Devices, systems, and methods for access cannula advancement

Abstract

A device includes an access cannula (102), a piercing element, a handle (200). The access cannula (102) includes a lumen extending therethrough. The access cannula (102) is sized and shaped to extend through the endoscope shaft (240) to target tissue within a living body. The piercing element is sized and shaped to extend through the lumen of the access cannula (102) and project distally from the distal end of the access cannula (102). The handle (200) comprises a handle body and a mechanism for advancing the access cannula (102) from a proximal position relative to the piercing element, in which the piercing tip (106) of the piercing element is exposed distally from the distal end of the access cannula (102), to a distal position relative to the piercing element, in which the piercing tip (106) of the piercing element is exposed distally from the distal end of the access cannula (102). The distal end of the access cannula (102) covers the piercing tip (106) of the piercing element.

Description

This application is a divisional application of Chinese application No. 202180007639.0, entitled "Apparatus, System and Method for Injection Cannula Advancement". Priority requirements

[0001] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 987,740, filed March 10, 2020, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to endoscopic ultrasound (EUS) access devices, systems, and methods for accessing anatomical structures (e.g., the pancreaticobiliary tree). Background Technology

[0003] Endoscopic ultrasound (EUS) access surgery, performed under ultrasound guidance, can be used to access anatomical structures such as the pancreaticobiliary tree or the liver. Pancreaticobiliary access surgery, such as procedures that penetrate the bile duct to insert a stent and bypass obstructions, may differ from other types of access surgery because the target anatomical structure is very narrow. Many EUS access devices are not flexible enough for such procedures, and even when they are flexible enough, other difficulties may arise. For example, a long, thin instrument may easily create an initial puncture hole, but there is a risk of extending the instrument too far, such that it penetrates the entire thickness of the bile duct and enters other non-target tissue, creating an unwanted opening in the bile duct.

[0004] Furthermore, if the insertion cannula is not inserted deep enough into the anatomical structure before the sharps are removed, it may remain outside the structure after the sharps are withdrawn. Therefore, achieving the correct puncture depth is crucial for clinicians. Clinicians sometimes struggle to assess penetration depth because they may find it difficult to determine the transition point between the sharps and the insertion cannula under EUS and / or fluoroscopy to confirm that the cannula has been inserted into the structure to the appropriate depth. Summary of the Invention

[0005] This disclosure relates to an apparatus including an access cannula, a puncture element, and a handle. The access cannula includes an endometrium extending therethrough. The access cannula is sized and shaped to extend through an endoscope axis to a target tissue within a living body. The puncture element is sized and shaped to extend through the endometrium of the access cannula and distally extend from the distal end of the access cannula. The handle includes a handle body and a mechanism for advancing the access cannula from a proximal position relative to the puncture element to a distal position relative to the puncture element, wherein in the proximal position relative to the puncture element, the puncture tip of the puncture element is exposed distal to the distal end of the access cannula, and in the distal position relative to the puncture element, the distal end of the access cannula covers the puncture tip of the puncture element.

[0006] In one embodiment, at the proximal position, the puncture tip extends a first predetermined distance relative to the distal end of the insertion cannula, and when the advancement mechanism is actuated, the insertion cannula is advanced at least a first predetermined distance relative to the puncture element.

[0007] In one embodiment, the device further includes: a rotating hub fixed to the insertion cannula and coupled to the proximal end of the handle body, the rotating hub being rotatable relative to the handle body and slidable relative to the handle body a second predetermined distance; and a cap fixed to the puncture element and coupled to the rotating hub, wherein, when the cap and the rotating hub are coupled, the puncture tip extends a first predetermined distance relative to the distal end of the insertion cannula.

[0008] In one embodiment, the proximal end of the handle includes an end cap, the distal portion of the rotating hub is inserted into the end cap to attach the rotating hub to the handle, the end cap having a base against which a first spring is positioned.

[0009] In one embodiment, the rotating hub includes a first proximal flange and a second distal flange, with a shaft extending therebetween, the shaft having a washer and a second spring that can slide thereon and is constrained between the first and second flanges.

[0010] In one embodiment, the end cap further includes a deformable tab located at its proximal end, which allows a washer to be inserted therein and prevents the washer from retracting, such that when the rotating hub is inserted into the end cap, the washer is positioned at its distal end against a first spring and at its proximal end against the deformable tab.

[0011] In one embodiment, the cover has a distal portion and two wings attached thereto, the distal portion being sized and shaped to cover the proximal portion of the rotating hub, each wing having a tab extending radially inward from the distal end of the wing.

[0012] In one embodiment, as the cover is pushed onto the rotating hub, a tab extending from the wing locks onto a first flange of the rotating hub, securing the cover and the rotating hub to each other, wherein pressing down the proximal portion of the wing extends the distal end, causing the wing to unlock from the first flange.

[0013] In one embodiment, the propulsion mechanism is loaded by locking the wing onto the first flange, thereby pushing the washer into the end cap a third predetermined distance and compressing the first and second springs, and releasing the cap so that the first spring, while the second spring remains compressed between the washer and the second flange, pushes the washer proximally back against the deformable protrusion and the rotating hub a third distance.

[0014] In one embodiment, the loaded propulsion mechanism is unloaded by unlocking the wing from the first flange, causing the second spring to push the second flange of the rotating hub distally relative to the cover.

