Removable mechanism for verifying device access

Abstract

The Luer device includes a connector with a body and a lumen, and a clip (112) with an outer portion and an inner portion. The body includes a distal portion coupled to the cannula (104) and a proximal portion that slidably receives the medical device (108). The outer portion extends along a longitudinal axis from the proximal end to the distal end and includes a channel. A longitudinal slot extends along the outer portion, such that the channel opens to and communicates with the exterior of the clip through the slot. The inner portion extends along the inner surface of the channel that defines the jaws and is formed from a material that is pressed against the device and connector to seal the proximal end of the connector and direct fluid distally therethrough and through a space extending between the inner surface of the cannula and the outer surface of the device when the clip is moved from an open configuration toward a closed configuration in an operative position.

Description

[Background technology]

[0001] Endoscopic ultrasound (EUS) is a minimally invasive procedure performed using a specialized endoscope to visualize internal organs (e.g., the digestive (gastrointestinal) tract and nearby structures) using high-frequency sound waves. According to one application, EUS may be used, for example, to facilitate biliary drainage after the failure of conventional endoscopic retrograde cholangiopancreatography (ERCP), which utilizes contrast agents and X-rays to identify and treat obstructions within the duct. EUS may also be used to gain guidewire access to the common bile duct or pancreatic duct. The success of the EUS access procedure depends on initial duct puncture and the stability of the access cannula within the duct during guidewire passage.

[0002] According to some current procedures, once access is gained into a duct or other anatomical structure via a sharp or other needle advanced through an access cannula and puncturing the duct or tissue wall, the sharp is removed and a contrast agent or saline solution is injected through the access cannula into the target site, allowing verification of the access cannula's position within the duct via fluoroscopic visualization. After the desired location of the access cannula is confirmed, a guidewire is threaded therethrough to the target site to facilitate advancement of other therapeutic / diagnostic devices to the target site. If it is determined via fluoroscopic visualization that the access cannula is not inserted into the duct as desired, the process of reinserting the sharp through the access cannula and positioning the cannula must be repeated, resulting in lost time and the potential for losing track of the access cannula's position relative to the duct. Summary of the Invention

[0003] The present disclosure relates to a luer device for accessing the bile duct. The device includes a connector and a clip. The connector includes a body extending longitudinally from a proximal end to a distal end. The connector includes a lumen extending therethrough. The connector body includes a distal portion sized, shaped, and configured to couple to the proximal end of an access cannula, and a proximal portion of the body sized, shaped, and configured to slidably receive a medical device received within the access cannula.

[0004] The clip is configured to be clipped onto the proximal portion of the connector and a portion of the medical device extending therefrom. The clip includes an outer portion and an inner portion. The outer portion extends along a longitudinal axis from the proximal end to the distal end and includes a channel extending therethrough along the longitudinal axis. A longitudinal slot extends along the entire length of the outer portion, such that the channel opens to and communicates with an exterior of the clip through the longitudinal slot. The inner portion extends along the inner surface of the channel defining the jaws and is formed from a material that is pressed against the medical device and connector to seal the proximal end of the connector and direct fluid distally therethrough and through a space extending between the inner surface of the access cannula and the outer surface of the medical device when the clip is moved from an open configuration toward a closed configuration in an operative position.

[0005] In one embodiment, the longitudinal slot defines a pair of jaws that are movable between an open configuration in which the longitudinal edges defining the jaws are moved away from one another and a closed configuration in which the longitudinal edges are moved toward one another, drawing the longitudinal edges of the inner portions toward one another and sealing the proximal end of the connector.

[0006] In one embodiment, the clip is biased towards the closed configuration. In one embodiment, the outer portion of the clip includes a pair of wings each extending laterally from a corresponding one of the jaws in a direction away from the longitudinal edge of the jaws such that when the pair of wings is drawn toward one another, the jaws are moved away from one another toward an open configuration, and when the pair of wings is released, the jaws are allowed to return toward a closed configuration.

[0007] In one embodiment, the inner portion is formed from a softer material than the outer portion of the clip. In one embodiment, the connector includes a fluid connection port that is fluidly connected to the lumen of the connector via a connection tube such that fluid is injected through the fluid connection port.

[0008] In one embodiment, the proximal portion of the connector has a smaller cross-sectional area than the distal portion of the connector. In one embodiment, the distal portion of the connector includes threads along its interior surface for threadably engaging corresponding threads along the proximal end of the access cannula.

[0009] In one embodiment, the outer portion of the clip is rotatable relative to the inner portion to move the clip from an open configuration toward a closed configuration. Additionally, the present disclosure relates to a Luer device including a proximal component, a distal component, an inner portion, and a tubular member. The proximal component extends along a longitudinal axis from the proximal end to the distal end and includes a channel extending therethrough. A longitudinal slot extends along the entire length of the proximal component, such that the channel of the proximal component opens to and communicates with an exterior of the proximal component through the longitudinal slot. The longitudinal slot defines a pair of jaws that are movable between an open configuration in which longitudinal edges defining the jaws are moved away from one another and a closed configuration in which the longitudinal edges are moved toward one another.

[0010] The distal component is rotatably longitudinally aligned with and rotatably coupled to the proximal component such that the distal component is rotatable about its longitudinal axis relative to the proximal component, the distal component extends from the proximal end to the distal end and includes a channel extending therethrough, a longitudinal slot extends along the entire length of the distal component such that the channel of the distal component opens to and is in communication with an exterior of the distal component through the longitudinal slot, and a distal portion of the distal component includes threads along its interior for threaded engagement with the proximal end of the access cannula.

[0011] The inner portion extends along the inner surface of the channel of the proximal component that defines the jaws and along the inner surface of the unthreaded proximal portion of the distal component, the inner portion being formed from a material that forms a seal around the medical device when pressed against it.

[0012] The tubular member is received within the inner portion along its distal portion, and the distal end of the tubular member corresponds to the distal end of the inner portion, such that when the proximal portion is in a closed configuration in an operating configuration over the medical device, the distal components are coupled to the access cannula, and the medical device is received within the tubular member, the proximal end of the tubular member is sealed and fluid is directed distally through the access channel around the medical device.

[0013] In one embodiment, the inner portions extend along the inner surface of the proximal component such that the longitudinal edges of the inner portions are separated from each other when the proximal portion is in the open configuration and are drawn toward each other when the proximal portion is in the closed configuration.

