Real-time sampling system

Abstract

To provide a device and system for allowing real-time viewing of a procedure beyond a distal end of an endoscope.SOLUTION: An exemplary device includes a sheath with at least two lumens, and a handle. The handle includes a connector that connects to a proximal end of an endoscope, a shaft portion that rotatably connects to a proximal end of the connector, and a manifold that is slidably received by the shaft portion. The manifold connects to the sheath and allows insertion of a radial ultrasound probe and a medical tool into the sheath. A stopping device in the manifold avoids accidental needle deployment.SELECTED DRAWING: Figure 17

Description

Background Art

[0001] The description in this section merely provides background information regarding the present disclosure and may not constitute prior art.

[0002] Currently available tools for the visualization and sampling of peripheral lung tumors by ultrasound have limited range of movement and diagnostic capabilities. Usually, during peripheral sampling, the guide sheath is inserted through the bronchoscope and extended far beyond the reach of the bronchoscope, so the distal end of the guide sheath is not visible. The radial endobronchial ultrasound (EBUS) mini-probe first passes through the guide sheath and is screwed in and used to measure the approximate location of the tumor.

[0003] Unfortunately, peripheral tumors located away from one side of the airway (as opposed to tumors centered around the airway perimeter) have a substantially low diagnostic rate in part due to the limitations of current radial EBUS technology, whereby the operator can recognize the depth from the probe but not the direction of the tumor. The sampling needle needs to extend off-axis from the length of the catheter, and thus knowledge of the rotational orientation of the needle and the sampling target is required. The radial ultrasound probe does not show the orientation of the needle with respect to the lesion. The radial ultrasound image is a 360° image that allows the user to confirm the lesion, but the user cannot identify whether the needle is pointing at the lesion.

Summary of the Invention

[0004] The present invention provides a device that enables real-time observation of a patient's tissue sample or drug delivery procedure beyond the field of view of an endoscope that can be used to transfer the device.

[0005] An exemplary device includes a sheath and a handle having at least two lumens. The handle includes a connector that connects to the proximal end of an endoscope, a shaft portion that rotatably connects to the proximal end of the connector, and a manifold that is slidably received by the shaft portion. The manifold includes a distal end that connects to the sheath. The distal end includes at least two lumens, each lumen having a longitudinal axis that aligns with one of each of the at least two lumens of the connected sheath. The manifold also includes a first proximal port having a longitudinal axis that coincides with the longitudinal axis of one of the distal end's longitudinal axes, and a second proximal port having a longitudinal axis that is angularly related to the longitudinal axis of the second lumen of the two lumens of the distal end. The first proximal port receives a radial ultrasound probe, and the second proximal port receives a medical instrument. The second proximal port allows the medical instrument to pass through the second lumen of the two lumens of the distal end.

[0006] In one embodiment, the medical device includes a needle. The actuator includes a distal end connected to the proximal end of the needle and a proximal end connected to a suction source.

[0007] In another embodiment, the shaft portion includes a buckling prevention device that limits buckling of at least one of the sheaths or medical instruments within the shaft portion, and the manifold includes a buckling prevention device that limits buckling of the medical instruments within the manifold. The buckling prevention device may include a nesting tube.

[0008] In yet another embodiment, the sheath includes a distal end having a distal support member, a proximal support member, and at least two longitudinal support members connected between the distal and proximal support members. The distal support member, the proximal support member, and the at least two longitudinal support members are formed from a machined, punched, or laser-cut hypotube. The distal and proximal support members are ring-shaped.

[0009] In another embodiment, the distal end includes an inclined surface that allows the distal end of the medical instrument to deflect as the medical instrument is advanced distally. The proximal support member includes a support that provides support to the inclined surface.

[0010] In yet another embodiment, the second proximal port receives the medical device in a predetermined orientation such that when the medical device is received into the second proximal port, the distal end of the medical device is oriented in a predetermined orientation with respect to the inclined surface.

[0011] Further features, advantages, and application areas will become apparent from the descriptions provided herein. It should be understood that the descriptions and specific examples are intended for illustrative purposes only and are not intended to limit the scope of this disclosure.

