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 related to the present disclosure and may not constitute prior art in some cases.

[0002] Currently available tools for visualizing and sampling peripheral lung tumors by ultrasound have limited range of movement and diagnostic capabilities. Usually, during peripheral sampling, a guide sheath is fed through a bronchoscope and extended far beyond the reach of the bronchoscope, so the distal end of the guide sheath is not visible. A 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] The exemplary device includes a sheath having at least two lumens and a handle. The handle includes a connector that connects to the proximal end of the endoscope, a shaft portion rotatably connected to the proximal end of the connector, and a manifold 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 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 ends, and a second proximal port including a longitudinal axis that is in an angular relationship to the longitudinal axis of the second lumen of the two lumens of the distal end. The first proximal port receives a radial ultrasonic probe, and the second proximal port receives a medical tool. The second proximal port enables the medical tool to pass through the second lumen of the two lumens of the distal end.

[0006] In one aspect, the medical tool 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 aspect, the shaft portion includes a buckling prevention device that limits buckling of at least one of the sheath or the medical tool within the shaft portion, and the manifold includes a buckling prevention device that limits buckling of the medical tool within the manifold. The buckling prevention device may include a nested tube.

[0008] In yet another aspect, 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 support member and the proximal support member. The distal support member, the proximal support member, and the at least two longitudinal support members are formed from machined, punched, or laser-cut hypodermic tubes. The distal support member and the proximal support member are ring-shaped.

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

[0010] In yet another aspect, the second proximal port receives 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 in a predetermined orientation with respect to the inclined surface.

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

[0012] The drawings described herein are for illustrative purposes only and are in no way intended to limit the scope of the present disclosure. The components in the drawings are not necessarily to scale and emphasis is placed on illustrating the principles of the present invention. The drawings include the following.

Brief Description of the Drawings

[0013]

Figure 1

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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 now to FIG. 1, bronchoscope system 10 includes a bronchoscope 12 having 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 ultrasonic probe 22. The radial ultrasonic probe 22, as well as a medical device 30, such as a sampling and / or drug delivery needle, is received within the bronchoscope 12 via the handle 20.

[0016] The display device 18 communicates with the bronchoscope 12 and / or the signal processor 24 via wired or wireless signals. The display device 18 presents an image generated based on information received from the bronchoscope 12 and / or the signal processor 24, which receives image information from the bronchoscope imaging device and / or the radial ultrasonic transducer at the distal end of the radial ultrasonic probe 22. A therapeutic bronchoscope (e.g., BF-X190 manufactured by Olympus (registered trademark)) is an example of the bronchoscope 12, and a radial endobronchial ultrasound (EBUS) mini-probe manufactured by Olympus (registered trademark) is an example of the radial ultrasonic probe 22.

[0017] Figures 2-4 show a Floating Real-Time Sampling Device (RTSD) 48 having a plurality of lumen sheaths 50 extending beyond the distal end of an endoscope (e.g., 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. The flexible needle 70 is inserted into the angled side port 54 of the handle 52. The 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 that includes a distal portion 60 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 that 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 within the sheath 50. The needle actuator 58 includes a proximal port for receiving a stylet (not shown) attached to a stylet knob 64 or for connecting to a syringe for generating a suction pressure via a luer or similar fitting. In one embodiment, the stylet is curved at the distal portion to conform the needle 70 to a curve when both exit 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 the needle 70 or another medical device. The distal tip 66 of the sheath 50 includes an exit ramp 78 of the working channel lumen 76 and a window 80 surrounding a portion of the radial EBUS probe lumen 74. The window 80 is distal to the exit ramp 78. A port 82 at the distal end of the sheath 50 allows ultrasonic gel to be inserted within the lumen 74.

[0019] Figures 5, 6-1, 6-2, 6-3, and 6-4 illustrate 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, a proximal ring 92, and two orientation pins (i.e., longitudinal components, ultrasonic reflective or echo generating members) 94 that extend between the rings 90, 92. A casing material, such as Pebax® or an equivalent material, is applied (formed or reflowed) onto the hypotube and onto the section of the catheter adjacent to the hypotube using a mandrel or an equivalent tool.

