WO2019109029A1

WO2019109029A1 - Rotatable endoscopic clip with folding prongs

Info

Publication number: WO2019109029A1
Application number: PCT/US2018/063462
Authority: WO
Inventors: Edwin J. Hlavka; Benjamin Merrifield; Adam Smith
Original assignee: Endogear Llc
Priority date: 2017-12-01
Filing date: 2018-11-30
Publication date: 2019-06-06

Abstract

A tissue manipulation tool for use in a working channel of an endoscope. The tool has a first, flexible configuration allowing the tool to be delivered through a curved lumen and a second, rigid configuration allowing the tool to manipulation tissue. The tool may be an endoscopic clip.

Description

ROTATABLE ENDOSCOPIC CLIP WITH FOLDING PRONGS

FIELD OF THE INVENTION

[0001] The present invention relates to clip devices and, specifically, endoscopically delivered clip devices that may be used to stop gastrointestinal bleeding, mark locations, manipulate tissue, and close perforations and mucosal defects. While this invention is described in terms of endoscopic clip devices and systems in detail here, due to its slim delivery profile, unique and advantageous orientation, folding lockable clamp arms, and suitability for remote highly manipulable actuation to provide clamping or closure in otherwise difficult to access locations, the present clip device is contemplated to have several applications beyond endoscopic use. Additional applications may take advantage of some or all of the principal features of the present invention and also be adapted for larger functional purposes such as, for example, use in construction and repair, waste securement and/or retrieval, maneuverability and handling of toxic substances, access to items crowded and or high shelves, or any application where remote closure, clamping, grabbing, or retrieval of items from otherwise difficult to access locations is desired.

BACKGROUND OF THE INVENTION

[0002] Endoscopic clips or clamps are generally devices used in conjunction with an endoscope, typically in the working channel of an endoscope, to manipulate tissue. Endoscopic clips are often used in tubular organs, such as the colon, to clamp onto targeted tissue. These clips are then released and remain affixed to the targeted tissue until the tissue necrosis and falls off, allowing the clip to be passed naturally.

[0003] Ideally, such a clip will have a low profile, such that it may easily pass through the scope and allow the user to view both the clip and the targeted tissue when extended from the scope. Currently available endoscopic clips emerge from the endoscope and have jaws that open to form a "V-shape," facing forward. This configuration is suitable for clipping targets and defects directly in front of the scope but poses a problem when the target is oblique to the tip of the scope. In the narrow space of the colon or small bowel, for example, most targets lie lateral to, not directly in front of the endoscope. The lateral location of the targeted tissue makes it difficult to manipulate the V-shaped clip to an orientation that allows the jaws to grab the targeted tissue.

[0004] Another shortfall associated with V-shaped clips is that, because the jaws are attached to a pivot at the proximal end, they are limited in how much tissue may be grabbed. If the jaws are opened wide enough to grab a substantial amount of tissue, the angle at which they close is too great and the tissue gets forced out of the jaws as they jaws pivot toward each other.

[0005] There is thus a need for an improved endoscopic clip that addresses these needs.

OBJECTS AND SUMMARY OF THE INVENTION

[0006] The endoscopic clip device of the present invention includes several features that render it particularly well-suited for effective use in tight spaces, such as those accessible by endoscopes, and a signification improvement over conventional endoscopic clips. One, some, or all of the following features is provided by various embodiments of the present invention.

[0007] For example, one aspect of the invention provides a device for use through a working channel of an endoscope comprising a body having a rigid first component and a rigid second component; a coupler translatable along the second component and releasably engageable with the first component; wherein in a first configuration, the coupler is disengaged from the first component such that the first component and the second component are able to move independently of each other, thereby allowing the first component and second component to be advanced through a working channel of a flexible endoscope; wherein in a second configuration, the couple is engaged with the first component such that the first component and the second component are fixed in an axially aligned relationship with each other for manipulating tissue. The first component may be releasable from the device. Furthermore, the sheath may be sized for insertion into the working channel, thereby separating the body and the coupler from an inner wall fo the working channel. Additionally, the coupler may define a a lumen and wherein in the first configuration, the first component is axially separated from the coupler and wherein in the second configuration, the first component is partially contained within the coupler lumen.

[0008] The device may have at least one tissue manipulation device that is operatively connected to the first component.

