DEVICES, SYSTEMS AND METHODS FOR CATHETERS WITH MOVABLE PARTS - Patent application

Abstract

The present disclosure relates generally to the field of medical devices for accessing a body lumen. In one embodiment, a catheter (300) may include a shaft (302) having a proximal end (302p), a distal end (302d), a movable portion (306) proximal to the distal end, and a first lumen extending along the length of the shaft between the proximal end and the distal end. A plurality of slots (310) may be disposed along the movable portion and may be spaced apart from one another. The plurality of slots may extend radially toward the first lumen.

Description

[Technical field]

[0001] The present disclosure relates generally to the field of medical devices for accessing body lumens. In particular, the present disclosure relates to medical devices, systems, and methods for targeted access to one or more body lumens, for example, via a catheter having an actuating portion. [Background technology]

[0002] Medical professionals may face technical difficulties when accessing a body lumen, for example, when performing an endoscopic cannulation procedure that may involve advancing a guidewire and / or an endoscopic device (e.g., a sphincterotome, cannula, catheter, etc.) against, into, or through a tortuous patient tissue structure. For example, the target body lumen (e.g., the biliary sphincter) may be oriented at a difficult angle to the endoscopic device, have a very small or sealed opening, contain tortuous tissue, or have a formed blockage, such as a stone, or a benign or malignant stricture. Precise control of the movement and force of the device and of the guidewire may be difficult. Even experienced medical professionals may require many attempts to successfully open an opening and access a body lumen, especially when dealing with friction and patient-specific pathologies associated with a particular body lumen. The likelihood of causing trauma to tissues including or surrounding the target body passageway may increase with the number of opening or entry attempts. In some instances, the medical professional may abandon the procedure altogether. In another example, traumatized tissue is often prone to post-operative infection. It is with these considerations in mind that the improvements of the present disclosure may be useful. Summary of the Invention

[0003] In one aspect of the disclosure, a catheter can include a shaft having a proximal end, a distal end, a movable portion proximal to the distal end, and a first lumen extending along a length of the shaft between the proximal end and the distal end. A plurality of slots can be aligned along the movable portion and spaced apart from one another, with the plurality of slots extending radially toward the first lumen.

[0004] In various embodiments described herein and otherwise within the scope of the present disclosure, the wire may be coupled to the distal end of the shaft. The wire may extend externally along the movable portion of the shaft. The wire may be disposed within a first lumen proximal to the movable portion. The wire may be disposed across the plurality of slots at a substantial midpoint. Each of the plurality of slots may extend radially through the first lumen. A second lumen may extend through the shaft and the plurality of slots may be external to the second lumen. The wall thickness around the second lumen may be about 0.075 mm or about 0.05 mm to about 0.10 mm. The cross-sectional profile of the plurality of slots transverse to the longitudinal axis along the length of the shaft may include a U-shape, a V-shape, a box shape, or combinations thereof. The axial spacing between each of the plurality of slots along the length of the shaft may be greater than the axial length of each of the plurality of slots. The plurality of slots may be uniformly distributed along the length of the movable portion. The handle may be coupled to the proximal end of the wire. The handle may be configured to move the wire proximally and distally through the first lumen.

[0005] In another aspect of the disclosure, a catheter may include a shaft including a proximal end, a distal end, a central longitudinal axis therethrough, a movable portion proximal to the distal end, and a first lumen extending along the length of the shaft between the proximal end and the distal end. A wire may be coupled to the distal end. The wire may extend external to the shaft along the movable portion. The wire may extend into the first lumen proximal to the movable portion. At least one slot may be disposed along the movable portion. The slot may extend radially toward the first lumen. The slot may be disposed between the central longitudinal axis and the wire.

[0006] In various device embodiments described herein and otherwise within the scope of this disclosure, the slot may extend radially through the first lumen. The second lumen may extend along the length of the shaft. The slot may be external to the second lumen. The wall thickness of the second lumen may be about 0.075 mm or between about 0.05 mm and about 0.10 mm.

