Patent Publication Number: US-2015073391-A1

Title: Medical device with a movable tip

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 61/877,132, filed Sep. 12, 2013, the entire disclosure of which is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure pertains to medical devices, and methods for manufacturing and use of these medical devices. More particularly, the present disclosure pertains to medical devices for accessing a body lumen along a biliary and/or pancreatic tract. 
     BACKGROUND 
     A wide variety of intracorporeal medical devices have been developed for medical use, for example, for endoscopic procedures. Some of these devices include guidewires, catheters, catheter systems, endoscopic instruments, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices. 
     SUMMARY 
     This disclosure provides design, material, manufacturing method, and use alternatives for medical devices and medical systems. 
     In one aspect, the present disclosure provides a medical guidewire for accessing a body lumen along a biliary and/or pancreatic tract. The guidewire may include an elongated member having a distal end and a proximal end. A movable distal tip may be positioned at the distal end of the elongated member. The guidewire may also include an electromechanical actuator for actuating movement of the distal tip. The actuation of the electromechanical actuator may actuate movement of the adjustable distal tip and facilitate cannulation of one or more of a bile duct and a pancreatic duct. 
     In another aspect, the present disclosure provides a medical device for use with an endoscope for accessing a body lumen along a biliary and/or pancreatic tract. The medical device may include an elongated member having a proximal end, a distal end, and a lumen defined therein. An enabled distal tip may be disposed at the distal end of the elongated member. An actuator element may be in mechanical communication with the distal tip to enable movement of the distal tip. The medical device may also include a control mechanism in electrical communication with the actuator element. The control mechanism may be capable of effecting mechanical movement of the actuator element. Adjustment of the control mechanism may adjust movement of the distal tip. 
     In another aspect, the present disclosure provides a method for accessing a body lumen along a biliary and/or pancreatic tract using a guidewire. The guidewire may have an electromechanical actuator capable of actuating movement of a distal tip of the guidewire. The guidewire may have an electromechanical actuator in communication with a distal tip of the guidewire. The guidewire may be advanced through a body lumen to a location where a common duct splits into a first duct and a second duct. The electromechanical actuator may be actuated to effect movement of the distal tip of the guidewire adjacent the first duct. The guidewire may be advanced into the first duct. 
     The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which: 
         FIG. 1  is a schematic overview of the biliary tree; 
         FIG. 2  is a schematic side view of a portion of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 3  is a schematic cross-sectional side view of a portion of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 4  is a schematic cross-sectional side view showing a portion of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 5  is a schematic view of illustrative movements of a distal tip of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 6  is a schematic view of illustrative movements of the distal tip of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 7  is a schematic view of illustrative movements of the distal tip of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 8  is a schematic cross-sectional side view of a portion of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 9  is a schematic cross-sectional side view of a portion of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 10  is a schematic cross-sectional side view of a portion of an illustrative guidewire according to an aspect of the present disclosure; 
         FIG. 11  is a schematic cross-sectional side view of a portion of an illustrative guidewire with pull wires according to an aspect of the present disclosure; 
         FIG. 12  is a schematic cross-sectional side view of a portion of an illustrative guidewire with pull wires according to an aspect of the present disclosure; and 
         FIG. 13  is a schematic flow diagram of an illustrative method of using a guidewire according to an aspect of the present disclosure. 
     
    
    
     While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure. 
     DETAILED DESCRIPTION 
     For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
     All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure. 
     The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 
     As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
     It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, or characteristic may also be used in connection with other embodiments whether or not explicitly described unless clearly stated to the contrary. 
     The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. 
     As discussed herein, it may be desirable for a distal tip of a medical device (e.g., a guidewire) to be flexible to navigate effectively through a body lumen. For example, flexible distal tips of guidewires may be capable of facilitating navigation through narrow passages such as the papilla of Vater and/or other passages. In some instances, a flexible distal tip of a guidewire may facilitate steering the guidewire into a target body lumen that is closely situated to structures such as lesions, stones or other build-up and/or has such structures situated therein. 