[0014] In one embodiment, the proximal component includes a pair of wings each extending laterally from a corresponding one of the jaws in a direction away from the longitudinal edge of the jaws such that when the pair of wings is drawn toward one another, the jaws are moved away from one another toward an open configuration, and when the pair of wings is released, the jaws are allowed to return toward a closed configuration.

[0015] In one embodiment, the inner portion is formed from a softer material than the outer portion of the clip. In one embodiment, the device further includes a fluid connection port in fluid communication with the tubular member, the fluid connection port configured to extend outside the proximal component when the proximal component is in the closed configuration.

[0016] In one embodiment, the distal component is rotatable relative to the inner portion such that when the distal component is moved distally relative to the access cannula during threaded engagement therebetween, the distal end of the inner portion is forced distally against the proximal end of the access cannula, directing fluid flow distally through the tubular member and through the space extending between the interior of the access channel and the outer surface of the medical device.

[0017] The present disclosure further relates to a method of treating a bile duct, the method including coupling a connector to a proximal end of an access cannula, the access cannula including a medical device housed therein and a distal end for insertion into a target duct, a distal portion of the connector engaged with the proximal end of the access cannula and a portion of the medical device extending proximally from the access cannula slidably received within the proximal portion of the connector; clipping a clip over the proximal portion of the connector and the portion of the device extending proximally therefrom, the clip including an inner portion that presses against the medical device and the connector to seal the proximal end of the connector when the clip is in the clipped configuration; injecting fluid into a channel of the connector via a fluid injection port in fluid communication with the connector, wherein the proximal end of the connector is sealed so that the fluid is directed distally through the connector and through a space extending between an inner surface of the access channel and an outer surface of the medical device.

[0018] In one embodiment, the method further includes verifying via fluoroscopic visualization whether the distal end of the access cannula is positioned within the target vessel as desired. In one embodiment, clipping the clip includes moving the clip from an open configuration toward a closed configuration, the clip including an outer portion extending along a longitudinal axis from a proximal end to a distal end and including a channel extending therethrough along the longitudinal axis, a longitudinal slot extending along the entire length of the outer portion whereby the channel opens to and communicates with an exterior of the clip through the longitudinal slot, an inner portion extending along an inner surface of the channel defining the jaws, and as the clip is moved from the open configuration toward the closed clipped configuration, the longitudinal edges of the inner portion are drawn toward each other and the inner portion is formed of a material that presses against and forms a seal around the medical device and a connector received therein.

[0019] In one embodiment, moving the clip between the open and closed configurations includes drawing a pair of wings, each extending laterally from a corresponding one of the jaws, toward each other to move the jaws of the clip away from each other toward the open configuration, and releasing the wings to allow the jaws to return toward the closed configuration.

[0020] In one embodiment, the medical device is one of a needle and a guidewire. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a perspective view of a system according to an exemplary embodiment of the present disclosure. [Figure 2] FIG. 2 is a cross-sectional view of the system according to FIG. [Figure 3] 3 is a side view of a proximal portion of an access cannula and a medical device received therein, according to the system of FIG. 1. FIG. [Figure 4] FIG. 4 is a side view of an access cannula and a distal portion of a medical device inserted into a target vessel and / or anatomical structure according to an exemplary embodiment of the system of FIG. 1, wherein the medical device is a needle and fluid is injected through the access cannula around the needle. [Figure 5] 5 is a side view of an access cannula and a distal portion of a medical device according to another exemplary embodiment of the system of FIG. 1, where the medical device is a guidewire and fluid is injected through the access cannula around the guidewire. [Figure 6] 6 is a partially transparent side view of a connector of a luer device according to the system of FIG. 1. FIG. [Figure 7] 7 is a plan view of a clip of a luer device clipped onto a medical device according to the system of FIG. 1. FIG. [Figure 8] 8 is a plan view of a clip of a Luer device in an open configuration according to the system of FIG. 1. FIG. [Figure 9]9 is a plan view of a clip of a Luer device in a closed configuration according to the system of FIG. 1. FIG. [Figure 10] FIG. 10 is a plan view of a clip of a Luer device according to another exemplary embodiment of the present disclosure in an open configuration. [Figure 11A] 11A is a plan view of a clip of a Luer device according to the system of FIG. 10 in a closed configuration according to a first embodiment. [Figure 11B] 11B is a plan view of a clip of a Luer device according to the system of FIG. 10 in a closed configuration according to a second embodiment. [Figure 12] FIG. 12 is a perspective view of a system according to another exemplary embodiment of the present disclosure. [Figure 13] FIG. 13 is a cross-sectional view of the system according to FIG. [Figure 14] 14 is a cross-sectional view of a Luer device according to another exemplary embodiment of the present disclosure attached to the medical device and access cannula of the system of FIG. 12. [Figure 15] 15 is a perspective view of the luer device of FIG. 14. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0022] The present disclosure can be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals. This disclosure relates to endoscopic ultrasound (EUS) systems and procedures, and in particular to a device (e.g., a Luer device) connectable to an access cannula to facilitate fluid insertion through the access cannula and around a medical device received therein. Exemplary embodiments describe a device configured to be coupled to the proximal end of the access cannula and a medical device received therein, whereby a fluid solution (e.g., contrast agent or saline or echogenic medium) can be injected distally through a space between the inner surface of the access cannula and the outer surface of the medical device to facilitate confirmation of proper placement of the access cannula via fluoroscopy or EUS visualization.

[0023] While some of the exemplary embodiments specifically describe Luer devices as configured for use with an access cannula for accessing the bile duct, it will be understood by those skilled in the art that the Luer devices of the present disclosure may be used with a variety of other endoscopic devices (e.g., catheters) in which it is desired to inject fluids around and through a medical device received therein and into a target area within the body. Furthermore, while the exemplary embodiments describe Luer devices connectable to an access cannula, it will be understood by those skilled in the art that the present disclosure also relates to Luer accessory devices intended to interact with a Luer coupled to the access cannula to facilitate fluid insertion through the access cannula. For example, in a further exemplary embodiment, the Luer accessory device can be interference-fitted around and interface with a Luer connected to the access cannula. It should also be noted that the terms “proximal” and “distal” as used herein are intended to refer to directions toward (proximal) and away from (distal) a user of the device (e.g., a physician).

