Tissue clipping device

Abstract

To reduce difficulties and / or risks associated with surgery applied via a transverse approach.SOLUTION: A device includes: a flexible insertion section extending from a distal end which, during use is inserted into a target site to a proximal end which remains outside the body; an end effector coupled to a distal end of the insertion section; and a control wire received within the insertion section and extending from a proximal end coupled to an actuator to a distal end coupled to the end effector. The control wire is movable within the insertion section to operate the end effector. The control wire and the insertion section include a bending part in a distal portion thereof configured so that, in a resting state, the control wire and the insertion section bend through a predetermined arc at a selected bending radius. A distal portion of the control wire passes into and through a working channel of an insertion device without plastic deformation of the control wire.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] The present invention generally relates to devices, systems, and methods for treating tissue within a natural body lumen that is accessed via an insertion device.

Background Art

[0002] Minimally invasive procedures deep within the gastrointestinal tract are becoming more widespread, but also have underlying potential problems that have not been fully addressed to date. For example, in procedures such as ECRP (endoscopic retrograde cholangiopancreatography), these and similar procedures are often best accomplished with an insertion instrument such as a duodenoscope that is specially configured to observe and treat anatomical structures that extend perpendicular to the longitudinal axis of the device. Thus, the characteristics of currently available clips often pose problems. That is, for many procedures, physicians may prefer a duodenoscope that includes an optical lens with a field of view perpendicular to the axis along which the device extends, and similarly includes a port for insertion of a treatment device along a transverse axis. However, many treatment devices (e.g., hemostatic clips) are best suited for use along the longitudinal axis of the insertion device, and can increase the difficulties and / or risks associated with procedures in which those treatment devices are applied via a transverse approach.

Summary of the Invention

[0003] The present invention relates to a device for treating tissue. The device may comprise a flexible insertion section extending from a distal end inserted into a target site in a living body during use to a proximal end remaining outside the living body during use; an end effector coupled to the distal end of the insertion section; and a control wire extending from a proximal end coupled to an actuator, which is received within the insertion section and remains accessible to the user during use, to a distal end coupled to the end effector. The control wire is movable within the insertion section to operate the end effector, and the control wire and insertion section include a bend in their distal portions, which, in a stationary state, is configured to bend the control wire and insertion section through a predetermined arc with a selected bending radius. The distal portion of the control wire is configured to enter and pass through a working channel of the insertion device without plastic deformation of the control wire.

[0004] In this embodiment, the insertion section includes a bushing, the distal end of which is coupled to an end effector, which is a tissue clipping device. In one embodiment, the clipping device includes a sliding element coupled to the distal end of a control wire, the sliding element being coupled to a tissue gripping arm of the tissue clipping device, so that as the control wire is moved proximal and distally within the insertion section, the sliding element slides proximal and distally within the capsule of the tissue clipping device, causing the arm to move in and out of the capsule.

[0005] In this embodiment, the proximal portion of the sliding element includes a contact surface on its radially outer portion, the contact surface being sized to engage when the proximal portion of the sliding element is pulled proximal so as to move out of the capsule and into the bushing, the radially outer portion of the sliding element pushing a portion of the bushing radially outward to disengage the bushing's locking structure from the corresponding locking structure of the capsule and separate the capsule from the bushing.

[0006] In this embodiment, the bent portion of the control wire is configured such that, in a stationary state, the insertion section bends through an arc of approximately 90 degrees. In this embodiment, the bent portion of the control wire is configured such that, in a stationary state, the insertion section bends through an arc of approximately 45 degrees.

[0007] In this embodiment, the distal portion of the sliding element further comprises opposing directional fingers, each of which is set to be sized and shaped to pass through a corresponding opening in one of the arms in order to maintain a desired orientation of the arms.