     In some instances, the devices and methods that are disclosed herein may be useful for diagnostic or therapeutic procedures in the biliary and/or pancreatic tracts, among being useful for other purposes. Access to the pancreaticobiliary system, as facilitated by the devices disclosed herein, may be required to diagnose and/or treat a variety of conditions, including but not limited to tumors, gallstones, infection, sclerosis, and pseudo cysts. The device disclosed herein may also be useful for navigation in other parts of the body such as the cardiovascular system and so forth. 
     Endoscopic retrograde cholangio pancreatography (ERCP) may be used to diagnose and treat conditions of the common bile duct, including, for example, gallstones, inflammatory strictures, leaks (e.g., from trauma, surgery, etc.), and cancer. In an ERCP procedures, through an endoscope, a physician may view the inside of the stomach and/or the duodenum. Often, dyes may be injected into the ducts in the biliary tree and pancreas so that the area can be seen using X-rays. These procedures may necessitate gaining and keeping access to the papilla of Vater, the common bile duct, and/or the pancreatic duct, which may be technically challenging, may require extensive training and practice to gain proficiency, and may require one or more expensive tools in order to perform. 
     During an ERCP procedure, a number of steps are typically performed while the patient is often sedated and/or anaesthetized. For example, an endoscope may be inserted through the mouth, down the esophagus, into the stomach, through the pylorus into the duodenum, to a position at or near the papilla of Vater (also referred to as the ampulla of Vater), which is the opening of the common bile duct and the pancreatic duct. Due to the shape of the papilla, and the angle at which the common bile and pancreatic ducts meet the wall of the duodenum, the distal end of the endoscope is generally placed just past the papilla. Due to the positioning of the endoscopes beyond the papilla, the endoscopes typically used in these procedures are usually side-viewing endoscopes. The side-viewing feature provides imaging along the lateral aspect of the tip rather than from the end of the endoscope. Such orientation may allow a clinician to obtain an image of the medial wall of the duodenum, where the papilla of Vater is located, even though the distal tip of the endoscope is beyond the opening. 
       FIG. 1  illustrates an overview of the biliary system or tree. The papilla of Vater  14  is located in a portion of the duodenum  12 . For the purpose of this disclosure, the papilla of Vater  14  is understood to be of the same anatomical structure as the ampulla of Vater. The papilla of Vater  14  generally forms the opening where the pancreatic duct  16  and the common bile duct  18  empty into the duodenum  12 . The hepatic ducts, denoted by the reference numeral  20 , are connected to the liver  22  and empty into the common bile duct  18  (also referred to as the bile duct). Similarly, the cystic duct  24  is connected to the gall bladder  26  and also empties into the common bile duct  18 . In general, an endoscopic or biliary procedure may include advancing a medical device to a suitable location along the biliary tree and then performing the appropriate intervention. 
     Accessing a desired target along the biliary tree involves advancing the endoscope through the duodenum  12  to a position adjacent to the papilla of Vater  14 , and advancing a medical device, which may be a guidewire, through the endoscope and through the papilla of Vater  14  to the intended target. The intended target may be, for example, the pancreatic duct  16  or the common bile duct  18 . 
     The physician or clinician may advance the catheter through the papilla  14  and then attempt to advance the guidewire into the intended target duct. Sometimes, however, the clinician may end up inadvertently advancing the guidewire (and/or catheter) into an undesired duct. When the guidewire advances into the “undesired” duct, the clinician may be required to retract and advance the guidewire to a desired duct until the guidewire reaches the desired duct. This recurring procedure of retracting and advancing the guidewire may cause damage to surrounding tissue. Alternatively, the clinician may choose to pull the catheter from the body while leaving the guidewire in the non-target duct and then replace the catheter (or advance a new catheter) and load a second guidewire through the catheter to access the “desired” target duct. Such a technique may improve the chances of accessing the desired duct, for example, because the initial guidewire may partially block the “undesired” duct. Each of these procedures, however, may include removal of the catheter from the biliary tree and subsequent steps may involve re-cannulation of the papilla of Vater  14  (e.g., insertion of the medical device through the papilla). In addition, repeated cannulation of, for example, the common bile duct  18  and/or the pancreatic duct  16  may cause undesired side effects such as irritation or inflammation of tissue in the ducts and post-ERCP complications such as pancreatitis. 
