Multi-lumen device for ultrasound imaging

Abstract

A medical device (102) includes a central lumen (106) extending from a proximal end to a distal end of the medical device, the central lumen configured to receive a probe (120). A distal portion of the probe includes a transducer (124) positioned at a fixed location relative to the medical device in a configuration in which the probe is received by the central lumen. The medical device further includes an irrigation lumen (112, 116) extending from the proximal end of the medical device to a distal-most opening (114) of the irrigation lumen. The irrigation lumen is disposed radially outward of the central lumen and is in fluid communication with a fluid source at the proximal end of the medical device. The distal-most opening is proximal of the fixed location such that a fluid flow received from the fluid source and expelled by the irrigation lumen via the distal-most opening at least partially circumferentially surrounds the transducer.

Description

Cross-references to related applications

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 550,663, filed February 7, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure generally relates to systems and apparatuses for ultrasound imaging. More specifically, aspects of this disclosure relate to multi-lumen ultrasound imaging apparatuses with enhanced flushing and / or bending. Background Technology

[0003] As part of a biopsy procedure, an ultrasound imaging device (such as a radial ultrasound probe) can first be guided into the body's lumen and used to identify the target area (e.g., a suspicious area) within the lumen to be biopsied. Typically, an ultrasound imaging device includes a bend-free and reusable single-lumen catheter. The single-lumen catheter can house the imaging components of the ultrasound imaging device, such as transducers configured to emit and receive sound waves to generate ultrasound images. Summary of the Invention

[0004] According to several aspects, the technology described herein relates to a medical device. An example medical device includes a central lumen and a flushing lumen. The central lumen extends from a proximal end of the medical device to a distal end and is configured to receive a probe. The distal portion of the probe includes a transducer configured to perform ultrasound imaging, and in the configuration where the probe is received by the central lumen, the transducer is positioned at a fixed location relative to the medical device. The flushing lumen extends from the proximal end of the medical device to its distalmost opening. The flushing lumen is located radially outside the central lumen and is in fluid communication with a fluid source at the proximal end of the medical device. The distalmost opening is proximal to the fixed location such that a flow of fluid received from the fluid source and discharged from the flushing lumen via the distalmost opening at least partially surrounds the transducer radially.

[0005] In any of the example medical devices described herein, a flushing lumen is a first flushing lumen extending from the proximal end of the medical device to a first distal opening at a fixed location proximally, and the medical device further includes a second flushing lumen. The second flushing lumen extends from the proximal end of the medical device to a second distal opening and is disposed radially outside the central lumen. The second flushing lumen is in fluid communication with a fluid source at the proximal end of the medical device, and the second distal opening is proximal to the fixed location. In some aspects, the central lumen is in fluid communication with a fluid source at the proximal end of the medical device, and the central lumen is further configured to provide fluid received from the fluid source through the central lumen to the distal end of the medical device.

[0006] In some examples, the medical device includes an outer sheath and an inner sheath, the inner sheath being positioned within the outer sheath and extending distally from it. A central lumen is the lumen of the inner sheath. A flushing lumen lies between the inner and outer sheaths.

[0007] In other examples, the medical device includes a multi-lumen catheter and a cap coupled to the multi-lumen catheter. The multi-lumen catheter includes a first portion of a central lumen and a first portion of a flushing lumen. The cap includes a second portion of the central lumen and a second portion of the flushing lumen to extend the flushing lumen to a distal opening. In some examples, the medical device further includes a bending wire coupled to the cap, wherein the bending wire is configured to bend a distal portion of the medical device. In such examples, the multi-lumen catheter further includes a bending lumen, wherein the bending wire extends through the bending lumen, and the distal end of the bending wire extends distal to the distal end of the bending lumen. Additionally, the cap further includes a bending cavity aligned with the bending lumen, wherein the bending cavity receives the distal end of the bending wire, and the distal end of the bending wire is secured to the cap. In other examples, at least the distal portion of the multi-lumen catheter and the cap form a bending region, and the distal portion of the multi-lumen catheter includes a first material that is more flexible than a second material constituting the proximal portion of the multi-lumen catheter.

[0008] In another example, a multi-lumen catheter and a cap connected to the multi-lumen catheter are the first device, and the medical device further includes a second device. The second device includes a single-lumen catheter and a probe, wherein the probe is received within the lumen of the single-lumen catheter, and the single-lumen catheter is configured to be received by and extend through the central lumen of the first device, such that a distal portion of the single-lumen catheter, including a transducer, extends distally across the first device. In a configuration where the transducer is in operation, the distal portion of the single-lumen catheter is positioned such that the distal opening of the flushing lumen of the first device is located at a predetermined distance proximal to the transducer.

[0009] In some examples, a multi-lumen catheter is coupled to the proximal end of the cap, and the medical device further includes a single-lumen catheter coupled to the distal end of the cap and extending distally from the distal end of the cap to the distal end of the medical device. The single-lumen catheter includes a third portion of a central lumen, wherein the transducer is fixedly positioned within the single-lumen catheter when the probe is received by the central lumen.

[0010] In other examples, the medical device includes a multi-lumen catheter and an overmolded component. The multi-lumen catheter includes a first portion of a central lumen and a first portion of a flushing lumen. The overmolded component is distally attached to the multi-lumen catheter. In some examples, the overmolded component includes a proximal portion comprising a second portion of the central lumen and a second portion of the flushing lumen to extend the flushing lumen to its distal opening. The overmolded component also includes a distal portion comprising a third portion of the central lumen, wherein the transducer is positioned within the distal portion of the overmolded component when the probe is received by the central lumen. In other examples, a bending wire is integrated with the proximal portion of the multi-lumen catheter and the overmolded component, wherein the bending wire is configured to bend the distal portion of the medical device.

[0011] According to other aspects, the technology described herein relates to a medical device. An example medical device includes a proximal multi-lumen catheter. The proximal multi-lumen catheter includes a central lumen and a flushing lumen. The flushing lumen is located radially lateral to the central lumen and is in fluid communication with a fluid source at a proximal end of the medical device. The example medical device further includes: a distal single-lumen catheter extending the central lumen from the proximal end of the medical device to the distal end; and a cap configured to connect the proximal multi-lumen catheter to the distal single-lumen catheter, wherein the cap extends the flushing lumen to its distalmost opening. The example medical device further includes a probe including a transducer at a distal portion of the probe. The probe is received by the central lumen and extends through the central lumen toward the distal end of the medical device. The transducer is positioned at a fixed location within the distal single-lumen catheter, wherein the distalmost opening of the flushing lumen is proximal to the fixed location, such that a flow of fluid received from a fluid source and discharged from the flushing lumen via the distalmost opening at least partially surrounds the transducer radially.

[0012] In some examples, the cap may include a step configured to receive and secure the distal single-lumen catheter to the cap. In other examples, the cap and the distal single-lumen catheter each comprise a proximal and distal portion of an overmolded component of the medical device. In yet another example, the medical device may further include a bend wire integrated with the proximal multi-lumen catheter and the cap.

[0013] According to another aspect, the technology described herein relates to a medical device. An example medical device includes a multi-lumen catheter. The multi-lumen catheter includes a central lumen and a flushing lumen disposed radially outside the central lumen and in fluid communication with a fluid source at a proximal end of the medical device. The example medical device also includes a cap coupled to the multi-lumen catheter, which extends the central lumen and the flushing lumen to a distal end of the medical device. At least a distal portion of a single-lumen catheter, separate from the medical device and having a probe including a transducer positioned at a fixed location in the distal portion of a single-lumen catheter, is configured to be removably extended through the central lumen and beyond the distal end of the medical device, such that a flow of fluid received from the fluid source and discharged by the flushing lumen at the distal end of the medical device at least partially surrounds the distal portion of the single-lumen catheter radially.

[0014] It is understood that the foregoing general description and the following detailed description are exemplary and illustrative only, and do not limit the claimed invention. As used herein, the terms “comprising,” “including,” “having,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements may include not only those elements but also other elements not expressly listed or inherent to such processes, methods, articles, or apparatuses. The term “exemplary” is used in the sense of “example” rather than “ideal.” The term “distal” refers to a direction away from the operator / towards the treatment site, and the term “proximal” refers to a direction towards the operator. The term “about” or similar terms (e.g., “substantially”) include values ​​+ / - 10% of the stated value. Attached Figure Description

[0015] The accompanying drawings, which are incorporated in and form part of this specification, illustrate examples of this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0016] Figures 1A to 1C Different views of an exemplary system having a first ultrasound imaging device are depicted.

[0017] Figure 2A and Figure 2B Different views of the adjustable bend multi-lumen catheter are depicted.

[0018] Figures 3A to 3C Different views of the hat are depicted, which is configured to connect to Figure 2A and Figure 2B An adjustable, multi-lumen catheter is used to form at least a portion of an ultrasound imaging device.

[0019] Figures 4A to 4C Different views of the second ultrasound imaging device are depicted.

[0020] Figures 5A to 5DDifferent views of the third ultrasound imaging device are depicted.

[0021] Figures 6A to 6D Different views of the fourth ultrasound imaging device are depicted. Detailed Implementation

[0022] As briefly described above, as part of a biopsy procedure, an ultrasound imaging device (such as a radial ultrasound probe) can first be navigated into the body's lumen and used to identify the target area (e.g., a suspicious area) within the lumen to be biopsied. An example biopsy procedure could be a peripheral lung biopsy, which requires access to small airways in the peripheral region of the lung.

