Device Delivery via Biliary Access Device

Abstract

The delivery end cap assembly is configured for use with a biliary access device and configured to allow a medical device to be delivered through the biliary access device. The delivery end cap assembly includes a fixed portion configured to be releasably securable to a proximal end of the handle after one or more removable components are removed from the handle, a tapered portion extending proximally from the fixed portion, a rotating hub configured to be coupled to the fixed portion, a valve configured to be coupled to the rotating hub, and a lumen extending through the delivery end cap assembly configured to allow a medical device within an introducer sheath to be advanced through the biliary access device.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods for making and using medical devices. More particularly, the disclosure relates to the use of biliary access devices for the subsequent delivery of medical devices such as expandable stents. [Background technology]

[0002] A wide variety of medical devices have been developed for medical use, for example, for use in accessing and interacting with fluids and structures within body cavities. Some of these devices include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and / or systems used to deliver such devices. These devices may be manufactured by any of a variety of different manufacturing methods and used according to any of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing, and use alternatives for medical devices. As an example, an assembly for deploying a medical device in a patient's bile or pancreatic duct includes a biliary access device and a delivery end cap assembly. The biliary access device includes a handle and an electrosurgical sheath movable relative to the handle, the electrosurgical sheath including an electrosurgical tip and forming an electrosurgical sheath lumen extending therethrough. An access cannula is extendable through the electrosurgical sheath lumen and forming a cannula lumen extending therethrough, the access cannula being configured to be removable from the biliary access device. A sharp stylet is extendable through the cannula lumen and configured to be removable from the biliary access device. The access end cap assembly is positionable at a proximal end of the handle and configured to be removable from the biliary access device. The delivery end cap assembly is configured to be securable to the proximal end of the handle in place of the access end cap assembly. The delivery end cap assembly includes a fixing portion configured to be releasably securable to the proximal end of the handle and a lumen extending therethrough and configured to receive a medical device.

[0004] Alternatively or additionally, the delivery end cap assembly may further include a tapered portion extending proximally from the fixed portion, a rotation hub configured to be coupled to the fixed portion, and a valve configured to be coupled to the rotation hub, with the lumen of the delivery end cap assembly extending through each of the tapered portion, the rotation hub, and the valve.

[0005] Alternatively or additionally, the access endcap assembly may further include a rotating hub. Alternatively or additionally, the sharpened stylet may further include a sharpened cap configured to releasably secure the sharpened stylet to the rotating hub.

[0006] Alternatively or additionally, the access cannula may be operatively coupled to the rotation hub such that rotation of the rotation hub causes rotation of the access cannula. Alternatively or additionally, the access cannula may be operatively coupled to the rotation hub such that removal of the rotation hub also removes the access cannula from the biliary access device.

[0007] Alternatively or additionally, when the access cannula and sharp stylet are removed from the biliary access device and the delivery end cap assembly is secured to the proximal end of the handle of the biliary access device, the lumen of the delivery end cap assembly may be positionable to align and communicate with the electrosurgical sheath lumen such that the electrosurgical sheath is adapted to accommodate a medical device extending through the electrosurgical sheath lumen.

[0008] Alternatively or additionally, the medical device may include an expandable stent disposed within the introducer sheath. Alternatively or additionally, the introducer sheath is configured to engage a proximal end of the electrosurgical sheath lumen such that an expandable stent can be advanced from the introducer sheath through the electrosurgical sheath lumen using a mandrel.

[0009] Alternatively or additionally, the handle may include an inner member and an outer member, the inner member being slidably disposed within the outer member, and translation of the inner member relative to the outer member may effect translation of the sharpened stylet.

[0010] Alternatively or additionally, the handle may further include an electrosurgical actuator slidably coupled to an outer member of the handle, such that translating the electrosurgical actuator relative to the handle may cause translation of the electrosurgical sheath.