[0012] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of this disclosure. The elements in the drawings are not necessarily to a specific scale and are focused on illustrating the principles of the invention. The drawings include: [Brief explanation of the drawing]

[0013] [Figure 1] This figure shows a real-time system (RTS) and an endoscope. [Figure 2] This is a side view of the RTS. [Figure 3] Figure 2 is a cross-sectional view of the sheath of the RTS component shown. [Figure 4] Figure 2 shows a longitudinal cross-sectional view of the distal end of the RTS. [Figure 5] This is a perspective view of the distal end. [Figure 6-1] This is a side view of the distal end. [Figure 6-2] This is a top view of the distal end. [Figure 6-3] This is a perspective view of the components at the distal end. [Figure 6-4] Figure 6-3 is a top view of the distal end components. [Figure 7]It is an enlarged view of the braided section at the distal end. [Figure 8-1] It shows a side view of the distal end of the ultrasonic transducer and the ultrasonic plane generated by the target lesion. [Figure 8-2] It shows an ultrasonic image where the ultrasonic transducer is in a first orientation with respect to the target lesion. [Figure 8-3] It shows an ultrasonic image where the ultrasonic transducer is in a second orientation with respect to the target lesion. [Figure 9-1] It shows a part of the handle of the RTS. [Figure 9-2] It shows the handle part of FIG. 9-1 in a partially exploded view. [Figure 9-3] It shows an X-ray diagram of a part of the handle of the RTS. [Figure 10] It shows an exemplary RTS handle. [Figure 11] It is a longitudinal sectional view of the handle shown in FIG. 10. [Figure 12] It is a sectional view of a part of the proximal end of the handle shown in FIG. 10. [Figure 13] It is a second longitudinal sectional view of the distal end of the handle shown in FIG. 10. [Figure 14] It is a sectional view of a part of the distal end of the RTS. [Figure 15] It is a perspective view of the distal end of the RTS. [Figure 16] It is a side view of an exemplary proximal end of the RTS. [Figure 17] It is a partial X-ray side view of the RTS handle of FIG. 16.

Mode for Carrying Out the Invention

[0014] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or use.

[0015] Referring here to Figure 1, the bronchoscopy system 10 includes a bronchoscope 12 equipped with an insertion tube 14, and a real-time system 16. The real-time system 16 includes a handle 20, a signal processor 24, a display device 18, and a radial ultrasound probe 22. The radial ultrasound probe 22, as well as a medical device 30, such as a sampling and / or drug delivery needle, is received into the bronchoscope 12 via the handle 20.

[0016] The display device 18 communicates with the bronchoscope 12 and / or signal processor 24 via wired or wireless signal communication. The display device 18 displays an image generated based on information received from the bronchoscope 12 and / or signal processor 24, which receive image information from the bronchoscopy imaging device and / or radial ultrasound transducer at the distal end of the radial ultrasound probe 22. A therapeutic bronchoscope (e.g., the BF-X190 from Olympus®) is an example of the bronchoscope 12, and an Olympus® radial intrabronchial ultrasound (EBUS) miniprobe is an example of the radial ultrasound probe 22.

[0017] Figures 2-4 show a floating real-time sampling device (RTSD) 48 having multiple lumen sheaths 50 extending beyond the distal end of an endoscope (e.g., a bronchoscope 12). The endoscope is used to maneuver the RTSD 48 within a selected airway. The handle 52 of the floating RTSD 48 is not attached to the endoscope. A flexible needle 70 is inserted into an angled side port 54 of the handle 52. A second non-angled access port 56 receives a radial EBUS probe 72. The proximal end of the needle 70 is attached to a removable needle actuator 58 which includes a distal portion 60 that is received within the angled side port 54. A safety stop component 62 is attached to the distal portion 60. The safety stop component 62 contacts the angled side port 54 when the needle actuator 58 is advanced distally. The safety stop component 62 is sized and / or positioned on the distal portion 60 to limit the distance the distal tip of the needle 70 extends beyond the sheath 50. In one embodiment, the safety stop component 62 allows the needle 70 to extend beyond the ultrasonic plane generated by the ultrasonic transducer of the radial EBUS probe 72 when the probe 72 is inserted into the sheath 50. The needle actuator 58 includes a proximal port for receiving a stylet (not shown) to be attached to the stylet knob 64, or for connecting to a syringe to generate suction pressure via a Luer or similar fitting. In one embodiment, the stylet is curved at the distal portion to match the curve of the needle 70 when both have exited the sheath 50.