     Further, several factors may complicate the cannulation of the papilla of Vater  14  such as an irregular sphincter orientation, floppy or irregular intraductal segments, variations of the biliary or pancreatic take-off levels, presence of stones or strictures in the lumen, and/or inflammation of the common bile or the pancreatic ducts. Difficult cannulations carry a high risk of perforation or other damage to tissue. 
     In one example procedure, physicians may use a technique for cannulation which involves identification of a bile trail by pushing against the papilla or applying suction to encourage bile to be released from the papilla. Prolonged probing and/or suction, however, may lead to adverse effects such as inflammation of the papilla. Thus, there is a need to develop medical devices that may facilitate cannulation of the papilla without causing harm to the tissue and/or the papilla. 
     Disclosed herein are example medical devices such as medical guidewires that may improve access to the desired location along the biliary tree. In general, these devices and methods may allow a catheter, guidewire, or the like to successfully access a target location along the biliary tree (e.g., the common bile duct  18  and/or the pancreatic duct  16 ). 
       FIG. 2  illustrates a portion of an example medical guidewire  210 . The guidewire  210  may include a shaft or elongated member  212  having a proximal end  214  and a distal end  216 . The elongated member  212  may have a lumen  220  extending longitudinally from the proximal end  214  to the distal end  216 . The distal end  216  of the guidewire  210  may also include a distal tip  230  that may be connected to the distal end  216 . 
     The elongated member  212  may be unitarily formed (e.g., monolithic) or formed of two or more interconnected features, members, and/or components. As shown in  FIGS. 2-4  and  8 - 11 , the elongated member  212  may be formed of at least a main body  224  and a distal tip  230 , where the lumen  220  extends therethrough. The elongated member  212  may have any dimensions as desired to facilitate travel through body lumens. In one example, the main body  224  may have a maximum diameter length D′ and the distal tip  230  may have a maximum diameter length D″, where the maximum diameter length D″ is less than the maximum diameter length D′. 
     In some instances, as shown in  FIG. 2 , the distal tip  230  of the elongated member  212  may be an assembly of smaller components. The distal tip  230  may include a body  234  and a deflectable tip  232 . In some instances, the body  234  and/or the deflectable tip  232  may be tapered to facilitate traversal of the distal tip  230  through narrow openings. Alternatively, the body  234  and/or the deflectable tip  232  may have uniform diameters throughout their lengths. The shape of the distal tip  230  may be designed to correspond with the anatomy of the body lumen that is being accessed. 
     The deflectable tip  232  may be configured to bend and/or rotate at an angle from an undeflected position along longitudinal axis L-L (see  FIG. 3 ). The deflectable tip  232  may be freely bendable and/or rotatable with respect to the body  234  of the distal tip  230 . 
     In some instances, the entire or substantially entire distal tip  230  may be configured to be moved and/or steered to access a target body lumen. Illustratively, the distal tip  230  may move independent of the main body  224  of the elongated member  212 . Also, the distal tip  230  may be capable of and/or configured to undergo different motions, for example, vibration motions (e.g., side-to-side with respect to a longitudinal axis L-L), rotation motions (e.g., concentric or substantially concentric motion about the longitudinal axis L-L), longitudinal oscillation (e.g., in and out axial movement along the longitudinal axis L-L), etc. to facilitate access to and/or through the target body lumen. In some instances, the entire or substantially entire guidewire  210  may undergo different motions and/or may be steered or, alternatively, a portion (e.g., proximal end  214 , the mid-portion  215 , the distal end  216 , etc.) of the guidewire  210  may undergo different motion and/or may be steered. Illustrative motions of the distal tip  230  and/or the guidewire  210  will be discussed infra with reference to  FIGS. 5-7 . 