[0007] In another aspect, a method of cannulating an opening in a body lumen may include inserting a catheter into a body lumen of a patient. A wire coupled to a distal end of the catheter may be moved proximally. A portion of the catheter may bend toward the opening in the body lumen. The wire may extend through at least a portion of a first lumen of the catheter. The catheter may include a plurality of slots along a movable portion of the catheter, the plurality of slots may extend radially toward the first lumen.

[0008] In various embodiments of the devices and methods described herein and otherwise within the scope of this disclosure, bending the movable portion of the catheter may include decreasing an axial width of each of the plurality of slots. Fluid may be supplied into the body lumen through a second lumen of the catheter. Moving the wire proximally may include pulling the wire toward the handle of the catheter outside of the plurality of slots along the movable portion. A portion of the body lumen may be severed by electrically activating the wire. [Brief description of the drawings]

[0009] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale, in which each identical or nearly identical component shown is typically designated by a single numeral, and for the sake of clarity, not every component is labeled in each figure, nor every component of each embodiment is shown, unless illustration is necessary to enable those skilled in the art to understand the disclosure. [Figure 1A] FIG. 1A shows a perspective view of a catheter in an arcuate configuration, according to one embodiment of the present disclosure. [Figure 1B] FIG. 1B shows a perspective view of an exemplary embodiment of a catheter handle, for use with, for example, the catheter of FIG. 1A. [Diagram 2] FIG. 2 shows a perspective view of a catheter in an arcuate configuration, according to one embodiment of the present disclosure. [Figure 3A] FIG. 3A shows an isometric view of a catheter according to one embodiment of the present disclosure. [Figure 3B] FIG. 3B shows a right side view of the catheter of FIG. 3A. [Figure 3C] FIG. 3C shows a perspective view of the catheter of FIGS. 3A and 3B in an arcuate configuration. [Figure 3D] FIG. 3D shows a cross section of the catheter of FIGS. 3A-3C. [Figure 3E] FIG. 3E shows another cross-section of the catheter of FIGS. 3A-3D. [Figure 4A] FIG. 4A shows a right side view of a slot in a catheter according to one embodiment of the present disclosure. [Figure 4B] FIG. 4B shows a right side view of a slot in a catheter according to one embodiment of the present disclosure. [Figure 4C] FIG. 4C shows a right side view of a slot in a catheter according to one embodiment of the present disclosure. [Diagram 5] 5A and 5B show isometric views of a finite element analysis of a catheter with a slot according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present disclosure is not limited to the specific embodiments described. The terminology used in this specification is for the purpose of describing only specific embodiments, and is not intended to limit beyond the scope of the appended claims. Unless otherwise defined, all technical terms used in this specification have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs.

[0011] Although embodiments of the present disclosure may be described with specific reference to medical devices and systems (e.g., endoscopic devices, accessory tools, and / or guidewires inserted near or through the papilla, etc.) for selectively accessing, cannulating, dilating, and / or resecting along the openings to the common bile duct (CBD) or pancreatic duct (PD) during endoscopic retrograde cholangiopancreatography (ERCP), it should be understood that such medical devices and systems may be used in a variety of medical procedures (including, for example, imaging therapy procedures, balloon angioplasty / angiography procedures, thrombolysis procedures, urological or gynecological procedures, etc.) for guiding one or more devices through the tissue structures of a duct, lumen, blood vessel, or body lumen. Medical devices herein are not limited to use with duodenoscopes, and may include a variety of medical devices for accessing body passages (including, for example, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. devices). The disclosed medical devices and systems may be inserted at a variety of access points and through a variety of approaches, for example, percutaneously, endoscopically, laparoscopically, or a combination thereof.

[0012] As used herein, the singular forms "a," "an," and "the" are intended to indicate the plural as well, unless the context clearly indicates otherwise. The terms "comprises" and / or "comprising" or "includes" and / or "including," as used herein, specify the presence of stated features, regions, steps, elements, and / or configurations, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, configurations, and / or groups thereof.