[0018] The sheath 50 includes a radial EBUS probe lumen 74 for receiving the probe 72 and a smaller working channel lumen 76 for receiving a needle 70 or another medical device. The distal tip 66 of the sheath 50 includes an exit inclined surface 78 of the working channel lumen 76 and a window 80 enclosing a portion of the radial EBUS probe lumen 74. The window 80 is distal to the exit inclined surface 78. A port 82 at the distal end of the sheath 50 allows ultrasound gel to be inserted into the lumen 74.

[0019] Figures 5, 6-1, 6-2, 6-3, and 6-4 show an example of the distal tip 66 of the sheath 50. In one embodiment, the distal tip 66 is formed from a hypotube 88 that has been processed (machined, punched, or etched) to include a distal ring 90 extending between rings 90, 92, a proximal ring 92, and two orientation pins (i.e., longitudinal components, ultrasonic reflecting or echo generating members) 94. A casing material, such as Pebax® or an equivalent material, is applied (molded or reflowed) over the hypotube and the section of the catheter adjacent to the hypotube using a mandrel or equivalent tool.

[0020] In one embodiment, the hypotube 88 is pressed in a plastic mold or externally coated and aligned with the probe lumen 74 of the sheath 50 using a mandrel.

[0021] As shown in Figure 7, a section of the sheath 50 immediately proximal to the distal tip 66 may include a braided section 96 of thin wire (e.g., stainless steel) surrounding the radial EBUS probe lumen 74 and the working channel lumen 76. The braided section 96 provides increased torque response and a steeper bending radius without excessively impairing flexibility. The braided section 96 can also reduce the risk of tools (e.g., needles) penetrating the lumen and sheath walls. In one embodiment, the braided section 96 includes a helix of three adjacent wires.

[0022] Figure 8-1 shows a side view of the distal end 66 aligned adjacent to the target. The ultrasound probe 72 received within the distal end 66 generates the ultrasound images shown in Figures 8-2 and 8-3 based on the ultrasound plane 98 generated by the transducer of the ultrasound probe 72. The orientation pin 94 generates an ultrasound artifact that appears as a headlight 100 in the ultrasound image. The headlight 100 allows the operator to understand the orientation of the distal end 66 relative to the target. With knowledge of orientation, the operator can rotate the sheath 50 using the handle so that the target tumor (see reflection 102) is in the correct position relative to where the needle 70 emerges from the sheath 50.

[0023] Figures 9-1, 9-2, and 9-3 show the keying mechanism of the needle 70 and needle actuator 58, which are properly keyed to the sheath 50. The distal portion 60 of the needle actuator 58 includes an actuator keying pin 110 at its distal end. The angled side port 54 of the handle 52 includes two offset keyways 112, 114. One keyway 114 is constructed within the port 54. The other keyway 112 is a separate part that rotates over the built-in keyway 114. The keyways 112, 114 are intentionally offset so that the user must rotate the actuator 58 to remove it from the handle 52. To insert the actuator, 1) align the keying pin 110 with the first keyway 112, 2) push it past the split O-ring, and 3) then rotate it counterclockwise to align it with the second keyway 114 and insert the rest of the actuator 58. When fully inserted, the actuator 58 will fit snugly within the O-ring.

[0024] In one embodiment, Figures 10 to 13 show an exemplary RTS handle 122 including a scope mounting portion 124, a handle shaft 126, and a manifold 128. The scope mounting portion 124 is mounted to a port on the endoscope handle. The handle shaft 126 is mounted to the scope mounting portion 124 so that the handle shaft 126 can rotate about its longitudinal axis. The handle shaft 126 slidably receives the manifold 128. The manifold 128 is mounted to a multi-lumen sheath (e.g., sheath 50) that is received within the mounted scope. The manifold 128 includes a first port 130 for receiving an ultrasound probe (e.g., probe 72) and a second angled port 132 for receiving an actuator handle 134 that provides control of a medical device (e.g., needle 70, cell brush, forceps, etc.). The first port 130 may include a low-force holding device 154. The low-force holding device 154 keeps the probe 72 moving longitudinally relative to the handle 122 without crushing the sheath of the probe 72.

