System for maintaining ultrasonic contact with intraluminal tissue

Abstract

An intraluminal ultrasound device configured to be inserted within an inner wall defining a lumen of a patient can include a housing extending from a proximal section to a distal section along a central axis. The housing can include a transducer configured to capture ultrasound images and a mounting component configured to receive the transducer. The intraluminal ultrasound device can also include a force generation system operable to maintain contact between the inner wall and the transducer, in turn causing a reduction in an air gap between the lumen and the transducer.

Description

Priority Statement

[0001] This patent application claims the benefit of priority to U.S. Patent Application Serial No. 63 / 594,714 (Attorney’s File No. 5409.835PRV), filed October 31, 2023, entitled “SYSTEMS FOR MAINTAINING ULTRASONIC CONTACT WITH INTRALUMINAL TISSUE”, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The examples described herein generally relate to ultrasound devices. More specifically, the examples described herein generally relate to techniques for maintaining contact between ultrasound and intraluminal tissue. 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 gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary ducts, intestines, colon, etc.), renal regions (e.g., kidneys, ureters, bladder, urethra), and other internal organs (e.g., reproductive system, sinus cavities, submucosal regions, respiratory tract, etc.). Summary of the Invention

[0004] The inventors of this disclosure have recognized that ultrasound imaging has limitations for endobronchial ultrasound imaging devices (e.g., endobronchial ultrasound (EBUS) endoscopes, sampling devices, etc.) where contact between the intraluminal tissue and the transducer cannot be maintained. Specifically, obtaining high-quality ultrasound (“US”) images depends on US energy propagating from the transducer element into the patient tissue at least as deep as the tissue structure of interest, which reflects a portion of the US energy back to the transducer element. The transducer element generates signals based on the reflected portion of the US energy, and these signals are used to generate an image of the tissue structure of interest. Because air has extremely low acoustic impedance relative to body tissue, the air gap residing between the US transducer and the tissue structure of interest can create an undesirable ultrasound barrier. This “impedance mismatch” causes most of the US waves reaching the tissue-air surface to be reflected. This severely limits the penetration of US waves into the tissue outside the luminal wall and can result in poor or even non-existent imaging of the tissue structure of interest. Maintaining contact between the transducer and the tissue within the lumen can become particularly difficult when a small ultrasonic device is present and the diameter of the tissue within the lumen is larger than the diameter of the small ultrasonic device. Therefore, the inventors have developed a system for maintaining contact between the transducer and the tissue within the lumen.

[0005] In some examples, the ultrasound sampling device may be configured to insert within the inner wall of a lumen defining a patient and may include a connector extending from a proximal portion to a distal portion. The connector may include a side outlet ramp extending from the proximal portion of the connector and through a side portion of the connector. The side outlet ramp may guide the instrument through the side portion of the connector and toward the inner lumen wall. The ultrasound sampling device may include a housing extending from the proximal segment along a central axis to the distal segment. The housing may include mounting features configured to receive a transducer and a force generation system. The force generation system may operate to maintain contact between the inner lumen wall and the transducer to reduce the air gap between the inner lumen wall and the transducer.

[0006] In some examples, a system for acquiring ultrasound images of intraluminal tissue defining a lumen in a patient may include: a control handle; and an insertion tube extending from the control handle. The insertion tube may be configured for insertion into the lumen and may include a working lumen. The system may include an ultrasound sampling device configured for insertion into the working lumen, such that the ultrasound sampling device can extend beyond the distal tip of the insertion tube and into the lumen. The ultrasound sampling device may include a connector extending from a proximal portion to a distal portion. The connector may include a side outlet ramp extending from the proximal portion of the connector and through a side portion of the connector. The side outlet ramp may guide an instrument through the side portion of the connector toward the intraluminal tissue. A housing may extend from the proximal segment along a central axis to the distal segment. The housing may include mounting features configured to receive a transducer and a force generation system operable to maintain contact between the intraluminal tissue and the transducer to reduce the air gap between the intraluminal tissue and the transducer.

[0007] In some examples, an intraluminal ultrasound device—configured for insertion within the inner wall of a lumen defining a patient's body—may include a housing extending from a proximal segment along a central axis to a distal segment. The housing may include a transducer configured to capture ultrasound images and mounting features configured to receive the transducer. The intraluminal ultrasound device may also include a force-generating system operable to maintain contact between the inner wall and the transducer, thereby reducing the air gap between the lumen and the transducer. Attached Figure Description

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

[0009] Figure 1 This is a schematic diagram of an example of an intrabronchial ultrasonic sampling device.

[0010] Figure 2 This is a schematic diagram of an example of the imaging and control system of an ultrasonic sampling device.

[0011] Figure 3 This is a cross-sectional view of a portion of an example of an ultrasonic sampling device.

[0012] Figure 4 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in a retracted configuration.

[0013] Figure 5 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in an extended configuration.

[0014] Figure 6This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in a retracted configuration.

[0015] Figure 7 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in an extended configuration.

[0016] Figure 8 This is a perspective view of a portion of an example of an ultrasonic sampling device with an example pressure generation system.

[0017] Figure 9 This is a perspective view of a portion of an example of an ultrasonic sampling device with an example pressure generation system.

[0018] Figure 10 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in a deflation configuration.

[0019] Figure 11 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in an expansion configuration.

[0020] Figure 12 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in a retracted configuration.

[0021] Figure 13 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in an extended configuration.

[0022] Figure 14 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in a retracted configuration.

[0023] Figure 15 This is a cross-sectional view of a portion of an example ultrasonic sampling device, where the example pressure generation system is in an extended configuration.

[0024] Figure 16 This is a side view of an example sampling device.

[0025] Figure 17 This is a cross-sectional view of a port in an example actuator of an example sampling device.

[0026] Figure 18 This is a schematic diagram of an exemplary computer-based clinical decision support system (CDSS).

[0027] Figure 19 It is a block diagram of an example machine on which one or more examples can be implemented. Detailed Implementation

[0028] Intraluminal ultrasound (US) imaging enables real-time imaging of anatomical structures located outside the luminal wall. For example, endobronchial ultrasound (EBUS) devices allow physicians to obtain a real-time image stream of structures of interest, such as solitary pulmonary nodules (SPNs) located adjacent to a patient's airway. Obtaining high-quality US images may require US energy to propagate from the transducer element into the patient's tissue, at least as deep as the structure of interest. The structure of interest reflects a portion of the US energy back to the transducer element. The transducer element generates a signal based on the reflected portion of the US energy, and these signals can generate an image of the structure of interest.

[0029] Because air has a low acoustic impedance relative to body tissue, the air gap residing between the US transducer and the tissue of interest can create an undesirable ultrasound barrier. This "impedance mismatch" can cause most of the US waves reaching the tissue-air surface to be reflected. The reflection of US waves from the tissue-air surface severely restricts US wave penetration into the tissue outside the luminal wall and may result in poor imaging or even absence of the tissue of interest.

[0030] Some existing endoluminal ultrasound devices may include an elastomeric balloon capable of surrounding a transducer. The elastomeric balloon can communicate with the lumen, allowing the endoluminal ultrasound device to advance to a portion of the lumen adjacent to the tissue of interest during the medical procedure. The elastomeric balloon can then be filled with a fluid (e.g., saline, gel, etc.) to provide contact between the transducer and the lumen wall, without an air gap that could cause harmful impedance mismatch. However, these systems with elastomeric balloons do not facilitate the positioning of the transducer against the tissue within the patient's lumen, and these systems still present imaging problems when the lumen is larger than the diameter of the device.

[0031] Therefore, the inventors of this disclosure have recognized the importance of maintaining contact between the ultrasonic transducer and the tissue to reduce the accumulation of air or other debris between the ultrasonic transducer and the lumen wall. As discussed herein, air and other debris between the ultrasonic transducer and the lumen wall can interfere with the ultrasonic signal and negatively affect the ultrasonic images captured by the transducer. In response, the inventors of this disclosure have developed techniques for maintaining contact between ultrasound and the tissue within the lumen.

[0032] In some examples, the ultrasound sampling device may be configured to be inserted into the inner wall of a lumen defining a patient, and the ultrasound sampling device may include a connector extending from a proximal portion to a distal portion. The connector may include a side outlet ramp extending from the proximal portion of the connector and through a side portion of the connector. The side outlet ramp may guide the instrument through the side portion of the connector and toward the inner lumen wall. The ultrasound sampling device may include a housing extending from the proximal segment along a central axis to the distal segment. The housing may include mounting features configured to receive a transducer and a force generation system. The force generation system is operable to maintain contact between the inner lumen wall and the transducer to reduce the air gap between the inner lumen wall and the transducer.

[0033] In some examples, a system for acquiring ultrasound images of intraluminal tissue defining a lumen in a patient may include: a control handle; and an insertion tube extending from the control handle. The insertion tube may be configured for insertion into the lumen and may include a working lumen. The system may include an ultrasound sampling device configured for insertion into the working lumen, such that the ultrasound sampling device can extend beyond the distal tip of the insertion tube and into the lumen. The ultrasound sampling device may include a connector extending from a proximal portion to a distal portion. The connector may include a side outlet ramp extending from the proximal portion of the connector and through a side portion of the connector. The side outlet ramp may guide an instrument through the side portion of the connector toward the intraluminal tissue. A housing may extend from the proximal segment along a central axis to the distal segment. The housing may include mounting features configured to receive a transducer and a force generation system operable to maintain contact between the intraluminal tissue and the transducer to reduce the air gap between the intraluminal tissue and the transducer.

[0034] In some examples, an intraluminal ultrasound device—configured to be inserted within the inner wall defining a patient's lumen—may include a housing extending along a central axis from a proximal segment to a distal segment. The housing may include a transducer configured to capture ultrasound images and mounting features configured to receive the transducer. The intraluminal ultrasound device may also include a force-generating system operable to maintain contact between the inner wall and the transducer, thereby reducing the air gap between the lumen and the transducer. (See reference...) Figures 1 to 19 This describes such systems and technologies.

[0035] The foregoing discussion is intended to provide an overview of the subject matter of this patent application. The foregoing discussion is not intended to provide an exclusive or exhaustive explanation of the invention. The following description is included to provide further information regarding this patent application.

