Tip assembly for a real-time sampling system

Abstract

An apparatus and system for effective real-time visualization for use with medical devices is disclosed. The apparatus includes a handle that receives a medical device and an imaging component, a flexible shaft that includes at least two lumens and is attached to the handle, and an end cap that is attached to the flexible shaft. The end cap includes a first lumen, an exit port located at a proximal end of the end cap, a first slit, and a second slit. The first lumen of the end cap receives the imaging component from the flexible shaft. The exit port receives the medical device from the flexible shaft. The slits are longitudinally located on an outer surface of the end cap at a distal portion of the end cap. The first lumen of the end cap opens to a slot for better tissue communication.

Description

BACKGROUND

[0001] FIG. 1 illustrates a distal end of an example real-time sampling device. The distal end includes a probe lumen for receiving a radial ultrasound probe and two smaller lumens for receiving orientation pins. The pins reflect ultrasound signals whereby shadows are projected, as shown in FIG. 2. SUMMARY

[0002] The present disclosure provides an example system for effective real-time visualization of medical devices. The system includes an imaging system having a radial ultrasound probe, an image processor in signal communication with the radial ultrasound probe, and a display configured to display an ultrasound image based on a signal received from the image processor. The system further includes a device including a handle configured to receive a medical device and the radial ultrasound probe and a flexible shaft attached to the handle at a proximal end. The flexible shaft includes a first lumen configured to receive the radial ultrasound probe from the handle and a second lumen configured to receive the medical device from the handle. The device further includes an end cap attached to a distal end of the flexible shaft. The end cap includes a first lumen, an exit port at a proximal end, a first slit, and a second slit. The first lumen of the end cap receives the radial ultrasound probe from the first lumen of the flexible shaft when the end cap is attached to the flexible shaft. The exit port receives the medical device from the second lumen of the flexible shaft when the end cap is attached to the flexible shaft. The slits are longitudinally located on an outer surface of the end cap at a distal portion of the end cap.

[0003] In an aspect, at least one ultrasound reflective material is located in each slit.

[0004] In another aspect, the device includes a slot at a distal end of the end cap. The slot receives the radial ultrasound probe from the first lumen of the end cap at a proximal end of the end cap.

[0005] In yet another aspect, the slits are located on at least one surface of the end cap adjacent to the slot or on another surface of the end cap at a proximal end of the slot. The slits can be located on a longitudinal half of the end cap that is opposite to another longitudinal half of the end cap that includes the exit port. The surface of the end cap adjacent to the slot is located on the longitudinal half of the end cap that includes the slits.

[0006] In still another aspect, the end cap includes a second port at the distal end. The second port provides access to the first lumen of the end cap. The second port of the end cap has a smaller cross-sectional diameter than the first lumen of the end cap.

[0007] Further features, advantages and applications of the present disclosure will be apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0008] The drawings described herein are for purposes of illustration only and are not intended to limit the scope of the present disclosure in any way. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the application. The drawings in which:

[0009] FIG. 1 is a perspective view of an end piece formed in accordance with an embodiment of the prior art;

[0010] FIG. 2 shows an ultrasound image produced by a radial ultrasound device used within the end piece of FIG. 1 ;

[0011] Figure 3 An exemplary bronchoscope system with a real-time system is illustrated;

[0012] Figure 4 is a perspective view of a distal end of a real-time system piece formed in accordance with an embodiment;

[0013] Figure 5 shows an ultrasound image produced by a radial ultrasound device used within the piece of Figure 4 ;

[0014] Figure 6 is a perspective view of a distal end of a real-time system piece formed in accordance with an embodiment;

[0015] Figure 7 is a perspective view of a distal end of a real-time system piece formed in accordance with an embodiment;

[0016] Figure 8 is a perspective view of a distal end of a real-time system piece formed in accordance with an embodiment;

[0017] Figure 9 is a cross-sectional view of a piece of Figure 8 ;

[0018] Figure 10 is a perspective view of a distal end of a real-time system piece formed in accordance with an embodiment; and

[0019] Figure 11 is a cross-sectional view of a piece of Figure 10 ; DETAILED DESCRIPTION

[0020] The following description is merely illustrative in nature and is not intended to limit the disclosure, application and uses. The following description illustrates various embodiments for providing a real-time system by way of example only.

[0021] Reference is now made to Figure 3 , a bronchoscope system 10 includes a bronchoscope 12 with an insertion tube 14 and a real-time system 16. The diagnostic bronchoscope (e.g., by Olympus®) is used to perform a bronchoscopy procedure on a patient. The real-time system 16 is used to provide real-time images of the patient's airways to the physician performing the bronchoscopy procedure. The BF-P190) is an example of a bronchoscope 12. The real-time system 16 includes a signal processor 24, a display device 18, a guide wire 22 connected through a handle device 20 to a radial ultrasound transducer (not shown). The real-time system 16 also includes a motor controller 40 connected through the handle device 20 to a distal motor (not shown).