[0011] Alternatively or additionally, the delivery end cap assembly may further include a modified rotation hub. As another example, a delivery end cap assembly is configured for use with a biliary access device configured to provide 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 to provide access, and the delivery end cap assembly is configured to allow a medical device to be delivered through the biliary access device. The delivery end cap assembly includes a stationary portion configured to be releasably securable to a proximal end of the handle after the one or more removable components are detached from the handle. A tapered portion extends proximally from the stationary portion, and a rotating hub is configured to be coupled to the stationary portion. A valve is configured to be coupled to the rotating hub. A lumen extends through the delivery end cap assembly and is configured to allow a medical device within an introducer sheath to be advanced through the biliary access device.

[0012] Alternatively or additionally, one of the one or more removable components may include a sharpened stylet operably associated with a sharpened stylet cap removably securable to the biliary access device.

[0013] Alternatively or additionally, one of the one or more removable components may include an access cannula operably coupled with a rotating hub that is removably securable to the biliary access device.

[0014] Alternatively or additionally, the medical device may include an expandable stent disposed within an introducer sheath configured to abut a proximal end of the sheath such that the expandable stent can be advanced through the biliary access device using a mandrel.

[0015] In another example, a medical device is delivered using a biliary access device configured to provide an access opening providing access to a desired site within a patient's anatomy, the access device including a handle and a stylet extendable distally from the handle within a sheath. The access device is used to reach the desired site within the patient's anatomy, and the stylet is extended to provide a puncture at the desired site, the puncture creating an access opening. The stylet is withdrawn from the sheath and handle. A delivery end cap assembly is attached to the handle, the delivery end cap assembly configured to provide access to a lumen extending through the sheath. A guidewire is extended through the access device and through the access opening. A medical device is extended through the delivery end cap assembly and down the guidewire to the desired site. The medical device is deployed at the desired site.

[0016] Alternatively or additionally, the sheath may include an electrosurgical sheath having an electrosurgical tip disposed at a distal end of the electrosurgical sheath, and the method may further include the step of enlarging the access opening formed by the stylet using the electrosurgical tip.

[0017] Alternatively or additionally, the medical device may include an expandable stent disposed within an introducer sheath configured to abut a proximal end of the electrosurgical sheath such that the expandable stent can be advanced through the biliary access device using a mandrel.

[0018] Alternatively or additionally, the delivery end cap assembly may include a fixed portion configured to be releasably fixable to the proximal end of the handle after the stylet is removed from the handle, a tapered portion extending proximally from the fixed portion, a rotary hub configured to be coupled to the fixed portion, a valve configured to be coupled to the rotary hub, and a lumen extending through the delivery end cap assembly, the lumen extending through the delivery end cap assembly being configured to allow a medical device within the introducer sheath to advance through the bile duct access device.

[0019] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following drawings and detailed description illustrate these embodiments more specifically. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention may be more fully understood in view of the following detailed description of various embodiments of the invention related to the accompanying drawings. [Figure 1A] FIG. 1A is a side view of an exemplary bile duct access device. [Figure 1B] FIG. 1B is a plan view of the exemplary bile duct access device of FIG. 1A. [Figure 1C] FIG. 1C is a partial side view of the exemplary bile duct access device of FIGS. 1A and 1B. [Figure 1D] FIG. 1D is a partial side view of the exemplary bile duct access device of FIGS. 1A and 1B. [Figure 1E] FIG. 1E is a partial side view of the exemplary bile duct access device of FIGS. 1A and 1B. [Diagram 2] FIG. 2 is a diagram showing a method of using the exemplary bile duct access device of FIGS. 1A and 1B to provide access. [Diagram 3] FIG. 3 is a diagram showing a method of using the exemplary bile duct access device of FIGS. 1A and 1B to provide access. [Figure 4]A diagram showing a method of using the exemplary bile duct access devices of FIGS. 1A and 1B to provide access. [Diagram 5] A diagram showing a method of using the exemplary bile duct access devices of FIGS. 1A and 1B to provide access. [Figure 6A] A side view of an exemplary delivery end cap assembly that can be used with the exemplary bile duct access devices of FIGS. 1A and 1B to deliver a medical device. [Figure 6B] A perspective view of a portion of the exemplary delivery end cap assembly of FIG. 6A. [Figure 6C] A perspective view of a portion of the exemplary delivery end cap assembly of FIG. 6A. [Figure 6D] A perspective view of a portion of the exemplary delivery end cap assembly of FIG. 6A. [Figure 6E] A perspective view of a portion of the exemplary delivery end cap assembly of FIG. 6A. [Figure 7] A partially exploded side view of a portion of the exemplary delivery end cap assembly of FIG. 6A in combination with the exemplary bile duct access devices of FIGS. 1A and 1B. [Figure 8] A side view of the exemplary delivery end cap assembly of FIG. 6A fixed to the exemplary bile duct access devices of FIGS. 1A and 1B. [Figure 9] An exploded perspective view of a portion of the exemplary delivery end cap assembly of FIG. 6A in combination with the exemplary bile duct access devices of FIGS. 1A and 1B. [Figure 10] A side view of an exemplary assembly for deploying a medical device. [Figure 11] A cross-sectional view taken along line 10-10 of FIG. 10. [Figure 12A] A side view showing an expandable stent being delivered through the exemplary assembly of FIG. 10. [Figure 12B] A side view showing an expandable stent being delivered through the exemplary assembly of FIG. 10. [Figure 13]FIG. 1 is a flow diagram illustrating an exemplary method. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] While the disclosure is susceptible 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.