[0023] Typically, conventional ultrasound imaging devices comprise catheters with only a single lumen. An example single-lumen catheter may house the imaging components of an ultrasound imaging device, such as a probe including a transducer configured to emit and receive sound waves for generating ultrasound images. Sound waves, and particularly high-frequency sound waves (e.g., 30-40 MHz), do not propagate or travel well in air. Therefore, when an ultrasound imaging device captures images in human lumens (such as the airways of the lungs) where there is little to no naturally flowing fluid, a single-lumen catheter may be connected to a fluid source so that fluid can flush through the single lumen and past the transducer housed therein to aid sound wave transmission (e.g., to achieve better coupling of the transducer to the human lumen environment). However, once fluid exits the single-lumen catheter through its distal opening, it may not, for example, flow upwards and back around the portion of the catheter housing the transducer, thus limiting the amount of fluid available to facilitate coupling of the transducer to the external human lumen environment.

[0024] Furthermore, conventional ultrasound imaging devices may lack bending mechanisms, and therefore lack maneuverability and / or operability. This lack of maneuverability can make navigating the device through body lumens, particularly smaller ones such as the airways in the peripheral lung region, more challenging and time-consuming. Additionally, once the ultrasound imaging device is positioned at or near the target area, the lack of maneuverability can inhibit any adjustments to the position of the probe (especially the transducer) relative to the target area.

[0025] Furthermore, conventional ultrasound imaging devices are typically reusable. Reusable devices require post-processing between medical procedures to clean and / or sterilize them, which can be costly in terms of both time and money. For example, post-processing time can cause delays between procedures, and despite this, reuse may still pose a risk of cross-contamination to patients. Additionally, reusable ultrasound imaging devices may be susceptible to damage or breakage, especially when subjected to post-processing.

[0026] Therefore, various aspects of this disclosure relate to multi-lumen devices for ultrasound imaging to provide enhanced fluid flushing. Additionally, at least some embodiments of the multi-lumen device may include a bending mechanism. Furthermore, the multi-lumen device may be a single-use device or a disposable device.

[0027] The following text is for reference only. Figures 1A to 1C One example device described may be a non-bending multi-lumen device consisting of an inner sheath and an outer sheath. This non-bending multi-lumen device may be disposable or single-use. The inner diameter of the inner sheath may form a central lumen configured to receive a probe, which includes a transducer. In some examples, the central lumen may also be in fluid communication with a fluid source, allowing fluid to flow through the central lumen and through the transducer. The inner sheath may be positioned within and extend distally from the outer sheath to form one or more flushing lumens between the inner and outer sheaths. The terminating end of the flushing lumen at the distal end of the outer sheath may include distal openings positioned proximal to at least the portion of the inner sheath that houses the transducer (e.g., an imaging window). The proximal positioning of the distal openings helps ensure that the fluid supplied via the flushing lumens flushes out (e.g., displaces) air, such that the fluid at least partially surrounds the transducer-containing portion of the inner sheath radially to supplement and enhance the effect of the fluid supplied via the central lumen, resulting in improved acoustic transmission.

[0028] Other example devices may include adjustable-bend multi-lumen devices. These adjustable-bend multi-lumen devices may also be disposable or single-use. Each of these adjustable-bend multi-lumen devices may include at least a multi-lumen catheter and a cap integrated with an adjustment mechanism, such as... Figures 2A to 2B and Figures 3A to 3C As shown. A multi-lumen catheter can be coupled to a cap, and each of the cap and the multi-lumen catheter can include a corresponding central lumen (e.g., forming a continuous central lumen) and one or more corresponding flushing lumens (e.g., forming a continuous flushing lumen). The continuous central lumen can be configured to receive a probe, wherein a distal portion of the probe, including a transducer, can extend through and distally across the continuous central lumen. The terminating ends of the flushing lumens can include distal openings positioned proximal to the transducer-receiving portion (e.g., an imaging window) of the bendable multi-lumen device, for reasons similar to those described above regarding non-bendable lumen devices.

[0029] Additionally, the multi-lumen catheter may include a bending lumen configured to receive the distal ends of one or more bending wires of a bending mechanism. The distal ends of the bending wires may extend across the multi-lumen catheter and into one or more bending cavities of the cap, wherein the bending wires may be secured to the wall of the bending cavity. The bending mechanism may further include one or more actuators, with the proximal ends of the bending wires connected to these actuators. Upon receiving an operator action, the actuators may be configured to actuate the bending wires to achieve maneuverability of the distal portion of the device (e.g., the bending area of ​​the multi-lumen catheter connected to the cap). The maneuverability provided by the bending mechanism facilitates navigation of the bendable multi-lumen device through human lumens. Furthermore, when the bendable multi-lumen device is positioned near a desired target, the maneuverability of the bending area provided by the bending mechanism allows adjustment of the distal portion of the probe and specifically the transducer's position relative to the target area to help improve image quality.

[0030] refer to Figures 4A to 4C An example of an adjustable bendable multi-lumen device described may include: a first device comprising a multi-lumen catheter coupled to a cap; and a second device comprising a single-lumen catheter (e.g., an imaging window) including a probe received within a single lumen of the catheter. The second device may be inserted into the first device and positioned distally beyond the distal end of the first device such that a distal opening at the terminating end of the flushing lumen of the first device is positioned proximal to at least a distal portion of the second device (which houses a transducer).

[0031] refer to Figures 5A to 5D Another example of a bendable multi-lumen device described may include a single device having a bendable multi-lumen component that is attached proximally to a single-lumen catheter (e.g., an imaging window). The bendable multi-lumen component may include a multi-lumen catheter coupled to a cap. The single-lumen catheter may be received by and attached to the cap. The single-lumen catheter may be configured to receive at least a distal portion of a probe (which includes a transducer) in a fixed position, such that a distal opening at the termination of the flushing lumen of the bendable multi-lumen component is positioned proximally to the transducer.

[0032] refer to Figures 6A to 6D Another example of an adjustable-bend multi-lumen device described may include a single device having a multi-lumen catheter proximally attached to an overmolded member. The overmolded member may include a proximal portion consisting of a cap and / or features of the cap, and a distal portion (e.g., an imaging window) in the form of a single-lumen catheter. The distal portion of the overmolded member may be configured to receive at least the distal portion of a probe (which includes a transducer) at a fixed location within its lumen, such that a distal opening at the terminating end of the flushing lumen (e.g., located distal to the proximal portion) is positioned proximal to the transducer.

[0033] The specific examples included throughout this disclosure implement ultrasound imaging systems, and more specifically, radial ultrasound imaging systems configured to perform radial ultrasound imaging within the airways in the peripheral region of the lungs. However, it should be understood that the techniques according to this disclosure can be adapted to other ultrasound imaging systems for imaging other human lumens, particularly those with limited or no natural fluid flow and / or content. It should also be understood that the examples above are merely illustrative. The techniques and methods of this disclosure can be adapted to any suitable activity.

[0034] Now refer to the attached diagram, Figure 1A An exemplary system 100 with a first ultrasound imaging device 102 (hereinafter referred to as device 102 for simplicity) is depicted. System 100 may also include a control unit 130, a display device 140, and / or a fluid source 150. Device 102 may be a medical device, and specifically a non-bending ultrasound imaging device, which may be removably connected to the control unit 130, display device 140, and / or fluid source 150 to perform ultrasound imaging during diagnostic and / or interventional medical procedures. Device 102 may be a disposable or single-use device, such that device 102 can be removed from system 100 and discarded or disposed of after the medical procedure is completed.

[0035] An example medical procedure may include a peripheral lung biopsy in which ultrasound imaging performed by system 100 can be used to identify a target region (e.g., a suspicious region) within the airway of a peripheral region of the lung from which a tissue sample is to be collected. For example, the distal portion of device 102 may be positioned within an airway in a peripheral region of the lung expected to contain a lesion or other similar abnormality and navigated through that airway. Once the target region has been identified using ultrasound imaging provided by system 100, device 102 can be removed from the airway and discarded. In some examples, the biopsy device and / or ultrasound-guided biopsy device may be positioned at the location of the identified target region before or after removal of device 102 to collect a sample from that target region.

[0036] Figure 1A A perspective view including the distal portion of device 102. Figure 1B Depicting along Figure 1A The cross-sectional view of device 102 taken by line 1B in the figure. Figure 1C A front view of the distal end 103 of the device 102 is depicted. (See also...) Figures 1A to 1CThe device 102 may include an inner sheath 104 and an outer sheath 110. The inner sheath 104 and outer sheath 110 may form a non-bending multi-lumen catheter. In some examples, the inner sheath 104 and outer sheath 110 may be fixed relative to each other. For example, the inner sheath 104 and outer sheath 110 may be axially fixed to each other and / or fixed in the direction of rotation. Additionally, while the inner sheath 104 and outer sheath 110 are described as separate sheaths connected to each other to form the device 102, in other examples, the device 102 may be constituted by a single sheath having the characteristics of both the inner sheath 104 and outer sheath 110 (e.g., a single multi-lumen extruded sheath). The inner sheath 104 and / or outer sheath 110 may be constituted by one or a combination of different types of plastic materials, including both thermoplastics and thermosetting plastics, such as PEBAX®, nylon, polytetrafluoroethylene (PTFE), and expanded PTFE. In some examples, at least the outer sheath 110 may be in the form of a composite coil or braided layer to improve torque and / or rotational flexibility.

[0037] The inner sheath 104 may include a central lumen 106 extending from the proximal end (not shown) of the device 102 to the distal end 103 of the device 102. A distal opening 108 of the central lumen 106 may be located at the distal end 103 and may face distally. Specifically, the distal opening 108 may be located at the most distal end 103 of the device 102.

