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 technology]

[0001] The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.

[0002] Currently available tools for ultrasound visualization and sampling of peripheral lung tumors are limited in range and diagnostic capabilities. Typically, during peripheral sampling, a guide sheath is fed through the bronchoscope and extended far beyond the reach of the bronchoscope so that the distal end of the guide sheath is not visible. A radial endobronchial ultrasound (EBUS) mini-probe is threaded through the guide sheath first and is used to determine the approximate location of the tumor.

[0003] Unfortunately, peripheral tumors located off to one side of the airway (as opposed to tumors centered around the airway) have a substantially lower diagnostic yield, in part due to limitations of current radial EBUS technology, which allows the operator to perceive the depth from the probe but not the direction of the tumor. The sampling needle must extend off-axis from the length of the catheter, and therefore knowledge of the rotational orientation of the needle and the sampling target is required. Radial ultrasound probes do not show the orientation of the needle relative to the lesion. The radial ultrasound image is a 360° image that allows the user to see the lesion, but the user cannot distinguish whether the needle is pointing at the lesion or not. Summary of the Invention

[0004] The present invention provides a device for enabling real-time observation of a patient's tissue sample or drug delivery procedure beyond the viewing range of the endoscope that may be used to deliver the device.

[0005] An exemplary device includes a sheath having at least two lumens and a handle. The handle includes a connector that connects to a proximal end of the 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 a respective 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 a second 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 tool. The second proximal port allows the medical tool to pass through the second of the two lumens of the distal end.

[0006] In one aspect, the medical tool includes a needle. The actuator includes a distal end that connects to a proximal end of the needle and a proximal end that connects to a source of suction.

[0007] In another aspect, the shaft portion includes an anti-buckling device to limit buckling of at least one of the sheath or the medical implement within the shaft portion, and the manifold includes an anti-buckling device to limit buckling of the medical implement within the manifold. The anti-buckling device may include a telescoping 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, stamped, or laser cut hypotubes. The distal support member and the proximal support member are ring shaped.

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

[0010] In yet another aspect, the second proximal port receives the medical tool in a predetermined orientation such that a distal end of the medical tool is in the predetermined orientation relative to the inclined surface when the medical tool is received in the second proximal port.

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

[0012] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. The components in the drawings are not necessarily to scale, emphasis instead being placed on illustrating the principles of the invention. In the drawings: [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 shows a real-time system (RTS) and an endoscope. [Diagram 2] FIG. 2 is a side view of the RTS. [Diagram 3] FIG. 3 is a cross-sectional view of the sheath of the RTS component shown in FIG. [Figure 4] FIG. 3 is a longitudinal cross-sectional view of the distal end of the RTS shown in FIG. [Diagram 5] FIG. [Figure 6-1] FIG. 2 is a side view of the distal end. [Figure 6-2] FIG. 2 is a top view of the distal end. [Figure 6-3] FIG. 13 is a perspective view of the components of the distal end. [Figure 6-4] FIG. 6-4 is a top view of the distal end components shown in FIG. 6-3. [Figure 7]FIG. 13 is a close-up view of the braided section at the distal end. [Figure 8-1] 1 shows a side view of the distal end of an ultrasound transducer and an ultrasound plane generated by a target lesion. [Figure 8-2] An ultrasound image is shown with the ultrasound transducer in a first orientation relative to the target lesion. [Figure 8-3] An ultrasound image is shown with the ultrasound transducer in a second orientation relative to the target lesion. [Figure 9-1] Shows part of the RTS handle. [Figure 9-2] 9-2 shows the handle portion of FIG. 9-1 in a partially exploded view. [Figure 9-3] An X-ray view of a portion of the handle of the RTS is shown. [Figure 10] 1 shows an exemplary RTS handle. [Figure 11] FIG. 11 is a longitudinal cross-sectional view of the handle shown in FIG. [Figure 12] 11 is a cross-sectional view of a portion of the proximal end of the handle shown in FIG. 10. [Figure 13] FIG. 11 is a second longitudinal cross-sectional view of the distal end of the handle shown in FIG. [Figure 14] FIG. 2 is a cross-sectional view of a portion of the distal end of the RTS. [Figure 15] FIG. 2 is a perspective view of the distal end of the RTS. [Figure 16] FIG. 2 is a side view of the proximal end of an exemplary RTS. [Figure 17] FIG. 17 is a partial x-ray side view of the RTS handle of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0015] 1, a bronchoscope system 10 includes a bronchoscope 12 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 and a medical device 30, such as a sampling and / or drug delivery needle, are received within the bronchoscope 12 via the handle 20.