[0022] 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 numerical values ​​herein are assumed to be modified by the term "about," whether or not expressly stated. The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numerical values ​​that are rounded to the nearest significant figure.

[0023] Enumerating numeric 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 used in its sense including "and / or" unless the content clearly dictates otherwise.

[0024] 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.

[0025] Figure 1A is a side view and Figure 1B is a top view of an exemplary biliary access device 10. Although the present disclosure focuses on gaining access and ultimately delivering a medical device as biliary access device 10, it will be understood that this is merely exemplary as the concepts described herein are equally applicable to accessing and ultimately delivering a medical device to any of a variety of different regions or systems of the human anatomy.

[0026] The exemplary biliary access device 10 can be used to access the bile duct and pancreatic duct, as well as pancreatic pseudocysts, through an accessory channel of an ultrasound endoscope. The biliary access device 10 allows for the placement of a guidewire for a rendezvous procedure, and the placement of ancillary devices, such as a stent delivered over the guidewire. The biliary access device 10 has the ability to puncture a target site through a patient's stomach or duodenum, advance and guide a guidewire to the target site, and dilate a fistula. The biliary access device 10 can be used under endoscopic ultrasound (EUS) guidance, under fluoroscopy, or even under direct visualization.

[0027] The exemplary biliary access device 10 includes a handle 12 including an inner member 14 and an outer member 16. The inner member 14 may, for example, be slidably disposed within and extend distally of the outer member 16. The handle 12 includes a nut 18 that may secure the biliary access device 10 to an endoscope accessory or other channel. A length adjustment mechanism 20 is coupled to the nut 18 and may be used to adjust the relative length of the biliary access device 10. In some examples, a scale 22 is disposed along the inner member 14 and may be used as a guide in adjusting the relative length of the biliary access device 10. The length adjustment mechanism 20 includes a locking feature 24 that may be used to lock the length adjustment mechanism 20 in place relative to the inner member 14 to adjust the relative length of the biliary access device 10. The bile duct access device 10 includes a first actuating member 26 and a second actuating member 28. In some examples, the first actuating member 26 is fixed to the distal end of the outer member 16 and is actuated to move the outer member 16 relative to the inner member 14, and thus to translate the outer member 16 longitudinally parallel to the inner member 14. A scale 30 may be disposed on the inner member 14 as a guide for moving the outer member 16 relative to the inner member 14.

[0028] By using the scale 30 in combination with the first actuating member 26, it will be understood that the operator can control the axial parallel translation of the outer member 16 relative to the inner member 14, and thus the longitudinal parallel translation of any inner member fixed to the outer member 16. Accordingly, the operator can translate one or more inner members a specific distance parallel to each other as indicated by the scale 30. The first actuating member 26 includes an actuating button 32 that can be depressed to move the first actuating member 26 relative to the inner member 14. As seen in FIG. 1B, the inner member 14 includes a slot 34 that allows the first actuating member 26 and thus the outer member 16 to translate longitudinally parallel to the inner member 14.