[0036] Figure 1This is a schematic diagram of an endoscope system 100, which may include: a control system 102; and an endobronchial ultrasound sampling arrangement, the endobronchial ultrasound sampling arrangement including an endoscope 104 and a medical device 108 that can be attached to the endoscope 104, and the medical device 108 including a distal end 110 extending from the distal end of the endoscope 104 via a distal working channel port (e.g., working channel port 112). 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.

[0037] Endoscope 104 may be 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 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. Control system 102 may include control unit 114, display unit 116, input unit 118, light source 120, fluid source 122, and suction pump 124.

[0038] The control system 102 may include various ports for connection to the endoscope system 100. The control unit 114 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 120 may include an output port for transmitting light, for example, via an optical fiber link, to the endoscope 104. Additionally or alternatively, the endoscope 104 may include one or more light sources positioned near the distal end 110 to illuminate internal anatomical structures for capturing images (e.g., still images or video streams) of the internal anatomical structures. The fluid source 122 may include a port for transferring fluid to the endoscope 104. The fluid source 122 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 124 may include a port for creating a vacuum from the endoscope 104 to generate suction, for example, for extracting fluid from an anatomical region into which the endoscope 104 is inserted. Display unit 116 and input unit 118 can be used by the operator of endoscope system 100 to control the functions of endoscope system 100 and view the output of endoscope 104, such as a real-time video stream provided by imaging device 144. Control unit 114 can also generate signals or other outputs by processing the anatomical area into which endoscope 104 is inserted. Control unit 114 can generate electrical outputs, acoustic outputs, fluid outputs, etc., for processing the anatomical area by, for example, cauterization, cutting, freezing, etc.

[0039] Endoscope 104 may include an insertion section 126, a functional section 128, and a handle section 130, which may be coupled to a cable section 132 and a connector section 134. The insertion section 126 extends distally from the handle section 130, and the cable section 132 extends proximally from the handle section 130. The insertion section 126 may be elongated and includes a bend section and a functional section 128 that may be attached to its distal end. The bend section may be controllable (e.g., controlled by a steering controller 136 on the handle section 130) to manipulate the distal end through tortuous anatomical pathways (e.g., stomach, duodenum, kidney, ureter, trachea, lung, etc.). The insertion section 126 may also include one or more working channels (e.g., internal lumens), which may be elongated and support the insertion of one or more therapeutic instruments, such as a bronchoscope, into the functional section 128. The working channel can extend between the handle section 130 and the functional section 128. The insertion section 126 can also provide additional functions such as fluid channels, guide wires, and traction wires (e.g., via suction or flushing channels).

[0040] The connector section 134 can be connected to the control unit 114 to connect the endoscope 104 to various features of the control unit 114, such as the input unit 118, the light source 120, the fluid source 122, and the suction pump 124.

[0041] Handle section 130 may include a steering controller 136 and a cable attachment portion 138, the cable attachment portion 138 including a stress-relieving shield to protect the endoscope cable from mechanical stress (e.g., bending and / or twisting). The steering controller 136 may be a knob, lever, or other actuation mechanism, which can be used to control the advance of the endoscope 104 within the patient (e.g., by hinged to a bent section proximal to the distal end of insertion section 126). The steering controller 136 may be connected to a traction line or other actuation mechanism extending through insertion section 126. Endoscope 104 may also include a proximal working channel port 140, configured to facilitate the delivery of components into the proximal working channel port 140 and through a working channel extending through insertion section 126 and extending from distal working channel port 112. Figure 1 and Figure 2 As illustrated, the proximal working channel port 140 can be configured to facilitate the attachment of the medical device 108 to the handle portion 130 of the endoscope 104, thereby facilitating the delivery of a cryoprobe into the patient's anatomy.

[0042] According to the example, the control system 102 can be mounted on a mobile platform (e.g., a trolley 142) having a housing for a light source 120, a suction pump 124, and an image processing unit 202. Figure 2Shelves such as ) etc. Alternatively, Figure 1 and Figure 2 The components of the control system 102 shown can be directly mounted on the endoscope 104 to make the endoscope "independent".

[0043] Functional segment 128 may include components for processing and diagnosing a patient's anatomy. Functional segment 128 may include an imaging device 144 (e.g., a tip-on-chip image sensor based on complementary metal-oxide-semiconductor (CMOS), an illumination device 146 (e.g., a light-emitting diode), and a distal working channel port 112 located at the distal end of functional segment 128.

[0044] like Figure 1As shown, medical device 108 can extend from the distal working channel port 112 at the distal end face of the functional segment 128 of endoscope 104. Medical device 108 can be configured to attach to the proximal working channel port 140 of endoscope 104 such that medical device 108 extends through the working channel of endoscope 104 (e.g., through the insertion segment 126 to the distal working channel port 112) and protrudes from the distal end of endoscope 104. Medical device 108 may include a sheath extension mechanism 148 for advancing or retracting a flexible sheath of medical device 108 within the working channel to control how far the distal end of medical device 108 extends distally from the distal working channel port 112. The medical device 108 may also include an instrument actuator 150 for controllably advancing and retracting a medical instrument (e.g., a biopsy needle) within the lumen of the medical device 108, wherein the lumen extends from the handle of the medical device 108 through the lumen to a lateral outlet ramp at or near the distal end. For example, manipulating the instrument actuator 150 when the distal end 110 of the medical device 108 extends beyond the distal end of the endoscope 104 can control the advancement or retraction of the biopsy needle from the lateral outlet port of the medical device 108, thereby facilitating the treatment or biopsy of target anatomical structures within the patient's body located beyond the distal end of the endoscope 104. A sheath extension mechanism 148 may be configured to extend the medical device 108 beyond the distal end of the endoscope 104, for example, to navigate the medical device 108 to a target region within the patient's body. The sheath extension mechanism 148 may slide along the housing 152 of the medical device 108. The housing 152 may include markings indicating the amount by which the medical device 108 extends beyond the distal end of the endoscope 104 (e.g., the amount by which it extends beyond the distal working channel port 112, expressed in inches, centimeters, or other suitable linear distance units). The instrument actuator 150 may be configured to extend the instrument from the medical device 108 to obtain a tissue sample from the patient. A side exit port may be located proximally to the transducer 160 and configured to deflect the instrument at an acute angle about the longitudinal axis of the distal end 110 of the medical device 108, such that a tissue sample can be obtained from the patient when the instrument and the tissue sample are within the transducer's field of view. In other words, the configuration of the side exit port relative to the transducer 160 may facilitate real-time visualization of the instrument within a target anatomical structure (e.g., real-time visualization of the biopsy needle and the target nodule being biopsied). The medical device 108 will be discussed in more detail herein. In particular, various embodiments of the force generation system 162 can be operable to force the ultrasonic transducer 160 against the lumen wall, thereby generating sufficient juxtaposition to remove unwanted air gaps and ensure high image quality. As mentioned above, maintaining contact between the transducer and the tissue within the lumen may be impractical when the outer diameter of the ultrasonic device is smaller than the inner diameter of the lumen (e.g., an airway).Therefore, the force generation system 162 can provide a market improvement compared to conventional ultrasonic devices that lack the ability to generate and maintain adhesion in this case.

[0045] Figure 2 yes Figure 1 A schematic diagram of an endoscope system 100, which includes a control system 102 and an endobronchial ultrasound arrangement, the endobronchial ultrasound arrangement including an endoscope 104 and a medical device 108 that can extend through a distal working channel port of the endoscope 104. Figure 2 Components of a control system 102 coupled to each of endoscope 104 and medical device 108 are schematically illustrated. Control system 102 may include: a control unit 114, which may include or be coupled to image processing unit 202, treatment generator 204, and drive unit 206; and a light source 120, input unit 118, and display unit 116. Control unit 114 may include, or communicate with, an endoscope, surgical instrument, and 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 instrument, and endoscopic system through materials and components including optical enhancements. Control unit 114 may activate the camera (e.g., imaging device 144) to observe target tissue distal to the endoscopic system. Similarly, control unit 114 may activate light source 120 or illumination device 146 to illuminate the camera's field of view. Figure 1 and Figure 2 In the illustrated embodiment, activating the camera and light source 120 or illumination device 146 allows the operator to observe the patient's internal anatomy in real time as the distal end of the endoscope 104 advances, and also allows the operator to observe the distal end of the medical device 108 advancing beyond the distal end of the endoscope 104. Because the external contour or diameter of the medical device 108 is smaller than that of the endoscope 104 (e.g., because the medical device 108 is fitted within the working channel of the endoscope 104), the advancement of the medical device 108 beyond the endoscope 104 enables tissue manipulation or sampling in anatomical regions (e.g., airways) that are too small for the endoscope 104 to pass through.

[0046] The connector section 134 can be connected to the control unit 114 to connect the endoscope 104 to various features of the control unit 114, such as the image processing unit 202, the treatment generator 204, etc. Port 138 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 114 via cable section 132. The proximal working channel port 140 can be used to connect the connector section 134 to various inputs and outputs, such as video, air, light, and electricity.

[0047] Image processing unit 202, ultrasound image processing unit 208, and light source 120 can each be coupled to endoscope 104 (e.g., at functional section 128) or medical device 108 via wired or wireless connections. Control system 102 can accordingly illuminate the anatomical region, collect signals representing the anatomical region, process the signals representing the anatomical region, and display an image representing the anatomical region on display unit 116. Ultrasound image processing unit 208 can be configured to receive signals from endoscope 104 or medical device 108 (e.g., from...). Figure 1 The transducer 160 receives ultrasound signals, which can be converted into ultrasound images and transmitted to the display unit 116 or any other component of the endoscope system 100. The control system 102 may include a light source 120 to illuminate the anatomical area using light of a desired spectrum (e.g., broadband white light, narrowband imaging using electromagnetic wavelengths, etc.). The control system 102 may be connected (e.g., via an endoscope connector) to the endoscope 104 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from diagnostic devices, etc.).

[0048] Fluid source 122 ( Figure 1 The endoscope 104 (as shown) can communicate with the control unit 114 and may include one or more air sources, saline sources, or other fluid sources, as well as associated fluid pathways (e.g., air passages, flushing passages, suction passages, etc.) and connectors (barbed fittings, fluid seals, valves, etc.). The control system 102 may also include a drive unit 206, which may include a motorized actuator for advancing the distal section of the endoscope 104.