[0015] In one embodiment, the device further includes a cap attached to the puncture element and a rotating hub attached to the insertion cannula. Attaching the cap to the rotating hub proximal to the handle automatically loads the propulsion mechanism.

[0016] In one embodiment, the propulsion mechanism is unloaded by unlocking the cover from the rotating hub.

[0017] In one embodiment, the device further includes a cap fixed to a puncture element; and a rotating hub fixed to an insertion cannula, the rotating hub having a movable hinge that, in an extended position, prevents longitudinal movement of the rotating hub relative to the handle body, the movable hinge being pressed into a depressed position by a mechanism in the cap, allowing the rotating hub to move longitudinally relative to the handle body.

[0018] In one embodiment, the device further includes a spring that abuts against the rotating hub when the movable hinge is in an extended position, wherein pressing the movable hinge unloads the spring and moves the rotating hub relative to the handle body a predetermined distance. This disclosure also relates to an device comprising: an access cannula including an inner lumen extending therethrough, the access cannula being sized and shaped to extend through an endoscope axis to target tissue within a living body; a puncture element being sized and shaped to extend through the inner lumen of the access cannula and distally extend from a distal end of the access cannula; and a handle including a handle body, a rotating hub fixed to the access cannula, and a cap fixed to the puncture element, the handle including a mechanism for advancing the rotating hub relative to the handle body from a proximal position to a distal position while the cap remains substantially stationary relative to the handle body.

[0019] This disclosure also relates to a system comprising: an endoscope including an endoscope axis; an access cannula including an endoscope lumen extending therethrough, the access cannula being sized and shaped to extend through the endoscope axis to a target tissue within a living body; a puncture element being sized and shaped to extend through the endoscope lumen and distally extend from a distal end of the access cannula; and a handle including a handle body, a rotating hub fixed to the access cannula, and a cap fixed to the puncture element, the handle including a mechanism for advancing the rotating hub relative to the handle body from a proximal position to a distal position while the cap remains substantially stationary relative to the handle body.

[0020] Furthermore, the present invention relates to a method. The method includes advancing an access cannula into target tissue within a living body via an endoscope axis, the access cannula including an endometrial lumen extending therethrough; advancing a puncture element through the endometrial lumen such that a puncture tip of the puncture element extends distally beyond the distal end of the access cannula; securing a cap to a proximal end of the puncture element; connecting the cap to a proximal end of a handle; and actuating a mechanism in the handle to advance the access cannula from a proximal position relative to the puncture element to a distal position relative to the puncture element, wherein in the proximal position relative to the puncture element, the puncture tip is exposed distal to the distal end of the access cannula, and in the distal position relative to the puncture element, the distal end of the access cannula covers the puncture tip of the puncture element.

[0021] In one embodiment, at the proximal position, the puncture tip extends a first predetermined distance relative to the distal end of the insertion cannula, and when the advancement mechanism is actuated, the insertion cannula is advanced at least a first predetermined distance relative to the puncture element.

[0022] In one embodiment, the proximal end of the handle includes a rotating hub attached to the handle body, the rotating hub being fixed to the insertion cannula, rotatable relative to the handle body, and slidable relative to the handle a second predetermined distance.

[0023] In one embodiment, the cover is connected to the rotating hub, and this connection automatically loads the propulsion mechanism.

[0024] In one embodiment, the method further includes unloading the propulsion mechanism by unlocking the cover from the rotating hub. Attached Figure Description

[0025] Figure 1 The distal aspect of an endoscope access device in a puncture configuration is shown according to various exemplary embodiments described herein.

[0026] Figure 2 It shows Figure 1 The image shows a magnified view of the distal end of the endoscope insertion device.

[0027] Figure 3 It shows Figure 1 The distal side of the endoscope entry device is shown, where the sharp object is retracted.

[0028] Figure 4 An example of controlling the entry process according to a first exemplary embodiment is shown. Figure 1 The handle of the endoscope insertion device.

[0029] Figure 5 It shows Figure 4 An exploded view of the proximal end of the handle.

[0030] Figure 6-13 It shows Figure 4Views of the proximal end of the handle at different stages of assembly and deployment of the cannulation advancement mechanism.

[0031] Figure 14 A method for loading and deploying an insertion cannula propulsion mechanism is shown.

[0032] Figure 15 An exploded view of the proximal end of a handle for controlling the entry process according to a second exemplary embodiment is shown.

[0033] Figure 16 It shows Figure 15 The rotating hub is located at the proximal end of the handle shown in the diagram.

[0034] Figure 17 It shows Figure 15 The pointed cap near the proximal end of the handle is shown.

[0035] Figure 18a The initial puncture configuration is shown. Figure 1 The distal end of the endoscope insertion device is shown.

[0036] Figure 18b The configuration after puncture is shown. Figure 1 The distal end of the endoscope insertion device is shown. Specific Implementation

[0037] This disclosure can be understood with reference to the following description and accompanying drawings, wherein like elements are indicated by like reference numerals. An exemplary embodiment describes an endoscopic access device having the following features: when a clinician is ready to remove a sharp instrument, i.e., after puncture is completed, it advances a cannula distally relative to the tip of the sharp instrument (“sharp instrument”) to reduce the possibility of insufficient puncture depth and failure to access the puncture site.

