to connect the endoscope 104 to various features of the control unit 106, such as the image processing unit 202, the treatment generator 206, etc. In this example, port 130 can be used to insert another instrument or device, such as a sub-scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, etc., into the endoscope 104. Such instruments and devices can be independently connected to the control unit 106 via cable section 124. In this example, port 132 can be used to connect the connector section 126 to various inputs and outputs, such as video, air, light, and electricity.

[0032] Image processing unit 202, ultrasound image processing unit 204, and light source 112 can each be coupled to endoscope 104 (e.g., at functional section 120) or sampling device 136 via wired or wireless connections. Imaging and control system 102 can accordingly illuminate the anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on display unit 108. Ultrasound image processing unit 204 can be configured to receive ultrasound signals from either endoscope 104 or sampling device 136, which can be converted into an ultrasound image and transmitted to display unit 108 or any other component of endoscope system 100. Imaging and control system 102 may include light source 112 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrowband imaging using preferred electromagnetic wavelengths, etc.). The imaging and control system 102 may be connected to the endoscope 104 (e.g., via an endoscope connector) for signal transmission (e.g., light output from a light source, video signals from an imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, etc.).

[0033] Fluid source 114 ( Figure 1 The endoscope 104 (shown in the diagram) can communicate with control unit 106 and may include one or more air sources, saline sources, or other fluid sources, as well as associated fluid paths (e.g., air passages, flushing passages, suction passages, etc.) and connectors (barbed fittings, fluid seals, valves, etc.). Imaging and control system 102 may also include drive unit 208, which may include a motorized actuator for advancing the distal segment of endoscope 104.

[0034] Figure 3 The illustration shows a perspective view of a portion of an example distal tip 302 of a sampling device 300. The sampling device 300 (e.g., Figure 1 and Figure 2 The sampling device 136 shown may be an example of an endobronchial ultrasound (EBUS) sampling device that can be inserted into a patient's airway (e.g., a bronchus via the trachea) to obtain a biopsy sample, capture images, remove (e.g., resect) one or more tissues from the patient's lungs, etc. In some examples, the sampling device 300 may be an EBUS sampling device that facilitates real-time ultrasound imaging of a target tissue, such as a solitary pulmonary nodule (SPN), during surgery on the target tissue. Exemplary procedures of this type include obtaining a biopsy sample of the target tissue (e.g., for removal and pathological analysis), performing ablation on the target tissue, and injecting medication into the target tissue, etc. The distal tip 302 may be connected to the insertion segment 28 of the sampling device 300. Figure 1 and Figure 2The distal tip 302 is inserted into the patient's lung. It can be rigidly connected to the insertion segment 28 via a connector that helps maintain the distal tip 302 in the direction in which the insertion segment 28 is turned within the patient. The distal tip 302 can also be attached to the insertion segment 28 via a rotatable connector that allows a medical professional to further influence or turn the distal tip 302 as it extends into the patient.

[0035] Distal tip 302 (e.g., functional segment 30) Figure 1 and Figure 2 The distal end 302 can perform tasks during a bronchoscopy procedure. For example, it can capture images of the patient's lungs (e.g., digital images, ultrasound images, etc.), capture samples (e.g., using a biopsy needle extending from any part of the distal end 302), or remove one or more objects (e.g., using a scalpel, forceps, etc.). The distal end 302 may include a connector 304 and a housing 312.

[0036] The connector 304 may extend from the proximal portion 306 along the longitudinal axis LA to the distal portion 308. The distal portion 308 of the connector 304 may be coupled to the proximal segment 314 of the housing 312. The connector 304 may include a lumen 309 and a side outlet ramp 310. The lumen 309 and the side outlet ramp 310 may extend within the connector. For example, the lumen 309 may extend from the proximal portion 306 to the side outlet ramp 310, and the side outlet ramp 310 may extend from the lumen 309 through a side portion of the connector 304. The lumen 309 may be generally circular and may mate with a flexible needle lumen embedded within the flexible sheath of an EBUS endoscope. Therefore, instruments (e.g., biopsy (or sampling) needles, scalpels, forceps, laser-cut TBNA needles, ablation devices, etc.) can extend through a port on the proximal end of the EBUS endoscope, through the flexible needle lumen, into lumen 309, into the side exit bevel 310, and ultimately out of the side exit bevel 310. Thus, the side exit bevel 310 can be configured to guide the instrument 311 through the side of the connector 304 and toward the patient's tissue.

[0037] The housing 312 may extend from the proximal segment 314 along the central axis CA to the distal segment 316. The housing 312 may include a mounting feature 318 configured to receive the transducer 320. The mounting feature 318 may taper toward or past the central axis CA as the housing 312 extends from the proximal segment 314 toward the distal segment 316. As illustrated, the mounting feature 318 may converge toward the central axis CA near the distal tip of the distal segment 316, and this converging nature of the mounting feature 318 may cause the transducer 320 to tilt forward toward the distal tip of the distal segment 316. The taper of the mounting feature 318 may shift the distal boundary of the transducer's field of view 322 forward, such that the field of view 322 of the transducer 320 captures the instrument 311 at a greater depth as the instrument 311 extends from the side exit ramp 310 and into the patient's tissue. Alternatively, the forward-tilting nature of the linear transducer causes the field of view generated by the linear transducer to tilt forward relative to the side exit port, which increases the depth at which the target nodule can be biopsied while remaining within the field of view. This is because the deeper the sampling device penetrates into the tissue (e.g., further from the transducer), the farther the sampling device travels from the proximal end of the FOV to the distal end of the FOV. Once the sampling device extends beyond the distal end of the FOV, the distal tip of the sampling device (e.g., a biopsy needle) no longer images. This is similar to the linear transducer and device (e.g., as described in U.S. Patent Publication 2022 / 0313208). Figure 2 Compared to an EBUS sampling device whose longitudinal axis is aligned (e.g., parallel) with the longitudinal axis of the device depicted in A, the forward-tilting nature of the linear transducer increases the distance the needle can extend from the exit ramp to the distal end while remaining within the FOV—thus enabling deeper sampling during real-time visualization of the sampling device within the US image.

