Guide sheath with window and markings indicating location thereof

A system for determining orientation of a guide sheath introduced by a bronchoscope or similar device. An example system includes a display device, a scope device and a guide sheath. The guide sheath includes a window occupying a predefined circumferential sector of a distal end of the guide sheath and a plurality of markings configured to visually indicate location/orientation and/or distance of the window. The plurality of markings includes a plurality of first markings located along a longitudinal center axis of the window and a plurality of second markings located along one or more other longitudinal axes that are radially separated from the longitudinal center axis of the window by more than 45°.

BACKGROUND

The tools that are currently available for the ultrasound visualization and sampling of peripheral tumors are limited in their range of motion and diagnostic capabilities. Typically, during peripheral sampling a guide sheath is fed through a bronchoscope and extended so far beyond the reach of the bronchoscope that the distal end of the guide sheath is not visible. A radial endobronchial ultrasound (EBUS) miniprobe is then threaded through the guide sheath and used to determine the approximate location of the tumor.

Unfortunately, a peripheral tumor that is located off to one side of an airway (as opposed to one that is centered around an airway) has a substantially lower diagnostic yield in part due to the limitations of current radial EBUS technology, which allows the operator to discern the depth from the probe, but not the direction of the tumor.

SUMMARY

The present invention provides an improved guide sheath for use with a medical scope, such as a bronchoscope.

Accordingly, pursuant to one aspect of the present invention, an example system includes a display device, a scope device and a guide sheath. A radial ultrasound device, a sampling device or medicant delivery device may be inserted through the guide sheath. The guide sheath includes a window occupying a predefined circumferential sector of a distal end of the guide sheath. The window may be an actual opening in the guide sheath to be used in conjunction with an ultrasound gel or another substance conducive to ultrasound or the window may be a portion of the guide sheath that is ultrasound permeable, distinct from the material of the remainder of the guide sheath. The radial ultrasound device includes a radial transducer that can be positioned at the window and configured to send image signals to the display device. The window may also be a port for allowing passage of a sampling device or a device for delivering a medicant. In addition, the guide sheath includes a plurality of markings configured to visually indicate location of the window. The plurality of markings includes a plurality of first markings located along a longitudinal center axis of the window and a plurality of second markings located along one or more other longitudinal axes that are radially separated from the longitudinal center axis of the window by more than 45°.

In one aspect of the invention, the scope device includes a handle, an insertion tube having a proximal end attached to the handle. The insertion tube includes a working channel and a camera located at a distal end of the insertion tube adjacent to the working channel. The camera generates images approximately along a longitudinal axis associated with the insertion tube.

In another aspect of the invention, the plurality of first markings includes two or more pointer markers that point along the longitudinal center axis towards the window.

In still another aspect of the invention, the plurality of second markings includes two or more pointer markings that point in the shortest direction towards the longitudinal center axis of the window along the circumference of the guide sheath.

In yet another aspect of the invention, the plurality of second markings includes two or more non-pointer markers located on a side of the guide sheath that is approximately opposite to a side associated with the window.

In still yet another aspect of the invention, at least a portion of the plurality of first markers indicates a distance value associated with the window for a center of the window.

DETAILED DESCRIPTION

Referring now toFIG. 1, a bronchoscope system10includes a bronchoscope12with an insertion tube14, a radial ultrasound device16and a display device18. A sampling device or a medicant delivery device, such as a needle, may be used with the bronchoscope12. The display device18is in wired or wireless signal communication with the bronchoscope12and/or the radial ultrasound device16. The display device18presents images generated based on information received from bronchoscope12and/or the radial ultrasound device16. A diagnostic bronchoscope (e.g., BF-X190 produced by Olympus®) is an example of the bronchoscope12and the radial endobronchial ultrasound (EBUS) miniprobes produced by Olympus® are examples of the radial ultrasound device16.

As shown inFIG. 2, a distal end22of the insertion tube14includes a working channel26, a camera24and one or more lights28. In certain procedures, a guide sheath30is received within the working channel26of the bronchoscope12through the insertion tube14to exit the distal end22. The camera24and light(s)28are directed distantly such that they illuminate and capture images still and/or video) of at least the guide sheath30and surrounding tissue as the guide sheath30extends distally from the insertion tube14.