[0049] Figure 3The illustration shows a cross-sectional view of a portion of an example of a sampling device 300. The sampling device 300 may be configured to be inserted into a lumen 290, which may be defined by the inner wall 288 of an airway or airway of the lung, or by the inner wall or tissue of a patient, or by any other lumen. The sampling device 300 may be inserted directly into the lumen 290, or may extend from a magnifying glass that guides the sampling device 300 toward a target location within the lumen 290. The sampling device 300 may include a connector 310 and a housing 330.

[0050] The connector 310 may extend from the proximal portion 312 to the distal portion 314. The connector 310 may include a side outlet ramp 320. The side outlet ramp 320 may extend from the proximal portion 312 and pass through the side of the connector 310 within the connector 310. The side outlet ramp 320 may guide an instrument 322 (e.g., a sampling needle, cutting device, light source, liquid source, etc.) through the side of the connector 310 toward the inner wall 288.

[0051] The housing 330 may extend from the proximal portion 334 along the central axis 332 to the distal portion 336. The housing may include mounting features 338 and a force generation system 340. Mounting features 338 may be configured to receive a transducer 341. The transducer 341 may include elements for emitting ultrasound signals and receiving ultrasound signals reflected by the patient's tissue to generate ultrasound images (e.g., a piezoelectric micromechanical ultrasound transducer (pMUT) element).

[0052] The force generation system 340 can be operable to maintain contact between the inner wall 288 and the transducer 341, thereby reducing the air gap between the inner wall 288 and the transducer 341. The inventors of this disclosure have discovered many potential configurations of the force generation system 340 that can be used to reduce the air gap between the inner wall 288 and the transducer 341, some of which will be referred to herein. Figures 4 to 15 Discussion will follow. However, the inventors recognize that any element of any force generation system 340 can be combined to produce different variations of the force generation system 340. Additionally, other systems that can reduce the air gap between the inner wall 288 and the transducer 341 can be used on the sampling device 300.

[0053] We will discuss this together. Figure 4 and Figure 5 . Figure 4 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 400, wherein the example pressure generation system 440 is in a retracted configuration 442. Figure 5 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 400, wherein an example of a pressure generation system 440 is in an extended configuration 444.

[0054] The housing 430 of the ultrasonic sampling device 400 may include a slot 450. The slot 450 may be opposite a mounting feature 438 within the housing 430. The slot 450 may allow the pressure generation system 440 to operate between a retracted configuration 442 and an extended configuration 444. The pressure generation system 440 may include a force generation line 446.

[0055] Force generating line 446 may extend between distal segment 448 and proximal segment 449. Distal segment 448 may be distal segment 436 of housing 430. Proximal segment 449 may extend to allow a medical professional to directly or indirectly manipulate force generating line 446 by means of axial force 445, thereby exposing force generating line 446. Therefore, proximal segment 449 of force generating line 446 may be configured to receive axial force 445. Axial force 445 may cause force generating line 446 to operate between retracted configuration 442 and extended configuration 444.

[0056] In the extended configuration 444 ( Figure 5 In the retracted configuration 442, the force generating line 446 can extend through the slot 450 of the housing 430 to contact the inner wall 288. This contact between the force generating line 446 and the inner wall 288 forces the transducer 441 toward the side of the inner wall 288 opposite to the position where the force generating line 446 contacts the inner wall 288. Forcing the transducer 441 toward the lumen 290 reduces the air gap between the lumen 290 and the transducer 441, thereby improving the imaging capability of the transducer 441. Figure 4 In the first configuration 440, the force generating line 446 may be within the housing 430. In the second configuration 442, the force generating line 446 may be entirely within the housing 430. In the third configuration 442, a portion of the force generating line 446 may extend through the slot 450 to aid in guiding the ultrasonic sampling device 400 and to prevent play within the lumen 290 as the ultrasonic sampling device 400 navigates toward the target nodule.

[0057] The force generating line 446 can be manufactured with shape memory, allowing it to form a rectangular prism or any other shape to increase contact between the force generating line 446 and the inner wall 288 when it is in the extended configuration 444. The rectangular shape of the force generating line 446 can increase the surface contact area between it and the inner wall 288, providing greater stability to the ultrasound sampling device 400 when clinicians are performing medical procedures close to target tissue sites.

[0058] The force generating line 446 may include one or more sensors (sensors 447) (e.g., force sensors, capacitive sensors, image sensors, etc.) to detect one or more system characteristics (e.g., the force applied to the force generating line 446, the contact between the force generating line 446 and the inner wall 288, the linear length of the force generating line 446 extending from the housing 430, any other property or characteristic of the force generating line 446, etc.).

[0059] Sensor 447 can assist clinicians in deploying and guiding the force-generating line 446 within the lumen 290. For example, sensor 447 can be integrated with a control system (e.g., control unit 114). Figure 2 )) communicate with endoscope system 100 ( Figure 1 The system of the ultrasound sampling device 300 may generate an alarm or send a control signal. In another example, sensor 447 may sense the movement and position of force generation line 446, and therefore, the control system may automatically control the deployment of force generation line 446 within the patient until force generation line 446 is in a predetermined position. The predetermined position may be a location where the ultrasound sampling device 400 can obtain a sample from the target nodule, or any other location within the patient.

[0060] We will discuss this together. Figure 6 and Figure 7 . Figure 6 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 600, wherein the example pressure generation system 640 is in a retracted configuration 642. Figure 7 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 600, wherein the example pressure generation system 640 is in an extended configuration 644.

[0061] The housing 630 may include a channel 650. The channel 650 may be formed in the housing 630 opposite to the mounting feature 638. The channel 650 may be configured to allow the pressure generating system 640 to operate between a retracted configuration 642 and an extended configuration 644.

[0062] The pressure generating system 640 may include a coil 656. The coil 656 is operable between a retracted configuration 642 and an extended configuration 644. The coil 656 may extend between a distal segment 658 and a proximal segment 660. The distal segment 658 of the coil 656 may include shape memory, such that when the coil 656 is positioned in the extended configuration 644, the distal segment 658 of the coil 656 bends. When the coil 656 is in the extended configuration 644, the distal segment 658 of the coil 656 may be bent such that the portion of the coil 656 located proximal to the distal tip 659 of the coil 656 contacts the inner wall 288.

[0063] The proximal segment 660 of the coil 656 can extend toward the controller from the ultrasound sampling device 600, allowing the clinician to control the coil 656 by changing the force 662 applied to it. Therefore, the proximal segment 660 of the coil 656 can be configured to receive the force 662 applied to it by the clinician, causing the coil 656 to operate between a retracted configuration 642 and an extended configuration 644.

[0064] Therefore, in the extended configuration 644, the coil 656 can extend through the channel 650 of the housing 630 to contact the lumen 290 and press the transducer 641 toward the inner wall 288, opposite to the contact between the coil 656 and the inner wall 288, to improve contact and reduce the air gap between the transducer 641 and the inner wall 288.

[0065] In the retracted configuration 642 ( Figure 6 In this configuration, the coil 656 can be completely contained within the housing 630. In another example, in the retracted configuration 642, the coil 656 can extend through the channel 650 long enough that the shape memory of the coil 656 can begin to bend the coil 656 such that the proximal portion of the coil 656 at the distal tip 659 can contact the inner wall 288 to provide support to help guide the ultrasonic sampling device 600 through the lumen 290 toward the target nodule.

[0066] The distal tip 659 of the curl curve 656 may include contact feature 664 (e.g. Figure 7 (As shown). Contact feature 664 can increase the surface area of ​​the distal tip 659 to reduce the pressure generated by the engagement of the distal tip 659 with the inner wall 288.

[0067] The increased surface area of ​​the distal tip 659 can also help sensors (e.g., force sensors, capacitance sensors, image sensors, etc.) detect one or more system features (e.g., the force applied to the coil 656, the contact between the coil 656 and the inner wall 288, the linear length of the coil 656 extending from the housing 630, any other property or feature of the coil 656, etc.).

[0068] The force generating line 646 may include one or more sensors (sensors 647) (e.g., force sensors, capacitive sensors, image sensors, etc.) to detect one or more system features (e.g., the force applied to the force generating line 646, the contact between the force generating line 646 and the inner wall 288, the linear length of the force generating line 646 extending from the housing 630, any other property or feature of the force generating line 646, etc.).

[0069] Sensor 647 can assist clinicians in deploying and guiding the force-generating line 646 within the lumen 290. For example, sensor 647 can be integrated with a control system (e.g., control unit 114). Figure 2 )) communicate with endoscope system 100 ( Figure 1 The system of the ultrasound sampling device 300 may generate an alarm or send a control signal. In another example, sensor 647 may sense the movement and position of force generation line 646, and therefore, the control system may automatically control the deployment of force generation line 646 within the patient until force generation line 646 is in a predetermined position. The predetermined position may be the location where the ultrasound sampling device 600 can obtain a sample from the target nodule, or any other location within the patient.

[0070] We will discuss this together. Figure 8 and Figure 9 . Figure 8 The illustration shows a portion of an example of an ultrasonic sampling device 800 having an example pressure generation system 840. Figure 9 The illustration shows a portion of an example of an ultrasonic sampling device 800 having an example pressure generation system 840.

[0071] The pressure generation system 840 may include a suction system 866. The suction system 866 may be fluidly connected to a suction pump 124. Figure 1 A vacuum source, or any other vacuum source, can be used to generate a suction force on a portion of the inner wall 288, thereby pulling the inner wall 288 toward the transducer 841. Therefore, the suction system 866 can be configured to keep the inner wall 288 against the transducer 841 to reduce the air trapped between the inner wall 288 and the transducer 841.

[0072] like Figure 8 As shown, the suction system 866 may include an inlet 868. The inlet 868 may surround the periphery 839 of the mounting feature 838. The inlet 868 may extend from the housing 830 beyond the mounting feature 838 and the transducer 841. Therefore, the inlet 868 may be closer to the inner wall 288 than the transducer 841 to provide suction force to pull the inner wall 288 toward the transducer 841 or to pull the transducer 841 (and the ultrasonic sampling device 800) toward the inner wall 288.

[0073] like Figure 9As shown, the suction system 866 may include multiple suction ports (ports 870). Ports 870 may be formed within the housing 830 surrounding the mounting feature 838. One port 870, two ports 870, three ports 870, four ports 870, or any number of ports 870 may be present. Ports 870 may be configured to introduce suction force into the inner wall 288 to pull the inner wall 288 toward the transducer 841, or to pull the ultrasonic sampling device 800 (or transducer 841) toward the inner wall 288 to prevent air gaps between the inner wall 288 and the transducer 841, thereby improving the imaging capability of the ultrasonic sampling device 800.