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

[0021] As shown in FIG. 7, the section of the sheath 50 immediately proximal to the distal tip 66 may include a braided section 96 of thin wires (e.g., stainless steel) that surrounds the radial EBUS probe lumen 74 and the working channel lumen 76. The braided section 96 provides an increased torque response and a sharper bend radius without unduly sacrificing flexibility. The braided section 96 may also reduce the risk of a tool (e.g., a needle) penetrating the lumen and the sheath wall. In one example, the braided section 96 includes a helix of three adjacent wires.

[0022] FIG. 8-1 shows a side view of the distal end 66 positioned adjacent to the target. The ultrasonic probe 72 received within the distal end 66 generates ultrasonic images shown in FIGS. 8-2 and 8-3 based on the ultrasonic plane 98 generated by the transducer of the ultrasonic probe 72. The alignment pin 94 generates an ultrasonic artifact that appears as a headlight 100 in the ultrasonic image. The headlight 100 enables the operator to understand the orientation of the distal end 66 with respect to the target. Using the knowledge of the orientation, the operator can rotate the sheath 50 using the handle so that the target tumor (see reflection 102) is in the appropriate position relative to where the needle 70 exits the sheath 50.

[0023] FIGS. 9-1, 9-2, and 9-3 show the keying mechanism of the needle 70 and the needle actuator 58 that is 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 key grooves 112, 114. One key groove 114 is constructed within the port 54. The other key groove 112 is a separate part that rotates over the built-in key groove 114. The key grooves 112, 114 are intentionally offset so that the user must rotate the actuator 58 in order to remove it from the handle 52. To insert the actuator, 1) align the keying pin 110 with the first key groove 112, 2) push it through the split O-ring, and 3) then rotate counterclockwise to align it with the second key groove 114 and insert the remaining portion of the actuator 58. The actuator 58 will fit snugly within the O-ring when fully inserted.

[0024] In one embodiment, FIGS. 10-13 show an exemplary RTS handle 122 that includes a scope attachment portion 124, a handle shaft 126, and a manifold 128. The scope attachment portion 124 is attached to a port of the endoscope handle. The handle shaft 126 is attached to the scope attachment portion 124 such that the handle shaft 126 can rotate about a longitudinal axis. The handle shaft 126 slidably receives the manifold 128. The manifold 128 is attached to a plurality of lumen sheaths (e.g., sheath 50) that are received within the attached scope. The manifold 128 includes a first port 130 that receives an ultrasonic probe (e.g., probe 72) and a second angled port 132 that receives 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 retention device 154. The low-force retention device 154 continues to move the probe 72 longitudinally relative to the handle 122 without crushing the sheath of the probe 72.

[0025] The handle 134 includes a proximal port that receives a luer accessory 136. The luer accessory 136 includes a medical device attachment point 139 that is coupled to the proximal end of a medical device (not shown). The luer accessory 136 receives a stylet (not shown) through the proximal port and guides the stylet into the hollow medical device through a tapered lumen. The luer accessory 136 includes a tab when engaging the actuator handle 134 to clockwise orient the distal end of the medical device such that it is properly oriented relative to the bevel of the distal end of the catheter. The luer accessory 136 and the attached medical device (e.g., needle) can be removed from the actuator handle 134 without removing the actuator handle 134 from the manifold 128 and the handle 122 after a tissue sample has been obtained.

[0026] The actuator handle 134 includes a plunger and a sliding upper hypodermic tube. The plunger and the sliding upper hypodermic tube always remain attached within the actuator handle 134. The manifold 128 includes a stationary lower hypodermic tube. The sliding upper hypodermic tube is sized to be received within the stationary lower hypodermic tube. These nested hypodermic tubes reduce buckling of the needle 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 and keep them in a buckled state. The plates 140 slide adjacent to each other and can be nested very closely along the axial dimension as the manifold 128 moves in the distal direction. The manifold 128 is attached to one of the adjacent plates 140 such that it can pull the plates 140 apart or push them 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 disposed between the handle shaft 126 and the scope attachment portion 124 to maintain the vacuum capability within the handle 122. The handle shaft 126 is connected to the scope attachment portion 124 using a rotation detent 142.