As shown inFIG. 3-1, the distal end22of the guide sheath30includes a side window34through which a needle (not shown) could pass. Also, a transducer36of the radial ultrasound device16may be exposed to surrounding tissue at the side window34. The distal end of the guide sheath30beyond the side window34may be sealed to facilitate lateral movement of a needle and/or keep the transducer36of the radial ultrasound device16from protruding beyond the end of the guide sheath30. Instead of protracting the radial ultrasound transducer36beyond the distal tip of the guide sheath30as it currently done, the transducer36remains within the guide sheath30. This allows the radial ultrasound transducer36to selectively receive signals from the side window34and not the surrounding guide sheath30, due to the guide sheath30being impermeable to ultrasound signals. This allows the operator to determine the orientation of the target tissue (e.g., lesion) relative to the guide sheath30and thus the insertion tube14due to markings on the guide sheath30.

The window34may be an actual opening in the guide sheath or the window may be a portion of the guide sheath that is ultrasound permeable, distinct from the material of the remainder of the guide sheath. The window34may also be a port for allowing passage of a sampling device or a device for delivering a medicant (e.g., needle).

Typically, during peripheral sampling the guide sheath30is extended so far out of the insertion tube14that the distal end of the guide sheath30is not visible. Markings40-46are included along the distal portion of the guide sheath30. The markings40-46are viewable in images produced by the camera24and presented on the display device18, thus making the operator aware of the orientation of the side window34relative to the point of view of the camera24. The markings40-46may include arrows or triangles that point the user in the direction of the side window34, colors to indicate the orientation of the side window34or some other indicators. The operator can change the orientation of the side window34by turning the proximal portion of the guide sheath30. While force applied to proximal portion of the guide sheath30will most likely not translate perfectly to the distal portion of the guide sheath30, the markings40-46on the guide sheath30allow the operator to discern the orientation of the side window34relative to the point of view of the camera24.

As shown inFIG. 3-1, the markings40located on a side of the guide sheath30that coincides with the side window34include arrows that point to the side window34. The markings40are centered on a longitudinal centerline of the side window34. As shown inFIGS. 3-2 and 3-4, the markings42and46are triangles or arrows that point toward the side of the guide sheath30that includes the side window34. If lines were extended from the markers42and46around the circumference of the guide sheath30, then these lines would perpendicularly intersect with the longitudinal centerline of the side window34. Thus, when the operator sees the guide sheath34showing markings42in the image generated by the camera24, the operator would know that if target tissue appeared in the image produced by the transducer36, then that target tissue would be located to the right of the current position of the guide sheath30regardless of where the feedback associated with the target tissue appears on the image produced by the transducer36at the display device18.

As shown inFIG. 3-3, the markings44include “x”s that indicate that the side window34is located on the opposite side of the guide sheath30. Other markings may be included that would similarly indicate that the side window34is co-located with the markings, to the immediate left or right of the currently visible side or on the opposite side from the currently visible side.

FIG. 4shows an example image48produced by the transducer24and presented on the display device18of the guide sheath30within a lumen50of the human body, such as a bronchial tube. As shown, the guide sheath30extends from a distal end of the insertion tube14into the lumen50. The image48shows the markings40pointing towards the side window34at the distal end of the guide sheath30.

FIG. 5shows a side view of the very distal end of the guide sheath30with the side window34directed at a tumor54located adjacent to but outside of the lumen50. The markings46point up towards the side of the guide sheath30that includes the side window34.FIG. 6illustrates an example image generated by the radial ultrasound transducer36when used with the guide sheath30as shown inFIG. 5. A first feedback area56shows noise at a radial distance comparable to the distance between the radial ultrasound transducer36and the wall of the guide sheath30. The first feedback area56represents the portion of the guide sheath30that is not associated with the side window34. A second feedback area58provides feedback of tissue ultrasonically illuminated through the side window34. In this example, the second feedback area58identifies the tumor54.

As shown inFIG. 7, a guide sheath60includes a side window62at the distal end and markings64-68along the shaft of the guide sheath60along a longitudinal centerline of the side window62. In this example, the first markings64closest to the side window62are chevrons, the second markings66are triangles and the third markings68are double chevrons. The markings64-68may include different colors and/or patterns in order to identify a measure of depth from the end of the insertion tube14to the side window34. The markings64-68may be at 2 mm increments, at other distance increments or at varying distance increments, Thus, the transition between the first and second markings is approximately 10 mm from the side window62.

