Navigation catheter assembly with an endoscopic vision probe

Abstract

The assembly (100) for intravascular navigation includes a guiding catheter (10), an endoscopic probe (20), and a fluid delivery module (13). The guiding catheter includes a lumen (12) having an outlet aperture (122) at its distal end (102). The endoscopic probe (20) includes a flexible probe body (21) and an imaging device (22) attached to the probe body at the distal end. The probe body and the imaging device are sized to be slidably received within the lumen (12). The fluid delivery module (30) disposed at the proximal end of the guiding catheter (10) includes a first port (321) in communication with the lumen (12) for receiving the endoscopic probe (20), and a second port (322) in fluid communication with the lumen for delivering fluid to the lumen. The first port (321) includes a fluid seal (34) configured to fluid-tightly seal the first inlet port (321) against the probe body (21) while the second port (322) remains in fluid communication with the lumen (12).

Description

Technical Field

[0001] The present disclosure relates to a catheter assembly that enables enhanced navigation and endoscopic imaging beyond the reach of conventional endoscopes, particularly in small lumens.

Background Art

[0002] The deep lung is a system in which internal lumens (bronchi) form a complex maze that is difficult to explore, ranging from small to very small. Furthermore, endoscopic imaging of these structures is difficult due to the presence of physiological fluids. Since a respiratory physician needs to access the deep lung in order to continue a biopsy during a lung cancer screening, several techniques for accessing the deep lung have been developed.

[0003] One such approach is fluoroscopic imaging combined with electromagnetic navigation. The catheter is equipped with a trackable marker that is monitored as the catheter is moved within the body. The position of the catheter is synthesized onto a fluoroscopic image or other image obtained from an external source. The drawback of this technique is that only virtual or indirect visualization of the target anatomical features can be obtained.

[0004] (Patent Document 1) describes a flexible tubular catheter having an internal channel sized to receive an image capture probe. The image capture probe is distally extendable beyond the distal end of the catheter and includes a distal portion having a stereo camera or a monocular camera that captures a video image or an ultrasonic image provided to a tracking system. One or more external images of the patient's anatomical structure are obtained from an external imaging device located outside the patient's anatomical structure. The external images include images of the catheter and the imaging probe. The relative position between the imaging probe and the distal end of the catheter is determined based on the external images and / or additional sensors provided on the catheter and the imaging probe, such as electromagnetic sensors. The relative orientation between the imaging probe and the distal end of the catheter is determined by aligning the distal end of the catheter with an anatomical landmark and detecting the anatomical landmark in the image from the imaging probe. Alternatively, sensors for determining a roll angle are provided on the catheter and the imaging probe to detect the relative orientation. By doing so, an image of a target structure created by the imaging probe can be presented to a virtual anatomical model of the patient's anatomical structure.

[0005] The disadvantages of the above system are that it is complex to obtain a virtual visualization although the anatomical target position is appropriate, and it is costly. Yet another disadvantage is that physiological fluids may render the video images captured by the imaging probe useless. For this reason, ultrasonic imaging probes are preferred. However, ultrasonic images require further interpretation.

[0006] (Patent Document 2) describes a surgical instrument having a hollow guide shaft that accepts both an endoscope and an expandable catheter. By positioning a camera, a light source, and a pair of suction openings coaxially at the distal end face, the endoscope can be made smaller. In addition, a plurality of irrigation openings extend radially through the annular side wall of the endoscope. To obtain a small and integrated structure, all camera and light source wires, as well as suction and irrigation channels, can be embedded in an integrated endoscope body, but the diameter size of the endoscope body inevitably becomes larger, thereby reducing the navigation ability of the endoscope in a small cavity. As an alternative, the suction and irrigation channels can be made smaller, but this increases the pressure loss when fluid flows through the channels of the endoscope, thereby reducing performance.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0008] Therefore, in this technical field, there is a need to provide a catheter system having improved navigation and / or imaging capabilities compared to prior art catheter systems, particularly with respect to navigation and visualization in small, remote cavities such as deep in the lungs. There is a need to provide such a catheter system that is less complex and / or more economical in this technical field.

Means for Solving the Problems

[0009] Accordingly, according to the present disclosure, an assembly for intravascular navigation as recited in the appended claims is provided. The assembly according to the present disclosure includes a guiding catheter and an endoscopic probe. The guiding catheter includes an elongate flexible tubular catheter body defining a lumen having an exit aperture at a distal end of the guiding catheter. The endoscopic probe includes an elongate flexible probe body and an imaging device attached to the distal end of the probe body and configured to capture a visual image, particularly a (video) camera or the like. The probe body and the imaging device are sized to be slidably received within the lumen.

[0010] According to a first aspect, the assembly according to the present disclosure advantageously includes a fluid delivery module attached to or attachable to a proximal end of the guiding catheter. The fluid delivery module includes a first port configured to receive the endoscopic probe such that the first port is in communication with the lumen and is configured to deploy the endoscopic probe through the lumen, and a second port configured to deliver fluid to the lumen. The first port includes a fluid seal configured to fluid-tightly seal the first inlet port against the probe body while the second port remains in fluid communication with the lumen. Advantageously, the fluid seal is configured to slidably receive the probe body while enabling the fluid-tight sealing of the first insertion port. The fluid seal can be further configured to tighten a sealing member against the probe body.

[0011] One advantage of the assembly provided with the fluid delivery module is that, while the endoscope probe is housed in the lumen, the lumen of the guiding catheter can be flushed with the fluid supplied through the second inlet port. Such flushing can clean the external components of the imaging device, such as the lens, which may be wetted by body fluids during intraluminal navigation. By doing so, the endoscope probe advantageously does not need to include any fluid supply or fluid suction channels and can thus be made of a small diameter. In addition, by combining a guiding catheter that slidably receives the endoscope probe, navigation functions, such as a torque transmission function, can be incorporated into the guiding catheter, and the diameter of the endoscope probe body can be kept small. As a result, a very small assembly can be obtained while still providing complete navigation and endoscope functions. This assembly can further eliminate the need for a plurality of channels, etc., and thus has a very simple structure and is therefore more economical than prior art devices. Furthermore, due to the simple structure, some components, particularly the endoscope probe, which is the most expensive component, can be easily cleaned and / or sterilized, and thus at least some components of the assembly can be advantageously reused.

[0012] According to a second aspect of the present disclosure, which can be provided in addition to or in place of the first aspect, the assembly according to the present disclosure advantageously further comprises a mounting module. The mounting module comprises a connector system configured to fix the mounting module to a support such as the handle of an endoscope and advantageously to provide access to the instrument channel of the endoscope. The mounting module can further comprise a telescopic tubular body extending from a first end to a second end opposite the first end and defining an internal channel of the mounting module sized to slidably receive the catheter body. The connector system is advantageously provided at the second end.

