Tissue clamping device

Abstract

A tissue clamping device includes a flexible insertion section extending from a distal end inserted into a target site during use to a proximal end retained in vitro; an end effector coupled to a 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 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 line and the insertion section comprise a bend in a distal portion thereof configured such that, in a rest state, the control line and the insertion section bend through a predetermined arc at a selected bend radius. The distal portion of the control line enters and passes through the working channel of the insertion device without plastic deformation of the control line.

Description

This case is a divisional application of invention patent application number 202080042518.5 Priority declaration

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 879,874, filed on July 29, 2019; the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present invention generally relates to devices, systems and methods for treating tissue within a naturally occurring body cavity accessed via an insertion device. Background Art

[0003] Minimally invasive procedures deep within the digestive tract, while increasingly common, have also highlighted potential issues that have not been 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 often 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 physician may prefer a duodenoscope that includes optics having a field of view that is transverse to an axis along which the device extends and includes a port for inserting a therapeutic device along a similar transverse axis. However, many therapeutic devices (e.g., hemostatic clips) are best suited for administration along the longitudinal axis of the insertion device and may increase the difficulties and / or risks associated with procedures in which they are administered via a transverse approach. Summary of the invention

[0004] The present invention relates to a device for treating tissue. The device may include a flexible insertion section extending from a distal end inserted into a target site in 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 wire received in the insertion section and extending from a proximal end coupled to an actuator maintained accessible to a 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 the insertion section include a bend in a distal portion thereof, which is configured so that in a static state, the control wire and the insertion section bend 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.

[0005] In one embodiment, the insertion section includes a hub having a distal end coupled to an end effector, the end effector being a tissue grasping device.

[0006] In one embodiment, the clamping device includes a slidable element connected to the distal end of the control line, and the slidable element is connected to the tissue clamping arm of the tissue clamping device, so that when the control line moves proximally and distally within the insertion section, the slidable element slides proximally and distally within the capsule of the tissue clamping device to move the arm in and out of the capsule.

[0007] In one embodiment, the proximal portion of the slidable element includes an abutment surface radially outwardly thereof that 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 a portion of the sleeve radially outwardly to disengage the locking structure of the sleeve from the corresponding locking structure of the capsule to separate the capsule from the sleeve.

[0008] In one embodiment, the bend in the control wire is configured such that in the static state the insertion section bends through an arc of approximately 90 degrees.

[0009] In one embodiment, the bend in the control wire is configured such that the insertion section bends through an arc of approximately 45 degrees in the static state.

[0010] In one embodiment, the distal portion of the slidable element further includes opposing orientation fingers, each of which is sized and shaped to pass through a corresponding opening in one of the arms to maintain a desired orientation of the arm.

[0011] In one embodiment, the device further comprises a widened section and a proximal abutment surface on the arm that defines the maximum extent to which the arm can be drawn proximally into the balloon.

[0012] In one embodiment, the sleeve is connected to the capsule of the tissue clamping device via a connector, the connector including a plurality of arms distributed around the circumference of the connector, each of the arms including 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 including 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 that is angled relative to a surface of the locking wall that contacts 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 the locking wall and disengages therefrom to separate the connector and the capsule from the sleeve.

[0013] In one embodiment, the bushing includes first and second arms extending distally over a portion of the capsule, each of the arms including a pin extending into a corresponding socket formed in an outer wall of the capsule, the pin forming a pivot connection allowing the capsule to rotate relative to the bushing.

[0014] In one embodiment, the slidable element includes a yoke and a tension member coupled to each other via a frangible link.

[0015] In one embodiment, the device further comprises a first hole at a proximal end of the bend; a second hole at a proximal end of the end effector; and 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 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.

[0016] 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 through the insertion device along a longitudinal axis; and a tissue treatment device. The device may include a flexible insertion segment extending from a distal end inserted into a target site in vivo during use to a proximal end maintained outside the body during use; an end effector coupled to the distal end of the insertion segment; and a control wire received within the insertion segment and extending from a proximal end coupled to an actuator, the control wire and the insertion segment including a bend in a distal portion thereof, which is configured so that in a static state, the control wire and the insertion segment bend through a predetermined arc at a selected bending radius, 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.

[0017] In one embodiment, the system further comprises an elevator at a distal end of the insertion device, the elevator changing the curvature of each of the control wire and the insertion device.

