Orientation pin for devices using radial ultrasound
By attaching an echo orientation pin to the catheter device, the problem of difficult to determine the tumor direction in radial ultrasound technology is solved, and the accuracy and diagnostic rate of peripheral lung tumor sampling are improved.
Patent Information
- Application Number
- CN202510603060.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2018-02-28
- Filing Date
- 2019-02-27
- Publication Date
- 2025-07-11
AI Technical Summary
Existing radial ultrasound techniques are difficult to determine the direction of the tumor in peripheral lung tumor sampling, resulting in a low diagnosis rate, especially tumors located outside the airway side.
The echo orientation pin attached to the catheter device is used to indicate the rotational orientation of the catheter device by the orientation pin visible on the ultrasound image, ensuring that the medical device is accurately directed to the target.
Improve the accuracy and diagnostic rate of peripheral lung tumor sampling, and ensure the correct orientation for the lesions through 360° image feedback.
Smart Images
Figure CN120284314A_ABST
Abstract
Description
[0001] This application is a divisional application of the invention patent application with the application date of February 27, 2019, the application number of 201910145571.7, and the title of "Orientation Pin for a Device Using Radial Ultrasound". Technical Field
[0002] 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
[0003] The descriptions in this section only provide background information related to the present disclosure and may not constitute prior art.
[0004] 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. Then a radial endobronchial ultrasound (EBUS) microprobe is threaded through the guiding sheath and used to determine the approximate location of the tumor.
[0005] Unfortunately, peripheral tumors located outside of one side of the airway (compared to tumors around the center of the airway) have significantly lower diagnostic rates, partly 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
[0006] 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 the medical device passing through the catheter device. When the ultrasound probe visualizes the 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.
[0007] 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.
[0008] 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.
[0009] 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 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.
[0010] 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.
[0011] In other aspects of the present invention, the cap portion includes one or more materials that are permeable to ultrasonic signals, and the alignment pins include one or more materials that are impermeable to ultrasonic signals. The alignment pins further include one or more echo features, such as laser scribing, pits, holes, etc.
[0012] 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.
[0013] Based on the description provided herein, other features, advantages, and scopes of applicability 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
[0014] 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:
[0015] Figure 1 An example of a bronchoscope system formed in accordance with an embodiment of the present invention is shown;
[0016] Figure 2A is a side view of the distal end of the device formed in accordance with an embodiment of the present invention;
[0017] Figure 2B is Figure 2A a side view of the distal end of the device rotated 90° about the longitudinal dimension;
[0018] Figure 3 is Figure 2A a cross-sectional view of a portion of the device shown in
[0019] Figure 4 is Figure 2B a cross-sectional view of a portion of the device shown in ; and
[0020] Figure 5 is Figure 2A a perspective view of a portion of the distal end of the main duct portion of the device of
[0021] Figure 6 is Figure 5 a lateral X-ray view of the distal end of the main duct portion of
[0022] Figure 7 is Figure 2A a perspective view of the proximal end of the cap portion of the device of
[0023] Figure 8 is Figure 7 a lateral X-ray view of the cap portion of
[0024] Figure 9 is an exemplary image generated by a radial ultrasound probe used with the components shown in FIGS. 2 through Figure 8
[0025] Figure 10 is a cross-sectional view of the main duct and cap formed according to an embodiment of the present invention;
[0026] Figure 11 is Figure 10 a perspective view of a portion of the distal end of the main duct portion of the device of
[0027] Figure 12 is Figure 10 a lateral X-ray view of the distal end of the main duct portion of
[0028] Figure 13 is Figure 10 a perspective view of the proximal end of the cap portion of the device of
[0029] Figure 14 is Figure 10 a lateral X-ray view of the cap portion of
[0030] Figure 15 is a lateral view of the distal end of the device formed according to an embodiment of the present invention;
[0031] Figure 16 is Figure 15 a cross-sectional view of a portion of the device shown in
[0032] Figure 17 is Figure 15 a cross-sectional view of a 90° partial rotation of the device shown in
[0033] Figure 18 is Figure 2A a cross-sectional perspective view of the proximal end of the cap portion of the device of
[0034] Figure 19 is Figure 18 a side X-ray view of the cap portion of DETAILED DESCRIPTION
[0035] The following description is merely exemplary in nature and is not intended to limit the present disclosure, its application, or uses.