[0074] The suction system 866 may include one or more sensors (sensor 847) (e.g., force sensor, capacitive sensor, image sensor, flow sensor, etc.) to detect one or more system characteristics (e.g., pressure within the suction system 866, contact between the housing 830 and the inner wall 288, volume of air supplied to the suction system 866, etc.).

[0075] Sensor 847 can help clinicians deploy aspiration system 866. For example, sensor 847 can be integrated with a control system (e.g., control unit 114). Figure 2 )) communicate with endoscope system 100 ( Figure 1 The control system may generate an alarm or send a control signal from any system in the system of the ultrasound sampling device 800 or the ultrasound sampling device 800. During the insertion of the ultrasound sampling device 800 into the patient, the control system may automatically control the aspiration system 866 (e.g., turn on or adjust the aspiration power).

[0076] We will discuss this together. Figure 10 and Figure 11 . Figure 10 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 1000, wherein the example pressure generation system 1040 is in a venting configuration 1042. Figure 11 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 1000, wherein the example pressure generation system 1040 is in an expansion configuration 1044.

[0077] The housing 1030 may include an air bladder slot 1052, and the pressure generating system 1040 may include an air bladder 1072 connected to a pump 1074 (e.g., a suction pump 124). Figure 1The airbag slot 1052 may be opposite the mounting feature 1038 within the housing 1030. The pump 1074 is operable to inflate and deflate the paired airbags 1072 respectively between the inflatable configuration 1044 and the deflate configuration 1042. The pump 1074 can inflate the airbag 1072 such that it extends through the airbag slot 1052 to contact the patient's inner wall 288 and reduce the air gap between the inner wall 288 and the transducer 1041. When the airbag 1072 deflates toward the deflate configuration 1042, it retracts through the airbag slot 1052 and enters the housing 1030. In the deflate configuration 1042, a portion of the airbag 1072 may extend beyond the airbag slot 1052 beyond the housing 1030.

[0078] The airbag 1072 may include one or more sensors (sensors 1047) (e.g., force sensors, capacitive sensors, image sensors, pressure sensors, flow sensors, etc.) to detect one or more system characteristics (e.g., pressure generated by the airbag 1072, contact between the airbag 1072 and the inner wall 288, the volume of air pumped into or out of the airbag 1072, any other property or characteristic of the airbag 1072, etc.). Although described primarily in the case where the airbag is filled with air to create adhesion, it is conceivable that the airbag or a simple bag-like or inflatable mechanism may be filled with water, saline solution, CO2, or any other suitable fluid.

[0079] Sensor 1047 can help clinicians deploy balloon 1072 and guide sampling device 300 within lumen 290. Figure 3 For example, sensor 1047 can be integrated with a control system (e.g., control unit 114). Figure 2 )) communicate with endoscope system 100 ( Figure 1 The system may generate an alarm or send a control signal, either within the ultrasound sampling device 1000 or within the system of the ultrasound sampling device 1000. In another example, sensor 1047 may sense the movement and position of the ultrasound sampling device 1000, and therefore, the control system may automatically control the deployment of balloon 1072 to position the ultrasound sampling device 1000 at a predetermined location within the patient's body. The predetermined location may be a position where the ultrasound sampling device 1000 can obtain a sample from the target nodule, the location of which may be determined before or during the procedure.

[0080] We will discuss this together. Figure 12 and Figure 13 . Figure 12 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 1200, wherein the example pressure generation system 1240 is in a retracted configuration 1242. Figure 13The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 1200, wherein the example pressure generation system 1240 is in an extended configuration 1244.

[0081] The housing 1230 may include a linear groove 1260. The linear groove 1260 may be formed on the side of the housing 1230 opposite to the mounting feature 1238. The pressure generating system 1240 may include a flexible member 1276. The flexible member 1276 may extend between a proximal portion 1278 and a distal portion 1280. The proximal portion 1278 of the flexible member 1276 may be fixedly attached to the housing 1230. The pressure generating system 1240 may also include an actuation line 1282. The actuation line 1282 may be attached to the distal portion 1280 of the flexible member 1276 such that applying tension to the actuation line 1282 causes the distal portion 1280 of the flexible member 1276 to translate toward the proximal portion 1278 of the flexible member 1276. As the distal portion 1280 of the flexible member 1276 translates toward the proximal portion 1278 of the flexible member 1276, the flexible member 1276 bends and extends through the linear groove 1260 of the housing 1230 to contact the inner wall 288 and reduce the air gap between the transducer 1241 and the inner wall 288.

[0082] The flexible member 1276 may include shape memory such that when the tension from the actuation line 1282 is removed, the distal portion 1280 of the flexible member 1276 translates away from the proximal portion 1278 of the flexible member 1276, and the flexible member 1276 retracts through the linear groove 1260 of the housing 1230 and retracts into the housing 1230.

[0083] The flexible member 1276 may include one or more sensors (sensor 1247) (e.g., force sensor, capacitive sensor, image sensor, etc.) to detect one or more system features (e.g., force applied to the flexible member 1276, contact between the flexible member 1276 and the inner wall 288, etc.).

[0084] Sensor 1247 can assist clinicians in deploying and guiding ultrasound sampling device 1200 within lumen 290. For example, sensor 1247 can be integrated with a control system (e.g., control unit 114). Figure 2 )) communicate with endoscope system 100 ( Figure 1The system may generate an alarm or send a control signal, either within the ultrasound sampling device 1200 or any other system within the system. In another example, sensor 1247 may sense the movement and position of the ultrasound sampling device 1200, the flexible member 1276, or the actuation wire 1282, and thus, the control system may automatically control the deployment of the flexible member 1276 from the ultrasound sampling device 1200 and into the patient's body. Furthermore, the control system may navigate the ultrasound sampling device 1200 to a predetermined location within the patient's body. The predetermined location may be a position where the ultrasound sampling device 1200 can obtain a sample from the target nodule, the location of which may be determined before or during the procedure.

[0085] We will discuss this together. Figure 14 and Figure 15 . Figure 14 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 1400, wherein the example pressure generation system 1440 is in a retracted configuration 1442. Figure 15 The illustration shows a cross-sectional view of a portion of an example of an ultrasonic sampling device 1400, wherein the example pressure generation system 1440 is in an extended configuration 1444.

[0086] The housing 1430 may include a linear groove 1460. The linear groove 1460 may be formed on the side of the housing 1430 opposite to the mounting feature 1438. The force generating system 1440 may include a flexible line 1476. The flexible line 1476 may extend between a proximal portion 1478 and a distal portion 1480. The proximal portion 1478 of the flexible line 1476 may be fixedly attached to the housing 1430. The pressure generating system 1440 may also include an actuation line 1482. The actuation line 1482 may be attached to the distal portion 1480 of the flexible line 1476 such that applying tension to the actuation line 1482 causes the distal portion 1480 of the flexible line 1476 to translate toward the proximal portion 1478 of the flexible line 1476. As the distal portion 1480 of the flexible line 1476 translates toward the proximal portion 1478 of the flexible line 1476, the flexible line 1476 bends and extends through the linear groove 1460 of the housing 1430 to contact the inner wall 288 and reduce the air gap between the transducer 1441 and the inner wall 288.

[0087] The flexible line 1476 may include one or more sensors (sensor 1447) (e.g., force sensor, capacitive sensor, image sensor, etc.) to detect one or more system features (e.g., force applied to the flexible line 1476, contact between the flexible line 1476 and the inner wall 288, etc.).

[0088] Sensor 1447 can assist clinicians in deploying and guiding ultrasound sampling device 1400 or flexible wire 1476 within a patient. For example, sensor 1447 can be integrated with a control system (e.g., control unit 114). Figure 2 )) communicate with endoscope system 100 ( Figure 1 The system may generate an alarm or send a control signal, either within the ultrasound sampling device 1400 or the flexible wire 1476. In another example, sensor 1447 may sense the movement or position of the ultrasound sampling device 1400 or the flexible wire 1476 within the patient's body, and therefore, the control system may automatically control the deployment of the ultrasound sampling device 1400 or the flexible wire 1476 within the patient's body. The control system may navigate the ultrasound sampling device 1400 to a predetermined position and then deploy the flexible wire 1476 to position the transducer 1441 toward a target nodule adjacent to the patient.

[0089] like Figures 1 to 15 As shown in the example, the endoscope system (e.g., sampling device 300) Figure 3 ), ultrasonic sampling device 400 ( Figure 4 ), Ultrasonic sampling device 600 ( Figure 6 ), Ultrasonic sampling device 800 ( Figure 8 ), Ultrasonic sampling device 1000 ( Figure 10 ), Ultrasonic sampling device 1200 ( Figure 12 ) and ultrasonic sampling device 1400 ( Figure 14 The sampling device can be directly inserted into the patient's body. In other examples, the sampling device (e.g., sampling device 300) can be directly inserted into the patient's body. Figure 3 ), ultrasonic sampling device 400 ( Figure 4 ), Ultrasonic sampling device 600 ( Figure 6 ), Ultrasonic sampling device 800 ( Figure 8 ), Ultrasonic sampling device 1000 ( Figure 10 ), Ultrasonic sampling device 1200 ( Figure 12 ) and ultrasonic sampling device 1400 ( Figure 14 Another form of sampling device 1600 can be inserted into the patient's body. Figure 16 This is a side view of an example of a sampling device 1600 according to at least one example of the present disclosure. The sampling device 1600 can be used with an insertion device 1630, such as an endoscope or bronchoscope. Figure 16 (Only a portion is shown in the image) Combined operation. As previously described, the insertion device 1630 may include an insertion catheter capable of being inserted into the body via an orifice or other opening. The insertion device 1630 may receive an elongated instrument 1602 (e.g., a sampling device 300). Figure 3 ), ultrasonic sampling device 400 ( Figure 4 ), Ultrasonic sampling device 600 ( Figure 6 ), Ultrasonic sampling device 800 ( Figure 8 ), Ultrasonic sampling device 1000 ( Figure 10 ), Ultrasonic sampling device 1200 ( Figure 12) and ultrasonic sampling device 1400 ( Figure 14 The elongated instrument 1602 can be extended to a desired location via an insertion catheter. For example, the elongated instrument 1602 can be inserted through the working channel of a bronchoscope and extend from a port on the distal end of the bronchoscope. In this way, because the elongated instrument 1602 has a smaller outer diameter than the bronchoscope, it can extend further into the bronchial structures than the bronchoscope. The elongated instrument 1602 can be a sampling probe, which may include an imaging probe (which may be incorporated into the distal tip of the elongated instrument) and a sampling needle within a flexible lumen catheter. The elongated instrument 1602 can be inserted via the insertion device 1630 to obtain tissue samples located at a desired location within the body. The elongated instrument 1602 may also include a core needle that can be removably inserted into or through a needle, as further described below.

