Patent Publication Number: US-2023135620-A1

Title: Device delivery via biliary access device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/272,845, filed Oct. 28, 2021, which is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure pertains to medical devices, and methods for manufacturing and using medical devices. More particularly, the disclosure is directed to using a biliary access device to subsequently deliver a medical device such as an expandable stent. 
     BACKGROUND 
     A wide variety of medical devices have been developed for medical use, for example, for use in accessing body cavities and interacting with fluids and structures in body cavities. Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and/or systems used for delivering such devices. 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. 
     SUMMARY 
     This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. As an example, an assembly for deploying a medical device within a biliary or pancreatic duct of a patient includes a biliary access device and a delivery endcap assembly. The biliary access device includes a handle and an electrosurgical sheath that is movable relative to the handle, the electrosurgical sheath including an electrosurgical tip and defining an electrosurgical sheath lumen extending through the electrosurgical sheath. An access cannula is extendable through the electrosurgical sheath lumen and defines a cannula lumen extending through the access cannula, the access cannula adapted to be removable from the biliary access device. A sharp stylet is extendable through the cannula lumen and is adapted to be removable from the biliary access device. An access endcap assembly is disposable at a proximal end of the handle and is adapted to be removable from the biliary access device. The delivery endcap assembly is adapted to be securable to the proximal end of the handle in place of the access endcap assembly. The delivery endcap assembly includes a securement portion that is adapted to be releasably securable to the proximal end of the handle, and a lumen that extends through the delivery endcap assembly and is adapted to accommodate the medical device therethrough. 
     Alternatively or additionally, the delivery endcap assembly may further include a tapered portion extending proximally from the securement portion, a rotation hub adapted to be coupled to the securement portion, and a valve adapted to be coupled to the rotation hub, where the lumen of the delivery endcap assembly extends through each of the tapered portion, the rotation hub and the valve. 
     Alternatively or additionally, the access endcap assembly may further include a rotation hub. 
     Alternatively or additionally, the sharp stylet may further include a sharp cap that is adapted to releasably secure the sharp stylet to the rotation hub. 
     Alternatively or additionally, the access cannula may be operably coupled with the rotation hub such that rotation of the rotation hub causes rotation of the access cannula. 
     Alternatively or additionally, the access cannula may be operably coupled with the rotation hub such that removal of the rotation hub also removes the access cannula from the biliary access device. 
     Alternatively or additionally, the lumen of the delivery endcap assembly may be positionable in alignment and in communication with the electrosurgical sheath lumen such that the electrosurgical sheath is adapted to accommodate the medical device extending through the electrosurgical sheath lumen once the access cannula and the sharp stylet have been removed from the biliary access device and the delivery endcap assembly has been secured to the proximal end of the handle of the biliary access device. 
     Alternatively or additionally, the medical device may include an expandable stent disposed within an introducer sheath. 
     Alternatively or additionally, the introducer sheath may be adapted to engage a proximal end of the electrosurgical sheath lumen such that a mandrel may be used to advance the expandable stent from the introducer sheath through the electrosurgical sheath lumen. 
     Alternatively or additionally, the handle may include an inner member and an outer member, the inner member slidingly disposed within the outer member, and translating the inner member relative to the outer member may cause the sharp stylet to translate. 
     Alternatively or additionally, the handle may further include an electrosurgical actuator slidingly coupled with the outer member of the handle, and translating the electrosurgical actuator relative to the handle may cause the electrosurgical sheath to translate. 
     Alternatively or additionally, the delivery endcap assembly may further include a modified rotation hub. 
     As another example, a delivery endcap assembly is adapted for use with a biliary access device that is adapted for providing access to a treatment site, the biliary access device including a handle, a sheath extending proximally from the handle and one or more removable components extending proximally within the sheath, the one or more removable components adapted for providing access, the delivery endcap assembly adapted to permit a medical device to be delivered through the biliary access device. The delivery endcap assembly includes a securement portion adapted to be releasably securable to a proximal end of the handle after the one or more removable components have been removed from the handle. A tapered portion extends proximally from the securement portion and a rotation hub is adapted to be coupled to the securement portion. A valve is adapted to be coupled to the rotation hub. A lumen extends through the delivery endcap assembly and is adapted to permit a medical device within an introducer sheath to be advanced through the biliary access device. 