[0013] Advantageously, the attachment module further comprises a handle member and a first locking system configured to lock the movement of the guiding catheter relative to the handle member with respect to at least one of translation along the longitudinal axis of the telescopic tubular body and rotation about the longitudinal axis, the first locking system being attached to the telescopic tubular body at the first end. Advantageously, the guiding catheter comprises a first connector member, which can be arranged at the proximal end of the guiding catheter, and is advantageously configured to be releasably interlocked with the corresponding connector member of the first locking system so as to enable an integral movement of the guiding catheter and the handle member. The attachment module can further comprise a second locking system configured to axially fix the guiding catheter relative to the connector system and / or the support, and this second locking system can be arranged at the second end.

[0014] One advantage of the assembly according to the second aspect is that it facilitates navigation extended beyond the reach of conventional endoscopes. Specifically, the attachment module provides easier but more accurate manipulation of the guiding catheter, which facilitates distal navigation of the guiding catheter and the endoscope probe, thereby improving visualization of anatomical structures and enabling improved diagnosis.

[0015] Advantageously, the assembly further comprises an endoscope, which comprises an endoscope handle connected to an endoscope body. The endoscope body comprises an instrument channel (commonly referred to as a working channel), the endoscope handle comprises an insertion port in communication with the instrument channel, and the guiding catheter is configured to be slidably received within the instrument channel and through the insertion port. The endoscope can further comprise a second imaging device arranged at the distal end of the endoscope body. The endoscope handle can form a support and can comprise connector parts configured to cooperate with the connector system to attach the attachment module to the endoscope handle.

[0016] In another aspect, methods of performing an endoscopic examination are disclosed herein, particularly for performing an endoscopic examination in the pulmonary ducts. These methods utilize the assembly according to the present disclosure. In a first operation, a guiding catheter is inserted into an anatomical cavity or lumen. The guiding catheter can be inserted directly or through the instrument channel of an endoscope, and an attachment module of the assembly can be attached to this instrument channel. In an optional second operation, the guiding catheter is distally deployed beyond the distal tip of the endoscope, optionally by operating the handle member of the attachment module to which the guiding catheter is attached. In a third operation, the guiding catheter is advanced through the anatomical cavity or lumen. The guiding catheter is advanced, for example, beyond the distal tip portion of the endoscope. In a fourth operation, an image is captured by an imaging device at the distal tip of the endoscopic probe. These images can be displayed on a proximal visual display. In an optional fifth operation, for example, when the guiding catheter and / or the endoscopic probe reach an anatomical target location, the guiding catheter can be fixed in place relative to the endoscope by operating the second locking system of the attachment module. In a sixth operation, external components such as the lens or screen of the imaging device of the endoscopic probe may be soiled or stained by body fluids during advancement, impairing proper visualization. Fluid is supplied into the lumen through the second inlet port of the fluid delivery module (e.g., by operating a flow control valve) to flush and clean the distal tip of the endoscopic probe. For this purpose, the endoscopic probe can be retracted until the imaging device (distal portion) is fully housed inside the lumen of the guiding catheter, is in the same plane as the distal tip of the guiding catheter, or extends at least partially from the distal tip. At this time, the imaging device is ready to be redeployed at or beyond the exit aperture of the guiding catheter.In a seventh operation that can be performed in addition to or instead of the sixth operation, the endoscopic probe is retracted into the lumen, and advantageously, the imaging device is completely within the lumen of the guiding catheter, i.e., the imaging device is proximal to the exit aperture of the lumen. As a result, a porthole effect occurs, and anatomical structures can be suitably imaged by the imaging device while within the lumen. Optionally, the distal tip of the catheter body or the exit aperture is held in contact with the anatomical target structure. By doing so, the distal tip of the catheter body advantageously maintains the anatomical structure in the desired position while being imaged by the imaging device. In an optional eighth operation, a diagnostic or surgical procedure can be performed, including the measurement of anatomical structures. Additionally or alternatively, the endoscopic probe is removed from the guiding catheter, and a surgical (e.g., biopsy) instrument is deployed through the guiding catheter. It will be understood that the order of operations described above is exemplary and that it is possible to change or perform several operations simultaneously.

[0017] Another method of performing an endoscopy according to the present disclosure, particularly a bronchoscopy or a bronchoscopy, is to advance an endoscopic device through an anatomical cavity or lumen until it reaches an anatomical standby position, and to deploy a guiding catheter according to an aspect of the present disclosure through an instrument channel of the endoscopic device. The guiding catheter can be deployed beyond the distal tip of the endoscope, for example, to reach an anatomical target position, which can be made immobile or fixed relative to a reference that can be the endoscope or a fixed reference attached to or external to the patient. The endoscopic probe is deployed through the guiding catheter to image the anatomical target position. To do so, the endoscopic probe can be deployed beyond the exit aperture of the guiding catheter or, alternatively, retracted from the exit aperture to provide a visual porthole effect for imaging the anatomical target position.

[0018] Advantageously, a navigation path along an anatomical cavity or lumen is determined, for example, based on medical imaging techniques, and an endoscope, guiding catheter and / or endoscopic probe is advanced along the navigation path. Advantageously, a trackable marker, in particular an electromagnetic responsive device, is tracked along the navigation path. The trackable marker can be incorporated into an endoscope, guiding catheter and / or endoscopic probe.

[0019] Advantageously, a virtual model of the anatomical cavity or lumen is determined. The virtual model is mapped to an image captured by an endoscope device and / or endoscopic probe based on positions determined through the trackable marker.

[0020] A probe with a trackable marker is deployed through an endoscope and / or guiding catheter, and the endoscope and / or guiding catheter including the tracking probe is advanced along the navigation path. The tracking probe can be retracted from the guiding catheter when the guiding catheter is at the anatomical target position, such that the tracking probe can be determined, in particular, by tracking the trackable marker. Advantageously, the (distal) position of the guiding catheter is fixed. With the tracking probe removed, the endoscopic probe according to aspects of the present disclosure can be deployed through the (lumen of the) guiding catheter, and the anatomical target position is imaged by the imaging device of the endoscopic probe. Based on the image captured by the imaging device, a visual inspection of the anatomical target position can be performed. Additionally or alternatively, a surgical instrument is deployed through the guiding catheter, and a surgical intervention such as a biopsy is performed at the anatomical target position.

[0021] Alternatively, the endoscopic probe according to aspects of the present disclosure can comprise a trackable marker and can act as a tracking probe in the above method.

[0022] Thus, in the method according to the present disclosure, an endoscopic probe advantageously enables a further visual inspection of an anatomical target position in order to verify the condition and / or position of the anatomical target position determined by a medical imaging technique by means of a detailed visual inspection. This is useful for appropriately evaluating the condition and / or position prior to performing a surgical intervention such as a biopsy.

[0023] Here, aspects of the present disclosure will be described in more detail with reference to the accompanying drawings, in which like reference numerals denote like features.