[0038] Figure 1 The distal aspect of an endoscopic access device 100 according to various exemplary embodiments described herein is shown. The access device 100 includes an access cannula 102 having a flexible distal end 104 biased to present a J-shape (J-shaped tip) when unrestrained. A sharp instrument 106 with a pointed tip (i.e., a puncture element) is advanced through the lumen of the access cannula 102 such that the flexible J-shaped tip 104 is straightened by the rigidity of the sharp instrument 106 until the sharp instrument 106 extends distally beyond the distal end of the J-shaped tip 104 to a predetermined distance, allowing the sharp instrument 106 to puncture target tissue and the sharp instrument 106 and the J-shaped tip 104 to be advanced together into the target anatomical structure.

[0039] When the sharp instrument 106 is inserted, the distal end of the sharp instrument 106 protrudes distally beyond the distal end of the J-shaped end 104 by a distance 108, which is referred to as "recession". Figure 2As shown. The length of the sharp instrument 106 and the length of the insertion cannula 102 are designed such that when the sharp instrument 106 is fully inserted into the handle and the rotating hub 202 at the proximal end of the device 100 is in the proximal (loaded) position (explained in more detail below), the retraction 108 is the desired length for the initial puncture to perform the insertion procedure.

[0040] After advancing the J-shaped tip 104 and the sharpener 106 into the target anatomical structure as needed, the sharpener 106 is withdrawn proximally from the J-shaped tip 104, releasing the J-shaped tip 104 to return to its curved J-shape, as... Figure 3 As shown in the diagram. A guidewire can then be passed through the lumen of the cannula 102 and exit from the distal end of the J-shaped tip 104, inserted into the target anatomical structure in a desired direction determined based on the aiming of the curved end of the J-shaped tip 104. For example, before inserting the guidewire into the cannula 102, the J-shaped tip 104 can be rotated via the rotating hub 202 to orient the distal opening of the J-shaped tip 104 toward a desired location within the target anatomical structure as would be understood by those skilled in the art.

[0041] When the target anatomical structure is the bile duct, the J-shaped tip 104 can be rotated such that the distal opening of the lumen of the insertion cannula 102 faces upstream or downstream of the bile duct toward the bile duct outlet into the small intestine. When the J-shaped tip 104 is oriented as needed, a guidewire passes through the insertion cannula 102 to exit the opening at the distal end of the J-shaped tip 104 until it extends along the bile duct in the desired direction from the J-shaped tip 104 to the desired value. At this point, a flexible electrosurgical sheath 110 with an electrosurgical tip 112 can be advanced over the insertion cannula 102 and the J-shaped tip 104 to dilate the first and second orifices, wherein the insertion cannula 102 exits the small intestine through the first orifice and enters the target bile duct through the second orifice. As those skilled in the art will understand, when the tip 112 is located at and inside the entrance of one or both of the first and second orifices, the electrodes of the electrosurgical tip 112 can be activated to cut and widen the orifice to facilitate access to the target anatomical structure for further procedures (e.g., placement of a stent to bypass an obstruction).

[0042] A sharp instrument 106 is typically used to create an initiation hole in the anatomical structure through which the wider-diameter distal end 104 (J-shaped end) of the insertion cannula 102 can be pushed, such that when the sharp instrument 106 is removed, the J-shaped end 104 is firmly inserted through the puncture hole into the target location within the target anatomical structure. However, various complications can arise when performing this procedure. For example, a physician observing the puncture via ultrasound or fluoroscopy may not be able to discern the location of the end of the insertion cannula 102. Consequently, the insertion cannula 102 may not be inserted deep enough into the anatomical structure to maintain the entry point when the sharp instrument 106 is removed. In another example, the withdrawal of the sharp instrument 106 may provide a proximal traction force on the insertion cannula 102, disengaging the J-shaped end 104 from the puncture hole.

[0043] Figure 4 A handle 200 of an endoscopic insertion device 100 for controlling the insertion process according to a first exemplary embodiment is shown. The proximal end of the handle 200 includes a rotating hub 202 and a removable sharp cap 204. In this embodiment, an insertion cannula 102 is rigidly fixed to the rotating hub 202 and extends through the interior of the handle 200 and extends distally thereto. The rotating hub 202 has a channel extending therethrough, providing access from the proximal end of the rotating hub 202 to the lumen of the insertion cannula 102, particularly for insertion of a sharp instrument 106 and extending through the length of the insertion cannula 102.

[0044] In this embodiment, the sharps 106 is rigidly fixed to the sharps cap 204, such that pushing the sharps cap 204 distally advances the sharps 106 distally relative to the insertion cannula 102, and pulling the sharps cap 204 proximally retracts the sharps 106 proximally relative to the insertion cannula 102. The sharps cap 204 is coupled to the proximal end of the handle 200, and when the sharps cap 204 is thus coupled, the sharps 106 can extend to its distal position. When coupled, the sharps cap 204 is radially positioned about the rotating hub 202. The sharps cap 204 in... Figure 4 The image shows the handle 200 in a partially retracted position relative to the insertion cannula 102. The proximal aspect of the handle 200, including the rotating hub 202 and the sharps cap 204, will be described in more detail below regarding the insertion cannula advancement mechanism.

[0045] Handle 200 has a distal collar 206 that connects to a connector at the proximal end of the endoscope shaft. Handle 200 includes a length adjuster 208 by which the user adjusts the length of handle 200 such that, when connected to the endoscope, the length of the electrosurgical sheath 110 extends distally beyond the distance required at the distal end of the endoscope (i.e., length adjustment can be used to achieve the desired extension of the device from the endoscope). Handle 200 also includes a puncture actuator 210 that slides on the base 214 of handle 200 such that, when unlocked by puncture actuator lock 212, the insertion cannula 102 and the sharps 106 are pushed distally out of the electrosurgical sheath 110, allowing the J-shaped tip 104 and the sharps 106 to penetrate the target tissue to the desired depth.