[0024] As shown in FIGS. 1-9 , a system 100 according to an exemplary embodiment of the present disclosure includes a device 102 (e.g., a Luer device) configured to couple to a proximal end 106 of an access cannula 104 and a medical device 108 (e.g., a sharp, needle, guidewire) received therein to facilitate injection of a fluid 14 through the access cannula 104 and around the medical device 108. Injection of the fluid 14 (e.g., contrast agent, saline, echogenic medium) allows a user (e.g., a physician) to determine via fluoroscopy or EUS visualization whether the distal end 107 of the access cannula 104 is positioned as desired within the target vessel 10 or other anatomical location. According to an exemplary embodiment, as shown in FIGS. 1 and 2 , the device 102 further includes a connector 110 including a fluid injection port 118 and a clip 112.

[0025] Connector 110 includes a distal portion 114 configured to be coupled to the proximal end 106 of access cannula 104 and a proximal portion 116 sized, shaped, and configured to slidably receive therein a portion of medical device 108 extending proximally from access cannula 104. In the exemplary embodiment, a fluid injection port 118 extends laterally from proximal portion 116. Clip 112 is configured to be mounted over proximal portion 116 of connector 110 (e.g., over its proximal end 120 and the portion of medical device 108 extending proximally out of connector 110) and form a seal such that fluid 14 can be injected through fluid injection port 118 and pass distally through an annular space 122 between an inner surface 124 of access cannula 104 and an outer surface 126 of medical device 108. Successful placement of the access cannula 104 is confirmed when, under fluoroscopic visualization, the fluid 14 can be seen filling the target vessel 10 or another target anatomical structure. However, if the visualization shows that the fluid 14 does not fill the target vessel or anatomical structure, it indicates that the access cannula 104 has not been placed within the target vessel 10 or anatomical structure as desired.

[0026] The device 102 is configured to connect to any standard access cannula 104 configured for accessing a target duct 10 or other anatomical structure (e.g., in an EUS procedure such as biliary drainage). The access cannula 104 extends longitudinally from a proximal end 106 to a distal end 107 and includes a channel 130 extending therethrough. As shown in FIG. 3 , the proximal end 106 includes an engaging element, such as, for example, a thread 128 extending therealong. As described in further detail below, the thread 128 is configured to engage corresponding threads on the distal portion 114 of the connector 110. The channel 130 is configured to receive a medical device 108, such as, for example, a sharp or needle, that punctures the wall 12 of the target duct 10 so that the distal end of the access cannula 104 can be inserted therethrough into the target duct or another target anatomical structure. Once the access cannula 104 is properly positioned within the target vessel 10, the sharp or needle is removed, allowing another medical device (e.g., a guidewire) to be inserted through the channel 130 and into the target vessel 10, for example, to provide a guide along which a catheter may be inserted to drain the target vessel 10.

[0027] As mentioned above, during placement of the access cannula 104, it may be desirable to confirm via fluoroscopic visualization that the distal end of the access cannula 104 is properly positioned within the target vessel 10. Current procedures require the user to remove the sharp or needle before injecting the fluid solution 14 for fluoroscopic visualization. However, if fluoroscopic visualization indicates that the access cannula is not properly positioned within the target vessel 10, the user is required to reinsert the sharp or needle to re-pierce the tissue of the vessel 10 so that the access cannula can be properly inserted therein. This reinsertion of the sharp consumes valuable time and risks the user losing track of the location of the access cannula 104 adjacent to the target vessel 10 as they manipulate the device.

[0028] 4, device 102 allows for injection of fluid solution 14 for fluoroscopic visualization around the needle sharp and through access cannula 104 while the needle is received in access cannula 104. Additionally, if, for example, an access cannula 104 properly inserted into vessel 10 is at risk of being displaced out of the target vessel (e.g., due to limited insertion depth in smaller vessels or if anatomical movement may cause access cannula 104 to be displaced out of a previously accessed vessel), a user (e.g., a physician) may wish to double-check that the cannula is properly placed before proceeding with the drainage procedure. 5, the device 102 of the present disclosure allows for the injection of a fluid solution 14 through the channel 130 of the access cannula 104 while a medical device 108, such as, for example, a sharp, needle, or guidewire, is still received therein; i.e., fluid can be supplied to the distal end of the access cannula 104 to confirm its position without removing the guidewire from the access cannula 104. Those skilled in the art will understand that once the guidewire has been successfully positioned in the target vessel or other target anatomical structure, it is desirable to maintain this position so that additional devices can be inserted into the target structure without removing the guidewire and repeating its placement.

[0029] According to an exemplary embodiment, connector 110 of device 102 is configured to couple to both access cannula 104 and a medical device 108 received in access cannula 104. As shown in FIG. 6 , connector 110 includes a body 111 extending longitudinally from a proximal end 120 to a distal end 136 and including a lumen 132 extending therethrough. Body 111 of connector 110 includes both a distal portion 114 configured to engage proximal end 106 of access cannula 104 and a proximal portion 116 configured to slidably engage medical device 108.

[0030] Lumen 132 extends through both distal portion 114 and proximal portion 116. According to an exemplary embodiment, proximal portion 116 has a smaller cross-sectional area (e.g., diameter) than distal portion 114, such that the portion of lumen 132 extending through proximal portion 116 has a smaller cross-sectional area than the portion of lumen 132 extending through distal portion 114, and proximal portion 116 sealingly engages medical device 108, such that fluid introduced into connector 110 via fluid injection port 118 flows distally into access cannula 104.

[0031] In the exemplary embodiment, the portion of lumen 132 extending through proximal portion 116 substantially corresponds to the shape and size of the medical device 108 received therein. In the exemplary embodiment, distal portion 114 is sized, shaped, and configured to be disposed over the proximal end 106 of access cannula 104 and includes threads 134 along its inner surface, e.g., along the surface of lumen 132, configured to threadingly engage corresponding threads on the proximal end 106 of access cannula 104, such that when distal portion 114 is rotated about its longitudinal axis, threads 128 thread onto the proximal end 106 of access cannula 104, sealingly connecting connector 110 to access cannula 104. Connector 110 in this embodiment is configured to engage access cannula 104 such that lumen 132 of connector 110 extends substantially coaxially with channel 130.