[0090] The sampling device 1600 described herein can be coupled to the insertion device 1630 using a connector 1606 at the distal end 1608 of the sampling device 1600. An elongated instrument 1602, operable by the sampling device 1600, can extend through the connector 1606 and can be inserted into the insertion conduit of the insertion device 1630. The elongated instrument 1602 can be fixed to an actuator 1612, which is movably coupled to a housing 1614. The actuator 1612 can move along the housing 1614 between the proximal end 1610 and the distal end 1608 of the sampling device 1600 (the proximal and distal ends of the sampling device correspond to the proximal and distal ends of the housing 1614) to extend and retract the elongated instrument 1602 relative to the insertion device 1630. Movement of actuator 1612 along housing 1614 in the distal and proximal directions can respectively cause elongated instrument 1602 to extend distally or retract into the port at the distal end of insertion device 1630. Anti-buckling device may be received within housing 1614 to provide lateral support to elongated instrument 1602 as actuator 1612 moves elongated instrument 1602 through housing 1614.

[0091] The flexible lumen of the elongated instrument 1602 can be secured to the actuator 1612, and the needle can be received into the flexible lumen via the actuator 1612. In some embodiments, the proximal port 1616 can be configured to receive and secure an imaging probe, such as an endobronchial radial ultrasound (EBUS) probe, configured to generate real-time ultrasound images of tissue surrounding the distal end of the elongated instrument 1602. The needle inlet guide 1618 can be configured to receive and engage the needle actuator 1620, to which the sampling needle can be secured. The needle inlet guide 1618 and the needle actuator 1620 can be movably coupled to the orientation interface 1622. The orientation interface 1622 can be configured to maintain the orientation of the needle actuator 1620 relative to the needle inlet guide 1618 to control the orientation of the sampling needle, as further described below. The needle actuator 1620 can removably receive an end cap 1624, which can be coupled to a core needle and used to releasably secure the core needle within the sampling needle. Depending on the location of the target tissue within the patient's anatomy, the core needle can be used to prevent the sampling needle from collecting non-target tissue. For example, if the operator is targeting tissue several millimeters or centimeters beyond the airway wall, the operator can fully insert the core needle into the sampling needle as the sampling needle advances through the non-target tissue. Then, when the operator sees on a real-time image generated by the imaging probe that the needle has reached or nearly reached the target tissue, the core needle can be withdrawn to allow the target tissue to enter the sampling needle core. The needle actuator may also include a release mechanism 1626, which the operator can actively engage to allow the sampling needle to be advanced into the sampling position, as further described below.

[0092] Figure 17This is a cross-sectional view of port 1616 in actuator 1612 of sampling apparatus 1600 according to at least one example of the present disclosure. Sampling apparatus 1600 may include an imaging probe 1648. Proximal port 1616 of actuator 1612 may be configured to receive and guide imaging probe 1648 into a first lumen 1644 of flexible lumen conduit 1640. Flexible lumen conduit 1640 may include a proximal end portion 1642 that can be coupled to actuator 1612. Flexible lumen conduit 1640 may define a second lumen 1646 configured to receive sampling needle 1650. The second lumen 1646 of flexible lumen conduit 1640 may extend into the first lumen 1644 and may be configured to retain sampling needle 1650 away from imaging probe 1648. In other examples, the flexible lumen catheter 1640 may define only a single lumen configured to receive a sampling needle 1650 and the distal end of an elongated instrument 1602, the distal end of which may include an imaging element (e.g., a linear ultrasound transducer) incorporated into a distal tip of a bevel adjacent to a (side outlet port) ramp configured to guide the sampling needle 1650 into the field of view of the imaging element. As further described below, the sampling needle 1650 may be coupled to and controlled by a needle actuator 1620.

[0093] Sampling needle 1650 can be located at base 1652 ( Figure 16 The sampling needle 1650 extends between the tip 1654 and the end 1655. The sampling needle 1650 may also include a lumen 1651. The lumen 1651 can be used to collect samples from the patient. The needle actuator 1620 can be slidably mounted on the needle inlet guide tube 1618 (which may also be further described below). The sampling needle 1650 can extend from the needle actuator 1620 through the needle inlet guide tube 1618 and into a second lumen 1646 of the flexible lumen catheter 1640, through which the sampling needle 1650 can extend into the body to collect samples. The needle inlet guide tube 1618 can also be connected to the actuator 1612. Thus, when the needle inlet guide tube 1618 and the imaging probe 1648 are secured to the actuator 1612, movement of the actuator 1612 along the housing 1614 can advance the elongated instrument 1602 and the imaging probe 1648 and sampling needle 1650 contained therein.

[0094] Figure 18 The illustration shows a schematic diagram of an exemplary computer-based clinical decision support system (CDSS) 1800, which can be configured based on any component from an endoscopy system (e.g., control unit 114, display unit 116, input unit 118, light source 120, fluid source 122, suction pump 124, steering controller 38, all of which are...). Figure 1The endoscope system (e.g., endoscope system 100) is controlled by inputs from any of the sensors (447, 647, 847, 1047, 1247, or 1447). Figure 1 ), sampling device 300 ( Figure 3 ), ultrasonic sampling device 400 ( Figure 4 ), Ultrasonic sampling device 600 ( Figure 6 ), Ultrasonic sampling device 800 ( Figure 8 ), Ultrasonic sampling device 1000 ( Figure 10 ), Ultrasonic sampling device 1200 ( Figure 12 ) and ultrasonic sampling device 1400 ( Figure 14 The CDSS 1800 may include an input interface 1802 through which medical information such as age, weight, gender, or any other patient-specific information, or procedure-specific information such as the location of the abnormality, the planned path for the procedure, the planned steps of the procedure, etc., can be provided as input features to the artificial intelligence (AI) model 1804. The processor 1806 (e.g., the control unit 114) Figure 1 ) or hardware processor 1902 ( Figure 19 The system can perform inference operations, where inputs from any component of the endoscope system, signals from any sensor, medical information, procedure-specific information, etc., are applied to the AI ​​model to generate suggested medical procedures, automate medical procedures, etc. The user interface (UI) can be used (with clinicians) to communicate suggested medical procedures, suggestions for changes to medical procedures, or thresholds set based at least in part on any inputs to the CDSS 1800.

[0095] Input interface 1802 can be a CDSS 1800 with one or more medical devices (e.g., endoscope system 100). Figure 1 ), sampling device 300 ( Figure 3 ), ultrasonic sampling device 400 ( Figure 4 ), Ultrasonic sampling device 600 ( Figure 6 ), Ultrasonic sampling device 800 ( Figure 8 ), Ultrasonic sampling device 1000 ( Figure 10 ), Ultrasonic sampling device 1200 ( Figure 12 ) and ultrasonic sampling device 1400 ( Figure 14A direct data link between the input interface 1802 and other components of the endoscopy system (CDSS 1800) can generate at least some of the input features. For example, input interface 1802 can directly transmit inputs, medical information, procedure-specific information, etc., from any component of the endoscopy system to CDSS 1800 during treatment and / or diagnostic medical procedures. Additionally or alternatively, input interface 1802 can be a classic user interface that facilitates interaction between the user and CDSS 1800. For example, input interface 1802 can be an improved user interface through which the user can manually input medical information, procedure-specific information, etc. Additionally or alternatively, input interface 1802 can provide CDSS 1800 with access to an electronic patient record from which one or more input features can be extracted. Such an electronic patient record can be stored in database 1801. In any of these cases, input interface 1802 can be configured to collect one or more subsequent input features associated with a specific patient when or before using CDSS 1800 to evaluate the safest and most effective procedure for completing a planned medical procedure.

[0096] Based on one or more of the aforementioned input features, processor 1806 uses AI model 1804 to perform inference operations to generate the safest and most efficient medical procedure for performing medical tasks. For example, input interface 1802 can pass any medical information, medical procedure information, output from any component of an endoscopy system, or signals from any sensor to the input layer of AI model 1604, which then propagates these input features to the output layer via AI model 1804. AI model 1804 can provide the computer system with the ability to perform tasks without explicit programming by inferring based on patterns discovered in data analysis. AI model 1804 explores the research and construction of algorithms (e.g., machine learning algorithms) that can learn from existing data and make predictions about new data. Such algorithms operate by building AI models from example training data to make data-driven predictions or decisions expressed as outputs or evaluations.

[0097] There are two common paradigms for machine learning (ML): supervised ML and unsupervised ML. Supervised ML uses prior knowledge (e.g., examples that correlate inputs with outputs or outcomes) to learn the relationship between inputs and outputs. The goal of supervised ML is to learn a function that, given training data, best approximates the relationship between training inputs and outputs, so that the ML model can achieve the same relationship given inputs to generate the corresponding outputs. Unsupervised ML trains ML algorithms using information that is neither classified nor labeled, allowing the algorithm to operate on that information without guidance. Unsupervised ML is useful in exploratory analytics because it can automatically identify structures in the data.

[0098] Common tasks for supervised ML are classification and regression problems. Classification problems—also known as categorization problems—aim aim to classify items into one of several category values ​​(e.g., is the object an apple or an orange?). Regression algorithms aim to quantify some items (e.g., by assigning scores to certain input values). Some examples of commonly used supervised ML algorithms are logistic regression (LR), Naive Bayes, random forest (RF), neural networks (NN), deep neural networks (DNN), matrix factorization, and support vector machines (SVM).

[0099] Some common tasks in unsupervised ML include clustering, representation learning, and density estimation. Examples of commonly used unsupervised ML algorithms include K-means clustering, principal component analysis, and autoencoders.