[0009] The device may also or alternatively have a flexible pusher connected to a proximal end of the second component.

[0010] The device may additionally or alternatively have a sheath housing the body and the coupler.

[0011] Another aspect of the invention provides a method of manipulating tissue via a working channel of an endoscope comprising: navigating an endoscope to a target location; advancing a device in a flexible configuration through a working channel of the endoscope; reconfiguring the device to a fixed alignment configuration once the device is near a distal end of the working channel; and using the device in the rigid configuration to manipulate tissue. Reconfiguring the device to a rigid configuration may involve advancing a coupler to span a junction between two rigid components of the device such that each component is fixed in alignment with the other component. Furthermore, using the device in the fixed alignment configuration to manipulate tissue comprises clamping tissue between two jaws.

[0012] The method may further include releasing at least a portion of the device and leaving the at least a portion at the target site.

[0013] Additionally or alternatively, the method may include the step of rotating at least one jaw from a longitudinal orientation to a substantially perpendicular configuration relative to the working channel.

[0014] If the method includes clamping the tissue between two jaws, the method may further include locking the two jaws in place after the tissue is clamped, and releasing a portion of the device, including the jaws. [0015] Another aspect of the invention includes an endoscopic tissue device deployable through a working channel of an endoscope comprising: a pusher catheter; a rigid pusher attached to a distal end of the pusher catheter; a body rail joined to the rigid pusher with a junction; a coupler connected to one of the rigid pusher and the body rail and moveable from a first position axially separated from the junction to a second position spanning the junction; wherein when the coupler is in the first position, the junction allows the body rail to pivot relative to the rigid pusher; wherein when the coupler is in the second position, the coupler constrains the junction such that the body rail is unable to pivot relative to the rigid pusher. The coupler may be connected to the rigid pusher. The coupler may also surround the rigid pusher.

[0016] The device may also include opposing jaws connected to the body rail, wherein one jaw is moveable relative to the other jaw. The opposing jaws may further be pivotable from a first configuration in which the jaws are oriented longitudinally and a second configuration in which the jaws are oriented perpendicular to the first position. The jaws may also be lockable.

[0017] Another aspect of the invention includes a device for use through a working channel of an endoscope comprising: a body; a first prong pivotally connected to the body and having a first configuration in which the first prong is aligned with the body, and a second configuration in which the first prong is substantially perpendicular to the body; a second prong translatably connected to the body such that a longitudinal position of the second prong may be changed, the second prong having a first configuration in which the second prong is aligned with the body, and a second configuration in which the second prong is substantially perpendicular to the body; a pusher slidable relative to the body and associated with the second prong such the pusher is usable to change the longitudinal position of the second prong in either a distal or proximal direction.

[0018] The device may also include a pull-wire connected to the first prong such that tension placed on the pull-wire pivots the first prong from the first configuration to the second configuration; and a lock usable to engage the first prong such that the rotational position is fixed. The pull-wire may also be constructed and arranged such that distal force applied to the pull-wire pivots the first prong from the second configuration to the first configuration. Tension placed on the pull-wire may also cause the second prong to rotate from the first configuration to the second configuration.

[0019] Yet another aspect of the invention pertains to a method of implanting a tissue clamp comprising: navigating the tissue clamp through a working channel of an endoscope to a target site, the tissue clamp having a first prong and a second prong; deploying the prongs from a first configuration to a second configuration by applying a first longitudinal force to a pull-wire; linearly translating one of the jaws toward the other, trapping tissue therebetween, by applying a second longitudinal force to a pusher; releasing the tissue clamp by applying additional tension to the pull-wire; wherein the first longitudinal force is independent of the second longitudinal force.

[0020] Still another aspect of the invention pertains to a device for use through a working channel of an endoscope comprising: a body; a sheath surrounding the body; a distal prong pivotally connected to the body and having a first configuration in which the distal prong is aligned with the body, and a second configuration in which the distal prong is substantially perpendicular to the body; a proximal prong translatably connected to the body such that a longitudinal position of the proximal prong may be changed, the proximal prong having a first configuration in which the proximal prong is aligned with the body, and a second configuration in which the proximal prong is substantially perpendicular to the body; a pusher housed within the sheath, slidable relative to the body and associated with the proximal prong such the pusher is usable to change the longitudinal position of the proximal prong in either a distal or proximal direction; wherein the sheath remains stationary relative to the working channel during deployment of the device.