[0046] Handle 200 also includes an electrosurgical slider 216 slidably mounted on puncture actuator 210, the slider 216 being connected to an electrosurgical sheath 110. Sheath 110 extends distally from slider 216 through handle 200 such that sheath 110 can be advanced distally from an initial proximal position on insertion cannula 102 to bring electrosurgical tip 112 at the distal end of sheath 110 into contact with target tissue, thereby allowing treatment of tissue (e.g., cauterization of openings formed through the gastrointestinal wall and tissue surrounding the inlet to the target pancreaticobiliary lumen) by applying energy from tip 112.

[0047] The handle 200 includes a generator connection 222 and an end cap 220 extending therefrom, at which power can be connected to the device 100, specifically to the electrosurgical sheath 110. The electrosurgical slider 216 is held in a desired position above the puncture actuator 210 by an electrosurgical slider lock 218. Depressing the slider lock 218 allows the electrosurgical slider 216 to slide on the puncture actuator 210.

[0048] Figure 5 An exploded view of the proximal end of the handle 200 is shown, including the insertion cannula advancement mechanism to maintain the puncture depth of the insertion cannula 102 during sharps removal 106. Figure 6-13 A view of the proximal end of the handle 200 is shown at different stages of the assembly and deployment of the propulsion mechanism. The handle 200 includes an end cap spring 264 and a rotating hub spring 262 for loading and deploying the propulsion mechanism, which will be explained in more detail below.

[0049] End cap 220 has a distal end 226 connected to the proximal end of handle 200 and a proximal end 224 with an opening therein for receiving the distal portion of rotating hub 202. End cap 220 is cannulated, such that rotating hub 202 and access cannula 102 can extend through it. Proximal end 224 of end cap 220 has two or more radially inwardly extending deformable tabs 228, in Figure 9As can be seen more clearly, the washer 260 is held in place within the end cap 220 when assembling the proximal end of the handle 200. The dimensions of the inner surface of the end cap 220 decrease from a larger diameter proximal portion to a smaller diameter distal portion, and this reduction in size forms a base 230 on which the end cap spring 264 is mounted, which will be explained further below.

[0050] A rotating hub 202 extends from a proximal end 232 connected to a sharps cap 204 to a distal end 234, which in turn connects to an end cap 220. The rotating hub 202 includes a proximal portion 236 whose outer diameter and shape are defined to be received within a distal portion 248 of the sharps cap 204. A first flange 238, having a flared, tapered shape, extends distally from the proximal portion 236 for locking the sharps cap 204 to it, as will be explained further below. A shaft 240 extends from the first flange 238 to a second flange 242, and a grooved distal portion 244 extends from the second flange 242 to the distal end 234 for locking the rotating hub 202 in a temporarily fixed position relative to the handle 200. The grooves in the distal portion 244 engage aspects within the handle 200 that provide resistance to rotation of the rotating hub 202, but can be overcome by sufficient force to allow the rotating hub 202 to rotate incrementally and remain temporarily locked in a position awaiting further rotation.

[0051] The sharps cap 204 has a proximal portion 246 that can be gripped by a surgeon. A sharps 106 extends from the interior of the proximal portion 246 through a hollow distal portion 248 that extends over the proximal portion 236 of the rotating hub 202 when the sharps cap 204 is engaged with the proximal portion 236 of the rotating hub 202. A flange portion 254 with a larger diameter connects the proximal portion 246 and the distal portion 248, and two wings 250 are attached to the flange portion 254 for locking the sharps cap 204 to and unlocking the sharps cap 204 from the rotating hub 202. The wings 250 extend from the proximal end to the distal end 256 and are attached to the flange portion 254 at a midpoint thereon, such that the proximal portion of each wing 250 can be pressed down, i.e., pushed radially inward, to widen the distal portion. The distal portion of each wing 250 has a radially inwardly projecting protrusion 252 that locks onto the first flange 238 of the rotating hub 202, as... Figure 11-12 As shown, the sharps cap 204 is connected to the rotating hub 202. Pressing down the proximal end of the wing 250 widens the distal end to unlock the sharps cap 204 from the rotating hub 202, and when the propulsion mechanism is loaded, the rotating hub 202 is simultaneously released to advance the J-shaped end 104 onto the distal end of the sharps 106.

[0052] The propulsion mechanism includes a washer 260 disposed around the shaft 240 of the rotating hub 202, specifically between and slidable relative to the first and second flanges 238, 242. A rotating hub spring 262 is also disposed between the first and second flanges 238, 242, specifically between the washer 260 and the second flange 242, such that the rotating hub spring 262 can be compressed by sliding the washer 260 distally on the shaft 260. An end cap spring 264 is positioned within an end cap 220 against a base 230. While the rotating hub spring 262 has a smaller diameter, such that it is contained on the shaft 240 via the second flange 242, the end cap spring 264 has a larger diameter, such that the second flange 242 can be inserted into the end cap spring 264 without interfering with it. The end cap spring 264 can be pressed against the base 230 by the washer 260 in the following manner.