[0038] Device 102 may also include probe 120. For example... Figure 1B As shown, the central lumen 106 can be configured to receive or accommodate a probe 120. The probe 120 can be an ultrasound probe. In some examples, the probe 120 can be a radial ultrasound probe. The distal portion 122 of the probe 120 can include a transducer 124. The transducer 124 can be configured to receive an electrical signal generated by the control unit 130 and convert the electrical signal into mechanoacoustic waves. The transducer 124 can emit sound waves into the surrounding environment (e.g., airways in the peripheral region of the lungs), and the sound waves can be reflected by internal structures within the environment and return to the transducer 124. The transducer 124 can then convert the returned sound waves into electrical signals, which are transmitted to the control unit 130 for processing (e.g., to generate an ultrasound image). The control unit 130 can then provide the ultrasound image to a display device 140 for display. Although Figure 1B Only one transducer is shown (e.g., transducer 124), but in other examples, the distal portion 122 of probe 120 may include multiple transducers.

[0039] The distal portion 122 of the probe 120, including the transducer 124, can be positioned at a fixed location within the distal portion of the central lumen 106, as described in further detail below. The distal portion of the central lumen 106 where the transducer 124 is located may also be referred to herein as the visualization area or imaging window. The proximal portion of the probe 120 may include a shaft 126. The shaft 126 may accommodate connecting elements (not shown) (such as cables, wires, etc.) extending from the control unit 130 to the transducer 124 to enable communication of the aforementioned electrical signals between them.

[0040] Sound waves, and especially high-frequency sound waves (e.g., 30-40 MHz), do not propagate or travel well in air. When device 102 is operated, a fluid (such as water or any other similar flushing solution) may be needed to flush transducer 124 (e.g., to displace air and surround the transducer) to aid sound wave propagation and ensure optimal image quality. This flushing can be critical when system 100 is used for ultrasound imaging in human luminal environments where the lumen naturally contains little or no fluid (e.g., in the airways of the peripheral region of the lungs). Accordingly, the proximal end (not shown) of central lumen 106 may be configured mechanically and fluidly connected to fluid source 150 to establish fluid communication between central lumen 106 and fluid source 150.

[0041] Fluid source 150 may include a reservoir containing fluid to be used for rinsing. In some examples, fluid source 150 may include one or more syringes containing fluid (such as water) for rinsing. The syringes may be pre-filled with a predetermined volume of fluid. The syringes may be mechanically coupled to (e.g., inserted into) a corresponding lumen of device 102, such as central lumen 106. An operator may actuate the syringe to expel fluid from the syringe by, for example, pressing down on the plunger of the syringe. As the fluid flows distally through central lumen 106, at least a portion of the fluid may remain within the lumen due to, for example, surface tension and / or capillary action.

[0042] In other examples, fluid source 150 may be an automated fluid delivery device communicatively coupled to control unit 130 via a wired or wireless connection, such that fluid source 150 can receive commands or signals from control unit 130. Fluid source 150 may be a device distinct from or integrated with control unit 130 (e.g., a component of control unit). Example commands or signals received from control unit 130 may cause fluid source 150 to initiate and subsequently terminate the discharge of at least a portion of the fluid in the reservoir to device 102. Thus, when central lumen 106 is in fluid communication with fluid source 150, and fluid source 150 discharges fluid in response to a command received from control unit 130, fluid may flow through central lumen 106 to distal end 103 of device 102 and exit from distal opening 108 (e.g., as shown in the image). Figure 1B (As depicted by the arrow in the image).

[0043] As fluid is discharged toward and exits the distal opening 108, it flows through the central lumen 106, allowing it to pass over the probe 120 positioned within it. However, once the fluid exits the distal opening 108, it may not be able to flow proximally upwards and back around the distal portion of the device 102, and therefore not back around the transducer 124. As a result, providing fluid flushing solely through the central lumen 106 may be insufficient to ensure a constant fluid flow around the transducer 124 for sound wave transmission.

[0044] Therefore, in addition to the central lumen 106, the device 102 may also include one or more flushing cavities disposed radially outside the central lumen 106, such as a first flushing cavity 112 and a second flushing cavity 116. For example, an inner sheath 104 may be positioned within an outer sheath 110 to form the first flushing cavity 112 and the second flushing cavity 116 between the inner sheath 104 and the outer sheath 110. In some examples, the first flushing cavity 112 and the second flushing cavity 116 may each extend parallel to the central longitudinal axis of the device 102, such that the cross-sections of the first flushing cavity 112 and the second flushing cavity 116 may be parallel to each other, such as... Figure 1B As shown.

[0045] The first flushing lumen 112 may extend from a first proximal end (not shown) at the proximal end of the device 102 to a first terminating end 113. The first terminating end 113 may be proximal to the distal end 103 of the device 102 because the inner sheath 104 may extend distally beyond the distal end of the outer sheath 110. The first terminating end 113 may be the distal end of the outer sheath 110 and may include a first distal opening 114 facing distally. The first distal opening 114 may be the distal opening of the first flushing lumen 112. The first distal opening 114 may be proximal to a fixed position (e.g., proximal to the visualization area or imaging window) where the distal portion 122 of the probe 120 is located through the distal portion of the central lumen 106. For example, the first distal opening 114 may be located at a first predetermined distance proximal to the transducer 124.

[0046] The second flushing lumen 116 may extend from a second proximal end (not shown) at the proximal end of device 102 to a second terminating end 117 proximal to the distal end 103 of device 102 (because, as described above, the inner sheath 104 may extend distally beyond the distal end of the outer sheath 110). The second terminating end 117 may be the distal end of the outer sheath 110 and may include a distally facing second distal opening 118. The second distal opening 118 may be the distal opening of the second flushing lumen 116. The second distal opening 118 may be proximal to a fixed location (e.g., proximal to the visualization area or imaging window) where the distal portion 122 of probe 120 is located together with the distal portion of the central lumen 106. For example, the second distal opening 118 may be located at a second predetermined distance proximal to transducer 124. In some examples, the first distal opening 114 and the second distal opening 118 may be located at the same predetermined distance proximal to transducer 124 (e.g., the first predetermined distance and the second predetermined distance may be substantially equal). In other words, the first distal opening 114 and the second distal opening 118 can be located at the same axial position along the device 102.

[0047] like Figure 1AAs shown, the outer sheath 110 may include a protrusion 119 (e.g., two protrusions 119) between the first flushing lumen 112 and the second flushing lumen 116. The protrusion 119 may project radially inward from the outer sheath 110 into the inner sheath 104 to separate the first flushing lumen 112 from the second flushing lumen 116. In some examples, the radially inner surface of the protrusion 119 may be fixedly coupled to the inner sheath 104, or may otherwise be sealed relative to the inner sheath 104 to help retain fluid within the first flushing lumen 112 and the second flushing lumen 116. The surface 121 of the protrusion 119 may define the sides of the first flushing lumen 112 and the second flushing lumen 116. In several aspects, the distal end of the protrusion 119 may be distal to some portion or entirely of the first termination end 113 and the second termination end 117. In some examples, and as... Figure 1B As most clearly shown, the edge 123 between the surface 121 of the protrusion 119 and the distal surface of the protrusion 119 may be inclined or angled distally relative to the central longitudinal axis of the central lumen 106 (e.g., compared to the central longitudinal axis perpendicular to the central lumen).

[0048] Each of the first proximal end of the first flushing cavity 112 and the second proximal end of the second flushing cavity 116 can be configured to be mechanically and fluidly connected to a fluid source 150 to establish fluid communication between the flushing cavities 112, 116 and the fluid source 150. When the first flushing cavity 112 is in fluid communication with the fluid source 150, and the fluid source 150 (e.g., based on manual actuation or in the case of automation in response to a command received from the control unit 130) supplies fluid, fluid can flow through the first flushing cavity 112 to the first termination end 113 and exit from the first distal opening 114 (e.g., as shown in the image). Figure 1B (As depicted by the arrows in the diagram). Similarly, when the second flushing lumen 116 is in fluid communication with the fluid source 150, and the fluid source 150 supplies fluid (e.g., based on manual actuation or in the case of automation in response to a command received from the control unit 130), fluid can flow through the second flushing lumen 116 to the second termination end 117 and exit from the second distal opening 118 (e.g., as shown by the arrows in the diagram). Figure 1B (As depicted by the arrow in the image).

[0049] In some examples, for instance, when the proximal end of device 102 is mechanically connected to fluid source 150, each of the central lumen 106, the first flushing lumen 112, and the second flushing lumen 116 can simultaneously establish fluid communication with fluid source 150. Therefore, when fluid source 150 provides fluid based on manual actuation or in the case of automation in response to a command received from control unit 130, fluid can be provided simultaneously through the central lumen 106, the first flushing lumen 112, and the second flushing lumen 116. In other examples, the central lumen 106, the first flushing lumen 112, and / or the second flushing lumen 116 can establish fluid communication with fluid source 150 independently of each other. As an example, when the fluid source 150 includes one or more syringes, a single syringe may be mechanically and fluidly connected simultaneously to each of the central lumen 106, the first flushing lumen 112, and the second flushing lumen 116, such that when the syringe is actuated, flushing fluid can be synchronously passed through each of the central lumen 106, the first flushing lumen 112, and the second flushing lumen 116. Alternatively, different syringes (e.g., a first syringe, a second syringe, and a third syringe) may be mechanically and fluidly connected to each of the central lumen 106, the first flushing lumen 112, and the second flushing lumen 116, such that when the respective syringe is actuated, flushing fluid can be independently passed through each of the central lumen 106, the first flushing lumen 112, and the second flushing lumen 116.