[0029] The second actuating member 28 is configured to translate relative to the outer member 16 as enabled by the slot 36 seen in FIG. 1B. The second actuating member 28 includes an actuating button 29 that can be used to move the second actuating member 28 relative to the outer member 16. In some examples, the second actuating member 28 may be operably coupled to an electrosurgical element, and thus the second actuating member 28 may include an electrical connection 38 through which the electrosurgical element can be powered.

[0030] Biliary access device 10 includes several components at the proximal end 39 that provide the functionality of biliary access device 10 in providing access to a desired site and that can be removed from biliary access device 10 to allow a medical device to be delivered through biliary access device 10. Biliary access device 10 includes an end cap 40, a sharpened cap 42, and a rotating hub 44 that is partially visible beneath sharpened cap 42.

[0031] 1C, the sharp cap 42 is operably coupled to the sharp stylet 46. For example, a proximal end region of the sharp stylet 46 may be fixedly attached to and extend distally from the sharp cap 42. 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 the 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. The sharp cap 42 thus includes a gripping feature 50 that may be used to remove the sharp cap 42 (and thus the sharp stylet 46) from the end cap 40. The sharp cap 42 also includes a fastening feature 52 (e.g., a distally extending tab) that can be used to releasably secure the sharp cap 42 to the end cap 40. In some examples, as shown, the sharp cap 42 can include a luer fitting 54 that can be used to attach additional elements to the sharp cap 42.

[0032] 1D, the access cannula 56 extends distally from the end cap 40 and the rotation hub 44. The access cannula 56 is formed with a cannula lumen 57 that extends therethrough. The cannula lumen 57 extends through the entire length of the access cannula 56 until the cannula lumen 57 opens at the proximal end to a luer fitting 58. In some examples, the cannula lumen 57 may be dimensioned to accommodate a sharp stylet 46 that extends therethrough. In some examples, the distal region of the access cannula 56 may have a particular shape to allow access to tortuous portions of the patient's anatomy. For example, the distal region of the access cannula 56 may have a J-shape (shown in dashed lines) when the sharp stylet 46 is withdrawn from the distal region of the access cannula 56, while the sharp stylet may straighten the J-shaped tip of the access cannula 56 when inserted into the access cannula 56. By rotating the access cannula 56 and with the shaped distal region, the operator may, for example, guide the access cannula 56 into a particular duct or duct bifurcation. The rotation hub 44 includes a luer fitting 58, although other attachment techniques are envisioned that may be used to attach additional elements to the rotation hub 44 when the sharp cap 42 is removed or otherwise not present.

[0033] 1E, an electrosurgical sheath 58 extends distally from the second actuation member 28. The electrosurgical sheath 58 includes an electrosurgical tip 60 disposed at a distal end 62 of the electrosurgical sheath 58. An electrosurgical sheath lumen 64 extends therethrough. In some examples, the electrosurgical sheath lumen 64 may be dimensioned to accommodate the access cannula 56 extending therethrough. In some examples, the electrosurgical sheath lumen 64 also extends through the electrosurgical tip 60 to a distal-most extent of the electrosurgical sheath 58. It will thus be appreciated that the electrosurgical sheath lumen 64 provides a pathway for delivery and deployment of medical devices that may be advanced through the electrosurgical sheath lumen 64 once certain elements have been removed from the biliary access device 10.

[0034] Additional details regarding the internal structure of the exemplary biliary access device 10 are described in U.S. Patent Application Publication No. 2021 / 0282807, filed February 18, 2021, entitled "DEVICE, A SYSTEM, AND A METHOD FOR ACCESS CANNULA ADVANCEMENT," and U.S. Patent Application Publication No. 2021 / 0236105, filed February 2, 2021, entitled "MEDICAL DEVICE ROTATION ASSEMBLIES AND METHODS OF USING THE SAME," which are incorporated by reference in their entireties herein.

