METHOD, APPARATUS, AND A SYSTEM FOR FACILITATING BENDING OF AN INSTRUMENT IN A SURGICAL OR MEDICAL ROBOTIC ENVIRONMENT

INCORPORATION BY REFERENCE AND CROSS-REFERENCE TO RELATED

APPLICATIONS

[0001] This application is the International Patent Application which claims priority from of U.S. Patent No. 14/479,095 (Attorney Docket No. 41663-706.501), filed September 5, 2014, which was a continuation-in-part of U.S. Application No. 14/201,610, (Attorney Docket No. 41663-707.201), filed March 7, 2014, which claimed priority to Provisional Application No. 61/774,901 (Attorney Docket No. 41663-707.101), filed March 8, 2013, the entire contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention. The field of the present application pertains to medical devices. More particularly, the field of the invention pertains to an apparatus, system, and method for performing surgery.

[0003] 2. Description of the Related Art. Robotic surgery has many benefits to improve patient recovery time and allows precise control of medical and surgical application instruments. In robotics, an end effector is the device at the "end" of a robotic arm, designed to interact with the environment. As the end effector is the portion of a robot that interacts with the work environment, the exact nature of the end effector depends on the robot's application. For example, several examples of end effectors could include a set of forceps, a pair of scissors, a laser, a camera, a cautery tool, a needle, or any other instrument tip that would benefit from being able to be repositioned.

[0004] In the medical field, end effectors may have articulation capabilities that enable them to navigate through anatomical structures in order to reach the operative region. These articulating devices may have bending flexures that comprise a multitude of small moving parts. Typically, these devices present manufacture challenges due to the smaller geometries involved.

[0005] In addition to manufacturing challenges relating to the material of the bending flexures themselves, bending flexures in these articulable end effectors often contain a plethora of structures that enable a remote operator to perform the procedure, including pull wires, electrical wires, fluidic lines, and optical fibers. The presence of these components within the bending flexure also impact the device's performance and stability. [0006] FIG. 1 illustrates how components within a bending flexure may be affected by bending moments in the bending flexure. In FIG. 1A, the bending flexure 100, comprising a proximal shaft 101 and distal articulation region 102, is unarticulated. Thus, bending flexure 100 remains perfectly straight, while pull wires 103 and 104 remain lax and of equal length. When unarticulated, bending flexure 100 remains concentric to the neutral axis 105 that runs longitudinally through the length of the bending flexure 100. When unarticulated, the path length of the pull wires 103 and 104 are of equal length within the distal bending flexure 102.

[0007] In FIG. IB, the bending flexure 100 is articulated to the right. Accordingly, within the distal articulation region 102, the path length of pull wire 103 is extended to a distance represented by 106. In contrast, the path length of pull wire 104 is compressed to a distance represented by 107. As a result, the pull wires 103 and 104 exhibit uneven amounts of slack when exiting from the proximal shaft 101. The amount of extension and compression of the path length is proportional to its location relative to the neutral axis 105 in the bending flexure 100. As a rule, path lengths always elongate in the regions further from the direction of articulation, while shortening in paths closer to the direction of articulation.

[0008] Developing bending flexures for medical devices also raises a number of design challenges because the ideal articulable end effector is both stiff and bendable, depending on the scenario and required use. For example, when the physician is inserting and driving the end effector into a patient, the device must be relatively stiff in order for the device to pass through and around existing anatomical structures. However, when the physician needs to direct the distal end of the device to reach an operative region, the device is ideally very flexible and bendable. Balancing these design challenges is a constant obstacle for designers.

[0009] Existing solutions for bending flexures in small articulable instruments are manufactured using thin-walled tubes, such as hypotubes. Existing manufactures cut intricate patterns into the tubing in order to create reliefs that yield a preferential bending direction. If a large deflection is required; much of the tubing material is removed in order to allow for such bending. The resulting structure, however, is a thin-walled tube with a significant portion of material eliminated, which inevitably loses much of its structure and ability to remain mechanically stable. Especially when the outer diameter of the bending flexure is small, the walls of hypotube do not provide sufficient strength and rigidity when large degree articulations are required and where a surgical tool at the distal end requires rigidity to perform desired procedures.