[0013] As used herein, "proximal end" refers to the end of the device along the device that is closest to the medical professional when introducing the device into a patient, and "distal end" refers to the end of the device or object along the device that is furthest from the medical professional during implantation, positioning, guidance, or delivery.

[0014] As used herein, the conjunction "and" includes each of the structures, configurations, features, etc. so connected, unless the context clearly dictates otherwise, and the conjunction "or" includes one or more of the one or the other of the structures, configurations, features, etc. so connected, singly and in any combination and in any number, unless the context clearly dictates otherwise.

[0015] All numerical values ​​herein are presumed to be modified by the term "about", whether or not expressly indicated. The term "about", in the context of numerical values, generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (i.e., in non-numeric contexts) may be presumed to have the common and accustomed definition(s) as understood from or consistent with the context of the present specification, unless otherwise specified. Recitation of numerical ranges by multiple endpoints includes all numbers within the range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0016] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," and the like, indicate that the described embodiment(s) may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, it will be within the knowledge of one of ordinary skill in the art that when a particular feature, structure, or characteristic is described in connection with one embodiment, it also affects such feature, structure, or characteristic in connection with other embodiments, unless expressly stated to the contrary. That is, it is contemplated that various individual elements described below, even if not explicitly shown in a specific combination, can be combined or arranged with each other to form other additional embodiments or to complement and / or enhance the described embodiment(s), as can be understood by one of ordinary skill in the art.

[0017] To facilitate smooth and effective advancement of the catheter into / through the targeted body lumen, medical professionals may manually rotate, oscillate, linearly advance, and / or reciprocate the catheter to "wiggle" against, into, or through the body lumen. For example, ERCP may be performed by gastroenterologists and surgical endoscopists to diagnose and treat various abnormalities of the pancreaticobiliary system. In such procedures, physicians may use catheters such as sphincterotomes to cannulate openings in the body lumen (e.g., sites such as papillary orifices, CBD, PD, etc.). The catheter may include a guidewire lumen, such that after initial cannulation, a guidewire may be inserted through the guidewire lumen and into the opening of the body lumen (e.g., CBD or PD). The catheter may include a cutting wire for dilating / resecting / accessing tissue to open an access opening (e.g., for sphincterotomy, etc.). Alternatively, the guidewire may precede the catheter and then be used to guide the catheter to and into the opening (e.g., for dilatation in the case of a sphincterotome). The catheter may have a flexible distal end with a movable portion that can be articulated (e.g., bowed, folded, steered, manipulated, etc.) by connecting the wires (e.g., cutting wires) of the device. Curving of the catheter may be performed to facilitate cannulation of the opening of the body lumen (e.g., to facilitate insertion through the papilla into or toward the hepatopancreatic duct or common bile duct). The distal end of the catheter needs to be extended into the opening of the body lumen so that the cutting wire can extend to the tissue of the opening to dilate or cut. The target tissue or lumen to be treated may be located past the initial cannulation point and further past the opening of the body lumen so that the device is further steered through the body lumen and opening to the target tissue.

[0018] Referring to FIG. 1A, a perspective view of a catheter 100 is illustrated in accordance with an embodiment of the present disclosure. The catheter 100 includes a shaft 102 having a proximal end 102p and a distal end 102d. The shaft 102 includes a movable portion 106 that can be steered substantially out of alignment with the remainder of the shaft 102 extending from the movable portion 106 to the proximal end 102p. The movable portion 106 can be manipulated, for example, to direct the distal end 102d toward a target area (e.g., an opening of a body lumen), thereby directing an accessory and / or a fluid (e.g., contrast agent) that extends, for example, through an accessory lumen 112 of the shaft 102 to the body lumen. The catheter 100 is in an arcuate configuration in which the movable portion 106 is pulled into an arc by a wire 104. The wire 104 passes through a wire lumen 108 along the shaft 102 proximal to the movable portion 106. The wire 104 extends externally outside the shaft 102 along the movable portion 106 from a proximal end 106p of the movable portion 106 to where the wire 104 is attached to a distal end 106d of the movable portion 106. The movable portion 106 may transition between an arcuate configuration and a substantially straight configuration by moving the wire 104 through the wire lumen 108 so that tension is applied and released from the distal end 106d of the movable portion 106. One or more markings 116 along the shaft 102, along the movable portion 106, and also on edges of the movable portion 106, including the distal end 102d, as shown, for example, may aid in visualization of portions of the shaft 102 during navigation and manipulation of the catheter 100.