[0053] Figure 6-13 The diagram shows a view of the proximal end of the handle 200 at different stages of the assembly and deployment of the propulsion mechanism. Figure 6 The arrangement of washer 260 and swivel hub spring 262 relative to swivel hub 202 is shown, while Figure 7 An end cap spring 264 is shown, which is arranged inside the end cap 220 against the base 230. Figure 8 The rotating hub 202 is shown inserted into the end cap 220. Figure 9 A perspective view of the proximal end of the handle 200 is shown, with the rotating hub 202 fully inserted into the end cap 220. The deformable tab 228 allows the washer 260 to be pressed into the end cap 220, but is shaped to retain the washer 260 within the end cap 220, even when a force is applied proximally to the washer 260, i.e., when the end cap spring 264 is pressed against the washer 260. Note that when the proximal end of the handle 200 is... Figure 9 When arranged as shown, the insertion and propulsion mechanism has not yet been loaded.

[0054] The loading and deployment of the propulsion mechanism Figure 10-13 As shown in the figure, and will be used Figure 14 The method 300 shown is described. The propulsion mechanism is loaded simultaneously with attaching the sharps cap 204 to the rotating hub 202. In 305, the sharps 106 is introduced into the insertion tube 102 and pushed distally, such that the sharps cap 204 is pushed distally onto the handle 200, specifically onto the rotating hub 202, until the distal end 256 of the wing 250 is adjacent to the washer 260, as shown. Figure 10 As shown. In this position, the distal end of the sharp instrument 106 is within the J-shaped end 104, that is, it is not exposed on the distal side of the J-shaped end 104.

[0055] In 310, the sharps cover 204 is further pushed distally across the rotating hub 202, causing the distal end 256 of the wing 250 to push the washer 260 distally, as... Figure 11As shown. Several actions occur simultaneously during this step. The advancement of the sharps cap 204 relative to the rotating hub 202 pushes the distal end of the sharps 106 into the distal end of the cannula 102, making the sharps 106 usable for piercing the target anatomical structure during the entry process. This advancement also causes the protrusion 252 on the wing 250 to pass over the first flange 238 of the rotating hub 202 to lock the sharps cap 204 to the rotating hub 202. The position of the protrusion 252 on the wing 250 relative to the distal end 256 of the wing is such that the washer 260 maintains a predetermined distance from the first flange 238 of the rotating hub 202. The pushing of the washer 260 compresses the rotating hub spring 262 (abutting against the second flange 242 of the rotating hub 202) and the end cap spring 264 (abutting against the base 230 of the end cap 220).

[0056] In step 315, the sharps cap 204 is released, allowing the end cap spring 264 to push the washer 260 proximally back to its initial position against the tab 228 of the end cap 220, as... Figure 12 As shown. However, due to the locking configuration of the sharps cap 204 and the rotating hub 202, both the sharps cap 204 and the rotating hub 202 are pushed proximally by the end cap spring 264. In this state, the rotating hub spring 262 is compressed and loaded. The surgeon can use the sharps 106 extending from the access cannula 102 to perform puncture of the target anatomical structure. When the target anatomical structure has been penetrated to a sufficient depth and the surgeon is ready to remove the sharps, the method proceeds to 320.

[0057] In 320, the proximal end of the wing 250 of the sharps cap 204 is pressed down, i.e., pushed radially inward, to move the distal end 256 (more specifically, the protrusion 252) of the wing 250 radially outward, to release the sharps cap 204 from the rotating hub 202 and allow the rotating hub spring 262 to depressurize. Because the washer 260 is in its proximal position, and because the force of the spring 262 cannot push further proximal, the depressurization of the spring 262 instead applies a force to the second flange 242 of the rotating hub 202 and forces the rotating hub 202 to push distally relative to the sharps cap 204, as... Figure 13 As shown. This returns the sharps cap 204 and the rotating hub 202 to their initial positions, i.e. Figure 10 The location shown.

[0058] At this point, the J-shaped end 104 of the insertion cannula 102 has been forced past the tip of the sharps 106 without altering the position of the sharps 106. During insertion, this movement further secures the insertion cannula 102 to the puncture site formed by the sharps 106. The sharps cap 204 unlocks from the rotating hub 202, allowing it to retract proximally, thereby pulling the sharps 106 proximally. The J-shaped end 104 returns to its J-shaped configuration, and the sharps 106 is finally removed from the handle 200, making the insertion cannula 102 available for other aspects of the procedure, such as guidewire insertion.

[0059] Figure 15 A partially exploded view of the distal end of a handle 400 according to a second exemplary embodiment is shown. The handle 400 is substantially similar to the handle 200 described above, but the rotating hub 202, sharps cap 204, and end cap 220 are replaced by a rotating hub 402, a sharps cap 404, and an end cap 420. Figure 1-3 The insertion cannula 102, sharp instrument 106, and electrosurgical sheath 110 described herein can be used with the handle 400. A second embodiment includes a spring 470 that is loaded against the rotating hub 402 and can be released to push the rotating hub 402 distally.

[0060] exist Figure 16 The rotating hub 402, seen in more detail, extends from the proximal end 426 to the distal end 428 and has a distal portion 430 slidably coupled to the inner surface of the end cap 420. The distal portion 430 is dimensioned such that its diameter substantially corresponds to the diameter inside the end cap 420, and the rotating hub 402 remains in a fixed position relative to the handle 400 without any applied force. However, the distal portion 430 and the end cap 420 are loosely fitted enough that rotational forces on the rotating hub 402 allow the hub 402 to rotate relative to the handle 400 and translate into rotation for insertion into the cannula 102 and its J-shaped end 104.