[0038] For example, such as Figure 3 As shown, angle 324 can be the angle along the tapering of housing 312 or mounting feature 318 and the field of view 322 of transducer 320. Figure 3 As shown, angle 324 can be an acute angle (i.e., less than 90 degrees) such that the field of view 322 extends beyond the distal edge 321 of the transducer 320. Angle 326 can be the angle between the connector 304 and the tapered portion of the housing 312 or mounting feature 318. Figure 3 As shown, angle 326 can be an obtuse angle (i.e., greater than 90 degrees). Therefore, transducer 320 is tilted toward the distal end segment 316 of housing 312 such that the field of view 322 of transducer 320 extends beyond the distal edge 321 of transducer 320.

[0039] Additionally, the tapering of the housing 312 and mounting feature 318 helps the transducer 320 engage with the tissue of the lung's airway, helping to prevent air gaps between the transducer 320 and the inner wall of the lung's airway, thereby helping to improve the ultrasound images captured by the transducer 320. Furthermore, the tapering of the housing 312 and mounting feature 318 helps the distal tip 302 navigate through the patient's airway and lungs because the housing 312 has a smaller diameter at the distal portion of the distal tip 302, which makes it easier to navigate into the patient's new airway and lung regions compared to a distal tip with a uniform diameter from the proximal end to the distal end.

[0040] Transducer 320 may be a linear array transducer. Transducer 320 may extend from a proximal edge 331 to a distal edge 321. Transducer 320 may be configured to capture ultrasound images of a patient's tissue during sampling of a target tissue of the patient via instrument 311. Transducer 320 will be discussed in more detail herein.

[0041] The foregoing discussion is intended to provide an overview of the subject matter of this disclosure. The foregoing discussion is not intended to provide an exclusive or exhaustive explanation of the invention. Further information regarding this patent application is included in the following description.

[0042] An intraluminal sampling device is disclosed, configured to sense the extension of a needle sheath from an outlet port and to notify a clinician when the needle sheath has been properly extended from the outlet port. In this way, the proposed system confirms for a healthcare provider when the needle sheath has been properly positioned so that the biopsy needle can be extended without damaging the device. Generally, the proposed intraluminal sampling device may include some form of sensor incorporated into the sampling device or onto the needle sheath, or both, that provides a feedback signal when the needle sheath has extended a predetermined amount from the outlet port of the working channel or has otherwise reached a predetermined position within the working channel.

[0043] Figure 4 The illustration shows sampling device 400 (e.g., sampling device 136). Figure 1 ) or sampling device 300 ( Figure 3 The image shows a perspective view of a portion of the distal tip of an example sampling device 400, which has sampling instruments within a protective sheath and a working lumen of an elongated member. The sampling device 400 can be inserted into a patient to obtain one or more samples from the patient's tissue, perform biopsies, etc. The sampling device 400 may include an elongated member 402, a medical device 420, and one or more sensors (e.g., sensor 440).

[0044] Elongated member 402 (e.g., insertion segment 28) Figure 1) or distal tip 302 ( Figure 3 The elongated member 402 may extend longitudinally between the proximal segment 404 and the distal segment 406. The elongated member 402 may be made of a flexible material, such as a polymer, rubber, any other biocompatible material, or any combination thereof. The elongated member 402 may define a lumen 408 extending from the proximal segment 404 to the distal segment 406.

[0045] Lumen 408 (e.g., lumen 309) Figure 3 The sampling device 400 may be configured to allow one or more of a tool, instrument, fluid, debris, tissue, etc., from the distal segment 406 to exit the sampling device 400. The lumen 408 may include an inlet port 410 formed on the proximal segment 404 of the elongated member 402. Figure 2 (as shown) and an outlet port 412 formed on the distal end section 406 of the elongated member 402. The outlet port 412 may define the outlet of the lumen 408.

[0046] Medical devices 420 (e.g., devices 311) Figure 3 The device can be inserted into the elongated member 402. In the example, at least a portion of the medical device 420 may be configured to be inserted into the lumen 408 via the inlet port 410 and guided out of the lumen 408 toward the patient's tissue via the outlet port 412. The medical device may include a protective sheath 422.

[0047] A protective sheath 422 may extend longitudinally between a proximal portion 424 and a distal portion 426. The protective sheath 422 may be configured to protect the medical device 420 when it is inserted into the inlet port 410 and extends through the lumen 408. The protective sheath 422 may be flexible, allowing it to be guided through the lumen 408 toward the outlet port 412. The protective sheath 422 may include a working lumen 428 (shown in dashed lines).