Brief Description of the Drawings

[0024]

Figure 1

Figure 2

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Figure 4

Figure 5A

Figure 5B

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Figure 8A

Figure 8B

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Figure 13

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Figure 16

DETAILED DESCRIPTION OF THE INVENTION

[0025] Referring to FIGS. 1-3, an exemplary assembly 100 includes a catheter 10, a probe 20, and a fluid delivery module 30. The catheter 10 extends from a proximal end 101, which, for example, coincides with the side closer to the operator, to a distal end 102, which is configured to reach, for example, an anatomical target location to be visualized. It will be understood that in this specification, the terms "proximal" and "distal" are used with reference to the operator who operates the assembly.

[0026] The catheter 10 includes an elongate flexible catheter body 11 that can extend from the proximal end 101 to the distal end 102. The catheter body 11 is tubular and includes a lumen 12 that reaches from an inlet aperture 121 at the proximal end 101 to an outlet aperture 122 at the distal end 102.

[0027] The catheter body 11 can be configured to be inserted into a natural or surgically created anatomical opening. Advantageously, as will be described in more detail later, the catheter body 11 is configured to be inserted into the instrument channel of a conventional endoscope. The outer diameter of the catheter body 11 is advantageously 3.0 mm or less, preferably 1.2 mm to 2.8 mm, and more preferably 1.5 mm to 2.8 mm.

[0028] The catheter body 11 is advantageously made of a radiopaque material or includes a radiopaque material so as to facilitate its localization by an external imaging technique such as, for example, computed tomography or fluoroscopy. Advantageously, the catheter body 11 is configured to transmit torque between the proximal end 101 and the distal end 102. Efficient torque transmission can be achieved by providing suitable reinforcing blades on the wall of the catheter body 11. By doing so, rotation about the longitudinal axis of the catheter body 11 occurring at the proximal end 101 can be transmitted to the distal end 102, enabling navigation within the anatomical cavity. Alternatively or in addition, the catheter can comprise an actuation system, for example with a cable or the like, to enable the catheter body to be maneuvered. Further or alternatively, the catheter body can be given a preformed shape, for example a bent, wavy or other suitable shape that facilitates navigation.

[0029] The catheter body 11 is advantageously straight at the distal end 102, although a slightly curved shape can also be contemplated. The outlet aperture 122 of the lumen 12 is advantageously located at the distal tip of the catheter body 11. The distal tip is advantageously atraumatic so as not to damage tissue while advancing through the anatomical cavity. By way of example, the outer peripheral edge of the distal tip of the catheter body 11 can be rounded and / or made of a softer material, such as an elastic material. In some examples, the reinforcing blades of the wall of the catheter body extend up to somewhat in front of the distal tip, and the distal tip preferably has no reinforcement.

[0030] At the proximal end 101, the catheter 10 can comprise a connector module 13, such as a screw connector or a luer lock fitting, for fluid-tightly connecting the catheter 10 to the fluid delivery module 30 in an advantageously releasable manner. The connector module 13 can comprise an inlet aperture 121. The proximal portion of the lumen 12 can extend through the connector module 13 until it proceeds into the catheter body 11. The connector module 13 can further comprise one or more locking members 131, the operation of which will be further described later.

[0031] The fluid delivery module 30 comprises a tubular body 31 having an internal channel 32. This comprises a first inlet port 321, a second inlet port 322 and an outlet port 323, all of which communicate with the channel 32. A connector 33 cooperates with the connector module 13 of the catheter 10 to fluid-tightly fix the catheter 10 and the fluid delivery module to each other. As a result, the channel 32 of the fluid delivery module 30 communicates with the lumen 12 of the catheter 10 via the outlet port 323 and the inlet aperture 121. Alternatively, it is also possible to manufacture the catheter 10 and the fluid delivery module 30 as a single integral structure and dispense with the connectors 13 and 33.

[0032] A first inlet port 321 that can be aligned coaxially with the outlet port 323 is configured to receive the insertion of the endoscope probe 20. The probe 20 is inserted through the channel 32 via the first inlet port 321 and further deployed through the lumen 12 via the outlet port 323 and the inlet aperture 121. A seal system 34 is preferably provided at or in relation to the first inlet port 321. The seal system 34 includes a sealing member 341, which is configured to fluid-tightly seal the channel 32 and / or the first inlet port 321 when the endoscope probe 20 is inserted therethrough. The sealing member 341 can be formed of a soft or elastic material, such as an elastomeric material. The sealing member 341 can include a through-hole configured to slidably receive the probe body 21. Optionally, the sealing member 341 can be housed within one or more cooperating, for example threaded, connector members 342, 343 configured to tighten and release the sealing member 341, as known in the art.

[0033] The second inlet port 322 communicates with the channel 32, preferably at a position downstream of the first inlet port 321. The second inlet port 322 is configured as a fluid delivery port and / or a fluid suction port. In use, the second inlet port 322 can be connected to an external fluid source 35. Preferably, a valve 351 (FIG. 1), such as a flow control valve, is provided in fluid communication with the second inlet port 322. The valve 351 can be connected to the fluid source 35 and operated to deliver fluid to the lumen 12 when necessary. By way of example, the valve 351 is a normally closed valve and includes an interface such as a control knob or push button as known in the art, which, when operated, opens the flow path of the valve 351 to supply fluid from the fluid source 35 to the second inlet port 322 and further to the lumen 12. The fluid source 35 can include, for example, a gas such as CO2 or air, or a liquid such as saline, physiological solution or contrast agent, the latter being particularly suitable for applications in the bile duct. The fluid source 35 can be a syringe. In that case, the valve 351 can be omitted.

[0034] With the endoscope probe 20 inserted and the sealing member 341 tightened against the probe 20, fluid can be delivered into the lumen 12 through the second inlet port 322. Thereby, fluid can be supplied to the lumen 12 while preventing the fluid from exiting from the first inlet port 321.

[0035] Referring to FIGS. 4, 5A, and 5B, the endoscope probe 20 includes an elongated flexible probe body 21. The probe body 21 has a length advantageously greater than the length of the catheter body 11 and can be fully inserted through the lumen 12 of the catheter 10 from the proximal end 101 to the distal end 102. In some cases, the endoscope probe 20 can be deployed beyond the distal tip portion (exit aperture 122) of the catheter 10.

[0036] An imaging device 22, preferably a video imaging device, is provided at the distal end of the endoscope probe 20. The imaging device 22 is preferably provided on the distal tip surface of the endoscope probe 20 and can include a camera 221 preferably configured to capture visual images. The camera 221 can be TM a CMOS (complementary metal oxide semiconductor) image sensor such as an Omnivision image sensor, an optical fiber imaging system, or any other suitable light-based imaging system capable of capturing, for example, visible light and / or infrared light. The camera 221 preferably includes an image sensor having a size of 1 mm × 1 mm or less. The camera 221 can further include one or more lenses forming, for example, the distal tip surface of the endoscope probe 20. The imaging device can further include a light source 222 provided by an optical fiber or a light emitting diode (LED). By way of example, the light source 222 can be arranged coaxially with the optical axis of the camera 221. The light source can be arranged circumferentially around the camera 221.

