Navigation catheter assembly with endoscope visual probe

Abstract

An assembly (100) for endoluminal navigation comprises a guide catheter (10), an endoscopic probe (20) and a fluid delivery module (13). The guide catheter includes a lumen (12) having an outlet orifice (122) at a distal end (102). An endoscope probe (20) comprises a flexible probe body (21) and an imaging device (22) attached to the probe body at a distal end. The probe body and the imaging device are sized to be slidably received in the internal cavity (12). A fluid delivery module (30) disposed at the proximal end of the guide catheter (10) includes a first port (321) in communication with the lumen (12) for receiving an endoscopic probe (20), and a second port (322) in fluid communication with the lumen for delivering fluid thereto. The first port (321) comprises a fluid seal (34) configured to fluid-tight seal the first inlet port (321) against the probe body (21), while the second port (322) is in fluid communication with the inner cavity (12).

Description

Technical Field

[0001] The present disclosure relates to catheter assemblies that allow for expanded navigation, particularly in smaller lumens, and endoscopic imaging beyond the range of conventional endoscopes. Background Art

[0002] The deep lung is a system of small to very small lumens (bronchi) that form a complex maze that is difficult to explore. In addition, endoscopic imaging of these structures is difficult due to the presence of physiological fluids. Because pulmonologists need to reach the deep lung to perform biopsies during lung cancer screening, some technologies have been developed to reach the deep lung.

[0003] One such technique is fluorescence imaging combined with electromagnetic navigation. The catheter includes a trackable marker that is monitored as the catheter moves within the body. The location of the catheter is incorporated into the fluorescence image or other image obtained from an external source. The disadvantage of this technique is that only a virtual or indirect visualization of the target anatomical features is obtained.

[0004] US2021 / 0100627 describes a flexible tubular catheter having an internal channel sized to receive an image capture probe. The image capture probe may extend distally beyond the distal end of the catheter and include a distal portion having a stereo camera or a monoscopic camera for capturing a video or ultrasound 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 image includes an image 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 image and / or an additional sensor (such as an electromagnetic sensor) disposed on the catheter and the imaging probe. 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, a sensor for determining a roll angle is provided in the catheter and the imaging probe to detect the relative orientation. By doing so, an image of a target structure generated by the imaging probe can be presented in a virtual anatomical model of the patient's anatomical structure.

[0005] The disadvantages of the above system are its complexity in obtaining accurate and virtual visualization of anatomical target locations, and its high cost. Another disadvantage is that physiological fluids may render the video images taken by the imaging probe useless. For this reason, ultrasound imaging probes are preferred. However, ultrasound images require further interpretation.

[0006] US2020 / 0178775 describes a surgical instrument having a hollow guide shaft that receives both an endoscope and a dilatation catheter. The endoscope can be made compact by coaxially positioning a camera, a light source, and a pair of suction openings at the distal end face. In addition, a plurality of flushing openings extend radially through the annular sidewall of the endoscope. Although all camera and light source wires as well as suction channels and flushing channels can be embedded in an integral endoscope body to obtain a compact and integral structure, the diameter size of the endoscope body will inevitably increase, which will reduce the navigation capability of the endoscope in a small cavity. Alternatively, the size of the suction channel and the flushing channel can be made smaller, but this will increase the pressure drop when the fluid flows through the channel of the endoscope, thereby limiting performance. Summary of the invention

[0007] Therefore, there is a need in the art to provide catheter systems that have improved extended navigation and / or imaging capabilities compared to prior art catheter systems, particularly with respect to navigation and visualization in small and remote cavities (such as the deep lungs). There is a need in the art to provide such catheter systems with reduced complexity and / or economy.

[0008] Therefore, according to the present disclosure, a kind of assembly for intracavitary navigation as set forth in the attached claims is provided. The assembly according to the present disclosure includes a guide catheter and an endoscopic probe. The guide catheter includes an elongated flexible tubular catheter body, which defines an inner cavity, and the inner cavity has an exit orifice at the distal end of the guide catheter. The endoscopic probe includes an elongated flexible probe body and an imaging device (such as a (video) camera) that is particularly configured to capture visual images, and the imaging device is attached to the distal end of the probe body. The size of the probe body and the imaging device is determined to be slidably received in the inner cavity.

[0009] According to a first aspect, an assembly according to the present disclosure advantageously includes a fluid delivery module attached to or attachable to the proximal end of a guide catheter. The fluid delivery module includes: a first port configured to communicate with an inner cavity and configured to receive an endoscopic probe for deployment through the inner cavity; and a second port configured to deliver a fluid to the inner cavity. The first port includes a fluid seal configured to seal a first inlet port against a probe body in a fluid-tight manner, while the second port maintains fluid communication with the inner cavity. Advantageously, the fluid seal is configured to slidably receive the probe body while enabling the first inlet port to be sealed in a fluid-tight manner. The fluid seal may be further configured to tighten the sealing member against the probe body.

[0010] An advantage of the above-mentioned assembly provided with a fluid delivery module is that, when the endoscopic probe is contained in the inner cavity, the assembly allows the inner cavity of the guide catheter to be flushed with a fluid supplied through the second inlet port. This flushing makes it possible to clean the external parts of the imaging device (such as lenses, etc.), which may be contaminated by body fluids during intracavitary navigation. By doing so, the endoscopic probe can be made into a small diameter, because the endoscopic probe advantageously does not need to include any fluid supply channel or fluid suction channel. In addition, the combination of the guide catheter that slides to receive the endoscopic probe allows the navigation function (such as torque transmission capability, etc.) to be integrated in the guide catheter, and the diameter of the body of the endoscopic probe is kept small. Therefore, a very compact assembly is obtained, while still being provided with complete navigation and endoscope functions. The assembly further has a very simple structure, because the requirement for multiple channels, etc. can be omitted, and is therefore more economical than the equipment of the prior art. In addition, due to the simple structure, some parts can be easily cleaned and / or sterilized, specifically the endoscopic probe as the most expensive part, and therefore at least some parts of the assembly are advantageously reusable.

[0011] According to a second aspect of the present disclosure, which may be provided in addition to or alternatively to the first aspect, the assembly according to the present disclosure advantageously further includes an attachment module. The attachment module includes a connector system configured to securely connect the attachment module to a support (such as a handle of an endoscope) and advantageously provide access to an instrument channel of the endoscope. The attachment module may further include a telescopic tubular body extending from a first end to a second end opposite to the first end, and defining an internal passage of the attachment module, the size of the internal passage being determined to slidably receive the catheter body. The connector system is advantageously disposed at the second end.

[0012] Advantageously, the attachment module further comprises: a handle member; and a first locking system, which is attached to the telescopic tubular body at a first end and is configured to lock the movement of the guide catheter relative to the handle member in at least one of the following aspects: translation along the longitudinal axis of the telescopic tubular body and rotation around the longitudinal axis. Advantageously, the guide catheter comprises a first connector member, which can be arranged at the proximal end of the guide catheter and is configured to be releasably interlocked with the corresponding connector member of the first locking system so as to achieve the overall movement of the guide catheter and the handle member. The attachment module may further comprise a second locking system, which is configured to axially fix the guide catheter relative to the connector system and / or the support, and the second locking system may be arranged at the second end.

