Tissue clamping device

Abstract

A device includes a flexible insertion section extending from a distal end inserted into a target site during use to a proximal end retained outside the body; an end effector coupled to the 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 bend in a distal portion thereof that is configured such that, in a stationary state, the control wire and the insertion section bend through a predetermined arc at a selected bend radius. The distal portion of the control wire enters and passes through a working channel of an insertion device without the control wire being plastically deformed.

Description

[0001] Priority Claim

[0002] This invention claims priority to U.S. Provisional Patent Application Serial No. 62 / 879,874, filed Jul. 29, 2019; the disclosure of which is incorporated herein by reference. Technical Field

[0003] This invention generally relates to devices, systems, and methods for treating tissue within a naturally occurring body cavity accessed via an insertion device. Background Art

[0004] Minimally invasive surgery deep within the digestive tract, while increasingly common, has highlighted potential problems that were not fully addressed previously. For example, in procedures such as ECRP (Endoscopic Retrograde Cholangiopancreatography), the characteristics of currently available clips are often problematic because these and similar procedures are typically best served by insertion instruments (such as, duodenoscopes) that are specifically configured to view and treat anatomical structures that extend transverse to the longitudinal axis of the device. That is, for many procedures, a doctor may prefer a duodenoscope that includes optics having a field of view transverse to the axis, along which the device extends and includes ports for inserting treatment devices along a similar transverse axis. However, many treatment devices (e.g., hemostatic clips) are best suited for application along the longitudinal axis of the insertion device and can increase the difficulty and / or risk associated with procedures that apply them via a transverse approach. Summary of the Invention

[0005] This invention relates to a device for treating tissue. The device can include a flexible insertion segment that extends distally from a target site inserted into a living body during use to a proximal end that is held outside the body during use; an end effector coupled to the distal end of the insertion segment; and a control line received within the insertion segment and extending proximally from an actuator that is held user-accessible during use to a distal end coupled to the end effector. The control line can move within the insertion segment to operate the end effector, and the control line and the insertion segment include a bend in their distal portions that is configured such that, in a rest state, the control line and the insertion segment bend through a predetermined arc with a selected bending radius. The distal portion of the control line is configured to enter and pass through the working channel of an insertion device without plastic deformation of the control line.

[0006] In one embodiment, the insertion segment includes a bushing, the distal end of which is coupled to the end effector, which is a tissue clamping device.

[0007] In one embodiment, the clamping device includes a slidable element coupled to the distal end of a control line, the slidable element being coupled to the tissue clamping arms of the tissue clamping device such that when the control line is moved proximally and distally within the insertion segment, the slidable element slides proximally and distally within the bladder of the tissue clamping device to move the arms into and out of the bladder.

[0008] In one embodiment, the proximal portion of the slidable element includes an abutment surface on its radial exterior, sized to engage such that when the proximal portion of the slidable element is pulled proximally out of the bladder into the bushing, the radial exterior of the slidable element radially outwardly pushes a portion of the bushing to disengage the locking structure of the bushing from the corresponding locking structure of the bladder to separate the bladder from the bushing.

[0009] In one embodiment, the bend in the control line is configured such that in a rest state the insertion segment bends through an arc of approximately 90 degrees.

[0010] In one embodiment, the bend in the control line is configured such that in a rest state the insertion segment bends through an arc of approximately 45 degrees.

[0011] In one embodiment, the distal portion of the slidable element further includes opposing orienting fingers, each of which is sized and shaped to maintain the desired orientation of the arm through a corresponding opening in one of the arms.

[0012] In one embodiment, the device further includes a widened segment and a proximal abutment surface on the arm that define the maximum extent to which the arm can be pulled proximally into the bladder.

[0013] In one embodiment, the bushing is coupled to the bladder of the tissue clamping device via a coupler, the coupler including a plurality of arms circumferentially distributed about the coupler, each of the arms including a recess sized and shaped to engage a locking wall of the bushing to couple the bushing to the coupler, each of the recesses including a proximal surface and a distal surface that engage the locking wall of the bushing, the first of the proximal and distal surfaces forming an inclined plane that is angled relative to the surface of the locking wall with which the inclined plane contacts, the orientation of the inclined plane being set such that when a predetermined compression is applied between the bushing and the coupler, the inclined plane slides on and disengages from the locking wall to separate the coupler and the bladder from the bushing.

