Alignment pins for a device using radial ultrasound

Abstract

The present invention is titled "Orientation Pins for Devices Using Radial Ultrasound". The present invention provides a system for determining the orientation of the distal end of a catheter. The system includes a flexible shaft having a first lumen, a second lumen, a third lumen, a fourth lumen, a first orientation pin, and a second orientation pin. The first orientation pin is received within the third lumen, and the second orientation pin is received within the fourth lumen. The flexible shaft includes a cross-sectional dimension, and the third lumen and the fourth lumen include longitudinal axes located on the same half of the cross-sectional dimension of the catheter. The second lumen includes an outlet and a ramp for exposing at least a portion of the second lumen of the cap portion. The distal end of the flexible shaft is made of a material that is transmissive to ultrasound signals, and the orientation pins include one or more materials that are non-transmissive to ultrasound signals.

Description

Technical Field

[0001] The present invention relates to a system for determining the orientation of the distal end of a catheter, and more particularly to an orientation pin for a device using radial ultrasound. Background Art

[0002] The description in this section merely provides background information related to the present disclosure and may not constitute prior art.

[0003] Currently available tools for ultrasound visualization and peripheral lung tumor sampling are limited in their range of motion and diagnostic capabilities. Generally, during peripheral sampling, a guiding sheath is fed through a bronchoscope and extends beyond the scope of the bronchoscope, such that the distal end of the guiding sheath is not visible. A radial endobronchial ultrasound (EBUS) microprobe is then threaded through the guiding sheath and used to determine the approximate location of the tumor.

[0004] Unfortunately, peripheral tumors located outside of the airway side (compared to tumors around the airway center) have significantly lower diagnostic rates, in part due to the limitations of current radial EBUS technology, which allows the operator to discern the depth of the probe but not the direction of the tumor. The sampling needle extends off-axis from the length of the catheter, and thus the rotational orientation of the needle and the sampling target needs to be known. The radial ultrasound probe does not show the orientation of the needle relative to the lesion. The radial ultrasound image is a 360° image, which allows the user to see the lesion; however, the user cannot determine whether the needle is pointing at the lesion. Summary of the Invention

[0005] The present invention provides an improved guiding sheath for use with a medical scope such as a bronchoscope. The present invention uses an echo orientation pin attached to a catheter device. The orientation pin is visible on an ultrasound image, thereby warning the user of the rotational orientation of a medical device passing through the catheter device. When the ultrasound probe visualizes a target, the ultrasound probe image also shows the orientation pin, thereby warning the user of the direction in which the medical device will protrude. If the medical device will protrude in the wrong direction, the user can rotate the catheter device until the orientation pin, and thus the medical device, points at the target.

[0006] Thus, according to one aspect of the present invention, an exemplary system includes a flexible catheter portion having a first lumen, a second lumen, a third lumen, a fourth lumen, a first orientation pin, and a second orientation pin. The first orientation pin is received within the third lumen, and the second orientation pin is received within the fourth lumen.

[0007] In yet another aspect of the present invention, the system further includes a cap portion. A first lumen and a second lumen are included within the catheter portion. The cap portion includes a first lumen, a second lumen, a third lumen, and a fourth lumen. A first alignment pin is received within the third lumen of the cap portion, and a second alignment pin is received within the fourth lumen of the cap portion.

[0008] In other aspects of the present invention, the cap portion includes a cross-sectional dimension. The third lumen and the fourth lumen of the cap portion include longitudinal axes that are located on the same half of the cross-sectional dimension of the cap portion. The second lumen of the flexible catheter portion and the cap portion and the third lumen and the fourth lumen of the catheter portion and the cap portion are located on the same half of the cross-sectional dimension.

[0009] In other aspects of the present invention, the cap portion further includes an outlet for exposing at least a portion of the second lumen of the cap portion and a ramp located at the distal end of the second lumen of the cap portion.

[0010] In other aspects of the present invention, the cap portion includes one or more materials that are transmissive to ultrasonic signals, and the alignment pins include one or more materials that are non-transmissive to ultrasonic signals. The alignment pins further include one or more echo features, such as laser scribing, pits, holes, etc.

[0011] In other aspects of the present invention, three or more alignment pins may be used. For example, a third alignment pin may be positioned adjacent to one of the other pins, thereby generating an ultrasonic image that easily allows a person to quickly understand the direction of rotation of the target.