[0010] Therefore, it would be advantageous to have a method and apparatus for facilitating the bending of an instrument with large degrees of articulation while maintaining a sufficient amount of stiffness in order to provide stability at the end effector, all while ensuring ease of manufacturing.

SUMMARY OF THE INVENTION

[0011] Embodiments described herein are directed to a method, apparatus, and system for bending of an instrument with large degrees of articulation while maintaining ease of manufacturing.

[0012] In one aspect, the present invention provides for a medical device that comprises an elongated body for use in medical procedures comprising a spine along the length of the elongated body; a series of ribs along the length of the elongated body, wherein the series of ribs form a corresponding series of ribbed voids along the length of the elongated body; and a non-cylindrical lumen longitudinally oriented within the elongated body, wherein the lumen has walls of uneven thickness formed from the elongated body.

[0013] In related devices, the spine is solid along the length of the elongated body. In some embodiments, the spine comprises a series of spinal ribs that form a series of corresponding spinal voids. In some embodiments, the ribs contain eyelets configured to convey an ancillary component along the length of the elongated body. In some embodiments, the ribbed voids are teardrop-shaped.

[0014] In related devices, the lumen is configured to convey an ancillary component along the length of the elongated body. In some embodiments, the present invention further comprises a forceps tool that is within the lumen. In some embodiments, the present invention further comprises a control wire that is configured to actuate an end effector that is operatively coupled to the control wire, wherein the control wire is positioned within the lumen proximal to the neutral axis of the elongated body. In some embodiments, the present invention further comprises a pull wire that is configured to articulate the elongated body. In some embodiments, the pull wire is positioned within the lumen and away from the neutral axis in order to maximize mechanical advantage. In some embodiments, the lumen comprises an upper region and a lower region. In some embodiments, the upper region of the lumen is proximal to the neutral axis and the lower region is away from the neutral axis. In some embodiments, the lumen is configured to convey a plurality of ancillary components.

[0015] In related devices, the present invention further comprises a shaft, comprising a distal end and proximal end, wherein the elongated body is aligned longitudinally within the shaft, and the elongated body is configured to extend from the distal end of the shaft. [0016] In another aspect, the present invention provides for a method for performing medical procedures comprises directing an elongated tool towards an operative site, the tool comprising a proximal portion and distal portion; extending a longitudinally-aligned elongated body from the distal portion of the tool; articulating the elongated body towards the operative site; a series of ribs along the length of the elongated body, wherein the series of ribs form a corresponding series of voids along the length of the elongated body; and a non- cylindrical lumen longitudinally oriented within the elongated body, wherein the lumen has walls of uneven thickness formed from the elongated body.

[0017] In a related method, the tool is a flexible shaft. In some embodiments, the spine comprises a series of spinal ribs that form a series of corresponding spinal voids. In some embodiments, the lumen is configured to convey an ancillary component along the length of the elongated body.

[0018] In another aspect, the present invention provides for a medical device comprising an elongated body for use in medical procedures comprising a spine along the length of the elongated body; a series of ribs along the length of the elongated body, wherein the series of ribs form a corresponding series of voids along the length of the elongated body; and a plurality of lumens longitudinally oriented within the elongated body.

[0019] In a related device, the elongated body is cylindrical. In some embodiments, the spine is solid along the length of the elongated body. In some embodiments, the spine comprises a series of spinal ribs that form a series of corresponding spinal voids. In some embodiments, the ribs contain eyelets configured to convey an ancillary component along the length of the elongated body. In some embodiments, the voids are teardrop-shaped. In some embodiments, the lumens are each configured to convey an ancillary component along the length of the elongated body. In some embodiments, the device further comprises a forceps tool that is located within a lumen within the plurality of lumens that is proximal to the neutral axis of the elongated body. In some embodiments, the device further comprises a control wire that is located within a lumen in the plurality of lumens that is proximal to the neutral axis of the elongated body, and that is configured to actuate an end effector that is operatively coupled to the control wire. In some embodiments, the device further comprises a pull wire that is configured to articulate the elongated body and is located within a lumen in the plurality of lumens away from the neutral axis of the elongated body. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The invention will be described, by way of example, and with reference to the accompanying diagrammatic drawings, in which:

[0021] FIGS. 1A - IB illustrate how components within a bending flexure may be affected by bending moments;

[0022] FIGS. 2A - 2B illustrate external views of a flexible bending flexure in accordance with an embodiment of the present invention;

[0023] FIG. 3 illustrates a view of a flexible bending flexure in accordance with an embodiment of the present invention;

[0024] FIGS. 4A - 4C illustrate views of a flexible bending flexure in accordance with an embodiment of the present invention;

[0025] FIGS. 5A - 5C illustrate various views of a bending flexure 500, in accordance with an embodiment of the present invention;

[0026] FIGS. 6A - 6B illustrate aspects of a bend section incorporated into an end effector, according to an embodiment of the present invention;

[0027] FIGS. 7A - 7D illustrate aspects of a bending flexure in accordance with an embodiment of the present invention;

[0028] FIG. 8 illustrates a side view of a flexible bending flexure in accordance with an embodiment of the present invention;

[0029] FIGS. 9A - 9C illustrate views of an endoscopic device incorporating a distally- located tool, in accordance with an embodiment of the present invention; and

[0030] FIGS. 10A - 10B illustrates components that comprise an articulating tool, in accordance with an embodiment of the present invention.

[0031] FIG. 11 illustrates a flexure that has been shape-set to be curved when relaxed, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0032] Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components.

[0033] For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0034] The embodiments described herein are directed to an apparatus for a distal bending flexure of minimally invasive surgical instrument having a large degree of articulation and providing sufficient rigidity to resolve the required forces during remote surgical procedures. Other embodiments provide methods of using the distal bending flexure and methods for making it.

[0035] FIG. 2 illustrates external views of a flexible bending flexure in accordance with an embodiment of the present invention. In FIG. 2 A, bending flexure 200 has material removed or "cut out" to create a series of voids 201 to reduce bending stiffness in the direction of voids 201. Additionally, the pattern of voids 201 allows for more predictable bend behavior. FIG. 2B illustrates an alternate view of a flexible bending flexure 200 where the external material is transparent. FIG. 2B clearly shows that the spine 202 of bending flexure 200, i.e., portion of the bending flexure 200 furthest from the intended bend direction, remains solid. The solid construction of the spine 202 helps to maintain the integrity of bending flexure 200. Skilled artisans would recognize that the length of the bending section, shapes of the voids and ribbing may be configured for bending flexure 200 to exhibit different properties.

[0036] In various embodiments, the "spine" of a flexure may be portion of the flexure that is opposite the direction of articulation, opposite the location of ribbing, or opposite location of any pull wires or articulation means.

[0037] FIG. 3 illustrates a view of a flexible bending flexure in accordance with an embodiment of the present invention. In FIG. 3, bending flexure 300 has material removed or "cut out" to create a series of voids 301 to reduce bending stiffness in the direction of voids 301. Much like voids 201 from FIG. 2, the voids 301 in bending flexure 300 allow for more predictable bend behavior in the direction of the voids 301. The remaining material of bending flexure 300 also forms ribs 302, much like the ribs 203 of material in FIG. 2. In bending flexure 300, the ribs 302 may be used to convey a control lumen through extruded eyelets 303 that run through every single one of the ribs 301. A central lumen 304 that passes longitudinally through the solid portion of bending flexure 300 may be used for other purposes, such as a working channel for tools, a control lumen for a guidewire, or a control lumen for a grasper. A solid spine 305 in bending flexure 300 may be maintained to preserve the integrity and stiffness of the structure.

[0038] FIG. 4 illustrates views of a flexible bending flexure in accordance with an embodiment of the present invention. Specifically, FIG. 4A illustrates a flexible bending flexure 400 in an unarticulated position, in accordance with an embodiment of the present invention. In FIG. 4A, bending flexure 400 comprises a bending section 401, a solid spine 402, solid ribs 403, and voids 404 created by the removal of material. The ribs 403 also contain a series of concentric eyelets that may be used to convey a pull wire tendon 406 from the proximal end 407 of the bending flexure 400 to the distal end 408, where the tendon is fixedly coupled to the flexure 400.