     Alternatively or additionally, one of the one or more removable components may include a sharp stylet operably coupled with a sharp stylet cap removably securable to the biliary access device. 
     Alternatively or additionally, one of the one or more removable components may include an access cannula operably coupled with a rotation hub removably securable to the biliary access device. 
     Alternatively or additionally, the medical device may include an expandable stent disposed within an introducer sheath, the introducer sheath adapted to butt up against a proximal end of the sheath such that a mandrel may be used to advance the expandable stent through the biliary access device. 
     In another example, a medical device is delivered using a biliary access device adapted to provide an access aperture providing access to a desired site within the patient&#39;s anatomy, the access device including a handle and a stylet distally extendable from the handle within a sheath. The access device is used to reach the desired site within the patient&#39;s anatomy and the stylet is extended to provide a puncture at the desired site, the puncture forming the access aperture. The stylet is withdrawn from the sheath and the handle. A delivery endcap assembly is attached to the handle, the delivery endcap assembly adapted to provide access to a lumen extending through the sheath. A guidewire is extended through the access device and through the access aperture. The medical device is extended through the delivery endcap assembly and down the guidewire to the desired site. The medical device is deployed at the desired site. 
     Alternatively or additionally, the sheath may include an electrosurgical sheath with an electrosurgical tip disposed at a distal end of the electrosurgical sheath, and the method may further include using the electrosurgical tip to enlarge the access aperture formed by the stylet. 
     Alternatively or additionally, the medical device may include an expandable stent disposed within an introducer sheath, the introducer sheath adapted to butt up against a proximal end of the electrosurgical sheath such that a mandrel may be used to advance the expandable stent through the biliary access device. 
     Alternatively or additionally, the delivery endcap assembly may include a securement portion adapted to be releasably securable to a proximal end of the handle after the stylet has been removed from the handle, a tapered portion extending proximally from the securement portion, a rotation hub adapted to be coupled to the securement portion, a valve adapted to be coupled to the rotation hub, and a lumen extending through the delivery endcap assembly, where the lumen extending through the delivery endcap assembly is adapted to permit a medical device within an introducer sheath to be advanced through the biliary access device. 
     The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which: 
         FIG.  1 A  is a side view of an illustrative biliary access device; 
         FIG.  1 B  is a top view of the illustrative biliary access device of  FIG.  1 A ; 
         FIG.  1 C  is a side view of a portion of the illustrative biliary access device of  FIGS.  1 A and  1 B ; 
         FIG.  1 D  is a side view of a portion of the illustrative biliary access device of  FIGS.  1 A and  1 B ; 
         FIG.  1 E  is a side view of a portion of the illustrative biliary access device of  FIGS.  1 A and  1 B ; 
         FIGS.  2  through  5    show a method of using the illustrative biliary access device of  FIGS.  1 A and  1 B  to provide access; 
         FIG.  6 A  is a side view of an illustrative delivery endcap assembly usable with the illustrative biliary access device of  FIGS.  1 A and  1 B  for delivering a medical device; 
         FIGS.  6 B through  6 E  are perspective views of portions of the illustrative delivery endcap assembly of  FIG.  6 A ; 
         FIG.  7    is a partial exploded side view of the illustrative delivery endcap assembly of  FIG.  6 A  in combination with the illustrative biliary access device of  FIGS.  1 A and  1 B ; 
         FIG.  8    is a side view of the illustrative delivery endcap assembly of  FIG.  6 A  secured to the illustrative biliary access device of  FIGS.  1 A and  1 B ; 
         FIG.  9    is a perspective exploded view of the illustrative delivery endcap assembly of  FIG.  6 A  in combination with the illustrative biliary access device of  FIGS.  1 A and  1 B ; 
         FIG.  10    is a side view of an illustrative assembly for deploying a medical device; 
         FIG.  11    is a cross-sectional view taken along line  10 - 10  of  FIG.  10   ; 
         FIGS.  12 A and  12 B  are side views showing an expandable stent being delivered through the illustrative assembly of  FIG.  10   ; and 
         FIG.  13    is a flow diagram showing an illustrative method. 