[0013] An advantage of the assemblies according to the second aspect is that these assemblies facilitate extended navigation beyond the range of conventional endoscopes. Specifically, the attachment module provides easier and more precise manipulation of the guide catheter, which facilitates distal navigation of the guide catheter and the endoscopic probe, and thereby facilitates improved visualization of anatomical structures, thereby achieving improved diagnosis.

[0014] Advantageously, the assembly further comprises an endoscope comprising an endoscope handle connected to the endoscope body. The endoscope body comprises an instrument channel (commonly referred to as a working channel), wherein the endoscope handle comprises an access port communicating with the instrument channel, wherein the guide catheter is configured to be slidably received in the instrument channel and pass through the access port. The endoscope may further comprise a second imaging device arranged at a distal end of the endoscope body. The endoscope handle may form a support and may comprise a connector portion configured to cooperate with the connector system to attach the attachment module to the endoscope handle.

[0015] On the other hand, methods for performing endoscopy, particularly in the lung passages, are disclosed herein. These methods utilize components according to the present disclosure. In a first operation, a guide catheter is inserted into an anatomical cavity or lumen. The guide catheter may be inserted directly or via an instrument channel of an endoscope, to which an attachment module of the component may be mounted. In a second optional operation, the guide catheter is deployed distally beyond the distal end of the endoscope, which may be performed by manipulating a handle member of the attachment module to which the guide catheter is attached. In a third operation, the guide catheter is navigated through the anatomical cavity or lumen. The guide catheter may, for example, be navigated beyond the distal end of the endoscope. In a fourth operation, an image is taken at the distal end of the endoscopic probe with an imaging device. These images may be displayed on a visual display at the proximal side. In a fifth optional operation, the guide catheter may be fixedly fixed in place relative to the endoscope by operating a second locking system of the attachment module, for example, when the guide catheter and / or the endoscopic probe reaches the anatomical target position. In the sixth operation, the outer part (such as lens or screen) of the imaging device of the endoscopic probe may be soiled or contaminated by body fluids during navigation, thereby damaging normal visualization. Fluid is supplied to the inner cavity via the second inlet port of the fluid delivery module (for example, by operating the flow control valve), and the distal end of the endoscopic probe is rinsed and cleaned by the fluid. For this reason, the endoscopic probe can be retracted until the imaging device (distal part) is fully received in the inner cavity of the guide catheter, flush with the distal end of the guide catheter, or at least partially extends from the distal end. Now, the imaging device is ready to be deployed again at the outlet orifice of the guide catheter or beyond the outlet orifice. In the seventh operation that can be performed as a supplement or alternatively to the sixth operation, the endoscopic probe is retracted inside the inner cavity, advantageously making the imaging device completely located in the inner cavity of the guide catheter, that is, the imaging device is located at the proximal side of the outlet orifice of the inner cavity. Therefore, a porthole effect is produced, thereby allowing the imaging device to properly image the anatomical structure when the imaging device is in the inner cavity. Alternatively, the distal end of catheter body or outlet orifice are held against the anatomical target structure. By doing so, the distal end of catheter body is advantageously maintained in the desired position by imaging equipment when the anatomical structure is imaged. In the 8th optional operation, perform diagnosis or surgical procedure, which can include measuring the anatomical structure. Additionally or alternatively, the endoscopic probe is removed from the guiding catheter, and surgery (for example, biopsy) instrument is deployed through the guiding catheter. It should be appreciated that the order of the above-mentioned operation is illustrative and can change, or some operations are performed simultaneously.

[0016] Another method of performing an endoscopy, particularly an endoscopy or bronchoscopy in a pulmonary passage according to the present disclosure includes navigating an endoscopic device through an anatomical cavity or lumen until an anatomical parking position is reached; and deploying a guide catheter according to various aspects of the present disclosure through an instrument channel of the endoscope. The guide catheter can be deployed beyond the distal end of the endoscope, for example to reach an anatomical target location, and its position is fixed or fixed relative to a reference point, which can be a fixed reference point of the endoscope or attached to the patient or external to the patient. The endoscopic probe is deployed through the guide catheter to image the anatomical target location. To this end, the endoscopic probe can be deployed beyond the exit orifice of the guide catheter, or alternatively retracted from the exit orifice to create a visual porthole effect to image the anatomical target location.

[0017] Advantageously, a navigation route along an anatomical cavity or lumen is determined, for example based on medical imaging techniques, and an endoscope, a guide catheter and / or an endoscopic probe is navigated along the navigation route. Advantageously, a trackable marker, in particular an electromagnetically sensitive device, is tracked along the navigation route. The trackable marker may be integrated in the endoscope, the guide catheter and / or the endoscopic probe.

[0018] Advantageously, a virtual model of the anatomical cavity or lumen is determined. Based on the positions determined by the trackable markers, the virtual model is mapped to images captured with the endoscopic device and / or the endoscopic probe.

[0019] A tracking probe including a trackable marker is deployed through an endoscope and / or a guide catheter, and the endoscope and / or the guide catheter including the tracking probe navigates along a navigation route. The tracking probe can be retracted from the guide catheter, specifically when the guide catheter is at (as can be determined by tracking the trackable marker) an anatomical target position, and advantageously, the (distal) position of the guide catheter is fixed. When the tracking probe is removed, an endoscopic probe according to various aspects of the present disclosure can be deployed through the guide catheter (the lumen of the guide catheter), and the anatomical target position is imaged with an imaging device of the endoscopic probe. Visual inspection of the anatomical target position can be performed based on the image captured by the imaging device. Additionally or alternatively, a surgical instrument is deployed through the guide catheter, and surgical intervention (such as a biopsy) is performed at the anatomical target position.

[0020] Alternatively, an endoscopic probe according to aspects of the present disclosure may include trackable markers and may serve as a tracking probe in the above-described methods.