[0032] Connector 110 further includes a fluid injection port 118 connected to its body 111. In the exemplary embodiment, fluid injection port 118 is connected to a proximal portion 116 of body 111, for example, via a connecting tube 152, such that fluid injection port 118 is in fluid communication with lumen 132 of connector body 111. Fluid injection port 118 is configured to be coupled to a fluid source, such as, for example, a syringe.

[0033] Clip 112 is configured, for example, to clip onto and form a seal around proximal portion 116 of connector 110 and a portion of medical device 108 extending proximally from proximal end 120 of connector 110. Clip 112 thus forms a seal around proximal end 120 of connector 110 and medical device 108, as shown in FIG. 7 , such that fluid 14 injected into lumen 132 of connector 110 via fluid injection port 118 is prevented from leaking through proximal end 120 and is directed distally through lumen 132 of connector 110 and channel 130 of access cannula 104 along a fluid path through annular space 122 extending around medical device 108. In other words, as described above, fluid 14 flows distally from port 118 through annular space 122 between an inner surface 124 of access cannula 104 and an outer surface 126 of medical device 108, and exits the distal end of access cannula 104. Thus, as fluid 14 is delivered to annular space 122 and exits the distal end of access cannula 104, a user observing the fluid (e.g., under fluoroscopic visualization) will determine whether fluid 14 has reached target vessel 10 (i.e., whether the distal end of the access cannula is disposed within target vessel 10).

[0034] According to an exemplary embodiment, as shown in FIGS. 7-9 , clip 112 includes an outer portion 138 configured to move clip 112 between an open configuration (shown in FIG. 8 ) and a closed configuration (shown in FIGS. 7 and 9 ) and an inner portion 140 configured to form a seal at proximal end 120 of connector 110. In this embodiment, outer portion 138 is formed of a material that tolerates sufficient deformation to allow outer portion 138 to be moved between the open and closed configurations, as described in further detail below. In one example, outer portion 138 is formed of a plastic material, such as acrylic. Inner portion 140 is formed of a softer material than outer portion 138 and is configured to form a seal around an element or device against which it is pressed. In one embodiment, inner portion 140 may be formed of a softer plastic material, such as silicone.

[0035] Outer portion 138 includes a pair of interconnected jaws 142 that are movable between an open configuration in which longitudinal edges 144 of jaws 142 are separated from one another to allow a portion of connector 110 and medical device 108 to be received therebetween, and a closed configuration in which edges 144 are drawn toward one another to press inner portion 140 against the portion of connector 110 and medical device 108 received between jaws 142. In other words, jaws 142 are movable toward (closed configuration) and away from (open configuration) a longitudinal axis along which outer portion 138 extends.

[0036] In one exemplary embodiment, the jaws 142 may be formed from a single element that is integrally formed with one another and bent to form a substantially tubular shape through which the jaws 142 define a longitudinally extending channel 156, the channel 156 opening to its exterior via a longitudinal slot 154 extending along its entire length. The longitudinal slot 154 is defined via the longitudinal edges 144. In the exemplary embodiment, the cross section of the outer portion 138 is shown such that the inner surface 148 extending along the pair of jaws has a substantially circular or C-shape. In the exemplary embodiment, the jaws 142 are biased toward a closed configuration. The jaws 142 are movable between an open configuration and a closed configuration via a pair of wings 146, each of which extends laterally from a corresponding one of the jaws 142 in a direction extending away from the longitudinal edges 144 of the jaws 142. Pulling the wings 146 toward each other moves the outer portion 138 from a biased closed configuration toward an open configuration, and releasing the wings 146 allows the jaws 142 to return to the closed configuration under their natural bias.

[0037] As mentioned above, inner portion 140 is formed of a softer material than the material of outer portion 138. The material of inner portion 140 is selected such that it forms a fluid-tight seal at proximal end 120 of connector 110 when clip 112 is in the closed configuration. Inner portion 140 extends along inner surfaces 148 of jaws 142 such that longitudinal edges 150 of inner portion 140 extend along longitudinal edges 144 of jaws 142. Thus, when outer portion 138 is moved between the open and closed configurations, longitudinal edges 150 of inner portions 140 are correspondingly separated from and drawn toward each other, respectively.

[0038] In particular, in the open configuration, the longitudinal edges 150 are separated from one another to allow the connector 110 and medical device 108 to be moved over the longitudinal edges 150 between the jaws 142. In the closed configuration, the longitudinal edges 150 are pressed against one another such that the inner portion 140 extends around and presses against to form a seal around the proximal portion 116 of the connector 110 and the portion of the medical device 108 extending proximally therefrom. In an exemplary embodiment, the clip 112 may be clipped or attached onto the connector 110 and the medical device 108 such that the fluid injection port 118 and / or the connecting tubing 152 extend between the longitudinal edges 144, 150 of the outer portion 138 and inner portion 140 of the clip 112, respectively.

[0039] While in the illustrative embodiment, clip 112 is shown and described as being disposed along a substantial length of proximal portion 116 of connector 110, it will be understood by those skilled in the art that this is not required and clip 112 may be configured to extend along any desired length of proximal portion 116, so long as clip 112 extends over proximal end 120 to form the desired fluid-tight seal. As discussed above, the seal formed at proximal end 120 of connector 110 prevents fluid 14 from flowing proximally out of connector 110, thereby causing fluid provided via fluid injection port 118 to move distally through connector 110 along a fluid path defined via an annular space 122 between an inner surface 124 of channel 130 of access cannula 104 and an outer surface 126 of medical device 108. Thus, fluid 14 injected through access cannula 104 travels through access cannula 104, around any medical device 108 received therein, and passes distally from access cannula 104. This allows the position of the distal end of access cannula 104 to be observed (e.g., to visually confirm successful placement of access cannula 104 within target vessel 10).

[0040] For example, according to an exemplary method of utilizing system 100 to treat a bile duct, distal end 107 of access cannula 104 is to be positioned within target duct 10 of a patient. As will be appreciated by those skilled in the art, this may be accomplished by advancing an endoscope through the GI tract to a location adjacent to the target bile duct (e.g., within the stomach, duodenum, and / or small intestine). Access cannula 104, with connector 110 coupled to its proximal end 106, is advanced distally through the working channel of the endoscope, with the sharp extending distally from distal end 107 of access cannula 104, puncturing the wall of the GI tract and then the wall 12 of duct 10.

