Orientation pins for device using radial ultrasound

A system for determining orientation of a distal end of a catheter. The system includes a radial ultrasound system configured to generate images based on data received from a radial ultrasound probe. The system also includes a display device to present the generated images, a medical device, and a catheter system. The catheter system includes a flexible shaft having a first lumen configured to receive the radial ultrasound probe and a second lumen configured to receive the medical device, a cap portion having a longitudinal axis, and at least one orientation pin. The cap portion includes a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the fourth lumen and the exit port.

BACKGROUND

The tools that are currently available for the ultrasound visualization and sampling of peripheral lung 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. A sampling needle that extends off-axis from the length of the catheter and, therefore, requires a knowledge of rotational orientation of the needle and the sampling target. The radial ultrasound probe does not show the orientation of the needle to the lesion. The radial ultrasound image is a 360° image that allows the user to see a lesion, however, the user cannot tell if the needle is pointing towards the lesion.

SUMMARY

Various disclosed embodiments include illustrative devices, systems, and methods. As will be explained below, such embodiments can provide real-time sampling.

In an illustrative embodiment, a device including a flexible shaft having: a first lumen, and a second lumen; a cap portion having a longitudinal axis, and at least one orientation pin. The cap portion includes a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the second lumen, of the flexible shaft, and the exit port of the cap portion. The at least one orientation pin is positioned adjacent to the third lumen of the cap portion. At least a portion of the third lumen, the exit port, the ramp, and the at least one orientation pin intersect a plane perpendicular to the longitudinal axis.

In another illustrative embodiment, a system includes a radial ultrasound system, a display device, a medical device, and a catheter system. The radial ultrasound system includes a radial ultrasound probe and a signal processor configured to be in data communication with the radial ultrasound probe and generate one or more images based on data received from the radial ultrasound probe. The display device is configured to present the generated one or more images. The catheter system includes a flexible shaft, a cap portion having a longitudinal axis, and at least one orientation pin. The flexible shaft includes a first lumen and a second lumen. The cap portion includes a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the second lumen, of the flexible shaft, and the exit port of the cap portion. The at least one orientation pin is positioned adjacent to the third lumen of the cap portion. At least a portion of the third lumen, the exit port, the ramp, and the at least one orientation pin intersect a plane perpendicular to the longitudinal axis.

In another illustrative embodiment, a method includes providing a flexible shaft having a first lumen and a second lumen, providing a cap portion having a longitudinal axis, a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the second lumen and the exit port; and providing at least one orientation pin positioned adjacent to the third lumen of the cap portion; and attaching a distal end of the flexible shaft to the proximal end of the cap portion. At least a portion of the third lumen, the exit port, the ramp, and the at least one orientation pin intersect a plane perpendicular to the longitudinal axis

DETAILED DESCRIPTION

Referring now toFIG.1, a bronchoscope system10includes a bronchoscope12with an insertion tube14, a radial ultrasound system16and an access device20. The radial ultrasound system16includes a signal processor24, a display device18and a radial ultrasound probe22. The radial ultrasound probe22and a medical device30, such as a needle for sampling and/or medicant delivery, are received within the bronchoscope12via a handle component of the access device20.

The display device18is in wired or wireless signal communication with the bronchoscope12and/or the signal processor24. The display device18presents images generated based on information received from the bronchoscope12and/or the signal processor24that receives image information from a radial ultrasound transducer at the distal end of the radial ultrasound probe22. 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.

The present invention uses echogenic orientation pins that are attached to the torqueable insertion device. The orientation pins are visible on the ultrasound image and thus alert the user to the rotational orientation of the distal end of the access device20and the needle relative to a target.