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

[0029] The components within the handle 122 turn the bevel of the needle clockwise with respect to the handle 122 for proper alignment of the needle with the distal exit bevel (FIG. 14). The handle 122 also includes a removable stop 138. The position of the stop 138 on the handle 134 indicates the location where the needle intersects the ultrasonic plane generated by the ultrasonic probe.

[0030] The manifold 128 includes a nested tube 152 for reducing the buckling of the needle.

[0031] As shown in FIG. 14, the outlet inclined surface of the second lumen of the catheter may be made of a rigid plastic (e.g., polyimide, PEEK), nitinol or 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 inclined surface distal section 160 is supported by a hypo tube component 164 similar to that shown in FIGS. 5, 6-1 to 6-4. The component 164 is curved or bent such that a portion (e.g., the distal end) provides support to the inclined surface distal section 160. In one embodiment, the component 164 is formed to be on the inner surface of the inclined surface distal section 160.

[0033] As shown in FIG. 15, an exemplary distal end 190 includes a headlight pin 192 that is angled with respect to the longitudinal axis of the probe lumen 194. When the ultrasonic transducer (i.e., the ultrasonic plane) moves in the distal direction, a visual difference will be observed in the generated image. The ultrasonic artifact generated by the pin 192 will appear to move so as to converge on the generated image as the probe is advanced. This will help the user to delineate where the needle exits. It will also help the user to know where in the tip the probe is located.

[0034] As shown in FIGS. 16 and 17, the needle handle shaft 204 includes a complete or partial annular groove 206 at or near its distal end. The second angled port of the manifold includes a safety device 200 that prevents inadvertent advancement of the needle beyond the end of the needle sheath. The safety device 200 includes a button 208 attached to a spring-loaded actuator arm that is fixed distally within the angled port. The proximal end of the actuator arm includes a circular or semi-circular device that is disposed 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 semi-circular device of the safety device 200 engages the groove 206 using a snap or click action and / or sound. Advancement of the needle handle shaft 204 distally continues when the force applied to the needle handle shaft 204 exceeds a threshold amount, whereby the circular or semi-circular shaped device is deflected through the tapered edge. Advancement of the needle handle shaft 204 distally may also continue after depressing the button 208 to disengage it from the needle handle shaft 204.

[0036] After the needle is deployed or when the groove 206 is distal to the circular or semi-circular device, the circular or semi-circular device is received within the groove 206. The vertical edge of the groove 206 prevents proximal movement of the needle handle shaft 204. To continue pulling beyond this blocked position, the user depresses the button 208, thereby moving the circular or semi-circular shaped device so that it no longer blocks the vertical edge of the groove 206.

[0037] [Embodiment] A device comprising a sheath having at least two lumens and a handle, the handle including a connector configured to connect to the proximal end of an endoscope, a shaft portion rotatably connected to the proximal end of the connector, and a manifold slidably received by the shaft portion, the manifold having a distal end configured to connect to the sheath, the distal end having two lumens each having a longitudinal axis aligned with a respective lumen of at least two lumens of the connected sheath, a first proximal port having a longitudinal axis configured to coincide with one of the longitudinal axes of the distal end and configured to receive a radial ultrasonic probe, and a second proximal port configured to receive a medical instrument, the second proximal port having a longitudinal axis angled with respect to the longitudinal axis of a second lumen of the two lumens of the distal end and configured such that the medical instrument can pass through the second lumen of the two lumens of the distal end.

[0038] The device of A, wherein the shaft portion includes a longitudinal slot configured to slidably receive the manifold.

[0039] The device of A or B, wherein the medical instrument comprises a needle.

[0040] The device of C, further comprising an actuator having a distal end configured to connect to the proximal end of the needle and a proximal end configured to connect to a suction source.

[0041] The device of any one of A - D, wherein the shaft portion comprises a first anti - buckling device configured to limit buckling of at least one of the sheath or the medical instrument within the shaft portion.

[0042] A device according to any one of A - E, wherein the manifold comprises a first anti - buckling device configured to limit buckling of a medical instrument within the manifold.

[0043] A device according to E or F, wherein the anti - buckling device comprises a nested tube.

