Medical systems, devices, and related methods

Abstract

According to one aspect, a method of removing material from a body lumen is disclosed. The method may include disposing a first medical device within the body lumen, and expanding an expandable member at a distal portion of the first medical device from a contracted state to an expanded state. The expandable member may abut the body lumen in the expanded state. The method may further include providing a fluid to a fluid lumen of the first medical device, the fluid being deployed within the body lumen, applying an ultrasonic signal from a second medical device to the first medical device, and moving the first medical device distally through the body lumen while the expandable member is in the expanded state to remove material from the body lumen.

Description

[Technical field]

[0001] Various aspects of the present disclosure relate generally to the manipulation of bodily matter, including visualization, washing, cleaning, and other manipulation of bodily matter. More particularly, at least certain embodiments of the present disclosure relate to systems, devices, and associated methods for performing ultrasonic endoscopic procedures, among other aspects. [Background technology]

[0002] Advances in technology have enabled users of medical systems, devices, and methods to perform increasingly complex procedures on subjects. Diseases and other conditions of the gallbladder, pancreas, and bile ducts (e.g., the pancreaticobiliary system) are associated with reduced quality of life, significant morbidity, and mortality. The pancreaticobiliary system can develop tumors, injuries, leaks, blockages, lesions, and other problems, which can lead to diseases such as biliary colic, cholecystitis, choledocholithiasis, pancreatitis, pancreatic duct stones, chronic abdominal pain, and other problematic health conditions. In some cases, diseases of the pancreaticobiliary system can be associated with nutritional disorders, such as malnutrition, obesity, and high cholesterol.

[0003] Biliary stones are a disease that affects millions of patients each year. ERCP (endoscopic retrograde cholangiopancreatography) is currently the standard of care and is preferable to open surgery, but it comes with its own drawbacks and risks. ERCP procedures usually require a sphincterotomy to access the bile duct, which can cause inflammation or pancreatitis at the site. Fluoroscopy is commonly used to aid in visualization, but this poses health risks and requires the use of large, specialized equipment. Smaller stone fragments or biliary sludge may go undetected, despite being associated with approximately 20-40% of cases of acute pancreatitis.

[0004] There is a need for systems, devices and methods designed to manipulate bodily matter, particularly for use in treating the pancreaticobiliary system. Summary of the Invention

[0005] Aspects of the present disclosure relate, inter alia, to systems, devices, and methods for treating the pancreaticobiliary system. Each of the aspects disclosed herein may include one or more of the features described in association with any of the other disclosed aspects.

[0006] According to one aspect, a method of removing material from a body lumen is disclosed. The method may include disposing a first medical device within the body lumen, and expanding an expandable member at a distal portion of the first medical device from a retracted state to an expanded state. The expandable member may abut the body lumen in the expanded state. The method may further include providing a fluid to a fluid lumen of the first medical device, the fluid being deployed within the body lumen, applying an ultrasonic signal from a second medical device to the first medical device, and moving the first medical device distally through the body lumen while the expandable member is in the expanded state to remove material from the body lumen.

[0007] In other aspects, the method may include one or more of the following features: The fluid lumen may be fluidically coupled to a plurality of openings at a distal end of the first medical device, at least one opening may be elliptical and at least one opening may be circular. The first medical device may include at least one echogenic feature. The method may further include placing a guidewire within the body lumen and moving the first medical device along the guidewire. The expandable member may be configured to expand radially outward from a central longitudinal axis of the medical device. The first medical device may include a cap at a distal end of the first medical device, the fluid lumen of the first medical device being closely connected to an internal channel of the cap, and applying fluid to the fluid lumen of the first medical device rotates the cap about the central longitudinal axis of the first medical device. The expandable member may be a first expandable member, and the method may include, after providing fluid to the fluid lumen of the first medical device, expanding a second expandable member at a distal portion of the first medical device from a contracted state to an expanded state, the second expandable member abutting the body lumen in the expanded state and disposed distal to the first expandable member.

[0008] In other aspects, the method may include one or more of the following features: the first expandable member may be at an angle to a central longitudinal axis of the medical device when in the expanded state, and a radially outermost portion of the first expandable member may be distal to a radially innermost portion of the first expandable member when in the expanded state; the second expandable member may be in contact with the first expandable member when each of the first and second expandable members is in the expanded state; the second medical device may be disposed outside the body lumen; the expandable member may be a first expandable member coupled to a first shaft, and the method may further include expanding a second expandable member coupled to a second shaft disposed within the first shaft from a contracted state to an expanded state, and moving the second expandable member distally relative to the first expandable member. The moving of the second expandable member distally relative to the first expandable member can be caused at least in part by pressure from a fluid in a space between the first and second expandable members in the body lumen. The first and second expandable members can each form a seal with the body lumen. A distal opening of the fluid lumen is disposed between the first and second expandable members. The body lumen can be a common bile duct of the patient, and placing the first medical device can include entering the common bile duct through an opening made in the common bile duct.