[0008] In this embodiment, the device further includes an enlarged section and a proximal contact surface on the arm that define the maximum range to which the arm can be pulled proximal to the capsule. In this embodiment, the bushing is coupled to the capsule of the tissue clipping device via a coupler, the coupler includes a plurality of arms arranged around the circumference of the coupler, each arm including a recess set to be sized and shaped to engage with a locking wall of the bushing to couple the bushing, each recess including a proximal and distal surface that engage with the locking wall of the bushing, the first of the proximal and distal surfaces forming an inclined portion, the inclined portion being angled with respect to the surface of the locking wall with which the inclined portion contacts, and the inclined portion being oriented to slide across the locking wall and disengage from the locking wall in order to separate the coupler and capsule from the bushing when a predetermined compression is applied between the bushing and the coupler.

[0009] In this embodiment, the bushing includes first and second arms that overlap a portion of the capsule and extend distally, each arm including a pin that extends into a corresponding receiving portion formed in the outer wall of the capsule, the pins forming a pivoting connection that allows relative rotation of the capsule with respect to the bushing.

[0010] In one embodiment, the sliding element includes a yoke and a tension member connected to each other via a fragile link. In this embodiment, the device further comprises a first hole at the proximal end of a bend, a second hole at the proximal end of an end effector, and an actuation cord extending from a proximal end connected to an actuator accessible to the user during use to a distal end connected to the end effector, the actuation cord passing through an insertion section, exiting the first hole, entering the second hole, and connecting to the portion of the device that is distal to the bend.

[0011] The present invention also relates to a system for treating tissue. The system may comprise an insertion device including a port, a camera, and a working channel extending through it along a longitudinal axis, and a tissue treatment device. The tissue treatment device includes a flexible insertion section extending from a distal end inserted into a target site in a living body during use to a proximal end remaining outside the living body during use, an end effector coupled to the distal end of the insertion section, and a control wire extending from the proximal end, which is received within the insertion section and coupled to an actuator, wherein the control wire and insertion section include a bend in their distal portion, the bend is configured such that, in a stationary state, the control wire and insertion section bend through a predetermined arc with a selected bending radius, and the distal portion of the control wire may be configured to enter and pass through the working channel of the insertion device without plastic deformation of the control wire.

[0012] In this embodiment, the system further includes an elevator at the distal end of the insertion device, which changes the bends of the control wire and each of the insertion sections. In this embodiment, the camera of the insertion device is oriented perpendicular to the axis of the insertion device and creates a display area in a roughly conical volume that extends radially away from the longitudinal axis.

[0013] In addition, the present invention relates to a method for treating tissue. The method may include inserting a flexible insertion section into a working channel of an insertion device, the insertion section extending from a distal end that is inserted into a target site in a living body during use to a proximal end that remains outside the living body during use; inserting the insertion device at a target site in a living body; and advancing the insertion section through the working channel of the insertion device until an end effector coupled to the distal end of the insertion section exits the insertion device through a port, wherein the working channel of the insertion device extends substantially parallel to the longitudinal axis of the insertion device, the port extends substantially perpendicular to the longitudinal axis, and a control wire extending through the insertion section includes a bend in its distal portion, the bend in the control wire being configured, in a stationary state, to bend the insertion section from the working channel to the port through an arc substantially corresponding to the arc of the transition, thereby advancing the device.

[0014] In this embodiment, the insertion device is a duodenal endoscope, and the end effector is a tissue clipping device. In one embodiment, the method further includes positioning and oriented the insertion section such that the distal portion of the insertion section is generally stationary when the tissue clipping device exits through the port.

[0015] In one embodiment, the tissue clipping device includes a pin facing diametrically at its proximal end, and further includes operating a control wire to rotate the tissue clipping device laterally around the pin.

[0016] In one embodiment, the insertion section includes an actuation cord that extends from a proximal end to a distal end, passes through the insertion section, exits a first hole at the proximal end of the bend, enters a second hole at the proximal end of the tissue clipping device, and connects to the tissue clipping device, further comprising pulling the proximal end of the actuation cord until the actuation cord bends the tissue clipping device into a desired shape. [Brief explanation of the drawing]

[0017] [Figure 1A] Shows a clip assembly according to the first embodiment. [Figure 1B] Shows a close-up photograph of a partial cross-sectional view of the clip of FIG. 1. [Figure 2] Shows the clip assembly of FIG. 1 deployed from a duodenoscope. [Figure 3] Shows the clip assembly of FIG. 1 deployed at a position adjusted using the elevator of a duodenoscope. [Figure 4] Shows a cross-sectional view of a clip assembly according to a further embodiment. [Figure 5] Shows an embodiment of a coupling between a clip and a flexible insertion section. [Figure 6] Shows a second embodiment of a coupling between a clip and a flexible insertion section. [Figure 7A] Shows the clip assembly including the coupling of FIG. 6 in a first configuration. [Figure 7B] Shows the clip assembly of FIG. 7A in a second configuration. [Figure 8] Shows a clip assembly according to a further embodiment.