[0021] In the method according to the present disclosure, the endoscopic probe thus advantageously allows for additional visual inspection of the anatomical target location to be performed to verify the condition and / or position of the anatomical target location as determined by medical imaging techniques by close visual inspection. This can be beneficial in order to properly assess the condition and / or position before performing a surgical intervention such as a biopsy. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Various aspects of the present disclosure will now be described in more detail with reference to the accompanying drawings, in which like reference numerals indicate like features, and in which:

[0023] Figure 1 A plan view showing an embodiment of an assembly according to the present disclosure;

[0024] Figure 2 express Figure 1 A top view of a component;

[0025] Figure 3 Indicates along Figure 1 and Figure 2 A longitudinal cross-sectional view of the assembly along section line AA;

[0026] Figure 4 express Figure 1 A perspective view of the distal end of the assembly

[0027] Figure 5A express Figure 1 a longitudinal cross-sectional view of the distal end of the assembly, wherein the endoscopic probe is deployed beyond the distal end of the catheter body; Figure 5B express Figure 1 A longitudinal cross-sectional view of the distal end of the assembly of the catheter body, wherein the endoscopic probe is fully received in the lumen of the catheter body;

[0028] Figure 6 A perspective view showing another embodiment of an assembly according to the present disclosure, the assembly incorporating Figure 1 Components;

[0029] Figure 7 express Figure 6 A longitudinal cross-sectional view of an assembly of;

[0030] Fig. 8A Indicates included in Figure 6 A perspective view of an attachment module in an assembly of; Figure 8B express Fig. 8A Another perspective view of the attachment module;

[0031] Fig. 9 Denotes the handle attached to the proximal side of the endoscope. Figure 6 A perspective view of the components;

[0032] Fig.10 A perspective view showing the distal end of an endoscope, wherein Figure 6 The distal end of the catheter of the assembly is deployed beyond the distal face of the endoscope;

[0033] Fig.11 a flow chart representing the operation of a method of performing an endoscopy according to the present disclosure;

[0034] Fig.12 A computed tomography image representing a human lung in the transverse plane;

[0035] Fig.13 An image representing a virtual reconstruction of a bronchus;

[0036] Fig.14 express Fig.13 A virtually reconstructed image of the inner portion of the bronchus;

[0037] Fig.15 Indicates that it corresponds to Fig.14 Endoscopic images of the internal parts of the bronchi;

[0038] Fig.16 Represents an image captured by an endoscopic probe according to aspects of the present disclosure. DETAILED DESCRIPTION

[0039] refer to Figures 1 to 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 (e.g., corresponding to a side close to an operator) to a distal end 102 (e.g., configured to reach an anatomical target location to be visualized). It should be understood that the terms "proximal" and "distal" are used herein with reference to an operator manipulating the assembly.

[0040] The catheter 10 comprises an elongated flexible catheter body 11 which may extend from a proximal end 101 to a distal end 102. The catheter body 11 is tubular and comprises a lumen 12 from an inlet orifice 121 at the proximal end 101 to an outlet orifice 122 at the distal end 102.

[0041] The catheter body 11 can be configured to be inserted into a natural orifice or an anatomical orifice created by surgery. Advantageously, as will be described in further detail below, the catheter body 11 is configured to be inserted into an instrument channel of a conventional endoscope. The outer diameter of the catheter body 11 is advantageously 3.0 mm or less, advantageously between 1.2 mm and 2.8 mm, advantageously between 1.5 mm and 2.8 mm.

[0042] The catheter body 11 is advantageously made of or comprises radiopaque material, to help its positioning, for example, by external imaging techniques such as computed tomography or fluoroscopy. Advantageously, the catheter body 11 is configured to transmit torque between the proximal end 101 and the distal end 102. By arranging suitable reinforcing braid in the wall of the catheter body 11, effective torque transmission can be achieved. By doing so, the rotation around the longitudinal axis of the catheter body 11 realized at the proximal end 101 can be transferred to the distal end 102, so that navigation can be achieved in the anatomical cavity. Alternatively or additionally, the catheter can include an actuating system, for example, includes cables etc., so that the catheter body can be manipulated. Additionally or alternatively, the catheter body can be made to have a preformed shape, such as curved, wavy or other suitable shapes, so that navigation can be achieved.

[0043] The catheter body 11 is advantageously straight at the distal end 102, although a slightly curved shape can be envisioned. The outlet orifice 122 of the inner chamber 12 is advantageously arranged at the distal end of the catheter body 11. The distal end is advantageously trauma-resistant, to prevent tissue damage when navigating through the anatomical cavity. For example, the outer circumferential edge of the distal end of the catheter body 11 can be rounded and / or made of softer (e.g., elastic) material. In some examples, the reinforcement braid in the wall of the catheter body extends to slightly before the distal end, and the distal end advantageously does not have a reinforcement.

[0044] At the proximal end 101, the catheter 10 can include a connector module 13 (e.g., including a screw connector or a Luer lock fitting) to connect the catheter 10 to the fluid delivery module 30 in an advantageously releasable manner in a fluid-tight manner. The connector module 13 can include an inlet orifice 121. The proximal portion of the lumen 12 can extend through the connector module 13 until continuing through the catheter body 11. The connector module 13 can further include one or more locking members 131, the operation of which will be further described below.

[0045] The fluid delivery module 30 includes a tubular body 31 having an internal passage 32. The tubular body includes a first inlet port 321, a second inlet port 322, and an outlet port 323, all of which are in communication with the passage 32. The connector 33 cooperates with the connector module 13 of the catheter 10 to securely connect the catheter 10 and the fluid delivery module to each other in a fluid-tight manner. Therefore, the passage 32 of the fluid delivery module 30 is in communication with the lumen 12 of the catheter 10 through the outlet port 323 and the inlet orifice 121. Alternatively, the catheter 10 and the fluid delivery module 30 can be manufactured as a single integral structure, thereby omitting the connectors 13 and 33.

[0046] The first inlet port 321, which may be coaxially aligned with the outlet port 323, is configured to receive the insertion of the endoscopic probe 20. The probe 20 is inserted through the passage 32 via the first inlet port 321 and is further deployed through the lumen 12 via the outlet port 323 and the inlet orifice 121. The sealing system 34 is advantageously disposed at or connected to the first inlet port 321. The sealing system 34 includes a sealing member 341, which is configured to seal the endoscopic probe 20 fluid-tight when it is inserted through the passage 32 and / or the first inlet port 321. The sealing member 341 may be formed of a soft or elastic (e.g., elastomeric) material. The sealing member 341 may include a through hole configured to slidably receive the probe body 21. Optionally, the sealing member 341 may be accommodated in one or more cooperating (e.g., threaded) connector members 342, 343, which are configured to tighten and release the sealing member 341 as known in the art.

[0047] The second inlet port 322 is advantageously in communication with the passage 32 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 coupled to an external fluid source 35. Advantageously, the valve 351 ( Figure 1 ) (such as a flow control valve) is arranged to be in fluid communication with the second inlet port 322. Valve 351 can be connected to the fluid source 35 and can be operated when necessary to deliver fluid to the inner cavity 12. For example, valve 351 is a normally closed valve and includes an interface, such as a control knob or a push button as known in the art, which is configured to open the flow channel of valve 351 when operated to supply fluid from the fluid source 35 to the second inlet port 322 and further to the inner cavity 12. The fluid source 35 may include a gas (such as CO2 or air) or a liquid (such as a saline solution, a physiological solution or a contrast agent), which is particularly suitable for application in the bile duct. The fluid source 35 can be a syringe. In this case, valve 351 can be omitted.

[0048] With the endoscopic probe 20 inserted and the sealing member 341 tightened against the probe 20, fluid may be delivered to the lumen 12 through the second inlet port 322. This allows the lumen 12 to be supplied with fluid while preventing fluid from flowing out of the first inlet port 321.