[0018] In one embodiment, the camera of the insertion device is aimed transversely to the longitudinal axis of the insertion device, thereby creating a viewing area in a generally conical volume extending radially away from the axis.

[0019] In addition, the present invention relates to a method for treating tissue. The method may include inserting a flexible insertion segment into a working channel of an insertion device, the flexible insertion segment extending from a distal end to a proximal end, the distal end being inserted into a target site in vivo during use, and the proximal end remaining outside the body during use; inserting the insertion device into the target site in vivo; advancing the insertion segment through the working channel of the insertion device until an end effector coupled to the distal end of the insertion segment exits the insertion device via a port, the working channel of the insertion device extending substantially parallel to the longitudinal axis of the insertion device, and the port extending substantially transverse to the longitudinal axis, a control line extending through the insertion segment including a bend in its distal portion, the bend in the control line being configured such that in a static state, the control line bends the insertion segment through an arc substantially corresponding to a transition from the working channel to the port.

[0020] In one embodiment, the insertion device is a duodenoscope and the end effector is a tissue grasping device.

[0021] In one embodiment, the method further includes positioning and orienting the insertion section such that a distal portion of the insertion section is substantially at rest when the tissue grasping device is passed from the port.

[0022] In one embodiment, the tissue grasping device includes diametrically opposed pins at a proximal end thereof, further comprising an actuation control wire to laterally rotate the tissue grasping device about the pins.

[0023] In one embodiment, the insertion section includes an actuation cord extending from a proximal end to a distal end, through the insertion section, out of a first hole at the proximal end of the bend, into a second hole at the proximal end of the tissue clamping device, and connected to the tissue clamping device, which also includes pulling the proximal end of the actuation cord until the actuation cord bends the tissue clamping device to a desired shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1A A clip assembly according to a first embodiment is shown;

[0025] Figure 1B shows a close-up partial cross-sectional view of the clip of FIG1 ;

[0026] Figure 2 shows the clip assembly of FIG. 1 deployed from a duodenoscope;

[0027] Figure 3 The clip assembly of FIG. 1 is shown deployed using an elevator of a duodenoscope to adjust its position;

[0028] Figure 4 shows a cross-sectional view of a clip assembly according to another embodiment;

[0029] Figure 5 An embodiment of a coupling between a clip and a flexible insertion section is shown;

[0030] Figure 6 A second embodiment of the coupling between the clip and the flexible insertion section is shown;

[0031] Fig. 7A The first form includes Figure 6 A coupled clip assembly; and

[0032] Figure 7B Shown in the second form Fig. 7A The clamp assembly.

[0033] Figure 8 A clip assembly according to another embodiment is shown. DETAILED DESCRIPTION

[0034] The present invention may be further understood with reference to the following description and accompanying drawings, in which like elements are designated by like reference numerals. The present invention relates to a device 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 a device for clamping tissue in a position laterally offset relative to the longitudinal axis of the insertion device. It is noted that the terms "proximal" and "distal" as used herein refer to directions toward (proximal) and away from (distal) a user of the device.

[0035] Although the embodiments described herein are specifically configured to treat the gastrointestinal tract via a duodenoscope, those skilled in the art will appreciate that the embodiments described herein may also be used to close papillae (circular openings of the internal bile ducts) and to treat tissue defects in difficult-to-reach locations (whether approached via a transversely oriented port in a duodenoscope or a longitudinal port in a standard endoscope). For example, duodenoscopes are often used to perform resections in sections of the stomach that may need to be closed. Additionally, embodiments in which the bend is not as sharp as 90 degrees, for example, in which the bend is 45 degrees, may be used for front-viewing in scenarios where defect positioning is difficult and a standard endoscope cannot be utilized.

[0036] 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 that is 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 sleeve 18. The sleeve 18 is releasably coupled to a clip 20, which includes a pair of clamp arms 22 slidably received within a capsule 24. A control wire 26 extends from a proximal actuator (not shown) that is maintained accessible to the user outside the body outside the proximal end of the duodenoscope during use. The control wire 26 passes through the sleeve 18 into the capsule 24, where it is coupled to the clip 20, so that movement of the control wire 26 proximally and distally through the insertion section 14 causes the clamp arms 22 to move proximally and distally relative to the capsule 24.