[0039] FIG. 4B illustrates flexible bending flexure 400 in a slightly articulated position, in accordance with an embodiment of the present invention. As tensile forces are exerted on tendon 406 to "pull" it, the tendon 406 exerts compressive force on the top side of flexure 400, causing it to articulate towards the ribs 403 and voids 404. During articulation, the absence of material due to voids 404 relieves the compressive forces and allows for tighter articulation within material yield limit. The mechanical advantage of tendon 406 is enhanced during articulation the farther the tendon 406 exists from the neutral axis. Accordingly, some embodiments position tendons as far as possible from the neutral axis. In contrast, articulation results in extension forces on the spine 402 on the left side of the flexure 400 as the flexure 400 articulates to the right.

[0040] FIG. 4C illustrates flexible bending flexure 400 in a maximally articulated position, in accordance with an embodiment of the present invention. As additional tensile forces are exerted on tendon 406 to "pull" it, the compressive force on the right side of flexure 400 causes the flexure to dramatically bend to its right. In this position, the ribs 403 are touching each other, creating an effective "stop" to any further articulation. Articulation of this magnitude results in high extension stress / strain on the spine 402 on the left side of the flexure 400 as the flexure 400 articulates to the right.

[0041] FIG. 5 illustrates various views of a bending flexure 500, in accordance with an embodiment of the present invention. Specifically, FIG. 5A illustrates longitudinally-cutout view of bending flexure 500 with a solid spine 501, voids 502 created by removing material, and ribs 503 formed by the remaining material. At the base of each rib (503), solid rib linkages connect ribs (503) from one side of the flexure 500 to the other. The teardrop-shape of voids 502 reduces the material of bending flexure 500 to improve bendability, thus distributing strain along the length of the flexure 500. Conversely, the teardrop-shape also maximizes the length of the rib linkages, which improves the integrity and creates a "hard stop" for the articulation of the bending flexure 500. Ribs 503 also support and house the components that are required to articulate the structure and manipulate the end effector, such as a pull wire in a control lumen. The skilled artisan would appreciate the selection of shapes for the teardrop voids 502 and ribs 503 as a matter of design choice, as well as the amount of material left to form spine 501.

[0042] FIG. 5B illustrates a cross-sectional view of bending flexure 500, in accordance with an embodiment of the present invention. Specifically, FIG. 5B illustrates a cross- sectional view of a rib (503) from bending flexure 500, where a central lumen 505 runs down the length of bending flexure 500, allowing for components to pass through the flexure 500 for a variety of uses, such as a working channel for tools, a control lumen for a guidewire, or a control lumen for a grasper. In this embodiment, lumen 505 comprises an upper region 506 and lower region 507, each of which may accommodate a different tool or purpose. By design, the specific shape of the central lumen 505 provides room for components while also maximizing material in the bending flexure 500, providing rigidity and stiffness that enhances flexure integrity. A person of skill in the art would recognize that a variety of other lumen shapes to accommodate other purposes may be possible in bending flexure 500.

[0043] FIG. 5C illustrates a cross-sectional view of bending flexure 500, in accordance with an embodiment of the present invention. Specifically, FIG. 5C illustrates a cross- sectional view of a segment of bending flexure 500 with a void (502). As shown in FIG. 5C, even though the void creates open regions in flexure 500, the spine 501 of bending flexure 500, i.e., portion of the bending flexure 500 furthest from the intended bend direction, remains solid. While, the solid construction of the spine 501 helps to maintain the integrity of bending flexure 500, the removal of material to create the voids 502 reduces the compression strain on the direction of the bend, allowing for greater articulation in that direction.

[0044] In some embodiments, a tendon may be extended through the lower region 507 of lumen 505 and attached at the distal end of bending flexure 500. Referring back to FIG. 5A, when tension is applied to the tendon, bending flexure 500 will bend in a downward direction indicated by the arrow 509, because teardrop-shaped voids 502 permit ribs 503 to move inward, and a bend is realized along solid spine 501. Arrow 501 depicts the direction of the preferential bending away from the neutral axis in a downward direction. The skilled artisan would appreciate the selection of shapes for the teardrop voids 502 and ribs 503 as a matter of design choice, as well as the amount of material left to form spine 501.