Mode for Carrying Out the Invention

[0018] The present invention can be further understood from the following description and the accompanying drawings, and the same reference numerals may be assigned to similar elements. The present invention is directed to an apparatus and method for treating tissue at a right angle to the longitudinal axis of an insertion instrument such as a duodenoscope. More specifically, embodiments of the present invention are directed to an apparatus for clamping tissue at a position offset laterally with respect to the longitudinal axis of an insertion device. Note that the terms proximal and distal, as used herein, refer to the direction toward (proximal) and away from (distal) the user of the device.

[0019] The embodiments described herein are specifically configured for gastrointestinal procedures via a duodenoscope, but those skilled in the art will understand that the embodiments described herein can be used to close the papilla (the round opening of the bile duct) and to treat tissue defects in hard-to-reach locations, whether approached via a laterally directed port in a duodenoscope or via a longitudinal port in a standard endoscope. For example, duodenoscopes are often used for resection of a portion of the stomach where suturing may be required. Additionally, embodiments where the bend is not as sharp as about 90 degrees, such as where the bend is 45 degrees, can be used for a forward-viewing scope in scenarios where the location of the defect is difficult to handle and a standard endoscope cannot be used.

[0020] As shown in FIGS. 1-3, a treatment device 10 according to an embodiment of the present invention in this example is a clipping device inserted through a duodenoscope 12. The device 10 includes a flexible insertion section 14, which is formed as a tubular coil extending from a proximal end (not shown) to a distal end 16 coupled to a bushing 18 in this embodiment. The bushing 18 is releasably coupled to a clip 20 that includes a pair of clip arms 22 slidably received within a capsule 24. A control wire 26 extends from a proximal actuator (not shown), which remains accessible to a user outside the body outside the proximal end of the duodenoscope during use. The control wire 26 passes through the bushing 18 into the capsule 24 and is coupled to the clip 20, whereby proximal and distal movement of the control wire 26 through the insertion section 14 moves the clip arms 22 proximally and distally relative to the capsule 24.

[0021] Apart from the insertion section 14 and the control wire 26, the clip 20 of this embodiment can be constructed in any known way. Thus, the specific structure of the internal structure of the clip 20 and the connection between the clip 20 and the bushing 18 are exemplary. In this example, the control wire 26 includes an enlarged distal tip 28, which is received in a cavity 30 shaped to correspond to a yoke 32, which is slidably received in a capsule 24. The yoke 32 includes opposing arms 34, which grip a tab 36 extending proximal to the tension member 38. The clip arm 22 is bent around the tension member 38 with its proximal end coupled to the yoke 32.

[0022] As will be understood by those skilled in the art, the insertion section 14 is flexible, but the distal portion 40 of the device 10, extending from the proximal end of the bushing 18 to the distal end of the clip arm 22, is generally rigid. In applications where the user desires to deploy the clip through a port perpendicular to the longitudinal axis of the device, through which the clip is inserted, the rigidity of this distal portion 40 can cause difficulties for users of known clips. That is, the rigidity and length of this distal portion 40 can make it difficult for such a clip to bend around a bending radius through which it is required to exit a transverse port, for example, the port 42 of a duodenal endoscope 12. Since a scope such as a duodenal endoscope 12 is also oriented perpendicular to the longitudinal axis L of the duodenal endoscope 12, the viewing area 46 of the camera 48 of the duodenal endoscope 12 is a roughly conical volume extending radially away from axis L. A standard clip exiting through port 42 will generally extend distally away from the duodenal endoscope 12 outside the viewing area 46. As will be understood by those skilled in the art, a user who wishes to reorient this clip toward a target tissue site within the viewing area 46 may use the scope's elevator 52 to bend the clip. However, using the elevator 52 to advance such a sharp bend in the clip risks damaging the clip and / or the duodenal endoscope 12.