As shown inFIG. 8, a guide sheath70includes first and second side windows72and74. The first and second side windows72and74are located at different longitudinal positions and different radial positions of the guide sheath70. The guide sheath70may also include one or more sets of markings (not shown) for identifying relative position of one or both of the side windows72and74. The guide sheath70may include more than two side windows and more than two sets of markings.

As shown inFIG. 9, a guide sheath30-1includes a main lumen for receiving a transducer36-1. The main lumen includes a side window34-1at a distal end of the guide sheath30-1. The guide sheath30-1includes a second lumen82that extends from a proximal handle portion associated with the transducer36-1. A port86at a distal end of the guide sheath30-1exposes the second lumen82to an environment exterior to the guide sheath30-1. The port86may be significantly smaller than the side window34-1. In this example, the port86is located on an opposite side of the guide sheath30-1from the side window34-1. An inflatable balloon84, is positioned opposite from the side window34-1around the port86, such that when air or fluid, such as a saline solution, is passed into the second lumen82, the air or fluid exits the port86thus causing the balloon84to inflate/expand. The expanded balloon84applies a force to the guide sheath30-1by pushing against a wall of the passageway. The balloon84causes the guide sheath30-1to deflect such that a border around the side window34-1comes into full or partial abutment with the wall of the lumen50of the human body. The port86and/or the second lumen82may be located other locations around the guide sheath30-1provided the port86is able to provide air/fluid to the balloon84.

The guide sheath30-1includes a third lumen88that extends from the proximal handle portion associated with the transducer36-1to the side window34-1. An ultrasound compatible fluid is sent from the handle portion into the third lumen88to exit a port92near the side window34-1. The ultrasound compatible fluid provides a medium for effective ultrasound communication between the transducer36-1and targeted tissue (e.g., tumor54).

The features ofFIG. 9may be used in combination or individually.

As shown inFIG. 10, a guide sheath30-2includes a main lumen for a transducer36-2and a second lumen100that extends from a proximal handle portion associated with the transducer36-2. A port102is located at a distal end of the guide sheath30-2. The port102may be significantly smaller than the side window34-2. An inflatable balloon104is positioned around the distal end of the guide sheath30-2, such that when he fluid, such as a saline solution, is passed into the second lumen100, the fluid exits the port102thus causing the balloon104to expand. The fluid in the balloon104allows for ultrasound signal communication. The expanded balloon104makes contact with the tumor54or the wall of the lumen50, thus allowing for ultrasound signal transmission.

As shown inFIGS. 11-1 and 11-2, a guide sheath30-3includes a second lumen182that extends from a proximal handle portion. A port186at a distal end of the guide sheath30-3exposes the second lumen182to an environment interior to the guide sheath30-3. The port186may be significantly smaller than the side window34-1. In this example, the port186is located on an opposite side of the guide sheath30-3from the side window34-1. An inflatable balloon184is positioned opposite from and distal to the side window34-1around the port186, such that when air or fluid, such as a saline solution, is passed into the second lumen182, the air or fluid exits the port186thus causing the balloon184to inflate/expand. The expanded balloon184applies a force to a hinged ramp190by pushing against the interior walls of the guide sheath30-3. The balloon184causes the hinged ramp190to lift such that it angles up towards the side window34-1(FIG. 11-2). The hinged ramp190then is positioned to deflect any tool passed down the first lumen to be re-directed out of the window34-1. The guide sheath30-3includes markings similar to those on the guide sheath30ofFIGS. 3-1thru3-4.

As shown inFIGS. 12-1, 12-2 and 12-3, a sheath device includes a guide sheath202and an internal catheter204. The internal catheter204includes an ultrasound permeable material, an atraumatic tip, and an exit ramp206. The exit ramp206exposes an internal lumen of the internal catheter204to the environment outside of the internal catheter204via a port208. The exit ramp206directs movement of a needle or other medical tool. The guide sheath202includes markings similar to those on the guide sheath30ofFIGS. 3-1thru3-4.