[0025] The handle 134 includes a proximal port for receiving a Luer attachment 136. The Luer attachment 136 includes a medical device attachment point 139 that connects to the proximal end of a medical device (not shown). The Luer attachment 136 receives a stylet (not shown) through the proximal port and guides the stylet into the hollow medical device via a tapered lumen. The Luer attachment 136 includes a tab when engaging with the actuator handle 134 to rotate clockwise so that the distal end of the medical device is properly oriented with respect to the inclined surface of the distal end of the catheter. The Luer attachment 136 and the attached medical device (e.g., a needle) can be removed from the actuator handle 134 after the tissue sample has been obtained without removing the actuator handle 134 from the manifold 128 and handle 122.

[0026] The actuator handle 134 includes a plunger and a sliding upper hypotube. The plunger and the sliding upper hypotube remain permanently mounted within the actuator handle 134. The manifold 128 includes a stationary lower hypotube. The sliding upper hypotube is sized to be accommodated within the stationary lower hypotube. These nested hypotubes reduce needle buckling within the handle 122.

[0027] The handle shaft 126 includes one or more internal plates 140 that provide lateral support to the received sheath and / or needle, keeping them in a buckled state. The plates 140 slide adjacent to each other and can nest very tightly along the axial dimension as the manifold 128 moves distally. The manifold 128 mounts to one of the adjacent plates 140 so that the plates 140 can be pulled apart or pushed together when the sheath is pulled or extended. The plates 140 interlock when extended and are held in place using a rail system designed within the handle shaft 126. An O-ring 144 is positioned between the handle shaft 126 and the scope mounting section 124 to maintain the vacuum capacity within the handle 122. The handle shaft 126 connects to the scope mounting section 124 using a rotation stopper 142.

[0028] In one embodiment, the stylet is pre-curved at its distal end. The curved stylet curves the needle outside the sheath.

[0029] The components in the handle 122 rotate the inclination of the needle clockwise relative to the handle 122 for proper alignment of the needle with respect to the distal outlet inclined surface (Figure 14). The handle 122 also includes a removable stopper 138. The position of the stopper 138 on the handle 134 points to where the needle intersects with the ultrasonic plane generated by the ultrasonic probe.

[0030] The manifold 128 includes a nesting tube 152 for reducing needle buckling.

[0031] As shown in Figure 14, the outlet inclined surface of the second lumen of the catheter may be made of a rigid plastic (e.g., polyimide, PEEK), nitinol, stainless steel, or other equivalent material. The outlet inclined surface may be formed from a single tube having a straight proximal end 162 and a distal section 160.

[0032] In one embodiment, the distal section 160 of the inclined surface is supported by a hypotube component 164 similar to those shown in Figures 5, 6-1 to 6-4. The component 164 is curved or bent at one end (e.g., the distal end) to provide support to the distal section 160 of the inclined surface. In one embodiment, the component 164 is formed to be on the inner surface of the distal section 160 of the inclined surface.

[0033] As shown in Figure 15, the exemplary distal end 190 includes a headlight pin 192 positioned at an angle to the longitudinal axis of the probe lumen 194. A visual difference will be observed in the generated image as the ultrasonic transducer (i.e., the ultrasonic plane) moves distally. The ultrasonic artifact generated by the pin 192 moves in such a way that it appears to converge in the generated image as the probe advances. This will help the user define where the needle emerges from and also help the user know where the probe is located within the tip.

[0034] As shown in Figures 16 and 17, the needle handle shaft 204 includes a full or partial annular groove 206 at or near its distal end. The second angled port of the manifold includes a safety device 200 to prevent accidental needle advance beyond the end of the needle sheath. The safety device 200 includes a button 208 attached to a spring-loaded actuator arm fixed distally within the angled port. The proximal end of the actuator arm includes a circular or semicircular device positioned around the lumen defined by the angled port.

[0035] In one embodiment, the groove 206 is defined by a proximal tapered edge and a distal vertical edge. When the needle handle shaft 204 is advanced into the manifold, the circular or semicircular device of the safety device 200 engages with the groove 206 using a snapping or clicking action and / or sound. The distal advance of the needle handle shaft 204 continues when the force applied to the needle handle shaft 204 exceeds a threshold amount, thereby deflecting the circular or semicircular device through the tapered edge. The distal advance of the needle handle shaft 204 may also continue after disengaging from the needle handle shaft 204 by pressing down the button 208.