[0050] The first termination end 113 and the second termination end 117 are positioned proximal to the fixed position of the distal portion 122 of the probe 120 within the central lumen 106 of the inner sheath 104. This helps ensure that fluid discharged from the first flushing lumen 112 and the second flushing lumen 116 via the first distal opening 114 and the second distal opening 118 at least partially flushes out (e.g., displaces) air radially and surrounds the portion of the inner sheath 104 including the transducer 124 (e.g., surrounds the visualization area or imaging window). The fluid supplied via the first flushing lumen 112 and the second flushing lumen 116 can supplement and enhance the fluid supplied via the central lumen 106 to improve acoustic wave transmission.

[0051] Although Figures 1A to 1C Two flushing lumens are shown, but in other examples, device 102 may include fewer or more flushing lumens. For example, device 102 may alternatively include only a single flushing lumen disposed radially outside the central lumen 106. As another example, device 102 may alternatively include three or more flushing lumens, each at least partially surrounding the inner sheath 104.

[0052] Control unit 130 may be a computing system, computing device, controller, or other similar independent processing unit. Control unit 130 may include at least one memory and at least one processor. The memory may be configured to store instructions to be executed by the processor to cause control unit 130 to perform corresponding operations, including but not limited to: transmitting instructions and / or signals to fluid source 150 (e.g., in the case of automation) to provide fluid from fluid source 150 to device 102; generating electrical signals and transmitting the electrical signals to device 102; receiving return electrical signals from device 102; processing the return electrical signals to generate an image; and displaying the image and / or other data (e.g., via display device 140). The memory may also include one or more data storage devices. Alternatively or additionally, control unit 130 may include one or more data storage devices separate from the memory.

[0053] Display device 140 can be configured to display data associated with one or more of device 102, control unit 130, and / or fluid source 150. In some examples, the displayed data may include an image generated by control unit 130 based on signals received from device 102. Additionally, the displayed data may indicate whether fluid is currently being supplied to device 102 from fluid source 150, the amount of fluid supplied, and / or the amount of fluid remaining in the reservoir of fluid source 150, and other similar examples. Display device 140 may include one or more combinations of a monitor, computing device screen, touchscreen display, etc. In some examples, display device 140 may be a separate device from control unit 130, communicatively coupled to control unit 130 via a wired and / or wireless connection. In other examples, display device 140 may be a display or screen of control unit 130 itself.

[0054] In some examples, control unit 130 may generate or cause the generation of one or more graphical user interfaces (GUIs) based on instructions or information stored in the memory of control unit 130, instructions or information received from device 102, instructions or information received from fluid source 150, etc., and may cause these GUIs to be displayed via display device 140. In addition to the displayed data, the GUI may also include text, visual elements, controls, etc. Display device 140 may include a touchscreen or a display with other input systems (e.g., mouse, keyboard, voice, etc.) for the operator of control unit 130 to control the functions of control unit 130, device 102, and / or fluid source 150 via control unit 130 and / or display device 140.

[0055] In some aspects, one or more components of system 100 (such as device 102, control unit 130, display device 140, and / or fluid source 150) may be network-connected and able to communicate with each other via wired or wireless networks. The network may be an electronic network. Networks may include wide area networks (“WANs”), local area networks (“LANs”), personal area networks (“PANs”), cellular networks (e.g., 3G, 4G, 5G, etc.), etc. In other examples, components of system 100 may communicate and / or connect to the network via a universal serial bus (USB) or other similar local low-latency connection or direct wireless protocol. Components of system 100 may use one or more standard communication protocols to connect via the network, enabling components to transmit and receive communications with each other across the network.

[0056] Although the various components in system 100 are Figure 1A While depicted as separate components, it should be understood that in some embodiments, a component or part of a component in system 100 may be integrated with or incorporated into one or more other components. For example, display device 140 and / or fluid source 150 may be integrated with control unit 130. In some embodiments, the operation or aspects of one or more of the components discussed above may be distributed among one or more other components. Any suitable arrangement and / or integration of various systems and devices can be used with system 100.

[0057] For reference Figures 1A to 1C As shown and described, the inner sheath 104 and outer sheath 110 of the device 102 form a non-bendable multi-lumen catheter of the system 100, which is configured to receive the probe 120. Figure 2A and Figure 2B A multi-lumen catheter 200 (hereinafter referred to as catheter 200) is depicted, which integrates a bending mechanism 250 and is configured to receive a probe 120. Figures 3A to 3C Different views of a cap 300 are depicted, which is configured to connect to the distal end of a catheter 200 to form at least a portion of a medical device, and specifically to form an adjustable-bend ultrasound imaging device (e.g., reference). Figures 4A to 4C The second ultrasound imaging device 400 and / or reference described Figures 5A to 5D At least a portion of the third ultrasound imaging device 500 described. The adjustable-bend ultrasound imaging device can replace device 102 in system 100 (e.g., can be used in place of or as a substitute for it). For example, the adjustable-bend ultrasound imaging device can be electrically and / or mechanically connected to control unit 130, display device 140, and / or fluid source 150. Similar to device 102, the adjustable-bend ultrasound imaging device can be a disposable device or a single-use device.

[0058] Figure 2AA three-dimensional view of the distal portion 201 of the catheter 200 is depicted. Figure 2B A bending mechanism 250 integrated with the catheter 200 is depicted. The catheter 200 is in Figure 2B The center is transparent to depict how the bending mechanism 250 is integrated. Figure 2B The dashed lines in other figures in this article depict other structures (e.g., Figure 2B The internal structure of the conduit 200. For example, the bending mechanism 250 may include one or more bending wires (such as a first bending wire 252 and a second bending wire 254) that are received by the conduit 200 and extend through and distally across the conduit. The bending mechanism 250 may also include an actuator 258 to actuate the first bending wire 252 and the second bending wire 254. In some examples, the actuator 258 may be disposed on a handle 256 to facilitate operation by an operator.

[0059] Now refer to Figure 2A and Figure 2B The catheter 200 may include a tubular body or a fitting 202. The fitting 202 may be constructed from one or a combination of different types of plastic materials, including both thermoplastics and thermosetting plastics, such as PEBAX®, nylon, polytetrafluoroethylene (PTFE), and expanded PTFE. In some examples, the fitting 202 may be in the form of a composite coil or braided layers to improve torque and / or rotational flexibility. While the fitting 202 may have some flexibility, it may also be sufficiently rigid to allow for maneuverability of the catheter 200 within the lumen of the human body, including the airway in the peripheral region of the lungs.

[0060] The fitting 202 may include an inner diameter 204 forming a central lumen 206. The central lumen 206 may include a proximal opening 207 at the proximal end 203 of the fitting 202 and a distal opening 208 at the distal end 205 of the fitting 202. The central lumen 206 of the catheter 200 may be similar to the central lumen 106 of the device 102. For example, the central lumen 206 may be configured to receive a probe 120. However, and as discussed in more detail below, the central lumen 206 may only be a first portion of the central lumen of a given ultrasound imaging device, and the distal portion 122 of the probe 120, including the transducer 124, may extend through the central lumen 206 and be positioned at a fixed location distal to the central lumen 206.

[0061] Additionally, the proximal opening 207 of the central lumen 206 can be configured to be mechanically connected to the fluid source 150 to establish fluid communication. Fluid from the fluid source 150 flowing through the central lumen 206 can help propel fluid through the probe 120. Figure 2A and Figure 2B Not shown in the image, but... Figures 1A to 1C (as shown in the diagram) to facilitate the transmission of acoustic waves by transducer 124. However, for the purposes of the above reference... Figures 1A to 1C For the same or similar reasons discussed, providing fluid flushing only via the central lumen 206 may be insufficient to ensure adequate fluid flow around the transducer 124. Therefore, in addition to the central lumen 206, the fitting 202 may also include one or more flushing cavities disposed radially outside the central lumen 206, such as a first flushing cavity 212 and a second flushing cavity 216.

[0062] For example, fitting 202 may include a wall 209 extending from an inner diameter 204 to an outer diameter 210. A first flushing lumen 212 and a second flushing lumen 216 may extend within the wall 209 from a proximal end 203 to a distal end 205 of fitting 202. In some examples, the first flushing lumen 212 and the second flushing lumen 216 may each extend parallel to the central longitudinal axis of fitting 202 and may be diametrically opposed to each other on fitting 202. At the proximal end 203 of fitting 202, the wall 209 may include a first proximal wall opening 213 for the first flushing lumen 212 and a second proximal wall opening 217 for the second flushing lumen 216. The first proximal wall opening 213 and the second proximal wall opening 217 may establish a fluid connection between fitting 202 and fluid source 150, such that fluid supplied from fluid source 150 can be received by the first flushing lumen 212 and the second flushing lumen 216 respectively and flow distally through the first flushing lumen and the second flushing lumen. At the distal end 205 of fitting 202, wall 209 may include a first distal wall opening 214 of a first flushing cavity 212 and a second distal wall opening 218 of a second flushing cavity 216. The first distal wall opening 214 and the second distal wall opening 218 may be configured to supply fluid from fitting 202 to cap 300, as described below. Figures 3A to 3C A more detailed description.

[0063] Additionally, the fitting 202 may include one or more bending lumens extending from the proximal end 203 to the distal end 205 of the fitting 202 within the wall 209, such as a first bending lumen 220 and a second bending lumen 224. At the proximal end 203 of the fitting 202, the wall 209 may include a third proximal wall opening 221 of the first bending lumen 220 and a fourth proximal wall opening 223 of the second bending lumen 224. At the distal end 205 of the fitting 202, the wall 209 may include a third distal wall opening 222 of the first bending lumen 220 and a fourth distal wall opening 226 of the second bending lumen 224. To integrate the bending mechanism 250 with the conduit 200, the first bending lumen 220 and the second bending lumen 224 can respectively receive the distal ends of the first bending wire 252 and the second bending wire 254 via a third proximal sidewall opening 221 and a fourth proximal sidewall opening 223 at the proximal end 203 of the fitting 202. The distal ends of the first bending wire 252 and the second bending wire 254 can then extend through and distally cross the first bending lumen 220 and the second bending lumen 224 via the third distal sidewall opening 222 and the fourth distal sidewall opening 226, respectively. The distal ends of the first bending wire 252 and the second bending wire 254 can then be received by the cap 300 and secured to it, as described below. Figures 3A to 3C A more detailed description.