[0009] In other aspects, a method for removing material from a body lumen of the pancreaticobiliary system may include disposing a first medical device within the body lumen, and expanding an expandable member at a distal portion of the first medical device from a retracted state to an expanded state. The first expandable member may abut the body lumen in the expanded state. The method may include providing a fluid to a fluid lumen of the first medical device to cause rotation of a cap at a distal end of the first medical device and dispersing the fluid radially outward from the first medical device in a plurality of directions, and applying an ultrasonic signal from a second medical device to the first medical device. In some aspects, the cap may include at least one echogenic feature and a fluid exit channel, and the fluid exit channel may extend to a radially outermost portion of the cap relative to a central longitudinal axis of the first medical device.

[0010] In other embodiments, the medical device may include a shaft including a working channel and at least one fluid lumen, an expandable member at a distal portion of the shaft, and at least one echogenic feature disposed at the distal portion of the shaft. In some embodiments, the expandable member may be a first expandable member, the shaft may be a first shaft, and the device may further include a second shaft extending from a distal end of the first shaft through the working channel, the second shaft being longitudinally movable relative to the first shaft, and the second expandable member disposed at a distal end of the second shaft. A distal opening of the at least one fluid lumen may be disposed between the first expandable member and the second expandable member. In some embodiments, the device may further include a first fluid channel fluidly coupled to the first expandable member, and a second fluid channel fluidly coupled to the second expandable member. Transitioning the first expandable member from the contracted state to the expanded state can include supplying fluid from a first fluid channel to an interior of the first expandable member, and transitioning the second expandable member from the contracted state to the expanded state can include supplying fluid from a second fluid channel to an interior of the second expandable member.

[0011] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. [Brief description of the drawings]

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1] FIG. 1 is a perspective view of a distal end of an exemplary medical device system within a body lumen, according to an embodiment of the present disclosure. [Diagram 2] 2 is a perspective view of a patient's body portion and a distal end of the exemplary medical device system of FIG. 1 according to an embodiment of the present disclosure. [Figure 3A] 3A and 3B are side views of a portion of an exemplary medical device within a body lumen, according to an embodiment of the present disclosure. [Figure 3B] 3A and 3B are side views of a portion of an exemplary medical device within a body lumen, according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a front view of a distal end of an exemplary medical device according to an embodiment of the present disclosure. [Diagram 5] FIG. 5 is a perspective view of a distal end portion of an exemplary medical device according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a perspective view of a distal end portion of an exemplary medical device with a distal end cap removed, according to an embodiment of the present disclosure. [Figure 7] FIG. 7 is a front cross-sectional view of the exemplary medical device of FIG. 5 according to an embodiment of the present disclosure. [Figure 8] FIG. 8 is a side cross-sectional view of the exemplary medical device of FIG. 5 according to an embodiment of the present disclosure. [Figure 9A] 9A and 9B are side views of a distal portion of an exemplary medical device system within a body lumen, according to an embodiment of the present disclosure. [Figure 9B]9A and 9B are side views of a distal portion of an exemplary medical device system within a body lumen, according to an embodiment of the present disclosure. [Figure 10] FIG. 10 is a side view of a portion of a medical device system according to an embodiment of the present disclosure. [Figure 11] FIG. 11 is a side view of the medical device system of FIG. 10 within a body lumen, according to an embodiment of the present disclosure. [Figure 12] 12-15 are side views of the exemplary medical device system of FIG. 10 within a body lumen, according to an embodiment of the present disclosure. [Figure 13] 12-15 are side views of the exemplary medical device system of FIG. 10 within a body lumen, according to an embodiment of the present disclosure. [Figure 14] 12-15 are side views of the exemplary medical device system of FIG. 10 within a body lumen, according to an embodiment of the present disclosure. [Figure 15] 12-15 are side views of the exemplary medical device system of FIG. 10 within a body lumen, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The present disclosure relates, inter alia, to systems, devices, and methods for treating the pancreaticobiliary system. Although examples of the disclosure focus on the pancreaticobiliary system and its various ducts / lumens, aspects of the disclosure may be applied to any other body lumen, including any lumen of the gastrointestinal system, urinary system, and the like. Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part of the device that is furthest from the user when introducing the device into a patient. In contrast, the term "proximal" refers to the part of the device that is closest to the user when placing the device within a patient. The proximal and distal directions are indicated throughout the drawings with arrows labeled "D" for the distal direction and "P" for the proximal direction. As used herein, the terms "comprises," "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal."

[0014] Embodiments of the present disclosure may be used to visualize and move targeted bodily matter in the endo-luminal space or to facilitate the process. In particular, some embodiments include ultrasound visualization devices and tissue cleaning catheter devices.

[0015] Endoscopic ultrasound procedures are performed with a specialized endoscope or other medical device that uses high-frequency sound waves to visualize nearby structures. One advantage of using endoscopic ultrasound is the ability to "see" through walls without the need for access, making it a safer alternative to fluoroscopy.