[0036] When the needle handle is pulled after the needle is deployed, or when the groove 206 is distal to a circular or semicircular device, the circular or semicircular device is received within the groove 206. The vertical edge of the groove 206 prevents the proximal movement of the needle handle shaft 204. To continue pulling beyond this obstructed position, the user presses the button 208, thereby moving the circular or semicircular device so as not to further obstruct the vertical edge of the groove 206.

[0037] [Embodiment] A. A device comprising a sheath having at least two lumens, a handle, the handle comprising a connector configured to connect to the proximal end of an endoscope, a shaft portion configured to be rotatably connected to the proximal end of the connector, and a manifold configured to be slidably received by the shaft portion, the manifold comprising a distal end configured to connect to the sheath, the distal end comprising two lumens, each having a longitudinal axis aligned with the respective lumens of at least two lumens of the connected sheath, A device comprising: a first proximal port having a longitudinal axis configured to coincide with the longitudinal axis of one of the distal ends, and configured to receive a radial ultrasound probe; and a second proximal port configured to receive a medical instrument, the second proximal port having a longitudinal axis at an angle to the longitudinal axis of the second lumen of two lumens at the distal end, and the second proximal port being configured to allow the medical instrument to pass through the second lumen of two lumens at the distal end.

[0038] B. Device A, wherein the shaft portion includes a longitudinal slot configured to slidably receive a manifold.

[0039] C. A medical device comprising a needle, device A or B.

[0040] Device C further comprises an actuator having a distal end configured to connect to the proximal end of a needle and a proximal end configured to connect to a suction source.

[0041] E. Any device A to D, comprising a first anti-buckling device configured such that the shaft portion limits the buckling of at least one of the sheath or medical instrument within the shaft portion.

[0042] Devices A through E, wherein the manifold comprises a first anti-buckling device configured to limit the buckling of medical instruments within the manifold.

[0043] G. Device E or F, in which the buckling prevention device comprises a nesting tube.

[0044] A to G, wherein the sheath has a distal end comprising a distal component, a proximal component, and at least two longitudinal components connected between the distal and proximal components.

[0045] I. A device of H, wherein the distal component, the proximal component, and at least two longitudinal components are formed from at least one of machined, punched, or laser-cut hypotubes.

[0046] J. A device of H or I in which the distal support member and the proximal support member are at least a partial ring.

[0047] K. A device of any of H to J, wherein the distal end has an inclined surface that allows the distal end of the medical instrument to be deflected when the medical instrument is advanced distally.

[0048] L. A device of K comprising a support configured to provide support to an inclined surface.

[0049] M. A K or L device in which a second proximal port receives a medical device in a predetermined orientation such that when the medical device is received in the second proximal port, the distal end of the medical device is oriented in a predetermined orientation with respect to the inclined surface.