[0021] Another aspect of the invention provides a method of implanting a tissue clamp comprising: navigating said tissue clamp through a working channel of an endoscope to a target site, said tissue clamp having a first prong and a second prong; deploying said prongs from a first configuration to a second configuration; positioning the said prongs with respect to the target site; linearly translating one of said jaws toward the other, trapping tissue therebetween; linearly translating one of said jaws away from the other, releasing the trapped tissue therebetween repositioning the said prongs with respect to the target site, and repeating trapping tissue therebetween; locking said prongs in the trapping position; releasing said tissue clamp.

[0022] The present inventive clip may be used to carry a payload of therapeutic material, one or more therapeutic agents or actives, or a sensor for uses such as detecting or measuring pH, blood characteristics or components, peptides, contractions, etc. For example, a small ‘pad’ or ‘strip’ impregnated with some substance or sensor may be fitted into or on the tissue-facing surfaces of within the interior cleft of the prongs. In yet another embodiment, a payload of therapeutic material or sensor may be worked into the rail. In cetain embodiments, the therapeutic material may include or consist essentially of a hemostatic agent, healing agent, or antimicrobial agent.

[0023] While particular embodiments of the present invention are described in detail below, it is noted that various design configurations may take advantage of one or more of the beneficial design configurations and above-noted features discovered and made possible by the present inventors.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which

[0025] Figure 1 is a perspective view of an embodiment of a device of the invention in a first configuration;

[0026] Figure 2 is an elevation view of an embodiment of a device of the invention in a first configuration;

[0027] Figure 3 is a top plan view of an embodiment of a device of the invention in a first configuration;

[0028] Figure 4 is a perspective view of an embodiment of a device of the invention in a second configuration; [0029] Figure 5 is a perspective view of an embodiment of a device of the invention in a second configuration with a first component in a partially-deployed state;

[0030] Figure 6 is a perspective view of an embodiment of a device of the invention in a second configuration with a first component in a fully-deployed, open state;

[0031] Figure 7 is a perspective view of an embodiment of a device of the invention in a second configuration with a first component in a fully-deployed, partially-closed state;

[0032] Figure 8 is a perspective view of an embodiment of a device of the invention in a second configuration with a first component in a fully-deployed, partially-closed state;

[0033] Figure 9 is a perspective view of an embodiment of a device of the invention in a second configuration with a first component in a fully-deployed, partially-closed state;

[0034] Figure 10 is a perspective view of an embodiment of a device of the invention in a second configuration with a first component in a fully-deployed, partially- closed state;

[0035] Figure 1 1 is a perspective view of an embodiment of a device of the invention in a second configuration with a first component in a fully-deployed, closed state;

[0036] Figure 12 is a perspective view of an embodiment of a device of the invention in a first configuration with a first component in a fully-deployed, closed state;

[0037] Figure 13 is a perspective view of an embodiment of a device of the invention with a first component in a fully-deployed, closed state, and released from a delivery device. DESCRIPTION OF EMBODIMENTS

[0038] Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

[0039] Referring to the Figures, there is shown an embodiment 10 of a device of the invention. The device 10, in its most general form, includes a body 20 having a rigid first component 30, a rigid second component 60, and a coupler 90 translatable along said second component 60 and releasably engageable with the first component 30. The device 10 is sized for passage through a flexible endoscope. Because the endoscope is flexible, and the first and second components 30 and 60 are rigid, the device 10 is designed to have more than one configuration.

[0040] In a first configuration, shown in Figures 1 -4 and 12, the coupler 90 is disengaged from the first component 30 as it has been translated proximally along second component 60 such that it is spaced apart from the first component 30. In this first configuration, the first component 30 and the second component 60 are able to move independently of each other, along at least one degree of freedom, thereby allowing the first component 30 and the second component 60 to be advanced through a working channel of a flexible endoscope while the endoscope is flexed. Figures 1 and 2 show a first degree of freedom, represented by curved arrow 12, illustrating a range of pivotal motion between the first component 30 and the second component 60. Figure 3 shows a second degree of freedom, as seen from a top view, represented by curved arrow 14. Arrow 14 illustrates a side-to-side pivotal motion between the first component 30 and the second component 60.