[0016] The catheter device may be delivered to the target tissue through an endoscope working channel over a guidewire to the target tissue site. One or more fluid jets of the catheter device may propel fluid toward the bodily matter and remove the matter from the body lumen. An expandable portion of the catheter device may move the matter through the body lumen to facilitate its removal. All or a portion of the catheter device may be formed from any biocompatible material, such as shape memory polymers, polymers, metals, plastics, and / or shape memory metals (such as Nitinol), or any combination of materials.

[0017] FIG. 1 illustrates a medical device system 103 within a patient's body lumen 104. The medical device system 103 may include a medical device 100 and a guidewire 106. In some examples, the medical device system 103 may further include an endoscope 200 (shown in FIG. 2) or other medical devices (e.g., a ureteroscope, bronchoscope, duodenoscope, colonoscope, sheath, etc. for delivering the device 100 to a treatment site). The medical device 100 may be a catheter and may include a longitudinal shaft 101, a distal end portion 102, and a proximal portion (not shown in FIG. 1). The proximal portion of the medical device 100 may include one or more actuators, a handle, and / or one or more input ports for fluid, pneumatic, electrical, or other connections to the medical device 100.

[0018] The shaft 101 may include a working channel 118 extending longitudinally through the interior of the shaft 101 from the distal end portion 102 to a proximal portion of the shaft 101. The working channel 118 may be a cylindrical lumen configured to receive a guidewire 106, and the shaft 101 may be configured to move along the guidewire 106 to a target area within a patient's body. Although the working channel 118 is shown extending through a central portion of the shaft 101 and leading to a distal opening 116 at a central portion of the distal end portion 102, the working channel 118 may extend longitudinally through any portion of the shaft 101. The shaft 101 may include one or more echogenic features 133, such as a curved recess extending circumferentially about a central longitudinal axis 135 of the shaft 101. In other examples, one or more echogenic features 133 may include a recess formed in shaft 101 via a secondary heat forming process, such as branding shaft 101 or using a waffle iron. In some examples, echogenic feature 133 may include a coil, such as a metal wire coil or a coil of any other suitable material, extending around a radially outer surface of shaft 101 relative to longitudinal axis 135. In some examples, shaft 101 may include a combination of a recess in a radially outer surface of shaft 101 and a coil extending around a radially outer surface of shaft 101 relative to longitudinal axis 135. Echogenic feature 133 forms an exterior radius of curvature in a radially outer surface of shaft 101 relative to longitudinal axis 135, which may facilitate positioning a portion of the radially outer surface of shaft 101 perpendicular to an endoscope transducer. The echogenic features 133 can facilitate changing the angle of reflection of the ultrasound signal, allowing the ultrasound signal to reflect back towards the endoscope ultrasound transducer during operation.

[0019] The distal end portion 102 of the medical device 100 may also include an expandable member 120. The expandable member 120 may extend circumferentially around a radially outer surface of the shaft 101 relative to the axis 135 and may be fixedly coupled to the shaft 101 at its most distal end 122 and its most proximal end 124. The expandable member 120 may be generally cylindrical and may be adjacent to the radially outer surface of the shaft 101 relative to the axis 135 when in a contracted state. The expandable member 120 may be expanded radially outward relative to the axis 135 and may form a curved protrusion from the shaft 101. The expandable member 120 may be fluidly connected to the fluid lumen 119 and may be expanded by moving fluid into the expandable member 120 via the fluid lumen 119. The fluid lumen 119 may extend longitudinally through the shaft 101 and may be fluidly connected to a fluid source at a proximal portion of the medical device 100. In some examples, the expandable member 120 may be a balloon, either compliant or non-compliant. The expandable member 120 may be configured to conform to a radially inward surface of the body lumen to form a seal between the expandable member 120 and the wall of the body lumen 104, for example, to prevent movement of matter 108 (such as tissue, stones, slugs, or other debris) past the expandable member 120 and through the body lumen 104. For example, the expandable member 120 may form a seal with a radially inward surface (or wall) of the body lumen 104 such that matter 108 may be prevented by the expandable member 120 from moving proximally through the body lumen 104. The exterior surface of the expandable member 120 may be smooth, may be configured to be atraumatic, and may be configured to slide across the wall of the body lumen 104 when the expandable member 120 is in an expanded state. Although the expandable member 120 is shown with a circular shape when in the expanded configuration (shown in FIG. 1 ), the expandable member 120 is not so limited and may expand into any suitable shape to seal the body lumen 104 and prevent movement of the material 108 in a proximal direction therethrough.In some examples, when fluid is removed from the expandable member 120, such as when suction is applied to the fluid lumen 119 to remove fluid from within the expandable member 120, the expandable member can be configured to contract and move the expandable member 120 to a position adjacent to a radially outer surface of the shaft 101. For example, the expandable member 120 can be made of a resilient material.