[0064] As previously described, fitting 202 can be made of one or a combination of different types of plastic materials. In some examples, the distal end 205 of fitting 202, which at least forms a bending region (e.g., together with cap 300), can be made of a first material, while the proximal portion of fitting 202 can be made of a second material. The first material can be more flexible than the second material. For example, the first material can be expanded PTFE, and the second material can be PTFE. Expanded PTFE can be PTFE that has been expanded by a linear shrinkage process. Expanded PTFE has a lower density than PTFE. Lower density provides greater flexibility. Therefore, expanded PTFE at the bending region can provide a controlled area with increased flexibility for navigation and bending of fitting 202.

[0065] The proximal ends of the first bending wire 252 and the second bending wire 254 may be attached to the actuator 258. In some examples, the actuator 258 may be a lever mechanism that can be moved up or down or pushed to actuate the first bending wire 252 and the second bending wire 254. Alternatively or additionally, the actuator 258 may include a sliding mechanism, a rotating mechanism (e.g., a knob), a pushing mechanism, etc., to actuate the first bending wire 252 and the second bending wire 254. Actuating the first bending wire 252 and the second bending wire 254 may bend or move the bending region 260 (e.g., including the region where the conduit 200 is coupled to the cap 300 at the distal portion 201) along a first orientation plane (e.g., move to the right and left or up and down).

[0066] Figure 2A and Figure 2B The bending mechanism 250 is shown as having two bending wires and one actuator. However, in other examples, the bending mechanism 250 may have more or fewer bending wires. Additionally, in examples where the bending mechanism 250 may include more bending wires, the bending mechanism 250 may include at least two actuators to allow the bending region 260 to move in at least two directions (e.g., up and down, and left and right). For example, the bending mechanism 250 may include four bending wires, with two bending wires attachable to a first actuator and two bending wires attachable to a second actuator.

[0067] Furthermore, when the bending mechanism 250 may have more or fewer bending wires, the fitting 202 may have more or fewer bending cavities for receiving the bending wires. The first flushing cavity 212 and the second flushing cavity 216 may be alternatively configured, positioned, and / or arranged based on the number and corresponding positions of the bending cavities for receiving the bending wires. For example, if the bending mechanism 250 includes four bending cavities to receive four bending wires, these bending cavities may be positioned perpendicular (90 degrees) to each other within the wall 209 of the fitting 202. In one example configuration, each of the first flushing cavity 212 and the second flushing cavity 216 may be divided into two parts by one of the bending cavities (e.g., forming a total of four flushing cavities). In another example configuration, the first flushing cavity 212 and the second flushing cavity 216 may be configured such that the first flushing cavity 212 and the second flushing cavity 216 are arranged or formed around or between the bending cavities. Flushing lumens of any configuration and / or arrangement (such as first flushing lumen 212 and second flushing lumen 216) can be used, wherein the flushing lumens are located radially outside the central lumen 206 (e.g., at least partially surrounding the central lumen).

[0068] Figures 3A to 3C Different views of a cap 300 configured to connect to the distal portion 201 of a conduit 200 are depicted. For example, Figure 3A A three-dimensional drawing of Hat 300 is depicted. Figure 3B A transparent three-dimensional view of the cap 300 is depicted, in which dashed lines indicate the internal structure of the cap 300 or... Figure 3B The structure that is otherwise not visible on the outside of the cap 300 in the view. Figure 3C A plan view of the proximal end 302 of the cap 300 is depicted. The cap 300 may be made of plastic, metal, or other similar materials. The cap 300 may be formed using 3D printing or may be machine-made.

[0069] Also refer to Figures 3A to 3CThe cap 300 may include a central lumen 306 extending from the proximal end 302 of the cap 300 to the distal end 304 of the cap 300. The central lumen 306 may include a proximal opening 307 at the proximal end 302 and a distal opening 308 at the distal end 304. The diameter of the proximal opening 307 may correspond to the inner diameter 204 of the fitting 202 of the catheter 200, such that when the cap 300 is distally connected to the catheter 200, the central lumen 306 of the cap 300 extends beyond the central lumen 206 of the catheter 200 to form a continuous lumen configured to receive the probe 120 and fluid flow from the fluid source 150. In other words, the central lumen 206 of the catheter 200 may be a first portion of the continuous central lumen, and the central lumen 306 of the cap 300 may be a second portion of the continuous central lumen distal to the first portion. As a result, fluid from fluid source 150 can flow through the central lumen 206 of fitting 202, enter the central lumen 306 via proximal opening 307, and exit the central lumen 306 via distal opening 308. In some aspects, this continuous lumen can be further extended via a single-lumen conduit distally coupled to or otherwise integrated with the cap 300 (e.g., a third portion forming the continuous central lumen distal to the second portion), as described in more detail below.

[0070] The cap 300 may include one or more flushing lumens extending from its proximal end 302 to a terminating end proximal to its distal end 304, including a first flushing lumen 312 and a second flushing lumen 316. For example, the first flushing lumen 312 of the cap 300 may correspond (align) with the first flushing lumen 212 of the fitting 202 to extend the first flushing lumen 212 to the first terminating end 313. In other words, the first flushing lumen 212 of the fitting 202 and the first flushing lumen 312 of the cap 300 may form from the proximal end 203 of the fitting 202 (… Figure 2B A continuous first flushing lumen extends to the first termination end 313. For example, a first proximal opening 311 of the first flushing lumen 312 on the proximal surface of the proximal end 302 of the cap 300 may correspond (align) with a first distal wall opening 214 of the first flushing lumen 212 of the fitting 202. The first distal opening 314 of the first flushing lumen 312 may be located at the first termination end 313 to allow fluid received from the fluid source 150 via the first flushing lumen 212 and the first flushing lumen 312 to drain at the first termination end 313. The first distal opening 314 may be the most distal opening of the continuous first flushing lumen.

[0071] Similarly, the second flushing lumen 316 of the cap 300 can correspond (align) with the second flushing lumen 216 of the fitting 202 to extend the second flushing lumen 216 to the second termination end 317. In other words, the second flushing lumen 216 of the fitting 202 and the second flushing lumen 316 of the cap 300 can be formed from the proximal end 203 of the fitting 202 ( Figure 2B A continuous second flushing lumen extends to the second termination end 317. For example, a second proximal opening 315 of the second flushing lumen 316 on the proximal surface of the proximal end 302 of the cap 300 may correspond (align) with a second distal wall opening 218 of the second flushing lumen 216 of the fitting 202. The second distal opening 318 of the second flushing lumen 316 may be located at the second termination end 317 to allow fluid received from the fluid source 150 via the second flushing lumen 216 and the second flushing lumen 316 to drain at the second termination end 317. The second distal opening 318 may be the most distal opening of the continuous second flushing lumen.

[0072] In some examples, and such as Figures 3A to 3B As shown, the portion of the cap 300 adjacent to the first termination end 313 and the second termination end 317 may be tilted inward or at an angle toward the central longitudinal axis of the cap 300. In other examples, the portion of the cap 300 adjacent to the first termination end 313 and the second termination end 317 may be substantially perpendicular to the central longitudinal axis of the cap 300.

[0073] As described in detail below, when the cap 300 is coupled to the conduit 200 to form at least a portion of the bendable ultrasound imaging device, the first termination end 313 and the second termination end 317 can be positioned proximal to the distal portion 122 of the probe 120, including the transducer 124, within the bendable ultrasound imaging device or relative to the fixed position of the bendable ultrasound imaging device. Proximal positioning helps ensure that fluid discharged via the first distal opening 314 and the second distal opening 318 at the first termination end 313 and the second termination end 317 of the cap 300 flushes out (e.g., displaces) air, such that the fluid at least partially surrounds the transducer 124 radially. This flushing can supplement and enhance the effect of the fluid discharged via the distal opening 308 of the central lumen 306 to improve sound wave transmission.

[0074] The interior of the cap 300 may include a step 330 (e.g., a lug or shelf) or other similar structure. In some embodiments, the step 330 may be configured to receive and secure a distal component of an adjustable-bend ultrasound imaging device to the cap 300 and the conduit 200, as referenced below. Figures 5A to 5D A more detailed description is provided. As shown in the figure, step 330 can be an annular step, wherein the inner diameter of step 330 corresponds to the central lumen 306, so that probe 120 can still extend through the central lumen 306 and cross the central lumen distally.

[0075] like Figure 3B and Figure 3C As shown, the cap 300 may further include one or more bending cavities, including a first bending cavity 320 and a second bending cavity 324. The first bending cavity 320 extends distally from a first bending opening 322 on a proximal surface of the proximal end 302, partially passing through the cap 300. The second bending cavity 324 extends distally from a second bending opening 326 on a proximal surface of the proximal end 302, partially passing through the cap 300.

[0076] For reference Figures 2A to 2B As shown and described, the distal ends of the first bending wire 252 and the second bending wire 254 can extend distally across the first bending cavity 220 and the second bending cavity 224 via the third distal sidewall opening 222 and the fourth distal sidewall opening 226. The first bending opening 322 and the second bending opening 326 of the cap 300 can correspond (align) with the third distal sidewall opening 222 and the fourth distal sidewall opening 226, respectively. Accordingly, the distal ends of the first bending wire 252 and the second bending wire 254 can be received by the first bending cavity 320 and the second bending cavity 324 via the first bending opening 322 and the second bending opening 326, respectively. Thus, one or more attachment or fixing mechanisms (e.g., adhesives, welding, etc.) can be used to fix the distal ends of the first bending wire 252 and the second bending wire 254 within the first bending cavity 320 and the second bending cavity 324 (e.g., to the walls of the first bending cavity and the second bending cavity) to connect the first bending wire 252 and the second bending wire 254 to the cap 300.