[0041] In a second configuration, shown in Figures 5-1 1 , the coupler 90 is engaged with the first component 30 such that the first component 30 and the second component 60 are fixed in an axially-aligned relationship with each other for manipulating tissue. In this configuration, the components 30 and 60 join as one rigid component, allowing the user to manually manipulate the first component 30 using the endoscope handle.

[0042] In some embodiments, the first component 30 includes a body rail 32 and at least one tissue manipulation feature that is integral with the body rail 32, such as in the case of a sharpened surface, or is attached to the body rail 32. In the embodiments shown in the Figures, the first component includes features that make it an endoscopic clip, and is discussed in greater detail below.

[0043] In one embodiment, the second component 60 generally comprises a pusher 62 having sidewalls 64, a closed side 66 and an open side 68. The hollow- bodied construction of the pusher 62 provides an interior space 70 for housing a control mechanism 1 10 of a delivery device 100. This is best seen in Figure 10. The closed side 66 provides rigidity and strength to the pusher 62.

[0044] The second component 60 has a distal end 72 that includes an extension 74. The extension 74 defines an aperture 76. The extension 74 and aperture 76 are configured to interact with the first component 30 as described in more detail below. Proximal of the extension 74 is a tab 78 that extends into the interior space 70. The function of the tab 78 is to act as a guide and holder for the control wire 170. The wire 170 is routed through a small hold in the tab. This helps keep the first and second components together until after the wire 170 is removed. The wire 170 is thus routed through the hole in tab 35 of the rail and a hole in tab 78 of the pusher and then into the latch plate 52.

[0045] The coupler 90 is shaped to ride along and substantially surround the pusher 62. A coupler tab 92 extends into the space 70 for attachment to the control mechanism 1 10. The coupler 90 has an open distal end 94 that is sized to surround a proximal end 34 of the first component 30 when in the second configuration. Rigidity in the second configuration is achieved as the coupler is in a position to surround both the proximal end 34 of the first component 30 and the distal end 72 of the second component 60. [0046] The delivery device 100 generally includes the control mechanism 1 10, a pusher catheter 130, an outer sheath 150 and a control wire 170. The control mechanism 1 10 may vary based on the tissue manipulator being used but is attached at its distal end to the coupler 90 and is usable to move the coupler into and out of engagement with the first component 30. The control wire 170 is routed through the control mechanism 1 10 and continues past its distal end through guide holes formed in a rail tab 35 (Figures 3 and 13) at a proximal end 34 of the first component 30, and terminates at a connection to a latch plate 52, discussed below.

[0047] The pusher catheter 130 is a flexible catheter but has a distal end 132 that is fixed to the rigid pusher 62 of the second component 60. The pusher catheter 130 has an open lumen 134 through which the control mechanism 1 10 passes.

[0048] The outer sheath 150 (see, e.g. Figure 9) is flexible and surrounds all of the components and is retractable and advanceable with respect to the first component 30. When the coupler 90 is disengaged from the first component 30, and the device is in the first configuration such that the first component 30 and the second componenet 60 are able to move independently of each other, the outer sheath 150 contains the first component 30 such that the flexibility of the first 30 and second 60 components relative to each other is limited by the flexing of the sheath 150. This also ensures that any tissue manipulation features associated with the first component 30 are not deployed prematurely. The outer sheath 150 also allows the device 10 to more easily pass through the working channel of the endoscope.

[0049] One embodiment of the device 10 has a first component 30 that includes the above-mentioned components along with a tissue-manipulation feature in the form of a first prong or jaw 36 and a second prong or jaw 38. The jaws are pivotable from a first, delivery configuration, seen in Figures 1 -4, to a second, deployed configuration shown in Figures 6-13, in which the jaws oppose each other.

[0050] The first prong or jaw 36 is distal and rotates counterclockwise when viewed from the orientation shown in Figure 4 in which the jaws deploy downwardly. Jaw 36 is connected to body rail 32 via pivot points 40. Rotation of jaw 36 is achieved by a slide 50, which is slidably connected to the body rail 32. The slide 50 includes a latch plate 52 at a proximal end and a catch 54 at a distal end. The latch plate 52 is connected to the control wire 170. The catch 54 at the distal end of the slide 50 passes through an engagement opening 42 on the distal end of the jaw 36. The engagement opening 42 is shown as formed by folding distal ends 44 inward but one skilled in the art will realize other acceptable ways to form a surface for acting against catch 54.