[0036] Referring now 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.
[0037] The display device 18 communicates with the bronchoscope 12 and / or the signal processor 24 by 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 ) is an example of the bronchoscope 12, and a radial endobronchial ultrasound (EBUS) mini-probe manufactured by is an example of the radial ultrasound device 16.
[0038] The present invention uses an echo-orientation pin attached to a twistable insertion device. The orientation 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.
[0039] FIGS. 2 to Figure 8An example of the distal end of the access device 20 is shown. 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 face of the catheter portion 40. The lumens 44, 46 extend to a proximal port (not shown) located at the handle portion, a port on the handle of a bronchoscope or other endoscopic device, or a location 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 ).
[0040] 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 alignment pin 80 and the second alignment 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-fit 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 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'.
[0041] 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).
[0042] In one embodiment, at least the proximal portion of the cap portion 42 is sized to be received within the 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.
[0043] 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 at the shortest arc distance visually located between the reflections of the orientation pins 80, 80' on the 360° image. This is illustrated by Figure 9 an exemplary image.
[0044] 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 minimal. Thus, the user will know that any medical device exiting the side port 70 will always exit at this minimal arc location. In the image 90, the medical device will exit the side port 70 at an approximate angular value between 350° and 080°. In the image 90, 000° will be 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 portion of the 360° image defined by the orientation pin feedback 92.
[0045] As Figures 10 to 14 shown, the orientation pins 180, 180' are only included in the cap portion 142 and there is no orientation pin lumen in the catheter portion 140.
[0046] 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 feature structures of the above-described cap devices 42, 142 and the feature structures shown in the following feature structures.
[0047] As Figure 18 and Figure 19 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.
[0048] Any of the above lumens can be exposed at its proximal end or distal end.
[0049] Embodiments
[0050] A. A catheter system, the catheter system comprising: a flexible shaft, the flexible shaft comprising: a first lumen;
[0051] 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.
[0052] B. The system according to A, wherein the flexible shaft comprises a cross-sectional dimension, 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.
[0053] C. The system according to A or B, wherein the flexible shaft is a catheter portion and further comprises 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 comprises: 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.
[0054] 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.
[0055] E. The system according to D, 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.
[0056] 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.
[0057] G. The system according to E or F, wherein the cap portion comprises one or more materials that are permeable to ultrasonic signals, and wherein the alignment pins comprise one or more materials that are impermeable to ultrasonic signals.
[0058] 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.
[0059] I. A catheter system, the catheter system comprising: a flexible shaft, the flexible shaft comprising: a first inner lumen;
[0060] 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
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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 one or more generated 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.
[0065] M. The system according to L, wherein the cap portion includes a cross-sectional dimension, and wherein the third and fourth inner cavities of the cap portion include longitudinal axes that are located on the same half of the cross-sectional dimension of the cap portion.
[0066] N. The system according to L or M, wherein the cap portion further includes: an outlet for exposing at least a portion of the second inner cavity of the cap portion; and a ramp located at a distal end of the second inner cavity of the cap portion.
[0067] O. The system according to any one of L to N, wherein the longitudinal axes of the second inner cavity of the catheter portion and the cap portion and the third and fourth inner cavities of the cap portion are located on the same half of the cross-sectional dimension.
[0068] P. The system according to any one of L to O, wherein the orientation pin includes at least one laser scribing, pit, hole, or other echo feature structure.
[0069] The description of the present invention is exemplary in nature only, 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 substance and scope of the present invention.