[0014] In one embodiment, the bushing includes a first arm and a second arm that extend distally over a portion of the bladder, each of the arms including a pin that extends into a corresponding socket formed in the outer wall of the bladder, the pin forming a pivot connection that permits rotation of the bladder relative to the bushing.

[0015] In one embodiment, the slidable element includes a yoke and a tension member that are coupled to each other via a frangible link.

[0016] In one embodiment, the device further includes a first hole at the proximal end of the bending portion; a second hole at the proximal end of the end effector; and an actuating cord that extends from the proximal end coupled to an actuator that remains user-accessible during use to the distal end coupled to the end effector, wherein the cord passes through an insertion section, exits the first hole, enters the second hole, and is coupled to a portion of the device remote from the bending portion.

[0017] The present invention also relates to a system for treating tissue. The system may include an insertion device including a port, a camera, and a working channel extending along a longitudinal axis through the insertion device; and a tissue treatment device. The device may include a flexible insertion section extending from a distal end inserted into a target site within a living body during use to a proximal end maintained outside the body during use; an end effector coupled to the distal end of the insertion section; and a control line received within the insertion section and extending from a proximal end coupled to an actuator, the control line and the insertion section including a bending portion in their distal portions, which is configured such that in a stationary state, the control line and the insertion section bend through a predetermined arc with a selected bending radius, and the distal portion of the control line is configured to enter and pass through the working channel of the insertion device without plastic deformation of the control line.

[0018] In one embodiment, the system further includes a lifter at the distal end of the insertion device that changes the bending portion of each of the control line and the insertion device.

[0019] In one embodiment, the camera of the insertion device is aimed transversely to the longitudinal axis of the insertion device, thereby creating an observation area in a generally conical volume extending radially away from the axis.

[0020] Additionally, the present invention relates to a method for treating tissue. The method may include inserting a flexible insertion section into the working channel of an insertion device, the flexible insertion section extending from a distal end to a proximal end, the distal end being inserted into a target site within a living body during use and the proximal end being maintained outside the body during use; inserting the insertion device into a target location within the living body; 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 via the port, the working channel of the insertion device extending substantially parallel to the longitudinal axis of the insertion device and the port extending substantially transversely to the longitudinal axis, the control line extending through the insertion section including a bending portion in its distal portion, the bending portion in the control line being configured such that in a stationary state, the control line causes the insertion section to bend through an arc substantially corresponding to the transition from the working channel to the port.

[0021] In one embodiment, the insertion device is a duodenoscope and the end effector is a tissue clamping device.

[0022] In one embodiment, the method further includes positioning and orienting the insertion segment such that the distal portion of the insertion segment is substantially in a stationary state when the tissue clamping device exits the port.

[0023] In one embodiment, the tissue clamping device includes diametrically opposed pins at its proximal end and further includes an actuation control line to rotate the tissue clamping device laterally about the pins.

[0024] In one embodiment, the insertion segment includes an actuation cord that extends from the proximal end to the distal end, passes through the insertion segment, exits a first hole at the proximal end of the bend, enters a second hole at the proximal end of the tissue clamping device, and is coupled to the tissue clamping device. It further includes pulling the proximal end of the actuation cord until the actuation cord bends the tissue clamping device into a desired shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1A Shows a clip assembly according to a first embodiment;

[0026] Figure 1B Shows a close-up partial cross-sectional view of the clip of FIG. 1;

[0027] Figure 2 Shows the clip assembly of FIG. 1 deployed from a duodenoscope;

[0028] Figure 3 Shows the deployment of the clip assembly of FIG. 1 adjusting its position using the elevator of a duodenoscope;

[0029] Figure 4 Shows a cross-sectional view of a clip assembly according to another embodiment;

[0030] Figure 5 Shows an embodiment of the connection between the clip and the flexible insertion segment;

[0031] Figure 6 Shows a second embodiment of the connection between the clip and the flexible insertion segment;

[0032] Figure 7A Shows a clip assembly including Figure 6 in a first configuration; and

[0033] Figure 7B Shows Figure 7A in a second configuration.