FIGS.2-8show an example of a distal end of the access device20. The access device20includes a catheter portion40and a cap portion42at a distal end of the catheter portion40. The catheter portion40extends from a handle portion (not shown). The catheter portion40includes a radial ultrasound lumen44, a second lumen46, a third lumen50and a fourth lumen50′. The lumens44,46,50,50′ are all accessible via a distal face of the catheter portion40. The lumens44,46extend to proximal ports (not shown) located at the handle portion, a port on a handle of the bronchoscope or other scope device, or at a position accessible by an operator. The lumens44,46allow devices to be inserted from the proximal ends all the way to the distal end of the catheter portion40. The radial ultrasound lumen44is sized to slidably receive a radial ultrasound probe (not shown). The second lumen46is sized to receive a medical device48, such as a needle. In one embodiment, the third and fourth lumens50,50′ extend only a predefined distance from the distal end of the catheter portion40(FIG.6).

As shown inFIGS.3,4,7and8, the cap portion42includes a first lumen54, a second lumen60, a third lumen62and a fourth lumen62′. A first orientation pin80and a second orientation pin80′ each include a proximal end and a distal end. The proximal ends of the pins80and80′ are at least partially received within the third and fourth lumens50and50′ of the catheter portion40. The distal ends of the pins80,80′ are at least partially received within the third and fourth lumens62,62′ of the cap portion42. The pins80,80′ may be pressure fitted into the lumens50,50′,62,62′ and/or are attached to one or more of the lumens50,50′,62,62′ with a reflow process, an adhesive or a welded joint. The pins80,80′ may have a variety of shapes, such as round, oval, rectangular, with the lumens50,50′,62,62′ having comparable shapes. In one embodiment, the pin80is a different shape than the pin80′ with the lumens50,50′,62,62′ having corresponding shapes. The pins80,80′ may include metal (e.g., stainless steel) or another material having ultrasound reflective properties. The pins80,80′ may include reflective features, such as etchings or grooves, for increasing the echogenicity of the pins80,80′.

In one embodiment, the catheter is made of a braided (stainless steel) sheath with PTFE liners in the lumens and Pebax making up the body and the outer jacket. The cap may be made out of polycarbonate, PEEK, Ultem, or TPX (polymethylpentene).

In one embodiment, at least a proximal portion of the cap portion42is sized to be received within slots at the distal end of the catheter portion40or is sized to receive the distal end of the catheter portion40, such that the pins80,80′ are received within the third and fourth lumens62,62′ and the first lumen54lines up with the radial ultrasound lumen44and the second lumen60lines up with the second lumen46of the catheter portion40. Other methods of temporarily or permanently attaching the cap portion42to the distal end of the catheter portion40may be used. The distal end of the second lumen60of the cap portion42includes a side port70and a ramp68. The ramp68causes the medical device48to deflect and exit the cap portion42through the side port70. The lumens54,62,62′ may be closed/sealed or opened at their distal ends.

When a radial ultrasound probe is positioned within the cap portion42, the radial ultrasound probe is able to produce a 360° image. The 360° image includes reflections of the orientation pins80,80′. Because the orientation pins80,80′ are located on the same half of the first lumen54, then any medical device passed through the second lumen60and out the side port70will interact with tissue visually located on the 360° image between the shortest arced distance between the reflections of the orientation pins80,80′. This is show by the example image ofFIG.9.

FIG.9illustrates an image90outputted to the display device18. The image90is generated by the radial ultrasound system16when the insertion tube14with an ultrasound transducer received at the distal end are positioned within a body lumen. The image90shows an image with 360° of imaging features. The image90also includes feedback92identifying the orientation pins. The side port70is located between the orientation pins80,80′ where the arc between the pins80,80′ is the smallest. Thus, a user will know that any medical device exiting the side port70will always exit at about this smallest arc location. In the image90, the medical device will exit the side port70between approximate angular values 350° to 080°. In the image90, 000° would be at the 12 o'clock position. Therefore, if a target is identified in a radial ultrasound image, all the user needs to do in order to have the medical device interact with that target is to rotate the catheter portion40until the target is located within a smallest pie of the 360° image that is bordered by the orientation pins feedback92.

As shown inFIGS.10-14, orientation pins180,180′ are only included in a cap section142and no orientation pin lumens are included in a catheter portion140.

As shown inFIGS.15-17, a catheter portion240does not include a cap portion. The catheter portion240includes at least all the features of the cap devices42,142described above and features shown in the following features.