[0020] The distal end portion 102 may include a curved, distal-most tip 136 configured to be atraumatic. In other examples, the distal-most tip 136 may not be curved and may be any suitable shape. The distal end portion 102 may include one or more fluid jet lumens 110, 112, 114. In some examples, all of the lumens 110, 112, 114 may be connected to a single fluid lumen extending longitudinally through the shaft 101. The lumens 110, 112, 114 may be configured to propel fluid out of the distal end of the medical device 100. In some examples, the lumens 110, 112, 114 may be configured to eject fluid from the distal portion 102 at an angle relative to the axis 135. In some examples, the lumens 110, 112, 114 may be configured to eject fluid outwardly from the medical device 100 in multiple directions that are angled relative to the axis 135. For example, the fluid emitted from the lumens 110, 112, 114 may form a cone shape 126, shown in dotted lines in FIG. 1. Ejecting the fluid at an angle toward the wall of the body lumen 104 may facilitate removal of the material 108 from the body lumen 104. In some examples, the lumens 110, 112, 114 may emit saline or specific enzymes configured to break down tissue (e.g., stones), such as choleresterase enzymes. In other examples, the fluid lumens 110, 112, 114 may be configured to emit bubbles to facilitate coating of the walls of the body lumen 104. In some examples, the fluid lumens 110, 112, 114 may be configured to induce gas bubbles in the fluid to facilitate visualization of the ductal structures using ultrasound imaging techniques. For example, to induce bubbles or gas bubbles in a fluid spray, one of the fluid lumens 110, 112, 114 may be configured to receive a gas, which may then be combined with a liquid solution in another fluid lumen 110, 112, 114 at a small internal reservoir or an intersection with another fluid lumen 110, 112, 114 (not shown). This gas / liquid combination is then sprayed out of one or more openings in the fluid lumen 110, 112, 114 to generate the bubbles or gas-filled solution.

[0021] FIG. 2 illustrates the medical device system 103 positioned within a patient's body. The body portion illustrated in FIG. 2 includes portions of the pancreaticobiliary system, including the pancreas 261, liver 275, stomach 252, gallbladder 258, duodenum 254 (the upper part of the small intestine just downstream of the stomach), and common bile duct 260. The direction of fluid flow (downstream) in the pancreaticobiliary system is indicated by straight arrows throughout FIG. 2. The common bile duct 260 and pancreatic duct drain from the liver 275, gallbladder 258, and pancreas 261 to the duodenum 254. In some cases, the common bile duct 260 may be blocked as a result of a cyst, enlarged lymph nodes, gallstones, inflammation, strictures, or narrowing of the duct due to scarring, surgical injury, tumor, or other causes, resulting in insufficient drainage of bile and other materials through the common bile duct 260. The medical device system 103 can facilitate removal of material from the common bile duct 260 to improve drainage from the common bile duct 260. Some features of the medical device 100 have been omitted in Figure 2 solely for ease of illustration, and the medical device 100 of Figure 2 includes all of the attributes shown in Figure 1.

[0022] In operation, the medical device system 103 may include the medical device 100, a guidewire 106, and an insertion device, such as an endoscope 200 shown in FIG. 2. A user, who may be a doctor, nurse, physician assistant, or any other medical professional, may first place the guidewire 106 within the patient's body through the stomach 252, the duodenum 254, and the common bile duct 260. Specifically, the guidewire 106 may extend through an opening formed in the wall of the duodenum 254, from a distal end 288 of the common bile duct 260 to an opening 287 formed in the wall of the common bile duct 260 proximal (e.g., proximal from the ampulla of Vater), and through the common bile duct 260 into the duodenum 254. By placing the guidewire 106 in the opening 287, the bile duct 260, and the duodenum 254, the medical device 100 can access the common bile duct 260 from an antegrade access point and move through the common bile duct 260 in the same direction as fluid flow through the common bile duct 260 as the medical device 100 moves distally along the guidewire 106. Moving the medical device 100 through the common bile duct 260 in the same direction as the fluid flow can facilitate removal of debris from the common bile duct 260 as debris can be pushed through one or more fluid jets of the medical device 100 in the same direction as the fluid flow.

[0023] Once the guidewire 106 is positioned within the opening 287, the common bile duct 260, and the duodenum 254, the user can position the endoscope 200 within the duodenum 254 by placing the guidewire 106 within the working channel 231 of the endoscope 200 and moving the endoscope 200 distally along the guidewire 106 through the stomach 252 and the duodenum 254. In some examples, the guidewire 106 may already be positioned within the working channel 231 prior to and during placement of the guidewire 106 within the opening 287. The direction of movement of the endoscope 200 may be guided by the guidewire 106. Throughout the procedure, the user can apply an ultrasound signal 250 via a transducer of the endoscope 200 to visualize the medical device 100 through one or more organ walls. The user can monitor the position of the medical device 100 via ultrasound imaging.