[0035] 1A and 1B show an exemplary biliary access device 10 in a home position. In FIG. 2, actuation of the actuation button 32 causes the first actuation member 26 to move distally in the direction indicated by arrow 66. As a result, the sharpened stylet 46 moves distally a sufficient distance to be exposed beyond the electrosurgical sheath 58 from the distal end of the access cannula 56 and to contact the tissue where puncture is desired. The sharpened distal tip 48 of the sharpened stylet 46 penetrates the tissue and forms a puncture.

[0036] Activating the activation button 29 in FIG. 3 causes the second actuation member 28 to move distally in the direction indicated by the arrow 68. As a result, the electrosurgical sheath 58 moves distally relative to the access cannula 56 and the sharpened stylet 46, causing the electrosurgical tip 60 to contact the puncture. The sharpened cap 42 and the sharpened stylet 46 may be removed from the biliary access device 10 by withdrawing the sharpened stylet 46 proximally from the handle 12, as shown in FIG. 4. The electrosurgical tip 60 may then be actuated to create a larger opening where the puncture was originally created by the sharpened distal tip 48 of the sharpened stylet 46. In some instances, the electrosurgical tip 60 may be used to enlarge the opening to be an 8F (French) (2.67 mm) opening. In some instances, the opening may be referred to as a fistula, which refers to an opening between two body structures that do not normally have an opening between them, Next, the rotation hub 44 and attached access cannula 56 are removed from the biliary access device 10. The end cap 40 is also removed. The sharp cap 42 and sharp stylet 46 were previously removed. FIG. 5 shows the biliary access device 10 with these elements removed. The handle 12 includes a proximal end 70 configured to releasably secure the end cap 40, and the rotation hub 44 and sharp cap 42 are configured to be secured to the end cap 40. As described below, additional elements may be secured to the proximal end 70 in order to use the biliary access device 10 to deliver a medical device.

[0037] To prepare the biliary access device 10 to be used to deliver a medical device, with reference to Figure 5, the first actuating member 26 is moved in the direction indicated by arrow 72 (i.e., distally) to a full throw position, and the second actuating member 28 is moved in the direction indicated by arrow 74 (i.e., proximally) to a home position. In other words, the first actuating member 26 and the second actuating member 28 may be moved in opposite directions, allowing for the attachment of additional elements for delivery.

[0038] FIG. 6A is a side view of the delivery end cap assembly 80. The delivery end cap assembly 80 is configured to be securable to the proximal end 70 of the handle 12 (with the access end cap 40 removed) to enable use of the biliary access device 10 in subsequently delivering a medical device through a stoma created by the biliary access device 10 at an anatomical location reached by the biliary access device 10. The delivery end cap assembly 80 may include a delivery end cap 82, a delivery rotation hub 84, and / or a delivery valve 86. FIG. 6B is a perspective view of the delivery end cap 82. In some examples, the delivery valve 86 is a Touhy Borst style adapter that allows devices to extend into and through the delivery valve 86 without allowing fluids, such as various bodily fluids or saline, to leak out from around the device extending through the delivery valve 86.

[0039] The delivery end cap 82 may include a fixed portion 88 that may be configured to be releasably secured to the proximal end 70 of the handle 12. In some examples, the fixed portion 88 includes one or more latches 90 configured to interact with the proximal end 70 of the handle 12 to secure the fixed portion 88 to the proximal end 70 of the handle 12. Although there are shown to be several latches 90 (with another 180 degrees circumferentially of the fixed portion 88 from the visible latch 90), in some examples, other securing techniques may be used. For example, the fixed portion 88 may form a friction fit with the proximal end 70 of the handle 12. The fixed portion 88 may be configured to be threadedly engaged with the proximal end 70 of the handle 12. The fixed portion 88 may be snap-fit ​​to engage the proximal end 70 of the handle 12. These are just a few examples.