As shown inFIG. 12-2, a transducer210, the exit ramp206would be positioned distally relative to the guide sheath window. After the tumor is located, the internal catheter would be pulled proximally so that the ramp of the inner catheter aligns with the window, allowing the needle to exit the guide sheath through the window.

A. A system comprising: a display device; a scope device comprising: a handle; an insertion tube having a proximal end attached to the handle and a working channel; and a camera located at a distal end of the insertion tube adjacent to the working channel, the camera is configured to generate images approximately along a longitudinal axis associated with the insertion tube; a guide sheath received within the working channel, the guide sheath comprising: a window occupying a predefined circumferential sector of a distal end of the guide sheath; and a plurality of markings configured to visually indicate location of the window, the plurality of markings comprising: a plurality of first markings located along a longitudinal center axis of the window; and a plurality of second markings located along one or more other longitudinal axes that are radially separated from the longitudinal center axis of the window by more than 45°; and a radial ultrasound device configured to be received within the guide sheath, the radial ultrasound device comprises a radial transducer positioned at the window and configured to send image signals to the display device.

B. The system of A, wherein the plurality of first markings comprises two or more pointer markers that point along the longitudinal center axis towards the window.

C. The system A or B, wherein the plurality of second markings comprises two or more pointer markings that point in the shortest direction towards the longitudinal center axis of the window along the circumference of the guide sheath.

D. The system of A, B or C, wherein the plurality of second markings comprises two or more non-pointer markers located on a side of the guide sheath that is approximately opposite to a side associated with the window.

E. The system of A, B, C or D, further comprising one or more additional windows located at both a circumferentially different position and a longitudinally different position than the window.

F. The system of A, B, C, D or E, wherein at least a portion of the plurality of first markers indicates a distance value associated with the window for a center of the window.

G. The system of A, B, C, D, E or F, wherein the portion of the markers indicates a distance between the window or the center of the window and a distal end of at least one of a sheath or the working channel.

H. The system of A, B, C, D, E, F or G, wherein the portion of the markers comprises one or more first symbols and one or more second symbols, wherein the first symbols and second symbols are different.

I. The system of A, B, C, D, E, F, G or H, wherein the radial ultrasound device is a radial endobronchial ultrasound.

J. The system of A, B, C, D, E, F, G, H or I, wherein the scope device further comprises an ultrasound transducer.

K. The system of any of A-J, further comprising a sampling device having a distal end configured to exit the working channel at the window upon receiving a distal force.

L. The system of any of A-J, further comprising a medicant delivery device having a distal end configured to exit the working channel at the window upon receiving a distal force.

M. An apparatus comprising: a guide sheath received within the working channel, the guide sheath comprising: a window occupying a predefined circumferential sector of a distal end of the guide sheath; and a plurality of markings configured to visually indicate location of the window, the plurality of markings comprising: a plurality of first markings located along a longitudinal center axis of the window; and a plurality of second markings located along one or more other longitudinal axes that are radially separated from the longitudinal center axis of the window by more than 45°; and a radial ultrasound device configured to be received within the guide sheath, the radial ultrasound device comprises a radial transducer positioned at the window and configured to send image signals to the display device.

N. The apparatus of M, wherein the plurality of first markings comprises two or more pointer markers that point along the longitudinal center axis towards the window.

O. The apparatus of M or N, wherein the plurality of second markings comprises two or more pointer markings that point in the shortest direction towards the longitudinal center axis of the window along the circumference of the guide sheath.

P. The apparatus of any of M-O, wherein the plurality of second markings comprises two or more non-pointer markers located on a side of the guide sheath that is approximately opposite to a side associated with the window.

Q. The apparatus of any of M-P, further comprising one or more additional windows located at both a circumferentially different position and a longitudinally different position than the window.

R. The apparatus of any of M-Q, wherein at least a portion of the plurality of first markers indicates a distance value associated with the window for a center of the window.

S. The apparatus of any of M-R, wherein the portion of the markers indicates a distance between the window or the center of the window and a distal end of at least one of a sheath or a delivery device.

T. The apparatus of A any of M-S, wherein the portion of the markers comprises one or more first symbols and one or more second symbols, wherein the first symbols and second symbols are different.

U. The apparatus of any of M-T, wherein the radial ultrasound device is a radial endobronchial ultrasound.