[0024] Once the endoscope 200 is positioned within the duodenum 254 proximate to the common bile duct 260, the user can then move the medical device 100 through the working channel 118 with the guidewire 106 positioned within the working channel 231 of the medical device 100. As the user moves the medical device 100 distally from the working channel 231, the medical device 100 can move along the guidewire 106 out of the duodenum 254, through the opening 287, and into the common bile duct 260. The user can then expand / inflate the expandable member 120, for example, by applying a fluid flow to the fluid lumen 119 to fill the expandable member 120 with fluid. By expanding the expandable member 120, the medical device 100 can form a seal with the inner wall of the common bile duct 260 to prevent the movement of debris proximally or upstream within the common bile duct 260. For example, the formed seal of the medical device 100 can prevent the movement of debris proximally of the opening 287. The user can then apply fluid to the fluid lumens 110, 112, 114 to expel the fluid onto the inner wall and lumen of the common bile duct 260.

[0025] When the expandable member 120 is in the expanded state, the expandable member 120 can function as an anchor coupling the distal portion 102 of the medical device 100 to the common bile duct 260, which can facilitate maintaining a stable position of the medical device 100 while applying fluid to the common bile duct 260 from the fluid lumens 110, 112, 114. Expanding the expandable member 120 to the expanded state can also prevent the medical device 100 from migrating into smaller duct branches during a procedure. Fluid released from the fluid lumens 110, 112, 114 can clear debris from the walls of the common bile duct 260 and move the debris downstream toward the duodenum 254. The user can then push the medical device distally (e.g., downstream) while the expandable member 120 is in the expanded state, and a radially outer portion of the expandable member 120 will remain in contact with, and can effectively slide across, the inner wall of the common bile duct 260 as the medical device 100 moves distally. After removing or flushing debris (such as material 108) from the common bile duct 260, the user can release the expandable member 120 from contacting the inner wall of the common bile duct 260 by contracting the expandable member 120. The user may then remove the medical device 100, the endoscope 200, and the guidewire 106 from the patient's body.

[0026] 3A and 3B show an alternative embodiment of a medical device 300 disposed within a body lumen 360. The medical device 300 may include any of the features of the medical device 100 described herein. The medical device 300 may include a shaft 301, echogenic features 341-344, an expandable member 320, fluid lumens 310, 312, 314, and a working channel 316. In the medical device 300, the echogenic features 341-344 are longitudinally spaced apart from one another. The echogenic features 341-343 are disposed proximally from the expandable member 320, and the echogenic feature 344 is disposed distally from the expandable member 320. The fluid lumens 310, 312, 314 project fluid 326 radially outward from the longitudinal axis of the medical device 300 toward an inner wall 370 of the body lumen 360. FIG. 3A shows the expandable member 320 in a contracted state. In some examples, the expandable member 320 may contact the shaft 301 along the entire length of the expandable member 120. FIG. 3B shows the expandable member 320 in an expanded state, with a portion of the expandable member 320 spaced away from the shaft 301 and a portion of the expandable member 320 in contact with the inner surface 370 of the body lumen 360. As the expandable member 320 expands radially outward from the shaft 301 in all directions, the expandable member 320 can form a seal with the body lumen 360 and prevent debris from migrating past the expandable member 320 within the body lumen 360. In the expanded state, the expandable member 320 can secure the medical device 300 to the body lumen 360 and prevent the medical device 300 from moving toward the inner surface 370 of the body lumen 360.

[0027] 4 illustrates an alternative distal end 402 of a medical device 401. The medical device 401 may have any of the features of the medical device 100 described herein. The medical device 401 may include a working channel 415 extending longitudinally through the medical device 401 and fluid lumen openings 410, 412, 414, 416. The fluid lumen openings 414, 416 may be circular, and the fluid lumen openings 410, 412 may be elliptical, arcuate, and concave toward the working channel 416. The fluid lumen openings 410, 412 may emit a wider fluid jet than the fluid lumen openings 414, 416, which may facilitate removal of debris from the inner wall of the common bile duct 260.

[0028] FIG. 5 illustrates a distal portion 502 of an alternative embodiment of a medical device 500. The medical device 500 may have any of the features of any of the medical devices 100, 300 described herein. The medical device 500 may include a shaft 501, echogenic features 540-545, a working channel 517, and a cap 570. As shown in FIG. 6, the cap 570 may be removable, may include one or more echogenic features 545, 546, and may be coupled to the shaft 501 at a protrusion 562 and a flange 563 of the shaft 501. The protrusion 562 may extend distally from the shaft 501, and the flange 563 may extend radially outward from the protrusion 562 relative to an axis 599. In some examples, the flange 563 can include a chamfered edge portion 561 extending circumferentially around the flange 563, which can facilitate coupling the cap 570 to the shaft 501. The working channel 517 of the cap 570 can be aligned with the working channel 516 of the shaft 501 when the cap 570 is coupled to the shaft 501. The cap 570 can be configured to rotate about a central longitudinal axis 599 of the shaft 501 when the cap 570 is coupled to the shaft 501. A slot 584 in a proximal end portion of the cap 570 can facilitate coupling the cap 570 to the shaft 501, for example, by allowing a proximal portion of the cap 570 to flex radially outward to allow the cap 570 to receive the flange 563.