[0037] The clip 20 of this embodiment may be constructed in any known manner, except for the insertion section 14 and the control wire 26. Therefore, the specific configuration of the internal configuration of the clip 20 and the connection between the clip 20 and the bushing 18 are merely exemplary. In this example, the control wire 26 includes an enlarged distal tip 28, which is received in a correspondingly shaped cavity 30 in a yoke 32, which is slidably received in the capsule 24. The yoke 32 includes opposing arms 34 that clamp proximally extending lugs 36 of the tension member 38. The clip arms 22 are bent around the tension member 38, wherein the proximal ends of the clip arms 22 are coupled to the yoke 32.

[0038] As will be appreciated by those skilled in the art, while the insertion section 14 is flexible, the distal portion 40 of the device 10 extending from the proximal end of the hub 18 to the distal end of the clip arm 22 is substantially rigid. The rigidity of the distal portion 40 can present difficulties for users of known clips in applications where the user wishes to deploy the clip through a port transverse to the longitudinal axis of the device through which the clip is inserted. That is, the rigidity and length of the distal portion 40 can make it difficult for such clips to bend around the required bend radius exiting a transverse port such as the port 42 of the duodenoscope 12. Since a scope such as the 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. A standard clip exiting the port 42 will typically extend distally away from the scope 12 outside of the viewing area 46. As will be appreciated by those skilled in the art, a user who wishes to redirect the clip toward a target tissue site within the viewing area 46 can use the scope's elevator 52 to bend the clip. However, using lifter 52 to force such a sharp bend in the clip risks damaging the clip and / or mirror 12 .

[0039] The control wire 26 of the device 10 according to this embodiment is pre-processed to include a bend 50 so that in the static state, the insertion section 14 is bent about 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 sleeve 18 so that when the device 10 exits the 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; shorter distances may be preferred so that the tissue is closer to the scope 12. In this embodiment, the bend 50 extends about an arc angle α of about 90 degrees, with a change of about 10 degrees, namely 80 degrees to 100 degrees, so that the device 10 is generally transverse to the axis L.

[0040] However, in other embodiments, the arc angle α can be in a different angular form, such as 45 degrees, to be used in conjunction with a front sight to place lesions in inconvenient locations. The bend 50 is applied to the control wire 26 by mechanical plastic deformation that bends the control wire 26 into a predetermined shape. The control wire 26 is made of a hard and rigid material so that the control wire 26 can withstand the force of straightening the control wire 26 and rebound to its predetermined shape. Similarly, the tubular coil has a predetermined shape including a bend applied by heat treatment of the tubular coil. The tubular coil can also rebound to its predetermined shape after being forced into a straight shape. Therefore, a straightening force can be applied to the control wire 26 and the tubular coil for subsequent straightening, but after the straightening force is released, the control wire 26 and the tubular coil return to their corresponding predetermined shapes.

[0041] Those skilled in the art will appreciate that because the device 10 according to this embodiment initially extends from the port 42 within the viewing area 46 of the camera 48, the elevator 52 can be used as a fine correction for aiming the device 10 while the device 10 is being visualized by the camera 48, such as Figure 3 As described above, this arrangement of bend 50 in control wire 26 can be used with any known clamping device (or other end effector) that includes a flexible insertion section to deploy the device via a laterally aimed port (such as port 42 of scope 12). Device 10 has a natural tendency to move toward the path of least resistance, so device 10 can automatically align with port 42 to exit scope 12. In an exemplary embodiment, a proximal marker can be implemented on the proximal end of inner section 14 to allow the physician to track device 10 as it moves out of scope 12.

[0042] Figure 4 A clamping device 100 is shown, comprising a clamp 101 coupled to a bushing 104, the proximal end of which is coupled to the distal end of a flexible insertion section 106, through which a control line 108 extends to couple to a yoke 110, which incorporates into a single element the functions of the tension member and yoke of the clamp 20 described above. This eliminates the arms 34 of the yoke 32 gripping the lugs 36 of the tension member 38, thereby allowing a corresponding shortening of the clamp mechanism, which also allows the arms 114 of the yoke 110 to move further distally, thereby allowing a corresponding shortening of the clamp arms.

[0043] Those skilled in the art will appreciate that the clamping device 100 may be used with any standard insertion section and control wire, or may include a control wire / insertion section combination that includes the bend 50 described above for the control wire 26 and insertion section 14. The maneuverability of the device 100 according to this embodiment is further enhanced by the structure of the internal mechanism that couples the control wire 108 to the clamp arm 112, which enables the rigid portion of the device 100 to extend distally from the proximal end of the sleeve 104 through the capsule 102 to the distal end of the clamp arm 112.