[0037] Returning to FIG. 1, the imaging device 22 is connected to an external control unit 40 by suitable wiring 41, such as an optical fiber and / or a conductive wire or cable. The control unit 40 can include a visual display 42 for displaying the images captured by the imaging device 22.

[0038] Referring again to FIGS. 4 and 5A and 5B, the imaging device 22 can be housed in the thickened distal portion 23 of the endoscope probe 20. The distal portion (head) 23 is attached to the probe body 21 at the distal end of the probe body 21. The distal portion 23 can have a substantially cylindrical or spherical shape, or any other suitable shape that is rotationally symmetric, for example, with respect to the longitudinal axis. The optical lenses of the imaging device 22, such as the camera 221 and / or the light source 222, are preferably disposed on the distal tip surface of the distal portion 23.

[0039] The inner cavity 12 preferably has a diameter D3 of 0.9 mm to 2.6 mm, preferably 1.2 mm to 2.4 mm, for example 2.1 mm. The distal portion 23 preferably has a cross-sectional size larger than the diameter D2 of the probe body 21, for example a diameter D1. The outer diameter D1 of the distal portion 23 is preferably 0.8 mm to 2.4 mm, preferably 1.0 mm to 2.0 mm. The diameter D1 is smaller than the diameter D3 of the inner cavity 12 of the catheter 10, enabling the deployment of the distal portion 23 throughout the inner cavity 12 (Figure 5B), and it will be understood that the probe body 21 can have a considerably smaller diameter D2, for example 0.5 mm to 1.8 mm, preferably 0.6 mm to 1.5 mm. The ratio of the diameter D2 of the probe body 21 to the diameter D3 of the inner cavity 12 is preferably 0.15 to 0.9, preferably 0.3 to 0.75, preferably 0.5 to 0.75. The ratio of the diameter D1 of the distal portion 23 to the diameter D3 of the inner cavity 12 is preferably 0.3 to 0.95, preferably 0.5 to 0.9, for example 0.83 to 0.95. Alternatively, the distal portion 23 can have the same diameter as the probe body 21. The axial length L1 of the distal portion 23 is preferably as small as possible while being able to accommodate a part of the imaging device 22. A suitable axial length L1 of the distal portion 23 is 2 mm to 15 mm, preferably 3 mm to 10 mm.

[0040] Preferably, the ratio of the outer diameter D1 of the distal portion 23 to the outer diameter D2 of the probe body 21 is 1.05 to 2, preferably 1.1 to 1.67. The distal portion 23 preferably has a fixed (i.e., non-expandable or non-deployable) shape with a fixed outer diameter, for example. In some examples, the distal portion includes or consists of a cylindrical portion having, for example, an axial length L1, and the cylindrical portion has a fixed outer diameter D1.

[0041] For example, by using the ratios shown above and reducing the diameter of the probe body 21 compared to the diameter of the distal portion 23, a larger cross-section of the lumen becomes available for fluid flow. Thus, with the endoscope probe 20 including the distal portion 23 inserted within the catheter 10, fluid can be more easily delivered from the second inlet port 322 of the fluid delivery module 30 through the lumen, resulting in a smaller fluid pressure loss for a given flow rate or a larger flow rate for a given pressure loss along the lumen 12. This enables wetting of the front portion of the distal portion by delivering fluid, thereby allowing for cleaning of any optical lenses of the imaging device 22, such as the front portion (lens) of the camera module 221 and / or the light source 222.

[0042] Advantageously, the ratio of the diameter D1 of the distal portion 23 to the axial length L1 of the distal portion is advantageously from 0.1 to 0.4, advantageously from 0.2 to 0.3, and particularly from 0.23 to 0.27. This ratio ensures optimal navigation of the endoscope probe 20 through the lumen 12, especially when inserted into an anatomical cavity or when the catheter body has a curved or bent portion. The larger the value of L1, the smaller the diameter D1 needs to be selected to enable proper navigation through a possible bend in the lumen of the catheter body. On the other hand, when L1 is small, the diameter D1 can be selected to be larger.

[0043] The probe body 21 preferably houses only the wiring 41 and a suitable sheath, regardless of the presence or absence of a reinforcing material. Advantageously, the probe body 21 has no internal channels with distal outlet apertures, such as fluid supply and / or suction channels, or instrument channels, thereby resulting in small dimensions and a simple structure, which is further easily washable and sterilizable for use on multiple patients. This can reduce the cost of the endoscope probe per intervention. Alternatively, the probe body 21 can comprise one or more of such internal channels if possible due to size limitations. The probe body 21 can comprise a reinforcing material, optionally embedded in a sheath, that provides an axial stiffness suitable for deploying the endoscope probe through the catheter 10 (lumen 12). This reinforcing material can be further configured to include or consist of blades that transmit torque and / or twist or rotation to continue navigation beyond the outlet aperture 122 of the catheter 10. The distal tip of the distal portion 23 can be made non-traumatic, for example, by appropriate filleting or rounding of the distal tip.

[0044] Furthermore, the distal portion 23, which is thicker compared to the diameter of the probe body 21, forms a shoulder or flange 231 that advantageously facilitates the advancement of the endoscope probe 20 through the lumen 12 while flushing the lumen with fluid from the second inlet port 322.

[0045] Referring to FIGS. 6 - 9, another exemplary assembly 200 includes the assembly 100 and further comprises a mounting module 50 configured to attach the assembly 100 to the handle 60 of the endoscope 70. The mounting module 50 comprises a distal portion 51, a proximal portion 52, and a connection portion 53 connecting the distal portion 51 to the proximal portion 52.

[0046] The distal portion 51 of the attachment module 50 comprises a connector system 54 configured to firmly fix or attach the attachment module 50 (its distal portion 51) to the handle 60. The endoscope handle 60 is connected to the elongate body 75 of the endoscope 70 and provides access to the instrument channel 71 of the endoscope (FIG. 10). The connector system 54 mates or locks with a cooperating connector part 62 provided on the handle 60, for example circumferentially, adjacent to the insertion port 61 of the handle 60 that communicates with the instrument channel 71. The connector system 54 is configured to fix the attachment module 50 (its distal portion 51) relative to the insertion port 61 of the handle 60, at least with respect to the degree of freedom of axial (translational) movement, for example via a snap-fit connector. The connector system 54 can further be configured to fix the attachment module 50 (its distal portion 51) so as not to rotate, for example, with respect to the handle 60 in one or more degrees of rotational freedom.

[0047] The attachment module 50 comprises an internal channel 56 that extends from the proximal portion 52 through the connection portion 53 to the distal portion 51. The insertion port 561 (FIG. 7) at the proximal portion 52 provides access to the internal channel 56. The discharge port 562 at the distal portion 51 provides an outlet for the internal channel 56 and access from the internal channel 56 to the instrument channel 71 of the endoscope 70. The discharge port 562 can be coaxially aligned with the connector system 54. The internal channel 56 has a diameter sized to allow the catheter 10 to pass through. The catheter 10 has its distal end 102 inserted through the inlet port 561 and advanced until it passes beyond the discharge port 562, where the catheter 10 enters the instrument channel 71 of the endoscope 70. Referring to FIG. 10, the catheter 10 is further advanced through the instrument channel 71 until it passes beyond the distal tip 72 of the endoscope 70. The endoscope 70 can comprise a camera 73 or other imaging sensor arranged at the distal tip 72 and configured to capture visual images. One or more light sources 74 can similarly be provided at the distal tip.