     In some instances, a number of slots (not shown) may be provided on or at one or more portions of the guidewire  210  (e.g., a portion  250  of the guidewire  210 ) to impart flexibility to the distal tip  230 , thereby enabling the distal tip  230  to be further movable and/or steerable. Illustratively, the slots may be arranged circumferentially and along a longitudinal axis of the distal tip  230 . In some embodiments, the slots may be provided on an outer surface of the elongated member  212 , thereby imparting flexibility in movement of the elongated member  212 . Detailed description of the slots will be discussed infra. 
     In some instances, the distal tip  230  may be mechanically coupled to the main body  224  of the guidewire  210  at a connection  240 , as shown in  FIG. 2 . Details of such a mechanical coupling will be discussed in conjunction with subsequent figures. 
     The distal tip  230  may be made from biocompatible materials such as polymers, Nitinol (e.g., a nickel titanium alloy), stainless steel, or the like. In some instances, a proximal portion and a distal portion of the elongated member  212  may be made from different materials and may be connected together. For example, the distal portion of the elongated member  212  may be made from hydrophilic material and the proximal portion of the elongated member  212  may be made from either hydrophilic or hydrophobic material. In some embodiments, the proximal and distal portions may be a unitary structure made substantially from a single material. In such instances, the elongated member  212  may be coated wholly or partially with a hydrophilic coating to reduce friction at an outer surface of the guidewire  210 . 
     The above descriptions of the guidewire  210  are just examples. Other structures for the guidewire  210  are contemplated. 
       FIG. 3  is a cross-sectional view of a portion of the guidewire  210 . Here, the deflectable tip  232  is shown in its undeflected position (e.g., at a position concentric about the longitudinal axis L-L). The body  234  and/or the deflectable tip  232  of the distal tip  230  may be made of one or more solid pieces of material or may be made of at least one or more partially hollow materials allowing the lumen  220  to pass therethrough. 
     The body  234  and the deflectable tip  232  of the distal tip  230  may be made from any biocompatible material. Illustratively, the deflectable tip  232  may be made from the same material (e.g., stainless steel, Nitinol or polymers) as the body  234 . Alternatively, the deflectable tip  232  may be made of a material that is softer than a material of the body  234 . In some instances the deflectable tip  232  may be made of a material that is softer than a material of the main body  224  of the guidewire  210 . 
       FIG. 4  illustrates a portion of an example guidewire. As shown in  FIG. 4 , the body  234  of the distal tip  230  may include a region  236  protruding and/or extending radially around a circumference of the body  234 . The region  236  may be unitarily formed with the body  234  or connected to the body  234  with any connection technique, as desired. Illustratively, the region  236  may be located adjacent or near a proximal end  238  of the distal tip  230 . A distal portion of the main body  224  (e.g., a portion of the main body adjacent to or a part of the distal end  216  of the elongated member  212 ) may include a recess  226  formed therein to receive the region  236  of the distal tip  230 . Such a connection between the distal tip  230  and the main body  224  may form a snap-fit connection, or other connection type, between the region  236  and the recess  226  to form the connection  240 . Alternatively or in addition, one or more adjustment members (e.g., a ball bearing or other member), may be utilized to facilitate rotation of the distal tip  230  with respect to the main body  224 . 