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

[0017] 2-4 show a floating real-time sampling device (RTSD) 48 having a multi-lumen sheath 50 that extends beyond the distal end of an endoscope (e.g., bronchoscope 12). The endoscope is used to navigate 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 that 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 ultrasound plane generated by the ultrasound 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) attached to the stylet knob 64 or for connecting to a syringe for generating aspiration pressure via a luer or similar attachment. 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 bevel 78 of the working channel lumen 76 and a window 80 that surrounds a portion of the radial EBUS probe lumen 74. The window 80 is distal to the exit bevel 78. A port 82 at the distal end of the sheath 50 allows ultrasound gel to be inserted into the lumen 74.

[0019] 5, 6-1, 6-2, 6-3 and 6-4 show an example of a 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, stamped or etched) to include a distal ring 90, a proximal ring 92 and two orientation pins (i.e., longitudinal components, ultrasound reflective or echogenic members) 94 extending between the rings 90, 92. A casing material such as Pebax® or equivalent material is applied (formed or reflowed) over the hypotube and over the section of the catheter adjacent to the hypotube using a mandrel or equivalent tool.

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

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

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

[0023] 9-1, 9-2 and 9-3 show the keying mechanism of the needle 70 and needle actuator 58 that 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 built into the port 54. The other keyway 112 is a separate piece that rotates over the built-in keyway 114. The keyways 112, 114 are intentionally offset because 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 counterclockwise to align with the second keyway 114 and insert the remaining part of the actuator 58. When fully inserted, the actuator 58 will fit snugly within the O-ring.

[0024] In one embodiment, Figures 10-13 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 attaches to a port of an endoscope handle. The handle shaft 126 attaches to the scope mounting 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 attaches to a multi-lumen sheath (e.g., sheath 50) that is received within the attached scope. The manifold 128 includes a first port 130 that receives an ultrasound 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, cytology 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 the Luer fitting 136. The Luer fitting 136 includes a medical device attachment point 139 that is coupled to the proximal end of a medical device (not shown). The Luer fitting 136 receives a stylet (not shown) through the proximal port and directs the stylet through a tapered lumen into the hollow medical device. The Luer fitting 136 includes a tab when engaged with the actuator handle 134 to rotate the distal end of the medical device clockwise so that it is properly oriented relative to the beveled surface of the distal end of the catheter. The Luer fitting 136 and attached medical device (e.g., 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 attached within the actuator handle 134 at all times. The manifold 128 includes a stationary lower hypotube. The sliding upper hypotube is sized to be received within the stationary lower hypotube. These nested hypotubes 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, keeping them in a buckled state. The plates 140 slide next to each other and can nest very closely along the axial dimension as the manifold 128 moves distally. The manifold 128 attaches to an adjacent one of the plates 140 so that the plates 140 can be pulled apart or pushed together as the sheath is retracted or extended. The plates 140 interlock when extended and are held in place using a rail system designed into the handle shaft 126. An O-ring 144 is disposed between the handle shaft 126 and the scope mounting portion 124 to maintain vacuum capability within the handle 122. The handle shaft 126 connects to the scope mounting portion 124 using a rotational 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] Components in the handle 122 rotate the bevel of the needle clockwise relative to the handle 122 for proper alignment of the needle relative to the distal exit bevel (FIG. 14). The handle 122 also includes a removable stop 138. The location of the stop 138 on the handle 134 indicates where the needle will intersect the ultrasound plane generated by the ultrasound probe.