[0023] In this embodiment, the control wire 26 of the device 10 is pre-treated to include a bend 50 such that, in a stationary state, the insertion section 14 bends around a radius R. In this embodiment, the radius R may be in the range of 5 to 15 mm. The bend 50 preferably terminates at a selected distance D proximal to the bushing 18 so that when the device 10 exits the port 42, the bend 50 is positioned in a portion of the working channel of the duodenal endoscope 12 adjacent to the elevator 52 of the duodenal endoscope 12. In this embodiment, the distance D may be in the range of 0 to 12 mm, and a shorter distance may be preferred so that the tissue is closer to the duodenal endoscope 12. In this embodiment, the bend 50 extends around an arc angle α of about 90 degrees, i.e., 80 to 100 degrees, with variations of several tens of degrees, to orient the device 10 substantially perpendicular to the axis L.

[0024] However, in other embodiments, for use in forward-viewing scopes for lesions in hard-to-reach locations, the arc angle α may be a different angular configuration, for example, 45 degrees. The bend 50 is applied to the control wire 26 through mechanical plastic deformation that bends the control wire 26 into a predetermined shape. The control wire 26 is made of a rigid material so that it can withstand the force that straightens it and then spring back to its predetermined shape. Similarly, the tubular coil has a predetermined shape, which includes a bend given through heat treatment of the tubular coil. The tubular coil can also be forced into a straight shape and then spring back to its predetermined shape. Thus, a straightening force can be applied to the control wire 26 and the tubular coil to straighten them, but after the straightening force is released, the control wire 26 and the tubular coil return to their respective predetermined shapes.

[0025] Those skilled in the art will understand that, because the device 10 according to this embodiment initially extends out of port 42 within the viewing area 46 of camera 48, the device 10 is visualized by camera 48 as shown in Figure 3, while elevator 52 can be used as a precise correction for aiming the device 10. As shown above, this arrangement configuration with a bend 50 in the control wire 26 can be used with any known clipping device (or other end effector) that includes a flexible insertion section to facilitate deployment of the device through a transversely oriented port such as port 42 of the duodenal endoscope 12. The device 10 has a natural tendency to move towards the path with the least resistance, and therefore the device 10 can automatically align with port 42 for exiting the duodenal endoscope 12. In an exemplary embodiment, a proximal mark may be implemented at the proximal end of the internal section 14 so that a physician can track the device 10 as it exits the duodenal endoscope 12.

[0026] Figure 4 shows a clipping device 100, which comprises a clip 101 coupled to a bushing 104, the proximal end of which is coupled to the distal end of a flexible insertion section 106, and through the flexible insertion section 106, a control wire 108 extends to a yoke 110 that incorporates the functionality of the tension member and the yoke of the aforementioned clip 20 into a single element. This eliminates the arm 34 of the yoke 32 that grips the tab 36 of the tension member 38, allowing for a corresponding shortening of the clipping mechanism, which also allows the arm 114 of the yoke 110 to move further distally, allowing for a corresponding shortening of the clipping arm.

[0027] Those skilled in the art will understand that the clipping device 100 may be used with any standard insertion section and control wire, or may include a control wire / insertion section combination including the control wire 26 and the bend 50 as described above for the insertion section 14. The operability of the device 100 according to this embodiment is further enhanced by the structure of the internal mechanism that connects the control wire 108 to the clip arm 112, allowing the rigid portion of the device 100 to extend distally from the proximal end of the bushing 104 through the capsule 102 to the distal end of the clip arm 112.