[0048] The working lumen 428 may be configured to allow at least partial movement of one or more tools, instruments, devices, etc., through the medical device 420. The working lumen 428 may extend between the proximal portion 424 and the distal portion 426 of the protective sheath 422. For example, a sampling portion 430 of the medical device 420 may be slidably mounted within the working lumen 428 such that the distal tip 432 of the sampling portion 430 may extend beyond or retract into the distal portion 426 of the protective sheath 422. In this example, the sampling portion 430 may be a sampling needle, a scalpel, etc.

[0049] Sensor 440 can be configured to determine when medical device 420, and more specifically, when protective sheath 422 is in position where sampling portion 430 can extend without damaging lumen 408 or sampling portion 430. Reference will be made herein to... Figure 5 Sensor 440 will be discussed.

[0050] Figure 5 The illustration shows a perspective view of a portion of an example of a sampling device 400, which has a protective sheath 422 adjacent to the outlet port 412 of a lumen 408 of an elongated member 402.

[0051] As discussed herein, sampling device 400 may include sensor 440. Sensor 440 may be an electrical sensor, a mechanical or magnetic proximity sensor, an optical sensor, or any other sensor capable of detecting the protective sheath 422 within lumen 408. In an example, sensor 440 may be mounted adjacent to outlet port 412. In an example, sensor 440 may be a capacitive sensor configured to detect capacitance changes that occur due to contact between the needle sheath (e.g., protective sheath 422) and the sensor location. As shown below, in some embodiments, the needle sheath (shown in blue) includes a capacitive element disposed on its outer surface that provides a significant capacitance change upon contact with the capacitive sensor.

[0052] like Figure 5 As shown, the protective sleeve 422 can extend such that the distal portion 426 of the protective sleeve 422 can be adjacent to the outlet port 412. In this example, the distal portion 426 of the protective sleeve 422 may include a capacitor ring 434, and the sensor 440 may be configured to detect the presence of the capacitor ring 434 near the outlet port 412. In this example, the capacitor ring 434 may be configured to produce a significant capacitance change upon contact with or proximity to the sensor 440.

[0053] Sensor 440 can detect when the capacitive ring 434 of the protective sheath 422 is near the outlet port 412, and can generate a signal 442 to indicate that the protective sheath 422 is near the outlet port 412. Figure 5As shown, signal 442 can be sent to control unit 106, which in turn can generate alarms, signals, warnings, and other indications to alert the clinician to the proximity of the protective sheath 422 to exit port 412. As a specific but not limiting example, signal 442 can be transmitted to control unit 106 to cause display unit 108 to generate one or more graphical user interface (GUI) elements indicating that the protective sheath 422 is currently aligned with a predetermined alignment within the working channel. This exemplary predetermined alignment within the working channel can be selected such that the distal end of the protective sheath 422 is aligned within a side exit ramp adjacent to exit port 412, such that the protective sheath barely (if present) protrudes from the side exit port while fully residing within the side exit ramp to help impart curvature to the biopsy needle residing within the protective sheath 422. In this way, the generation of signal 442 helps the user position the protective sheath 422 at a precise location within the working channel, preventing the needle from damaging the side exit ramp, while also ensuring that the protective sheath 422 does not extend beyond the side exit port and into the patient's tissue (which could cause some degree of trauma—especially in narrow passages such as the peripheral lung region).

[0054] In one example, signal 442 may indicate that the distal tip 432 of sampling portion 430 may extend beyond the distal portion 426 of protective sheath 422 without damaging sampling device 400. In other examples, signal 442 may indicate that the distal portion 426 of protective sheath 422 is aligned with a lumen outlet (e.g., outlet port 412). Figure 5 As shown, sensor 440 can be mounted within sampling device 400 such that sensor 440 is adjacent to outlet port 412 of lumen 408. In another example, sensor 440 can be mounted within the distal portion 426 of protective sheath 422.

[0055] Figure 6 The illustration shows a perspective view of a portion of an example distal tip of a sampling device 400 when the protective sheath 422 is adjacent to the outlet port 412 of the lumen 408 of the elongated member 402 and the sampling portion 430 extends from the protective sheath 422. Figure 6 As shown, once the healthcare professional receives a signal confirming the position of the protective sheath 422 adjacent to the outlet port 412, the healthcare professional can extend the sampling portion 430 beyond the distal portion 426 of the protective sheath 422. In this example, the sampling portion 430 can extend into the patient's tissue and extend into the transducer 320 (in... Figure 3 The field of view 322 (discussed in) Figure 3(As discussed herein). As discussed herein, transducer 320 can help guide sampling portion 430 toward the target tissue area of ​​the patient.

[0056] As discussed herein, the proximity of the protective sheath 422 to the outlet port 412 means that the sampling portion 430 can extend beyond the distal portion 426 of the protective sheath 422 without damaging the sampling portion 430 or the lumen 408 of the elongated member 402. Therefore, signal 442 ( Figure 4 This can help reduce damage to the sampling device 400, or more specifically to the lumen 408 and the sampling section 430, and helps increase the predictability of the procedure without having to visually confirm that the protective sheath 422 extends distally beyond the outlet port 412. As discussed above, visual inspection can have several drawbacks, which can be avoided by utilizing the sampling device 400, including sensor 440, to generate signal 442 when the protective sheath 422 extends into proximity to the outlet port 412.