[0051] Proximal force placed on a latch plate 52 with the control wire 170 causes the slide 50 to slide from a distal position to a proximal position. Movement of the slide 50 causes the catch 54 to place a proximal force on the distal ends 44 of the jaw 36. The pivot points 40 prevent proximal linear movement by the jaw 36 resulting in a conversion of linear motion to rotational motion. The ends 44 interact with curved surfaces 46 formed in the body rail 32, which further facilitate rotation of the jaw 36. The interaction between the ends 44 and the top of the curved surfaces 44 also define the limits on the rotation, which is shown as 90 degrees.

[0052] The second prong or jaw 38 is proximal of the first prong 36 and rotates clockwise when viewed from the orientation shown in Figure 4, in which the jaws deploy downwardly. Jaw 38, unlike jaw 36, is not connected to the body rail 32 via pivot points. Rather, jaw 38 is formed with a proximal opening 48, which is sized and shaped to allow the body rail 32 to pass through the jaw 38 when the jaw 38 is in a deployed configuration. This allows jaw 38 to slide over the body rail 32 distally toward the first jaw 36 in order to grab tissue between the jaws 36 and 38.

[0053] The second prong or jaw 38 has a proximal end that includes at least one engagement hook 56. The engagement hook(s) 56 is sized and shaped for interaction with the aperture 76 of the extension 74 of second component 60. When the prong 38 is in the folded configuration, prior to delivery, the engagement hook 56 extends upwardly and through the aperture 76 of the extension 74.

[0054] Deployment of the second prong 38 is achieved by relative motion between the pusher catheter 130 and the body rail 32. As the second prong 38 is advanced distally, relative to the body rail 32, proximal ends 49 of the second prong 38 impact proximal curved surfaces 47 of the body rail 32. Relative motion between the pusher catheter 130 and the body rail 32 is achieved placing a distal force on the pusher catheter 130, while placing a proximal force or tension on the control wire 170. The control wire 170 is attached at its distal end to fixation point or latch plate 52 on the slide 50, which is connected to the body rail 32.

[0055] Having described all of the components of the device 10, a deployment sequence can be described that gives greater detail as to how the device 10 works. First a physician navigates an endoscope during a procedure, such as a colonoscopy. Having identified a target, the physician prepares to advance the device 10 through the working channel of the endoscope. The physician ensures that the outer sheath 150 is in its distal-most position, in which the rest of the device resides within the outer sheath 150. The outer sheath provides a layer of protection between the working channel and the device 10. The physician also ensures that the coupler 90 is disengaged from the first component 30, as seen in Figures 1 -4, placing the device 10 in the first configuration, thereby creating one or more degrees of freedom, as illustrated by arrows 12 and 14.

[0056] The device 10 is then advanced through the working channel. Ease of advancement is greatly enhanced by the flexibility provided by the degrees of freedom in the first configuration. The device 10 is advanced until the sheathed clip extends out of the working channel into the field of view of the endoscope. Once the distal end of the outer sheath 150 is out of the working channel and in view of the scope, the physician holds the sheath 150 while advancing the clip 30 out of the sheath into free space in the flexible configuration.

[0057] Next, the control wire 170 is retracted with respect to the control mechanism 1 10. Doing so causes: a) the rail 32 to get pulled back into the coupler 90, creating the rigid second configuration with the coupler 90 surrounding the the proximal end 34 of the first component 30. Because the pusher cannot also retract into the coupler, due to the width of the pusher head being wider than the coupler opening, the resulting effect is that the pusher moves forward with respect to the rail, thus rotating the proximal prong to the deployed position shown in Figure 5; and b) the wire 170 moves the latch plate 52 of the slide 50, which is connected to the body rail 32, from a distal to a proximal location, thus placing a proximal force on the catch 54 , which rotates the prong 36 as described above to the deployed position. Figures 5-1 1 show the coupler 90 in the locked, second configuration. Though the Figures show the proximal prong deploying first, events a) and b) may occur sequentially, in either order, or simultaneously

[0058] The wire 170 keeps the rail held into the coupler and the prongs deployed. The wire 170 and control mechanism 1 10 are thus effectively a grouped or ganged unit the clip is released.