[0028] The yoke 110 includes a pair of arms 114 extending from its intermediate section and includes a clip arm retaining section 116, which is joined to the proximal portion of the yoke 110 via a fragile joint 118 (for example, by being welded to or integrally formed with the yoke 110). The fragile joint 118 may be formed, for example, as a narrowed or weakened section of the clip arm retaining section 116. Distal to the fragile joint 118, the clip arm retaining section 116 includes a tongue-shaped portion 120. The tongue-shaped portion 120 is received between the clip arms 112 to bias them away from each other, so that as the clip arms 112 advance distally and exit the capsule 102, as shown in Figure 4, the clip arms 112 separate into tissue receiving configurations. This configuration also allows the proximal portions of the clip arms 112 to be shorter at the clip 20, thereby shortening the overall length of the clip 101. The clip arm holding section 116 also includes opposing directional fingers 122. Each of the opposing directional fingers 122 passes through a corresponding opening in one of the clip arms 112, which maintains the desired orientation of the clip arm 112 as the clip arm 112 moves proximal and distal through the capsule 102.

[0029] In this embodiment, the directional finger 122 is also set to a predetermined dimension so that it extends and slidably engages with the opposing surfaces of the capsule 102, ensuring that the clip arm 112 moves smoothly proximal and distal as the control wire 108 moves forward or backward through the insertion section 106. The clip arm 112 includes an enlarged section 124 and a proximal contact surface 126 that defines the maximum extent to which the clip arm 112 can be pulled proximal into the capsule 102. That is, as the clip arm 112 is pulled proximal into the capsule 102, the contact surface 126 extends laterally with respect to the longitudinal axis L of the device 100 to a degree greater than the diameter of the opening 128, so that the contact surface 126 eventually contacts the end of the capsule 102 surrounding the opening 128.

[0030] To deploy the clip 101 when it is positioned to grasp the target tissue as needed, the user pulls the control wire 108 proximal by acting on an actuator (e.g., a proximal handle (not shown)) until the contact surface 126 contacts the capsule 102. The user feels resistance to further proximal movement of the control wire 108. The user then applies more tension to the control wire 108 until a predetermined level of tension is reached, causing the fragile joint 118 to malfunction and the yoke 110 to be pulled proximal away from the clip arm holding section 116 through the capsule 102. As the yoke 110 moves proximal away from the clip arm holding section 116, the arm 114 of the yoke moves away from the proximal end 130 of the clip arm 112, freeing the proximal end 130 of the clip arm 112 to spring outward. As a result, the locking mechanism at the proximal end 130 of the clip arm 112 springs radially outward from axis L and engages with the locking mechanism 132 on the capsule 102. This causes the distal end of the clip arm 112 to be pulled toward axis L to grasp the tissue positioned between them, and the clip arm 112 is locked in the tissue grasping configuration.

[0031] In addition, after the yoke 110 is separated from the clip arm holding section 116, the yoke 110 is pulled further proximal so as to exit the proximal end of the capsule 102. At this point, the arm 114 of the yoke 110, which extends further radially away from axis L than the more proximal portion of the yoke 110, engages with the bushing coupling mechanism 134 that grips the corresponding coupling mechanism 136 of the capsule 102. As the yoke 110 is pulled proximal into the bushing 104, the arm 114 pushes the bushing coupling mechanism 134 radially outward away from axis L, moving them to disengage from the coupling mechanism 136 of the capsule 102, separating the clip 101 from the bushing 104 and insertion section 106, and the rest of the device 100 is withdrawn from the body, while the clip 101 remains locked onto the gripping portion of the target tissue. As will be understood by those skilled in the art, any known coupling, including the coupling shown in Figure 5 below, which thereby releasably connects the bushing to the clip's capsule, may be used.

[0032] As shown in Figure 5, the coupling 200 between the capsule 202 and the bushing 204 of the clipping device (e.g., device 100) includes a coupler 206. The distal end of the coupler 206 is formed as a tube 208 coupled to the capsule 202, while the proximal end of the coupler 206 includes a plurality of arms 210 arranged around the circumference of the tube 208. Each of the arms 210 includes a recess 212, the recess 212 having a proximal locking surface 214 that grips a radial projection 216 of the bushing 204. In this embodiment, the radial projection 216 is formed as an annular surface projecting radially outward away from the axis L so as to extend substantially perpendicularly away from the outer surface of the bushing 204. The proximal locking surface 214 of the arm 210 in this embodiment is also substantially perpendicular to the axis L so as to couple the capsule 202 to the bushing 204 so as not to move via the coupler 206.