[0049] refer to Figure 4 and FIG. 5A to FIG. 5B , the endoscopic probe 20 includes an elongated and flexible probe body 21. The probe body 21 has a length that is advantageously greater than the length of the catheter body 11, thereby allowing full insertion through the lumen 12 of the catheter 10 from the proximal end 101 to the distal end 102, and possibly allowing the endoscopic probe 20 to be deployed beyond the distal tip (exit orifice 122) of the catheter 10.

[0050] An imaging device 22 (advantageously a video imaging device) is provided at the distal end of the endoscopic probe 20. The imaging device 22 may include a camera 221, which is advantageously provided at the distal end face of the endoscopic probe 20 and is advantageously configured to capture visual images. The camera 221 may be a CMOS (complementary metal oxide semiconductor) image sensor (such as an Omnivision TM The imaging device may further include a light source 222, which may be provided by an optical fiber or a light emitting diode (LED). For example, the light source 222 may be arranged coaxially with the optical axis of the camera 221. The light source may be arranged circumferentially of the camera 221.

[0051] Return to reference Figure 1 The imaging device 22 is connected to an external control unit 40 via suitable wiring 41 (eg, optical fibers and / or conductive wires or cables). The control unit 40 may include a visual display 42 to display images captured by the imaging device 22.

[0052] Reference again Figure 4 and FIG. 5A to FIG. 5B , the imaging device 22 can be housed in a thickened distal portion 23 of the endoscopic 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, such as having rotational symmetry about the longitudinal axis. The optical lens of the imaging device 22 (e.g., camera 221 and / or light source 222) is advantageously arranged at the distal end face of the distal portion 23.

[0053] The inner cavity 12 advantageously has a diameter D3 between 0.9 mm and 2.6 mm, advantageously between 1.2 mm and 2.4 mm, such as 2.1 mm. The distal portion 23 advantageously has a cross-sectional size greater than the diameter D2 of the probe body 21, such as the diameter D1. The outer diameter D1 of the distal portion 23 is advantageously between 0.8 mm and 2.4 mm, advantageously between 1.0 mm and 2.0 mm. Although the diameter D1 is smaller than the diameter D3 of the inner cavity 12 of the catheter 10, to allow the distal portion 23 to be deployed through the inner cavity 12 ( Figure 5B), but it should be understood that the probe body 21 can have a relatively small diameter D2, for example between 0.5 mm and 1.8 mm, advantageously between 0.6 mm and 1.5 mm. The ratio of the diameter D2 of the probe body 21 to the diameter D3 of the lumen 12 is advantageously between 0.15 and 0.9, advantageously between 0.3 and 0.75, advantageously between 0.5 and 0.75. The ratio of the diameter D1 of the distal portion 23 to the diameter D3 of the lumen 12 is advantageously between 0.3 and 0.95, advantageously between 0.5 and 0.9, such as between 0.83 and 0.95. The distal portion 23 can alternatively have the same diameter as the probe body 21. The axial length L1 of the distal portion 23 is advantageously as small as possible while allowing for the accommodation of multiple portions of the imaging device 22. A suitable axial length L1 of the distal portion 23 is between 2 mm and 15 mm, advantageously between 3 mm and 10 mm.

[0054] Advantageously, the ratio of the outer diameter D1 of the distal portion 23 to the outer diameter D2 of the probe body 21 is between 1.05 and 2, advantageously between 1.1 and 1.67. The distal portion 23 advantageously has an outer shape of a fixed (i.e., non-expandable or non-deployable) geometry, for example, having a fixed (one or more) outer diameters. In some examples, the distal portion includes or consists of a cylindrical portion, for example, having an axial length L1, and the cylindrical portion has a fixed outer diameter D1.

[0055] By reducing the diameter of the probe body 21 compared to the diameter of the distal portion 23, for example using the ratios indicated above, a larger cross-section of the lumen is made available for fluid flow. Thus, with the endoscopic probe 20 (including the distal portion 23) inserted into the catheter 10, fluid can be more easily delivered through the lumen from the second inlet port 322 of the fluid delivery module 30, thereby obtaining a smaller fluid pressure drop for a given flow rate, or achieving a larger flow rate for a given pressure drop along the lumen 12. This enables wetting of the front of the distal portion by delivering the fluid, and thereby cleaning 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.

[0056] Advantageously, the ratio of the diameter D1 of the distal portion 23 to the axial length L1 of the distal portion is advantageously between 0.1 and 0.4, advantageously between 0.2 and 0.3, particularly between 0.23 and 0.27. This ratio ensures that the endoscopic probe 20 is optimally navigated through the inner cavity 12, particularly when the catheter body has a curved or curved portion, such as when inserted into an anatomical cavity. For larger L1 values, the diameter D1 should be selected to be smaller, to achieve correct navigation of possible curved portions through the inner cavity of the catheter body. On the other hand, when L1 is smaller, the diameter D1 can be selected to be larger.

[0057] The probe body 21 advantageously only accommodates wiring 41 and a suitable sheath with or without a reinforcement. Advantageously, the probe body 21 does not have an internal passage with a distal outlet orifice, such as a fluid supply and / or a suction passage or an instrument passage, so that it is compact in size and simple in structure, which can also be easily cleaned and sterilized for use in multiple patients. This allows the cost of the endoscopic probe to be reduced for each intervention. Alternatively, if size restrictions allow, the probe body 21 may include one or more such internal passages. The probe body 21 may include a reinforcement that may be embedded in the sheath, thereby providing a suitable axial rigidity for the endoscopic probe to be deployed through the catheter 10 (inner chamber 12). The reinforcement may include braid or be made up of braid, which may be configured to transmit torque and / or twist or rotate for continued navigation beyond the outlet orifice 122 of the catheter 10. The distal end of the distal portion 23 may be made traumatically-resistant, for example, by a suitable chamfer or rounded shape of the distal end.

[0058] Additionally, the thickened distal portion 23 , compared to the diameter of the probe body 21 , forms a shoulder or flange 231 , advantageously facilitating advancement of the endoscopic probe 20 through the lumen 12 while flushing the lumen with fluid from the second inlet port 322 .

[0059] refer to Figures 6 to 9 , another exemplary assembly 200 includes the assembly 100 and further includes an attachment module 50 configured to attach the assembly 100 to the handle 60 of the endoscope 70. The attachment module 50 includes a distal portion 51, a proximal portion 52, and a connecting portion 53 connecting the distal portion 51 to the proximal portion 52.

[0060] The distal portion 51 of the attachment module 50 includes a connector system 54 that is configured to secure or attach (the distal portion 51 of) the attachment module 50 to a handle 60. The endoscope handle 60 is connected to the elongated 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 portion 62 disposed on the handle 60, which is adjacent to (e.g., circumferentially of) an access port 61 of the handle 60 that communicates with the instrument channel 71. The connector system 54 is configured to securely connect (the distal portion 51 of) the attachment module 50 relative to the access port 61 of the handle 60 at least in terms of axial (translational) freedom of movement (e.g., via a snap-fit ​​connector). The connector system 54 can additionally be configured to securely connect (the distal portion 51 of) the attachment module 50, for example, rotationally in one or more rotational degrees of freedom of the handle 60.