[0041] The access cannula 104 is advanced with the sharp through the wall of the GI tract and moved further distally until the distal end 107 of the access cannula 104 enters the tract 10. The sharp / needle is then retracted within the access cannula 104 (e.g., to minimize the risk of contact between the sharp and the distal wall of the tract 10). The user then moves the connector 110 to a closed configuration, sealing the connector 110 around the portion of the sharp extending from the proximal end of the access cannula 104 and connecting the source fluid 14 to the port 118 of the device 102. As described above, the clip 112 can be moved from the biased closed configuration toward an open configuration by drawing the wings 146 of the outer portion toward each other, such that the connector 110 and medical device 108 can be received between the longitudinal edges 144, 150 of the outer portion 138 and inner portion 140 of the clip 112. Once the desired portion of the medical device 108 is received between the jaws 142, the wings 146 are released, allowing the clip 112 to return to the closed configuration under its natural bias. In the closed configuration, the inner portion 140, lining the inner surface 148 of the outer portion 138, presses against the connector 110 on the medical device 108 to form a seal at the proximal end 120 of the connector 110, as previously described.

[0042] As described above, clip 112 is clipped onto connector 110 such that fluid injection port 118 and / or connecting tubing 152 extend between longitudinal edges 150 of inner portion 140. It will be understood by those skilled in the art that connector 110 is formed of a material that is sufficiently rigid so as not to collapse when inner portion 140 is sealed therearound and / or thereto. Thus, fluid 14 can be infused around medical device 108 via fluid injection port 118, through lumen 132 of connector 110 and channel 130 of access cannula 104.

[0043] If the user wishes to confirm the placement of the access cannula 104, the user injects fluid 14 (e.g., contrast, saline, or echogenic medium) through the channel 130 and passes it along the sharp. The user can then observe, via a medical procedure (e.g., fluoroscopy and / or EUS), whether the fluid 14 is being delivered to the target vessel 10. If so, this indicates that the access cannula 104 is correctly placed. If it is observed that the fluid 14 does not fill the target vessel 10, this indicates that the access cannula 104 is not positioned within the target vessel 10 as desired. The user can then move the connector 110 to an open configuration, allowing the sharp to slide in and out of the access cannula 104. The user then again advances the sharp into the target vessel 10 (because the sharp has not been withdrawn from the access cannula 104 to deliver the fluid 14) and again advances the access cannula 104 over the sharp until the distal end 107 of the access cannula 104 is positioned within the vessel 10. The process of verifying the position of the access cannula 104 may then be repeated, without removing the sharp from the access cannula 104, until the proper position of the access cannula 104 within the vessel 10 is visually confirmed.

[0044] Once it has been confirmed that the access cannula 104 has successfully accessed the target vessel 10, the clip 112 may be removed and the sharp may then be withdrawn from the access cannula 104. The user may then advance another medical device 108, such as, for example, a guidewire, through the access cannula 104 and into the target vessel 10 to provide a guide along which other items (e.g., a catheter) may be slid into the target vessel 10 to treat the vessel 10. It will be appreciated that the connector 110 may remain coupled to the access cannula 104 during insertion of the guidewire. As mentioned above, in some cases, it may be desirable to confirm that access to the vessel 10 has not been lost during insertion of the guidewire before proceeding with the procedure. In these cases, the clip 112 is clipped over the connector 110 and guidewire, as described above, to form a seal at the proximal end 120 of the connector 110, so that fluid 14 can again be injected through the annular space 122 to confirm proper access of the access cannula 104 within the target vessel. Once the user has confirmed that the access cannula 104 remains properly within the target vessel 10, the user may proceed with treatment of the vessel 10.

[0045] Although in the exemplary embodiment, connector 110 is shown and described as a component of device 102 that is coupled to access cannula 104 prior to insertion of access cannula 104 into the body, it will be understood by those skilled in the art that in alternative embodiments, connector 110 may be coupled to access cannula 104 after initial insertion of the distal end of access cannula 104 into target vessel 10. In yet other embodiments, connector 110 may be integrally formed with access cannula 104.

[0046] 10-11B, another exemplary embodiment clip 212 is substantially similar to clip 112 described above and, as described above, can be used in place of clip 112 in device 102 of system 100. In particular, clip 212 is clipped or attached onto proximal portion 116, particularly proximal end 106 of access cannula 104, and proximal end 120 of connector 110, which is received within access cannula 104 and coupled to a portion of medical device 108 extending proximally from connector 110, to form a seal at proximal end 120 and prevent fluid injected into fluid injection port 118 from exiting proximal end 120. Rather, fluid is directed distally through annular space 122. Similar to clip 112, clip 212 includes an outer portion 238 configured to move clip 212 between an open configuration and a closed configuration, and an inner portion 240 configured to press against connector 110 and medical device 108 to form a fluid-tight seal therearound.

[0047] The outer portion 238 in this embodiment is moved between the open and closed configurations by rotating it about the longitudinal axis of the outer portion 238 relative to the inner portion 240. In the exemplary embodiment, the outer portion 238 is configured as an open tube including a longitudinal slot 254 extending along its entire length and defining the longitudinal edge 244. A channel 256 defined by the shape of the outer portion 238 opens to the exterior of the tube through the longitudinal slot 254. In one embodiment, the cross section of the outer portion 238 is substantially C-shaped. The outer portion 238 may be formed of a plastic material similar to the material from which the outer portion 138 is formed.

[0048] The inner portion 240 has a size, shape, and configuration to be received within the channel 256 of the outer portion 238 and has a length that substantially corresponds to that of the outer portion 238. Like the inner portion 140, the inner portion 240 is received within the channel 256 of the outer portion 238 in a substantially curved configuration that corresponds to the inner surface 248 of the outer portion 238 and defines a longitudinal edge 250 therebetween that forms a longitudinal slot 258. Like the inner portion 140, the inner portion 240 is formed of a material that is softer than the material forming the outer portion 238 and, in the exemplary embodiment, is formed of a material configured to be able to form a seal around an element that it surrounds. In one example, the inner portion 240 is formed of a plastic material, such as silicone.