[0033] Each distal surface of the recess 212 is formed as an inclined portion 218, which extends distally at an angle (for example, an angle in the range of 30 to 45 degrees from the inner surface of the arm 210) away from the radially outer edge of the distal surface 220 of the radial projection 216, thereby creating a gap between the more radially inward portion of the inclined portion 218 and the distal surface 220, while the radially outermost end of each inclined portion 218 contacts the distal surface 220. Thus, when the clip, including the coupling 200, is inserted into the target site in the body through the insertion device, the arm 210 locks the capsule 202 into the bushing 204 in an immovable position. However, as described above, once the clip is retracted into the capsule 202 to a point where it cannot be moved further proximal, the user applies an even greater proximal force to the control member 222, which is counteracted by a distal force as the insertion section 106 resists compression.

[0034] When this compression is applied to the coupler 206, the inclined portion 218 slides proximal against the distal surface 220 of the bushing 204, causing the proximal end of the arm 210 to rotate outward in the direction of arrow A in Figure 5. This moves the proximal locking surface 214 of the arm 210 so as to disengage from the radial projection 216 until the radial projection 216 is disengaged from the recess 212, thereby separating the bushing 204 from the coupler 206. Thus, the tube 208 and capsule 202 can rotate freely about axis L. In another embodiment, a triple-wire configuration may be used to produce a control wire-driven rotation, and the user rotates the clip so that it can be positioned as needed. In another embodiment, the capsule 202 may be fixed to the bushing 204, and therefore no rotation about axis L can occur.

[0035] As shown in Figures 6, 7A, and 7B, the apparatus 300, which includes a coupling mechanism according to a second embodiment, includes a capsule 302, which is coupled to a bushing 304 and houses a yoke 306 to which a control wire 308 is attached. When the clip is deployed, the yoke 306 is free to move proximal, with the control wire 308 exiting the capsule 302 and entering the bushing 304, so as long as the yoke 306 is free to move proximal, the yoke 306 operates in conjunction with a tension member (not shown) or any other known clamping mechanism. As will be seen below, the bushing includes an opposing arm 310, which extends around the proximal portion of the capsule 302, so that a diametrically opposed pin 312 at the distal end of the bushing 304 extends into a receiving portion 314 formed in the wall of the capsule 302. The arm 310 is spread outward via an inclined portion 315. The arms 310 extend around the outside of the capsule 302, and the arms 310 are separated from each other by a distance greater than the diameter of the capsule 302, while the inclined portion 315 defines a reduced diameter portion of the bushing 304 having a diameter less than the diameter of the capsule 302. As a result, the radially outer edge of the yoke 306, which is slidable within the capsule 302, abuts against and biases the radially outward inclined portion 315 when the yoke 306 is pulled proximally through the bushing 304, as will be described in more detail below.

[0036] However, those skilled in the art will understand that, as long as the inner diameter is reduced (in at least one direction), the outer diameter of the bushing 304 may remain constant over its entire length so that after the clip is deployed and the yoke 306 is pulled proximal through the bushing 304, the radial outer surface of the yoke 306 contacts at least a portion of the inner surface of the bushing 304, driving the arm 310 radially outward. In this way, the pin 312 is pushed radially outward so that the yoke 306 contacts the inclined portion 315 and drives them radially outward, freeing the capsule 302 from the bushing 304 and separating the clip from the insertion section 316, the bushing 304, the control wire 308 and the entire proximal portion of the device.

[0037] Furthermore, as will be understood by those skilled in the art, if the receiving portion 314 and pin 312 are made circular, the capsule 302 is rotatable relative to the bushing 304 and insertion section 316. This rotation is, of course, limited by any resistance to bending of the control wire 308. However, this rotation (shown in Figures 7A and 7B) can further assist in facilitating the application of a clip through a path involving a sharp bend, which may be encountered, for example, when the clip is passed longitudinally through a duodenal endoscope and then has to bend through an arc of about 90 degrees to exit the scope through a port facing laterally.