[0030] The manifold 128 includes telescoping tubes 152 to reduce needle buckling.

[0031] 14, the exit ramp of the catheter's second lumen may be made of hard plastic (e.g., polyimide, PEEK), Nitinol or stainless steel, or other equivalent materials. The exit ramp may be formed from a single tube having a straight proximal end 162 and distal section 160.

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

[0033] As shown in FIG. 15, an exemplary distal tip 190 includes a headlight pin 192 that is at an angle relative to the longitudinal axis of the probe lumen 194. As the ultrasound transducer (i.e., ultrasound plane) moves distally, a visual difference will be noted in the generated image. The ultrasound artifacts generated by the pin 192 move to appear to converge in the generated image as the probe is advanced. This will help the user define where the needle will emerge from. It will also help the user know where the probe is located within the tip.

[0034] 16 and 17, the needle handle shaft 204 includes a full or partial annular groove 206 at or near its distal end. A second angled port in 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 semicircular device that is disposed around the lumen defined by the angled port.

[0035] In one embodiment, the groove 206 is defined by a tapered edge on the proximal side and a vertical edge on the distal side. As 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 with a snap or click action and / or sound. Distal advancement of the needle handle shaft 204 continues when a force applied to the needle handle shaft 204 exceeds a threshold amount, causing the circular or semicircular shaped device to deflect through the tapered edge. Distal advancement of the needle handle shaft 204 may also continue after the button 208 is depressed to disengage the needle handle shaft 204.

[0036] When the needle handle is pulled after the needle is deployed, or when the groove 206 is distal to the circular or semicircular device, the circular or semicircular device is received within the groove 206. The vertical edge of the groove 206 blocks 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 semicircular shaped device so that it no longer blocks the vertical edge of the groove 206.

[0037] [Embodiment] A. A device comprising: a sheath having at least two lumens; a handle; a connector configured to connect to a 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 having a distal end configured to connect to the sheath, the distal end comprising two lumens, each lumen having a longitudinal axis aligned with a respective lumen of the at least two lumens of the connected sheath; 1. A device comprising: a first proximal port having a longitudinal axis configured to coincide with a longitudinal axis of one of the distal ends, the first proximal port being configured to receive a radial ultrasound probe; and a second proximal port configured to receive a medical tool, the second proximal port having a longitudinal axis in an angular relationship to a longitudinal axis of a second of the two lumens of the distal end, the second proximal port being configured to allow the medical tool to pass through the second of the two lumens of the distal end.

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

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

[0040] D. 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] E. Any of the devices 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 medical implement within the shaft portion.

[0042] F. Any of the devices of A-E, wherein the manifold comprises a first anti-buckling device configured to limit buckling of the medical implement within the manifold.

[0043] G. A device of E or F, wherein the anti-buckling device comprises a telescoping tube.

[0044] H. Any of the devices 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 and proximal components.

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

[0046] J. The device of H or I, wherein the distal support member and the proximal support member are at least partial rings.

[0047] K. Any of the devices of H-J, wherein the distal end includes an inclined surface that allows the distal end of the medical tool to deflect as the medical tool is advanced distally.

[0048] L. The device of K, wherein the proximal support member comprises a support configured to provide support to the inclined surface.

[0049] M. A device of K or L, wherein the second proximal port receives 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 the predetermined orientation relative to the inclined surface.