[0045] Referring back to FIG. 5B and 5C, due to the voids 502 in bending flexure 500, the neutral axis 508 of bending flexure 500 moves from the center of the bending flexure 500 towards the solid spine 501. It is this change in the physics of the bending flexure 500 that improves the bendability of the flexure 500. In some embodiments, the positioning of the lumens and their respective regions deliberately coincide with the location of the neutral axis 508 within bending flexure 500. For example, in certain embodiments, it may be advantageous to position a lumen or a region around the neutral axis for conveying a control wire for an end effector or a tool. In certain embodiments, it may be advantageous to position a lumen or a region away from the neutral axis to increase the mechanical advantage when articulating the flexure 500, such a pull wire.

[0046] Whereas existing solutions begin with a thin-walled tube, an alternative approach to manufacturing embodiments of the present invention include beginning with a solid cylindrical rod and removing material from the inside of the rod to create the appropriate lumens. This ensures that as much material remains in the bending flexure in order to provide structure and stiffness, while also providing the necessary space for required tools. The present invention may be the result of electro discharge machining cavities and voids out of a rod of solid material, such as nitinol. Alternatively, the material may be formed using extrusion techniques.

[0047] In some embodiments, the outer circumference of the bending flexure 500 has an approximately cylindrical shape, similar to that of a hypotube. Embodiments of the present invention provide a non-cylindrical lumen 505 through the bending flexure, which permits distributing material off-axis (i.e., non-uniform wall thickness) to provide structural rigidity to the bending flexure. Non-cylindrical lumen 505 provides a pathway 506 that may be used for the tools off-axis and a pathway 507 proximate to the neutral axis that may be used for auxiliary cables (not shown), such as tool actuating or articulating cables.

[0048] One embodiment provides placing the path of the ancillary components close to the neutral axis of the bending flexure. The placement reduces interactions between the articulation of the bending flexure and the ancillary components. This also contributes to a more predictable bend and end-effector behavior. In some embodiments, removing material from the cross section can both achieve a desired characteristic (e.g., bending stiffness of the bend section) and accommodate the articulation pull wire and the ancillary components.

[0049] In some embodiments, the bending flexure may be manufactured from a superelastic material. In other embodiments, the bending flexure is constructed from Nitinol, which has a superelastic phase at room and/or body temperature. In other embodiments, the bending flexure is constructed using other super elastic alloy, such as Nitinol tertiary alloys such as Ni-Ti-Co, Ni-Ti-Cu, and Ni-Ti-Fe.

[0050] In yet another embodiment, the moment of inertia may be tuned such that the structure achieves a significant bend by generating a moment on the structure and recovers to the original position when the moment is removed. In some embodiments, this actuation is accomplished by using a pull wire, which may be pulled in order to generate a moment and relaxed to relieve the moment.

[0051] In an alternative embodiment, the component is manufactured from a superplastic material, while the cross section allows a different inner profile by incorporating the relief on the profile, the device lends itself to be manufactured using the wire electric discharge machining (EDM) process without having to initially create a clearance hole.

[0052] One embodiment provides for placing the path of the ancillary components as close to the neutral axis of the bending flexure. Consequently, this reduces interactions between the articulation of the bending flexure and the ancillary components. Furthermore, this embodiment provides a more predictable bend and end effector behavior. For example, removing enough material from the cross section to accommodate the articulation pull wire and the ancillary components, hence, the bending stiffness can be manipulated in order to achieve a desired characteristic.

[0053] In certain embodiments, components that may be accommodated in the central lumen include pull wires for generating actuation at the end effector; fibers for illumination, laser, and vision; pneumatics and/or hydraulics; electrical wires; open lumen for a working channel (open architecture device, end effector is passed through working channel and is interchangeable); and a telescoping tube that supports an end effector.