[0038] As shown in Figure 8, the treatment device 400 may be substantially the same as the treatment device 10 described above. The device 400 may include a control wire 426, an insertion section 414, a bushing 418, a clip 420 including a clip arm 422, and a distal section 440. Similar to the distal section 40 described above, the distal section 440 extends from the proximal end of the bushing 418 to the distal end of the clip arm 422. The distal section 440 includes a capsule 424. The capsule 424 houses a coupling mechanism similar to that of devices 10 and 100-300. The coupling mechanism includes a yoke 432, a tab 436, a tension member 438, and a clip 420. Furthermore, the control wire 426 extends from a proximal end (not shown) to a distal end and has a bend 450 similar to the bend 50 of the control wire 26, which has a radius R' similar to the radius R of the device 10. In this embodiment, the bent portion 450 extends around an arc angle α', where α' is the same as the angle α of the device 10. In this embodiment, the distance D' is between the distal end of the bent portion 450 and the proximal end of the bushing 418, where D' is the same as the distance D of the device 10.

[0039] The device 400 includes a first hole 462 at the proximal end of the bent portion 450 and a second hole 464 at the proximal end of the distal portion 440. The first hole 462 and the second hole 464 are sized and shaped so that an actuating cord 470 can extend between them to allow for better placement of the clip 420. The cord 470 extends from the proximal end (not shown) to the distal end at the proximal end of the distal portion 440. A portion of the cord 470 extends through the insertion section 414 to the first hole 462. The proximal end of the cord 470 is accessible to the user, and as a result, the user can pull the cord 470 proximal to straighten it by pulling it proximal to the proximal end, thus forming a slanted side between the first hole 462 and the second hole 464 and further bending the bent portion 450. By applying different amounts of force when pressing the proximal end of the cord 470, the user controls the bending of the flex portion 450 and the position of the distal portion 440.

[0040] As will be further understood, a clip assembly that combines such a pivotal connection between a capsule and a bushing with a control wire (e.g., the control wire 26 described above) having a bend adjacent to the distal end of the insertion section can show considerable improvement in procedures requiring operation at a lateral port and / or access to hard-to-reach locations requiring a tight bending radius. Such a combination can be further improved by using a shorter clip mechanism of the apparatus 100 described above. Such an apparatus would be effective in either an insertion device such as an endoscope with a longitudinally oriented exit port to its working channel or an insertion device such as an endoscope with a lateral portion of the duodenoscope described above, for closing lesions in complex locations in the colon or other parts of the gastrointestinal tract, for example, in enclosed spaces or where the scope's available field of view is oblique.

[0041] Those skilled in the art will understand that various modifications can be made to the described embodiments without departing from the teachings of this application. For example, while the embodiments were described in relation to the treatment of internal bleeding and the closure of excision defects or holes in tissue, those skilled in the art will understand that the embodiments can be modified for use in similar structural applications. For similar structural applications, the insertion section may be included for biopsy forceps, and the curvature of the insertion section may be used to obtain samples in awkward or oblique positions. Additionally, the embodiments may be modified to include 30, 45, or 60-degree bends to suit different user needs and to be usable with forward-looking scopes.

Claims

1. A device for tissue treatment for insertion into an insertion device having a working channel, comprising: a flexible insertion section extending from a distal end that is inserted into a target site within a living body during use to a proximal end that remains outside the living body during use; an end effector coupled to a distal end of the insertion section; a control wire received within the insertion section and extending from a proximal end coupled to an actuator, the control wire being pre-processed to include a predetermined bend in a distal portion of the control wire, the control wire and the insertion section being configured to bend through a bend radius of 5 mm to 15 mm in a resting state, and the distal portion of the control wire being configured to enter and pass through the working channel of the insertion device without plastic deformation of the control wire.

2. The device of claim 1, wherein the insertion section includes a bushing, a distal end of the bushing is coupled to the end effector, the end effector being a tissue clipping device, and the bend in the distal portion of the control wire terminates a predetermined distance proximal to the bushing.