[0019] Referring to FIG. 1B, a proximal portion of a catheter, such as the catheter 100 of FIG. 1A, is illustrated according to an embodiment of the present disclosure. The proximal end 102p of the shaft 102 of the catheter 100 of FIG. 1A is coupled to a handle 150 in FIG. 1B. The handle 150 includes a slider 152 that is movable along the handle 150. The slider 152 is coupled to the wire 104 of FIG. 1A, and the slider 152 can be moved to move the wire 104 and manipulate the movable portion 106 of the catheter 100. An electrical connector 154 is disposed on the slider 152, and the slider 152 can electrically connect the wire 104 to a power source for electrically activating the wire 104 for a medical procedure as described herein. The accessory lumen 112 is in fluid communication with a first port 114 for introducing and removing an accessory into the accessory lumen 112. A second port 122 is in fluid communication with an additional lumen in the shaft 102 for additional accessories or fluids (eg, contrast media).

[0020] 2, a perspective view of a catheter 200 in an arcuate configuration is shown in accordance with an embodiment of the present disclosure. The distal end 202d of the shaft 202 of the catheter 200 has been manipulated, for example, toward a body lumen opening. An attachment 240 may be delivered through the attachment lumen 212 of the shaft and / or the shaft 202 may be moved along the attachment 240. The movable portion 206 of the shaft 202 is arced in the arcuate configuration. The movable portion 206 is pulled by a wire 204 into the arcuate configuration. The wire 204 passes through a wire lumen 208 along the shaft 202 proximal to the movable portion 206 and extends outside the shaft 202 along the movable portion 206 from a proximal end 206p to a distal end 206d of the movable portion 206. By moving wires 204 through wire lumens 208 such that tension is applied or released from distal end 206d of movable portion 206, movable portion 206 may transition between an arcuate configuration and a substantially straight configuration. As further defined and described below, kinks 218 along movable portion 206 result. Kinks 218 along movable portion 206 may cause curved movable portion 206 to have a less smooth arc along the movable portion's arc and a rougher transition along the movable portion's arc, as compared to the arc of movable portion 106 in, for example, the arcuate configuration of FIG. 1A or in other arcuate configurations shown and described herein.

[0021] As used herein, "kink," "kinked," and "kinking" refer to a sharp bend along a bow, bend, arc, or twist. A kink along the length of a shaft can occur when the shaft is elastically or plastically deformed an excessive distance or number of times per axial length, causing excessive compression of the portion of the shaft along the inside of the arc. Kinks can cause the shaft of a device to degrade or malfunction. For example, kinks can break the integrity of the outer surface of the shaft, causing one or more lumens in the shaft to collapse, become punctured, and / or become blocked. Kinks can prevent the movable portion of the shaft from further forming the desired arc for treatment in an arcuate configuration. A kink can result in a fold in a localized area of ​​the shaft, but the fold can be approximately midway along the arc of the arcuate curve. Kinks can impede or block access through the first and / or second lumens, thereby compromising tool access or fluid flow therethrough, for example.