[0061] The distal portion 430 of the rotating hub 402 can also slide longitudinally relative to the end cap 420, translating into longitudinal advancement or retraction of the insertion cannula 102 relative to the fixation device component. The insertion cannula advancement mechanism for the handle 400, explained in more detail below, slides the rotating hub 402 from an initial proximal position to a distal position while the sharps cap 404 remains in a fixed position, thereby advancing the insertion cannula 102 deeper into the target tissue past the sharps 106 during insertion, similar to the advancement mechanism described above for the handle 200. The advancement mechanism can be actuated just before the sharps cap 404 is released from the handle 400 to withdraw the sharps 106.

[0062] The rotating hub 402 has a flange portion 432 with a diameter larger than that of the distal portion 430, and therefore larger than the diameter of the inner surface of the end cap 420 where the distal portion 430 connects to the end cap 420, such that the flange 432 does not extend distally beyond the proximal end of the inner surface of the end cap 420. The intermediate portion 434 of the rotating hub 402 has two movable hinges 436 extending distally and radially outward from the first end 438 to the second end 440. The movable hinges 436 are located on opposite sides of the intermediate portion 434.

[0063] When the rotating hub 402 is in its proximal (i.e., loaded) position, the second end 440 of the hinge 436 abuts the proximal end of the end cap 420, thereby preventing the rotating hub 402 from moving distally relative to it. The movable hinge 436 is pressed down to allow the preloaded single or double spring 470 (e.g.) Figure 15 As shown, but Figure 16 (omitted) to advance the rotating hub 402 to its distal (i.e., unloaded) position in a manner that will be explained below. When the components are coupled, the proximal portion 442 of the rotating hub 402 is received in the sharpener cover 404.

[0064] exist Figure 17 The sharps cap 404, seen in more detail, is substantially hollow, having a cylindrical interior extending from a substantially closed proximal end 450 through it to an open distal end 452. The proximal end 450 has a hole through which a sharps sheath 454 extends, which is secured to the cap 404 and the sharps 106, and has a handle 456 near the proximal end of the cap 404 for manually advancing and retracting the cap 404, and a sharps 106 rigidly fixed relative to the fixing assembly. The sharps cap 404 slides on a rotating hub 402 to assemble the device in preparation for piercing target tissue. In the assembled configuration, the distal end 452 is positioned above a movable hinge 436 of the rotating hub 402.

[0065] The sharps cap 404 has a locking release portion 458 extending through its diameter and near its distal end 452. When the sharps cap 404 and the rotating hub 402 are assembled, the locking release portion 458 is positioned above the movable hinge 436. Pressing the locking release portion 458 causes the movable hinge 436 to be pressed down internally, disengaging the second end 440 of the hinge 436 from contact with the end cap 420 and allowing the rotating hub 402 to slide distally relative to it.

[0066] The rotating hub 402 has a spring 470 connected to the flange 432 and loaded against the sharps cap 404 during assembly. When the locking release 458 is actuated, the hinge 436 is depressed and the spring 470 is allowed to unload, propelling the rotating hub 402 distally relative to the sharps 106 (which remains in a fixed position) and into the cannula 102 a predetermined distance. Thus, the distal J-shaped end 104 is pushed past the sharps 106 and remains within the target anatomical structure during subsequent removal of the sharps 106.

[0067] Figure 18a The distal end of the device is shown according to the first or second embodiment when the device is in the loaded position and the sharpener 106 is extended in a puncture configuration. Figure 18b The distal end of the device is shown according to the first or second embodiment when the device is in the unloaded position and the cannula is advancing over the distal end of the sharps 106.

[0068] In a third embodiment, the device handle includes a sliding member that can be manually advanced to bring the insertion cannula above the tip of the sharps before removal, instead of using an automatic spring-loaded advancement mechanism as described above. The sliding member can be rigidly fixed to the rotating hub, such that longitudinal sliding of the sliding member also causes longitudinal movement of the rotating hub relative to the sharps. The sliding member can slide between a proximal position, in which the sharps are exposed for puncture, and a distal position, in which the sharps are covered. The sliding member is held in either position by friction or a latching mechanism.

[0069] In the fourth embodiment, the device handle includes a rack and pinion mechanism. The handle includes a rack connected to an insertion cannula. A gear is connected to the rack and has a shaft extending through its center and through both sides of the handle, its position fixed to the shaft but allowing rotation relative to it. A drive hub is located at one end of the shaft; rotating the drive hub causes the gear to rotate, the gear engaging the rack and pushing the insertion cannula proximally or distally depending on the direction of rotation.

[0070] In the fifth embodiment, a dual-position lever attached to the rotating hub is used to perform the distal / proximal movements described in the preceding embodiments.

[0071] Those skilled in the art will understand that changes can be made to the above embodiments without departing from the inventive concept. It should also be understood that structural features and methods associated with one embodiment can be incorporated into other embodiments. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but modifications are also covered within the scope of the invention as defined by the appended claims.