3. The device described in claim 2, wherein the predetermined distance is less than 12 mm.

4. The device of claim 1, wherein the bend in the distal portion of the control wire extends around an angle of 80 degrees to 100 degrees.

5. The device of claim 1, wherein the bend in the distal portion of the control wire extends around an angle of 90 degrees.

6. The device of claim 1, wherein the bend in the distal portion of the control wire extends around a 45 degree angle.

7. The device of claim 2, wherein the tissue clipping device includes a sliding element coupled to a distal end of the control wire, the sliding element coupled to a clip arm of the tissue clipping device, such that when the control wire is moved proximally and distally within the insertion section, the sliding element slides proximally and distally within the capsule of the tissue clipping device to move the clip arm in and out of the capsule.

8. The apparatus of claim 7, wherein the proximal portion of the sliding element includes an abutment surface on its radially outer portion, the abutment surface being sized to engage when the proximal portion of the sliding element is pulled proximally out of the capsule and into the bushing, and the radially outer portion of the sliding element presses a portion of the bushing radially outward to disengage locking structures of the bushing from corresponding locking structures of the capsule to separate the capsule from the bushing.

9. The device described in claim 7, wherein a distal portion of the sliding element further comprises opposing orienting fingers, each of which is sized and shaped to pass through an opening in a proximal portion of one of the clip arms to maintain a desired orientation of the clip arm.

10. The device of claim 7, further comprising an enlarged section and proximal abutment surface on the clip arm that defines the maximum extent to which the clip arm may be pulled proximally into the capsule.

11. The device of claim 2, wherein the bushing is coupled to the capsule of the tissue clipping device via a coupler including a plurality of arms arranged around the circumference of the coupler, each of the arms including a recess, the recesses sized and shaped to engage a protrusion of the bushing to couple the bushing to the coupler, each of the recesses including proximal and distal surfaces that engage a protrusion of the bushing, a first of the proximal and distal surfaces forming a sloped portion that is angled relative to a surface of the protrusion with which it contacts, the sloped portion being oriented such that when a predetermined compression is applied between the bushing and the coupler, the sloped portion slides and disengages from the protrusion to separate the coupler and the capsule from the bushing.

12. The apparatus of claim 8, wherein the bushing includes opposing arms extending distally over a portion of the capsule, each of the opposing arms including a pin extending into a corresponding receiving portion formed in the outer wall of the capsule, the pins forming a pivoting connection permitting relative rotation of the capsule with respect to the bushing.

13. The device of claim 7, wherein the sliding element includes a yoke coupled to a tension member by a breakable link, the breakable link configured to fail when a predetermined level of tension is applied to the control wire, and the yoke configured to be pulled proximally through the capsule after the breakable link fails.

14. The insertion section further includes a first hole at a position corresponding to a proximal end of the bend portion, a second hole in the insertion section at a location corresponding to a proximal end of the end effector; and an actuation cord extending from a proximal end coupled to an actuator accessible to a user during use to a distal end coupled to the end effector; The device of claim 1 , wherein the actuation cord passes through the insertion section, exits the first hole, enters the second hole, and couples to a portion of the device distal to the bend.

15. A system for treating tissue, comprising: an insertion device including a port, a camera, and a working channel extending therethrough along a longitudinal axis; Tissue treatment device and The tissue treatment device comprises: a flexible insertion section extending from a distal end that is inserted into a target site within a living body during use to a proximal end that remains outside of the living body during use; an end effector coupled to a distal end of the insertion section; a control wire received within the insertion section and extending from a proximal end coupled to an actuator; wherein the control wire is pre-treated to include a predetermined bend in a distal portion of the control wire, and wherein, in a resting state, the control wire and the insertion section are configured to bend through a bend radius of 5 mm to 15 mm, and the distal portion of the control wire is configured to enter and pass through the working channel of the insertion device without plastic deformation of the control wire.

16. The system of claim 15, further comprising an elevator at a distal end of the insertion device, the elevator configured to vary the bend of each of the control wires and the insertion section.

17. A system as described in claim 15 or 16, wherein the camera of the insertion device is oriented perpendicular to the longitudinal axis of the insertion device and creates a conical viewing area extending radially away from the longitudinal axis.

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