[0044] The yoke 110 includes a pair of arms 114 extending from a middle section thereof and includes a clamp arm retaining section 116 coupled to a proximal portion of the yoke 110 via a frangible joint 118 (e.g., by welding or integrally formed with the yoke 110), which can be formed, for example, as a narrowed or weakened section of the clamp arm retaining section 116. Distal to the frangible joint 118, the clamp arm retaining section 116 includes a tongue 120 received between the clamp arms 112 to bias the clamp arms 112 away from each other so that when the clamp arms 112 are pushed distally out of the capsule 102, the clamp arms 112 expand to a position such as Figure 4This arrangement also allows the proximal portion of the clamp arm 112 to be shorter than in the clip 20, thereby reducing the overall length of the clamp 101. The clamp arm retaining section 116 also includes opposed orientation fingers 122, each of which passes through a corresponding opening in one of the clamp arms 112 to maintain the desired orientation of the clamp arm 112 as the clamp arm 112 moves proximally and distally through the capsule 102.

[0045] In this embodiment, the orienting finger 122 is also sized so that it substantially extends across and slidably engages the opposing surface of the capsule 102 to ensure that the clamp arm 112 moves smoothly proximally and distally when the control wire 108 is advanced or retracted through the insertion section 106. The clamp arm 112 includes a widened section 124 and a proximal abutment surface 126 that defines the maximum extent to which the clamp arm 112 can be proximally drawn into the capsule 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, so that when the clamp arm 112 is drawn proximally into the capsule 102, the abutment surface 126 ultimately contacts the end of the capsule 102 surrounding the opening 128.

[0046] To deploy the clip once the clip 101 has been positioned to grip the target tissue as desired, the user withdraws the control wire 108 proximally (e.g., by actuating an actuator on a proximal handle (not shown)) until the abutment surface 126 contacts the capsule 102. The user will feel resistance to further proximal movement of the control wire 108. The user then applies increasing tension to the control wire 108 until, when a predetermined tension level is reached, the frangible joint 118 fails and the yoke 110 is pulled proximally through the capsule 102 away from the clamp arm retention section 116. As the yoke 110 moves proximally away from the clamp arm retention section 116, the arms 114 of the yoke move away from the proximal ends 130 of the clamp arms 112, releasing the proximal ends 130 of the clamp arms 112 to spring outward, causing the locking features on the proximal ends 130 of the clamp arms 112 to spring radially outward away from the axis L to engage the locking features 132 on the capsule 102. This locks the clamp arms 112 in a tissue clamping configuration, wherein the distal ends of the clamp arms 112 are drawn together toward the axis L to clamp tissue positioned therebetween.

[0047] Additionally, after the yoke 110 is separated from the clamp arm retaining section 116, it is pulled further proximally out of the proximal end of the capsule 102. At this point, the arms 114 of the yoke 110 extend radially farther away from the axis L than the more proximal portions of the yoke 110 to engage the hub coupling features 134, which grip corresponding coupling features 136 of the capsule 102. As the yoke 110 is pulled proximally into the hub 104, the arms 114 push the hub coupling features 134 radially outwardly away from the axis L, thereby disengaging them from engagement with the coupling features 136 of the capsule 102 and separating the clip 101 from the hub 104 and the insertion section 106, leaving the clip 101 locked onto the gripping portion of the target tissue while the remainder of the device 100 is withdrawn from the body. As will be appreciated by those skilled in the art, any known coupling means by which the bushing is releasably coupled to the bladder of the clip may be employed, including the following: Figure 5 The connecting parts.

[0048] like Figure 5 As shown, a coupling 200 between a capsule 202 and a sleeve 204 of a clamping 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, and the proximal end of the coupler 206 includes a plurality of arms 210 distributed around the circumference of the tube 208. Each of the arms 210 includes a recess 212 having a proximal locking surface 214 that grips a radial protrusion 216 of the sleeve 204. In this embodiment, the radial protrusion 216 is formed as an annular surface that protrudes radially outward away from the axis L to extend generally perpendicularly away from the outer surface of the sleeve 204. The proximal locking surface 214 of the arm 210 of this embodiment is also generally perpendicular to the axis L, so that the capsule 202 is firmly coupled to the sleeve 204 via the coupler 206.