[0029] 7 shows a front cross-sectional view of the cap 570 coupled to the shaft 501. As shown in FIG. 7, the working channel 517 aligns with the working channel 516 when the cap 570 is coupled to the shaft 501. The cap 570 may include a circular channel 582 configured to receive fluid from the fluid lumen 514 of the shaft 501. The circular channel 582 may be fluidly connected to a side jet channel 580. The side jet channel 580 may extend from the circular channel 582 to an outer surface of the cap 570. The side jet channel 580 may extend at an angle relative to the circular channel 582.

[0030] 8 shows a side cross-sectional view of the distal portion 502 of the medical device 500 with the cap 570 coupled to the shaft 501. The fluid lumen 514 may extend longitudinally through the shaft 501 and the protrusion 563, and the opening 594 (shown in FIG. 7) of the fluid lumen 514 may be aligned with the channel 582 when the cap is coupled to the shaft 501. The circular flange 595 of the cap 570 may extend radially inward toward the working channel 517 / 516, and the circular flange 595 may extend between the flange 563 and the distal end face 596 of the shaft 501. In some examples, the circular flange 595 may include a chamfer that facilitates coupling the cap 570 to the shaft 501, for example, by facilitating radial expansion of a proximal portion of the cap 570 when a user presses the cap 570 onto the protrusion 562. A seal may be formed between the distal most end of projection 562 / flange 563 and cap 570, preventing fluid from migrating out of circular channel 582 except through side jet channel 580. Circular flange 595 may prevent cap 570 from moving distally relative to shaft 501 during operation.

[0031] When fluid is provided to the fluid lumen 514, the fluid can exit the fluid lumen 514 into the circular channel 582 and pass through the side jet channel 580. An opening 515 in the side jet channel 580 allows the fluid to flow from the circular channel 582 into the side jet channel 580. The side jet channel 582 is angled relative to the circular channel 582 so that the force of the fluid flowing through the side jet channel 582 can rotate the cap 570 relative to the shaft 501 about the axis 599. As shown by the arrow 581 in FIG. 7, the cap 570 can rotate counterclockwise as the fluid flows through the circular channel 582 and the side jet channel 580. As the cap 570 is rotated by the force of the fluid flowing through the circular channel 582 and the side jet channel 580, the cap 570 ejects fluid from the side jet channel 580 in all directions radially outward from the axis 599. The cap 570 can provide a sprinkler effect by propelling fluid outwardly from the side jet channels 580. By providing the medical device 500 with a rotating cap 570, the medical device 500 does not require multiple fluid lumens.

[0032] 9A and 9B show an alternative embodiment of a medical device 900 disposed within a body lumen 960, with a guidewire 906 disposed within a working channel of the medical device 900. The medical device 900 may include a shaft 901, an expandable member 920, 922, a fluid lumen 912, and a working channel 917. The medical device 900 may include any of the features described herein with respect to the medical devices 100, 300, and 500. The expandable member 920 may be disposed proximally from the expandable member 922, which may be cone-shaped when in an expanded state. FIG. 9A shows the expandable member 920 in an expanded state and the expandable member 922 in a contracted state. 9A, the expandable member 920 may extend radially outward from a central longitudinal axis 999 of the shaft 901 and may be angled relative to the axis 999 such that a radially outermost portion of the expandable member 920 is distal to a radially innermost portion of the expandable member 920. Because the expandable member 920 is cone-shaped and angled relative to the axis 999, filling the body lumen 960 with fluid may push the expandable member 920 proximally and further radially outward from the axis 999, thus increasing the pressure applied to the body lumen 960 by the expandable member 920. Increasing the pressure applied to the body lumen 960 by the expandable member 920 may hold the medical device 900 in place even while pressure is applied to the medical device 900 from fluid filling the body lumen 960 distal to the expandable member 920. The expandable member 922 can be disposed adjacent to the expandable member 920, and the expandable member 922 can uniformly expand radially outward from the axis 999. In some examples, the expandable member 922 can be configured to abut (contact) the expandable member 920 when each of the expandable member 920 and the expandable member 922 is in an expanded state.