[0050] The description of this invention is essentially illustrative, and any modifications that do not depart from the spirit of the invention are intended to be within the scope of the invention. Such modifications are not considered to depart from the spirit and scope of the invention. [Additional note 1] It is a device, A sheath having at least two lumens, It comprises a handle, and the handle is A connector configured to connect to the proximal end of the endoscope, A shaft portion configured to be rotatably connected to the proximal end of the connector, The manifold is configured to be slidably received by the shaft portion, and the manifold is A distal end configured to connect to the sheath, wherein the distal end comprises at least two lumens, each lumen having a longitudinal axis aligned with one of the at least two lumens of the connected sheath, A first proximal port having a longitudinal axis configured to coincide with the longitudinal axis of one of the distal ends, and configured to receive a radial ultrasound probe, A second proximal port configured to receive a medical instrument, wherein the second proximal port has a longitudinal axis that is angularly related to the longitudinal axis of the second lumen of the two lumens at the distal end, and the second proximal port is configured to allow the medical instrument to pass through the second lumen of the two lumens at the distal end, A device comprising a locking mechanism configured to prevent distal movement of a medical instrument handle shaft below a predetermined threshold. [Additional note 2] The device according to Appendix 1, wherein the shaft portion includes a longitudinal slot configured to slidably receive the manifold. [Additional note 3] The device according to Appendix 1, wherein the medical instrument comprises a needle. [Additional note 4] It is an actuator, The distal end is configured to be connected to the proximal end of the needle, The proximal end is configured to be connected to a suction source, The device according to Appendix 3, further comprising an actuator having at least a partial annular groove configured to engage with the locking mechanism. [Additional note 5] The device according to Appendix 1, wherein the shaft portion comprises a first buckling prevention device configured to limit buckling of at least one of the sheath or the medical device within the shaft portion. [Additional note 6] The device according to Appendix 1, wherein the manifold comprises a first buckling prevention device configured to limit buckling of the medical instrument within the manifold. [Additional note 7] The device according to Appendix 6, wherein the buckling prevention device includes a nesting tube. [Additional note 8] The aforementioned sheath, It has a distal end, and the distal end is Distal components and Proximal components and, The device according to Appendix 1, comprising at least two longitudinal components connected between the distal component and the proximal component. [Additional note 9] The device according to Appendix 8, wherein the distal component, the proximal component, and the at least two longitudinal components are formed from at least one of machined hypotube, punched hypotube, or laser-cut hypotube. [Additional Note 10] The device according to Appendix 8, wherein the distal support member and the proximal support member are at least a partial ring. [Additional Note 11] The device according to Appendix 8, wherein the distal end comprises an inclined surface configured to allow the distal end of the medical instrument to deflect when the medical instrument is advanced distally. [Additional Note 12] The device according to appendix 11, wherein the proximal support member comprises a support that at least provides support to the inclined surface or is configured to function as the inclined surface. [Additional Note 13] The device according to Appendix 11, wherein the second proximal port is configured to receive the medical device in a predetermined orientation such that when the medical device is received in the second proximal port, the distal end of the medical device is oriented in a predetermined orientation with respect to the inclined surface. [Additional Note 14] It is a system, Endoscope and, A device comprising, the device is A sheath having at least two lumens, It comprises a handle, and the handle is A connector configured to connect to the port of the endoscope, A shaft portion configured to be rotatably connected to the proximal end of the connector, The manifold is configured to be slidably received by the shaft portion, and the manifold is A distal end configured to connect to the sheath, wherein the distal end comprises at least two lumens, each lumen having a longitudinal axis aligned with one of the at least two lumens of the connected sheath, A first proximal port having a longitudinal axis configured to coincide with the longitudinal axis of one of the distal ends, and configured to receive a radial ultrasound probe, A second proximal port configured to receive a medical instrument, wherein the second proximal port has a longitudinal axis that is angularly related to the longitudinal axis of the second lumen of the two lumens at the distal end, and the second proximal port is configured to allow the medical instrument to pass through the second lumen of the two lumens at the distal end, A system comprising a locking device configured to prevent distal movement of a medical instrument below a predetermined force threshold. [Additional Note 15] The system according to Appendix 14, wherein the shaft portion comprises a buckling prevention device configured to limit buckling of at least one of the sheath or the medical instrument within the shaft portion, and the manifold comprises a buckling prevention device configured to limit buckling of the medical instrument within the manifold. [Additional Note 16] The aforementioned sheath, It has a distal end, and the distal end is Distal member and Proximal member and The system according to appendix 14, comprising at least two longitudinal members connected between the distal member and the proximal member. [Additional Note 17] The system according to Appendix 16, wherein the distal end comprises an inclined surface configured to allow the distal end of the medical instrument to deflect when the medical instrument is advanced distally. [Additional Note 18] The system according to appendix 17, wherein the proximal support member comprises a support configured to provide support to the inclined surface. [Additional Note 19] The system according to Appendix 14, wherein the second proximal port is configured to receive the medical device in a predetermined orientation such that when the medical device is received in the second proximal port, the distal end of the medical device is oriented in a predetermined orientation with respect to the inclined surface. [Explanation of Symbols]