[0012] Based on the description provided herein, other features, advantages, and applicable scopes will become apparent. It should be understood that the specific embodiments and specific examples are for illustrative purposes only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The drawings described herein are for illustrative 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 drawn to scale, but rather the emphasis is placed on illustrating the principles of the present invention. In the drawings:

[0014] Figure 1 An example of a bronchoscope system formed in accordance with an embodiment of the present invention is shown;

[0015] Figure 2A is a side view of the distal end of the device formed in accordance with an embodiment of the present invention;

[0016] Figure 2B is Figure 2A a side view of the distal end of the device rotated 90° about the longitudinal dimension;

[0017] Figure 3 is Figure 2A a cross-sectional view of a portion of the device shown in

[0018] Figure 4 is Figure 2B a cross-sectional view of a portion of the device shown in ; and

[0019] Figure 5 is Figure 2A a perspective view of a portion of the distal end of the main conduit portion of the device of

[0020] Figure 6 is Figure 5 a side X-ray view of the distal end of the main conduit portion of the device of

[0021] Figure 7 is Figure 2A a perspective view of the proximal end of the cap portion of the device of

[0022] Figure 8 is Figure 7 a side X-ray view of the cap portion of the device of

[0023] Figure 9 is an exemplary image generated by a radial ultrasound probe used in conjunction with the components shown in FIGS. 2 through Figure 8 shown in

[0024] Figure 10 is a cross-sectional view of the main conduit and cap formed in accordance with an embodiment of the present invention;

[0025] Figure 11 is Figure 10 a perspective view of a portion of the distal end of the main conduit portion of the device of

[0026] Figure 12 is Figure 10 a side X-ray view of the distal end of the main conduit portion of the device of

[0027] Figure 13 is Figure 10 a perspective view of the proximal end of the cap portion of the device of

[0028] Figure 14 is Figure 10 a side X-ray view of the cap portion of the device of

[0029] Figure 15 is a side view of the distal end of the device formed in accordance with an embodiment of the present invention;

[0030] Figure 16 is Figure 15 a cross-sectional view of a portion of the device shown in

[0031] Figure 17 is Figure 15 a cross-sectional view of a 90° partial rotation of the device shown in

[0032] Figure 18 is Figure 2A a cross-sectional perspective view of the proximal end of the cap portion of the device of

[0033] Figure 19 is Figure 18 a lateral X-ray view of the cap portion of DETAILED DESCRIPTION

[0034] The following description is merely exemplary in nature and is not intended to limit the present disclosure, its application, or uses.

[0035] Now referring to Figure 1 , the bronchoscope system 10 includes a bronchoscope 12 having an insertion tube 14, a radial ultrasound system 16, and an access device 20. The radial ultrasound system 16 includes 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 needle for sampling and / or drug delivery, are received within the bronchoscope 12 via a handle member of the access device 20.

[0036] 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 a radial ultrasound transducer at the distal end of the radial ultrasound probe 22. A diagnostic bronchoscope (e.g., the BF-X190 manufactured by Olympus ® is an example of the bronchoscope 12, and a radial endobronchial ultrasound (EBUS) mini-probe manufactured by Olympus ® is an example of the radial ultrasound device 16.

[0037] The present invention uses an echo-orienting pin attached to a twistable insertion device. The orienting pin is visible on the ultrasound image and thus warns the user of the rotational orientation of the distal end of the access device 20 and the needle relative to the target.

[0038] FIGS. 2 to Figure 8Shows an example of the distal end of the access device 20. The access device 20 includes a catheter portion 40 and a cap portion 42 at the distal end of the catheter portion 40. The catheter portion 40 extends from a handle portion (not shown). The catheter portion 40 includes a radial ultrasound lumen 44, a second lumen 46, a third lumen 50, and a fourth lumen 50'. The lumens 44, 46, 50, 50' can all be accessed via the distal surface of the catheter portion 40. The lumens 44, 46 extend to proximal ports (not shown) located at the handle portion, ports on the handle of a bronchoscope or other endoscopic device, or locations accessible to the operator. The lumens 44, 46 allow devices to be inserted from the proximal end all the way to the distal end of the catheter portion 40. The radial ultrasound lumen 44 is sized to slidably receive a radial ultrasound probe (not shown). The second lumen 46 is sized to receive a medical device 48, such as a needle. In one embodiment, the third and fourth lumens 50, 50' extend only a predefined distance from the distal end of the catheter portion 40 ( Figure 6 ).