Claims

1. An apparatus comprising: An insertion cannula is inserted, which includes an inner lumen extending therethrough, the insertion cannula being sized and shaped to extend through the endoscope axis to a target tissue within the living body; The puncture element is sized and shaped to extend through the lumen of the insertion cannula and protrude distally from the distal end of the insertion cannula; A handle, comprising a handle body and a mechanism for advancing the insertion cannula from a proximal position relative to the puncture element to a distal position relative to the puncture element, wherein in the proximal position, the puncture tip of the puncture element is exposed distal to the distal end of the insertion cannula, and in the distal position, the distal end of the insertion cannula covers the puncture tip of the puncture element. as well as A rotating hub, which is fixed to the insertion cannula and coupled to the proximal end of the handle body, the rotating hub is rotatable relative to the handle body and slidable relative to the handle body a first predetermined distance, wherein the rotating hub includes a first proximal flange and a second distal flange, an axis extending therebetween, the axis having a slidable washer and a slidable first spring, wherein the first spring is constrained between the washer and the second flange.

2. The apparatus according to claim 1, further comprising: A cap, which is fixed to the puncture element and can be coupled to the rotating hub, wherein, when the cap and the rotating hub are coupled, the puncture tip extends a second predetermined distance relative to the distal end of the insertion cannula.

3. The apparatus according to claim 2, wherein, The cover also includes a deformable tab located at its proximal end, the deformable tab allowing the washer to be inserted therein and preventing the washer from retracting therefrom, such that when the rotating hub is inserted into the end cover, the washer is positioned against the second spring at its distal end and against the deformable tab at its proximal end.

4. The apparatus according to claim 3, wherein, The cover has a distal portion and two wings attached thereto, the distal portion being sized and shaped to cover the proximal portion of the rotating hub, each wing having a tab extending radially inward from the distal end of the wing.

5. The apparatus according to claim 4, wherein, The tab extending from the wing locks onto the first flange of the rotating hub, such that the deformable tab and the rotating hub are fixed to each other; wherein pressing down the proximal portion of the wing causes the distal end of the wing to extend, thereby unlocking the wing from the first flange.

6. The apparatus according to claim 5, wherein, The mechanism is loaded by locking the wing onto the first flange, thereby pushing the washer into the cover a third predetermined distance and compressing the first and second springs, and releasing the cover, such that the first spring pushes the washer proximally back a third predetermined distance against the cover and the rotating hub, while the second spring remains compressed between the washer and the second flange.

7. The apparatus according to claim 6, wherein, Unloading the mechanism from its loaded state by unlocking the wing from the first flange causes the second spring to push the second flange of the rotating hub distally relative to the cover.

8. The apparatus according to claim 1, further comprising: A cap is attached to the puncture element, wherein the cap is connected to the rotating hub at the proximal end of the handle body to autoload the mechanism.

9. The apparatus according to claim 1, further comprising: A cap is fixed to the puncture element, wherein the rotating hub has a movable hinge that, in the extended position, prevents longitudinal movement of the rotating hub relative to the handle body. The movable hinge can be pressed down to a pressed position by a mechanism in the cap, allowing the rotating hub to move longitudinally relative to the handle body.

10. The apparatus according to claim 1, further comprising: An end cap is located at the proximal end of the handle body, and the distal portion of the rotating hub is inserted into the end cap to connect the rotating hub to the handle body; the end cap has a base against which the first spring is positioned.

11. An apparatus comprising: An insertion cannula, comprising an inner lumen extending therethrough, is configured to extend through a flexible endoscope axis to a target site within the living body; The puncture element is sized and shaped to extend through the lumen of the insertion cannula and protrude distally from the distal end of the insertion cannula; A handle, comprising a handle body; A rotating hub, which is fixed to the insertion cannula and connected to the proximal end of the handle body, is rotatable relative to the handle body to rotate the insertion cannula to the desired position; An electrosurgical sheath that can slide on the insertion cannula, the electrosurgical sheath having electrodes at its distal end for cauterizing tissue around the opening formed by the puncture element in the tissue. as well as An advance mechanism is connected between the puncture element and the handle body. The advance mechanism is configured to advance the insertion cannula a first predetermined distance relative to the puncture element from a first position to a second position. In the first position, the puncture tip of the puncture element is exposed distal to the distal end of the insertion cannula. In the second position, the distal end of the insertion cannula covers the puncture tip of the puncture element.

12. The apparatus according to claim 1, wherein, The handle also includes a puncture actuator that is slidable relative to the handle body, such that when the puncture actuator moves distally on the handle body, it causes the insertion cannula and the puncture element to move distally, thereby causing the sharp instrument and the insertion cannula to extend distally relative to the handle.

13. The apparatus of claim 12, further comprising: A puncture actuator lock maintains the position of the puncture actuator relative to the handle body until the puncture actuator lock is unlocked, allowing the puncture actuator to be advanced distally relative to the handle body.

14. The apparatus of claim 11, further comprising: An electrosurgical slider, which is coupled to the electrosurgical sheath and is slidable relative to the handle body, to advance the electrosurgical sheath onto the insertion cannula.

15. The apparatus according to claim 11, wherein, The rotating hub is configured to be movable to a position where the puncture tip extends a second predetermined distance from the distal end of the insertion cannula, and when the advancement mechanism is actuated, the insertion cannula is advanced relative to the puncture element by at least the second predetermined distance.

16. The apparatus of claim 11, further comprising: A cap, which is fixed to the puncture element and can be coupled to the rotating hub, wherein when the cap is coupled to the rotating hub, the puncture tip extends a first predetermined distance relative to the distal end of the insertion cannula.

17. The apparatus according to claim 16, wherein, The cover has a base, a first spring is positioned against the base, and the rotating hub includes a proximal flange and a distal flange, with a shaft extending therebetween. The shaft has a washer and a second spring that are slidable thereon and confined between the proximal flange and the distal flange.