[0049] The distal surface of each of the recesses 212 is formed as a ramp 218 that extends distally away from the radially outer edge of the distal surface 220 of the radial projection 216 at an angle (e.g., an angle ranging between 30 and 45 degrees with the inner surface of the arm 210) such that the radially outermost end of each of the ramps 220 contacts the distal surface 220 while forming a gap between the more radially inwardly positioned portion of the ramp 218 and the distal surface 220. Thus, when the clip including the coupling 200 is inserted into a target site in the body through an insertion device, the arm 210 securely locks the capsule 202 to the bushing 204. However, as described above, when the clip is pulled into the capsule to a point where it cannot be moved further proximally into the capsule 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.

[0050] When such compression is applied to the coupler 206, the ramp 218 slides proximally against the distal surface 220 of the bushing 204, causing the proximal end of the arm 210 to slide proximally. Figure 5 214. The proximal locking surface 214 of the arm 210 is disengaged from the radial projection 216 until the radial projection 216 is disengaged from the recess 212, thereby separating the sleeve 204 from the coupler 206. Thus, the tube 208 and the capsule 202 can rotate freely about the axis L. In another embodiment, a triple wire configuration can be used to produce a control line driven rotation, wherein the user rotates the clip so that it can be placed as desired. In another embodiment, the capsule 202 can be fixed to the sleeve 204, so that rotation about the axis L is not possible.

[0051] like Figure 6 , 7A As shown in FIGS. 7B and 7B , a device 300 including a coupling mechanism according to a second embodiment includes a capsule 302 coupled to a bushing 304 and housing a yoke 306 to which a control line 308 is attached. The yoke 306 operates in conjunction with a tension member (not shown) or any other known clamping mechanism, so long as the yoke 306, along with the control line 308, is free to move proximally out of the capsule 302 into the bushing 304 when the clamp is deployed. As will be seen below, the bushing includes opposed arms 310 extending around a proximal portion of the capsule 302 such that diametrically opposed pins 312 at the distal end of the bushing 304 extend into receptacles 314 formed in the wall of the capsule 302. The arms 310 flare outwardly via an inclined portion 315. As the arms 310 extend around the exterior of the capsule 302, the arms 310 are separated from one another by a distance greater than the diameter of the capsule 302, and the inclined portion 315 defines a reduced diameter portion of the bushing 304 having a diameter smaller than the diameter of the capsule 302, such that, as described in more detail below, when the yoke 306 is pulled proximally through the bushing 304, the radially outer edge of the yoke 306, which is slidable within the capsule 302, will impact and push the inclined portion 315 radially outward.

[0052] However, those skilled in the art will appreciate that the outer diameter of the bushing 304 can remain consistent throughout its length, as long as the inner diameter decreases (in at least one direction) such that after the clip has been deployed and the yoke 306 is pulled proximally through 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 drive the arms 310 radially outward. Thus, when the yoke 306 contacts the ramped portion 315 and drives it radially outward, the pins 312 are pushed radially outward out of the receptacles 314, thereby releasing the capsule 302 from the bushing 304 and separating the clip from the insertion section 316, bushing 304, control wire 308, and the entire proximal portion of the device.

[0053] Furthermore, as will be appreciated by those skilled in the art, if the receptacle 314 and the pin 312 are rounded, the capsule 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 wire 308. However, such rotation (e.g., Fig. 7A and 7B ) can further help facilitate the use of the clip through paths that include sharp bends, such as, for example, a sharp bend that may be encountered when the clip is passed longitudinally through a duodenoscope and then must bend through an arc of approximately 90 degrees to exit the scope via a laterally facing port.

[0054] like Figure 8 As shown, the treatment device 400 can be substantially similar to the treatment device 10 described above. The device 400 can include a control wire 426, an insertion section 414, a sleeve 418, a clip 420 including a clip arm 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 sleeve 418 to the distal end of the clip arm 422. The distal portion 440 includes a capsule 424. The capsule 424 houses a coupling mechanism, which is similar to the coupling mechanism of the devices 10 and 100 to 300. The coupling mechanism includes a yoke 432, a lug 436, a tension member 438, and the clip 420. In addition, the control wire 426 has a bend 450 similar to the bend 50 of the control wire 26, which extends from a proximal end (not shown) to a distal end having a radius R' similar to the radius R of the device 10. In this embodiment, the bend 450 extends around an arc angle α', which is similar to the angle α of the device 10. In this embodiment, a distance D′ is between the distal end of the bend 450 and the proximal end of the hub 418 , which is similar to the distance D of the device 10 .