Claims
1. A catheter device, the catheter device comprising: A flexible shaft, the flexible shaft comprising: A first inner lumen; and A second inner lumen; A cap portion having a longitudinal axis, the cap portion comprising: A third inner lumen configured to align with the first inner lumen; A fourth inner lumen configured to align with the second inner lumen; An outlet, and A ramp disposed between the second inner lumen of the flexible shaft and the outlet of the cap portion; At least one orientation pin positioned adjacent to the third inner lumen of the cap portion, Wherein at least a portion of the third inner lumen, the outlet, the ramp, and the at least one orientation pin intersect a plane perpendicular to the longitudinal axis.
2. The device according to claim 1, wherein the at least one orientation pin comprises two orientation pins.
3. The device according to claim 2, wherein the two orientation pins comprise a longitudinal axis, the longitudinal axis and the outlet being on the same half of the cap portion.
4. The device according to claim 1, wherein the first inner lumen and the third inner lumen are configured to receive an ultrasound probe.
5. The device according to claim 4, wherein the second inner lumen and the fourth inner lumen are configured to receive a medical device.
6. The device according to claim 1, wherein the cap portion comprises one or more materials that are transmissive to ultrasound signals.
7. The device according to claim 6, wherein the at least one orientation pin comprises one or more materials that are non-transmissive to ultrasound signals.
8. A system, the system comprising: A radial ultrasound system, the radial ultrasound system comprising: A radial ultrasound probe, and A signal processor configured to communicate data 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, the catheter system comprising: A flexible shaft, the flexible shaft comprising: A first inner lumen configured to receive the radial ultrasound probe; and A second inner lumen configured to receive the medical device; A cap portion having a longitudinal axis, the cap portion comprising: A third inner lumen configured to align with the first inner lumen; A fourth inner lumen configured to align with the second inner lumen; An outlet, and A ramp disposed between the fourth inner lumen and the outlet; and At least one orientation pin positioned adjacent to the third inner lumen of the cap portion, Wherein at least a portion of the third inner lumen, the outlet, the ramp, And the at least one orientation pin intersect a plane perpendicular to the longitudinal axis.
9. The system according to claim 8, wherein the at least one orientation pin comprises two orientation pins.
10. The system according to claim 9, wherein the two alignment pins include longitudinal axes, and the longitudinal axes and the outlet are on the same half of the cap portion.
11. The system according to claim 8, wherein the cap portion includes one or more materials that are transmissive to ultrasonic signals.
12. The system according to claim 9, wherein the at least one alignment pin includes one or more materials that are non-transmissive to ultrasonic signals.
13. The system according to claim 8, wherein the one or more generated images are configured to include: an ultrasonic shadow image associated with the at least one alignment pin; image features responsive to a distal end of the medical device disposed distally of the outlet, wherein the ultrasonic shadow image and the image features are on the same half of the one or more generated images.
14. A method, the 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, a fourth lumen, an outlet, and a ramp, the third lumen configured to align with the first lumen, the fourth lumen configured to align with the second lumen, and the ramp disposed between the second lumen and the outlet; providing at least one alignment pin positioned adjacent to the third lumen of the cap portion; attaching a distal end of the flexible shaft to a proximal end of the cap portion, wherein at least a portion of the third lumen, the outlet, the ramp, and the at least one alignment pin intersect a plane perpendicular to the longitudinal axis.
15. The method according to claim 14, wherein providing at least one alignment pin includes providing two alignment pins.
16. The method according to claim 15, wherein attaching further includes positioning the longitudinal axes of the two alignment pins and the outlet on the same half of the cap portion.
17. The method according to claim 14, further comprising slidably receiving an ultrasonic probe in the first lumen and the third lumen.
18. The method according to claim 17, further comprising slidably receiving a medical device in the second lumen and the fourth lumen.
19. The method according to claim 14, wherein providing the cap portion includes forming the cap portion with one or more materials that are transmissive to ultrasonic signals.
20. The method according to claim 19, wherein providing at least one alignment pin includes forming the at least one alignment pin with one or more materials that are non-transmissive to ultrasonic signals.