     
    
    
     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. 
     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. 
     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 invention. 
       FIG.  1 A  is a side view of an illustrative biliary access device  10  and  FIG.  1 B  is a top view thereof. While the disclosure concentrates on gaining access and ultimately delivering a medical device as a biliary access device  10 , it will be appreciated that this is merely illustrative, as the concepts described herein are equally applicable to gaining access and ultimately delivery a medical device to any of a variety of different regions or systems of the human anatomy. 
     The illustrative biliary access device  10  may be used to access the biliary and pancreatic ducts as well as pancreatic pseudocysts through an accessory channel of an ultrasound endoscope. The biliary access device  10  facilitates guidewire placement for rendezvous procedures and for placement of ancillary devices such as stents that are delivered over the guidewire. The biliary access device  10  provides the ability to puncture a target site through the patient&#39;s stomach or duodenum, advance and direct a guidewire to the target site, and to dilate the fistula. The biliary access device  10  may be used under endoscopic ultrasound (EUS) guidance, fluoroscopy or even direct visualization. 
     The illustrative biliary access device  10  includes handle  12  that includes an inner member  14  and an outer member  16 . The inner member  14  may be slidingly disposed within and extend distal of the outer member  16 , for example. The handle  12  includes a nut  18  by which the biliary access device  10  may be secured to an accessory or other channel of an endoscope. A length adjustment mechanism  20  is coupled with the nut  18  and can be used to adjust the relative length of the biliary access device  10 . In some cases, a scale  22  is disposed along the inner member  14  and can be used as a guide in adjusting the relative length of the biliary access device  10 . The length adjustment mechanism  20  includes a securement feature  24  that may be used to secure the length adjustment mechanism  20  in place against the inner member  14 , and thus adjust the relative length of the biliary access device  10 . 
     The biliary access device  10  includes a first actuation member  26  and a second actuation member  28 . In some cases, the first actuation member  26  may be secured to a distal end of the outer member  16  and may be actuated to move the outer member  16  relative to the inner member  14  and thus cause the outer member  16  to translate longitudinally relative to the inner member  14 . A scale  30  may be disposed on the inner member  14  as a guide to moving the outer member  16  relative to the inner member  14 . 
     It will be appreciated that by using the scale  30  in combination with the first actuation member  26 , an operator may control axial translation of the outer member  16  relative to the inner member  14 , and hence control longitudinal translation of any internal members that are secured relative to the outer member  16 . Accordingly, the operator can cause one or more internal members to translate a particular distance, as indicated by the scale  30 . The first actuation member  26  includes an actuation button  32  that may be depressed in order to move the first actuation member  26  relative to the inner member  14 . As can be seen in  FIG.  1 B , the inner member  14  includes a slot  34  that allows the first actuation member  26  and thus the outer member  16  to translate longitudinally relative to the inner member  14 . 
     The second actuation member  28  is adapted to translate relative to the outer member  16 , as facilitated by the slot  36  seen in  FIG.  1 B . The second actuation member  28  includes an actuation button  29  that may be used to move the second actuation member  28  relative to the outer member  16 . In some cases, the second actuation member  28  may be operably coupled with an electrosurgical element, and thus the second actuation member  28  may include an electrical connection  38  by which the electrosurgical element may be powered. 
     The biliary access device  10  includes several components at a proximal end  39  that provide functionality for the biliary access device  10  in providing access to a desired site, and that can be removed from the biliary access device  10  in order to allow a medical device to be delivered through the biliary access device  10 . The biliary access device  10  includes an end cap  40 , a sharp cap  42  and a rotation hub  44  that is partially visible underneath the sharp cap  42 . 