[0048] Referring again to FIGS. 6 - 9, a handle member 58 is provided at the proximal portion 52 of the attachment module 50. The handle member 58 is fixedly attached to the proximal end of the telescopic tubular body 57, and the length of the telescopic tubular body 57 can be extended in the proximal direction from the distal portion 51. The telescopic tubular body 57 preferably forms a connection portion 53, connects the handle member 58 to the distal portion 51 (discharge port 562), and defines an internal channel 56.

[0049] The handle member 58 can be operated by an operator, as will be described later. A lock connector 59 is provided at the proximal portion 52, preferably circumferentially with respect to the insertion port 561, and can be preferably incorporated into the handle member 58. The lock connector 59 cooperates with one or more lock members 131 of the connector module 13 of the catheter 10 to lock the movement of the catheter 10 relative to the handle member 58 with respect to one or more degrees of freedom. In particular, the lock member 131, preferably formed as a wing-shaped tab, is configured to engage without clearance in a corresponding slot 591 of the lock connector 59 to lock the rotation of the catheter 10 about the longitudinal axis 209 relative to the handle member 58 and / or to lock the translation of the catheter 10 along the longitudinal axis 209 relative to the handle member 58. The lock connector 59 preferably provides a releasable connection of the lock member 131, such as a snap-fit connector. It will be understood that the positions of the lock member 131 and the corresponding slot 591 can alternatively be reversed such that the lock member is provided on the lock connector 59 and the slot 591 is provided on the connector module.

[0050] When the locking member 131 of the catheter 10 is locked to the locking member 59, the operator can easily apply rotational and / or axial movement to the catheter 10 by operating the handle member 58. As an example, by pushing the handle member 58 distally, the members of the telescopic tubular body 57 are folded together, and as a result, the catheter 10 advances further distally inside the instrument channel 71 of the endoscope 70. Additionally or alternatively, the handle member 58 can be rotated about the longitudinal axis 209 relative to the endoscope handle 60 (and thus relative to the connector system 54 / distal portion 51), whereby rotation or torque is applied to the catheter 10 proximally, and this rotation or torque can be transmitted towards the distal end 102 through the structure of the catheter body 11. Thus, the attachment module 50 can facilitate the operation and navigation of the assembly, particularly beyond the distal tip of the endoscope 70.

[0051] The attachment module 50 can further include a locking system 55 that is configured to fix or lock the movement of the guiding catheter 10 relative to the distal portion 51, particularly relative to the connector system 54 and / or the instrument channel 71, with respect to one or more degrees of freedom. In one example, the locking system 51 is configured to lock or restrain the translational degree of freedom of the guiding catheter 10 along the longitudinal axis 209 relative to the distal portion 51 of the attachment module 50 and / or the instrument channel 71. The rotational degree of freedom of the guiding catheter 10 about the longitudinal axis 209 relative to the distal portion 51 / instrument channel 71 can be left free or can be further locked by the locking system 55.

[0052] In a specific example, the locking system 55 can include a sleeve 551, which is formed of a soft or elastic material, such as an elastomeric material, and has a through bore configured to pass through the guiding catheter 10. The sleeve 551 is housed within a housing 552, which can have, for example, a conical recess for receiving the sleeve 551. A member 553 is rotatable relative to the housing 552, thereby applying a force to the sleeve 551, which acts to reduce the diameter of the through hole of the sleeve 551, for example, by deforming the sleeve 551. The member 553 can be configured to rotate about the longitudinal axis 209, although other configurations and axes of rotation are possible as known in the art. The locking system 55 is preferably releasable.

[0053] The locking system 55 is advantageous when the guiding catheter 10 reaches its final or target position. Thus, the locking system 55 can be operated to fix the (axial) position of the guiding catheter 10 relative to the instrument channel 71 and the distal tip of the endoscope 70 without movement. This avoids the catheter 10 being inadvertently displaced from its desired position by any inadvertent operation of the handle member 58.

[0054] The guiding catheter 10, the fluid delivery module 30, and the attachment module 50 can be formed of one or a combination of polymers and / or synthetic materials, such as a medical grade silicone material and a medical grade thermoplastic material such as polypropylene or polycarbonate. At least some portions of the guiding catheter can be disposable. The endoscope probe 20 is preferably formed of a material that can be cleaned and / or sterilized between uses on different patients. At least some portions of the endoscope probe 20 can be reusable for use on different patients.

[0055] At least some portions of the catheter body 11 and / or the endoscope probe 20 can be formed of or include a radiopaque material to facilitate their localization. Referring to FIG. 5A, the catheter body 11 and / or the endoscope probe 20 can include one or more trackable markers 223 that enable (initial) tracking by electromagnetic navigation, optionally in combination with fluoroscopic imaging, as is known in the art. The trackable marker is preferably an electromagnetic responsive device disposed within or on any one of the catheter body 11, the probe body 21, and the distal portion 23 of the endoscope probe. In the present disclosure, electromagnetic navigation can be utilized in combination with visual guidance by the imaging device 22 to improve positioning accuracy and orientation within the body.

[0056] The probe body 21 preferably has a suitable axial stiffness or rigidity to prevent buckling while the endoscope probe is advanced or deployed through the lumen 12 of the guiding catheter 10. In some examples, the probe body 21 can include a central wire made of a nickel-titanium alloy (nitinol) or other suitable metal alloy, and a sheath. The central wire preferably forms the core of the probe body and is disposed within the sheath. Such a central wire can impart appropriate stiffness and buckling resistance to the probe body. Electrical and optical wires and cables can be similarly disposed within the sheath. The central wire and the sheath can extend substantially along the entire length of the probe body, for example, from the proximal end to the distal end of the probe body.

[0057] Referring to FIGS. 11-16, a method 80 of performing an endoscopic examination using an assembly as disclosed herein can begin with an operation 81 in which a lesion such as a pulmonary nodule (FIG. 12, arrow 91) is discovered within a patient's body. The lesion can be discovered by a medical imaging examination such as a computed tomography (CT) image 90 of the lung, or by computed tomography (CT) or fluoroscopy of a target anatomical cavity or lumen. A healthcare provider may wish to further examine the lesion and / or perform a biopsy to investigate its malignancy in more detail. This requires an endoscopic intervention. In operation 82, an endoscopic navigation is planned. Operation 82 can begin by generating a virtual model 93 of an anatomical cavity or lumen 96, such as a bronchus, that can be obtained through the medical imaging examination performed in operation 81. Based on the virtual model 93, a navigation path 95 can be planned to reach the lesion 94 defined from operation 81, for example, through the bronchus from the trachea.