[0057] Figure 7 The illustration shows a partial perspective view of an example of the sampling device 400. (See figure.) Figure 7 As shown, sensor 440 can be incorporated into protective sleeve 422; for example, sensor 440 can be adjacent to the distal portion 426 of protective sleeve 422. Sensor 440 can be any type of sensor capable of detecting capacitance changes or detecting the extension of protective sleeve 422 from outlet port 412. In the example, sensor 440 can be a proximity sensor, optical sensor, magnetic sensor, electrical sensor, or any other sensor capable of detecting the extension of protective sleeve 422 at or beyond outlet port 412, etc.

[0058] Figure 8 The illustration shows a perspective view of a portion of the example sampling device 400. (As shown) Figure 8 As shown, sensor 440 can be integrated into elongated member 402; for example, sensor 440 can be positioned adjacent to outlet port 412 of lumen 408. Sensor 440 can be configured to detect the presence of protective sheath 422 of medical device 420 in the absence of another sensor, capacitor ring, etc., disposed on the protective sheath 422 of medical device 420. Here, sensor 440 can be a proximity sensor, optical sensor, magnetic sensor, or electrical sensor, or any other sensor capable of detecting the presence of protective sheath 422.

[0059] In the example, the protective sheath 422 may include echo distance markers disposed at different portions of the protective sheath 422, which may reflect ultrasonic waves when the protective sheath 422 is inserted into the field of view of an ultrasonic transducer (e.g., sensor 440).

[0060] Figure 9 The illustration shows a graphical representation of an example graphical user interface 900 of an endobronchial ultrasound system. The graphical user interface 900 can be displayed on a display unit 108 for viewing by one or more healthcare professionals. The graphical user interface 900 may include patient information 910, real-time imaging 920, and alarms 930. Patient information 910 may include patient-specific information (e.g., age, weight, height, blood type, etc.) related to the patient undergoing surgery. Real-time imaging 920 may include information from an imaging and control system or transducer (e.g., see [link to relevant documentation]). Figure 1 The imaging and control system 102 or imaging device 146, or see the .... Figure 2 Image processing unit 202, or see image .... Figure 3 Medical images received by one or more of the transducers 320, etc. Alarm 930 may be generated by the endoscopic examination system 100 ( Figure 1 ), sampling device 300 ( Figure 3 ), sampling device 400 ( Figure 4 Alarms such as 930 can be triggered to communicate with the user of the device (e.g., a medical professional). For example, alarm 930 may include an indication that the protective sheath is safe for deploying the device (e.g., a sampling needle) due to its proximity to the outlet port.

[0061] Figure 10 A schematic diagram of example method 1000 is illustrated. Method 1000 can be for a sampling device (e.g., see...). Figure 1 Sampling device 136, see Figure 3 The sampling device 300, etc., is used for reprocessing. A more specific example of method 1000 is discussed below. For convenience and clarity, the steps or operations of method 1000 are illustrated in a specific order; many of the operations discussed may be performed in different orders or in parallel without substantially affecting other operations. As discussed, method 1000 includes operations performed by multiple different actors, devices, or systems. It should be understood that a subset of the operations discussed in method 1000 may be attributed to a single actor, device, or system and may be considered a separate, independent process or method.

[0062] Reference Figure 10 For use with the therapeutic devices described above (e.g., see...) Figure 1 Sampling device 136 or see Figure 3 The reprocessing method 1000 of the sampling device 300 is described herein. The above-mentioned therapeutic instrument can be discarded after a single use, or it can be reused, for example, multiple times. In the case of a configuration that can be reused multiple times, for example... Figure 10 The reprocessing method 1000 shown may be relevant.

[0063] The operator can collect the used treatment device after it has been used for treatment and transport it to the factory, etc. (step S1). At this time, the used treatment device (e.g., endoscope 104, sampling device 136, or sampling device 300) can be transported in a dedicated container to prevent contamination from the treatment device (e.g., device 311, see...). Figure 3 ) pollution.

[0064] Then, the operator can clean and sterilize the collected and transported used treatment devices (step S2). Specifically, when cleaning the treatment devices, deposits adhering to the exterior of the distal tip 302 (e.g., connector 304 or housing 312) can be removed by using a brush or the like. After this, in order to remove pathogenic microorganisms from blood, body fluids, etc., the distal tip 302 can be cleaned using a cleaning solution containing isopropanol, proteolytic enzyme detergent, and alcohol. The cleaning solution is not limited to the cleaning solution described above, and other cleaning solutions can be used. Furthermore, in the sterilization of the treatment devices, in order to sterilize pathogenic microorganisms adhering to the distal tip 302, any one of autoclaving, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide, and hydrogen peroxide low-temperature sterilization can be used. Part of the distal tip 302, and specifically the connector 304 ( Figure 3 ) and housing 312 ( Figure 3 The connector 304 and housing 312 can be disassembled by actuating the clamping or fixing features to disconnect them.

[0065] The operator can perform an acceptance inspection on the used treatment device (step S3). Specifically, the operator can check whether the used treatment device has obvious defects or whether the used treatment device has exceeded the maximum number of reprocessing cycles.