18. The apparatus according to claim 17, wherein, The cover also includes a deformable tab at its proximal end, the deformable tab allowing the washer to be inserted therein and preventing the puncture element from retracting from the cover, such that when the rotating hub is inserted into the cover, the washer is positioned against the first spring at its distal end and against the deformable tab at its proximal end.

19. The apparatus according to claim 18, wherein, The cover has a distal portion and two wings attached thereto, the distal portion being sized and shaped to cover the proximal portion of the rotating hub, each wing having a tab extending radially inward from the distal end of the wing.

20. The apparatus according to claim 19, wherein, The tab is configured such that when the cover is advanced on the rotating hub, the extended tab locks onto the proximal flange, thereby securing the cover and the rotating hub to each other.

21. The apparatus according to claim 20, wherein, The propulsion mechanism is loaded by pushing the washer into the cover a third predetermined distance and compressing the first and second springs, and releasing the cover so that the first spring pushes the washer back a third predetermined distance to the proximal side against the deformable protrusion and the rotating hub, while the second spring remains compressed between the washer and the distal flange.

22. The apparatus according to claim 21, wherein, By unlocking the wing from the proximal flange to unload the propulsion mechanism in a loaded state, the second spring pushes the distal flange of the rotating hub distally relative to the cover.

23. The apparatus according to claim 21, wherein, The propulsion mechanism is unloaded by unlocking the cover from the rotating hub.

24. An apparatus comprising: An insertion cannula, comprising an inner lumen extending therethrough, is configured to extend through a flexible endoscope axis to a target site within the living body; The puncture element is sized and shaped to extend through the lumen of the insertion cannula and protrude distally from the distal end of the insertion cannula; A handle, comprising a handle body; A rotating hub, which is fixed to the insertion cannula and connected to the proximal end of the handle body, is rotatable relative to the handle body to rotate the insertion cannula to the desired position; An electrosurgical sheath that can slide on the access cannula and has electrodes at its distal end configured to cauterize tissue around the opening formed by the puncture element in the tissue; as well as A puncture actuator that is slidable relative to the handle body, such that when the puncture actuator moves distally on the handle body, it causes the insertion cannula and the sharp instrument to move distally, thereby advancing the sharp instrument and the insertion cannula distally relative to the handle.

25. The apparatus of claim 24, further comprising: A propulsion mechanism is connected between the puncture element and the handle body, the propulsion mechanism being configured to advance the insertion cannula a first predetermined distance relative to the puncture element from a first position to a second position, in the first position, the puncture tip of the puncture element is exposed distal to the distal end of the insertion cannula; In the second position, the distal end of the inserted cannula covers the puncture tip of the puncture element.

26. The apparatus according to claim 25, wherein, The rotating hub has a movable hinge that, in the extended position, prevents longitudinal movement of the rotating hub relative to the handle body; the movable hinge can be pressed down to a pressed position, allowing the rotating hub to move longitudinally relative to the handle body.

27. The apparatus of claim 26, further comprising: A spring is loaded against the rotating hub when the movable hinge is in the extended position; wherein pressing the movable hinge will unload the spring and cause the rotating hub to move a predetermined distance relative to the handle body.

28. The apparatus of claim 24, further comprising: An electrosurgical slider, which is coupled to the electrosurgical sheath and is slidable relative to the handle body, to advance the electrosurgical sheath onto the insertion cannula.

29. An apparatus comprising: An insertion cannula is inserted, which includes an inner lumen extending therethrough, the insertion cannula being sized and shaped to extend through the endoscope axis to a target tissue within the living body; The puncture element is sized and shaped to extend through the lumen of the insertion cannula and protrude distally from the distal end of the insertion cannula; A handle, comprising a handle body and a mechanism for advancing the insertion cannula from a proximal position relative to the puncture element to a distal position relative to the puncture element, wherein in the proximal position, the puncture tip of the puncture element is exposed distal to the distal end of the insertion cannula, and in the distal position, the distal end of the insertion cannula covers the puncture tip of the puncture element. An electrosurgical sheath that can slide on the access cannula and has electrodes at its distal end, the electrodes being configured to cauterize the tissue surrounding the opening formed by the puncture element in the tissue. as well as A puncture actuator that is slidable relative to the handle body, such that when the puncture actuator moves distally on the handle body, it causes the insertion cannula and the sharp instrument to move distally, thereby advancing the sharp instrument and the insertion cannula distally relative to the handle; as well as A rotating hub, which is fixed to the insertion cannula and connected to the proximal end of the handle body, is rotatable relative to the handle body and slidable relative to the handle body a first predetermined distance, wherein the rotating hub includes a first proximal flange and a second distal flange, and a shaft extends therebetween, the shaft having a washer and a first spring that are slidable thereon and confined between the first flange and the second flange.

30. The apparatus of claim 29, further comprising: A cap, which is fixed to the puncture element and can be coupled to the rotating hub, wherein, when the cap and the rotating hub are coupled, the puncture tip extends a second predetermined distance relative to the distal end of the insertion cannula.

31. The apparatus of claim 29, further comprising: The cover is fixed to the puncture element, and the rotating hub has a movable hinge that, in the extended position, prevents longitudinal movement of the rotating hub relative to the handle body. The movable hinge can be pressed down to a depressed position, allowing the rotating hub to move longitudinally relative to the handle body.

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