[0022] The real-time system 16 includes a medical device 30, such as a needle for tissue sampling and / or drug delivery, which is slidably received in an inner lumen of a catheter (not shown). The catheter is attached at a proximal end to the handle device 20. The catheter passes through the handle and insertion tube 14 of the bronchoscope 12. The real-time system 16 can be used separately from the bronchoscope system 12.

[0023] The display device 18 is in wired or wireless signal communication with the signal processor 24. The display device 18 presents images based on image information received from the signal processor 24, which receives the image information from the radial ultrasound transducers (not shown) of the radial ultrasound probe.

[0024] Figure 4 An example end piece 31 attached to a distal end 32 of a flexible catheter 33 is shown. The flexible catheter 33 is attached at a proximal end to the handle device 20 and includes an inner lumen capable of receiving a radial ultrasound device, as well as a smaller working channel for receiving a medical device 30 through the handle device 20. In one embodiment, the smaller working channel has an inner diameter that is less than half of the inner diameter of the inner lumen that receives the radial ultrasound device. The end piece 31 includes a first inner lumen 34 that is coaxial with the main inner lumen of the flexible catheter 33 when attached to the main inner lumen of the flexible catheter 33. The first inner lumen 34 can be capped at a distal end to retain any ultrasound conducting fluid or gel within the inner lumen 34. The end piece 31 includes an exit ramp 36 that allows the medical device 30 received in the working channel of the flexible catheter 33 to exit on one side of the end piece 31 near the proximal end. The end piece 31 can be attached to the flexible catheter 33 with epoxy, heat welding, or metal-to-metal welding. The ramp 36 can be made of steel, while an ultrasound (i.e., US) window (i.e., a portion of the end piece 31) around the location where the probe is received is made of plastic, with the ramp 36 welded to the braided material (not shown) of the sheath at the proximal end and the ramp 36 connected to the US window at its distal end with epoxy.

[0025] The end component 31 includes two longitudinal slits (i.e., grooves) 38, 39 extending from a distal end to a longitudinal point near the exit ramp 36. The slits 38, 39 are configured to receive ultrasonically reflective material, such as a metal rod, flat wire, high-density film, metallic paint, or other material that can be inserted into the slits 38, 39. This material can be inserted into the slits 38, 39 in a molten or liquid state and then cooled to a solid state. In one embodiment, stainless steel pins are used in the slits 38, 39 to provide orientation of the exit ramp 36 toward a target, such as... Figure 5 The ultrasound image 42 is shown. The centerline of the exit ramp 36 divides the slits 38 and 39 in two.

[0026] Because slits 38 and 39 are located on the outer edge of end member 31, ultrasound reflection is more precise (i.e., minimal shadowing). Various angles between slits 38 and 39 can be used to provide an optimal balance of orientation and visibility for the medical device and target. In one embodiment, the material within slits 38 and 39 and / or slits 38 and 39 has a width greater than or equal to 0.006 inches and less than or equal to 0.020 inches.

[0027] The material within slits 38 and 39 can be flat, linear, circular, hexagonal, or parabolic in shape to reflect the ultrasonic signal back to the transducer of the ultrasonic probe.

[0028] like Figure 6 As shown, the end cap component 50 includes a proximal portion comprising an outlet ramp 56 positioned relative to the working channel of the flexible catheter 33. The end cap component 50 also includes a distal portion comprising a groove 60 coaxial with the lumen 54 of the proximal portion, all of which are coaxial with the lumen of the flexible catheter 33 receiving the ultrasound probe. The cross-section of the distal portion is generally D-shaped. This provides direct contact between the ultrasound probe and surrounding tissue. Adjacent to the groove 60 is... Figure 4 The slits 38 and 39 are configured as slits (i.e., grooves) 68 and 70 to receive ultrasonic reflective material.

[0029] like Figure 7 As shown, end cap component 80 includes a proximal portion comprising an outlet ramp 86, which, when attached to flexible catheter 33, is positioned relative to the working channel of the attached flexible catheter 33. End cap component 80 includes a distal portion comprising a groove 90 coaxial with the lumen 84 of the proximal portion, all of which are coaxial with the lumen of the flexible catheter 33 receiving the ultrasound probe. Groove 90 is less surrounded by material of end cap component 80 compared to groove 60 of end cap component 50. Smaller slits (i.e., recesses) 92, 94 are longitudinally positioned within the outer circular portion of the distal portion and... Figure 4 The slits 38 and 39 are configured to receive ultrasonic reflective material.