[0040] 6B is a first perspective view of the delivery end cap 82 highlighting the distally extending tapered portion 92, and FIG. 6C is a second perspective view of the delivery end cap 82 highlighting the opposite proximal end 96. The delivery end cap 82 includes a lumen 94 extending longitudinally through the delivery end cap 82 from the proximal end to the distal end of the delivery end cap 82. The opposite proximal end 96 may include one or more latches, such as a pair of latches 98 configured to engage the rotation hub 84. Other fastening techniques are also envisioned.

[0041] The tapered portion 92 may be frustoconical and may include an outer wall that tapers to a smaller diameter distally to or toward the distal end of the tapered portion 92, and / or an inner wall that tapers to a smaller diameter distally to or toward the distal end of the tapered portion 92 (forming a lumen therethrough). As described below, the tapered portion 92 is configured to engage a sheath extending within the biliary access device 10 to provide a continuous lumen extending therethrough. In some examples, the sheath extending through the biliary access device 10 may be an electrosurgical sheath 58. In some examples, a separate sheath or hypotube may extend between the electrosurgical sheath 58 and the tapered portion 92 and the lumen 94 extending through the tapered portion 92. Thus, the lumen through delivery end cap 82 (including through tapered portion 92 ) may be aligned with and disposed in communication with a lumen of a sheath, such as the lumen of electrosurgical sheath 58 .

[0042] The delivery rotation hub 84 is configured to engage the latch 98 to secure the rotation hub 84 to the delivery end cap 82. FIG. 6D is a perspective view of the delivery rotation hub 84. The delivery rotation hub 84 includes a lumen 100 extending therethrough. 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 portion 102 configured to seat within the end 96 of the delivery end cap 82 and be held in place at the end 96 via the latch 98. Other fastening mechanisms for fixedly or rotatably attaching the delivery rotation hub 84 to the delivery end cap 82 are also envisioned. 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, a delivery valve 86.

[0043] FIG. 6E is a perspective view of the delivery valve 86. As mentioned above, in some examples, the delivery valve 86 can be a Touhy Borst type adapter. The delivery valve 86 includes a lumen 106 extending therethrough. 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. Thus, 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 end cap 82, and into the lumen of the sheath extending therefrom, such that the medical device can be delivered through the sheath and deployed out of the sheath to a treatment site. The delivery valve 86 includes a first region 108 configured to be secured relative to the delivery rotation hub 84. In some examples, the first region 108 frictionally engages a luer fitting 104 that is in place on the delivery rotating hub 84. The delivery valve 86 includes a first knurled portion 110 and a second knurled portion 112 separated by a cylindrical portion 114.

[0044] FIG 7 is an exploded view showing the delivery end cap assembly 80 disposed adjacent the proximal end 70 of the handle 12, and FIG 8 is a side view showing the delivery end cap 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 a latch mechanism 116 (e.g., tabs, ears, slots, recesses, etc.) configured to engage with a latch 80 formed as part of the delivery end cap 82. Thus, the delivery end cap assembly 80 can be easily secured to the proximal end 70 of the handle 12.

[0045] 9 is a perspective view of the biliary access device 10 in a state to receive the delivery end cap assembly 80. With the sharp cap 42 and sharp stylet 46 removed, and the end cap 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 end cap 82 may be configured to abut against or otherwise align with and communicate with the lumen 118 visible in the biliary access device 10. The lumen 118 may represent, for example, a proximal portion of the electrosurgical sheath 58.

[0046] 10 is a side view of an exemplary assembly 120 that may be used to deploy a medical device within a desired treatment site. As an example, the exemplary assembly 120 may be configured to deploy a medical device such as an expandable stent. In some examples, the exemplary assembly 120 may be configured to deploy a medical device such as an expandable stent within a patient's bile or pancreatic duct, or within a pancreatic pseudocyst. In some examples, the assembly 120 may be considered an example of a combination of a biliary access device 10 (with certain components removed once access to the target anatomical structure is obtained) and a delivery end cap assembly 80.