       FIG. 5  shows side-to-side motion of the guidewire  210 . The guidewire  210  may be introduced into a central lumen of a catheter, cannula, or sphincterotome  300 . The guidewire  210  and the sphincterotome  300  may be inserted into a proximal portion of an endoscope shaft  302 , and may be advanced through a central lumen of the endoscope shaft  302 , toward the side opening  304 . The sphincterotome  300  and the guidewire  210  may emerge from the opening  304 , and may extend through or otherwise engage the plug/elevator  306 . As the sphincterotome  300  and the distal tip  230  of the guidewire  210  extend from the opening  304 , the plug  306  may be moved to facilitate positioning of the sphincterotome  300  and the guidewire  210 . In one example, the plug  306  may be tilted to redirect the sphincterotome  300  and the guidewire  210  into alignment with the papilla  14 . As the sphincterotome  300  and the guidewire  210  extend farther out from the opening  304 , portions of the guidewire  210  may be extended from the sphincterotome  300  so that the distal tip  230  may advance toward the papilla  14 . 
     In one instance, the distal tip  230  while traversing through the papilla  14  may move normal to or substantially normal to the longitudinal axis L-L of the distal tip  230 , in a repeated side-to-side motion, as indicated by A and A′ in  FIG. 5 , (e.g., vibrate). Such repeated movements of the distal tip  230  may help it wiggle through the narrow passage within the papilla of Vater  14  to access the common bile duct  18  and/or the pancreatic duct  16 . In some embodiments, such movements of the distal tip  230  may also be helpful in navigating past stones and lesions that may be present within the body lumen (e.g., within the papilla of Vater  14 , the pancreatic duct  16 , the common bile duct  18 , etc.). Movement of the distal tip  230  may be designed to have an insignificant impact on a patient&#39;s body tissue to minimize damage to body tissue or other body parts that it may contact. 
     In some instances, for example as shown in  FIG. 6 , the distal tip  230  may undergo axial motion as indicated by a line B-B′. The distal tip  230  may move back and forth (e.g., in and out) along the longitudinal axis L-L in a direction indicated by the line B-B′. In some instances, such back and forth movement along the longitudinal axis L-L of the distal tip  230  may be longitudinal oscillation movement, which may facilitate navigation of the guidewire  210  through the papilla of Vater  14  and/or other narrow passages, while limiting the impact on a patient&#39;s body of such traversing. 
       FIG. 7  shows rotational motion of the distal tip  230 . The distal tip  230  may rotate around the longitudinal axis L-L in a clockwise direction C or in a counter-clockwise direction. Such rotational motion may facilitate navigating through the papilla of Vater  14  and/or other narrow passages, while limiting the impact on a patient&#39;s body of such traversing. 
     In some instances, the guidewire  210  may be capable of being moved in a plurality of movements simultaneously or in sequence. In one example, the guidewire  210  may be longitudinally oscillated and vibrated simultaneously or sequentially. In another example, the guidewire  210  may be longitudinally oscillated and rotated simultaneously or sequentially. In another example, the guidewire  210  may be vibrated and rotated simultaneously or sequentially. In yet another example, the guidewire  210  may be longitudinally oscillated, vibrated, and/or rotated. In some instances, the guidewire  210  may be bending while also longitudinally oscillating, vibrating, and/or rotating. 
     The guidewire  210  may include an electromechanical actuator  270  that may be used for actuating the movement of the distal tip  230  and/or other portions of the guidewire  210 , thereby facilitating cannulation of the papilla of Vater, the common bile duct, the pancreatic duct, and/or other body lumens. As shown in  FIG. 8 , an electromechanical actuator  270  may be provided for actuating the movement of the distal tip  230 , thereby facilitating cannulation of the common bile duct  18  or the pancreatic duct  16  (not shown in  FIG. 8 ). 
