Patent Publication Number: US-2020297311-A1

Title: Dual lumen catheter

Description:
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 (rEBUS) probe is then threaded through the guide sheath and used to determine the approximate location of the tumor. 
     Currently, there is limited room in the working channel of an endoscope (e.g., bronchoscope) for an ultrasound probe and medical device (e.g., a needle) delivered in a conventional dual-lumen catheter without having to shrink the size of current off-the-shelf ultrasound probes and/or medical devices. 
     SUMMARY 
     The present disclosure describes an improved guide sheath for use with a medical scope, such as a bronchoscope. 
     An exemplary catheter includes a first lumen and a second lumen adjacent to the first lumen. The catheter occupies an arc around the first lumen, wherein the arc is greater than 180° and less than 360°, thus creating a lengthwise opening to the first lumen. The catheter material surrounds the second lumen in a cross-sectional dimension. 
     In one aspect, the second lumen has a smaller inner diameter than the first lumen. Also, the catheter can be slidably received within a working channel of an endoscope. 
     In another aspect, the second lumen can slidably receive a medical device and the first lumen can receive an imaging device. The imaging device includes a probe. 
     In still another aspect, the lengthwise opening of the first lumen is defined by a first flexible edge and a second flexible edge. A first chord measurement between the first and second edges has a first value when the imaging device is not occupying the first lumen. A second chord measurement between the first and second edges has a second value when the imaging device is occupying the first lumen. The first chord measurement is less than the second chord measurement. 
     In yet another aspect, the first and second edges exhibit a snap-like action upon receiving the imaging device. 
     In still yet another aspect, a needle is introduced into the second lumen prior to the procedure and the probe is snapped into the trough (first lumen) prior to insertion into an endoscope. 
     Further features, advantages, and areas of applicability will become 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 THE DRAWINGS 
       The drawings described herein are for illustration purposes 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 invention. In the drawings: 
         FIG. 1  illustrates an example of a bronchoscope system formed in accordance with an embodiment of the disclosure; 
         FIG. 2  is a side view of a real-time system formed in accordance with an embodiment of the disclosure; 
         FIG. 3  is a perspective, x-ray view of a distal portion of a catheter included in the device shown in  FIG. 2 ; 
         FIG. 4  is a plan view of the distal end of the catheter shown in  FIG. 3 ; 
         FIG. 5  is a perspective, x-ray view of a catheter formed in accordance with an embodiment of the disclosure; and 
         FIG. 6  is a side, x-ray view of the distal end of a catheter system formed in accordance with an embodiment of the disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. The invention improves the ability HCPs to sample tissue or deliver substances with real-time feedback. 
     Referring now to  FIG. 1 , a bronchoscope system  10  includes a bronchoscope  12  with 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 medicant delivery, are received within the bronchoscope  12  via a handle component and a sheath/catheter component of the access device  20 . 
     The display device  18  is in wired or wireless signal communication with the bronchoscope  12  and/or the signal processor  24 . The display device  18  presents images generated based on information received from the bronchoscope  12  and/or the signal processor  24  that receives image information from a radial ultrasound transducer at the distal end of the radial ultrasound probe  22 . A diagnostic endoscope (e.g., BF series produced by Olympus®) is an example of the bronchoscope  12  and the radial endobronchial ultrasound (rEBUS) probes produced by Olympus® are examples of the radial ultrasound device  16 . 
       FIG. 2  illustrates an access device  20 - 1  that includes a two-port handle component  32  that attaches to a dual-lumen catheter  40 . Attached at a distal end of the dual-lumen catheter  40  is a cap  42 . As will be shown in more detail below, the dual-lumen catheter  40  includes a fully enclosed lumen that is in communication with a first access port  44  of the two-port handle component  32  and an open trough that is in communication with a second access port  46  of the two-port handle component  32 . The first access port  44  is configured to receive a medical device  48 , such as a needle, and direct the medical device into the enclosed lumen within the dual-lumen catheter  40 . The second access port  46  is configured to receive and direct the radial ultrasound probe  22  into the open trough of the dual-lumen catheter  40 . 
     In one embodiment, the two-port handle component  32  may include a hinged door or removable section that allows access to an internal lumen that connects the second access port  46  to the open trough of the dual-lumen catheter  40 . When the hinged door or removable section is in an opened configuration, the internal lumen is made accessible such that the radial ultrasound probe  22  may be placed directly into the internal lumen. This allows one to simultaneously place a shaft of the radial ultrasound probe  22  into the internal lumen of the two-port handle  32  and into the open trough of the dual-lumen catheter  40 . 
       FIGS. 3 and 4  illustrates views of an exemplary dual-lumen catheter  60 . The dual-lumen catheter  60  includes a first enclosed lumen  62  configured to receive a medical device. The dual-lumen catheter  60  includes a second lumen  64  sized to receive the radial ultrasound probe  22 . The second lumen  64  is not fully enclosed by the material of the dual-lumen catheter  60 . The second lumen  64  has a cross-section similar to that of a trench, trough or open channel. The second lumen  64  includes a central axis that is offset from a central axis of the dual-lumen catheter  60 . The position of the central axis of the second lumen  64  relative to the central axis of the dual-lumen catheter  60  is selected that when the radial ultrasound probe  22  is inserted into the second lumen  64 , the outer surface of the radial ultrasound probe  22  that is exposed is at a distance from the central axis of the dual-lumen catheter  60  that is between being slightly less to slightly greater than the actual radius of the dual-lumen catheter  60 . Thus, because the dual-lumen catheter  60  does not occupy the space fully around the second lumen  64 , the overall diameter of the dual-lumen catheter  60  can be optimized. In other words, the size of the first and second lumens  62 ,  64  can be maximized. 