[0059] With both prongs 36 and 38 deployed, the proximal prong 38 may be translated distally relative to the distal prong 36, bringing the two prongs 36 and 38 into closer proximity. This is accomplished by further relative motion between the pusher catheter 130 and the grouped wire 170 + control mechanism (tube) 1 10. The pusher catheter 130 is moved distally or proximally while the [wire 170 + control mechanism 1 10] is held in position, Figures 7-10 show the proximal prong 38 being translated toward the distal prong 36.

[0060] One advantage of the design of the present invention is the control provided over the distal prong 36. It has been found that when the distal prong 36 is in the deployed position, it is useful for manipulating tissue using a pulling or“raking” motion due to the fact that the prong 36 is unable to rotate past 90 degrees. Thus, the physician can use the prong 36 to pull tissue proximally. Doing so causes the tissue to bunch up on the jaw 36, allowing greater purchase to be attained by the device 10.

[0061] As the proximal prong 38 and distal prong 36 are moved together, tissue is trapped therebetween. The outward force provided by the tissue as it is squeezed between the jaws 36 and 38 locks the jaws in the deployed position. Figure 1 1 shows the prongs 36 and 38 in the fully closed position.

[0062] Once the tissue has been grabbed between the prongs 36 and 38, and the physician is satisfied with the position of the clip, the first component 30 may be released from the remainder of the device, as shown in Figure 13. The first component 30 is held to the second component 60 with the coupler 90 and the control wire 170. To release the first component 30, the control wire 170 is pulled until the control wire 170 is released from the latch plate 52. The wire 170 is pulled proximally, until it clears both the latch plate 52 and the rail tab 35 on the proximal end of the rail 32.

[0063] One skilled in the art will realize there are several ways to connect the control wire 170 to the latch plate 52 such that it may be released. For example, the latch plate 52 could break away from the first component 30; the control wire 170 could have a breaking point that is achievable by pulling on the wire 170; the latch plate 52 could be formed with a slot that releases the wire 170, etc. Good results have been achieved by placing a polymer plug at the end of the control wire 170 that slides off the end of the wire 170 with sufficient force.

[0064] After the control wire 170 has been released from the latch plate 52, the first component 30 is released from the second component 60 by simply a slight distal motion of the pusher, which pushes the entire clip 30 distally. A slight upward lift or rotation of the second component 60 will lift the extension 74 of the second component 60 from the engagement hook 56 of the first component 30. The second component 60 can now be retracted back into the sheath 150.

[0065] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims

What is claimed is:

1. A device for use through a working channel of an endoscope comprising: a body having a rigid first component and a rigid second component;

a coupler translatable along said second component and releasably engageable with said first component;

wherein in a first configuration, said coupler is disengaged from said first component such that said first component and said second component are able to move independently of each other, thereby allowing the first component and second component to be advanced through a working channel of a flexible endoscope;

wherein in a second configuration, said coupler is engaged with said first component such that said first component and said second component are fixed in an axially-aligned relationship with each other for manipulating tissue.

2. The device of claim 1 further comprising at least one tissue manipulation device operatively connected to said first component.

3. The device of claim 1 further comprising a flexible pusher connected to a proximal end of said second component.

4. The device of claim 1 wherein said first component is releasable from said device.

5. The device of claim 1 wherein said device comprises an endoscopic clip.

6. The device of claim 1 further comprising a sheath housing said body and said coupler.

7. The device of claim 1 wherein said sheath is sized for insertion into said working channel, thereby separating said body and said coupler from an inner wall of said working channel.

8. The device of claim 1 wherein said coupler defines a lumen and wherein in said first configuration said first component is axially separated from said coupler and wherein in said second configuration, said first component is partially contained within said coupler lumen.

9. A method of manipulating tissue via a working channel of an endoscope comprising:

navigating an endoscope to a target location;

advancing a device in a flexible configuration through a working channel of the endoscope;

reconfiguring the device to a fixed alignment configuration once the device is near a distal end of the working channel;

using the device in the rigid configuration to manipulate tissue.

10. The method of claim 9 further comprising releasing at least a portion of the device and leaving the at least a portion at the target site.

11. The method of claim 9 wherein reconfiguring the device to a rigid configuration comprises advancing a coupler to span a junction between two rigid components of the device such that each component is fixed in alignment with the other component.