[0047] FIG. 11 is a cross-sectional view taken along line 11-11 of FIG. 10. Sheath 132, which may represent, for example, electrosurgical sheath 58 (or a separate sheath, if present), is axially aligned with lumen 94 extending through delivery end cap 82. Sheath 132 extends through thread device 130, which functions to support sheath 132 as it passes through outer member 16. As can be seen, lumen 94 extending through delivery end cap 82 is axially aligned with lumen 100 extending through delivery rotation hub 84 and lumen 106 extending through delivery valve 86. Any medical device that can be adapted to pass through lumens 58, 94, 100 and 106 may be delivered through assembly 120. While a variety of different medical devices are contemplated for delivery through assembly 120, in some examples, assembly 120 may be configured to deliver an expandable stent as the medical device.

[0048] 12A and 12B are side views showing an expandable stent delivered through the exemplary assembly of FIG. 10. In FIG. 12A, an expandable stent 140 is shown advanced through an electrosurgical sheath 130 that forms part of the biliary access device 10 and that is combined with a delivery end cap assembly 80 to form the assembly 120. It will be appreciated that the electrosurgical sheath 130 is shown as transparent to show the expandable stent 140. Within the electrosurgical sheath 130, a mandrel 142 can be seen that urges the expandable stent 140 distally. In FIG. 12B, the expandable stent 140 has passed the electrosurgical tip 60 and is beginning to emerge from the electrosurgical sheath 130.

[0049] 13 is a flow diagram illustrating an exemplary method 150 of delivering a medical device using a biliary access device (such as biliary access device 10) configured to provide an access opening that provides access to a desired site within a patient's anatomy, the access device including a handle and a stylet extendable distally from the handle within a sheath. In some examples, the sheath includes an electrosurgical sheath having an electrosurgical tip disposed at a distal end of the electrosurgical sheath, and the method 150 further includes enlarging the access opening formed by the stylet using the electrosurgical tip.

[0050] An access device is used to reach a desired site within a patient's anatomy, as shown in block 150. A stylet is extended to provide a puncture at the desired site, forming an access opening, as shown in block 154. The stylet is then withdrawn from the sheath and handle, as shown in block 156. A delivery end cap assembly is attached to the handle, as shown in block 158, and is configured to provide access to a lumen extending through the sheath. A guidewire is extended through the access device and through the access opening, as shown in block 160. A medical device is extended through the delivery end cap assembly and down the guidewire to the desired site, as shown in block 162. The medical device is deployed at the desired site, as shown in block 164.

[0051] In some examples, the medical device to be delivered includes an expandable stent disposed within an introducer sheath configured to abut a proximal end of the electrosurgical sheath such that the expandable stent can be advanced through the biliary access device using a mandrel. In some examples, the delivery end cap assembly includes a fixed portion configured to be releasably securable to the proximal end of the handle after the stylet is removed from the handle, a tapered portion extending proximally from the fixed portion, a rotating hub configured to be coupled to the fixed portion, a valve configured to be coupled to the rotating hub, and a lumen extending through the delivery end cap assembly configured to allow the medical device within the introducer sheath to be advanced through the biliary access device.

[0052] The devices described herein, including but not limited to the biliary access device 10, the delivery end cap assembly 80, and the assembly 120, may be formed of a variety of different materials. In some examples, the biliary access device 10, the delivery end cap assembly 80, and the assembly 120 may be formed from one or more polymeric materials. In some examples, various components of the biliary access device 10, the delivery end cap assembly 80, and the assembly 120 may be formed from a polymer, such as polyurethane.

[0053] Additional examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (e.g., PEBA available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, and the like. Polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS AmericanSuch materials include, but are not limited to, polyvinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonates, ionomers, biocompatible polymers, another suitable material, or mixtures, combinations, copolymers thereof, polymer / metal composites, and the like.

[0054] It should be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, using any of the features of one illustrative embodiment in other embodiments. The scope of the invention is, of course, defined in the language expressed in the appended claims.