[0049] 10 , in the open configuration, the outer portion 238 and the inner portion 240 are positioned relative to one another such that the longitudinal slots 254 of the outer portion 238 and the longitudinal slots 258 of the inner portion 240 are aligned with one another to allow the connector 110 and medical device 108 to be passed therethrough and received within the central portion 260 of the clip 212. As shown in FIG. 11A , in the closed configuration, the outer portion 238 is rotated about its longitudinal axis relative to the inner portion 240, increasing the curvature of the inner portion 240 such that the longitudinal edges 250 of the inner portion 240 are drawn toward one another. Thus, as the clip 212 is moved toward the closed configuration, the inner portion 240 is forced around the connector 110 and the medical device 108 to seal the proximal end 120 of the connector 110. The outer portion 238 can be rotated relative to the inner portion 240 to move the clip 212 between an open configuration and a closed configuration, as desired. As shown in FIG. 11B, in a further exemplary embodiment, the longitudinal edges 250 can be drawn toward each other until the longitudinal edges 250 contact each other and completely enclose the medical device 108 therein.

[0050] It will be understood by those skilled in the art that clip 212 may be utilized in a manner substantially similar to clip 112 described above with respect to system 100. However, clip 212 should be mounted over a portion of proximal portion 116 of connector 110 that extends proximally of fluid injection port 118 and / or connecting tube 152 so as not to interfere with fluid injection port 118 and / or connecting tube 152 when clip 112 is moved from the open configuration toward the closed configuration.

[0051] 12-13 , a system 300 according to another exemplary embodiment of the present disclosure is substantially similar to system 100 described above, except as detailed below. System 300 includes a device 302 (e.g., a Luer device) that can be used in a manner substantially similar to device 102, as described above with respect to system 100. Like device 102, device 302 is configured to be coupled to a proximal end 306 of an access cannula 304 and a medical device 308 received therein. Medical device 308 and access cannula 304 are substantially similar to medical device 108 and access cannula 104 described above with respect to system 100. However, device 302 does not require the components of a separate connector 110, as described above with respect to device 102. Rather, as described in further detail below, device 302 includes a fluid pathway constructed therein such that any fluid injected through fluid injection port 318 is directed through access cannula 304, around medical device 308, and into space 322 between an inner surface 324 of the channel of access cannula 304 and an outer surface 326 of medical device 308.

[0052] Device 302 includes a proximal component 364 and a distal component 366 rotatably coupled to one another such that distal component 366 is rotatable about its longitudinal axis relative to proximal component 364. Proximal component 364 may be configured substantially similar to clip 112 described above, and distal component 366 may be configured substantially similar to clip 212 described above.

[0053] In particular, the proximal component 364, like the clip 112, includes an outer portion 338 including a pair of jaws 342 that are curved and connected to one another to define a substantially tubular shape including a longitudinal slot 354 extending along the entire length thereof, allowing the longitudinal edges 344 of the jaws 342 to move away from and toward one another, respectively, between open and closed configurations. As described above, the shape of the jaws 342 is such that, in a cross-sectional view of the jaws 342, the inner surface 348 extending along the jaws 342 has a substantially circular or C-shape. Like the clip 112, the jaws 342 are biased toward the closed configuration. Also like the clip 112, the outer portion 338 of the proximal component 364 of the device 302 also includes a pair of wings 346, each of which extends laterally from a corresponding one of the jaws 342 in a direction extending away from the longitudinal edges 344 of the jaws 342. Pulling the wings 346 toward each other moves the outer portion 338 from a closed configuration toward an open configuration, and releasing the wings 346 allows the jaws 342 to return to their biased closed configuration.

[0054] Similar to clip 212, distal component 366 includes an outer portion 368 including a pair of jaws 370 that are curved and connected to define a substantially tubular shape with a longitudinal slot 372 extending along its entire length such that longitudinal edges 374 of jaws 370 are separated from one another. In the exemplary embodiment, jaws 370 are shaped such that, in a cross-sectional view of jaw 370, an inner surface 376 extending along the interior of jaw 370 has a substantially circular or C-shape. In this embodiment, distal portion 378 of distal component 366 includes threads 380 extending along its inner surface 376 so that distal component 366 can be rotated relative to proximal component 364 to threadably engage access cannula 304 when device 302 is clipped onto proximal end 306 of access cannula 304 and medical device 308, as described in further detail below.

[0055] According to an exemplary embodiment, the outer portion 368 of the distal component 366 may be rotatably connected to the outer portion 338 of the proximal component 364. For example, the outer portions 368, 338 may have corresponding circumferentially extending tongue-and-groove connection mechanisms that facilitate relative rotation therebetween about their longitudinal axes. Similar to the clip 212, the distal component 366 can be moved between open and closed configurations by rotating the outer portion 368 relative to the inner portion 340 (and the proximal component 364), as described in further detail below.

[0056] Similar to the device 102 and clip 212 described above, the device 302 includes an inner portion 340 having a correspondingly curved shape such that the inner portion 340 extends along the inner surfaces 348, 376 of the proximal and distal components 364, 366, respectively. However, the inner portion 340 may extend longitudinally along the inner surface 348 of the proximal component 364, and the proximal unthreaded portion 382 may extend along the inner surface 376 of the distal component 366. Similar to the inner portions 140, 240 described above, the inner portion 340 is formed of a softer material than the material forming the outer portions 338, 368 of the proximal and distal components 364, 366, respectively, and forms a seal around the medical device 308 and / or access cannula 304.

[0057] In the exemplary embodiment, in the open configuration, the inner portion 340 is configured such that the distance between the longitudinal edges 350 corresponds to the longitudinal slots 354, 372 of the proximal and distal components 364, 366, such that the desired portions of the medical device 308 and the access cannula 304 can be passed through the longitudinal slots 354, 372 and between the longitudinal edges 350 to be received within the curvature of the inner portion 340 between the jaws 342, 370 of the proximal and distal components 364, 366, respectively. The proximal and distal components 364, 366 can be moved between the open and closed configurations substantially similar to that described above with respect to the clips 112, 212. In particular, the wings 346 of the proximal component 364 can be drawn toward each other, thereby positioning the proximal component 364 over the medical device 308 and the distal component 366 over the proximal end 306 of the access cannula 304. Releasing the wings 346 seals the proximal component 364 onto the medical device 308 .