     With reference to  FIG.  1 C , the sharp cap  42  is operably coupled with a sharp stylet  46 . For instance, a proximal end region of the sharp stylet  46  may be fixedly secured to the sharp cap  42  and extend distally therefrom. The sharp stylet  46  includes a sharp distal tip  48  that may be used to form a puncture in tissue by moving the outer member  16  distally relative to the inner member  14  to expose the sharp distal tip  48  at a distal end of the device  10 . The sharp cap  42  may fit over the rotation hub  44  and may be releasably securable to the end cap  40 . Accordingly, the sharp cap  42  includes grasping features  50  that may be used to remove the sharp cap  42  (and hence the sharp stylet  46 ) from the endcap  40 . The sharp cap  42  also includes securement features  52  (e.g., distally extending tabs) that may be used to releasably secure the sharp cap  42  to the endcap  40 . In some cases, as illustrated, the sharp cap  42  may include a luer fitting  54  that may be used to attach additional elements to the sharp cap  42 . 
     With reference to  FIG.  1 D , an access cannula  56  extends distally from the endcap  40  and the rotation hub  44 . The access cannula  56  defines a cannula lumen  57  extending through the access cannula  56 . The cannula lumen  57  may extend through the entire length of the access cannula  56  such that the cannula lumen  57  opens out to a luer fitting  58  at a proximal end. In some instances, the cannula lumen  57  may be dimensioned to accommodate the sharp stylet  46  extending therethrough. In some cases, a distal region of the access cannula  56  may have a particular shape in order to facilitate accessing tortuous portions of the patient&#39;s anatomy. For example, a distal region of the access cannula  56  may have a J-shape (shown in dashed lines) when the sharp stylet  46  has been withdrawn from the distal region of the access cannula  56 , whereas the sharp stylet may straighten the J-shape tip of the access cannula  56  when inserted therein. By rotating the access cannula  56 , and by virtue of the shaped distal region, an operator can steer the access cannula  56  into a particular duct or branch of a duct, for example. The rotation hub  44  includes a luer fitting  58  that can be used to attach additional elements to the rotation hub  44  when the sharp cap  42  has been removed or it otherwise not present. Other attachment techniques are also contemplated. 
     With reference to  FIG.  1 E , an electrosurgical sheath  58  extends distally from the second actuation member  28 . The electrosurgical sheath  58  includes an electrosurgical tip  60  that is disposed at a distal end  62  of the electrosurgical sheath  58 . An electrosurgical sheath lumen  64  extends through the electrosurgical sheath  58 . In some instances, the electrosurgical sheath lumen  64  may be dimensioned to accommodate the access cannula  56  extending therethrough. In some cases, the electrosurgical sheath lumen  64  also extends through the electrosurgical tip  60  to a distalmost extent of the electrosurgical sheath  58 . It will be appreciated, therefore, that the electrosurgical sheath lumen  64  provides a path for delivering and deploying a medical device that can be advanced through the electrosurgical sheath lumen  64  once particular elements have been removed from the biliary access device  10 . 
     Additional details regarding the internal structure of the illustrative biliary access device  10  may be found in US 2021/0282807, filed Feb. 18, 2021 and entitled DEVICE, A SYSTEM, AND A METHOD FOR ACCESS CANNULA ADVANCEMENT; and US 2021/0236105, filed Feb. 2, 2021 entitled MEDICAL DEVICE ROTATION ASSEMBLIES AND METHODS OF USING THE SAME, which applications are incorporated by reference herein in their entirety. 
       FIGS.  1 A and  1 B  show the illustrative biliary access device  10  in a home position. In  FIG.  2   , the first actuation member  26  has been moved distally in a direction indicated by an arrow  66  by actuating the actuation button  32 . As a result, the sharp stylet  46  is moved distally a sufficient distance be exposed from the distal end of the access cannula  56  and beyond the electrosurgical sheath  58  and to contact tissue in which a puncture is desired. The sharp distal tip  48  of the sharp stylet  46  will penetrate the tissue and form a puncture. 