[0051] 10 Bronchoscopy system, 12 Bronchoscope, 14 Insertion tube, 16 Real-time system, 18 Display device, 20 Handle, 22 Radial ultrasound probe, 24 Signal processor, 30 Medical device, 48 Real-time sampling device (RTSD), 50 Multiple lumen sheath, 52 Handle, 54 Angled side port, 56 Second non-angled access port, 58 Needle actuator, 60 Distal section, 62 Safety stop component, 64 Stylet knob, 66 Distal tip, 70 Flexible needle, 72 Radial EBUS probe, 74 Radial EBUS probe lumen, 76 Working channel lumen, 78 Outlet inclined surface, 80 Window, 82 Port, 88 Hypotube, 90,92 Ring, 94 Orientation pin, 96 Braided section, 98 Ultrasound plane, 100 Headlight, 102 Reflector, 110 Actuator keying pin, 112, 114 Offset keyway, 122 RTS handle, 124 Scope mounting section, 126 Handle shaft, 128 Manifold, 130 First port, 132 Second angled port, 134 Actuator handle, 136 Luer fitting, 138 Stopper, 139 Medical device mounting point, 140 Internal plate, 142 Rotation stopper, 144 O-ring, 152 Nesting tube, 154 Low-force holding device, 160 Inclined distal section, 162 Proximal end, 164 Part, 190 Distal end, 192 Headlight pin, 194 Probe lumen, 200 Safety device, 204 Needle handle shaft, 206 Annular groove, 208 Button

Claims

1. It is a device, A sheath comprising a first lumen and a second lumen, It comprises a handle, and the handle is A connector that can be connected to the proximal end of the endoscope, A shaft portion rotatably connected to the proximal end of the connector, The manifold is slidably received by the shaft portion, and the manifold is A distal end connectable to the sheath, the distal end comprising a first manifold lumen aligned with the longitudinal axis of the handle and connectable to the first lumen, and a second manifold lumen aligned with the longitudinal axis and connectable to the second lumen, A probe port connected to the proximal end of the lumen of the first manifold, configured to receive an ultrasonic probe, An angled port, angled with respect to the longitudinal axis and connected to the proximal end of the lumen of the second manifold, is configured to receive a sampling needle and guide the sampling needle into the lumen of the second manifold, A device comprising: a safety mechanism disposed within the angled port, configured to prevent distal movement of the medical instrument handle shaft below a predetermined threshold.

2. The device according to claim 1, wherein the safety mechanism includes a keying mechanism connected to the angled port, the keying mechanism securing a medical instrument actuator within the handle.

3. The device according to claim 2, wherein the safety mechanism includes a first keyway connectable to the angled port.

4. The device according to claim 3, wherein the safety mechanism includes a second keyway disposed within the inner radius of the proximal end of the angled port and within the first keyway.

5. The device according to claim 4, wherein the second keyway is rotationally offset with respect to the first keyway.

6. The device according to claim 2, wherein the safety mechanism is configured to receive a keying pin disposed at the distal end of the medical instrument actuator.

7. The device according to claim 6, wherein the safety mechanism receives the keying pin through a first keyway in a first rotational orientation and receives the keying pin through a second keyway in a second rotational orientation.

8. The device according to claim 4, wherein the safety mechanism includes a divided O-ring disposed between the first keyway and the second keyway and is configured to provide feedback upon complete insertion of the medical instrument actuator into the angled port.

9. A manifold device, wherein the manifold device is configured to connect to an endoscope instrument and enable the introduction of an imaging probe and a sampling needle, and the manifold device is A probe port connected to the proximal end of the lumen of the first manifold, configured to receive the imaging probe, An angled port, which is angled with respect to a longitudinal axis aligned with the lumen of the first manifold and connected to the proximal end of the lumen of the second manifold, is configured to receive the sampling needle and guide the sampling needle into the lumen of the second manifold, A manifold device comprising: a safety mechanism disposed within the angled port, configured to prevent distal movement of the sampling needle actuator shaft below a predetermined threshold; and a safety mechanism.

10. The manifold device according to claim 9, wherein the safety mechanism includes a first keyway connectable to the angled port.

11. The manifold device according to claim 10, wherein the safety mechanism includes a second keyway disposed within the inner radius of the proximal end of the angled port and within the first keyway.

12. The manifold device according to claim 11, wherein the second keyway is offset in the rotational direction with respect to the first keyway.

13. The manifold device according to claim 11, wherein the safety mechanism is configured to receive a keying pin disposed at the distal end of the sampling needle actuator.

14. The manifold device according to claim 13, wherein the safety mechanism is configured to receive the keying pin through the first keyway in a first rotational orientation and to receive the keying pin through the second keyway in a second rotational orientation.

15. The manifold apparatus according to claim 11, wherein the safety mechanism includes a divided O-ring disposed between the first keyway and the second keyway, and is configured to provide feedback when the sampling needle actuator is fully inserted into the angled port.

Images