[0058] As described in further detail below, upon sealing the proximal component 364 onto the medical device 308, the distal component 366 can be rotated relative to the proximal component 364, the inner portion 340, and the access cannula 304 to move the distal component 366 from an open configuration toward a closed configuration such that the threads 380 of the distal component 366 engage the threads 328 at the proximal end 306 of the access cannula 304. As the outer portion 368 is rotated relative to the inner portion 340 toward the closed configuration, the longitudinal edges 350 of the portion of the inner portion 340 received therein are drawn toward each other, reducing its cross-sectional area (e.g., diameter), and the distal component 366 is moved distally relative to the access cannula 304 as it is threadably engaged with the access cannula 304. Thus, in the closed configuration, the inner portion 340 is sealed against the proximal end 306 of the access cannula 304.

[0059] Device 302 includes a built-in fluid pathway configured, in the exemplary embodiment, as a tubular member 310 housed within the curvature of inner portion 340, extending between proximal component 364 and distal component 366. Tubular member 310 is fluidly connected to fluid injection port 318, for example, via connecting tube 352, such that fluid injected through fluid injection port 318 is directed into and passes through tubular member 310.

[0060] Tubular member 310 is configured such that when proximal component 364 is moved from the open configuration toward the closed configuration in the operating position, inner portion 340 is pressed and sealed against medical device 308 and proximal end 320 of tubular member 310, such that fluid provided through tubular member 310 is prevented from leaking proximally therefrom and is instead directed distally therethrough into space 322 between inner surface 324 of access cannula 304 and outer surface 326 of medical device 308. Distal end 336 of tubular member 310 corresponds to distal end 341 of inner portion 340, such that when distal component 366 is threadedly engaged with proximal portion 306 of access cannula 304, distal end 341 is pressed and sealed against proximal end 306 of access cannula 304, such that fluid passing through tubular member 310 is directed into space 322. The fluid injection port 318 and the connecting tube 352 are configured such that when the device 302 is in a closed configuration, the connecting tube 352 and / or the fluid injection port 318 extend along the inner portion 340 between the longitudinal edges 350.

[0061] Device 302 can be utilized in a substantially similar manner as device 102 of system 100. As described above, while proximal component 364 and distal component 366 of device 302 are in an open configuration, device 302 can be disposed over medical device 308, such that medical device 308 is slidably received within tubular member 310. In the open configuration, device 302 can be moved distally relative to medical device 308 until distal component 366 is disposed over proximal end 306 of access cannula 304. In this position, proximal component 364 can be moved toward a closed configuration (e.g., by releasing wings 346 and allowing outer portion 338 to return to its biased configuration). In the closed configuration, proximal component 364 is sealed over medical device 308 and proximal end 320 of tubular member 310.

[0062] Once the proximal component 364 is in the closed configuration, the distal component 366 can be moved toward the closed configuration by rotating the distal component 366 relative to the proximal component 364 (and relative to the inner portion 340 and the access cannula 304), whereby the threads 380 of the distal component 366 engage the threads 328 of the proximal end 306 of the access cannula 304. As described above, closing the distal component 366 seals the inner portion 340 around the tubular member 310, forcing the tubular member 310 against the proximal end 306 of the access cannula 304, thereby directing fluid received therein through the access cannula 304, as described above.

[0063] According to another exemplary embodiment, rather than having the respective outer portions 338, 368 of the proximal and distal components 364, 366 rotatably connected to one another, the outer portions 338, 368 of the proximal and distal components 364, 366 may be separable from one another and from the inner portion 340. Thus, once the inner portion 340 and tubular member 310 are positioned on the medical device 308, the proximal and distal components 364, 366 may be independently clipped thereon, as desired.

[0064] In particular, inner portion 340 may be positioned over a portion of medical device 308 such that distal end 341 of inner portion contacts and / or is pressed distally against proximal end 306 of access cannula 304. Proximal component 364 may then be clipped onto the proximal portion of inner portion 340, including the proximal end of tubular member 310 housed therein, and distal component 366 may be clipped onto distal end 341 and a portion of proximal end 306 of inner portion 340. In an exemplary embodiment, the distal component 366 may be mounted over the inner portion 340 and the proximal end 306 and rotated relative thereto about its longitudinal axis, such that when the threads 380 of the distal component 366 threadably engage with the threads 328 along the proximal end 306, the inner portion 340 is sealed against the distal end 336 of the tubular member 310 and the proximal end 306 of the access cannula 304.

[0065] 14-15 , another exemplary embodiment of a device 402 (e.g., a Luer device) is substantially similar to device 302 described above and may be used in place of device 302 in system 300. Like device 302, device 402 is configured to be coupled to a proximal end 306 of an access cannula 304 and a medical device 308 received therein. Device 402 includes an inner portion 440 extending from a first end to a second end, a tubular member 410 housed within the curvature of inner portion 440, a proximal component 464, and a distal component 466. Inner portion 440 and tubular member 410 are configured to receive medical device 308 in a manner substantially similar to inner portion 340 and tubular member 310 described above.

[0066] Similar to tubular member 310, tubular member 410 is fluidly connected to a fluid infusion portion 418, for example, via a connecting tube 452, such that fluid infused through fluid infusion port 418 is directed into and passes through tubular member 410. Furthermore, proximal component 464 and distal component 466 are configured to be rotatably coupled to one another, such that distal component 466 is rotatable about its longitudinal axis relative to proximal component 464. Each of proximal component 464 and distal component 466 may be configured substantially similar to clip 212 described above.

[0067] In particular, the proximal component 464, like the clip 212, includes an outer portion 438 including a pair of jaws 442 curved and connected to one another to define a substantially tubular shape with a longitudinal slot 454 extending along their entire lengths, thereby allowing the longitudinal edges 444 of the jaws 442 to move away from and toward one another between open and closed configurations, respectively. Additionally, the distal component 466, like the distal component 366, includes an outer portion 468 including a pair of jaws (not shown), curved and connected to one another to define a substantially tubular shape with a longitudinal slot (not shown) extending along their entire lengths, such that the longitudinal edges (not shown) of the jaws (not shown) are separated from one another.