     In  FIG.  3   , the second actuation member  28  has been moved distally in a direction indicated by an arrow  68  by actuating the actuation button  29 . As a result, the electrosurgical sheath  58  is moved distally relative to the access cannula  56  and the sharp stylet  46  such that the electrosurgical tip  60  is brought into contact with the puncture. The sharp cap  42  and the sharp stylet  46  may be removed from the biliary access device  10 , as shown in  FIG.  4    by withdrawing the sharp stylet  46  proximally from the handle  12 . The electrosurgical tip  60  may then be actuated in order to create a larger aperture where the puncture was originally created by the sharp distal tip  48  of the sharp stylet  46 . In some cases, the electrosurgical tip  60  may be used to enlarge the opening to be an  8 F (French) opening. In some cases, the opening may be referred to as a fistula, which refers to an opening between two bodily structures that do not normally have an opening therebetween. 
     Next, the rotation hub  44  and attached access cannula  56  are removed from the biliary access device  10 . The endcap  40  is also removed. The sharp cap  42  and the sharp stylet  46  were previously removed.  FIG.  5    illustrates the biliary access device  10  with these elements removed. The handle  12  includes a proximal end  70  that is adapted to releasably secure the endcap  40  thereto, with the rotating hub  44  and the sharp cap  42  adapted to be secured to the endcap  40 . As will be discussed, additional elements may be secured to the proximal end  70  in order to now use the biliary access device  10  for delivering a medical device. 
     To prepare the biliary access device  10  to be used to deliver a medical device, and with reference to  FIG.  5   , the first actuation member  26  is moved in a direction indicated by an arrow  72  (i.e., distally) to a full throw position and the second actuation member  28  is moved in a direction indicated by an arrow  74  (i.e., proximally) to a home position. In other words, the first actuation member  26  and the second actuation member  28  may be moved in opposition directions. This allows attachment of additional elements for delivery. 
       FIG.  6 A  is a side view of a delivery endcap assembly  80 . The delivery endcap assembly  80  is adapted to be securable to the proximal end  70  of the handle  12  (with the access endcap  40  removed) in order to facilitate use of the biliary access device  10  in subsequently delivering a medical device through a fistula created by the biliary access device  10  at an anatomical location reached by the biliary access device  10 . The delivery endcap assembly  80  may include a delivery endcap  82 , a delivery rotation hub  84  and/or a delivery valve  86 .  FIG.  6 B  is a perspective view of the delivery endcap  82 . In some cases, the delivery valve  86  is a Touhy Borst adaptor that enables devices to be extended into and through the delivery valve  86  without allowing fluid such as various bodily fluids or saline from leaking out around whatever device is being extended through the delivery valve  86 . 
     The delivery endcap  82  may be considered as including a securement portion  88  that may be adapted to be releasably secured to the proximal end  70  of the handle  12 . In some cases, the securement portion  88  includes one or more latches  90  that are adapted to interact with the proximal end  70  of the handle  12  in order to secure the securement portion  88  to the proximal end  70  of the handle  70 . While shown as being several latches  90  (there is another latch 180 degrees about the circumference of the securement portion  88  from the visible latch  90 ), in some cases other securement techniques may be used. For example, the securement portion  88  may form a frictional fit with the proximal end  70  of the handle  12 . The securement portion  88  may be adapted to be threadedly engaged with the proximal end  70  of the handle  12 . The securement portion  88  may be snap fit into engagement with the proximal end  70  of the handle  12 . These are just examples. 
       FIG.  6 B  is a first perspective view of the delivery endcap  82  highlighting a tapered portion  92  extending distally while  FIG.  6 C  is a second perspective view of the delivery endcap  82  highlighting an opposing proximal end  96 . The delivery endcap  82  includes a lumen  94  that extends longitudinally through the delivery endcap  82  from the proximal end to the distal end of the delivery endcap  82 . The opposing proximal end  96  may include one or more latches, such as a pair of latches  98  that are adapted to engage the rotation hub  84 . Other securement techniques are also contemplated. 