[0034] Figure 8 Shows a clip assembly according to another embodiment. DETAILED DESCRIPTION

[0035] The present invention can be further understood with reference to the following description and drawings, in which like elements are labeled with like reference numerals. The present invention relates to an apparatus and method for treating tissue transverse to the longitudinal axis of an insertion instrument such as a duodenoscope. More specifically, the present embodiment relates to an apparatus for clamping tissue at a position laterally offset relative to the longitudinal axis of the insertion device. It should be noted that as used herein, the terms "proximal" and "distal" refer to directions toward (proximal) and away from (distal) the user of the device.

[0036] Although the embodiments described herein are specifically configured to treat the gastrointestinal tract via a duodenoscope, those skilled in the art will understand that the embodiments described herein can also be used to close the papilla (the circular opening of the bile duct) and treat tissue defects in difficult-to-reach locations (approachable either through a laterally oriented port in a duodenoscope or through a longitudinally oriented port in a standard endoscope). For example, a duodenoscope is commonly used to perform resections in segments of the stomach where closure may be required. Additionally, embodiments where the bend is not as sharp as 90 degrees, for example, where the bend is 45 degrees, can be used for forward-viewing endoscopes in scenarios where the defect location is inconvenient and a standard endoscope cannot be utilized.

[0037] As shown in FIGS. 1 to 3, in this example, a treatment device 10 according to an embodiment of the present invention is a clamping device inserted through a duodenoscope 12. The device 10 includes a flexible insertion section 14, which in this embodiment is formed as a tubular coil extending from a proximal end (not shown) to a distal end 16 coupled to a bushing 18. The bushing 18 is releasably coupled to a clip 20, which includes a pair of clip arms 22 slidably received within a bladder 24. A control line 26 extends from a proximal actuator (not shown), which remains externally accessible to the user outside the body at the proximal end of the duodenoscope during use. The control line 26 passes through the bushing 18 into the bladder 24, where it is coupled to the clip 20 such that movement of the control line 26 proximally and distally through the insertion section 14 causes the clip arms 22 to move proximally and distally relative to the bladder 24.

[0038] In addition to the insertion section 14 and the control line 26, the clip 20 of this embodiment can be constructed in any known manner. Thus, the specific construction of the internal structure of the clip 20 and the connection between the clip 20 and the bushing 18 are merely exemplary. In this example, the control line 26 includes an enlarged distal tip 28 received within a cavity 30 of corresponding shape within a yoke 32, which is slidably received within the bladder 24. The yoke 32 includes opposing arms 34 that grip a proximally extending lug 36 of a tension member 38. The clip arms 22 are bent around the tension member 38, with the proximal ends of the clip arms 22 coupled to the yoke 32.

[0039] As those skilled in the art will appreciate, although the insertion segment 14 is flexible, the distal portion 40 of the device 10 extending from the proximal end of the bushing 18 to the distal end of the clamping arm 22 is substantially rigid. In applications where a user desires to deploy a clip through a port transverse to the longitudinal axis of the device (through which the clip is inserted), the rigidity of this distal portion 40 can pose difficulties for users of known clips. That is, the rigidity and length of the distal portion 40 may make it difficult for such a clip to bend around the radius of curvature required to exit a transverse port such as port 42 of a duodenoscope 12. Since a scope such as duodenoscope 12 is also aimed transverse to the longitudinal axis L of the scope 12, the viewing area 46 of the camera 48 of the scope 12 is a generally conical volume extending radially away from the axis L. Standard clips exiting port 42 will typically extend distally away from the scope 12 outside of the viewing area 46. As those skilled in the art will appreciate, a user who desires to reorient the clip towards a target tissue site within the viewing area 46 can use the elevator 52 of the scope to bend the clip. However, using the elevator 52 to force such a sharp bend in the clip risks damaging the clip and / or the scope 12.