[0061] The attachment module 50 includes an internal passage 56 extending from the proximal portion 52 through the connecting portion 53 to the distal portion 51. The access port 561 at the proximal portion 52 ( Figure 7 ) provides access to the internal channel 56. An exit port 562 at the distal portion 51 provides an exit from the internal channel 56 and access from the internal channel 56 to the instrument channel 71 of the endoscope 70. The exit port 562 can be coaxially aligned with the connector system 54. The diameter of the internal channel 56 is sized to allow the catheter 10 to pass through. The catheter 10 is inserted through the entry port 561 with the distal end 102 and advanced until it exceeds the exit port 562, where the catheter 10 enters the instrument channel 71 of the endoscope 70. Reference Fig.10 , the catheter 10 is further advanced through the instrument channel 71 until it is beyond the distal tip 72 of the endoscope 70. The endoscope 70 may include a camera 73 or other imaging sensor disposed at the distal tip 72 and configured to capture visual images. One or more light sources 74 may also be disposed at the distal tip.

[0062] Reference again Figures 6 to 9 , a handle member 58 is disposed at the proximal portion 52 of the attachment module 50. The handle member 58 is fixedly attached to the proximal end of a telescoping tubular body 57, the length of which can extend in a proximal direction from the distal portion 51. The telescoping tubular body 57 advantageously forms a connecting portion 53, thereby connecting the handle member 58 to the distal portion 51 (exiting the port 562) and defining an internal passage 56.

[0063] The handle member 58 can be manipulated by an operator, as described below. The locking connector 59 can be disposed at the proximal portion 52, advantageously on the circumference of the access port 561, and advantageously integrated in the handle member 58. The locking connector 59 cooperates with one or more locking 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 in one or more degrees of freedom. In particular, the locking member 131, advantageously shaped as a wing-shaped tab, is configured to be tightly engaged in the corresponding slot 591 of the locking connector 59 to lock the rotation of the catheter 10 relative to the handle member 58 around the longitudinal axis 209 and / or the translation of the catheter 10 relative to the handle member 58 along the longitudinal axis 209. The locking connector 59 advantageously provides a releasable connection of the locking member 131 (e.g., a snap-fit ​​connector). It should be understood that the positions of the locking member 131 and the corresponding slot 591 can be alternatively reversed, with the locking member being disposed on the locking connector 59 and the slot being disposed on the connector module.

[0064] When the locking member 131 of the catheter 10 is locked into the locking member 59, the operator can easily impart rotational and / or axial motion to the catheter 10 by manipulating the handle member 58. For example, pushing the handle member 58 distally will cause the members of the telescoping tubular body 57 to collapse into each other and thereby cause the catheter 10 to be further distally advanced within 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 therefore relative to the connector system 54 / distal portion 51), which will cause a rotation or torque to be applied proximally to the catheter 10, which can be transmitted toward the distal end 102 through the structure of the catheter body 11. Thus, the attachment module 50 can facilitate manipulation and navigation of components, particularly beyond the distal tip of the endoscope 70.

[0065] The attachment module 50 may further include a locking system 55 configured to secure or lock the movement of the guide catheter 10 in one or more degrees of freedom relative to the distal portion 51, in particular relative to the connector system 54 and / or the instrument channel 71. In one example, the locking system 51 is configured to lock or clamp the translational freedom of the guide catheter 10 along the longitudinal axis 209 relative to the distal portion 51 and / or the instrument channel 71 of the attachment module 50. The rotational freedom of the guide catheter 10 around the longitudinal axis 209 relative to the distal portion 51 / instrument channel 71 can be free or can be additionally locked by the locking system 55.

[0066] In a particular example, the locking system 55 can include a sleeve 551 formed of a soft or elastic (e.g., elastomeric) material and having a through hole configured to receive the guide catheter 10 therethrough. The sleeve 551 is housed in an enclosure 552, which can, for example, have a conical recess that receives the sleeve 551. The member 553 can be rotated relative to the enclosure 552, thereby exerting a force on the sleeve 551 that is used 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 advantageously releasable.

[0067] The locking system 55 is convenient when the guide catheter 10 has reached the final or target position. The locking system 55 can then be operated to fixedly secure the (axial) position of the guide catheter 10 relative to the instrument channel 71 and the distal tip of the endoscope 70. This prevents any inadvertent manipulation of the handle member 58 from undesirably moving the catheter 10 away from its desired position.

[0068] The guide 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 medical grade silicone materials) and medical grade thermoplastic materials (such as polypropylene or polycarbonate). At least some portions of the guide catheter can be disposable. The endoscopic probe 20 is advantageously formed of materials that can be cleaned and / or sterilized between uses with different patients. At least some portions of the endoscopic probe 20 can be reused for different patients.

[0069] At least some portions of the catheter body 11 and / or the endoscopic probe 20 may be formed of or include a radiopaque material to facilitate positioning thereof. Figure 5A , the catheter body 11 and / or the endoscopic probe 20 may include one or more trackable markers 223 that allow (initial) tracking via electromagnetic navigation, possibly in combination with fluorescence imaging as known in the art. The trackable marker is advantageously an electromagnetically sensitive device that is disposed in or on any of the catheter body 11, the probe body 21, and the distal portion 23 of the endoscopic probe. In the present disclosure, electromagnetic navigation may be utilized in combination with the visual guidance of the imaging device 22 to improve positioning accuracy and orientation within the body.

[0070] The probe body 21 advantageously has suitable axial stiffness or rigidity to prevent buckling when the endoscopic probe is advanced or deployed through the lumen 12 of the guide catheter 10. In some examples, the probe body 21 may include a sheath and a center conductor made of nickel-titanium alloy (nitinol) or other suitable metal alloys. The center conductor advantageously forms the core of the probe body and is arranged inside the sheath. Such a center conductor can impart suitable rigidity and anti-buckling properties to the probe body. Electrical and optical wires and cables can also be arranged inside the sheath. The center conductor and sheath can extend substantially along the entire length of the probe body, such as extending from its proximal end to the distal end.

[0071] refer to Figures 11 to 16 , a method 80 of performing an endoscopy using the components disclosed herein may begin at operation 81, in which a lesion, such as a pulmonary nodule ( Fig.12, arrow 91). The lesion can be discovered by medical imaging examinations, such as by computed tomography (CT) or fluoroscopic imaging of the anatomical cavity or lumen of interest, such as CT image 90 of the lung. The practitioner may wish to further examine the lesion and / or perform a biopsy to investigate its malignancy. This requires endoscopic intervention. In operation 82, endoscopic navigation is planned. Operation 82 can begin with generating a virtual model 93 of an anatomical cavity or lumen 96 (e.g., a bronchus), which can be obtained by the medical imaging examination performed in operation 81. A navigation route 95 can be planned based on the virtual model 93, such as from the trachea through the bronchus to the lesion 94 defined from operation 81.