[0077] In some examples, and as described in more detail below, an adjustable-bend ultrasound imaging device, at least partially formed by catheter 200, cap 300, and bending mechanism 250, can be inserted into and navigated through a human lumen (e.g., through an airway in the peripheral region of the lung). In addition to the rigidity of at least catheter 200, the maneuverability provided by bending mechanism 250 facilitates this navigation. Furthermore, when the adjustable-bend ultrasound imaging device is positioned near a desired target, the maneuverability provided by bending mechanism 250 allows for adjustment of probe 120, and specifically transducer 124, relative to the target area to help improve image quality. Specific examples of adjustable-bend ultrasound imaging devices, at least partially formed by catheter 200, cap 300, and / or bending mechanism 250, are described below.

[0078] Figures 4A to 4CA second ultrasound imaging device 400 is depicted; for brevity, it will be referred to as device 400 below. Device 400 may replace device 102 in system 100 (e.g., it may be used in place of or interchangeably with it). For example, device 400 may be electrically and / or mechanically connected to control unit 130, display device 140, and / or fluid source 150, as referenced above. Figure 1A Detailed description. Device 400 may include two separate devices, namely a first device 402 and a second device 404. Each of the first device 402 and the second device 404 may be a single-use device or a disposable device, such that device 400 as a whole is a single-use device. Alternatively, one of the first device 402 or the second device 404 may be a reusable device. Figure 4A A perspective view depicting the distal portion of the first device 402 is shown. Figure 4B A perspective view depicts a second device 404 received by the distal portion of the first device 402 and extending distally from that distal portion. Figure 4C Depicting along Figure 4B The cross-sectional view of device 400 taken by line 4C.

[0079] Also refer to Figures 4A to 4C The first device 402 may be a multi-lumen component, which includes a catheter 200 connected to a corresponding cap 300. (See above reference.) Figures 2A to 2B and Figures 3A to 3C As described in detail, the first flushing lumen 212 of the conduit 200 is in fluid communication with the fluid source 150 via a first proximal sidewall opening 213, and can extend from the first flushing lumen 312 of the cap 300 to a first termination end 313 including a first distal opening 314 (e.g., forming a continuous first flushing lumen). Similarly, the second flushing lumen 216 of the conduit 200 is in fluid communication with the fluid source 150 via a second proximal sidewall opening 217, and can extend from the second flushing lumen 316 of the cap 300 to a second termination end 317 including a second distal opening 318 (e.g., forming a continuous second flushing lumen). Therefore, fluid supplied from the fluid source 150 can be received by the continuous first flushing lumen and the second flushing lumen and flow distally through the continuous first flushing lumen and the second flushing lumen, and exit from the first distal opening 314 and the second distal opening 318, respectively.

[0080] Alternatively, the first device 402 may be an adjustable bend multi-lumen component, which further includes an adjusting mechanism, such as the one described above. Figure 2B The bending mechanism 250 is described in detail, and it is integrated with the conduit 200 and the cap 300. For example, and as... Figure 4CAs shown, the distal ends of the first bending wire 252 and the second bending wire 254 can be received by the first bending lumen 220 and the second bending lumen 224 of the conduit 200, respectively, and extend through the first bending lumen and the second bending lumen. The corresponding first bending lumen 320 and second bending lumen 324 of the cap 300 can then be configured to receive the distal ends of the first bending wire 252 and the second bending wire 254 and secure them to the cap 300. The proximal ends of the first bending wire 252 and the second bending wire 254 can be attached to the actuator 258. Figure 2B This is to actuate the first and second bending wires to move the bending region of the first device 402 along at least one directional plane (e.g., up / down, left / right, etc.), as described in more detail below. The bending region may include at least a cap 300. In some examples, the bending region may also include a portion of the conduit 200 connected to the distal portion of the cap 300.

[0081] Now for reference Figures 4B to 4C The second device 404 may include a catheter 405 having a single lumen 406 (e.g., a single-lumen catheter), the probe being received by the lumen 406 of the catheter 405 and positioned at a fixed location within the lumen (e.g., a visualization area or imaging window). In some examples, the second device 404 may be a commercially available ultrasound device. The second device 404 may be located via the central lumen 206 of the catheter 200 (… Figures 2A to 2B ) and the central lumen 306 of cap 300 ( Figures 3A to 3C The second device 404 is removably inserted into the first device 402 and extends through the first device arrangement. In some examples, the second device 404 may be less rigid (e.g., more flexible) than the first device 402.

[0082] The catheter 405 can also be in fluid communication with a fluid source 150. For example, the catheter 405 can be in fluid communication with the fluid source 150 via a proximal opening (not shown) of a lumen 406. As a result, when fluid is supplied from the fluid source 150, the fluid can also be received by the lumen 406 and flow distally through the lumen, and exit from the catheter 405 via a distal opening 408 of the lumen 406. As the fluid flows toward and exits the distal opening 408, the fluid can flow through the probe 120 positioned within the lumen 406.

[0083] With the transducer 124 of device 400 in an operational configuration, the distal portion of the second device 404 may extend distally beyond the distal end of the first device 402. In some examples, the outer surface of the conduit 405 and / or the inner surface of the lumen 406 may include one or more stop structures (not shown), such as barbs, stops, protrusions, or other similar structures. When the second device 404 is inserted and extends through the first device 402, the stop structure may limit the distance by which the second device 404 may extend distally from the first device 402. For example, the stop structure may be positioned at a location on the outer surface of the conduit 405, a predetermined distance proximal to the location of the transducer 124 at the distal portion 122 of the probe 120 within the lumen 406. This predetermined distance helps ensure that fluid discharged from the continuous first and second flushing lumens via the first distal opening 314 and the second distal opening 318 flushes (e.g., displaces) air, such that the fluid at least partially surrounds the portion of the conduit 405 including the transducer 124 radially. This can supplement and enhance the fluid supplied via the lumen 406 to improve sound wave transmission. Furthermore, the conduit 405 may have a narrower outer diameter / width than the diameter / width of the portion of the cap 300 defining the first and second distal openings 314 and 318, such that fluid from the first and second distal openings 314 and 318 can surround the conduit 405 and the transducer 124.

[0084] In some examples, the first device 402 can be independently inserted into a human lumen and navigated through the lumen (e.g., through an airway in the peripheral region of the lung) to a desired target area, and then the second device 404 can be inserted into the first device 402. Alternatively, the second device 404 can be inserted into the first device 402 before navigation through the human lumen. In addition to the rigidity of the first device 402 provided by at least the conduit 200, the maneuverability provided by the bending mechanism 250 included in and / or integrated with the first device can facilitate this navigation. Further, when the distal portion of the second device 404 extends through the first device 402 and distally over the first device setting, and is positioned near the desired target area to be imaged, the operator of the device 400 can actuate the actuator 258 on the handle 256. This actuation can cause movement (e.g., up and down or left and right) of the distal portion of the first device 402, which causes a corresponding movement of the second device 404 to adjust the position of the transducer 124 relative to the target area to help improve image quality.

[0085] Figures 5A to 5DA third ultrasound imaging device 500 is depicted, referred to as device 500 below for brevity. Device 500 may replace device 102 in system 100 (e.g., may be used in place of or interchangeably with it). For example, device 500 may be electrically and / or mechanically connected to control unit 130, display device 140, and / or fluid source 150. Device 500 may be a single-use device or a disposable device. Figure 5A A three-dimensional view of device 500 is depicted. Figure 5B A partially transparent stereoscopic view of device 500 is depicted. Figure 5C Depicting along Figure 5B The cross-sectional view of device 500 taken from line 5C. Figure 5D A front view of the distal end 503 of the device 500 is depicted.

[0086] Also refer to Figures 5A to 5D The device 500 may include a multi-lumen component 502 attached to the proximal end of a single-lumen fitting or catheter 504. The multi-lumen component 502 may include a catheter 200 coupled to a corresponding cap 300. (See above reference.) Figures 2A to 2B and Figures 3A to 3C As described in detail, the first flushing lumen 212 of the conduit 200 is in fluid communication with the fluid source 150 via a first proximal sidewall opening 213, and can extend from the first flushing lumen 312 of the cap 300 to a first termination end 313 including a first distal opening 314 (e.g., forming a continuous first flushing lumen). Similarly, the second flushing lumen 216 of the conduit 200 is in fluid communication with the fluid source 150 via a second proximal sidewall opening 217, and can extend from the second flushing lumen 316 of the cap 300 to a second termination end 317 including a second distal opening 318 (e.g., forming a continuous second flushing lumen). Therefore, fluid supplied from the fluid source 150 can be received by the continuous first flushing lumen and the second flushing lumen and flow distally through the continuous first flushing lumen and the second flushing lumen, and exit from the first distal opening 314 and the second distal opening 318, respectively.