[0066] Next, the operator can disassemble the used treatment device (step S4). The distal tip 302 can be disassembled by removing the housing 312 from the connector 304 and removing all components from the connector 304 and the housing 312.

[0067] After step S4, some components are replaced (step S5). For example, any component of the distal tip 302 or any component within the connector 304 or housing 312 can be replaced during step S4.

[0068] After step S5, the operator can proceed with the treatment of the new device (e.g., device 311, see [link]). Figure 3Assembly is then performed (step S6). In some examples, step S6 may include adding an identifier to indicate that the device has been modified from its original state, such as adding a label or other marking to designate the device for reprocessing, refurbishment, or remanufacturing.

[0069] After step S6, the operator can inspect and test the newly formed therapeutic device (step S7). Specifically, the remanufacturing operator verifies the newly formed therapeutic device through various functional tests (e.g., device 311, see...). Figure 3 It has the same effectiveness and safety as the original product.

[0070] Following step S7, the operator sequentially applies new treatment instruments (e.g., instrument 311, see [link]). Figure 3 The sterilization and storage (step S8) and transportation (step S9) of the device. In step S8, sterilization treatment with a sterilizing gas such as ethylene oxide gas or propylene oxide gas may be applied to the new therapeutic device (e.g., device 311, see step S9). Figure 3 The device is stored in a storage container until it is used.

[0071] Perform steps S1 to S9 as described above to realize the therapeutic device (e.g., device 311, see...). Figure 3 The reprocessing of the medical device. Any of steps S1 through S9 may be performed by one or more participants in any order. Furthermore, steps S1 through S9 are exemplary steps and are not intended to be performed by an operator for refurbishing, remanufacturing, or supplementing the medical device (e.g., device 311, see [link]). Figure 3 A complete list of steps.

[0072] Figure 11A block diagram of an example machine 1100 on which any or more of the techniques (e.g., methods) discussed herein may be performed. As described herein, the example may include logic or components or mechanisms in machine 1100, or may be operated by logic or components or mechanisms in machine 1100. A circuit system (e.g., a processing circuit system) is a collection of circuits implemented in a tangible entity of machine 1100 that includes hardware (e.g., simple circuits, gates, logic, etc.). The relationships between circuit system components can be flexible over time. A circuit system includes components that can perform specific operations individually or in combination during operation. In the example, the hardware of the circuit system may be designed in an immutable manner to perform specific operations (e.g., hardwired). In the example, the hardware of the circuit system may include physical components (e.g., execution units, transistors, simple circuits, etc.) connected in a variable manner to encode instructions for specific operations, and the variably connected physical components include machine-readable media that are physically modified (e.g., magnetically grounded, electrically grounded, movable placement of immutable aggregate particles, etc.). When physical components are connected, the underlying electrical characteristics of the hardware composition are altered, for example, from an insulator to a conductor or vice versa. Instructions enable embedded hardware (e.g., an execution unit or loading mechanism) to create components of a circuit system within the hardware via variable connections to perform parts of a specific operation during operation. Thus, in the example, a machine-readable medium element is part of the circuit system, or communicatively coupled to other components of the circuit system during device operation. In the example, any physical component can be used in more than one component of more than one circuit system. For example, during operation, an execution unit can be used at one point in time in a first circuit of a first circuit system and reused by a second circuit of the first circuit system, or reused at different times by a third circuit of the second circuit system. Additional examples of these components of machine 1100 are provided below.

[0073] In alternative examples, machine 1100 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, machine 1100 may operate as a server machine, a client machine, or both in a server-client network environment. In the examples, machine 1100 may be used as a peer-to-peer (P2P) (or other distributed) network environment. Machine 1100 may be a personal computer (PC), tablet PC, set-top box (STB), personal digital assistant (PDA), mobile phone, network device, network router, switch, or bridge, or any machine capable of executing instructions (sequentially or otherwise) specifying actions to be taken by that machine. Furthermore, although only a single machine is illustrated, the term "machine" should also be understood to include any set of machines that individually or collectively execute a set (or more) of instructions to perform any or more of the methods discussed herein, such as cloud computing, Software as a Service (SaaS), or other computer cluster configurations.

[0074] Machine (e.g., computer system) 1100 may include a hardware processor 1102 (e.g., a central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 1104, static memory (e.g., memory or storage device for firmware, microcode, basic input / output (BIOS), unified extensible firmware interface (UEFI), etc.) 1106, and mass storage device 1108 (e.g., hard disk drive, tape drive, flash memory, or other block device), some or all of which may communicate with each other via an interconnect link (e.g., bus) 1130. Machine 1100 may also include a display unit 1110, an alphanumeric input device 1112 (e.g., keyboard), and a user interface (UI) navigation device 1114 (e.g., mouse). In this example, the display unit 1110, the input device 1112, and the UI navigation device 1114 may be a touchscreen display. Machine 1100 may additionally include a storage device (e.g., a drive unit) 1108, a signal generation device 1118 (e.g., a speaker), a network interface device 1120, and one or more sensors 1116, such as a Global Positioning System (GPS) sensor, a compass, an accelerometer, or other sensors. Machine 1100 may include an output controller 1128, connected, for example, serially (e.g., Universal Serial Bus (USB), in parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connections, to communicate with or control one or more peripheral devices (e.g., printers, card readers, etc.).