[0100] Another type of machine learning is federated learning (also known as collaborative learning), which trains algorithms on multiple distributed devices that store local data without exchanging data. This approach differs significantly from traditional centralized machine learning techniques, where all local datasets are uploaded to a single server. It also differs from more classic distributed methods, which typically assume that local data samples are uniformly distributed. Federated learning enables multiple participants to build general, robust machine learning models without sharing data, allowing it to address critical issues such as data privacy, data security, data access permissions, and access to heterogeneous data.

[0101] In some examples, the AI ​​model can be trained continuously or periodically by the processor 1806 before performing the inference operation. Then, during the inference operation, patient-specific input features provided to the AI ​​model can propagate from the input layer through one or more hidden layers and ultimately to the output layer corresponding to the proposed medical procedure. For example, where the patient's age, size, or any other medical information about the patient, as well as medical information indicating the location of a target nodule within the patient's body, may be difficult to obtain, the processor 1806 can suggest a smaller version of the endoscope, suggest different paths that could improve imaging and sampling results, or implement thresholds or techniques for energy, speed, or other parameters of the sampling device for any cutting, ablation, or removal procedure.

[0102] During and / or after the inference operation, the output interface 1808 can transmit any safest and most effective medical procedure, which can be communicated to the user via the user interface (UI) and / or automatically cause any component of the endoscope system to perform the desired operation. For example, in the case of poor image quality, the processor 1806 can transmit a signal to the light source 120 to change the brightness, color, saturation, or any other optical parameters of the transmitted light, and to the fluid source 122 ( Figure 1 Send a control signal to change the supply to suction pump 124. Figure 1 The CDSS 1800 can send signals to the suction pump 124 to change the speed or volume of fluid supplied to the imaging site, and to increase or decrease the suction volume supplied to the imaging site. These are exemplary actions that the CDSS 1800 can take to aid in the guidance and process of medical procedures. However, the inventors of this application have considered how the CDSS 1800 can contribute to any aspect of medical procedures, such as preoperative planning, intraoperative execution, or postoperative procedural analysis.

[0103] Figure 19A block diagram of an exemplary machine 1900 is illustrated, on which any one or more of the techniques (e.g., methods) discussed herein can be performed. As described herein, the example may include, or may be operated by, logic or components or mechanisms in the machine 1900. A circuit system (e.g., a processing circuit system) is a collection of circuits implemented in a tangible entity of the machine 1900, including hardware (e.g., simple circuits, gates, logic, etc.). The relationships between circuit system components can be flexible over time. A circuit system includes components that can perform specific operations individually or in combination during operation. In the example, the hardware of the circuit system may be designed in an invariant 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 invariant aggregate particles, etc.). When physical components are connected, the underlying electrical characteristics of the hardware components are altered, for example, from an insulator to a conductor or from a conductor to an insulator. 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 1900 are provided below.

[0104] In alternative examples, machine 1900 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, machine 1900 may operate as a server machine, a client machine, or both in a server-client network environment. In the examples, machine 1900 may act as a peer-to-peer (P2P) (or other distributed) network environment. Machine 1900 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 (sequentially or otherwise) executing instructions specifying actions to be taken by that machine. Furthermore, although only a single machine is shown, the term "machine" should also be considered to include any set of machines that individually or jointly 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.

[0105] Machine (e.g., computer system) 1900 may include a hardware processor 1902 (e.g., a central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 1904, static memory (e.g., memory or storage device for firmware, microcode, basic input / output (BIOS), unified extensible firmware interface (UEFI), etc.) 1906, and mass storage device 1908 (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) 1930. Machine 1900 may also include a display unit 1910, an alphanumeric input device 1912 (e.g., keyboard), and a user interface (UI) navigation device 1914 (e.g., mouse). In this example, the display unit 1910, the input device 1912, and the UI navigation device 1914 may be a touchscreen display. Machine 1900 may further include a storage device (e.g., a drive unit) 1908, a signal generation device 1918 (e.g., a speaker), a network interface device 1920, and one or more sensors 16 such as a Global Positioning System (GPS) sensor, a compass, an accelerometer, or other sensors. Machine 1900 may include an output controller 1928, connected via, for example, serial (e.g., Universal Serial Bus (USB)), 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., a printer, a card reader, etc.).

[0106] The registers of processor 1902, main memory 1904, static memory 1906, or mass storage device 1908 may be or include machine-readable medium 1922 on which one or more sets of data structures or instructions 1924 (e.g., software) are stored, said set of one or more sets of data structures or instructions 1924 embodying or being utilized by any one or more of the techniques or functions described herein. During execution of instructions 1924 by machine 1900, instructions 1924 may also reside wholly or at least partially within any one of the registers of processor 1902, main memory 1904, static memory 1906, or mass storage device 1908. In this example, one or any combination of hardware processor 1902, main memory 1904, static memory 1906, or mass storage device 1908 may constitute machine-readable medium 1922. Although machine-readable medium 1922 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 1924.

[0107] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions for use by machine 1900 and to enable machine 1900 to perform any or more of the techniques disclosed herein, or capable of storing, encoding, or carrying data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In examples, non-transitory machine-readable media includes machine-readable media having a plurality of particles with invariant (e.g., stationary) mass and thus being a composition of matter. Therefore, a non-transitory machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transitory machine-readable media can include: non-volatile memory, such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable hard disks; magneto-optical disks; and CD-ROM and DVD-ROM discs.

[0108] In the example, information stored on or otherwise provided on machine-readable medium 1922 may represent instruction 1924, such as instruction 1924 itself or a format from which instruction 1924 can be derived. Such a format from which instruction 1924 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 1924 in machine-readable medium 1922 may be processed by processing circuitry into instructions to perform any of the operations discussed herein. For example, deriving instruction 1924 from information (e.g., processed by processing circuitry) 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 1924.

[0109] In the example, the derivation of instruction 1924 may include the assembly, compilation, or interpretation (e.g., by processing circuitry) of information to create instruction 1924 according to some intermediate or preprocessed format provided by machine-readable medium 1922. Information provided in multiple parts can be combined, unpacked, and modified to create instruction 1924. For example, the information may be in multiple compressed source code packages (or object code, or binary executable code, etc.) on one or more remote servers. The source code packages may be encrypted during transmission over a network and, if necessary, decrypted, decompressed, assembled (e.g., linked), and compiled or interpreted at the local machine (e.g., compiled or interpreted into libraries, standalone executables, etc.), and executed by the local machine.

[0110] Commands 1924 can also be transmitted or received via the communication network 1926 using the transmission medium through the network interface device 1920, 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., networks known as Wi-Fi). ®The IEEE 502.11 family of standards, the IEEE 502.15.4 family of standards, peer-to-peer (P2P) networks, etc., are examples of such standards. In this example, network interface device 1920 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas to connect to communication network 1926. In this example, network interface device 1920 may include multiple antennas to perform wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) technologies. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions for execution by machine 1900, and the term "transmission medium" may include digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0111] The following non-limiting examples detail certain aspects of this topic to address challenges and provide the benefits described herein.

[0112] Example 1 is an ultrasound sampling device configured to be inserted into the inner wall of a lumen defining a patient. The ultrasound sampling device includes: a connector extending from a proximal portion to a distal portion, the connector including a side outlet ramp extending from the proximal portion of the connector and passing through a side portion of the connector, the side outlet ramp guiding an instrument through the side portion of the connector and toward the inner wall; a housing extending from the proximal portion along a central axis to the distal portion, the housing including a transducer configured to capture ultrasound images and mounting features configured to receive the transducer; and a force generation system operable to maintain contact between the inner wall and the transducer, thereby reducing the air gap between the lumen and the transducer.

[0113] In Example 2, the subject matter of Example 1 may optionally include: wherein the housing includes a groove opposite to the mounting feature, and wherein the force generating system includes: a force generating line extending between a distal end section and a proximal end section, the distal end section of the force generating line being attached to a distal end section of the housing, the proximal end section of the force generating line being configured to receive an axial force that causes the force generating line to move between an extended configuration and a retracted configuration.

[0114] In Example 3, the subject matter of Example 2 may optionally include: wherein, in the extended configuration, the force-generating line extends through the groove of the housing to contact the inner wall defining the lumen of the patient and reduce the air gap between the inner wall and the ultrasound sampling device, and wherein, in the retracted configuration, the force-generating line is located within the housing.

[0115] In Example 4, the subject matter of any one or more of Examples 1 to 3 may optionally include: wherein the housing includes a channel opposite the mounting feature, and wherein the force generating system includes: a coil curve operable between an extended position and a retracted position, the coil curve extending between a distal end segment and a proximal end segment, the distal end segment of the coil curve including shape memory processing such that, when the coil curve is in the extended position, the distal end segment of the coil curve bends such that a proximal portion of the coil curve at the distal tip of the coil curve contacts the inner wall, the proximal end segment being configured to receive an axial force to move the coil curve between the extended position and the retracted position.

[0116] In Example 5, the subject matter of Example 4 may optionally include: wherein, in the extended position, the coiled curve extends through the channel of the housing to contact the inner wall and reduce the air gap between the lumen and the transducer, and wherein, in the retracted position, the coiled curve is adjacent to the channel within the housing.

[0117] In Example 6, the subject matter of any one or more of Examples 4 to 5 may optionally include: wherein the distal tip of the curl includes a contact feature configured to increase the surface area of ​​the distal tip to reduce the pressure generated by the distal tip engaging the inner wall.

[0118] In Example 7, the subject matter of any one or more of Examples 1 to 6 may optionally include: wherein the force generation system includes: a suction system configured to generate a suction force on a portion of the inner wall to pull the inner wall and the transducer together.

[0119] In Example 8, the subject matter of Example 7 may optionally include: wherein the suction system includes an inlet surrounding the periphery of the mounting feature such that, when the transducer is mounted within the mounting feature, the inlet extends above the transducer, and the inlet introduces the suction force into the lumen to pull the inner wall and the transducer together.

[0120] In Example 9, the subject matter of any one or more of Examples 7 to 8 may optionally include: wherein the suction system includes a plurality of suction ports formed in the housing around the mounting feature, the plurality of suction ports introducing the suction force into the lumen to pull the inner wall and the transducer together.