[0058] In operation 83, a navigation through the anatomical cavity or lumen 96 along the planned path 95 is performed using an endoscope 70 such as a bronchoscope. The endoscope 70 can be inserted into the anatomical cavity or lumen 96 through an anatomically or surgically created artificial opening. The endoscope 70 is guided through the anatomical cavity or lumen 96 via an endoscopic vision provided by a camera 73 and a light source 74 of the endoscope 70.

[0059] In operation 84, the virtual model 93 of the anatomical cavity or lumen 96 can be mapped to the actual anatomical cavity or lumen 96 by mapping the virtual image 97 to the endoscopic image 98 of the actual anatomical cavity or lumen. For this purpose, trackable markers can be utilized to track the position of the endoscope advanced along the navigation path 95. Trackable markers such as electromagnetic markers can be provided on the endoscope or on a probe or surgical instrument inserted through the endoscope. The probe can be inserted into a guiding catheter such as the guiding catheter 10, and the guiding catheter can be inserted into the instrument channel 71 of the endoscope 70. The position of the trackable marker can be tracked by non-contact measurement relative to a fixed reference according to a known method. From the tracked position of the endoscope, the position of the image captured by the endoscope can be determined, and the virtual image 97 can be mapped to the endoscopic image 98.

[0060] In operation 85, the distal tip 72 of the endoscope has reached an anatomical standby position where it cannot reach the front, for example, because the anatomical structure is too small, too rigid, and / or too complex for the anatomical structure to pass through. If not already done, the guiding catheter 10 is inserted into the instrument channel 71 of the endoscope 70. The guiding catheter 10 can be further deployed (distally) beyond the distal tip of the endoscope and advanced along the navigation path 95, as shown, for example, in FIG. 10. The advancement of the guiding catheter 10 can be tracked by a trackable marker provided on the guiding catheter or a tracking probe inserted into the guiding catheter. The tracking probe can be the endoscope probe 20 according to the present disclosure or another probe.

[0061] Optionally, the attachment module 50 of the assembly 200 is attached to the handle 60 of the endoscope 70, and the guiding catheter 10 is inserted into the insertion port of the handle 60 through the insertion port 561 and via the internal channel 56, and is further deployed through the instrument channel 71 of the endoscope 70 until the distal end 102 of the guiding catheter 10 reaches the distal tip 72 of the endoscope 70. The locking member 131 of the connector module 13 can be in locking engagement with the locking member 59. The member of the telescopic tubular body 57 can be fully extended at this position.

[0062] To move the guiding catheter, while the members 59 and 131 are in a locked engagement state, the handle member 58 can be operated to move in the distal direction (towards the distal portion 51 and the handle 60). By doing so, the member of the telescopic tubular body 57 is folded, and the guiding catheter 10 advances distally through the instrument channel 71 and beyond the distal tip 72. Optionally, the handle member 58 can be rotated about the longitudinal axis 209, and the rotation can be transmitted to the guiding catheter 10 through the members 59 and 131. Thereby, rotation of the distal end 102 of the guiding catheter 10 / catheter body 11 can be imparted, facilitating navigation.

[0063] In operation 86, the guiding catheter 10 reaches near the location of the lesion 94 as can be determined by tracking as described above. Advantageously, the guiding catheter 10 is fixed in place relative to the endoscope and / or relative to a fixed (patient) reference. The guiding catheter 10 can be fixed so as not to move in place relative to the endoscope 70 by operating the locking system 55. Thereby, the handle member 58 is released, and in some cases the locking member 131 is disengaged from the connector member 59. When a tracking probe other than the endoscope probe 20 is used for navigation, the tracking probe is removed from the guiding catheter, and instead the endoscope probe 20 is inserted.

[0064] When the endoscopic probe 20 is provided with, for example, a trackable marker, as an alternative method, it can be pre-inserted into the lumen 12 of the catheter 10 while the catheter body 11 is being deployed through the instrument channel 71 of the endoscope. As an alternative method, the endoscopic probe 20 can be continuously inserted. While the endoscopic probe 20 is being deployed through the lumen 12 of the guiding catheter 10, a pressurized fluid that can be a gas such as CO2 or a liquid such as physiological saline can be supplied to the lumen at a suitable pressure, particularly through the second inlet port 322 of the fluid delivery module 30. By supplying some fluid while the endoscopic probe 20 is being deployed, it is possible to facilitate the advancement of the endoscopic probe 20 through the lumen 12, particularly when the distal portion 23 of the endoscopic probe 20 is thickened.

[0065] In operation 87, the guiding catheter 10 and / or the endoscopic probe 20 are in an anatomical target position, that is, in the vicinity of the lesion 94. In order to visually inspect the region of the lesion 95, with the guiding catheter 10 (catheter body 11) fixed, the endoscopic probe 20 can be advanced beyond the exit aperture 122 of the catheter 10. An image 99 of the lesion can be taken by the endoscopic probe 20 and, optionally, visualized on the visual display 42 for examination.

[0066] When the endoscopic probe is slightly retracted inside the lumen 12, the keyhole effect can be utilized to improve the field of view by the imaging device 22. As an example, in order to suitably image the anatomical structure by the keyhole effect, while retracting the endoscopic probe 20 (proximally) inside the lumen, the distal tip of the catheter body or the exit aperture 122 can be held against the anatomical target structure. By doing so, the distal tip of the catheter body advantageously maintains the anatomical structure in the desired position.

[0067] The lens or screen of the imaging device 22 may be soiled or stained by body fluids during navigation, impairing proper visualization. Fluid is supplied to the lumen 12 via the second inlet port 322 of the fluid delivery module 30 (e.g., by operating the valve 351) to flush and clean the distal tip of the endoscope probe 20. Flushing can be performed when the distal portion 23 is fully contained within the lumen 12, or when the (outer) lens of the imaging device 22 is coplanar with the outlet aperture 122, or when at least a portion of the distal portion 23 still extends distally beyond the outlet aperture 122. Thereafter, the imaging device 22 is ready to be redeployed at or beyond the outlet aperture 122 of the guiding catheter 10.

[0068] In operation 88, a diagnostic or surgical procedure is performed. Anatomical structures, such as diameter or length measurements, can be made, in some cases, using the endoscope probe 20. By way of example, the measurement can be made based on visual images captured by the imaging device 22. Alternatively, it is also possible to measure the length within an anatomical structure by advancing or retracting the endoscope probe 20 relative to the guiding catheter 10. Thereby, the imaging device 22 can serve as a visual aid for determining the start and end of the anatomical structure of interest. The control unit 40 can be configured to determine measurement values from one or more images captured by the imaging device 22. By way of example, the control unit 40 can be implemented as a computing unit with a user interface that enables the operator to select a position on the visual display 42, and the control unit is configured to determine the measurement value based on the selected position.