     The tapered portion  92  may be frustoconical, and may include an outer wall tapering to a smaller diameter in a distal direction to or toward the distal end of the tapered portion  92  and/or an inner wall (defining a lumen therethrough) tapering to a smaller diameter in a distal direction to or toward the distal end of the tapered portion  92 . As will be discussed, the tapered portion  92  is adapted to engage a sheath extending within the biliary access device  10  in order to provide a contiguous lumen extending therethrough. In some cases, the sheath extending through the biliary access device  10  may be the electrosurgical sheath  58 . In some cases, another sheath or hypotube may extend between the electrosurgical sheath  58  and the tapered portion  92  and the lumen  94  extending therethrough. Thus, the lumen through the delivery endcap  82  (including through the tapered portion  92 ) may be placed in alignment and communication with the lumen of the sheath, such as the lumen of the electrosurgical sheath  58 . 
     The delivery rotation hub  84  is adapted to engage the latches  98  in order to secure the rotation hub  84  to the delivery endcap  82 .  FIG.  6 D  is a perspective view of the delivery rotation hub  84 . The delivery rotation hub  84  includes a lumen  100  that extends through the delivery rotation hub  84 . The lumen  100  is aligned with and in communication with the lumen  94  of the tapered portion  92 . The delivery rotation hub  84  includes an annular engagement section  102  that is adapted to seat into the end  96  of the delivery endcap  82  and be held in place there via the latches  98 . Other securement mechanisms that fixedly attach or rotationally attach the delivery rotation hub  84  to the delivery endcap  82  are also contemplated. The delivery rotation hub  84  may include a luer fitting  104  that may be used to couple other devices to the delivery rotation hub  84 , such as but not limited to the delivery valve  86 . 
       FIG.  6 E  is a perspective view of the delivery valve  86 . As noted, in some cases, the delivery valve  86  may be a Touhy Borst adaptor. The delivery valve  86  includes a lumen  106  that extends through the delivery valve  86 . The lumen  106  is aligned with and in communication with both the lumen  100  of the delivery rotation hub  84  and the lumen  94  of the tapered portion  92 . Accordingly, a medical device can be advanced through the lumen  106  of the delivery valve  86 , then through the lumen  100  of the delivery rotation hub  84 , then through the lumen  94  of the tapered portion  92  of the delivery endcap  82  and into the lumen of the sheath extending therefrom, such that the medical device can be delivered through the sheath and deployed out from the sheath to a treatment site. The delivery valve  86  includes a first region  108  that is adapted to be secured relative to the delivery rotation hub  84 . In some cases, the first region  108  frictionally engages the luer fitting  104  in place on the delivery rotation hub  84 . The delivery valve  86  includes a first knurled portion  110  and a second knurled portion  112 , divided by a cylindrical portion  114 . 
       FIG.  7    is an exploded view, showing the delivery endcap assembly  80  disposed proximate the proximal end  70  of the handle  12  and  FIG.  8    is a side view showing the delivery endcap assembly  80  secured to the proximal end  70  of the handle  12 . It can be seen that the proximal end  70  of the handle  12  includes latching features  116  (e.g., tabs, ears, slots, recesses, etc.) that are adapted to engage the latches  80  formed as part of the delivery endcap  82 . Accordingly, the delivery endcap assembly  80  may be easily secured relative to the proximal end  70  of the handle  12 . 
       FIG.  9    is a perspective view of the biliary access device  10 , ready to receive the delivery endcap assembly  80 . With the sharp cap  42  and sharp stylet  46  removed, as well as the endcap  40 , rotation hub  44  and access cannula  56  removed, the biliary access device  10  includes a lumen  118  visible at the proximal end of the biliary access device  10 . It will be appreciated that the lumen  94  extending through the delivery endcap  82  may be adapted to butt up against the lumen  118  visible within the biliary access device  10 , or otherwise be aligned with and in communication with the lumen  118 . The lumen  118  may represent a proximal portion of the electrosurgical sheath  58 , for example. 
       FIG.  10    is a side view of an illustrative assembly  120  that may be used for deploying a medical device within a desired treatment site. As an example, the illustrative assembly  120  may be adapted for deploying a medical device such as an expandable stent. In some cases, the illustrative assembly  120  may be adapted for deploying a medical device such as an expandable stent within a patient&#39;s biliary or pancreatic duct, or even within a pancreatic pseudocyst. In some cases, the assembly  120  may be considered as being an example of combining the biliary access device  10  (with certain components removed once access to the target anatomy has been gained) with the delivery endcap assembly  80 . 