[0040] The control line 26 of the device 10 according to this embodiment is pre-treated to include a bend 50 such that in a rest state, the insertion segment 14 bends around a radius R. In this embodiment, the radius R can range from 5 to 15 mm. The bend 50 preferably ends at a selected distance D proximal to the bushing 18 such that when the device 10 exits port 42, the bend 50 will be located in a portion of the working channel of the scope 12 adjacent to the elevator 52 of the scope 12. In this embodiment, the distance D can range from 0 to 12 mm; a shorter distance may be preferred such that the tissue is closer to the scope 12. In this embodiment, the bend 50 extends around an arc angle α of approximately 90 degrees, with a variation of approximately 10 degrees, i.e., 80 degrees to 100 degrees, to aim the device 10 generally transverse to the axis L.

[0041] However, in other embodiments, the arc angle α can be in a different angular configuration, such as 45 degrees, for use with a forward-viewing scope for lesions in inconvenient locations. The bend 50 is applied to the control line 26 by mechanical plastic deformation of bending the control line 26 into a predetermined shape. The control line 26 is made of a hard and rigid material such that the control line 26 can withstand the force to straighten the control line 26 and snap back to its predetermined shape. Similarly, the tubular coil has a predetermined shape that includes a bend applied by heat treatment of the tubular coil. The tubular coil can also snap back to its predetermined shape after being forced into a straight shape. Thus, a straightening force can be applied to the control line 26 and the tubular coil for subsequent straightening, but after the straightening force is released, the control line 26 and the tubular coil return to their respective predetermined shapes.

[0042] Those skilled in the art will understand that since the device 10 according to this embodiment initially extends from within the viewing area 46 of the camera 48 through the port 42, while the device 10 is being visualized by the camera 48, the elevator 52 can be used for fine correction of the aiming of the device 10, as Figure 3 shown. As described above, this arrangement of the bend 50 in the control line 26 can be used with any known clamping device (or other end effector) that includes a flexible insertion section for deploying the device through a laterally aimed port (such as the port 42 of the mirror 12). The device 10 has a natural tendency to move along the path of least resistance, and thus the device 10 can automatically align with the port 42 to exit the mirror 12. In an exemplary embodiment, a proximal marker can be implemented on the proximal end of the inner section 14 to allow the doctor to track the device 10 as it exits the mirror 12.

[0043] Figure 4 A clamping device 100 is shown, which includes a clip 101 coupled to a bushing 104, the proximal end of the bushing 104 being coupled to the distal end of a flexible insertion section 106 through which a control line 108 extends to be coupled to a yoke 110 that incorporates the functions of the tension member and the yoke of the clip 20 described above into a single element. This eliminates the arm 34 of the yoke 32 that clamps the lug 36 of the tension member 38, thereby allowing a corresponding shortening of the clip mechanism, which also allows the arm 114 of the yoke 110 to move further distally, thereby allowing a corresponding shortening of the clip arms.

[0044] Those skilled in the art will understand that the clamping device 100 can be used with any standard insertion section and control line, or can include a control line / insertion section combination that includes the bend 50 for the control line 26 and the insertion section 14 as described above. The maneuverability of the device 100 according to this embodiment is further enhanced by the structure of coupling the control line 108 to the internal mechanism of the clip arms 112, which enables the rigid portion of the device 100 to extend distally from the proximal end of the bushing 104 through the bladder 102 to the distal ends of the clip arms 112.

[0045] The yoke 110 includes a pair of arms 114 extending from its intermediate section and includes a clip arm holding section 116 coupled to the proximal portion of the yoke 110 via a frangible joint 118 (e.g., by welding or formed integrally with the yoke 110), and the frangible joint 118 can be formed, for example, as a narrowed or weakened section of the clip arm holding section 116. Distal to the frangible joint 118, the clip arm holding section 116 includes a tongue 120 received between the clip arms 112 to bias the clip arms 112 away from each other such that when the clip arms 112 are pushed distally out of the bladder 102, the clip arms 112 deploy to as Figure 4In the tissue receiving configuration shown. This arrangement also allows the proximal portion of the jaw arms 112 to be shorter than in the clip 20, thereby reducing the overall length of the clip 101. The jaw retaining section 116 also includes opposing orientation fingers 122, each of which holds the desired orientation of the jaw arms 112 as the jaw arms 112 move proximally and distally through the bladder 102 via corresponding openings in one of the jaw arms 112.