[0054] In certain embodiments, the top opening, or lumen, accommodates the ancillary components and the bottom opening accommodates the articulating wire that controls the bending of the apparatus. A skilled artisan would appreciate different lumen configurations and placements based at least in part on the medical, surgical, or other application of the bending apparatus may be used without deviating from the present invention. [0055] FIG. 6 illustrates aspects of a bend section incorporated into an end effector, according to an embodiment of the present invention. Specifically, FIG. 6A illustrates an isometric view of a bend section 600 incorporated into an end effector interface 601 with an end effector that includes a grasper 602 at its distal end. Control over the grasper 602 is maintained by a pull wire 605 conveyed through the central lumen 604 of bend section 600. Articulation of bend section 600 may be controlled with pull wire 605 this is conveyed through eyelets in the ribs 606 of bending flexure 600.

[0056] FIG. 6B illustrates a close-up isometric view of the bend section 600, in accordance with an embodiment of the present invention. Similar to embodiments disclosed earlier, the bend section 600 has teardrop-shaped voids 607 that improve articulation in a desired bending direction. Moreover, the presence of ribs 606 and voids 607 create a "hard stop" (a feedback of hitting a barrier) when the ribs 606 come in contact during articulation.

Consequently, the ribs 606 and voids 607 help to prevent over articulation and potential damage to the structure of the bending flexure 600.

[0057] FIG. 7 illustrates aspects of a bending flexure in accordance with an embodiment of the present invention. Specifically, FIG. 7A illustrates an isometric view of a bending flexure in accordance with an embodiment of the present invention. In FIG. 7A, bending flexure 700 has material removed in order to create ribs 701 and voids 702, similar to the previously discussed embodiments. In addition, bending flexure 700 has a spinal gap 703 created by removing material from what was a solid spine in other embodiments. Even though FIG. 7A shows bending flexure 700 as a tubular elongated member with material removed to create ribs 701, voids 702, and a spinal gap 703, it would be appreciated that a similar structure could be created by removing material from a solid elongated tubular member in order to improve the stiffness, rigidity and structural integrity of the member.

[0058] The key difference in bending flexure 700 from FIG. 7 from previous embodiments is that the presence of spinal gap 703 reduces the extension strain resulting from an articulating motion towards the ribs 701 and voids 702. In practice, as the bending flexure 700 is articulated, the spinal gap 703 closes due to the extension strain, effectively holding the internal components in place, such as tools, pull wires, etc.

[0059] FIG. 7B illustrates a side view of the bending flexure 700 that highlights the structure of the ribs 701 and the shape of voids 702. As shown in FIG. 7B, voids 702 exhibit a teardrop-shape that resembles the void shapes in the previous embodiments. Additionally, the ribs 701 provide support for eyelets 704 that run the length of the bending flexure 700. [0060] FIG. 7C illustrates a cross-sectional view of a segment of bending flexure 700 that coincides with a void (702), in accordance with an embodiment of the present invention. As shown in FIG. 7C, bending flexure 700 may have material removed to create a lumen 705 with accessible via the spinal gap 703. Lumen 705 may also be structured to provide for several subregions, lower region 706, left region 707, and right region 708, that may accommodate different tools and components, such as pull wires and cables or articulation, control wires for tools, and other ancillary components. As discussed earlier, the spinal gap 703 provides advantageous access to these components without having to rethread the components through the bending flexure. As with other embodiments, the bending flexure 700 is composed of solid material 709 outside of the lumen cut outs.

[0061] As shown in FIG. 7C, lumen 705 continues throughout bending flexure 700 such that lumen 705 is exposed due to the presence of a void (702). The presence of the void also moves the neutral axis 711 of the bending flexure 700 towards the spinal gap 703. As discussed earlier, during articulation in the direction of preferential bending 712, the spinal gap 703 will tend to close as the bending flexure 700 is articulated and will therefore minimize the possibility of having the ancillary components "escape" the inner profile lumens. During large articulations, the flexure will completely close. The spinal gap allows the structure to have lower bending stiffness and increases the ease of manufacturing.

[0062] FIG. 7D illustrates a cross-sectional view of a segment of bending flexure 700 that coincides with a rib (701), in accordance with an embodiment of the present invention. As shown in FIG. 7D, the ribs are solid throughout the cross-section to provide structural integrity to flexure 700.