[0075] The registers of processor 1102, main memory 1104, static memory 1106, or mass storage device 1108 may be or include machine-readable medium 1122 on which one or more sets of data structures or instructions 1124 (e.g., software) are stored, said set of one or more sets of data structures or instructions 1124 embodying or being utilized by any or more of the techniques or functions described herein. Instructions 1124 may also reside wholly or at least partially within any of the registers of processor 1102, main memory 1104, static memory 1106, or mass storage device 1108 during execution by machine 1100. In this example, one or any combination of hardware processor 1102, main memory 1104, static memory 1106, or mass storage device 1108 may constitute machine-readable medium 1122. Although machine-readable medium 1122 is illustrated as a single medium, the term "machine-readable medium" can include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store one or more instructions 1124.

[0076] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions for use by machine 1100 and to enable machine 1100 to perform any or more of the techniques of this disclosure, or capable of storing, encoding, or carrying data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, non-transitory machine-readable media includes machine-readable media having a plurality of particles with invariant (e.g., stationary) mass and thus being a component of matter. Therefore, a non-transitory machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transitory machine-readable media can include: non-volatile memory, such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable hard disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0077] In the example, information stored on or otherwise provided on machine-readable medium 1122 may represent instruction 1124, such as instruction 1124 itself or a format from which instruction 1124 can be derived. Such a format from which instruction 1124 can be derived may include source code, encoded instructions (e.g., in compressed or encrypted form), packaged instructions (e.g., divided into multiple packages), etc. The information representing instruction 1124 in machine-readable medium 1122 may be processed by a processing circuitry system into instructions to implement any of the operations discussed herein. For example, deriving instruction 1124 from information (e.g., processed by a processing circuitry system) may include: (e.g., from source code, object code, etc.) compiling, interpreting, loading, organizing (e.g., dynamic or static linking), encoding, decoding, encrypting, decrypting, packaging, unpacking, or otherwise manipulating the information into instruction 1124.

[0078] In the example, the derivation of instruction 1124 may include the assembly, compilation, or interpretation of information (e.g., by processing a circuit system) to create instruction 1124 according to some intermediate or preprocessed format provided by machine-readable medium 1122. Information provided in multiple parts may be combined, unpacked, and modified to create instruction 1124. For example, the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or more remote servers. The source code packages may be encrypted during transmission over a network and may be decrypted, decompressed, assembled (e.g., linked), and compiled or interpreted at the local machine (e.g., compiled or interpreted into libraries, standalone executables, etc.), and executed by the local machine, if necessary.

[0079] Commands 1124 can also be transmitted or received via communication network 1126 using a transmission medium via network interface device 1120, utilizing any of several transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Example communication networks may include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), LoRa / LoRaWAN or satellite communication networks, mobile phone networks (e.g., cellular networks, such as cellular networks compliant with 3G, 4G LTE / LTE-A, or 5G standards), conventional telephone (POTS) networks, and wireless data networks (e.g., IEEE 502.11 family of standards known as Wi-Fi®, IEEE 502.15.4 family of standards, peer-to-peer (P2P) networks, etc.). In the example, network interface device 1120 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connection to communication network 1126. In the example, network interface device 1120 may include multiple antennas to wirelessly communicate using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technology. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions for execution by machine 1100, and the term "transmission medium" includes digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0080] The following non-limiting examples detail certain aspects of this topic to address challenges and provide the benefits discussed herein.

[0081] Example 1 is a sampling device that can be inserted into a patient's body, the sampling device comprising: an elongated body extending longitudinally between a proximal and a distal segment, the elongated body including a lumen, an inlet port, and an outlet port, the lumen extending longitudinally within the elongated body, the inlet port being formed on the proximal segment of the elongated body and connected to the lumen, and the outlet port being formed on the distal segment of the elongated body and connected to the lumen; and a medical device capable of being inserted into the elongated body, at least a portion of the medical device being configured to be inserted into the lumen via the inlet port and guided out of the lumen via the outlet port toward the patient's tissue, the medical device including a protective sheath and a sensor, the protective sheath extending longitudinally between the proximal and distal portions, the sensor being configured to generate a signal indicating that the protective sheath is adjacent to the outlet port.

[0082] In Example 2, the subject matter of Example 1 includes, wherein the protective sheath includes a working lumen that extends between a proximal portion and a distal portion.

[0083] In Example 3, the subject matter of Example 2 includes a medical device comprising a sampling portion slidably mounted within a working lumen such that a distal tip of the sampling portion can extend beyond or retract within a distal portion of a protective sheath.

[0084] In Example 4, the subject matter of Example 3 includes a signal indicating that the distal tip of the sampling portion can extend beyond the distal portion of the protective sheath without damaging the sampling device.

[0085] In Example 5, the subject matter of Examples 3 to 4 includes, wherein the medical device is an intrabronchial ultrasound sampling device.

[0086] In Example 6, the subject of Example 5 includes, wherein the sampling portion is a sampling needle configured to obtain sample tissue from a patient.

[0087] In Example 7, the subject matter of Examples 1 through 6 includes, where the outlet port defines the lumen outlet.

[0088] In Example 8, the subject of Example 7 includes a signal indicating that the distal portion of the protective sheath is aligned with the lumen outlet.

[0089] In Example 9, the subject matter of Examples 7 and 8 includes a signal indicating that the distal portion of the protective sheath is adjacent to the lumen outlet.