As shown inFIGS.18and19, three orientation pins are use. Two pins are located in pin lumens362,362″ adjacent to one another on one half of a catheter342and a third pin is located in a pin lumen362′ on the other half of the catheter342. In one embodiment, the three pin lumens362,362′,362″ may be located in the cap portion, a single catheter or both.

Any of the lumens described above may be exposed at their proximal or distal ends.

EMBODIMENTS

A. A catheter device comprising: a flexible shaft comprising: a first lumen, and a second lumen; a cap portion having a longitudinal axis, the cap portion comprising: a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the second lumen, of the flexible shaft, and the exit port of the cap portion; and at least one orientation pin positioned adjacent to the third lumen of the cap portion, wherein at least a portion of the third lumen, the exit port, the ramp, and the at least one orientation pin intersect a plane perpendicular to the longitudinal axis.

B. The device of A, wherein the at least one orientation pin comprises two orientation pins.

C. The device of B, wherein the two orientation pins include longitudinal axes that are positioned on the same half of the cap portion as the exit port.

D. The device of A, wherein the first lumen and the third lumen are configured to receive an ultrasound probe.

E. The device of D, wherein the second lumen and the fourth lumen are configured to receive a medical device.

F. The device of A, wherein the cap portion comprises one or more materials that are permeable to ultrasound signals.

G. The device of F, wherein the at least one orientation pin comprises one or more materials that are non-permeable to ultrasound signals.

H. A system comprising: a radial ultrasound system comprising: a radial ultrasound probe, and a signal processor configured to be in data communication with the radial ultrasound probe and generate one or more images based on data received from the radial ultrasound probe; a display device configured to present the generated one or more images; a medical device; and a catheter system comprising: a flexible shaft comprising: a first lumen configured to receive the radial ultrasound probe, and a second lumen configured to receive the medical device, a cap portion having a longitudinal axis, and at least one orientation pin. The cap portion comprising: a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the fourth lumen and the exit port. The at least one orientation pin is positioned adjacent to the third lumen of the cap portion, wherein at least a portion of the third lumen, the exit port, the ramp, and the at least one orientation pin intersect a plane perpendicular to the longitudinal axis.

I. The system of H, wherein the at least one orientation pin comprises two orientation pins.

J. The system of I, wherein the two orientation pins include longitudinal axes that are positioned on the same half of the cap portion as the exit port.

K. The system of H, wherein the cap portion comprises one or more materials that are permeable to ultrasound signals.

L. The system of I, wherein the at least one orientation pin comprises one or more materials that are non-permeable to ultrasound signals.

M. The system of H, wherein the generated one or more images are configured to include: an ultrasound shadow image related to the at least one orientation pin; an image feature responsive to a distal end of the medical device being disposed distal from the exit port, wherein the ultrasound shadow image and the image feature are disposed on same half of the generated one or more images.

N. A method comprising: providing a flexible shaft having a first lumen and a second lumen; providing a cap portion having a longitudinal axis, a third lumen configured to align with the first lumen, a fourth lumen configured to align with the second lumen, an exit port, and a ramp disposed between the second lumen and the exit port; providing at least one orientation pin positioned adjacent to the third lumen of the cap portion; and attaching a distal end of the flexible shaft to the proximal end of the cap portion, wherein at least a portion of the third lumen, the exit port, the ramp, and the at least one orientation pin intersect a plane perpendicular to the longitudinal axis.

O. The method of N, wherein providing at least one orientation pin comprises providing two orientation pins.

P. The method of O, wherein attaching further comprises positioning longitudinal axes of the two orientation pins on the same half of the cap portion as the exit port.

Q. The method of N, further comprising slidably receiving an ultrasound probe in the first lumen and the third lumen.

R. The method of Q, further comprising slidably receiving a medical device in the second lumen and the fourth lumen.

S. The method of N, wherein providing a cap portion comprises forming the cap portion of one or more materials that are permeable to ultrasound signals.

T. The method of S, wherein providing at least one orientation pin comprises forming the at least one orientation pin of one or more materials that are non-permeable to ultrasound signals.