[0046] In this embodiment, the orientation fingers 122 are also sized such that they extend substantially across and slidably engage opposing surfaces of the bladder 102 to ensure smooth proximal and distal movement of the jaw arms 112 as the control line 108 is advanced or retracted through the insertion section 106. The jaw arms 112 include a widened section 124 and a proximal abutment surface 126 that define the maximum extent to which the jaw arms 112 can be pulled proximally into the bladder 102. That is, the abutment surface 126 extends transversely relative to the longitudinal axis L of the device 100 to an extent greater than the diameter of the opening 128 such that when the jaw arms 112 are pulled proximally into the bladder 102, the abutment surface 126 eventually contacts the end of the bladder 102 surrounding the opening 128.

[0047] To deploy the clip when the clip 101 has been positioned to grasp the target tissue as desired, the user withdraws the control line 108 proximally (e.g., by actuating an actuator on a proximal handle (not shown)) until the abutment surface 126 contacts the bladder 102. The user will feel resistance to further proximal movement of the control line 108. The user then applies an increasing pulling force to the control line 108 until, when a predetermined pulling force level is reached, the frangible joint 118 fails and the yoke 110 is pulled proximally past the bladder 102 away from the jaw retaining section 116. As the yoke 110 moves proximally away from the jaw retaining section 116, the arms 114 of the yoke move away from the proximal end 130 of the jaw arms 112, releasing the proximal end 130 of the jaw arms 112 to spring outward such that the locking features on the proximal end 130 of the jaw arms 112 spring radially outward away from the axis L to engage the locking features 132 on the bladder 102. This locks the jaw arms 112 in the tissue grasping configuration, where the distal ends of the jaw arms 112 are pulled together toward the axis L to grasp the tissue positioned therebetween.

[0048] Additionally, after the yoke 110 is separated from the clamp arm retaining section 116, it is further pulled proximally out of the proximal end of the bladder 102. At this point, the arms 114 of the yoke 110 extend further radially away from the axis L compared to the more proximal portion of the yoke 110 to engage the bushing coupling feature 134, which clamps the corresponding coupling feature 136 of the bladder 102. When the yoke 110 is pulled proximally into the bushing 104, the arms 114 radially outwardly push the bushing coupling feature 134 away from the axis L, thereby disengaging it from engagement with the coupling feature 136 of the bladder 102 and separating the clip 101 from the bushing 104 and the insertion section 106, leaving the clip 101 locked onto the clamped portion of the target tissue while withdrawing the remainder of the device 100 from the body. As will be understood by those skilled in the art, any known coupling may be employed by which the bushing is releasably coupled to the clip bladder, and such coupling includes those described below Figure 5 couplings.

[0049] As Figure 5 shown, the coupling 200 between the bladder 202 and the bushing 204 of a clamping device (e.g., device 100) includes a coupler 206. The distal end of the coupler 206 is formed to couple to a tube 208 of the bladder 202, while the proximal end of the coupler 206 includes a plurality of arms 210 circumferentially distributed about the tube 208. Each of the arms 210 includes a recess 212 having a proximal locking surface 214 that clamps a radially protruding portion 216 of the bushing 204. In this embodiment, the radially protruding portion 216 is formed as an annular surface that protrudes radially outwardly away from the axis L and extends generally perpendicular to the outer surface of the bushing 204. The proximal locking surface 214 of the arms 210 of this embodiment is also generally perpendicular to the axis L such that the bladder 202 is firmly coupled to the bushing 204 via the coupler 206.