[0072] In operation 83, an endoscope 70, such as a bronchoscope, is used to perform navigation along a planned route 95 through an anatomical cavity or lumen 96. The endoscope 70 may be inserted into the anatomical cavity or lumen 96 via an anatomical orifice or a surgically formed artificial orifice. The endoscope 70 is guided through the anatomical cavity or lumen 96 via endoscopic vision provided by a camera 73 and a light source 74 of the endoscope 70.

[0073] In operation 84, the virtual model 93 of the anatomical cavity or lumen 96 can be mapped to the real anatomical cavity or lumen 96 by mapping the virtual image 97 to the endoscopic image 98 of the real anatomical cavity or lumen. To this end, a trackable marker can be used to track the position of the endoscope as the endoscope advances along the navigation route 95. A trackable marker (such as an electromagnetic marker) can be set on the endoscope, or on a probe or surgical instrument inserted through the endoscope. The probe can be inserted into a guide catheter (such as guide catheter 10), and the guide catheter is inserted into the instrument channel 71 of the endoscope 70. According to known methods, the position of the trackable marker can be tracked by non-contact measurement relative to a fixed reference point. From the tracked position of the endoscope, the position of the image captured by the endoscope can be determined, thereby allowing the virtual image 97 to be mapped to the endoscopic image 98.

[0074] In operation 85, the distal tip 72 of the endoscope has reached an anatomical parking position where the endoscope cannot be advanced further, e.g., because the anatomical structure is too small, too rigid, and / or too complex to be traversed. If not already done, the guide catheter 10 is inserted into the instrument channel 71 of the endoscope 70. The guide catheter 10 may be further (distally) deployed beyond the distal tip of the endoscope, e.g., as Fig.10 as shown, and proceed along navigation route 95.

[0075] The advancement of the guide catheter 10 can be tracked by a trackable marker disposed on the guide catheter or a tracking probe inserted into the guide catheter. The tracking probe can be the endoscopic probe 20 according to the present disclosure or a different probe.

[0076] Optionally, the attachment module 50 of the assembly 200 is mounted on the handle 60 of the endoscope 70, the guide catheter 10 is inserted through the access port 561 and into the access port of the handle 60 via the internal channel 56, and further deployed through the instrument channel 71 of the endoscope 70 until the distal end 102 of the guide catheter 10 reaches the distal tip 72 of the endoscope 70. The locking member 131 of the connector module 13 can be locked into engagement with the locking member 59. In this position, the members of the telescoping tubular body 57 can be fully extended.

[0077] To navigate the guide catheter, the handle member 58 can be manipulated while the members 59 and 131 are in locking engagement to move the handle member in the distal direction (toward the distal portion 51 and the handle 60). By doing so, the members of the telescoping tubular body 57 collapse, thereby causing the guide catheter 10 to advance through the instrument channel 71 and further distally beyond the distal tip 72. Optionally, the handle member 58 can be rotated about the longitudinal axis 209 and the rotation is transmitted to the guide catheter 10 through the members 59 and 131. This can cause the distal end 102 of the guide catheter 10 / catheter body 11 to rotate, which can assist in navigation.

[0078] In operation 86, the guide catheter 10 is brought into proximity with the location of the lesion 94, as may be determined by tracking as described above. Advantageously, the guide catheter 10 is fixed in position relative to the endoscope and / or relative to a fixed (patient) reference point. The guide catheter 10 may be fixedly secured in position relative to the endoscope 70 by operating the locking system 55. This allows the handle member 58 to be released and the locking member 131 to be released from the connector member 59. If a tracking probe other than the endoscopic probe 20 is used for navigation, the tracking probe is removed from the guide catheter and the endoscopic probe 20 is inserted instead.

[0079] The endoscopic probe 20 (e.g., if it includes a trackable marker) may alternatively be pre-inserted into the lumen 12 of the catheter 10 while the catheter body 11 is deployed through the instrument channel 71 of the endoscope. Alternatively, the endoscopic probe 20 may be inserted continuously. When the endoscopic probe 20 is deployed through the lumen 12 of the guide catheter 10, a pressurized fluid (which may be a gas (such as CO2) or a liquid (such as a saline solution)) may be supplied to the lumen at a suitable pressure, particularly via the second inlet port 322 of the fluid delivery module 30. Supplying some fluid while deploying the endoscopic probe 20 may facilitate advancement of the endoscopic probe 20 through the lumen 12, particularly when the endoscopic probe 20 is provided with a thickened distal portion 23.

[0080] In operation 87, the guide catheter 10 and / or endoscopic probe 20 are positioned at the anatomical target location, i.e., near the lesion 94. With the guide catheter 10 (catheter body 11) secured, the endoscopic probe 20 may be navigated beyond the exit orifice 122 of the catheter 10 to visually inspect the area of ​​the lesion 95. An image 99 of the lesion may be captured by the endoscopic probe 20 and may be visualized on the visual display 42 for inspection.

[0081] If the endoscopic probe is placed slightly inside the lumen 12, the porthole effect can be utilized to improve the vision of the imaging device 22. For example, the distal tip or exit orifice 122 of the catheter body can be held against the anatomical target structure while the endoscopic probe 20 is retracted (proximally) inside the lumen to properly image the anatomical structure through the porthole effect. By doing so, the distal tip of the catheter body advantageously maintains the anatomical structure in the desired position.

[0082] The lens or screen of the imaging device 22 may be soiled or contaminated by body fluids during navigation, thereby compromising normal 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), which flushes the tip of the endoscopic probe 20 and cleans it. Flushing can be performed when the distal portion 23 is fully received in the lumen 12, or the (external) lens of the imaging device 22 is flush with the outlet orifice 122, or at least a portion of the distal portion 23 still extends distally beyond the outlet orifice 122. Then, the imaging device 22 is ready to be deployed again at or beyond the outlet orifice 122 of the guide catheter 10.

[0083] In operation 88, a diagnostic or surgical procedure is performed. An anatomical structure, such as a diameter or length, may be measured with the aid of the endoscopic probe 20. For example, the measurement may be performed based on a visual image captured by the imaging device 22. Alternatively, the length within the anatomical structure may be determined by advancing or retracting the endoscopic probe 20 relative to the guide catheter 10. The imaging device 22 may thus be used as a visual aid to determine the start and end points of the anatomical structure of interest. The control unit 40 may be configured to determine a measurement based on one or more images captured by the imaging device 22. For example, the control unit 40 may include a user interface that allows an operator to select a position on the visual display 42 and a control unit implemented with a computing unit that is configured to determine a measurement based on the selected position.

[0084] Alternatively or additionally, the endoscopic probe 20 can be removed from the guide catheter 10 and another surgical instrument (such as a biopsy forceps or a brush) is deployed through the lumen 12 instead. Still alternatively, the surgical instrument can be deployed through another instrument channel (not shown) of the endoscope 70 to reach the anatomical target area. Here again, the endoscopic probe can be used as a visual aid for navigation and / or operation of the surgical instrument.