     The electromechanical actuator  270  may generate mechanical movements that cause resonance within or of parts of the distal tip  230 . Hence, the electromechanical actuator  270  may be employed to effect at least one of the motions such as vibration, longitudinal oscillation, and/or rotation to the distal tip  230  within or adjacent a desired duct or narrow passage. In some instances, the electromechanical actuator  270  may be a piezoelectric element, which may be attached to the elongated member  212 . The piezoelectric element may be used for generation of mechanical movements that may cause motion of the distal tip  230 . In some instances, the slots in the material and/or the material of the distal tip  230  may also contribute to cause resonance to its natural frequency. It is contemplated that composition and structure of the elongated member  212  may be at least partially chosen based on its resonant frequencies and the amplitude of oscillations. 
     In some instances, the electromechanical actuator  270  or an actuator element may be used in conjunction with a controller  272  to control the movement of the distal tip  230  of the guidewire  210 . For example, the piezoelectric element may be in electrical communication with the controller  272 . The controller  272  may be located at a position proximal the proximal end  214  of the guidewire  210  and the piezoelectric element may be located at one or more various locations on the guidewire  210 . The controller  272  may allow for selection of one or more types of movement of the distal tip  230  such as longitudinal oscillation movement, vibration movement, rotational movement, and/or other movements. Illustratively, the controller  272  may allow for adjustment of the selected movement(s) of the distal tip  230 , by controlling the frequency or amplitude of the movements. 
     As shown in  FIGS. 8-10 , the electromechanical actuator  270  may be located at various locations within the guidewire  210 . In some instances, the actuator element  270  may be disposed adjacent to the distal end  216  of the elongated member  212 , as shown in  FIG. 8 . In some instances, the electromechanical actuator  270  (e.g., a piezoelectric element) may be disposed adjacent to the proximal end  214  of the elongated member  212  as shown in  FIG. 9 . In other instances, the electromechanical actuator  270  may be attached to a mid-portion  215  of the elongated member  212 , where the mid-portion  215  is proximal to the distal end  216 , as shown in  FIG. 10 . Such locations of the electromechanical actuator  270  may provide and/or actuate various movements of the guidewire  210  such as rotational movements, vibration movements, and/or longitudinal oscillation movements of the entire guidewire  210  or a portion thereof. 
     In the above embodiments of various motions of the guidewire  210 , the entire guidewire  210  may undergo such motions as indicated above. Alternatively, the various motions of the guidewire  210  may be purposely substantially confined to one or more portions of the guidewire  210  (e.g., the distal tip  230 , the distal end  216 , the mid-portion  215 , the proximal end  214 , and/or other portions of the guidewire  210 ). In some instances, the movement of the guidewire  210  may be substantially confined to one or more portions of the guidewire  210  through selection of a position or placement of the electromechanical actuator  270  and/or through utilizing materials for the guidewire  210  with various properties to limit and/or expand the movements caused by the electromechanical actuator. 
     In some instances, the distal end  216  of the guidewire  210  may be steered manually or in other manners (e.g., automatically). For example, a user may be able to manually steer the distal tip  230  via pull wires  280  situated within and/or about the guidewire  210 , as shown in  FIG. 11 . In one example, one or more pull wires  280  may be connected to the distal end  216  of the guidewire  210  and may extend through the lumen  220  to the proximal end  214  where an operator may apply force, as desired, to one or more of the pull wires  280  to steer the distal end  216  of the guidewire  210 . Illustratively, the pull wires  280  may be pulled or adjusted proximally such that tension may be produced in the pull wires  280 , thereby deflecting the deflectable tip  232  of the distal tip  230 . In some instances, adjustment or tensioning of the pull wires  280  may steer the distal tip  230 . 
     The guidewire  210  may include both the electromechanical actuator  270  for actuating movement of the distal tip  230  and a connection of the pull wires  280  for steering the deflectable tip  232  (see  FIG. 11 ). In some instances, however, as shown in  FIG. 12 , the guidewire  210  may include one or two pull wires  280  for steering the distal tip  230  and may be operated/adjusted without use of the electromechanical actuator. In instances where the guidewire includes the pull wires  280 , the distal tip  230  may be deflectable and may be steered toward a target duct and/or other body passage. 