[0022] The ability of the movable portion of the catheter shaft to reversibly transition to an arcuate configuration may be important for medical procedures. Desired bending characteristics of the catheter shaft (e.g., for rapid cannulation) may include a uniformly smooth arc of bending angle, ease of transition to the arcuate configuration with minimal pulling force on the wire, and stability of the movable portion while in the arcuate configuration. Facilitating these bending characteristics may reduce trauma to the body lumen and may reduce the procedure time during which the patient may recover (from experiencing trauma caused by the medical device of the procedure) and / or be exposed to x-rays or other visual aids. Many of these desired bending characteristics of the movable portion of the shaft may be improved as the length of the movable portion is increased. For example, a movable portion length of about 30 mm may have better bending performance than a movable portion length of about 20 mm. However, increasing the length of the movable portion may also require increasing the length of the wire outside the shaft, which may undesirably cause deeper cutting of tissue when the shaft is in the arcuate configuration and the wire is electrically activated. It is therefore desirable to improve the bending performance of the moving part without increasing the length of the moving part.

[0023] 3A-3E, isometric, right side, and cross-sectional views of a catheter 300 are shown in accordance with an embodiment of the present disclosure. The catheter 300 includes a shaft 302 extending from a distal end 302d to a proximal end 302p. The catheter 300 is a multi-lumen catheter 300 including a wire lumen 308 and two accessory lumens 312. Although three lumens 308 and 312 are shown, in various embodiments, any number of lumens (e.g., 0, 1, 2, 4, 5, 10, etc.) may be employed. The shaft 302 includes a movable portion 306. The movable portion 306 is in a substantially straight configuration in FIGS. 3A and 3B, while the movable portion 306 is arced in an arcuate configuration in FIG. 3C. The movable portion 306 is pulled by a wire 304 into the arcuate configuration shown in FIG. 3C. The wires 304 pass through a wire lumen 308 along the shaft 302 proximal to the movable portion 306 and extend outside of the shaft 302 along the movable portion 306 from a proximal end 306p to a distal end 306d of the movable portion 306. By moving the wires 304 through the wire lumen 308 such that tension is applied or released from the distal end 306d of the movable portion 306, the movable portion 306 may transition between an arcuate configuration and a substantially axial configuration. Although the wire lumen 308 is illustrated as passing through the distal end 302d of the shaft 302, the wire lumen 308 and / or one or more accessory lumens 312 may terminate near proximal to the distal end 302d. The wires 304 may also terminate proximal to the distal end of the shaft 302 , eg, the ends of the wires 304 may extend into a wire lumen 308 and be anchored within the lumen 308 to a distal end 306 d of the movable portion 306 .

[0024] The movable portion 306 of the shaft 302 includes a plurality of spaced apart slots 310 disposed along the movable portion 306. In the substantially axial configuration of Figures 3A and 3B, each of the slots 310 has a gap space of distance d1. In the arcuate configuration of Figure 3C, each of the slots 310 has a gap space of distance d2, which is smaller than distance d1. In the arcuate configuration, the movable portion 306 of the shaft 302 has a smaller compression force along the shaft 302 (compared to the slotless movable portion 206 of Figure 2) because the walls of the slots 310 are flexible toward each other, reducing the gap space distance (i.e., from d1 to d2). The gap space of each of the slots 310 allows the movable portion 306 to transition into the arcuate configuration with a substantially uniform arc along the movable portion 306. Although nine slots 310 are shown, in various embodiments, any number of slots (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 20, 50, etc.) may be employed. As best illustrated in the cross-sectional view of shaft 302 in FIG. 3E taken along movable portion 306 in FIG. 3B, the slots extend radially (e.g., partially through or across, entirely through or across, etc.) toward wire lumen 308. The arc of the arcuate configuration of movable portion 306 in FIG. 3C is uniformly distributed along the slots (i.e., the shortened length from d1 to d2 of each of slots 310) rather than a substantially central portion of the arc that may kink the compressed portion of shaft 302. The depth d3 of slot 310 provides a wider gap for compression (i.e., along movable portion 306 in the arcuate configuration) compared to a slot or etched groove having a depth less than the depth of d3. The depth d3 of slot 310 may extend to a length, for example, as great as allowable such that the walls of shaft 302 around lumens 308 and 312 have a thickness t to maintain the functionality of lumens 308 and 312. In various embodiments, exemplary dimensions of slot 310 for illustrative purposes only may be d1 about 1.25 mm, d2 about 0.75 mm, d3 about 0.6 mm, and t about 0.075 mm (about 0.003 inches) or about 0.05 mm to about 0.10 mm.The wires 304 extend outside the slots 310 at the movable portion 306 and may rest against the shaft 302 substantially centrally across the slots 310 in the non-actuated configuration of the catheter 300 (e.g., as shown in FIGS. 3A, 3B, 3D, and 3E). In various embodiments, the axial length of the spacing between each of the slots 310 may be longer, similar, or shorter than the axial length of each of the slots 310, and the slots 310 may be uniformly or non-uniformly distributed along the length of the movable portion 306 depending on the desired curvature and / or parameters of the shaft 302. In various embodiments, an exemplary spacing between each slot 310 for illustrative purposes only may be between approximately 1 mm and 2 mm, or about 1.8 mm.