[0050] The distal surface of each of the recesses 212 is formed as an inclined surface 218 that extends distally at an angle (e.g., an angle between 30 and 45 degrees with the inner surface of the arm 210) away from the radially outer edge of the distal surface 220 of the radially protruding portion 216 such that the radially outermost end of each of the inclined surfaces 220 contacts the distal surface 220 while creating a gap between the more radially inwardly located portion of the inclined surface 218 and the distal surface 220. Thus, when the clip including the coupling 200 is inserted into a target site in the body via an insertion device, the arms 210 firmly lock the bladder 202 to the bushing 204. However, as described above, when the clip is pulled into the bladder to the point where it cannot be moved further proximally into the bladder 202, the user applies an increased proximally directed force to the control member 222, which is opposite to the distally directed force when the insertion section 106 resists compression.

[0051] When such compression is applied to the connector 206, the bevel 218 slides proximally against the distal surface 220 of the bushing 204, causing the proximal end of the arm 210 to rotate outwardly in the direction of arrow A of Figure 5 . This disengages the proximal locking surface 214 of the arm 210 from engagement with the radially projecting portion 216 until the radially projecting portion 216 disengages from the recess 212, thereby separating the bushing 204 from the connector 206. Accordingly, the tube 208 and the bladder 202 can rotate freely about the axis L. In another embodiment, a triple wire configuration can be used to produce control line-driven rotation, where the user rotates the clip such that it can be positioned as desired. In another embodiment, the bladder 202 can be fixed to the bushing 204, and thus, rotation about the axis L is not possible.

[0052] As Figure 6 , 7A and 7B show, an apparatus 300 including a coupling mechanism according to the second embodiment includes a bladder 302 that is coupled to a bushing 304 and houses a yoke 306, and a control line 308 is attached to the yoke 306. The yoke 306 operates in conjunction with a tension member (not shown) or any other known clamping mechanism, so long as when the clip is deployed, the yoke 306 is free to move proximally into the bushing 304 together with the control line 308. As will be seen below, the bushing includes opposing arms 310 that extend around a proximal portion of the bladder 302 such that diametrically opposed pins 312 at the distal end of the bushing 304 extend into sockets 314 formed in the wall of the bladder 302. The arms 310 flare outwardly via an inclined portion 315. When the arms 310 extend around the exterior of the bladder 302, the distance by which the arms 310 are separated from each other is greater than the diameter of the bladder 302, while the inclined portion 315 defines a diameter-reduced portion of the bushing 304 that has a diameter smaller than the diameter of the bladder 302, such that, as described in more detail below, when the yoke 306 is pulled proximally past the bushing 304, the radially outer edge of the yoke 306, which is slidable within the bladder 302, will impact and radially outwardly push the inclined portion 315.

[0053] However, those skilled in the art will understand that the outer diameter of the bushing 304 can remain consistent throughout its length, so long as the inner diameter is reduced (in at least one direction) such that after the clip has been deployed and the yoke 306 has been pulled proximally past the bushing 304, the radially outer surface of the yoke 306 contacts the inner surface of at least a portion of the bushing 304 to radially outwardly drive the arms 310. Thus, when the yoke 306 contacts the inclined portion 315 and radially outwardly drives it, the pins 312 are radially outwardly pushed out of the sockets 314, thereby releasing the bladder 302 from the bushing 304 and separating the clip from the insertion segment 316, the bushing 304, the control line 308, and the entire proximal portion of the apparatus.

[0054] In addition, as will be understood by those skilled in the art, if the socket 314 and the pin 312 are made circular, the bladder 302 will be rotatable relative to the bushing 304 and the insertion section 316. Of course, such rotation will be limited by any resistance to the bending of the control line 308. However, such rotation (as Figure 7A and 7B shown) can further help to facilitate the application of the clip through a path including a sharp bend, such as, for example, the sharp bend that may be encountered when the clip passes longitudinally through a duodenoscope and then has to bend through an arc of about 90 degrees to exit the scope via a laterally facing port.