[0069] As an alternative or in addition, the endoscopic probe 20 can be removed from the guiding catheter 10 and, instead, another surgical instrument, such as a biopsy forceps or a brush, can be deployed through the lumen 12. As yet another alternative, the surgical instrument can be deployed through another instrument channel (not shown) of the endoscope 70 to reach the anatomical target area. Here too, the endoscopic probe can be used as a visual aid for advancing and / or manipulating the surgical instrument.

[0070] It will be appreciated that some of the operations 81-88 can be omitted. In particular, operations 81, 82, 84, and 88 are optional. In addition, operations 81-88 need not be performed in the order described or shown in the figure of FIG. 11 and can be performed in any suitable order.

[0071] The assembly of the present disclosure is particularly suitable for surgical and / or diagnostic procedures in the pulmonary or biliary-pancreatic ducts, such as the biliary tract.

Example

[0072] Several prototypes of the endoscopic probe and the guiding catheter were fabricated and tested for the ability to flush the lumen of the guiding catheter while the endoscopic probe was fully contained within the lumen. The size specifications of the different prototypes are shown in Table 1. All probes had a probe body length of 2500 mm. Water was used as the flushing fluid. The flushing pressure was determined by opening 20 ml of water from a syringe into the lumen at a constant rate of 100 mm / min displacement of the syringe piston and measuring the force required. The syringe cylinder had a diameter of 20 mm (cross-sectional area of 314.16 mm 2 ). In addition to the flushing pressure, the flushing time was determined as the time required to empty 20 ml of water from the same syringe when a constant force of about 30 N was applied to the syringe piston.

[0073] The possibility of ensuring an appropriate flushing pressure and thus a flushing flow rate sufficient to moisten the front surface of the distal portion (imaging device 22) was observed for all prototypes where the diameter D2 of the probe body is smaller than the diameter D1 of the distal portion (head) of the endoscopic probe, i.e., the ratio D1 / D2 is greater than 1, specifically for prototypes numbered 1 to 5, 14, and 15. In prototypes where D1 = D2 (the diameter of the endoscopic probe head is equal to the diameter of the probe body), a moderate flushing pressure was observed only when D1 / D3 = D2 / D3 ≤ 0.84. In stark contrast, when the distal portion of the endoscopic probe is enlarged and the diameter of the probe body is reduced, the diameter of the distal portion may be as large as about D1 / D3 = 0.95, but still good cleaning is possible. As a result, the device according to the present disclosure enables further miniaturization of the endoscopic device (a smaller catheter when the diameter of the distal portion of the probe is the same), or the use of an improved imaging device (a larger distal portion when the diameter of the lumen of the catheter is the same).

[0074]

Table 1

[0075] Some aspects of the present disclosure are described in the following numbered clauses arranged in alphanumeric order. A1. A method of performing an endoscopic examination, comprising advancing an endoscopic device, preferably a bronchoscope, through an anatomical cavity or lumen, particularly until reaching an anatomical standby position; deploying a guiding catheter according to an aspect of the present disclosure through an instrument channel of the endoscopic device, preferably beyond the distal tip of the endoscopic device, preferably to reach an anatomical target position; fixing the position of the guiding catheter relative to a reference; deploying an endoscopic probe according to an aspect of the present disclosure through the guiding catheter and imaging an anatomical target position with an imaging device of the endoscopic probe; and a method comprising the above steps. A2. Further comprising determining a navigation path along an anatomical cavity or lumen, advancing the endoscope device comprising advancing the endoscope device along the navigation path, preferably, the navigation path comprising an anatomical standby position and / or an anatomical target position, the method according to clause A1. A3. The method according to clause A2, further comprising tracking a marker traceable along the navigation path. A4. The method according to clause A3, comprising deploying a tracking probe having a traceable marker through an instrument channel of the endoscope device. A5. The method according to clause A4, comprising retracting the tracking probe following fixing the position of the guiding catheter. A6. The method of clause A5, wherein following retracting the tracking probe, the endoscope probe is deployed through the guiding catheter. A7. The method according to clause A4, wherein the tracking probe is an endoscope probe. A8. Determining the navigation path comprises determining a virtual or digital model of the anatomical cavity or lumen and mapping the virtual or digital model to an image of the anatomical cavity or lumen captured by the endoscope device and / or the endoscope probe, the position of the image being determined based on tracking of the traceable marker, the method according to any one of clauses A3 - A7. B1. An intraluminal navigation assembly (100, 200), A guiding catheter (10) having a proximal end (101) and a distal end (102), the guiding catheter comprising an elongate flexible tubular catheter body (11) defining a lumen (12) of the catheter, the lumen (12) having an outlet aperture (122) at the distal end (102), the guiding catheter (10); An endoscope probe (20) comprising a flexible probe body (21) and an imaging device (22) attached to the probe body at the distal end of the probe body, the probe body and the imaging device being sized to be slidably received in the lumen (12). A fluid delivery module (30) attached or attachable to a guiding catheter (10) at the proximal end (101), the fluid delivery module comprising a first port (321) configured to communicate with the lumen (12), the first port (321) being configured to receive the endoscope probe (20) so as to be deployed through the lumen, and a second port (322) configured to deliver fluid to the lumen (12). Comprising An assembly comprising a fluid seal (34) configured to fluid-tightly seal the first inlet port (321) against the probe body (21) while the second port (322) remains in fluid communication with the lumen (12). B2. The assembly according to clause 1, wherein the fluid seal (34) comprises a seal member (341) provided with a through-hole configured to slidably receive the probe body (21), and preferably, the fluid seal comprises clamping means (342, 343) configured to clamp the seal member (341) against the probe body (21). B3. The assembly according to clause B1 or B2, further comprising a fluid source (35) configured to be connected to the second port (322). B4. The assembly according to clause B3, further comprising a flow control valve (351) connected between the second port (322) and the fluid source (35). B5. Further comprising an attachment module (50), the attachment module comprising a connector system (54) and a telescopic tubular body (57), the telescopic tubular body extending from a first end (52) to a second end (51) opposite the first end, defining an internal channel (56) of the attachment module (50), the internal channel being sized to slidably receive the catheter body (11), the connector system (54) being provided at the second end (51) and configured to fix the attachment module (50) to a support (60). The assembly (200) according to any one of clauses B1 to B4. B6. The attachment module further comprises a handle member (58) attached to the telescopic tubular body (57) at the first end (52), and a first locking system (59) configured to lock the movement of the guiding catheter (10) relative to the handle member with respect to at least one of translation along the longitudinal axis (209) of the telescopic tubular body and rotation about the longitudinal axis. The assembly according to clause B5. B7. The guiding catheter (10) comprises a first connector member (131) configured to be releasably interlocked with a corresponding connector member (591) of the locking system (59) so as to enable an integral movement of the guiding catheter and the handle member. The assembly according to clause B6. B8. The attachment module (50) further comprises a second locking system (55) configured to fix the guiding catheter (10) against axial movement relative to the support (60), preferably, the second locking system (55) being arranged at the second end (51). The assembly according to any one of clauses B5 to B7. B9. The catheter body (11) is configured to transmit torque and / or rotation from the proximal end (101) to the distal end (102) to advance the guiding catheter (10). The assembly according to any one of clauses B1 to 8. B10. The endoscope probe (20) comprises a distal portion (23) at the distal end of the probe body (21), the distal portion accommodating the imaging device (22) and having a diameter increased with respect to the diameter of the probe body (21), the assembly according to any one of clauses B1 to B9. B11. The ratio of the diameter of the probe body (21) to the diameter of the inner cavity (12) is from 0.15 to 0.9, and the ratio of the diameter (D1) of the distal portion (23) to the diameter of the inner cavity (12) is from 0.3 to 0.95, the assembly according to clause 10. B12. The imaging device (22) comprises a camera module (221) and a light source (222), the assembly according to any one of clauses 1 to 11. B13. The assembly further comprises an endoscope (70), the endoscope comprising an endoscope handle (60) connected to the endoscope body (75), the endoscope body comprising an instrument channel (71), the endoscope handle comprising an insertion port (61) communicating with the instrument channel (71), and the guiding catheter (10) being configured to be slidably received within the instrument channel (71) and through the insertion port (61), the assembly according to any one of clauses B1 to B12. B14. The endoscope (70) further comprises a second imaging device (73) disposed at the distal end of the endoscope body (75), the assembly according to clause B13. B15. The assembly further comprises an attachment module (50) according to any one of clauses B5 to B8, the endoscope handle (60) forming a support and comprising a connector component (62), and the connector system (54) being configured to cooperate with the connector component to attach the attachment module (50) to the endoscope handle (60), the assembly according to clause 13 or 14.