[0068] Additionally, the distal portion 478 of the distal component 466 includes threads 480 extending along its inner surface 476 such that the device 402 clips onto the proximal end 306 of the access cannula 304 and the medical device 308. The distal component 466 may be rotated relative to the proximal component 364 to threadably engage with the access cannula 304 in a manner substantially similar to the distal component 366 and proximal component 464 described above. While the distal component 466 and the proximal component 464 may be configured to rotate independently relative to one another, in further embodiments, the distal component 466 and the proximal component 464 may be configured to rotate together simultaneously. For example, in further embodiments, the distal component 466 and the proximal component 464 may be coupled to one another via a coupling mechanism such that the distal component 466 and the proximal component 464 may be rotated together in a single motion. In yet another embodiment, the distal component 466 and the proximal component 464 may be locked together via a locking mechanism and rotated together in a single motion.

[0069] Those skilled in the art will appreciate that changes can be made to the above-described embodiments without departing from the inventive concept thereof. It is further understood that structural features and methods associated with one of the embodiments can be incorporated into other embodiments. It is therefore understood that the invention is not limited to the particular embodiments disclosed, but rather, includes modifications within the scope of the invention as defined by the appended claims.

Claims

1. 1. A Luer device for accessing the bile duct, comprising: a connector including a body extending longitudinally from a proximal end to a distal end and a lumen extending therethrough, the body of the connector including a distal portion sized, shaped, and configured to couple to a proximal end of an access cannula, and a proximal portion of the body sized, shaped, and configured to slidably receive a medical device received within the access cannula; a clip configured to clip onto the proximal portion of the connector and a portion of the medical device extending therefrom; the clip includes an outer portion and an inner portion, the outer portion extending along a longitudinal axis from a proximal end to a distal end and including a channel extending therethrough along the longitudinal axis, a longitudinal slot extending along the entire length of the outer portion whereby the channel opens to and communicates with an exterior of the clip through the longitudinal slot, the inner portion extending along an inner surface of the channel defining jaws and formed from a material that is pressed against the medical device and the connector to seal the proximal end of the connector and direct fluid distally therethrough and through a space extending between an inner surface of the access cannula and an outer surface of the medical device when the clip is moved from an open configuration toward a closed configuration in an operative position.

2. 2. The luer device of claim 1, wherein the longitudinal slot defines a pair of jaws movable between the open configuration in which longitudinal edges defining the jaws are moved away from one another and the closed configuration in which the longitudinal edges are moved toward one another to draw the longitudinal edges of the inner portion toward one another and seal the proximal end of the connector.

3. The luer device of claim 2 , wherein the clip is biased toward the closed configuration.

4. 4. The luer device of claim 3, wherein the outer portion of the clip includes a pair of wings each extending laterally from a corresponding one of the jaws in a direction away from the longitudinal edge of the jaws such that when the pair of wings is drawn toward one another, the jaws are moved away from one another toward the open configuration and when the pair of wings is released, the jaws are allowed to return toward the closed configuration.

5. The luer device according to any one of claims 1 to 4, wherein the inner portion is formed of a softer material than the outer portion of the clip.

6. 6. The Luer device according to claim 1, wherein the connector includes a fluid connection port, the fluid connection port being fluidly connected to the lumen of the connector via a connection tube such that fluid is injected through the fluid connection port.

7. The luer device of any one of claims 1 to 6, wherein the proximal portion of the connector has a smaller cross-sectional area than the distal portion of the connector.

8. 8. The Luer device of claim 1, wherein the distal portion of the connector includes threads along an interior surface thereof for threadably engaging corresponding threads along the proximal end of the access cannula.

9. The luer device of any one of claims 1 to 8, wherein the outer portion of the clip is rotatable relative to the inner portion to move the clip from the open configuration towards the closed configuration.

10. 1. A lure device comprising: a proximal component extending along a longitudinal axis from a proximal end to a distal end, the proximal component including a channel extending therethrough, a longitudinal slot extending along the entire length of the proximal component, the channel opening to and communicating with an exterior of the proximal component through the longitudinal slot, the longitudinal slot defining a pair of jaws movable between an open configuration in which longitudinal edges defining the jaws are moved away from one another and a closed configuration in which the longitudinal edges are moved toward one another; a distal component rotatably longitudinally aligned with and rotatably coupled to the proximal component such that the distal component is rotatable about its longitudinal axis relative to the proximal component, the distal component extending from a proximal end to a distal end and including a channel extending therethrough, a longitudinal slot extending along the entire length of the distal component such that the channel opens to and communicates with an exterior of the distal component through the longitudinal slot, a distal portion of the distal component including threads along its interior for threaded engagement with the proximal end of an access cannula; an inner portion extending along an inner surface of the channel of the proximal component defining the jaws and along an inner surface along an unthreaded proximal portion of the distal component, the inner portion being formed from a material that forms a seal around a medical device when pressed against the medical device; a tubular member received within said inner portion along a distal portion thereof; a distal end of the tubular member corresponding to a distal end of the inner portion, whereby when the proximal portion is in the closed configuration in an operative configuration over the medical device, the distal component is coupled to the access cannula, and the medical device is received within the tubular member, the proximal end of the tubular member is sealed and fluid is directed distally through an access channel around the medical device.

11. 11. The luer device of claim 10, wherein the inner portions extend along the inner surface of the proximal component such that longitudinal edges of the inner portions are separated from one another when the proximal portion is in the open configuration and are drawn toward one another when the proximal portion is in the closed configuration.

12. 12. The luer device of claim 10 or 11, wherein the proximal component includes a pair of wings each extending laterally from a corresponding one of the jaws in a direction away from the longitudinal edge of the jaws such that, when the pair of wings is drawn toward one another, the jaws are moved away from one another toward the open configuration, and when the pair of wings is released, the jaws are allowed to return toward the closed configuration.

13. The luer device according to any one of claims 10 to 12, wherein the inner portion is formed from a softer material than the outer portion of the clip.

14. 14. The Luer device of claim 10, further comprising a fluid connection port fluidly connected to the tubular member, the fluid connection port configured to extend outside the proximal component when the proximal component is in the closed configuration.

15. 15. The Luer device of claim 10, wherein the distal component is rotatable relative to the inner portion such that when the distal component is moved distally relative to the access cannula during threaded engagement therebetween, the distal end of the inner portion is forced distally against the proximal end of the access cannula to direct fluid flow distally through the tubular member and through a space extending between an interior of the access channel and an outer surface of the medical device.

Images