[0039] As Figure 3 , Figure 4 , Figure 7 and Figure 8 shown, the cap portion 42 includes a first lumen 54, a second lumen 60, a third lumen 62, and a fourth lumen 62'. The first orientation pin 80 and the second orientation pin 80' each include a proximal end and a distal end. The proximal ends of the pins 80 and 80' are at least partially received within the third and fourth lumens 50 and 50' of the catheter portion 40. The distal ends of the pins 80, 80' are at least partially received within the third and fourth lumens 62, 62' of the cap portion 42. The pins 80, 80' can be press-fitted into the lumens 50, 50', 62, 62' and / or attached to one or more of the lumens 50, 50', 62, 62' by a reflux process, an adhesive, or a welded joint. The pins 80, 80' can have various shapes, such as circular, oval, rectangular, where the lumens 50, 50', 62, 62' have similar shapes. In one embodiment, the shape of the pin 80 is different from the shape of the pin 80', and the lumens 50, 50', 62, 62' have corresponding shapes. The pins 80, 80' can include a metal (e.g., stainless steel) or another material having ultrasonic reflection characteristics. The pins 80, 80' can include reflective feature structures, such as etchings or grooves, for increasing the echo reflectivity of the pins 80, 80'.

[0040] In one embodiment, the catheter is made of a braided (stainless steel) sheath with a PTFE liner in the lumen, and Pebax forms the body and the outer sheath. The cap can be made of polycarbonate, PEEK, Ultem, or TPX (polymethylpentene).

[0041] In one embodiment, at least the proximal portion of the cap portion 42 is sized to be received within a slot at the distal end of the catheter portion 40 or is sized to receive the distal end of the catheter portion 40 such that the pins 80, 80' are received within the third and fourth lumens 62, 62', and the first lumen 54 is aligned with the radial ultrasound lumen 44, and the second lumen 60 is aligned with the second lumen 46 of the catheter portion 40. Other methods of temporarily or permanently attaching the cap portion 42 to the distal end of the catheter portion 40 may be used. The distal end of the second lumen 60 of the cap portion 42 includes a side port 70 and a ramp 68. The ramp 68 deflects the medical device 48 and causes it to exit the cap portion 42 through the side port 70. The lumens 54, 62, 62' may be closed / sealed or open at their distal ends.

[0042] When the radial ultrasound probe is positioned within the cap portion 42, the radial ultrasound probe is capable of generating a 360° image. The 360° image includes reflections of the orientation pins 80, 80'. Since the orientation pins 80, 80' are located on the same half of the first lumen 54, any medical device passing through the second lumen 60 and exiting through the side port 70 will interact with tissue between the shortest arc distances visually located between the reflections of the orientation pins 80, 80' on the 360° image. This is illustrated by Figure 9 an exemplary image.

[0043] Figure 9 An image 90 output to the display device 18 is shown. The image 90 is generated by the radial ultrasound system 16 when the insertion tube 14 that receives the ultrasound transducer at its distal end is positioned within a body cavity. The image 90 shows an image having 360° imaging features. The image 90 also includes feedback 92 identifying the orientation pins. The side port 70 is located between the orientation pins 80, 80', where the arc between the pins 80, 80' is minimized. Thus, the user will know that any medical device exiting the side port 70 will always exit at this minimum arc location. In the image 90, the medical device will exit the side port 70 between approximately angular values of 350° and 080°. In the image 90, 000° will be located at the 12 o'clock position. Thus, if a target is identified in the radial ultrasound image, all the user needs to do to cause the medical device to interact with the target is to rotate the catheter portion 40 until the target is located within the smallest segment of the 360° image defined by the orientation pin feedback 92.

[0044] As Figures 10 to 14 shown, the orientation pins 180, 180' are only included in the cap portion 142 and no orientation pin lumen is included in the catheter portion 140.

[0045] As Figures 15 to 17As shown, the catheter portion 240 does not include a cap portion. The catheter portion 240 includes at least all of the features of the cap devices 42, 142 described above and the features shown in the following features.

[0046] As Figure 18 and Figure 19 As shown, three alignment pins are used. Two pins are located in the pin lumens 362, 362' adjacent to each other on one half of the catheter 342, and the third pin is located in the pin lumen 362' on the other half of the catheter 342. In one embodiment, the three pin lumens 362, 362', 362" can be located in the cap portion, a single catheter, or both.

[0047] Any of the above lumens can be exposed at its proximal or distal end.

[0048] Embodiment

[0049] A. A catheter system, the catheter system comprising: a flexible shaft, the flexible shaft comprising: a first lumen; a second lumen; a third lumen; a fourth lumen; a first alignment pin; and a second alignment pin, wherein the first alignment pin is received within the third lumen and the second alignment pin is received within the fourth lumen.