[0025] In addition to other features and advantages of providing multiple slots along a catheter shaft as described in this disclosure, the slots can also improve bending characteristics by reducing the mass of the moving portion of the shaft to allow it to bend and curve. The slot cutting process or other negative machining can ensure that the integrity of the catheter and lumen(s) is not compromised as compared to forming (e.g., molding) the catheter shaft with slots. The slot cutting process can be performed as a finishing step during manufacturing, thereby reducing the need for excessive manufacturing strategy changes during catheter shaft manufacturing.

[0026] 4A-4C, right side views of an exemplary shaft 402 (each with slots having different transverse profiles) are illustrated according to an embodiment of the present disclosure. The geometry of the slots may be selected depending on shaft parameters such as the number of lumens, the size of the lumens, the length of the shaft, the length of the movable portion, the material of the shaft, the desired arc shape in the arcuate configuration, the compression force, the compression distance of the flexible walls of the slots, manufacturability, etc. In FIG. 4A, the slot 410a has a profile that is U-shaped. In FIG. 4B, the slot 410b has a profile that is rectangular. In FIG. 4C, the slot has a profile that is valley-shaped and tapered. In various embodiments, the profile of the slots may include one or more of the shapes of FIG. 4A-4C, V-shaped, slit, channel, square, oval, combinations thereof, etc. The embodiments are not limited.

[0027] In accordance with an embodiment of the present disclosure, Figures 5A and 5B depict isometric views of finite element analysis of a slotted shaft 502 and an unslotted shaft 503, respectively. The shaft 502 includes a slot 510 along its length. An axial force vector 520 is applied to the distal end 502d of the shaft 502. The same axial force vector 520 is applied to the distal end 503d of the unslotted shaft 503. As illustrated by the shaded and labeled coloring throughout Figures 5A and 5B, the shaft 502 with the slot 510 is distorted more (ranging from dark blue to orange, i.e., roughly illustrating the distortion through color changes in about five colors), while the unslotted shaft 503 is distorted less (i.e., illustrating the distortion in about three colors), both under the same axial force 520 conditions. In other words, the slotted shaft 502 distorts more than the unslotted shaft 503 under the same axial force 520. As discussed herein, it is desirable to achieve greater shaft deflection without additional force.

[0028] In various embodiments, the distal portion and / or end of the shaft can be articulated via proximal or distal movement of one or more wires. Proximal movement of the wire pulls the distal end of the shaft, causing the distal portion of the shaft to bend toward the moved wire. A medical professional may move one or more wires via a handle at the proximal end of the shaft with a conductive piece (pulley piece) connected to the wire that can be actuated to move the wire within the wire lumen. In various embodiments, the wire lumen can be filled and / or occluded with a movable portion of the catheter shaft. In various embodiments, the shaft lumen can be configured to receive a guidewire, such that a distal portion of the guidewire can extend further distally beyond the distal end of the shaft. The shaft can include a distal portion configured (e.g., curved, flexible, bendable, rotatable, swingable, rotating, etc.) to move with movement of the wire in multiple directions (e.g., x, y, and / or z directions), thereby imparting the same or similar movement directions to the distal portion of the guidewire and / or the distal end of the shaft.