[0085] It should be understood that some of operations 81 to 88 may be omitted. In particular, operations 81, 82, 84, and 88 are optional. In addition, operations 81 to 88 do not need to be performed in accordance with Fig.11 The present invention does not necessarily require execution in the order described or depicted in the figures, but may be executed in any suitable order.

[0086] The assemblies of the present disclosure are particularly suitable for surgical and / or diagnostic procedures in the pulmonary or biliopancreatic tracts (eg, the bile duct).

[0087] Example

[0088] Several prototypes of endoscopic probes and guide catheters were built to test the ability to flush the lumen of the guide catheter when the endoscopic probe is fully contained inside the lumen. The size specifications of the different prototypes are listed in Table 1. All probes have a probe body length of 2500 mm. Water is used as the flushing liquid. The flushing pressure is determined by displacing the piston of the syringe at a constant speed of 100 mm / min to empty 20 ml of water from the syringe into the lumen and measuring the required force. The barrel of the syringe has a 20 mm diameter (cross-sectional area 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 approximately 30 N was applied on the plunger of the syringe.

[0089] For all prototypes where the probe body diameter D2 was less than the diameter D1 of the distal portion (head) of the endoscopic probe (i.e., the ratio D1 / D2 was greater than 1, specifically prototypes 1 to 5, 14, and 15), a moderate irrigation pressure and thus the possibility of ensuring an irrigation flow rate sufficient to wet the front of the distal portion (imaging device 22) was observed. For prototypes where D1=D2 (the diameter of the endoscopic probe head was equal to the diameter of the probe body), a moderate irrigation pressure was observed only when D1 / D3=D2 / D3≤0.84. In sharp contrast, when the endoscopic probe was made with an enlarged distal portion and the probe body had a smaller diameter, the diameter of the distal portion could be as high as D1 / D3=0.95 while still allowing good irrigation. Thus, the device according to the present disclosure allows further miniaturization of the endoscopic device (smaller catheter for the distal portion of the probe of equal diameter), or allows the use of improved imaging devices (larger distal portion for the same diameter lumen of the catheter).

[0090] Table 1: Sizes of various prototypes of endoscopic probes and guide catheters; characteristic diameter ratios and results of flushing tests (column "P": flushing pressure; column "T": flushing time; column "F": 1 = flushing possible; 0 = flushing not possible)

[0091]

[0092] Certain aspects of the disclosure are set forth in the following alphanumeric clauses.

[0093] A1. A method of performing an endoscopy, the method comprising:

[0094] navigating an endoscopic device, preferably a bronchoscope, through an anatomical cavity or lumen, in particular until an anatomical parking position is reached;

[0095] deploying a guide catheter according to aspects of the present disclosure through an instrument channel of the endoscopic device, preferably beyond a distal tip of the endoscopic device, preferably to an anatomical target location;

[0096] securing the position of the guide catheter relative to a reference point;

[0097] An endoscopic probe according to aspects of the present disclosure is deployed through the guide catheter and the anatomical target location is imaged by an imaging device of the endoscopic probe.

[0098] A2. The method described in clause A1 further includes determining a navigation route along the anatomical cavity or lumen, wherein navigating the endoscopic device includes navigating the endoscopic device along the navigation route, preferably wherein the navigation route includes the anatomical parking position and / or the anatomical target position.

[0099] A3. The method of clause A2, further comprising tracking a trackable marker along the navigation route.

[0100] A4. The method of clause A3, comprising deploying a tracking probe including the trackable marker through an instrument channel of the endoscopic device.

[0101] A5. The method of clause A4, comprising retracting the tracking probe after securing the position of the guide catheter.

[0102] A6. The method of clause A5, wherein, after retracting the tracking probe, the endoscopic probe is deployed through the guide catheter.

[0103] A7. A method as described in clause A4, wherein the tracking probe is the endoscopic probe.

[0104] A8. A method as described in any of clauses A3 to A7, wherein determining the navigation route includes 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 endoscopic device and / or the endoscopic probe, wherein the position of the image is determined based on tracking the trackable marker.

[0105] B1. A component (100, 200) for intracavitary navigation, the component comprising:

[0106] A guide catheter (10) having a proximal end (101) and a distal end (102), wherein the guide catheter comprises an elongated flexible tubular catheter body (11) defining an inner lumen (12) of the catheter, wherein the inner lumen (12) comprises an exit orifice (122) at the distal end (102),

[0107] An endoscopic probe (20) comprising a flexible probe body (21) and an imaging device (22) attached to the probe body at a distal end of the probe body, wherein the probe body and the imaging device are sized to be slidably received in the lumen (12), and

[0108] a fluid delivery module (30) attached or attachable to the guide catheter (10) at the proximal end (101), wherein the fluid delivery module comprises: a first port (321) configured to communicate with the lumen (12), wherein the first port is configured to receive the endoscopic probe (20) for deployment through the lumen; and a second port (322) configured to deliver fluid to the lumen (12),

[0109] The first port (321) includes a fluid seal (34) configured to seal the first inlet port (321) against the probe body (21) in a fluid-tight manner, while the second port (322) maintains fluid communication with the inner cavity (12).

[0110] B2. A component as described in clause B1, wherein the fluid seal (34) includes a sealing member (341) having a through hole configured to slidably receive the probe body (21), preferably wherein the fluid seal includes tightening devices (342, 343) configured to tighten the sealing member (341) against the probe body (21).

[0111] B3. The assembly of clause B1 or B2, further comprising a fluid source (35) configured to be coupled to the second port (322).

[0112] B4. The assembly of clause B3, further comprising a flow control valve (351) coupled between the second port (322) and the fluid source (35).

[0113] B5. The component (200) as described in any one of clauses B1 to B5, further includes an attachment module (50), wherein the attachment module includes 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 to the first end and defining an internal channel (56) of the attachment module (50), wherein the size of the internal channel is determined to slidingly receive the catheter body (11), wherein the connector system (54) is disposed at the second end (51) and is configured to securely connect the attachment module (50) to the support member (60).

[0114] B6. A component as described in clause B5, wherein the attachment module further includes: 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 guide catheter (10) relative to the handle member in at least one of: translation along the longitudinal axis (209) of the telescopic tubular body and rotation around the longitudinal axis.

[0115] B7. A component as described in clause B6, wherein the guide catheter (10) includes a first connector component (131) configured to releasably interlock with a corresponding connector component (591) of the locking system (59) to enable integral movement of the guide catheter and the handle component.

[0116] B8. A component as described in any of clauses B5 to B7, wherein the attachment module (50) further includes a second locking system (55), which is configured to axially fix the guide catheter (10) relative to the support member (60), preferably wherein the second locking system (55) is arranged at the second end (51).