[0055] As Figure 8 shown, the treatment device 400 can be substantially similar to the treatment device 10 described above. The device 400 can include a control line 426, an insertion section 414, a bushing 418, a clip 420 including clip arms 422, and a distal portion 440. Similar to the distal portion 40 described above, the distal portion 440 extends from the proximal end of the bushing 418 to the distal ends of the clip arms 422. The distal portion 440 includes a bladder 424. The bladder 424 houses a coupling mechanism that is similar to the coupling mechanisms of devices 10 and 100 to 300. The coupling mechanism includes a yoke 432, lugs 436, a tension member 438, and the clip 420. In addition, the control line 426 has a bend 450 that is similar to the bend 50 of the control line 26 and extends from a proximal end (not shown) to a distal end having a radius R' that is similar to the radius R of the device 10. In this embodiment, the bend 450 extends around an arc angle α', and the angle α' is similar to the angle α of the device 10. In this embodiment, the distance D' is between the distal end of the bend 450 and the proximal end of the bushing 418, and the distance D' is similar to the distance D of the device 10.

[0056] The device 400 includes a first hole 462 at the proximal end of the bend 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 such that an actuation cord 470 can extend therebetween to allow for better positioning of the clip 420. At the proximal end of the distal portion 440, the cord 470 extends from a proximal end (not shown) to a distal end. 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 such that the user can pull proximally on the proximal end of the cord 470 to straighten the cord 470, thereby forming a hypotenuse between the first hole 462 and the second hole 464 and further bending the bend 450. By applying different magnitudes of force when pulling on the proximal end of the cord 470, the user controls the bending of the bend 450 and the position of the distal portion 440.

[0057] As will be further understood, a clip assembly that combines such a pivotal connection between the bladder and the liner with a control line having a bend at the distal end of the insertion section adjacent thereto (e.g., the control line 26 described above) can exhibit significant improvements in procedures having a lateral port and / or in surgeries that require access to difficult-to-reach locations (requiring a sharp bend radius). By employing the shorter clip mechanism of the device 100 described above, such a combination can be further improved. Such a device will be effective in an insertion device, such as an endoscope having a longitudinally oriented outlet to its working channel or having a lateral portion of the duodenoscope described above, to, for example, close lesions in complex locations in the large intestine or other parts of the gastrointestinal tract, in confined spaces, or where the field of view available to the scope is angled.

[0058] Those skilled in the art will understand that various modifications can be made to the described embodiments without departing from the teachings of the present application. For example, while the embodiments have been described with respect to treating internal bleeding and closing resection defects or holes in tissue, those skilled in the art will understand that the embodiments can be modified for similar structural applications. For similar structural applications, an insertion section for a biopsy forceps can be included, where the curvature of the insertion section can be used to obtain samples in inconvenient or angled positions. Additionally, these embodiments can be modified to include bends of 30, 45, or 60 degrees to accommodate different user needs and be used on forward-viewing scopes.

Claims

1. A device for treating tissue, comprising: a flexible insertion section extending from a distal end that is inserted into a target site in vivo during use to a proximal end that remains outside the body during use; an end effector coupled to the distal end of the insertion section; as well as a control wire received within the insertion segment and extending from a proximal end coupled to an actuator, the control wire being pre-processed to include a bend in a distal portion of the control wire and configured to cause the insertion segment to bend through a predetermined arc at a selected bend radius when the insertion segment is in a static state, the distal portion of the control wire being configured to enter and pass through a working channel of an insertion device without plastic deformation of the control wire; wherein the insertion section comprises a sleeve, a distal end of the sleeve is coupled to the end effector, and the end effector is a tissue clamping device; wherein the tissue clamping device comprises a slidable element coupled to a distal end of the control wire, wherein the slidable element comprises a yoke and a tension member coupled to each other via a detachable link, the distal end of the control wire being attached to the yoke, the slidable element being coupled to a tissue clamping arm of the tissue clamping device, so that when the control wire moves proximally and distally within the insertion section, the slidable element slides proximally and distally within a balloon of the tissue clamping device to move the tissue clamping arm into and out of the balloon; The proximal portion of the slidable element includes an abutment surface on its radially outer portion, which is sized to engage, and when the proximal portion of the slidable element is pulled proximally out of the capsule into the sleeve, the radially outer portion of the slidable element pushes a portion of the sleeve radially outward to disengage the locking structure of the sleeve from the corresponding locking structure of the capsule to separate the capsule from the sleeve, thereby allowing the yoke to move out of the capsule together with the control line and into the sleeve. 2 . The device of claim 1 , wherein the bend in the control wire is configured such that the insertion section bends through an arc of approximately 90 degrees in a static state.