[0033] In operation, after placing the medical device 900 in the body lumen 960, the user may first expand the expandable member 920. In some examples, the user may expand the expandable member 920 to a position where the expandable member 920 abuts the body lumen 960 and forms a seal around the inner wall 970 of the body lumen 960. When the expandable member 920 is in the expanded state (shown in FIGS. 9A and 9B ), fluid may be prevented from moving proximally through the body lumen 960 beyond the expandable member 920. Once the expandable member 920 is in the expanded state, the user may then move fluid from the fluid lumen 912 to the body lumen 960, such as by actuating an actuator at a proximal portion of the medical device 900 to apply fluid to the fluid lumen 912. In some examples, the user may move the shaft 901 proximally or distally to distribute fluid from the fluid lumen 912 throughout the body lumen 960. After filling all or a portion of the body lumen 960 distal from the expandable member 920, the user can facilitate movement of fluid within the body lumen 960 to the duodenum 954 by expanding the expandable member 922. By expanding the expandable member 922 while the expandable member 920 is in an expanded state, fluid can be forced distally through the body lumen 960 and into the duodenum 954. Expanding the expandable member 922 while the expandable member 920 is in an expanded state can also facilitate movement of matter 908 (e.g., debris, tissue, stones, etc.) from the body lumen 960 to the duodenum 954. In some examples, the user may push the medical device 900 distally to assist in moving fluid and matter 908 distally through the body lumen 960. The user may then deflate the expandable member 922, which may relieve pressure in the body lumen 960 generated from both the expandable member 920 and the expandable member 922. After deflation of the expandable member 922, the user may deflate the expandable member 920 and move the medical device 900 distally through the body lumen 960 and repeat the steps described above if necessary to remove additional material 908 from the lumen 960. The user may then remove the medical device 900 from the patient's body.

[0034] 10 illustrates a distal portion of an alternative embodiment of a medical device 1000 for removing debris from a body lumen 1160. The medical device 1000 may have any of the features described herein in connection with any of the other medical devices 100, 300, 500, 900. The medical device 1000 may include a main shaft 1053 extending longitudinally to an expandable member 1054 and a distal end 1053' of the main shaft 1053. The expandable member 1054 may extend circumferentially around the main shaft 1053 and may be disposed proximate the distal end 1053' of the main shaft 1053. The fluid channel 1055 may extend longitudinally adjacent to the main shaft 1053, may be integral with the main shaft 1053, and / or may extend within the main shaft 1053. The fluid channel 1055 can be fluidly coupled to the expandable member 1054 and configured to supply fluid to the expandable member 1054. The main shaft 1053 can include a working channel 1019 extending longitudinally through the main shaft 1053. The working channel 1019 can be configured to receive the plunger shaft 1062 and the fluid channel 1052, which can move proximally and distally through the working channel 1019. The main shaft 1053 can further include a fluid channel 1061 extending within the main shaft 1053, which can be configured to supply fluid to a distal region of the expandable member 1054.

[0035] The plunger shaft 1062 may extend longitudinally through the main shaft 1053 and exit at a distal end 1053′ of the main shaft 1053. The second expandable member 1051 may be coupled to the distal end of the plunger shaft 1062. The working channel 1017 may extend longitudinally through the plunger shaft 1062 and may be configured to receive the guidewire 1006. The fluid channel 1052 may extend longitudinally adjacent to the plunger shaft 1062 and may be fluidly connected to the second expandable member 1051. In other examples, the fluid channel 1052 may be integral with and / or within the plunger shaft 1062. In some examples, the plunger shaft 1062, the fluid channel 1052, and the second expandable member 1051 can be configured to move through the working channel 1019 when the second expandable member 1051 is in a contracted state. The second expandable member 1051 can be configured to expand radially outward from a central longitudinal axis 1099 of the plunger shaft 1062. The expandable member 1054 can transition from a contracted state to an expanded state when fluid is supplied from the fluid channel 1055 to the expandable member 1054, and the second expandable member 1051 can transition from a contracted state to an expanded state when fluid is supplied from the fluid channel 1052 to the second expandable member 1051.

[0036] 11-15 illustrate an exemplary method for removing material from a body lumen 1160 using the medical device 1000. A user can first place a guidewire 1006 into a target body lumen 1160, such as the common bile duct 260. The user can then place the guidewire 1006 into the working channel 1017 and move the medical device 1000 distally along the guidewire 1006 into the target body lumen 1160. Once a distal portion of the medical device 1000, including the expandable members 1051, 1054 and the distal end 1053', is positioned within the body lumen 1160 (shown in FIG. 11), the user can then expand each of the expandable members 1051, 1054. FIG. 12 illustrates both expandable members 1051, 1054 in an expanded state, with each of the expandable members 1051, 1054 in contact with the body lumen 1160. Each of the expandable members 1051, 1054 may contact the body lumen 1160 around a radially outer surface of each expandable member 1051, 1054 relative to the central longitudinal axis 1099 and may form a seal around a portion or the entire circumference of the body lumen 1160.