[0029] In various embodiments, the wire may be electrically conductive and may be connected to a power source to deliver energy to the wire, the wire may be electrically insulated along at least a portion of its length, and / or may not be electrically insulated along at least a portion of its length.

[0030] In various embodiments, as described herein or otherwise within the scope of this disclosure, a sphincterotomy procedure may be performed according to one or more embodiments by articulating a device such that a distal end of the device faces an opening of a body lumen (such as, for example, the papilla of Vater). This distal end may be advanced through the body lumen and may be advanced through the lumen and / or toward the desired secretory duct. A guidewire may be advanced through the lumen of the device. The location and position of portions of the device and / or guidewire may be observed, for example, via fluoroscopy. Further articulation and advancement of the device and / or guidewire may be performed to achieve cannulation by curving a movable portion of the device such that the distal end is directed toward the opening of the body lumen. The medical professional may articulate the distal end of the device to manipulate and / or cannulate the opening of the body lumen. The medical professional may assist in creating an opening in the body lumen by applying a voltage to the wire and contacting tissue in the body lumen. The device may be removed from the patient and one or more guidewires may remain in place within the body lumen to guide another device used in the same procedure, or the same device used to perform the sphincterotomy may continue to be used for the same procedure.

[0031] In various embodiments, one or more shafts of the device may include multiple lumens projecting therefrom. These lumens may extend from the proximal end of the shaft to the distal end of the shaft, and a portion of the lumen(s) may be exposed to the exterior surface of the shaft. One or more lumens (e.g., wire lumens) may terminate at a point proximal to the distal end of the shaft. These lumens may be configured to receive precision instruments of the device and fluids (e.g., contrast agents, wires, guidewires) through at least a portion of the lumen, and these lumens may extend outside of the lumen from where a lumen is exposed to the exterior surface of the shaft. Such precision instruments may extend partially along the lumen, or may extend outside of the lumen along various portions of the lumen and exposed to the exterior surface of the shaft. Such precision instruments or portions of precision instruments that extend outside the lumen may be configured to penetrate the wall of the lumen and / or the shaft (e.g., through perforations, thin walls, openings, etc.) such that the precision instruments are outside the lumen at the outer surface of the shaft. One or more ends of the shaft may be tapered to a thinner outer diameter (compared to the remainder of the shaft), such that the inner diameter of some or all of the lumens is reduced and tapers distally toward a closed distal end. Additionally or alternatively, the shaft may be treated at its tip such that some or all of the wire lumens are closed at the end. The reduced distal or proximal end may have a smaller diameter than the diameter of the rest of the shaft. A portion of the lumen may be a C-shaped channel that extends along a portion of the flexible elongate shaft, for example, where a portion of the wire may extend outside the shaft. The channel may also include other shapes (e.g., U-shaped, V-shaped, triangular, box-shaped, or combinations of these shapes). The channels may be open or closed, which may have one or more portions with different wall thicknesses (e.g., thinner walls in one portion of the channel).

[0032] In various embodiments, the lumens within the shaft can be designed in various configurations and combinations, depending on the precise instrumentation and requirements for a particular application. For example, a lumen configured for a guidewire may also (or instead) be configured for delivery of contrast agents, etc. The embodiments described and illustrated herein are not intended to be exclusively inclusive of such lumens, and need not necessarily include all of the lumens illustrated.

[0033] In various embodiments, fluoroscopy can assist in positioning a system or medical device according to the present disclosure, or in identifying the location of a lumen, a wire, tissue, the presence of one or more objects such as gallstones, etc. A contrast agent may be injected through a lumen of the medical device into or around a body lumen to perform fluoroscopy. A guidewire may be retracted from the lumen, whereby contrast agent may be injected through the same lumen. Alternatively, contrast agent may be injected into a lumen containing the guidewire, whereby contrast agent flows through the lumen around the guidewire. Alternatively, one lumen or a portion of a multi-lumen shaft (e.g., a bifurcated lumen) may be dedicated to the flow of contrast agent from the medical device. Alternatively, a lumen may be used for a first purpose and then subsequently used for a second purpose, such as first to receive a guidewire and then to flow contrast agent.