[0063] In some embodiments where the presence of the spinal gap 703 is a concern, the bending flexure can be manufactured with a gap and then "shape set" in order to close the gap before integration into an assembly. The skilled artisan would appreciate that the shape of non-cylindrical lumen 705 can be varied to achieve desired bending and rigidity properties of the bending flexure. The cross section of the design depicted in FIG. 7C and 7D permit the inner profile to break out. By incorporating this relief on the profile, the device lends itself to be manufactured using the wire EDM process without having to initially create a clearance hole.

[0064] The presence of the spinal gap also has a benefit during the assembly process. Using the spinal gap, components, such as articulation/pull wires and ancillary components may be laterally, rather than axially, inserted into bending flexure 700. In cases of emergency, this capability allows bending flexure 700 to be replaced without having to sever the articulation/pull wires or any components.

[0065] FIG. 8 illustrates a side view of a flexible bending flexure in accordance with an embodiment of the present invention. While bending flexure 800 exhibits ribbing 801 and teardrop-shaped voids 802 consistent with previously-discussed embodiments, flexure 800 does not feature a solid spine or a longitudinally-oriented spinal gap. Instead, flexure 800 features a series of spinal voids 803 and spinal ribs 804 that minimize the extension forces on the spine of flexure 800 when articulation occurs in the direction 805 of the ribbing 801 and voids 802. In contrast to this embodiment, bending flexure 800 does not have extreme points of extension stress along its spine due to the spinal voids 804. Consistent with other embodiments, flexure may also exhibit solid ribbing joints and a proximal end 806 and distal end 807 where installed pull lumens may termination and be fixed coupled.

[0066] In some embodiments, the ribs may have gradations of thickness that may provide for a more consistent bend, and compensate for friction between pull wires in the lumen and the associated eyelets and/cavities that convey them down the length of the tool.

[0067] Use of the present invention may greatly enhance endoscopic procedures by providing dexterity at an endoscope's distal tip in order to perform various tasks, such as precise dissection and therapy delivery. Embodiments of the present invention may be delivered down the working channel of an endoscope, and its design allow it to be mounted on a flexible shaft.

[0068] FIG. 9 illustrates views of an endoscopic device incorporating a distally-located tool, in accordance with an embodiment of the present invention. In FIG. 9A, a tool 902 may be concentrically positioned within an endoscopic device 900 for extension beyond the distal tip 901 of endoscopic device 900. In some embodiments, the endoscopic device 900 may be flexible and steerable. In some embodiments, the endoscopic device 900 may be steerable robotically. In some embodiments, the endoscopic device 900 may be constructed using catheter-like methods.

[0069] The tool 902 may comprise a flexible shaft 903, a bending flexure 904, and an effector, such as forceps 905. In certain embodiments, the shaft 903 may be rolled within endoscopic device 900 and articulated independent of endoscopic device 900. In some embodiments, the shaft 903 may be extended a predetermined length from the distal end 901 of the endoscopic device 900. In some embodiments, the shaft may be constructed from coil pipes or metal-braided shafts. In some embodiments, the end effector may be a laser fiber or biopsy needle. Moreover, the end effector (such as forceps 905) may be rolled and rotated as well.

[0070] The shaft may also be used to route wires for articulation of the bending flexure 904 and the actuation of the forceps 905, where the torqueability of the forceps 905 may be inversely proportional to the length of endoscopic device 900 and tool 902. Pull wires in these embodiments may be constructed from nitinol to take advantage of both its "memory" and superelastic properties under different conditions. Responsiveness of nitinol pull wires may be increased by increasing pull wire axial stiffness through transitioning from nitinol to a stiffer material, such as stainless steel, or braided cable, or torque tube in the case of controlling forceps.

[0071] In some embodiments, multiple aspects of the endoscopic device 900, flexible shaft 903, and bending flexure 904 may be adjusted and manipulated in order to reach different operative regions. For example, to reach deeper into a patient, the endoscopic device 900 may be extended, retracted, rolled or articulated in several directions. Similarly, flexible shaft 903 may be extended from or retracted from endoscopic device 900. At the same time, flexure 904 may be rolled and articulated while endoscopic device 900 and shaft 903 are also being adjusted, allowing for access variety of different operative regions.