[0090] In Example 10, the subject matter of Examples 1 through 9 includes a sensor adjacent to an outlet port.

[0091] In Example 11, the subject matter of Examples 1 through 10 includes a sensor located on the distal portion of a protective sheath.

[0092] In Example 12, the subject matter of Examples 1 to 11 includes a first sensor adjacent to the outlet port and a second sensor adjacent to the distal portion of the protective sheath.

[0093] Example 13 is a sampling device that can be inserted into a patient's body. The sampling device includes: an elongated body extending longitudinally between a proximal and a distal portion and defining a lumen; a medical device insertable into the elongated body, at least a portion of which is configured to be inserted into the lumen, the medical device including a protective sheath and a sampling portion extending longitudinally between the proximal and distal portions and defining a working lumen, the sampling portion being slidably mounted within the working lumen and extendable relative to the protective sheath such that the sampling portion can be retracted within and distally extended from the protective sheath; and a sensor configured to generate a signal indicating adjacency between the protective sheath and an outlet of the lumen.

[0094] In Example 14, the subject matter of Example 13 includes a protective sheath comprising a working lumen that extends between a proximal portion and a distal portion.

[0095] In Example 15, the subject matter of Example 14 includes a signal indicating that the sampling portion can extend beyond the distal portion of the protective sheath without damaging the sampling portion.

[0096] In Example 16, the subject matter of Examples 13 to 15 includes a sensor configured to be adjacent to the outlet of the lumen.

[0097] In Example 17, the subject matter of Examples 13 to 16 includes a sensor configured to be adjacent to the distal portion of a protective sheath.

[0098] In Example 18, the subject matter of Examples 13 to 17 includes a first sensor adjacent to the outlet of the lumen and a second sensor adjacent to the distal portion of the protective sheath.

[0099] Example 19 is a method for reprocessing a sampling device, the method comprising: obtaining the sampling device of Example 13; sterilizing the sampling device; and storing the sampling device.

[0100] Example 20 is a device that includes means for implementing any one of Examples 1 through 19.

[0101] Example 21 is a system used to implement any one of Examples 1 through 19.

[0102] Example 22 is a method used to implement any one of Examples 1 through 19.

[0103] Example 23 is a device, system, or method for implementing any element of any of Examples 1 through 19.

[0104] The above detailed description includes reference to the accompanying drawings, which form a part of the detailed description. The drawings illustrate specific examples that can be practiced by way of illustration. These embodiments are also referred to herein as "examples". Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Furthermore, the inventors also contemplate examples (or one or more aspects thereof) using any combination or arrangement of those elements shown or described relative to a particular example (or one or more aspects thereof) shown or described herein, or relative to other examples (or one or more aspects thereof).

[0105] All publications, patents, and patent documents mentioned in this document are incorporated herein by reference in their entirety, as if they were individually incorporated by reference. In the event of any inconsistency between the usage in this document and those documents incorporated by reference, the usage in the incorporated reference shall be considered supplementary to the usage in this document; in the case of irreconcilable inconsistencies, the usage in this document shall prevail.

[0106] In this document, as is common in patent documents, the term "a" or "one" is used to include one or more, independent of any other instance or use of "at least one" or "one or more." In this document, unless otherwise indicated, the term "or" is used to mean a non-exclusive "or," such that "A or B" includes "A but not B," "B but not A," and "A and B." In the appended claims, the terms "comprising" and "in..." are used as concise English equivalents to the corresponding terms "including" and "wherein." Furthermore, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, or process that includes elements other than those listed after such terms in the claim is still considered to fall within the scope of that claim. Additionally, in the appended claims, the terms "first," "second," and "third," etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0107] As used herein, the term “about” means approximately, within a certain range, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies the range by extending the upper and lower boundaries of the stated value. Typically, the term “about” is used herein to modify numerical values ​​above and below the stated value by a change of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number to which the term is used. Thus, about 50% means a range of 45% to 55%. The numerical ranges listed in this document by endpoints include all numbers and fractions contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, the numerical ranges listed by endpoints in this document include subranges contained within those ranges (e.g., 1 to 5 includes 1 to 1.5, 1.5 to 2, 2 to 2.75, 2.75 to 3, 3 to 3.90, 3.90 to 4, 4 to 4.24, 4.24 to 5, 2 to 5, 3 to 5, 1 to 4, and 2 to 4). It is also understood that all numbers and their fractions are assumed to be modified by the term “about”.

[0108] The foregoing description is intended to be illustrative and not restrictive. For example, the examples described above (or one or more aspects thereof) can be used in combination with each other. Other examples may be used by one of ordinary skill in the art upon reading the foregoing description. The abstract is intended to allow the reader to quickly determine the nature of the technical disclosure, and it should be understood that the abstract is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the detailed description above, various features may be combined to simplify this disclosure. This should not be construed as implying that any unclaimed feature is necessary for any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Therefore, the appended claims are incorporated herein by reference to the detailed description, wherein each claim exists independently as a separate embodiment. The scope of the examples should be determined by reference to the full scope of the appended claims together with their equivalents.