     Medical devices such as the guidewires  210  described above may be used in various methods. A method  700 , as shown schematically in  FIG. 13 , for accessing a body lumen along a biliary and/or pancreatic tract using the guidewire  210  includes a number of consecutive, non-consecutive, simultaneous, non-simultaneous, or alternative steps. In the method  700 , the guidewire  210  having the electromechanical actuator  270  may be provided  702  and the electromechanical actuator  270  may be in communication with the distal tip  230  of the guidewire  210 . Further, the guidewire  210  may be advanced  704  to and/or through a location where a common duct (e.g., the papilla of Vater  14 ) splits into a first duct (e.g., the common bile duct  18  or the pancreatic duct  16 ) and a second duct (e.g., the common bile duct  18  and the pancreatic duct  16 ). Before, during, or after advancing the guidewire  210  to a location where the common duct splits into a first duct and a second duct, the electromechanical actuator  270  may be actuated  706  to effect movement (e.g., rotation, longitudinal or axial oscillation, and/or vibration) of the distal tip  230  of the guidewire  210  adjacent to, about, and/or within the first duct. The first duct may be a desired target duct such as the common bile duct  18  or pancreatic duct  16 . Then, the guidewire  210  may be advanced  708  into the first duct. In some instances, the controller  272  may be adjusted to adjust a frequency of movement or motion of the distal tip  230  adjacent, about, and/or within the first duct. 
     While the process steps illustrated above may provide a method for accessing a target body lumen, variations are also contemplated to these methods for achieving the same or a similar goal. 
     The materials that can be used for the various components of the systems presently disclosed may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to guidewires  210  referenced above. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar devices and/or components of devices disclosed herein. 
     The guidewire  210  and/or components thereof may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material. 
     Some examples of suitable polymers may include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP. 
     As alluded to herein, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “super elastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol. 
     In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming. 
     In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties. 
     In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a super elastic alloy, for example a super elastic nitinol can be used to achieve desired properties. In at least some embodiments, portions or all of the guidewire  210  may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the guidewire  210  in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the guidewire  210  to achieve the same result. 
     In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the guidewire  210 . For example, guidewire  210  or portions thereof may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The guidewire  210  or portions thereof may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others. 
     As alluded to above, the distal tip  230  and/or elongated member  212  may include one or more tubular members that may have slots formed therein. Various embodiments of arrangements and configurations of slots are contemplated. For example, in some embodiments, at least some, if not all of the slots are disposed at the same or a similar angle with respect to the longitudinal axis of the elongated member  212 . The slots can be disposed at an angle that is perpendicular, or substantially perpendicular, and/or can be characterized as being disposed in a plane that is normal to the longitudinal axis of the elongated member  212 . However, in other embodiments, the slots can be disposed at an angle that is not perpendicular, and/or can be characterized as being disposed in a plane that is not normal to the longitudinal axis of the elongated member  212 . Additionally, a group of one or more the slots may be disposed at different angles relative to another group of one or more the slots. The distribution and/or configuration of the slots can also include, to the extent applicable, any of those disclosed in U.S. Pat. No. 7,914,467, the entire disclosure of which is herein incorporated by reference. Some example embodiments of appropriate micromachining methods and other cutting methods, and structures for tubular members including slots and medical devices including tubular members are disclosed in U.S. Pat. Publication Nos. 2003/0069522 and 2004/0181174-A2; and U.S. Pat. Nos. 6,766,720; and 6,579,246, the entire disclosures of which are herein incorporated by reference. Some example embodiments of etching processes are described in U.S. Pat. No. 5,106,455, the entire disclosure of which is herein incorporated by reference. It should be noted that the methods for manufacturing guidewire  210  may include forming the slots in the elongated member  212  using these or other manufacturing steps. 
     It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention&#39;s scope is, of course, defined in the language in which the appended claims are expressed.