[0087] The single-lumen catheter 504 may include a proximal opening 507 ( Figure 5C The single-lumen catheter 504 has a central lumen 506 with a distal opening 508. The proximal end of the single-lumen catheter 504 can be received by a cap 300 and secured to the cap using a fixation mechanism (e.g., adhesive, welding, etc.). For example, and as... Figure 5CAs shown, the proximal end of the single-lumen catheter 504 can be received and secured to the central lumen 306 of the cap 300, wherein the proximal end of the single-lumen catheter 504 abuts against the step 330 of the cap 300. The proximal opening 507 of the central lumen 506 can correspond (align) with the distal opening 308 of the central lumen 306 of the cap 300. Therefore, the central lumen 506 can extend the central lumen 206 of the catheter 200 and the central lumen 306 of the cap 300 to the distal end 503 of the device. In other words, the central lumen 206 can be a first portion of a continuous central lumen extending from the proximal end of the device 500 to the distal end 503 of the device 500, the central lumen 306 can be a second portion of the continuous central lumen, and the central lumen 506 can be a third portion of the continuous central lumen.

[0088] A continuous central lumen can be configured to receive probe 120. Additionally, the proximal opening 207 of the central lumen 206 at the proximal end of device 500 can be fluidly connected to a fluid source 150. As a result, fluid received from the fluid source 150 via the proximal opening 207 can flow distally from the proximal end of device 500 to the distal end 503 of device 500 via the continuous central lumen and exit from the distal opening 508. Therefore, fluid can flow through probe 120 received within the continuous central lumen to help improve sound wave transmission.

[0089] In some respects, probe 120 can be positioned at a fixed location within a continuous central lumen, such that the first termination 313 and the second termination 317 of the continuous first flushing lumen and second flushing lumen are proximal to transducer 124. For example, when probe 120 is positioned at a fixed location, the distal portion 122 of probe 120, including transducer 124, can be positioned towards the distal end 503 of device 500 within the central lumen 506 of single-lumen conduit 504. This proximal positioning helps ensure that fluid discharged from the continuous first flushing lumen and second flushing lumen via first distal opening 314 and second distal opening 318 flushes (e.g., displaces) air, such that the fluid at least partially surrounds the portion of single-lumen conduit 504 including transducer 124 radially (e.g., around the visualization area or imaging window). This proximal flushing of the fluid can supplement and enhance the fluid supplied via the continuous central lumen and discharged from distal opening 508 to further improve acoustic wave transmission. Furthermore, the single-lumen catheter 504 may have a narrower outer diameter / width than the portion of the cap 300 that defines the first distal opening 314 and the second distal opening 318, such that fluid from the first distal opening 314 and the second distal opening 318 can surround the single-lumen catheter 504 and the transducer 124.

[0090] Additionally, the multi-lumen component 502 can be an adjustable-bend multi-lumen component, which further includes an adjustment mechanism, such as the one described above. Figure 2B The bending mechanism 250 is described in detail, and it is integrated with the conduit 200 and the cap 300. For example, and as... Figure 5C As shown, the distal ends of the first bending wire 252 and the second bending wire 254 can be inserted into the first bending lumen 220 and the second bending lumen 224 of the conduit 200, respectively, and extend through the first bending lumen and the second bending lumen. The corresponding first bending lumen 320 and second bending lumen 324 of the cap 300 can then be configured to receive and secure the distal ends of the first bending wire 252 and the second bending wire 254 to the cap 300. The distal ends of the first bending wire 252 and the second bending wire 254 can be secured to the cap 300 using a securing mechanism (e.g., using adhesive, welding, etc.). The proximal ends of the first bending wire 252 and the second bending wire 254 can be attached to the actuator 258. Figure 2B This actuates the first and second bending wires to steer or move the bending region at the distal portion of the multi-lumen component 502 along at least one directional plane (e.g., up / down, left / right). The bending region may include at least a cap 300. In some examples, the bending region may also include a portion of the conduit 200 connected to the distal portion of the cap 300.

[0091] In some examples, the device 500 can be inserted into a human lumen and navigated through the lumen (e.g., through airways in the peripheral region of the lungs) to a desired target area. In addition to the rigidity of the device 500 provided by at least the catheter 200, the maneuverability provided by the bending mechanism 250 included in and / or integrated with the device 500 can facilitate this navigation. Furthermore, when the distal end 503 of the device 500 is positioned near the desired target area to be imaged, the operator of the device 400 can actuate the actuator 258 on the handle 256. This actuation can cause movement (e.g., up and down or left and right) of the bending region at the distal portion of the multi-lumen component 502, which causes a corresponding movement of the single-lumen catheter 504 to adjust the position of the transducer 124 relative to the target area to help improve image quality.

[0092] Figures 6A to 6D A fourth ultrasound imaging device 600 is depicted, referred to as device 600 below for brevity. Device 600 may replace device 102 in system 100 (e.g., may be used in place of it, or interchangeably used with it). For example, device 600 may be electrically and / or mechanically connected to control unit 130, display device 140, and / or fluid source 150. Device 600 may be a single-use device or a disposable device. Figure 6A A perspective view of the distal portion of the device 600 is depicted. Figure 6B A partially transparent three-dimensional view of the distal portion of the device 600 is depicted. Figure 6C Depicting along Figure 6BThe cross-sectional view of device 600 taken by line 6C. Figure 6D A front view of the distal end 603 of the device 600 is depicted.

[0093] Also refer to Figures 6A to 6D The device 600 may include a multi-lumen catheter, such as catheter 200, attached to the proximal end of the distal component 601. In some examples, and as described in more detail below, the distal component 601 may be an overmolded component. The distal component 601 may include a proximal portion 602 coupled to catheter 200, and a distal portion 604 extending from the proximal portion 602 to the distal end 603 of the device 600. The distal component 601 may be similar to cap 300 and single-lumen catheter 504, combined into a single integral piece. The distal component 601 may have any of the features of cap 300 and / or single-lumen catheter 504. The distal component 601 may also include a central lumen 606 extending through the proximal portion 602 and the distal portion 604.

[0094] The central lumen 606 may include a proximal opening 607 and a distal opening 608. The proximal opening 607 of the lumen 606 of the distal component 601 may correspond (align) with the distal opening 208 of the central lumen 206 of the catheter 200. As a result, the central lumen 606 can extend the central lumen 206 to the distal end 603 of the device 600. In other words, the central lumen 206 of the catheter 200 and the central lumen 606 of the distal component 601 may form a continuous central lumen from the proximal end (not shown) of the device 600 to the distal end 603 of the device 600. The continuous central lumen may be configured to receive the probe 120. In addition, the proximal opening 207 of the central lumen 206 ( Figure 2B The probe 120 can be fluidly connected to the fluid source 150. As a result, fluid received from the fluid source 150 via the proximal opening 207 can flow from the proximal end of the device 600 to the distal end 603 of the device 600 via a continuous central lumen, and exit from the distal opening 608. Thus, fluid can flow through the probe 120 received within the continuous central lumen to help improve sound wave transmission.

[0095] The proximal portion 602 of the distal component 601 may be cap-shaped and include a cap 300 and similar features. For example, the proximal portion 602 may include a first flushing lumen 612 (having any characteristics of a first flushing lumen 312) extending from the proximal end of the proximal portion 602 to a first terminating end 613 proximal to the distal portion 604 of the distal component 601. The first terminating end 613 may include a first distal opening 614 facing distally. The first distal opening 614 may be proximal to a fixed position of the distal portion 122 of the probe 120 within the lumen 606. For example, the first distal opening 614 may be located at a first predetermined distance proximal to the transducer 124.

[0096] The proximal portion 602 may also include a second flushing lumen 616 (having any characteristics of the second flushing lumen 316) extending from the proximal end of the proximal portion 602 to a second terminating end 617 proximal to the distal portion 604 of the distal component 601. The second terminating end 617 may include a second distal opening 618 facing distally. The second distal opening 618 may be proximal to the fixed position of the distal portion 122 of the probe 120 within the lumen 606. For example, the second distal opening 618 may be located at a second predetermined distance proximal to the transducer 124. In some examples, the first distal opening 614 and the second distal opening 618 may be located at the same predetermined distance proximal to the transducer 124 (e.g., the first and second predetermined distances may be substantially equal). In other words, the first distal opening 614 and the second distal opening 618 may be located at the same axial position along the device 102.

[0097] The first flushing lumen 212 of the catheter 200 can be accessed via the first proximal sidewall opening 213 ( Figure 2B The first flushing lumen 612 is in fluid communication with the fluid source 150 and can extend from the first flushing lumen 612 to the first termination end 613 of the proximal portion 602 of the distal component 601. For example, the proximal opening of the first flushing lumen 612 of the proximal portion 602 can correspond (align) with the distal opening of the first flushing lumen 212 of the conduit 200 to form a continuous first flushing lumen from the proximal end of the device 600 to the first termination end 613 of the device 600. Similarly, the second flushing lumen 216 of the conduit 200 can be via a second proximal wall opening 217 ( Figure 2B The device 600 is in fluid communication with the fluid source 150 and can extend from the second flushing lumen 616 to the second termination end 617 of the proximal portion 602 of the distal component 601. For example, the proximal opening of the second flushing lumen 616 of the proximal portion 602 can correspond (align) with the distal opening of the second flushing lumen 216 of the conduit 200 to form a continuous second flushing lumen from the proximal end of the device 600 to the second termination end 617 of the device 600. Thus, fluid supplied from the fluid source 150 can be received by the continuous first flushing lumen and the continuous second flushing lumen and flow distally through the continuous first flushing lumen and the continuous second flushing lumen, and exit from the first distal opening 614 and the second distal opening 618, respectively.