[0030] like Figure 8 and Figure 9 As shown, in one embodiment, the end cap component 110 includes a side port 118, locating pin cavities 120, 122, and an ultrasonic cavity 116 similar to that shown in FIG. 1. The locating pin cavities 120, 122 may be filled with an ultrasonic reflective material (such as those shown above for use with ultrasound). Figure 3 The ultrasound-reflecting material may or may only comprise a gas / air cavity. The cavities 120, 122 may be open to the surrounding environment, thereby trapping air from the lungs. However, the endcap component 110 includes a narrow port 124 at its distal end for providing an inlet to the ultrasound cavity 116. Port 124 allows for the injection of an ultrasound-coupled fluid, such as a viscous gel (e.g., 100). After the ultrasound coupling fluid is injected, the ultrasound probe 126 is inserted into the ultrasound cavity 116. Because the ultrasound probe 126 has a larger diameter than the port 124, the ultrasound coupling gel remains trapped in the ultrasound cavity 116.

[0031] like Figure 10 and Figure 11 As shown, the headlight cavity 140 is cut into a probe cavity 142 with an end cap 130, such that the material placed in the headlight cavity 140 (i.e., the headlight 144) is exposed in the probe cavity 142. This allows the ultrasonic coupling gel inserted into the probe cavity 142 to directly contact the headlight 144, forming ideal coupling so that the US signal is reflected from the headlight 144 back to the US probe 148.

[0032] In one embodiment, the locating pin cavity and slit reflecting the ultrasonic signal may have one or more longitudinal breaks (i.e., locations where there is no cavity or slit or where no reflective material is used). Due to the breaks, the transducer's location at the end cap can be seen in the ultrasonic image. This is because the thickness of the ultrasonic plane in the longitudinal direction is less than the length of the end cap's US window.

[0033] The description of this invention is exemplary in nature only, and variations that do not depart from the spirit of the invention are intended to fall within its scope. Such variations should not be considered as departing from the spirit and scope of the invention.

[0034] Implementation Plan

[0035] A. An apparatus comprising:

[0036] A flexible shaft, the flexible shaft comprising:

[0037] First inner cavity;

[0038] Second inner cavity;

[0039] an end cap attached to a distal end of the flexible shaft, the end cap comprising:

[0040] a first lumen;

[0041] an exit port located at a proximal end of the end cap;

[0042] a first slit;

[0043] a second slit;

[0044] wherein the first lumen of the end cap is configured to receive an imaging tool from the first lumen of the flexible shaft when the end cap is attached to the flexible shaft, wherein the exit port is configured to receive a medical device from the second lumen of the flexible shaft when the end cap is attached to the flexible shaft, wherein the slit is located longitudinally on an outer surface of a distal portion of the end cap.

[0045] B. The apparatus of A, further comprising an ultrasonic reflective material located in the slit.

[0046] C. The apparatus of A or B, wherein the imaging tool comprises a radial ultrasound probe.

[0047] D. The apparatus of any of A-C, further comprising a slot located at a distal end of the end cap, the slot configured to receive an imaging tool from the first lumen of the end cap, wherein the first lumen of the end cap is located at a proximal end of the end cap.

[0048] E. The apparatus of D, wherein the slit is located on an outer surface of a portion of the end cap that includes the slot.

[0049] F. The apparatus of D or E, wherein the slit is located on a longitudinal half of the end cap that is opposite another longitudinal half of the end cap that includes the exit port.

[0050] G. The apparatus of any of D-F, wherein the slit is located on a surface of the end cap that is adjacent to the slot.

[0051] H. The apparatus of G, wherein the surface of the end cap that is adjacent to the slot is located on a longitudinal half of the end cap that includes the slit.

[0052] I. The apparatus of any of A-C, further comprising a second port located at a distal end of the end cap, the second port providing access to the first lumen of the end cap.

[0053] J. The apparatus of I, wherein the second port of the end cap has a smaller cross-sectional diameter than the first lumen of the end cap.

[0054] K. A system, comprising:

[0055] an imaging system, the imaging system comprising:

[0056] a radial ultrasound probe;

[0057] an image processor in signal communication with the radial ultrasound probe; and

[0058] a display configured to display an ultrasound image based on signals received from the image processor; and

[0059] a device, the device comprising:

[0060] a handle configured to receive a medical device and the radial ultrasound probe;

[0061] a flexible shaft attached at a proximal end to the handle, comprising:

[0062] a first lumen configured to receive the radial ultrasound probe from the handle; and

[0063] a second lumen configured to receive the medical device from the handle; and

[0064] an end cap attached to a distal end of the flexible shaft, the end cap comprising:

[0065] a first lumen;

[0066] an exit port located at a proximal end of the end cap;

[0067] a first slit; and

[0068] a second slit;

[0069] wherein the first lumen of the end cap is configured to receive the radial ultrasound probe from the first lumen of the flexible shaft when the end cap is attached to the flexible shaft, wherein the exit port is configured to receive a medical device from the second lumen of the flexible shaft when the end cap is attached to the flexible shaft, wherein the slits are located longitudinally on an outer surface of the end cap at a distal portion of the end cap.