[0037] Once both expandable members 1051, 1054 are in the expanded state, a user can apply fluid to the fluid channel 1061 to move fluid into the space in the body lumen 1160 between the expandable members 1051 and 1054. As fluid from the fluid lumen 1061 collects in the body lumen 1160, pressure is exerted in the body lumen 1160 from the fluid in the space between the expandable members 1051 and 1054, which pressure can move the expandable member 1051 distally relative to the expandable member 1054. FIGS. 13 and 14 show the distal movement of the expandable member 1051 relative to the expandable member 1054 as the fluid channel 1061 continues to supply fluid to the body lumen 1160. As the expandable member 1051 moves distally, material 1008 within the body lumen 1160 may be moved distally and pushed out of the body lumen 1160, for example, into a larger body lumen 1154 (e.g., the duodenum) connected to the body lumen 1160. The expandable member and / or shaft 1053 can remain in a fixed position as the expandable member 1051 and shaft 1062 move distally, and in some examples, the expandable member 1054 can form a seal with the body lumen 1160 to hold the expandable member 1054 in a fixed position while the expandable member 1051 moves distally. In some examples, the expandable member 1051 can be stopped when the expandable member 1051 reaches a narrower region 1088 (shown in FIG. 14 ) of the body lumen 1160. Once the desired amount of debris 1008 has been removed from the body lumen 1160, the user can return the expandable member 1051 to an unexpanded state, allowing fluid collected between the expandable member 1051 and the expandable member 1054 to flow out of the body lumen 1160. The user can then return the expandable member 1054 to an unexpanded state and remove the medical device 1000 from the patient's body.

[0038] Each of the aforementioned devices and systems can be used to visualize, manipulate, cleanse, flush, and / or move bodily matter. Any of the aforementioned devices can be used in conjunction with an insertion device, such as an endoscope or duodenoscope, with ultrasound imaging capabilities. In any of the aforementioned methods, a user can use ultrasound imaging technology to view one or more medical devices, which can be used to remove bile, slugs, or other matter from a patient's common bile duct.

[0039] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed devices and methods without departing from the scope of the disclosure. Other aspects of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as illustrative only.

Claims

1. 1. A medical device comprising: a shaft including a working channel and at least one fluid lumen; an expandable member at a distal portion of the shaft; at least one echogenic feature disposed on the distal portion of the shaft; A medical device comprising:

2. the expandable member is a first expandable member and the shaft is a first shaft; The medical device comprises: a second shaft extending through the working channel and exiting a distal end of the first shaft, the second shaft being longitudinally movable relative to the first shaft; a second expandable member disposed at a distal end of the second shaft; Further equipped with The medical device of claim 1 , wherein a distal opening of the at least one fluid lumen is disposed between the first and second expandable members.

3. a first fluid channel fluidly coupled to the first expandable member; a second fluid channel fluidly coupled to the second expandable member; and 3. The medical device of claim 2, further comprising: transitioning the first expandable member from a contracted state to an expanded state comprising supplying fluid from the first fluid channel to an interior of the first expandable member; and transitioning the second expandable member from a contracted state to an expanded state comprising supplying fluid from the second fluid channel.

4. 10. The medical device of claim 1, wherein the at least one fluid lumen is fluidly coupled to a plurality of openings at a distal end of the medical device, a first opening of at least one of the plurality of openings being oval and a second opening of at least one of the plurality of openings being circular.

5. The medical device of claim 1 , further comprising a guidewire configured to be placed within a body lumen, the medical device being configured to move along the guidewire.

6. The medical device of claim 1 , wherein the expandable member is configured to expand radially outward from a central longitudinal axis of the medical device.

7. 10. The medical device of claim 1, further comprising a cap at a distal end of the medical device, the at least one fluid lumen of the medical device being fluidly connected to an internal channel of the cap, the cap being configured to rotate about a central longitudinal axis of the medical device when fluid is applied to the at least one fluid lumen of the medical device.

8. the expandable member is a first expandable member; 10. The medical device of claim 1, further comprising a second expandable member at a distal portion of the medical device, the second expandable member configured to expand after fluid is provided to a fluid lumen of the medical device, the second expandable member being disposed distal to the first expandable member.

9. 9. The medical device of claim 8, wherein the first expandable member is angled relative to a central longitudinal axis of the medical device when in an expanded state, and a radially outermost portion of the first expandable member is distal to a radially innermost portion of the first expandable member when in an expanded state.

10. The medical device of claim 9 , wherein the second expandable member contacts the first expandable member when each of the first and second expandable members is in an expanded state.

11. the expandable member being a first expandable member coupled to a first shaft; 10. The medical device of claim 1, further comprising a second expandable member configured to be expanded from a contracted state to an expanded state, the second expandable member coupled to a second shaft disposed within the first shaft, the second expandable member configured to be moved distally relative to the first expandable member.

12. 12. The medical device of claim 11, wherein the second expandable member is configured to move distally relative to the first expandable member at least in part due to pressure from a fluid in a space between the first and second expandable members in a body lumen.

13. The medical device of claim 11 , wherein the first and second expandable members are each configured to form a seal with a body lumen.

14. The medical device of claim 10 , wherein a distal opening of the at least one fluid lumen is disposed between the first and second expandable members.

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