[0121] In Example 10, the subject matter of any one or more of Examples 1 to 9 may optionally include: wherein the housing includes an airbag groove opposite the mounting feature, and wherein the force generating system includes: an airbag fluidly connected to a pump, the pump being operable to inflate and deflate the airbag such that, when the pump inflates the airbag, the airbag extends through the airbag groove to contact the inner wall and reduce the air gap between the inner wall and the transducer, and when the airbag deflates, the airbag contracts toward the airbag groove.

[0122] In Example 11, the subject matter of any one or more of Examples 1 to 10 may optionally include: wherein the housing includes a linear groove opposite to the mounting feature, and wherein the force generating system includes: a flexible member extending between a proximal portion and a distal portion, the proximal portion of the flexible member being fixedly attached to the housing; and an actuation line attached to the distal portion of the flexible member such that applying tension to the actuation line causes the distal portion of the flexible member to translate toward the proximal portion of the flexible member.

[0123] In Example 12, the subject matter of Example 11 may optionally include: wherein, when the actuation line causes the distal portion of the flexible member to translate toward the proximal portion of the flexible member, the flexible member bends and extends through the linear groove of the housing to contact the inner wall, thereby causing the transducer and the inner wall to move together and reducing the air gap between the inner wall and the transducer.

[0124] In Example 13, the subject matter of Example 12 may optionally include: wherein the flexible member includes shape memory such that when the tension from the actuation line is removed, the distal portion of the flexible member translates away from the proximal portion of the flexible member, and the flexible member retracts through the linear groove and enters the housing.

[0125] Example 14 is a system for acquiring ultrasound images of intraluminal tissue defining a lumen in a patient. The system includes: a control handle; an insertion tube extending from the control handle and configured for insertion into the lumen, the insertion tube including a working lumen; and an ultrasound sampling device configured for insertion into the working lumen such that the ultrasound sampling device can extend beyond a distal tip of the insertion tube and into the lumen. The ultrasound sampling device includes: a connector extending from a proximal portion to a distal portion. The connector includes a side outlet ramp extending from the proximal portion of the connector and through the side of the connector, the side outlet ramp guiding an instrument through the side of the connector toward the intraluminal tissue; a housing extending from the proximal end section along a central axis to the distal end section, the housing including mounting features configured to receive the transducer; and a force generating system operable to maintain contact between the intraluminal tissue and the transducer to reduce the air gap between the intraluminal tissue and the transducer.

[0126] In Example 15, the subject matter of Example 14 may optionally include: wherein the housing includes a groove opposite to the mounting feature, and wherein the force generating system includes: a force generating line extending between a distal end section and a proximal end section, the distal end section of the force generating line being attached to a distal end section of the housing, the proximal end section of the force generating line being configured to receive an axial force that causes the force generating line to operate between an extended configuration and a retracted configuration.

[0127] In Example 16, the subject matter of Example 15 may optionally include: wherein, in the extended configuration, the force generating line extends through the groove of the housing to contact the intraluminal tissue and reduce the air gap between the intraluminal tissue and the transducer, and wherein, in the retracted configuration, the force generating line is located within the housing.

[0128] In Example 17, the subject matter of any one or more of Examples 14 to 16 may optionally include: wherein the housing includes a channel opposite the mounting feature, and wherein the force generating system includes: a coil curve operable between an extended position and a retracted position, the coil curve extending between a distal segment and a proximal segment, the distal segment of the coil curve including shape memory processing such that, when the coil curve is in the extended position, the distal segment of the coil curve bends such that a proximal portion of the coil curve at the distal tip of the coil curve contacts the intraluminal tissue, the proximal segment being configured to receive an axial force to operate the coil curve between the extended position and the retracted position.

[0129] In Example 18, the subject matter of Example 17 may optionally include: wherein, in the extended position, the curled curve extends through the channel of the housing to contact the intraluminal tissue and reduce the air gap between the intraluminal tissue and the transducer, and wherein, in the retracted position, the curled curve is adjacent to the channel within the housing.

[0130] In Example 19, the subject matter of any one or more of Examples 17 to 18 may optionally include: wherein the distal tip of the coiled curve includes a contact feature configured to increase the surface area of ​​the distal tip to reduce the pressure generated by the distal tip engaging the intraluminal tissue.

[0131] In Example 20, the subject matter of any one or more of Examples 14 to 19 may optionally include: wherein the force generating system includes: a suction system configured to generate a suction force on a portion of the intraluminal tissue to pull the intraluminal tissue and the transducer together and reduce the air gap between the intraluminal tissue and the transducer.

[0132] Example 21 is an intraluminal ultrasound device configured for insertion into the inner wall of a lumen defining a patient. The intraluminal ultrasound device includes: a housing extending from a proximal segment along a central axis to a distal segment, the housing including a transducer configured to capture ultrasound images and mounting features configured to receive the transducer; and a force generation system operable to maintain contact between the inner wall and the transducer, thereby reducing the air gap between the lumen and the transducer.

[0133] In Example 22, the subject matter of Example 21 may optionally include: wherein the housing includes a groove opposite to the mounting feature, and wherein the force generating system includes: a force generating line extending between a distal end section and a proximal end section, the distal end section of the force generating line being attached to a distal end section of the housing, the proximal end section of the force generating line being configured to receive an axial force that causes the force generating line to move between an extended configuration and a retracted configuration.

[0134] In Example 23, the subject matter of Example 22 may optionally include: wherein, in the extended configuration, the force-generating line extends through the groove of the housing to contact the inner wall of the lumen defining the patient and reduce the air gap between the inner wall and the ultrasound device within the lumen, and wherein, in the retracted configuration, the force-generating line is located within the housing.

[0135] In Example 24, the subject matter of any one or more of Examples 21 to 23 may optionally include: wherein the housing includes a channel opposite the mounting feature, and wherein the force generating system includes: a coil curve operable between an extended position and a retracted position, the coil curve extending between a distal end segment and a proximal end segment, the distal end segment of the coil curve including shape memory processing such that, when the coil curve is in the extended position, the distal end segment of the coil curve bends such that a portion of the coil curve located at the proximal end of the distal tip of the coil curve contacts the inner wall, the proximal end segment being configured to receive an axial force to move the coil curve between the extended position and the retracted position.

[0136] In Example 25, the subject matter of Example 24 may optionally include: wherein, in the extended position, the coiled curve extends through the channel of the housing to contact the inner wall and reduce the air gap between the lumen and the transducer, and wherein, in the retracted position, the coiled curve is adjacent to the channel within the housing.

[0137] In Example 26, the subject matter of any one or more of Examples 24 to 25 may optionally include: wherein the distal tip of the curl includes a contact feature configured to increase the surface area of ​​the distal tip to reduce the pressure generated by the distal tip engaging the inner wall.

[0138] In Example 27, the subject matter of any one or more of Examples 21 to 26 may optionally include: wherein the force generation system includes: a suction system configured to generate a suction force on a portion of the inner wall to pull the inner wall and the transducer together.

[0139] In Example 28, the subject matter of Example 27 may optionally include: wherein the suction system includes an inlet surrounding the periphery of the mounting feature such that, when the transducer is mounted within the mounting feature, the inlet extends above the transducer, and the inlet introduces the suction force into the lumen to pull the inner wall and the transducer together.

[0140] In Example 29, the subject matter of any one or more of Examples 27 to 28 may optionally include: wherein the suction system includes a plurality of suction ports formed in the housing around the mounting feature, the plurality of suction ports introducing the suction force into the lumen to pull the inner wall and the transducer together.

[0141] In Example 30, the subject matter of any one or more of Examples 21 to 29 may optionally include: wherein the housing includes an airbag groove opposite the mounting feature, and wherein the force generating system includes: an airbag fluidly connected to a pump, the pump being operable to inflate and deflate the airbag such that, when the pump inflates the airbag, the airbag extends through the airbag groove to contact the inner wall and reduce the air gap between the inner wall and the transducer, and when the airbag deflates, the airbag contracts toward the airbag groove.

[0142] In Example 31, the subject matter of any one or more of Examples 21 to 30 may optionally include: wherein the housing includes a linear groove opposite to the mounting feature, and wherein the force generating system includes: a flexible member extending between a proximal portion and a distal portion, the proximal portion of the flexible member being fixedly attached to the housing; and an actuation line attached to the distal portion of the flexible member such that applying tension to the actuation line causes the distal portion of the flexible member to translate toward the proximal portion of the flexible member.

[0143] In Example 32, the subject matter of Example 31 may optionally include: wherein, when the actuation line translates the distal portion of the flexible member toward the proximal portion of the flexible member, the flexible member bends and extends through the linear groove of the housing to contact the inner wall, thereby causing the transducer and the inner wall to move together and reducing the air gap between the inner wall and the transducer.

[0144] In Example 33, the subject matter of Example 32 may optionally include: wherein the flexible member includes shape memory such that when the tension from the actuation line is removed, the distal portion of the flexible member translates away from the proximal portion of the flexible member, and the flexible member retracts through the linear groove and enters the housing.

[0145] Example 34 is an apparatus, method, or device that includes any of the elements described in any of Examples 1 to 33.

[0146] The above detailed description may include 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).

[0147] 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.

[0148] 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.

[0149] 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”.

[0150] 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.

[0151] 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.

[0152] 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. An ultrasound sampling device configured to be inserted into the inner wall of a lumen defining a patient, the ultrasound sampling device comprising: A transducer configured to capture ultrasound images; A connector extending from a proximal portion to a distal portion, the connector comprising: A side outlet ramp extends from the proximal portion of the connector and passes through the side of the connector within the connector, the side outlet ramp guiding an instrument through the side of the connector and toward the inner wall; A housing extending from a proximal end segment along a central axis to a distal end segment, the housing comprising: Mounting features configured to receive the transducer; and A force generation system operable to maintain contact between the inner wall and the transducer, thereby reducing the air gap between the lumen and the transducer.

2. The ultrasonic sampling device according to claim 1, wherein, The housing includes a groove opposite to the mounting feature, and wherein the force generating system includes: A force generating line extends between a distal end section and a proximal end section, the distal end section of which is attached to the distal end section of the housing, and the proximal end section of which is configured to receive an axial force that causes the force generating line to move between an extended configuration and a retracted configuration.

3. The ultrasonic sampling device according to claim 2, wherein, In the extended configuration, the force-generating line extends through the groove of the housing to contact the inner wall defining the lumen of the patient and reduce the air gap between the inner wall and the ultrasound sampling device, and in the retracted configuration, the force-generating line is located within the housing.