[0098] In some respects, the first termination 613 and the second termination 617 of the proximal portion 602 of the distal component 601 can be positioned proximal to the fixed position of the distal portion 122 of the probe 120 within the continuous central lumen. For example, the distal portion 122 of the probe 120, including the transducer 124, can be positioned within the distal portion 604 of the distal component 601 toward the distal end 603 of the device 600. The proximal positioning of the first termination 613 and the second termination 617 helps ensure that fluid discharged from the continuous first flushing lumen and second flushing lumen via the first distal opening 614 and the second distal opening 618, respectively, flushes out (e.g., displaces) air, such that the fluid at least partially surrounds the distal portion 604 of the distal component 601 including the transducer 124 radially (e.g., around the visualization area or imaging window). This proximal flushing of the fluid can supplement and enhance the fluid supplied via the continuous central lumen and discharged from the distal opening 608 to further improve acoustic wave transmission. Similar to the single-lumen catheter 504, the distal portion 604 may have a smaller outer diameter / width than the portion of the proximal portion 602 that defines the first distal opening 614 and the second distal opening 618, such that fluid from the first distal opening 614 and the second distal opening 618 can surround the distal portion 604 and the transducer 124.

[0099] Additionally, device 600 may include a bending mechanism and / or may be integrated with a bending mechanism, as described in the reference above. Figure 2B The bending mechanism 250 is described. In such examples, the proximal portion 602 of the distal component 601 may further include a first bending cavity 620 and a second bending cavity 624. For example, and as... Figure 6C As shown, the distal ends of the first bending wire 252 and the second bending wire 254 can be inserted into the first bending lumen 220 and the second bending lumen 224 of the catheter 200 respectively and extended distally through the first bending lumen and the second bending lumen. Figure 6B and Figure 6C The proximal portion 602 of the distal component 601 shown corresponds (aligns) with the first bending cavity 220 and the second bending cavity 224, respectively. The first bending cavity 620 and the second bending cavity 624 can thus be configured to receive the distal ends of the first bending wire 252 and the second bending wire 254. The distal ends of the first bending wire 252 and the second bending wire 254 can be fixed to the distal walls of the first bending cavity 620 and the second bending cavity 624. The proximal ends of the first bending wire 252 and the second bending wire 254 can be attached to the actuator 258. Figure 2BThis actuates the first and second bending wires to cause the bending region at the distal portion of the device 600 to turn or move along at least one directional plane (e.g., up / down, left / right). The bending region may include the proximal portion 602 of the distal component 601. In some examples, the bending region may also include the distal portion of the conduit 200 connected to the proximal portion 602 of the distal component 601.

[0100] In some examples, the device 600 can be inserted into a human lumen and navigated through the lumen (e.g., through an airway in the peripheral region of the lung) to a desired target area. In addition to the rigidity of the device 600 provided by at least the catheter 200, the maneuverability provided by the bending mechanism 250 included in and / or integrated with the device 600 facilitates this navigation. Furthermore, when the distal end 603 of the device 600 is positioned near the desired target area to be imaged, the operator of the device 400 can actuate the actuator 258 on the handle 256. This actuation can cause movement (e.g., up and down or left and right) of the bending region at the distal portion of the device 600, which causes a corresponding movement of the distal portion 604 of the distal component 601 to adjust the position of the transducer 124 relative to the target area to help improve image quality.

[0101] In some aspects, the distal component 601 can be formed via injection molding. In some examples, the proximal portion 602 can take the form of a cap similar to the cap 300 when placed in a mold together with the conduit 200. In such examples, the conduit 200 and the proximal portion 602, integrated with the first bending wire 252 and the second bending wire 254, can be placed in the mold and injected with material. The mold can be configured such that the material can be melted, for example, to form the distal portion 604 (and in some examples, the proximal portion 602), and the proximal portion 602 can be connected to the distal portion 604 to form the distal component 601. Additionally, the mold can be further configured to connect at least a portion of the distal component 601 to the conduit 200, for example, to secure or otherwise attach the distal component 601 to the conduit 200 to form the device 600.

[0102] In other examples, both the proximal portion 602 and the distal portion 604 can be formed by a mold. In such examples, a conduit 200 having integration with the first bending wire 252 and the second bending wire 254 can be placed within the mold and injected with material. The mold can be configured such that the material can be melted, for example, to form the proximal portion 602 and the distal portion 604 into a single distal component 601. Furthermore, the mold can be further configured to connect at least a portion of the distal component 601 to the conduit 200, for example, to secure or otherwise connect the distal component 601 to the conduit 200 to form the device 600.

[0103] In any of the above examples, the distal component 601 may be formed and coupled to the catheter 200 before the probe 102 is received and positioned in a fixed position by the continuous central lumen formed by the central lumen 206 of the catheter 200 and the central lumen 606 of the distal component 601.

[0104] In other respects, other known or future manufacturing processes (such as heat shrinking, reflow soldering, etc.) may be used to form the distal part 601 and / or device 600. In examples where injection molding or other similar manufacturing processes are used to form device 600, the conduit 200 and the distal part 601 (including both the proximal portion 602 and the distal portion 604) may be formed from thermoplastic materials (such as Pebax and / or nylon).

[0105] While the principles of this disclosure have been described herein with reference to illustrative examples of specific applications, it should be understood that this disclosure is not limited thereto. Those skilled in the art and those who have received the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents fall within the scope of the examples described herein. Therefore, the invention should not be considered limited to the foregoing description.

Claims

1. A medical device comprising: A central lumen extending from the proximal end to the distal end of the medical device and configured to receive a probe, wherein the distal portion of the probe includes a transducer configured to perform ultrasound imaging, and wherein, in the configuration where the probe is received by the central lumen, the transducer is positioned at a fixed position relative to the medical device; and A flushing lumen extending from the proximal end of the medical device to its farthest opening, wherein the flushing lumen is located radially outside the central lumen, wherein the flushing lumen is in fluid communication with a fluid source at the proximal end of the medical device, and wherein the farthest opening is proximal to the fixed position such that a flow of fluid received from the fluid source and discharged from the flushing lumen via the farthest opening at least partially surrounds the transducer radially.

2. The medical device as claimed in claim 1, wherein, The flushing lumen is a first flushing lumen extending from the proximal end of the medical device to a first distal opening on the proximal side of the fixed position, and the medical device further includes: A second flushing lumen extends from the proximal end of the medical device to a second distal opening of the second flushing lumen and is located radially outside the central lumen, wherein the second flushing lumen is in fluid communication with the fluid source at the proximal end of the medical device, and the second distal opening is located proximal to the fixed position.

3. The medical device as claimed in claim 1 or 2, wherein, The central lumen is in fluid communication with the fluid source at the proximal end of the medical device, and wherein the central lumen is further configured to provide fluid received from the fluid source to flow through the central lumen to the distal end of the medical device.

4. The medical device as claimed in any one of claims 1 to 3, wherein, The medical device includes: outer sheath; and An inner sheath, located within and extending distally from the outer sheath, wherein the central lumen is the lumen of the inner sheath, and wherein the flushing lumen is between the inner and outer sheaths.

5. The medical device as claimed in any one of claims 1 to 3, wherein, The medical device includes: A multi-lumen catheter, the multi-lumen catheter comprising a first portion of the central lumen and a first portion of the flushing lumen; and A cap, connected to the multi-lumen catheter, the cap including a second portion of the central lumen and a second portion of the flushing lumen to extend the flushing lumen to the distal opening.

6. The medical device as claimed in claim 5, wherein, The medical device further includes: A bending wire is connected to the cap, wherein the bending wire is configured to bend the distal portion of the medical device.

7. The medical device as claimed in claim 6, wherein, The multi-lumen catheter further includes a bending lumen, wherein the bending wire extends through the bending lumen, and wherein the distal end of the bending wire extends to the distal side of the most distal end of the bending lumen; and The cap further includes a bending cavity aligned with the bending tube, wherein the bending cavity receives the distal end of the bending wire, and wherein the distal end of the bending wire is fixed to the cap.

8. The medical device as claimed in any one of claims 5 to 7, wherein, At least the distal portion of the multi-lumen catheter and the cap form a bending region, wherein the distal portion of the multi-lumen catheter includes a first material that is more flexible than a second material constituting the proximal portion of the multi-lumen catheter.

9. The medical device as claimed in any one of claims 5 to 8, wherein, The multi-lumen catheter and the cap connected to the multi-lumen catheter are a first device, and wherein the medical device further includes a second device, the second device comprising: Single-lumen catheters; and The probe, wherein the probe is received within the lumen of the single-lumen catheter, wherein the single-lumen catheter is configured to be received by and extend through the central lumen of the first device, such that the distal portion of the single-lumen catheter including the transducer extends distally across the first device.

10. The medical device of claim 9, wherein, With the transducer in operation, the distal portion of the single-lumen conduit is positioned such that the distal opening of the flushing lumen of the first device is located at a predetermined distance proximal to the transducer.

11. The medical device as claimed in any one of claims 5 to 8, wherein, The multi-lumen catheter is coupled to the proximal end of the cap, and wherein the medical device further comprises: A single-lumen catheter, the single-lumen catheter being coupled to the distal end of the cap and extending distally from the distal end of the cap to the distal end of the medical device, the single-lumen catheter including a third portion of the central lumen, wherein, when the probe is received by the central lumen, the fixed position where the transducer is located is located within the single-lumen catheter.

12. The medical device as claimed in any one of claims 1 to 3, wherein, The medical device includes: A multi-lumen catheter, the multi-lumen catheter comprising a first portion of the central lumen and a first portion of the flushing lumen; and An overmolded component is attached distally to the multi-lumen catheter.

13. The medical device of claim 12, wherein, The overmolded component includes: The proximal portion includes a second portion of the central lumen and a second portion of the flushing lumen to extend the flushing lumen to the distal opening; and The distal portion includes a third portion of the central lumen.

14. The medical device of claim 13, wherein, When the probe is received by the central lumen, the fixed position of the transducer is located within the distal portion of the overmolded component.

15. The medical device of claim 13, further comprising: A bending wire, which is integrated with the proximal portion of the multi-lumen catheter and the overmolded component, wherein the bending wire is configured to bend the distal portion of the medical device.

Images