Claims

Claim 1 An assembly for intravascular navigation, comprising a guiding catheter (10) having a proximal end (101) and a distal end (102), the guiding catheter comprising an elongate flexible tubular catheter body (11) defining a lumen (12) of the catheter, the lumen (12) having an outlet aperture (122) at the distal end (102); a guiding catheter (10); an endoscope probe (20) comprising a flexible probe body (21) and an imaging device (22) attached to the probe body at the distal end of the probe body, the probe body and the imaging device being sized to be slidably received within the lumen (12); an endoscope probe (20); a fluid delivery module (30) attached to or attachable to the guiding catheter (10) at the proximal end (101), the fluid delivery module comprising a first port (321) configured to communicate with the lumen (12) and configured to receive the endoscope probe (20) so as to be deployed through the lumen, and a second port (322) configured to deliver fluid to the lumen (12); a fluid delivery module (30); an endoscope (70) comprising an endoscope handle (60) connected to an endoscope body (75), the endoscope body comprising an instrument channel (71), the endoscope handle comprising an insertion port (61) communicating with the instrument channel (71), the guiding catheter (10) being configured to be slidably received within the instrument channel (71) and through the insertion port (61); an endoscope (70); comprising a fluid seal (34) configured to fluid-tightly seal the first inlet port (321) against the probe body (21) while the second port (322) remains in fluid communication with the lumen (12); The endoscope probe (20) includes a distal portion (23) at the distal end of the probe body (21), the distal portion accommodating the imaging device (22), and having a diameter (D ２ ), which is larger than the diameter (D ３ ) of the probe body (21) and smaller than the diameter (D １ ) of the inner lumen), an assembly. Claim 2 The fluid seal (34) includes a seal member (341) provided with a through hole configured to slidably receive the probe body (21). Preferably, the fluid seal includes clamping means (342, 343) configured to clamp the sealing member (341) against the probe body (21). The assembly according to claim 1.

3. The assembly according to claim 1 or 2, further comprising a fluid source (35) configured to be connected to the second port (322).

4. The assembly according to claim 3, further comprising a flow control valve (351) connected between the second port (322) and the fluid source (35).

5. The assembly (200) according to any one of claims 1 to 4, further comprising a mounting module (50), the mounting module including a connector system (54) and a telescopic tubular body (57), the telescopic tubular body extending from a first end (52) to a second end (51) opposite the first end, defining an internal channel (56) of the mounting module (50), the internal channel being sized to slidably receive the catheter body (11), the connector system (54) being provided at the second end (51) and configured to fix the mounting module (50) to a support (60).

6. The assembly according to claim 5, wherein the mounting module further comprises a handle member (58) attached to the telescopic tubular body (57) at the first end (52), and a first locking system (59) configured to lock the movement of the guiding catheter (10) relative to the handle member with respect to at least one of translation along the longitudinal axis (209) of the telescopic tubular body and rotation about the longitudinal axis.

7. The assembly according to claim 6, wherein the guiding catheter (10) comprises a first connector member (131) configured to be releasably interlocked with a corresponding connector member (591) of the locking system (59) so as to enable integral movement of the guiding catheter and the handle member.

8. The mounting module (50) further comprises a second locking system (55) configured to fix the guiding catheter (10) axially immovable relative to the support (60), preferably, the second locking system (55) is arranged at the second end portion (51), the assembly according to any one of claims 5 to 7.

9. The endoscope handle (60) forms the support and comprises a connector part (62), the connector system (54) is configured to cooperate with the connector part to attach the mounting module (50) to the endoscope handle (60), the assembly according to any one of claims 5 to 8.

10. The wall of the catheter body (11) comprises a reinforcing blade configured to transmit torque and / or rotation from the proximal end (101) to the distal end (102) for advancing the guiding catheter (10), the assembly according to any one of claims 1 to 9.

11. The probe body (21) comprises a reinforcing blade, the assembly according to any one of claims 1 to 10.

12. The probe body (21) comprises a sheath and a central wire made of a metal alloy disposed inside the sheath, preferably, the metal alloy is a nickel-titanium alloy, the assembly according to any one of claims 1 to 10.

13. The ratio of the diameter of the probe body (21) to the diameter of the inner cavity (12) is 0.15 to 0.9, and the ratio of the diameter of the distal portion (23) (D １ ) to the diameter of the inner cavity (12) is 0.3 to 0.

95. The assembly according to any one of claims 1 to 12.

14. The distal portion having an increased diameter has an axial length between 3 mm and 10 mm, the assembly according to any one of claims 1 to 13.

15. The distal portion has an outer diameter between 0.8 mm and 2.4 mm, the assembly according to any one of claims 1 to 14.

16. The axial length (L １ of the distal portion (23) to the diameter (D １ ) of the distal portion is 0.1 to 0.

4. The assembly according to any one of claims 1 to 15.

17. The distal portion has a shape having rotational symmetry with respect to the longitudinal axis of the endoscope probe, preferably a cylindrical shape, the assembly according to any one of claims 1 to 16.

18. The imaging device (22) comprises a camera module (221) and a light source (222), the assembly according to any one of claims 1 to 17.

19. The endoscope (70) further comprises a second imaging device (73) disposed at the distal end of the endoscope body (75), the assembly according to any one of claims 1 to 18.

20. A luminal navigation assembly comprising the guiding catheter, the endoscopic probe, and the fluid delivery module according to any one of claims 1 to 19.

Images