[0055] The device 400 includes a first hole 462 at the proximal end of the curved portion 450 and a second hole 464 at the proximal end of the distal portion 440. The size and shape of the first hole 462 and the second hole 464 are set so that the 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 the proximal end (not shown) to the 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 so that the user can pull proximally on the proximal end of the cord 470 to straighten the cord 470, thereby forming a bevel between the first hole 462 and the second hole 464 and further bending the curved portion 450. By applying different amounts of force when pulling the proximal end of the cord 470, the user controls the bend of the curved portion 450 and the position of the distal portion 440.

[0056] As will be further appreciated, a clip assembly combining such a pivotal connection between the balloon and the sleeve with a control line having a bend at the distal end adjacent the insertion section (e.g., control line 26 described above) can show significant improvements in operations with transverse ports and / or procedures requiring access to difficult to reach locations (requiring a sharp bend radius). This combination can be further improved by employing the shorter clip mechanism of the device 100 described above. Such a device would be effective in an insertion device, such as an endoscope having a longitudinally oriented outlet to its working channel or having a transverse portion of the duodenoscope described above, to, for example, close lesions in complex locations in the large intestine or other portions of the gastrointestinal tract, in confined spaces, or where the field of view available to the scope is oblique.

[0057] Those skilled in the art will appreciate that various modifications may be made to the described embodiments without departing from the teachings of the present application. For example, although embodiments have been described with respect to treating internal bleeding and closing excision defects or holes in tissue, those skilled in the art will appreciate that embodiments may be modified for similar structural applications. For similar structural applications, an insertion section for biopsy forceps may be included, wherein the curvature of the insertion section may be used to obtain a sample in an inconvenient or tilted position. Additionally, these embodiments may be modified to include a bend of 30, 45, or 60 degrees to accommodate different user needs and for use on a front sight.

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; a hemostatic clip releasably 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 predetermined 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 stationary 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 hemostatic clip comprises a slidable element coupled to a distal end of the control wire, the slidable element being coupled to a tissue clamping arm of the hemostatic clip such 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 hemostatic clip to move the tissue clamping arm into and out of the balloon; The proximal portion of the sliding element includes an abutment surface on its radial outer portion, which is sized to engage, and when the proximal portion of the sliding element is pulled proximally out of the capsule into the insertion section, the radial outer portion of the sliding element pushes the locking structure of the insertion section radially outward, causing the hemostatic clip to disengage from the insertion section. 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 orientation fingers, each of which is sized and shaped to pass through a corresponding opening in one of the tissue gripping arms to maintain a desired orientation of the tissue gripping arm within the balloon.

5. The method 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. A device according to claim 1, wherein the insertion section includes a sleeve, which is connected to the capsule via a connector, the connector including a plurality of arms distributed around its circumference, each of the arms including a recess, the size and shape of the recess being configured to engage a locking wall of the sleeve to connect the sleeve to the connector, each of the recesses including 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 slidable element comprises a yoke and a tension member coupled to each other via 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 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; a hemostatic clip releasably 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 predetermined 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 stationary 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 includes a distal end releasably coupled to the hemostatic clip; wherein the hemostatic clip comprises a slidable element coupled to a distal end of the control wire, the slidable element being coupled to a tissue clamping arm of the hemostatic clip such 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 hemostatic clip 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 insertion section, the radially outer portion of the slidable element pushes the locking structure of the insertion section radially outward, causing the locking structure of the insertion section to disengage from the corresponding locking structure of the capsule, thereby separating the capsule from the insertion section.

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

13. 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; a hemostatic clip releasably coupled to the distal end of the insertion section; as well as A control wire is received within the insertion section and extends from a proximal end connected to the actuator, the control wire including a bend in a distal portion thereof, configured so that when in a stationary state, the control wire and the insertion section bend through a predetermined arc at a selected bending radius, the distal portion of the control wire being configured to enter and pass through a working channel of the insertion device without the control wire being plastically deformed.

14. The device of claim 13, 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.

15. The device of claim 13, 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.

16. The device of claim 13, wherein the slidable element comprises a yoke and a tension member coupled to each other via a frangible link.

Images