[0117] B9. An assembly as described in any of clauses B1 to B8, wherein the catheter body (11) is configured to transmit torque and / or rotation from the proximal end (101) to the distal end (102) in order to navigate the guide catheter (10).

[0118] B10. A component as described in any of clauses B1 to B9, wherein the endoscopic probe (20) includes a distal portion (23) at the distal end of the probe body (21), wherein the distal portion accommodates the imaging device (22) and has an increased diameter relative to the diameter of the probe body (21).

[0119] B11. A component as described in clause B10, wherein the ratio of the diameter of the probe body (21) to the diameter of the inner cavity (12) is between 0.15 and 0.9, and the ratio of the diameter (D1) of the distal portion (23) to the diameter of the inner cavity (12) is between 0.3 and 0.95.

[0120] B12. An assembly as described in any of clauses B1 to B11, wherein the imaging device (22) includes a camera module (221) and a light source (222).

[0121] B13. A component as described in any of clauses B1 to B12, further comprising an endoscope (70), wherein the endoscope includes an endoscope handle (60) connected to the endoscope body (75), the endoscope body including an instrument channel (71), wherein the endoscope handle includes an access port (61) connected to the instrument channel (71), and wherein the guide catheter (10) is configured to be slidably received in the instrument channel (71) and pass through the access port (61).

[0122] B14. An assembly as described in clause B13, wherein the endoscope (70) further includes a second imaging device (73) arranged at the distal end of the endoscope body (75).

[0123] B15. The assembly as described in clause B13 or B14 further comprises an attachment module (50) as described in any one of clauses B5 to B8, wherein the endoscope handle (60) forms the support member and includes a connector portion (62), wherein the connector system (54) is configured to cooperate with the connector portion to attach the attachment module (50) to the endoscope handle (60).

Claims

1. A component for intracavitary navigation, the component comprising: A guide catheter (10) having a proximal end (101) and a distal end (102), wherein the guide catheter comprises an elongated flexible tubular catheter body (11) defining an inner lumen (12) of the catheter, wherein the inner lumen (12) comprises an exit orifice (122) at the distal end (102), An endoscopic probe (20) includes a flexible probe body (21) and an imaging device (22) attached to the probe body at a distal end of the probe body, wherein the probe body and the imaging device are sized to be slidably received in the lumen (12), a fluid delivery module (30) attached or attachable to the guide catheter (10) at the proximal end (101), wherein the fluid delivery module comprises: a first port (321) configured to communicate with the lumen (12), wherein the first port is configured to receive the endoscopic probe (20) for deployment through the lumen; and a second port (322) configured to deliver fluid to the lumen (12), and An endoscope (70) comprising an endoscope handle (60) connected to an endoscope body (75), the endoscope body comprising an instrument channel (71), wherein the endoscope handle comprises an access port (61) in communication with the instrument channel (71), wherein the guide catheter (10) is configured to be slidably received in the instrument channel (71) and pass through the access port (61), wherein the first port (321) comprises a fluid seal (34) configured to seal the first inlet port (321) against the probe body (21) in a fluid-tight manner, and the second port (322) maintains fluid communication with the inner cavity (12), The endoscopic probe (20) includes a distal portion (23) at the distal end of the probe body (21), wherein the distal portion accommodates the imaging device (22) and has a diameter (D1) that is larger than the diameter (D2) of the probe body (21) and smaller than the diameter (D3) of the inner cavity.

2. The assembly of claim 1, wherein: The fluid seal (34) comprises a sealing member (341) having a through hole configured to slidably receive the probe body (21), preferably wherein: The fluid seal includes tightening means (342, 343) configured to tighten the sealing member (341) against the probe body (21).

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

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

5. The assembly (200) according to any one of the preceding claims, further comprising an attachment module (50), wherein: The attachment module includes a connector system (54) and a telescopic tubular body (57), which extends from a first end (52) to a second end (51) opposite to the first end and defines an internal channel (56) of the attachment module (50), wherein the size of the internal channel is determined to slidingly receive the catheter body (11), wherein the connector system (54) is disposed at the second end (51) and is configured to securely connect the attachment module (50) to a support member (60).

6. The assembly of claim 5, wherein: The attachment module further includes: 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 guide catheter (10) relative to the handle member in at least one of: translation along the longitudinal axis (209) of the telescopic tubular body and rotation around the longitudinal axis.

7. The assembly of claim 6, wherein: The guide catheter (10) includes a first connector component (131) configured to releasably interlock with a corresponding connector component (591) of the locking system (59) to enable integral movement of the guide catheter and the handle component.

8. An assembly as claimed in any one of claims 5 to 7, wherein The attachment module (50) further comprises a second locking system (55) configured to axially fixedly secure the guide catheter (10) relative to the support (60), preferably wherein: The second locking system (55) is arranged at the second end (51).

9. An assembly as claimed in any one of claims 5 to 8, wherein The endoscope handle (60) forms the support and includes a connector portion (62), wherein the connector system (54) is configured to cooperate with the connector portion to attach the attachment module (50) to the endoscope handle (60).

10. An assembly as claimed in any one of the preceding claims, wherein: The wall of the catheter body (11) includes a reinforcing braid configured to transmit torque and / or rotation from the proximal end (101) to the distal end (102) to facilitate navigation of the guide catheter (10).

11. An assembly as claimed in any one of the preceding claims, wherein: The probe body (21) includes a reinforced braid.

12. An assembly as claimed in any one of claims 1 to 10, wherein: The probe body (21) comprises a sheath and a central wire arranged in the sheath and made of a metal alloy. Preferably, the metal alloy is a nickel-titanium alloy.

13. An assembly as claimed in any one of the preceding claims, wherein: The ratio of the diameter of the probe body (21) to the diameter of the inner cavity (12) is between 0.15 and 0.9, and the ratio of the diameter (D1) of the distal portion (23) to the diameter of the inner cavity (12) is between 0.3 and 0.

95.

14. An assembly as claimed in any one of the preceding claims, wherein: The distal portion having an enlarged diameter has an axial length of between 3 mm and 10 mm.

15. An assembly as claimed in any one of the preceding claims, wherein: The distal portion has an outer diameter between 0.8 mm and 2.4 mm.

16. An assembly as claimed in any one of the preceding claims, wherein: The ratio of the diameter (D1) of the distal portion (23) to the axial length (L1) of the distal portion is between 0.1 and 0.

4.

17. An assembly as claimed in any one of the preceding claims, wherein: The distal portion has a shape that is rotationally symmetrical about the longitudinal axis of the endoscopic probe, preferably a cylindrical shape.

18. An assembly as claimed in any one of the preceding claims, wherein: The imaging device (22) includes a camera module (221) and a light source (222).

19. An assembly as claimed in any one of the preceding claims, wherein: The endoscope (70) further includes a second imaging device (73) disposed at the distal end of the endoscope body (75).

20. An assembly for endoluminal navigation, the assembly comprising a guide catheter as claimed in any one of the preceding claims, an endoscopic probe and a fluid delivery module.

Images