Claims

1. 1. An assembly for deploying a medical device within a bile or pancreatic duct of a patient, comprising:

1. A biliary access device comprising: A handle and an electrosurgical sheath movable relative to the handle, the electrosurgical sheath including an electrosurgical tip and defining an electrosurgical sheath lumen extending therethrough; an access cannula extendable through the electrosurgical sheath lumen, the access cannula defining a cannula lumen extending therethrough, the access cannula being configured to be removable from the biliary access device; a sharpened stylet extendable through the cannula lumen, the sharpened stylet configured to be removable from the biliary access device; a biliary access device including an access end cap assembly positionable on a proximal end of the handle, the access end cap assembly configured to be removable from the biliary access device; a delivery endcap assembly configured to be securable to the proximal end of the handle in place of the access endcap assembly, a fastening portion configured to be releasably securable to the proximal end of the handle; a delivery end cap assembly including a lumen extending therethrough and configured to accommodate the medical device.

2. The delivery end cap assembly comprises: a tapered portion extending proximally from the fixed portion; a rotating hub configured to be coupled to the fixed portion; a valve configured to be coupled to the rotating hub, The assembly of claim 1 , wherein the lumen of the delivery end cap assembly extends through each of the tapered portion, the rotation hub, and the valve.

3. The assembly of claim 1 , wherein the access end cap assembly further comprises a rotation hub.

4. The assembly of claim 3 , wherein the sharpened stylet further comprises a sharpened cap configured to releasably secure the sharpened stylet to the rotation hub.

5. The assembly of claim 3 , wherein the access cannula is operatively coupled to the rotation hub such that rotation of the rotation hub causes rotation of the access cannula.

6. The assembly of claim 3 , wherein the access cannula is operatively coupled to the rotation hub such that removal of the rotation hub also removes the access cannula from the biliary access device.

7. 7. The assembly of claim 1, wherein when the access cannula and the sharp stylet are removed from the biliary access device and the delivery end cap assembly is secured to the proximal end of the handle of the biliary access device, the lumen of the delivery end cap assembly is positionable to align and communicate with the electrosurgical sheath lumen such that the electrosurgical sheath is adapted to accommodate the medical device extending through the electrosurgical sheath lumen.

8. The assembly of claim 1 , wherein the medical device comprises an expandable stent disposed within an introducer sheath.

9. The assembly of claim 8, wherein the introducer sheath is configured to engage a proximal end of the electrosurgical sheath lumen such that the expandable stent can be advanced from the introducer sheath through the electrosurgical sheath lumen using a mandrel.

10. the handle comprises an inner member and an outer member, the inner member being slidably disposed within the outer member; 7. The assembly of claim 1, wherein translating the inner member relative to the outer member causes the sharp stylet to translate.

11. The handle further includes an electrosurgical actuator slidably coupled to an outer member of the handle; The assembly of claim 9 , wherein translating the electrosurgical actuator relative to the handle causes the electrosurgical sheath to translate.

12. 1. A delivery end cap assembly configured for use with a biliary access device configured to provide 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 and removably attached to a proximal end of the handle, the one or more removable components configured to provide access, the delivery end cap assembly configured to allow a medical device to be delivered through the biliary access device, the delivery end cap assembly comprising: a securing portion configured to be releasably securable to the proximal end of the handle after the one or more removable components are detached from the handle; a tapered portion extending proximally from the fixed portion; a rotating hub configured to be coupled to the fixed portion; a valve configured to be coupled to the rotating hub; a lumen extending through the delivery end cap assembly; A delivery end cap assembly, the lumen extending through the delivery end cap assembly configured to allow a medical device within an introducer sheath to be advanced through the biliary access device.

13. The delivery end cap assembly of claim 12, wherein one of the one or more removable components includes a sharpened stylet operably associated with a sharpened stylet cap removably securable to the biliary access device.

14. The delivery end cap assembly of claim 12 or 13, wherein one of the one or more removable components includes an access cannula operably coupled to a rotating hub removably securable to the biliary access device.

15. 14. The delivery end cap assembly of claim 12 or 13, wherein the medical device comprises an expandable stent disposed within an introducer sheath configured to abut a proximal end of a sheath such that the expandable stent can be advanced through the biliary access device using a mandrel.

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