[0044] A device according to any one of A - G, wherein the sheath comprises a distal end having a distal component, a proximal component, and at least two longitudinal components connected between the distal component and the proximal component.

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

[0046] A device according to H or I, wherein the distal support member and the proximal support member are at least partial rings.

[0047] A device according to any one of H - J, wherein the distal end comprises an inclined surface that allows the distal end of the medical instrument to deflect when the medical instrument is advanced distally.

[0048] A device according to K, wherein the proximal support member comprises a support configured to provide support to the inclined surface.

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

[0050] The description of the invention is merely exemplary in nature and it is intended that variations that do not depart from the spirit of the invention are within the scope of the invention. Such variations are not to be regarded as departing from the spirit and scope of the invention. [Appendix 1] A device, comprising A sheath having at least two lumens, a handle, wherein the handle includes 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, a manifold configured to be slidably received by the shaft portion, wherein the manifold includes a distal end configured to connect to the sheath, the distal end having at least two lumens, each lumen having a longitudinal axis that aligns with one of the at least two lumens of the connected sheath, a first proximal port having a longitudinal axis configured to coincide with one of the longitudinal axes of the distal end, the first proximal port being configured to receive a radial ultrasonic probe, a second proximal port configured to receive a medical instrument, the second proximal port having a longitudinal axis that is in an angular relationship with the longitudinal axis of a second one of the two lumens of the distal end, the second proximal port being configured to enable the medical instrument to pass through the second one of the two lumens of the distal end, and a locking mechanism configured to impede distal movement of a medical instrument handle shaft below a predetermined threshold. A device. [Additional Item 2] The device according to claim 1, wherein the shaft portion includes a longitudinal slot configured to slidably receive the manifold. [Additional Item 3] The device according to claim 1, wherein the medical instrument includes a needle. [Additional Item 4] An actuator, including a distal end configured to connect to the proximal end of the needle, a proximal end configured to connect to a suction source, The device according to claim 3, further comprising an actuator comprising at least a partially annular groove configured to engage with the locking mechanism. [Claim 5] The device according to claim 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 instrument within the shaft portion. [Claim 6] The device according to claim 1, wherein the manifold comprises a first buckling prevention device configured to limit buckling of the medical instrument within the manifold. [Claim 7] The device according to claim 6, wherein the buckling prevention device includes a nested tube. [Claim 8] The sheath has a distal end, and the distal end a distal component, a proximal component, and at least two longitudinal components connected between the distal component and the proximal component, and the device according to claim 1. [Claim 9] The device according to claim 8, wherein the distal component, the proximal component, and the at least two longitudinal components are formed from at least one of a machined hypodermic tube, a punched hypodermic tube, or a laser cut hypodermic tube. [Claim 10] The device according to claim 8, wherein the distal support member and the proximal support member are at least partial rings. [Claim 11] The device according to claim 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. [Claim 12] The device according to claim 11, wherein the proximal support member comprises a support configured to at least provide support to or function as the inclined surface. [Claim 13] The device according to claim 11, wherein the second proximal port is configured to receive the medical tool in a predetermined orientation such that when the medical tool is received in the second proximal port, the distal end of the medical tool is in a predetermined orientation with respect to the inclined surface. [Claim 14] A system comprising an endoscope, and a device, wherein the device comprises a sheath having at least two lumens, and a handle, wherein the handle comprises a connector configured to connect to a port of the 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, wherein the manifold comprises a distal end configured to connect to the sheath, the distal end having at least two lumens, each lumen having a longitudinal axis that aligns with one of the at least two lumens of the connected sheath, a first proximal port having a longitudinal axis configured to coincide with one of the longitudinal axes of the distal end and configured to receive a radial ultrasonic probe, a second proximal port configured to receive a medical tool, the second proximal port having a longitudinal axis that is in an angular relationship with the longitudinal axis of the second lumen of the two lumens of the distal end, and the second proximal port being configured to allow the medical tool to pass through the second lumen of the two lumens of the distal end, A system comprising a lock device configured to impede distal movement of a medical instrument below a predetermined force threshold. [Appended Claim 15] The system according to appended claim 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. [Appended Claim 16] The sheath has a distal end, and the distal end has a distal member, a proximal member, and at least two longitudinal members connected between the distal member and the proximal member. The system according to appended claim 14. [Appended Claim 17] The system according to appended claim 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. [Appended Claim 18] The system according to appended claim 17, wherein the proximal support member comprises a support configured to provide support to the inclined surface. [Appended Claim 19] The system according to appended claim 14, wherein the second proximal port is configured to receive the medical instrument in a predetermined orientation such that when the medical instrument is received in the second proximal port, the distal end of the medical instrument is in a predetermined orientation with respect to the inclined surface.