[0050] The description of the invention is merely exemplary in nature and, therefore, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention. [Explanation of symbols]

[0051] 10 bronchoscope 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 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 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 attachment, 126 handle shaft, 128 manifold, 130 first port, 132 second angled port, 134 actuator handle, 136 luer attachment, 138 stop, 139 medical device attachment point, 140 internal plate, 142 rotational detent, 144 O-ring, 152 nested tube, 154 low force retention device, 160 angled 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. A device, comprising: a sheath having at least two lumens; and a handle, the handle comprising: a connector configured to connect to a proximal end of an endoscope; a shaft portion configured to rotatably connect to a proximal end of the connector; 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 at least two lumens, each lumen having a first longitudinal axis aligned with a respective one of the at least two lumens of the connected sheath; a first proximal port having a second longitudinal axis configured to coincide with the first longitudinal axis of one of the distal ends, the first proximal port being configured to receive a radial ultrasonic probe; a second proximal port configured to receive a medical implement, the second proximal port having a third longitudinal axis angled relative to the first longitudinal axis of a second of the two lumens at the distal end, the second proximal port configured to allow the medical implement to pass through the second of the two lumens at the distal end; A device comprising: a locking mechanism configured to prevent distal movement of a medical tool handle shaft below a predetermined threshold, the locking mechanism including an annular groove for locking movement of the medical tool handle shaft and a button for releasing movement of the medical tool handle shaft.

2. The device of claim 1 , wherein the shaft portion includes a longitudinal slot configured to slidably receive the manifold.

3. The device of claim 1 , wherein the medical tool comprises a needle.

4. An actuator, a distal end configured to connect to a proximal end of the needle; a proximal end configured to connect to a suction source; and 4. The device of claim 3, further comprising an actuator comprising: at least a partial annular groove configured to engage the locking mechanism.

5. The device of claim 1 , wherein the shaft portion comprises a first anti-buckling device configured to limit buckling of at least one of the sheath or the medical implement within the shaft portion.

6. The device of claim 1 , wherein the manifold comprises a first anti-buckling device configured to limit buckling of the medical implement within the manifold.

7. The device of claim 6 , wherein the anti-buckling device comprises a telescoping tube.

8. The sheath is a distal end, the distal end comprising: A distal component; and A proximal component; The device of claim 1 , comprising at least two longitudinal components connected between the distal and proximal components.

9. 10. The device of 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 hypotube, a stamped hypotube, or a laser cut hypotube.

10. The device of claim 8 , wherein the distal and proximal components are at least partial rings.

11. The device of claim 8 , wherein the distal end comprises a beveled surface configured to allow the distal end of the medical tool to deflect as the medical tool is advanced distally.

12. The device of claim 11 , wherein the distal component comprises a support configured to at least provide support to or function as the ramp surface.

13. 12. The device of 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 the predetermined orientation relative to the inclined surface.

14. 1. A system comprising: An endoscope and and a device, the device comprising: a sheath having at least two lumens; and a handle, the handle comprising: a connector configured to connect to a port of the endoscope; a shaft portion configured to rotatably connect to a proximal end of the connector; 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 at least two lumens, each lumen having a first longitudinal axis aligned with a respective one of the at least two lumens of the connected sheath; a first proximal port having a second longitudinal axis configured to coincide with the first longitudinal axis of one of the distal ends, the first proximal port being configured to receive a radial ultrasonic probe; a second proximal port configured to receive a medical implement, the second proximal port having a third longitudinal axis angled relative to the first longitudinal axis of a second of the two lumens at the distal end, the second proximal port configured to allow the medical implement to pass through the second of the two lumens at the distal end; a locking device configured to prevent distal movement of a medical tool below a predetermined force threshold, the locking device including an annular groove for locking movement of a handle shaft of the medical tool and a button for releasing movement of the handle shaft of the medical tool.

15. 15. The system of claim 14, wherein the shaft portion comprises an anti-buckling device configured to limit buckling of at least one of the sheath or the medical tool within the shaft portion, and the manifold comprises an anti-buckling device configured to limit buckling of the medical tool within the manifold.

16. The sheath is a distal end, the distal end comprising: A distal member. A proximal member; and The system of claim 14 comprising at least two longitudinal members connected between the distal member and the proximal member.

17. 17. The system of claim 16, wherein the distal end comprises a beveled surface configured to allow the distal end of the medical tool to deflect when the medical tool is advanced distally.

18. The system of claim 17 , wherein the distal member comprises a support configured to provide support to the ramp surface.

19. 18. The system of claim 17, 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 relative to the inclined surface.

Images