[0070] L. The system of K, further comprising at least one ultrasound reflective material located in each of the slits.

[0071] M. The system of K or L, wherein the device further comprises a slot located at a distal end of the end cap, the slot configured to receive a radial ultrasound probe from the first lumen of the end cap, wherein the first lumen of the end cap is located at a proximal end of the end cap.

[0072] N. The system according to M, wherein the slit is located on at least one of a surface of the end cap adjacent to the slot or an outer surface of a portion of the end cap that includes the slot.

[0073] O. The system according to M or N, wherein the slit is located on a longitudinal half of the end cap that is opposite to another longitudinal half of the end cap that includes the outlet port.

[0074] P. The system according to any one of M to O, wherein the surface of the end cap adjacent to the slot is located on a longitudinal half of the end cap that includes the slot.

[0075] Q. The system according to K or L, wherein the apparatus further comprises a second port located at a distal end of the end cap, the second port providing access to the first inner lumen of the end cap.

[0076] R. The system according to Q, wherein the second port of the end cap has a smaller cross-sectional diameter than the first inner lumen of the end cap.

[0077] While preferred embodiments of the present application have been described herein, the present application is not limited to these embodiments. Additionally, additions, omissions, substitutions and other modifications can be made without departing from the spirit or scope of the present application.

Claims

1. An apparatus comprising: a flexible shaft comprising: a first lumen configured to receive an imaging tool; and a second lumen; an end cap attached to a distal end of the flexible shaft, the end cap comprising: a first lumen configured to receive the imaging tool; an exit port located at a proximal end of the end cap, the exit port configured to receive a medical device from the second lumen of the flexible shaft when the end cap is attached to the flexible shaft; a first slit; and a second slit; wherein the first slit and the second slit are longitudinally located on an outer surface of the end cap at a distal portion of the end cap; a first ultrasonic reflective material disposed within the first slit; and a second ultrasonic reflective material disposed within the second slit.

2. The apparatus of claim 1, wherein at least one of the first ultrasonic reflective material or the second ultrasonic reflective material comprises a concave side.

3. The apparatus of claim 2, wherein the concave side faces the first lumen of the end cap.

4. The apparatus of claim 1, wherein at least one of the first ultrasonic reflective material or the second ultrasonic reflective material comprises a flat side.

5. The apparatus of claim 4, wherein the flat side faces the first lumen of the end cap.

6. The apparatus of claim 1, wherein the imaging tool comprises a radial ultrasound probe.

7. The apparatus of claim 1, wherein the first slit and the second slit are disposed on a same half of the end cap.

8. The apparatus of claim 7, wherein the exit port comprises a longitudinal axis disposed between the first slit and the second slit.

9. A system comprising: an imaging system comprising: a radial ultrasound probe; an image processor in signal communication with the radial ultrasound probe; and a display configured to display an ultrasound image based on signals received from the image processor; and an apparatus comprising: a handle configured to receive a medical device and the radial ultrasound probe; a flexible shaft attached at a proximal end to the handle, comprising: a first lumen configured to receive the radial ultrasound probe from the handle; and a second lumen configured to receive the medical device from the handle; and an end cap attached to a distal end of the flexible shaft, the end cap comprising: a first lumen; an exit port located at a proximal end of the end cap; a first slit; and a second slit; wherein the first lumen of the end cap is configured to receive the radial ultrasound probe from the first lumen of the flexible shaft when the end cap is attached to the flexible shaft; wherein the exit port is configured to receive the medical device from the second lumen of the flexible shaft when the end cap is attached to the flexible shaft; wherein the slits are longitudinally located on an outer surface of the end cap at a distal portion of the end cap; and at least one ultrasonic reflective material located in each slit.

10. The system of claim 9, wherein the apparatus further comprises a slot located at a distal end of the end cap, the slot configured to receive the radial ultrasound probe from a first lumen of the end cap, wherein the first lumen of the end cap is located at a proximal end of the end cap.

11. The system of claim 10, wherein the slit is located on at least one of a surface of the end cap adjacent to the slot or an outer surface of a portion of the end cap that includes the slot.

12. The system of claim 11, wherein the slit is located on a longitudinal half of the end cap that is opposite to another longitudinal half of the end cap that includes the exit port.

13. The system of claim 12, wherein the surface of the end cap adjacent to the slot is located on the longitudinal half of the end cap that includes the slit.

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