[0034] The disclosed method of cannulating an opening in a body lumen may include inserting a catheter into a body lumen of a patient. A wire coupled to a distal end of the catheter may be moved proximally along a handle of the catheter, e.g., via a slider. A portion of the catheter may be bent toward the opening of the body lumen, e.g., at the movable portion and / or at the distal end of the shaft of the catheter. The wire may pass through at least a portion of a first lumen of the catheter. The catheter may include a plurality of slots along the movable portion of the catheter, the plurality of slots extending radially toward the first lumen. Bending the portion of the catheter may include reducing an axial width of each of the plurality of slots. Fluid may be delivered through a second lumen of the catheter into the opening of the body lumen. Moving the wire proximally may include pulling the wire toward the handle of the catheter outside of the plurality of slots. A portion of the opening of the body lumen may be cut by electrically activating the wire.

[0035] All of the devices and / or methods disclosed and described herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of the present disclosure have been described in terms of preferred embodiments, it may be apparent to those skilled in the art that variations may be applied in the devices and / or methods and in the steps or sequence of steps of the methods described herein without departing from the concept, spirit and scope of the present disclosure. All such similar substitutes or modifications apparent to those skilled in the art are presumed to be within the spirit, scope and concept of the present disclosure as defined by the appended claims.

Claims

1. A catheter comprising: a shaft including a proximal end, a distal end, a movable portion proximal to the distal end, and a first lumen extending along a length of the shaft between the proximal end and the distal end; a plurality of spaced apart slots aligned along the movable portion, the plurality of slots extending radially toward the first lumen; A catheter comprising:

2. The catheter of claim 1 , further comprising a wire coupled to the distal end of the shaft and extending externally along the movable portion of the shaft.

3. The catheter of claim 2 , wherein the wire is disposed within the first lumen proximal to the movable portion.

4. The catheter of claim 2 , wherein the wire is disposed across the plurality of slots at a substantial midpoint.

5. 2. The catheter of claim 1, wherein each of the plurality of slots extends radially through the first lumen.

6. 2. The catheter of any preceding claim, further comprising a second lumen extending through the shaft, the plurality of slots being external to the second lumen.

7. The catheter of claim 6, wherein the wall thickness of the second lumen ranges from about 0.05 to about 0.10 mm.

8. 2. The catheter of any preceding claim, wherein a cross-sectional profile of the plurality of slots transverse to a longitudinal axis along the length of the shaft comprises a U-shape, a V-shape, a box-shape, or a combination thereof.

9. 2. The catheter of claim 1, wherein an axial spacing between each of the plurality of slots along the length of the shaft is greater than an axial length of each of the plurality of slots.

10. 2. A catheter according to any preceding claim, wherein the plurality of slots are uniformly distributed along the length of the movable portion.

11. The catheter of claim 2 , further comprising a handle coupled to a proximal end of the wire, the handle configured to move the wire proximally and distally through the first lumen.

12. A catheter comprising: a shaft including a proximal end, a distal end, a central longitudinal axis therethrough, a movable portion proximal to the distal end, and a first lumen extending along a length of the shaft between the proximal end and the distal end; a wire coupled to the distal end, the wire extending outside of the shaft along the movable portion and extending into a first lumen proximal to the movable portion; at least one slot disposed along the movable portion, the slot extending radially toward the first lumen and disposed between the central longitudinal axis and the wire; A catheter comprising:

13. The catheter of claim 12 , wherein the slot extends radially through the first lumen.

14. 14. The catheter of claim 12 or 13, further comprising a second lumen extending along the length of the shaft, the slot being external to the second lumen.

15. The catheter of claim 14, wherein the wall thickness of the second lumen ranges from about 0.05 mm to about 0.10 mm.

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