[0050] B. The system according to A, wherein the flexible shaft includes a cross-sectional dimension, wherein the third lumen and the fourth lumen include longitudinal axes located on the same half of the cross-sectional dimension of the flexible shaft.

[0051] C. The system according to A or B, wherein the flexible shaft is a catheter portion and further includes a cap portion, wherein the first lumen, the second lumen, the third lumen, and the fourth lumen are included within the catheter portion, wherein at least the proximal end of the first alignment pin is received within the third lumen, wherein at least the proximal end of the second alignment pin is received within the fourth lumen, wherein the cap portion includes: a first lumen; a second lumen; a third lumen; and a fourth lumen, wherein at least the distal end of the first alignment pin is received within the third lumen of the cap portion, and wherein at least the distal end of the second alignment pin is received within the fourth lumen of the cap portion.

[0052] D. The system according to C, wherein when the alignment pins are received within the third lumen and the fourth lumen of the catheter portion and the cap portion, the first lumen to the fourth lumen of the catheter portion are aligned with the first lumen to the fourth lumen of the cap portion.

[0053] E. The system according to D, wherein the cap portion further includes: an outlet for exposing at least a portion of the second lumen of the cap portion; and a ramp located at the distal end of the second lumen of the cap portion.

[0054] F. The system according to any one of A to E, wherein the second inner lumen of the catheter portion and the cap portion is on the same half of the cross-sectional dimension as the third and fourth inner lumens of the catheter portion and the cap portion.

[0055] G. The system according to E or F, wherein the cap portion comprises one or more materials that are transmissive to ultrasonic signals, and wherein the alignment pins comprise one or more materials that are non-transmissive to ultrasonic signals.

[0056] H. The system according to any one of A to G, wherein the alignment pins comprise at least one laser scribing, pit, hole, or other echo feature structure.

[0057] I. A catheter system, the catheter system comprising: a flexible shaft, the flexible shaft comprising: a first inner lumen; a second inner lumen; a first alignment pin; and a second alignment pin, a cap portion, the cap portion comprising: a first inner lumen; a second inner lumen; a third inner lumen; and a fourth inner lumen, wherein the first alignment pin is received within the third inner lumen of the cap portion, and wherein the second alignment pin is received within the fourth inner lumen of the cap portion.

[0058] J. The system according to I, further comprising a third alignment pin, and wherein the cap portion further comprises a fifth inner lumen configured to receive the third alignment pin.

[0059] K. The system according to I or J, wherein the alignment pins comprise at least one laser scribing, pit, hole, or other echo feature structure.

[0060] L. A system, the system comprising: a radial ultrasound system, the radial ultrasound system comprising: a signal processor; and a radial ultrasound probe, wherein the radial ultrasound probe communicates data with the signal processor, and wherein the signal processor is configured to 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, the catheter system comprising: a catheter portion, the catheter portion comprising: a first inner lumen configured to receive the radial ultrasound probe; and a second inner lumen configured to receive the medical device; a first alignment pin; a second alignment pin; and a cap portion, the cap comprising: a first inner lumen; a second inner lumen; a third inner lumen; and a fourth inner lumen, wherein the first alignment pin is received within the third inner lumen of the cap portion, and wherein the second alignment pin is received within the fourth inner lumen of the cap portion.

[0061] M. The system according to L, wherein the cap portion comprises a cross-sectional dimension, and wherein the longitudinal axes of the third and fourth inner lumens of the cap portion are on the same half of the cross-sectional dimension of the cap portion.

[0062] N. The system according to L or M, wherein the cap portion further comprises: an outlet for exposing at least a portion of the second inner lumen of the cap portion; and a ramp located at the distal end of the second inner lumen of the cap portion.

[0063] O. The system according to any one of L to N, wherein the longitudinal axes of the second inner lumen of the catheter portion and the cap portion and the third and fourth inner lumens of the cap portion are located on the same half of the cross-sectional dimension.

[0064] P. The system according to any one of L to O, wherein the orientation pin comprises at least one laser scribing, pit, hole or other echo feature structure.

[0065] The description of the present invention is merely exemplary in nature, and variations that do not depart from the gist of the present invention should be included within the scope of the present invention. These variations should not be regarded as departing from the essence and scope of the present invention.