3. The device of claim 1, wherein the bend in the control wire is configured such that the insertion section bends through an arc of approximately 45 degrees in a static state.

4. The device of claim 1, wherein the distal portion of the slidable element further comprises: Opposing orienting fingers, each of which is sized and shaped to pass through a corresponding opening in one of the tissue clamping arms to maintain a desired orientation of the tissue clamping arm.

5. The device according to claim 1, further comprising: A widened section and proximal abutment surface on the tissue gripping arm that defines the maximum extent to which the tissue gripping arm can be drawn proximally into the balloon.

6. The device according to claim 1, wherein the sleeve is connected to the capsule of the tissue clamping device via a connector, the connector comprising a plurality of arms distributed around the circumference of the connector, each of the arms comprising a recess, the size and shape of the recess being configured to engage the locking wall of the sleeve to connect the sleeve to the connector, each of the recesses comprising a proximal surface and a distal surface engaging the locking wall of the sleeve, the first of the proximal and distal surfaces forming a ramp, the ramp being angled relative to a surface of the locking wall contacted by the ramp, the orientation of the ramp being configured so that when a predetermined compression is applied between the sleeve and the connector, the ramp slides on and disengages from the locking wall to separate the connector and the capsule from the sleeve.

7. A device according to claim 1, wherein the bushing includes a first arm and a second arm extending distally above a portion of the sac, each of the arms including a pin extending into a corresponding socket formed in an outer wall of the sac, the pin forming a pivot connection allowing the sac to rotate relative to the bushing.

8. The device of claim 1, wherein the detachable link is a frangible link.

9. The device according to claim 1, further comprising: a first hole at a proximal end of the bend; a second aperture at a proximal end of the end effector; as well as an actuation cord extending from a proximal end coupled to the actuator that remains accessible to a user during use to a distal end coupled to the end effector, wherein the actuation cord passes through the insertion section, exits the first aperture, enters the second aperture, and couples to a portion of the device distal to the bend.

10. A system for treating tissue, comprising: an insertion device comprising a port, a camera, and a working channel extending through the insertion device along a longitudinal axis; as well as A tissue treatment device, comprising: a flexible insertion section extending from a distal end that is inserted into a target site in vivo during use to a proximal end that remains outside the body during use; an end effector coupled to the distal end of the insertion section; and a control wire received within the insertion segment and extending from a proximal end coupled to an actuator, the control wire being pre-processed to include a bend in a distal portion of the control wire and configured to cause the insertion segment to bend through a predetermined arc at a selected bend radius when the insertion segment is in a static state, 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; wherein the insertion section comprises a sleeve, a distal end of the sleeve is coupled to the end effector, and the end effector is a tissue clamping device; wherein the tissue clamping device comprises a slidable element coupled to a distal end of the control wire, wherein the slidable element comprises a yoke and a tension member coupled to each other via a detachable link, the distal end of the control wire being attached to the yoke, the slidable element being coupled to a tissue clamping arm of the tissue clamping device, so that when the control wire moves proximally and distally within the insertion section, the slidable element slides proximally and distally within a balloon of the tissue clamping device to move the tissue clamping arm into and out of the balloon; The proximal portion of the slidable element includes an abutment surface on its radial outer portion, which is sized to engage, and when the proximal portion of the slidable element is pulled proximally out of the capsule into the sleeve, the radial outer portion of the slidable element pushes the locking structure of the sleeve radially outward to disengage the locking structure of the sleeve from the corresponding locking structure of the capsule, so that the capsule is separated from the sleeve, thereby allowing the yoke to move out of the capsule together with the control line and into the sleeve.

11. The system according to claim 10, further comprising: An elevator at a distal end of the insertion device changes the curvature of each of the control wire and the insertion device.

12. A system according to any one of claims 10 to 11, wherein the camera of the insertion device is aimed transversely to the longitudinal axis of the insertion device to create an observation area in a generally conical volume extending radially away from the axis.

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