4. The ultrasonic sampling device according to any one of claims 1 to 3, wherein, The housing includes a channel opposite the mounting feature, and wherein the force generating system includes: A coiled curve, operable between an extended position and a retracted position, extending between a distal segment and a proximal segment, the distal segment of the coiled curve including shape memory processing such that, when the coiled curve is in the extended position, the distal segment bends such that a portion of the coiled curve located at the proximal end of the distal tip contacts the inner wall, the proximal segment being configured to receive an axial force to move the coiled curve between the extended position and the retracted position.

5. The ultrasonic sampling device according to claim 4, wherein, In the extended position, the coiled curve extends through the channel of the housing to contact the inner wall and reduce the air gap between the lumen and the transducer, and wherein, in the retracted position, the coiled curve is adjacent to the channel within the housing.

6. The ultrasonic sampling device according to any one of claims 4 to 5, wherein, The distal tip of the coiled curve includes a contact feature configured to increase the surface area of ​​the distal tip to reduce the pressure generated by the distal tip engaging the inner wall.

7. The ultrasonic sampling device according to any one of claims 1 to 6, wherein, The force generation system includes: A suction system configured to generate a suction force on a portion of the inner wall to pull the inner wall and the transducer together.

8. The ultrasonic sampling device according to claim 7, wherein, The suction system includes an inlet surrounding the periphery of the mounting feature, such that when the transducer is mounted within the mounting feature, the inlet extends above the transducer, and the inlet introduces the suction force into the lumen to pull the inner wall and the transducer together.

9. The ultrasonic sampling device according to any one of claims 7 to 8, wherein, The suction system includes a plurality of suction ports formed in the housing around the mounting feature, the plurality of suction ports introducing the suction force into the lumen to pull the inner wall and the transducer together.

10. The ultrasonic sampling device according to any one of claims 1 to 9, wherein, The housing includes an airbag groove opposite the mounting feature, and wherein the force generation system includes: An airbag, fluidly connected to a pump, operable to inflate and deflate the airbag such that when the pump inflates the airbag, the airbag extends through the airbag groove to contact the inner wall and reduce the air gap between the inner wall and the transducer, and when the airbag deflates, the airbag contracts toward the airbag groove.

11. The ultrasonic sampling apparatus according to any one of claims 1 to 10, wherein, The housing includes a linear groove opposite to the mounting feature, and wherein the force generating system includes: A flexible member extending between a proximal and a distal portion, the proximal portion of the flexible member being fixedly attached to the housing; and An actuation line is attached to the distal portion of the flexible member, such that applying tension to the actuation line causes the distal portion of the flexible member to translate toward the proximal portion of the flexible member.

12. The ultrasonic sampling device according to claim 11, wherein, When the actuation line causes the distal portion of the flexible member to translate toward the proximal portion of the flexible member, the flexible member bends and extends through the linear groove of the housing to contact the inner wall, thereby causing the transducer and the inner wall to move together and reducing the air gap between the inner wall and the transducer.

13. The ultrasonic sampling device according to claim 12, wherein, The flexible member includes shape memory, such that when the tension from the actuation line is removed, the distal portion of the flexible member translates away from the proximal portion of the flexible member, and the flexible member retracts through the linear groove and enters the housing.

14. A system for acquiring ultrasound images of intraluminal tissue in a patient, the intraluminal tissue defining a lumen, the system comprising: Control handle; An insertion tube extending from the control handle and configured to be inserted into the lumen, the insertion tube including a working lumen; as well as An ultrasonic sampling device, configured to be inserted into the working lumen such that the ultrasonic sampling device can extend beyond the distal end of the insertion tube and enter the lumen, the ultrasonic sampling device comprising: A connector extending from a proximal portion to a distal portion, the connector comprising: A side outlet bevel extends from the proximal portion of the connector and passes through the side of the connector within the connector, the side outlet bevel guiding the instrument through the side of the connector toward the intraluminal tissue; A housing extending from a proximal end segment along a central axis to a distal end segment, the housing comprising: Mounting features configured to receive the transducer; and A force generation system operable to maintain contact between the intraluminal tissue and the transducer, thereby reducing the air gap between the intraluminal tissue and the transducer.

15. The system according to claim 14, wherein, The housing includes a groove opposite to the mounting feature, and wherein the force generating system includes: A force generating line extends between a distal end section and a proximal end section, the distal end section of the force generating line being attached to the distal end section of the housing, and the proximal end section of the force generating line being configured to receive an axial force that causes the force generating line to operate between an extended configuration and a retracted configuration.

16. The system according to claim 15, wherein, In the extended configuration, the force-generating line extends through the groove of the housing to contact the intraluminal tissue and reduce the air gap between the intraluminal tissue and the transducer, and in the retracted configuration, the force-generating line is located within the housing.

17. The system according to any one of claims 14 to 16, wherein, The housing includes a channel opposite the mounting feature, and wherein the force generating system includes: A coiled curve, operable between an extended position and a retracted position, extending between a distal segment and a proximal segment, the distal segment of the coiled curve including shape memory processing such that, when the coiled curve is in the extended position, the distal segment of the coiled curve bends such that the proximal portion of the distal tip of the coiled curve contacts the intraluminal tissue, the proximal segment being configured to receive axial force to allow the coiled curve to operate between the extended and retracted positions.

18. The system according to claim 17, wherein, In the extended position, the curled curve extends through the channel of the housing to contact the intraluminal tissue and reduce the air gap between the intraluminal tissue and the transducer, and wherein, in the retracted position, the curled curve is adjacent to the channel within the housing.

19. The system according to any one of claims 17 to 18, wherein, The distal tip of the coiled curve includes a contact feature configured to increase the surface area of ​​the distal tip to reduce the pressure generated by the distal tip engaging the intraluminal tissue.

20. The system according to any one of claims 14 to 19, wherein, The force generation system includes: A suction system configured to generate a suction force on a portion of the tissue within the lumen to pull the tissue within the lumen and the transducer together and reduce the air gap between the tissue within the lumen and the transducer.

21. An intraluminal ultrasound device, the intraluminal ultrasound device being configured to be inserted into the inner wall of a lumen defining a patient, the intraluminal ultrasound device comprising: A transducer configured to capture ultrasound images; A housing extending from a proximal end segment along a central axis to a distal end segment, the housing comprising: Mounting features configured to receive the transducer; as well as A force generation system that can be operated to maintain contact between the inner wall and the transducer, thereby reducing the air gap between the lumen and the transducer.

22. The intraluminal ultrasonic device according to claim 21, wherein, The housing includes a groove opposite to the mounting feature, and wherein the force generating system includes: A force generating line extends between a distal end section and a proximal end section, the distal end section of which is attached to the distal end section of the housing, and the proximal end section of which is configured to receive an axial force that causes the force generating line to move between an extended configuration and a retracted configuration.

23. The intraluminal ultrasonic device according to claim 22, wherein, In the extended configuration, the force-generating line extends through the groove of the housing to contact the inner wall of the lumen defining the patient and reduce the air gap between the inner wall and the ultrasound device within the lumen, and wherein, in the retracted configuration, the force-generating line is located within the housing.

24. The intraluminal ultrasonic device according to any one of claims 21 to 23, wherein, The housing includes a channel opposite the mounting feature, and wherein the force generating system includes: A coiled curve, operable between an extended position and a retracted position, extending between a distal segment and a proximal segment, the distal segment of the coiled curve including shape memory processing such that, when the coiled curve is in the extended position, the distal segment bends such that a portion of the coiled curve located at the proximal end of the distal tip contacts the inner wall, the proximal segment being configured to receive an axial force to move the coiled curve between the extended position and the retracted position.

25. The intraluminal ultrasonic device according to claim 24, wherein, In the extended position, the coiled curve extends through the channel of the housing to contact the inner wall and reduce the air gap between the lumen and the transducer, and wherein, in the retracted position, the coiled curve is adjacent to the channel within the housing.

26. The intraluminal ultrasonic device according to any one of claims 24 to 25, wherein, The distal tip of the coiled curve includes a contact feature configured to increase the surface area of ​​the distal tip to reduce the pressure generated by the distal tip engaging the inner wall.

27. The intraluminal ultrasonic device according to any one of claims 21 to 26, wherein, The force generation system includes: A suction system configured to generate a suction force on a portion of the inner wall to pull the inner wall and the transducer together.

28. The intraluminal ultrasonic device according to claim 27, wherein, The suction system includes an inlet surrounding the periphery of the mounting feature, such that when the transducer is mounted within the mounting feature, the inlet extends above the transducer, and the inlet introduces the suction force into the lumen to pull the inner wall and the transducer together.

29. The intraluminal ultrasonic device according to any one of claims 27 to 28, wherein, The suction system includes a plurality of suction ports formed in the housing around the mounting feature, the plurality of suction ports introducing the suction force into the lumen to pull the inner wall and the transducer together.

30. The intraluminal ultrasonic device according to any one of claims 21 to 29, wherein, The housing includes an airbag groove opposite the mounting feature, and wherein the force generation system includes: An airbag, fluidly connected to a pump, operable to inflate and deflate the airbag such that when the pump inflates the airbag, the airbag extends through the airbag groove to contact the inner wall and reduce the air gap between the inner wall and the transducer, and when the airbag deflates, the airbag contracts toward the airbag groove.

31. The intraluminal ultrasonic device according to any one of claims 21 to 30, wherein, The housing includes a linear groove opposite to the mounting feature, and wherein the force generating system includes: A flexible member extending between a proximal and a distal portion, the proximal portion of the flexible member being fixedly attached to the housing; and An actuation line is attached to the distal portion of the flexible member, such that applying tension to the actuation line causes the distal portion of the flexible member to translate toward the proximal portion of the flexible member.

32. The intraluminal ultrasonic device according to claim 31, wherein, When the actuation line translates the distal portion of the flexible member toward the proximal portion of the flexible member, the flexible member bends and extends through the linear groove of the housing to contact the inner wall, thereby causing the transducer and the inner wall to move together and reducing the air gap between the inner wall and the transducer.

33. The intraluminal ultrasonic device according to claim 32, wherein, The flexible member includes shape memory, such that when the tension from the actuation line is removed, the distal portion of the flexible member translates away from the proximal portion of the flexible member, and the flexible member retracts through the linear groove and enters the housing.

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