Claims

1. A catheter system, the catheter system comprising: a flexible shaft, the flexible shaft comprising: a first lumen; a second lumen; a third lumen; and a fourth lumen; a cap portion attached to the distal end of the flexible shaft, the cap portion comprising: a first lumen configured to align with the first lumen of the flexible shaft; a second lumen configured to align with the second lumen of the flexible shaft; a third lumen; and a fourth lumen; a side port connected to the second lumen of the cap portion; a first alignment pin; and a second alignment pin, wherein the first alignment pin and the second alignment pin are disposed in a lumen adjacent to the first lumen and the second lumen of the cap portion, wherein at least the distal end of the first alignment pin is received within the third lumen of the cap portion, wherein at least the distal end of the second alignment pin is received within the fourth lumen of the cap portion, and wherein the first alignment pin and the second alignment pin comprise one or more materials that are non-transmissive to ultrasonic signals.

2. The catheter system according to claim 1, wherein the flexible shaft comprises a cross-sectional dimension, and wherein the third lumen and the fourth lumen comprise longitudinal axes located on the same half of the cross-sectional dimension of the flexible shaft.

3. The catheter system according to claim 1, wherein the flexible shaft is a catheter portion, wherein the first lumen, the second lumen, the third lumen, and the fourth lumen are included within the catheter portion, wherein at least the proximal end of the first alignment pin is received within the third lumen, wherein at least the proximal end of the second alignment pin is received within the fourth lumen.

4. The catheter system according to claim 3, wherein when the alignment pins are received within the third lumen and the fourth lumen of the catheter portion and the cap portion, the first lumen to the fourth lumen of the catheter portion are aligned with the first lumen to the fourth lumen of the cap portion.

5. The catheter system according to claim 4, wherein the cap portion further comprises: an outlet for exposing at least a portion of the second lumen of the cap portion; and a ramp located at the distal end of the second lumen of the cap portion.

6. The catheter system according to claim 2, wherein the second lumen of the catheter portion and the cap portion is located on the same half of the cross-sectional dimension as the third lumen and the fourth lumen of the catheter portion and the cap portion.

7. The catheter system according to claim 4, wherein the cap portion comprises one or more materials that are transmissive to ultrasonic signals.

8. The catheter system according to claim 1, wherein the alignment pins comprise at least one laser scribing, pit, hole, or other echo feature structure.

9. A catheter system, the catheter system comprising: a flexible shaft, the flexible shaft comprising: a first lumen; a second lumen; a first alignment pin; and a second alignment pin, a cap portion, the cap portion comprising: a first lumen; a second lumen; a third lumen; and Fourth inner cavity, wherein the first alignment pin is received in the third inner cavity of the cap portion, wherein the second alignment pin is received in the fourth inner cavity of the cap portion, wherein the first alignment pin and the second alignment pin comprise one or more materials that are impermeable to ultrasonic signals.

10. The catheter system according to claim 9, further comprising a third alignment pin, wherein the cap portion further comprises a fifth inner cavity configured to receive the third alignment pin.

11. The catheter system according to claim 9, wherein the alignment pin comprises at least one laser scribing, pit, hole or other echo feature structure.

12. A medical endoscope system, the medical endoscope system comprising: A radial ultrasound system, the radial ultrasound system comprising: A signal processor; and A radial ultrasound probe, wherein the radial ultrasound probe communicates data with the signal processor, wherein the signal processor is configured to 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, the catheter system comprising: A catheter portion, the catheter portion comprising: A first inner cavity configured to receive the radial ultrasound probe; and A second inner cavity configured to receive the medical device; A first alignment pin; A second alignment pin; and A cap portion, the cap portion comprising: A first inner cavity; A second inner cavity; A third inner cavity; and A fourth inner cavity, wherein the first alignment pin is received in the third inner cavity of the cap portion, wherein the second alignment pin is received in the fourth inner cavity of the cap portion, wherein the first alignment pin and the second alignment pin comprise one or more materials that are impermeable to ultrasonic signals.

13. The medical endoscope system according to claim 12, wherein the cap portion comprises a cross-sectional dimension, and wherein the longitudinal axes of the third inner cavity and the fourth inner cavity of the cap portion are located on the same half of the cross-sectional dimension of the cap portion.

14. The medical endoscope system according to claim 12, wherein the cap portion further comprises: An outlet for exposing at least a portion of the second inner cavity of the cap portion; and A ramp located at the distal end of the second inner cavity of the cap portion.

15. The medical endoscope system according to claim 13, wherein the longitudinal axes of the second inner cavities of the catheter portion and the cap portion are located on the same half of the cross-sectional dimension as the longitudinal axes of the third inner cavity and the fourth inner cavity of the cap portion.

16. The medical endoscope system according to claim 12, wherein the alignment pin comprises at least one laser scribing, pit, hole or other echo feature structure.

Images