     In one embodiment, the position of the central axis of the second lumen  64  relative to the central axis of the dual-lumen catheter  60  and dimensions of the second lumen  64  are selected so that the radius of the second lumen  64  extends at least as radially as the radius of the dual-lumen catheter  60 . 
     In one embodiment, the edges of the dual-lumen catheter  60  that define the opening of the second lumen  64  are made of a material that allows them to expand to a more open configuration to allow the radial ultrasound probe  22  to be inserted collaterally versus being slid into the second lumen  64  from the proximal end. The material may include a variety of thermoplastics (Pebax, polyurethane, PEEK, etc.) or thermoset (silicone, PTFE). The material around the the second lumen  64  trough should be rigid enough to hold the probe  22 , yet flexible enough to allow a snapping-in of the probe  22 . The insertion of the radial ultrasound probe  22  into the second lumen  64  may cause a clicking action or noise caused be the edges of the dual-lumen catheter  60  snapping back after being expanded to allow for the diameter of the probe  22 . 
     As shown in  FIGS. 5 and 6 , a dual-lumen catheter  70  includes an open lumen  72  and a medical device lumen  74 . At a distal end of the dual-lumen catheter  70  an exit port  78  provides access to the medical device lumen  74 . A ramp  80  at the exit port  78  allows a medical device  82  to be directed out of the exit port  78 . 
     In one embodiment, a cap section  90  is attachable to the distal end of the dual-lumen catheter  70 . The cap section  90  includes a lumen  94  for receiving a radial ultrasound probe and one or more lumens for receiving one or more orientation pins  92 . In one embodiment, a ramp  80 - 1  may also be included in the cap section  90  instead of being included in the catheter. 
     The orientation pins provide an echogenic feature, thus providing more visibility in the ultrasound image and thus alert the user to the rotational orientation of the distal end of the access device  20  and the needle relative to a target. 
     Embodiments 
     A. A catheter comprising: a first lumen; and a second lumen adjacent to the first lumen; wherein material of the catheter occupies an arc around the first lumen, wherein the arc is greater than 180° and less than 360°, thus creating a lengthwise opening to the first lumen. 
     B. The catheter of A, wherein the catheter material surrounds the second lumen in a cross-sectional dimension. 
     C. The catheter of A or B, wherein the second lumen has s smaller inner diameter than the first lumen. 
     D. The catheter of any of A-C, wherein the catheter is configured to be slidably received within a working channel of an endoscope. 
     E. The catheter of any of A-D, wherein the second lumen is configured to slidably receive a medical device. 
     F. The catheter of any of A-E, wherein the first lumen is configured to receive an imaging device. 
     G. The catheter of F, wherein the imaging device comprises a radial ultrasound probe. 
     H. The catheter of any of A-G, wherein the lengthwise opening of the first lumen is defined by a first flexible edge and a second flexible edge, wherein a first chord measurement between the first and second edges has a first value when the imaging device is not occupying the first lumen, wherein a second chord measurement between the first and second edges has a second value when the imaging device is occupying the first lumen, wherein the first chord measurement is less than the second chord measurement. 
     I. The catheter of H, wherein the first and second edges exhibit a snap-like action upon receiving the imaging device. 
     J. A catheter system comprising: a flexible shaft comprising: a first lumen; and a second lumen adjacent to the first lumen; wherein material of the catheter occupies an arc around the first lumen, wherein the arc is greater than 180° and less than 360°, thus creating a lengthwise opening to the first lumen; a cap portion configured to be received at a distal end of the flexible shaft, the cap portion comprising: a first lumen; and a second lumen; and a handle device configured to attach to a proximal end of the flexible shaft, the handle device comprising: a first access port; a second access port; a first lumen in communication with the first access port; and a second lumen in communication with the second access port, wherein the first lumen of the handle device is colinear with the first lumen of the flexible shaft and the second lumen of the handle device is colinear with the second lumen of the flexible shaft. 
     K. The catheter system of J, wherein the catheter material surrounds the second lumen in a cross-sectional dimension. 
     L. The catheter system of J or K, wherein the second lumen is smaller than the first lumen. 
     M. The catheter system of any of J-L, wherein the catheter is configured to be slidably received within a working channel of an endoscope. 
     N. The catheter system of any of J-M, wherein the second lumen of the flexible shaft and the second access port and the second lumen of the handle device are configured to slidably receive a medical device. 
     O. The catheter system of any of J-N, wherein the first lumen of the flexible shaft and the first access port and the first lumen of the handle device are configured to receive an imaging device. 
     P. The catheter system of  0 , wherein the imaging device comprises a radial ultrasound probe. 
     Q. The catheter system of any of J-P, wherein the lengthwise opening of the first lumen is defined by a first flexible edge and a second flexible edge, wherein a first chord measurement between the first and second edges has a first value when the imaging device is not occupying the first lumen of the flexible shaft, wherein a second chord measurement between the first and second edges has a second value when the imaging device is occupying the first lumen of the flexible shaft, wherein the first chord measurement is less than the second chord measurement. 
     R. The catheter system of Q, wherein the first and second edges exhibit a snap-like action upon receiving the imaging device. 
     The description of the invention is merely exemplary in nature and variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.