12. The method of claim 9 wherein using the device in the fixed alignment configuration to manipulate tissue comprises clamping tissue between two jaws.

13. The method of claim 9 further comprising rotating at least one jaw from a longitudinal orientation to a perpendicular configuration relative to the working channel.

14. The method of claim 12 further comprising:

locking the two jaws in place after the tissue is clamped; and,

releasing a portion of the device, including the jaws.

15. An endoscopic tissue device deployable through a working channel of an endoscope comprising:

a pusher catheter;

a rigid pusher attached to a distal end of the pusher catheter;

a body rail joined to the rigid pusher with a junction;

a coupler connected to one of said rigid pusher and said body rail and moveable from a first position axially separated from said junction to a second position spanning said junction;

wherein when said coupler is in said first position, said junction allows said body rail to pivot relative to said rigid pusher;

wherein when said coupler is in said second position, said coupler constrains said junction such that said body rail is unable to pivot relative to said rigid pusher.

16. The device of claim 15 wherein said coupler is connected to said rigid pusher.

17. The device of claim 16 wherein said coupler surrounds said rigid pusher.

18. The device of claim 15 further comprising opposing jaws connected to said body rail, wherein one jaw is moveable relative to the other jaw.

19. The device of claim 18 wherein said opposing jaws are pivotable from a first configuration in which the jaws are oriented longitudinally and a second configuration in which the jaws are oriented perpendicular to said first position.

20. The device of claim 18 in which said jaws are lockable.

21. A device for use through a working channel of an endoscope comprising: a body;

a first prong pivotally connected to the body and having a first configuration in which the first prong is aligned with the body, and a second configuration in which the first prong is substantially perpendicular to the body; a second prong translatably connected to the body such that a longitudinal position of the second prong may be changed, said second prong having a first configuration in which the second prong is aligned with the body, and a second configuration in which the second prong is substantially perpendicular to the body; a pusher slidable relative to the body and associated with the second prong such said pusher is usable to change said longitudinal position of said second prong in either a distal or proximal direction.

22. The device of claim 21 further comprising:

a pull-wire connected to said second prong such that tension placed on said pull-wire pivots said second prong from said first configuration to said second configuration; and

a lock usable to engage said second prong such that said longitudinal position is fixed.

23. The device of claim 22 wherein said pull-wire is constructed and arranged such that distal force applied to said pull-wire pivots said second prong from said second configuration to said first configuration.

24. A method of implanting a tissue clamp comprising:

navigating a tissue clamp through a working channel of an endoscope to a target site, said tissue clamp having a first prong and a second prong;

deploying said prongs from a first configuration to a second configuration by applying a first longitudinal force to a pull-wire;

linearly translating one of said jaws toward the other, trapping tissue therebetween, by applying a second longitudinal force to a pusher configured to interact with one of said jaws;

releasing said tissue clamp by applying additional tension to said pull-wire; wherein said first longitudinal force is independent of said second longitudinal force.

25. A device for use through a working channel of an endoscope comprising:

a body; a sheath surrounding said body;

a first prong pivotally connected to the body and having a first configuration in which the first prong is aligned with the body, and a second configuration in which the first prong is substantially perpendicular to the body;

a second prong translatably connected to the body such that a longitudinal position of the second prong may be changed, said second prong having a first configuration in which the second prong is aligned with the body, and a second configuration in which the second prong is substantially perpendicular to the body; a pusher housed within said sheath, slidable relative to the body and associated with the second prong such that said pusher is usable to change said longitudinal position of said second prong in either a distal or proximal direction;

wherein said sheath remains stationary relative to a working channel, through which the device is being used, during deployment of said device.

26. A method of implanting a tissue clamp comprising:

a) navigating a tissue clamp through a working channel of an endoscope to a target site, said tissue clamp having a first prong and a second prong;

b) deploying said prongs from a first configuration to a second configuration; c) positioning the said prongs with respect to the target site;

d) linearly translating one of said prongs toward the other, trapping tissue therebetween;

e) linearly translating one of said prongs away from the other, releasing the trapped tissue therebetween;

f) repeating steps c)-e) as necessary until targeted tissue is trapped between the prongs;

g) locking said prongs in the trapping position; and

h) releasing said tissue clamp.