       FIG.  11    is a cross-sectional view taken along the line  11 - 11  of  FIG.  10   . A sheath  132 , which may for example represent the electrosurgical sheath  58  (or a separate sheath if present), axially aligns with the lumen  94  extending through the delivery endcap  82 . The sheath  132  extends through a sled device  130  that functions to support the sheath  132  as it passes through the outer member  16 . As can be seen, the lumen  94  extending through the delivery endcap  82  axially aligns with the lumen  100  extending through the delivery rotation hub  84  as well as the lumen  106  extending through the delivery valve  86 . Any medical device that can fit through the lumens  58 ,  94 ,  100  and  106  can now be delivered through the assembly  120 . While a variety of different medical devices are contemplated for delivery via the assembly  120 , in some cases the assembly  120  may be considered as being adapted to deliver an expandable stent as the medical device. 
       FIGS.  12 A and  12 B  are side views showing an expandable stent being delivered through the illustrative assembly of  FIG.  10   . In  FIG.  12 A , an expandable stent  140  is shown being advanced through the electrosurgical sheath  130  that forms a part of the biliary access device  10  that, in combination with the delivery endcap assembly  80 , forms the assembly  120 . It will be appreciated that the electrosurgical sheath  130  is shown as being transparent in order to show the expandable stent  140 . A mandrel  142  can be seen within the electrosurgical sheath  130 , urging the expandable stent  140  distally. In  FIG.  12 B , the expandable stent  140  is beginning to emerge from the electrosurgical sheath  130 , passing through the electrosurgical tip  60 . 
       FIG.  13    is a flow diagram showing an illustrative method  150  of delivering a medical device using a biliary access device (such as the biliary access device  10 ) adapted to provide an access aperture providing access to a desired site within the patient&#39;s anatomy, the access device including a handle and a stylet distally extendable from the handle within a sheath. In some cases, the sheath includes an electrosurgical sheath with an electrosurgical tip disposed at a distal end of the electrosurgical sheath, and the method  150  further includes using the electrosurgical tip to enlarge the access aperture formed by the stylet. 
     The access device is used to reach the desired site within the patient&#39;s anatomy, as indicated at block  150 . The stylet is extended to provide a puncture at the desired site, the puncture forming the access aperture, as indicated at block  154 . The stylet is subsequently withdrawn from the sheath and the handle, as indicated at block  156 . A delivery endcap assembly is attached to the handle, the delivery endcap assembly adapted to provide access to a lumen extending through the sheath, as indicated at block  158 . A guidewire is extended through the access device and through the access aperture, as indicated at block  160 . The medical device is extended through the delivery endcap assembly and down the guidewire to the desired site, as indicated at block  162 . The medical device is deployed at the desired site, as indicated at block  164 . 
     In some cases, the medical device to be delivered includes an expandable stent disposed within an introducer sheath, the introducer sheath adapted to butt up against a proximal end of the electrosurgical sheath such that a mandrel may be used to advance the expandable stent through the biliary access device. In some cases, the delivery endcap assembly includes a securement portion adapted to be releasably securable to a proximal end of the handle after the stylet has been removed from the handle, a tapered portion extending proximally from the securement portion, a rotation hub adapted to be coupled to the securement portion, a valve adapted to be coupled to the rotation hub, and a lumen extending through the delivery endcap assembly, where the lumen extending through the delivery endcap assembly is adapted to permit a medical device within an introducer sheath to be advanced through the biliary access device. 
     The devices described herein, including but not limited to the biliary access device  10 , the delivery endcap assembly  80  and the assembly  120  may be formed of a variety of different materials. In some cases, the biliary access device  10 , the delivery endcap assembly  80  and the assembly  120  may be formed of one or more polymeric materials. In some cases, the various components of the biliary access device  10 , the delivery endcap assembly  80  and the assembly  120  may be formed of polymers such as polyurethane. 
     Additional examples of suitable polymers 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  85 A), 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  50 A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. 
     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.