[0109] The devices disclosed herein may be designed for single-use post-treatment or for multiple-use applications. However, in either case, the device may be repaired for reuse after at least one use. Repair may include a combination of the following steps: disassembly of the device, subsequent cleaning or replacement of specific parts, and subsequent reassembly. Specifically, the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. After cleaning and / or replacement of specific parts, the device may be reassembled at a repair facility or immediately before a surgical procedure by a surgical team for subsequent use. Those skilled in the art will understand that the repair of the device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. The use of these techniques and the resulting repair devices are within the scope of this application.

[0110] Preferably, the invention described herein is performed prior to surgical procedures. First, new or used instruments are obtained and, if necessary, cleaned. The instruments can then be sterilized. In one sterilization technique, the instruments are placed in a closed, sealed container, such as a plastic bag or a TYVEK® bag. The container and instruments are then placed in a radiation field, such as gamma radiation, X-rays, or high-energy electrons, that can penetrate the container. The radiation kills bacteria on the instruments and in the container. The sterile instruments can then be stored in a sterile container. The sealed container keeps the instruments sterile until they are opened in a medical facility. Any other techniques known in the art can also be used to sterilize the devices, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

Claims

1. A sampling device that can be inserted into a patient's body, the sampling device comprising: An elongated body extending longitudinally between a proximal segment and a distal segment, the elongated body comprising: A lumen that extends longitudinally within the elongated body; An inlet port, the inlet port being formed on the proximal segment of the elongated body and connected to the lumen; and An outlet port is formed on the distal end section of the elongated body and connected to the lumen; A medical device capable of being inserted into the elongated body, at least a portion of the medical device being configured to be inserted into the lumen via the inlet port and guided out of the lumen via the outlet port toward the patient's tissue, the medical device comprising: A protective sheath extending longitudinally between a proximal portion and a distal portion; and A sensor configured to generate a signal indicating that the protective sheath is adjacent to the outlet port.

2. The sampling device according to claim 1, wherein, The protective sheath includes: A working lumen that extends between the proximal portion and the distal portion.

3. The sampling device according to claim 2, wherein, The medical device includes: The sampling portion is slidably mounted within the working cavity, such that the distal tip of the sampling portion can extend beyond the distal portion of the protective sheath or retract into the distal portion of the protective sheath.

4. The sampling device according to claim 3, wherein, The signal indicates that the distal tip of the sampling portion can extend beyond the distal portion of the protective sheath without damaging the sampling device.

5. The sampling device according to claim 3, wherein, The medical device is an intrabronchial ultrasound sampling device.

6. The sampling device according to claim 5, wherein, The sampling portion is a sampling needle configured to obtain sample tissue from the patient.

7. The sampling device according to claim 6, comprising: A processor, including processing circuitry, is coupled to a memory including instructions configured, when initiated by the processing circuitry, to cause the processing circuitry to: An alarm is generated based on the signal, indicating that the protective sheath is near the outlet port; and Visual markers are transmitted to a display visible to a clinician using the sampling device, the visual markers including instructions that enable the clinician to safely extend the sampling needle from the protective sheath.

8. The sampling device according to claim 1, wherein, The outlet port defines the outlet of the lumen.

9. The sampling device according to claim 8, wherein, The signal indicates that the distal portion of the protective sheath is aligned with the lumen outlet.

10. The sampling device according to claim 8, wherein, The signal indicates that the distal portion of the protective sheath is adjacent to the lumen outlet.

11. The sampling device according to claim 1, wherein, The sensor is adjacent to the outlet port.

12. The sampling device according to claim 1, wherein, The sensor is located on the distal portion of the protective sheath.

13. The sampling device according to claim 1, wherein, A first sensor is provided adjacent to the outlet port, and a second sensor is provided adjacent to the distal portion of the protective sheath.

14. A sampling device that can be inserted into a patient's body, the sampling device comprising: An elongated body that extends longitudinally between a proximal end section and a distal end section and defines a lumen; A medical device capable of being inserted into the elongated body, at least a portion of the medical device being configured to be inserted into the lumen, the medical device comprising: A protective sheath extending longitudinally between a proximal and distal portion and defining a working lumen; and A sampling portion, slidably mounted within the working cavity, the sampling portion being extendable relative to the protective sheath, such that the sampling portion can retract within the protective sheath and extend distally from the protective sheath; and A sensor configured to generate a signal indicating that the protective sheath is adjacent to the outlet of the lumen.

15. The sampling device according to claim 14, wherein, The protective sheath includes: A working lumen that extends between the proximal portion and the distal portion.

16. The sampling device according to claim 15, wherein, The signal indicates that the sampling portion can extend beyond the distal portion of the protective sheath without damaging the sampling portion.

17. The sampling device according to claim 14, wherein, The sensor is positioned adjacent to the outlet of the lumen.

18. The sampling device according to claim 14, wherein, The sensor is positioned adjacent to the distal portion of the protective sheath.

19. The sampling device according to claim 14, wherein, A first sensor is provided adjacent to the outlet of the lumen, and a second sensor is provided adjacent to the distal portion of the protective sheath.

20. A method for reprocessing a sampling device, the method comprising: Obtain the sampling device according to claim 14; The sampling device is sterilized; as well as Store the sampling device.

21. The method of claim 20, comprising: Remove the sampling portion from the working lumen of the protective sheath; Remove the protective sheath from the lumen of the elongated body; The sampling portion, the protective sheath, and the elongated body are sterilized; and The sampling section, the protective sheath, and the elongated body are packaged together.

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