Description of the Reference Numerals

[0051] 10 Bronchoscope system, 12 bronchoscope, 14 insertion tube, 16 real-time system, 18 display device, 20 handle, 22 radial ultrasonic probe, 24 signal processor, 30 medical device, 48 real-time sampling device (RTSD), 50 multi-lumen sheath, 52 handle, 54 angled side port, 56 second non-angled access port, 58 needle actuator, 60 distal portion, 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 exit ramp, 80 window, 82 port, 88 hypodermic tube, 90, 92 rings, 94 alignment pin, 96 braided section, 98 ultrasonic plane, 100 headlight, 102 reflection, 110 actuator keying pin, 112, 114 offset key groove, 122 RTS handle, 124 scope attachment portion, 126 handle shaft, 128 manifold, 130 first port, 132 second angled port, 134 actuator handle, 136 luer fitting, 138 stop portion, 139 medical device attachment point, 140 internal plate, 142 rotation detent, 144 O-ring, 152 nested tube, 154 low-force retention device, 160 ramp distal section, 162 proximal end, 164 component, 190 distal end, 192 headlight pin, 194 probe lumen, 200 safety device, 204 needle handle shaft, 206 annular groove, 208 button

Claims

1. A device, comprising: a sheath having a first lumen and a second lumen; and a handle, the handle comprising: a connector connectable to a proximal end of an endoscope; a shaft portion rotatably connected to a proximal end of the connector; a manifold slidably received by the shaft portion, the manifold comprising: a distal end connectable to the sheath, the distal end including a first manifold lumen aligned with a 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 a proximal end of the first manifold lumen, the probe port configured to receive an ultrasound probe; an angled port connected to a proximal end of the second manifold lumen at an angle relative to the longitudinal axis, the angled port configured to receive a sampling needle and guide the sampling needle into the second manifold lumen; a safety mechanism disposed within the angled port, the safety mechanism configured to prevent distal movement of the medical tool handle shaft below a predetermined threshold.

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

3. The device of claim 1 , wherein the safety mechanism includes a first keyway connectable onto the angled port.

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

5. The device of claim 4 , wherein the second keyway is rotationally offset relative to the first keyway.

6. The device of claim 4 , wherein the safety mechanism is configured to receive a keying pin disposed at a distal end of the medical tool actuator.

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

8. 5. The device of claim 4, wherein the safety mechanism includes a split O-ring disposed between the first keyway and the second keyway and configured to provide feedback upon full insertion of the medical tool actuator into the angled port.

9. A manifold apparatus configured to connect to an endoscopic instrument to allow introduction of an imaging probe and a sampling needle, the manifold comprising: a probe port connected to a proximal end of the first manifold lumen, the probe port configured to receive the imaging probe; an angled port connected to a proximal end of a second manifold lumen at an angle relative to a longitudinal axis aligned with the first manifold lumen, the angled port configured to receive the sampling needle and guide the sampling needle into the second manifold lumen; a safety mechanism disposed within the angled port, the safety mechanism configured to prevent distal movement of the shaft of the sampling needle actuator below a predetermined threshold.

10. The device of claim 9 , wherein the safety mechanism includes a first keyway connectable onto the angled port.

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

12. The device of claim 11 , wherein the second keyway is rotationally offset relative to the first keyway.

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

14. 14. The device of claim 13, wherein the safety feature 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. 12. The device of claim 11, wherein the safety mechanism includes a split O-ring disposed between the first keyway and the second keyway and configured to provide feedback upon full insertion of the sampling needle actuator into the angled port.

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