[0072] FIG. 9B illustrates a side view of an endoscopic device incorporating distally- located tool 902, which comprises flexible shaft 903 and bending flexure 904, in accordance with an embodiment of the present invention. In FIG. 9B, the shaft 903 has been retracted, allowing articulation of bending flexure 904 almost immediately from the distal end 901 of endoscopic device 900.

[0073] FIG. 9C illustrates a side view of an endoscopic device incorporating distally- located tool 902, which comprises flexible shaft 903 and bending flexure 904, in accordance with an embodiment of the present invention. In FIG. 9C, the bending flexure 904 is extended to greater extent than in FIG. 9C, allowing access to articulation of bending flexure 904 to reach operative regions further away from the distal end 901 of endoscopic device 900. In some embodiments, the bending flexure 904 may be shape-set to curve in a predetermined direction, such that extension of flexure 904 from the distal tip 901 of endoscopic device 900 results in increased reach in the direction of the shape-set curve.

[0074] When deployed through a flexible endoscopic device, such as 900, a flexible shaft 903, and a flexible bending flexure, such as 904, the end effector may have as six degrees of articulation when accounting for both articulation and roll capabilities of the various components. However, where constrained, less than six degrees of articulation will result. [0075] FIG. 10 illustrates components that comprise an articulating tool, in accordance with an embodiment of the present invention. FIG. 10A specifically illustrates a cutout side view of an articulating tool 1000 that comprises a forceps 1001, a bushing 1002, a bending flexure 1003, a pull wire 1004, a shaft 1005, and a stainless steel tube 1006. In some embodiments, the shaft may be flexible.

[0076] FIG. 10B illustrates a side view of the forceps 1001 from FIG. 10A, in accordance with an embodiment of the present invention. As shown in FIG. 10B, forceps grasper-rod 1001 comprises a grasper 1007 with prongs 1008 and transmission rod 1009. In some embodiments, the grasper 1007 and transmission rod 1009 may be constructed from nitinol in order to take advantage of its high strainability and stiffness. In certain instances, both components may be formed using a unibody construction in order to simplify the design and increase robustness. Moreover, nitinol's high strain limits allows the transmission rod 1009 a larger diameter, which increases torque transmission as torsional stiffness of an elongated member scales with the diameter of the member. In some embodiments, a stainless steel tube 1006 may be coupled to the transmission rod 1009 in order to improve torsional rigidity.

[0077] Returning to FIG. 10B, forceps 1001 may be retracted or extended within articulating tool 1000, through lumens in the bushing 1002, the bending flexure 1003, and shaft 1005. In an "open" state, the width of the prongs 1008 of grasper 1007 exceeds the diameter of the bushing 1002, thus retracting forceps 1001 into the articulating tool 1000 "closes" the prongs. Conversely, extending the forceps 1001 out of the bushing 1002

"opens" the prongs 1008 of grasper 1007. This simple means of (open-close) actuation greatly simplifies the tool, which is particular important at smaller geometries.

[0078] The bushing 1002 may be formed from hard materials and may include a low friction coating. In some embodiments, the bushing 1002 is formed from stainless steel or sapphire for their hardness properties. In certain embodiments, the bushing has a radiused edge to increase smoothness and reduce friction where the bushing rubs against the prongs 1008.

[0079] The bending flexure 1003 contains ribbing and voids consistent with earlier- discussed embodiments. Additionally, a pull wire 1004, running through concentric eyelets 1010 in the ribbing, may be used to articulate the bending flexure 1003 in the direction of the ribbing and voids. In certain embodiments, the transmission rod 1009 may be coated with a low friction coating, such as polytetrafluoroethylene (PTFE), to reduce friction between the transmission rod 1009 and the bending flexure 1003. In some embodiments, the interior of the bending flexure 1003 may be smoothed with an electropolish to reduce friction with the transmission rod 1009.

[0080] While contemplated for a range of sizes, the preferred embodiments of the present invention may be below 2 millimeters in diameter. In particular, embodiments are particularly useful for delivering rigidity and stability in miniature devices with sub-1 millimeter diameters.

[0081] While previously disclosed embodiments have included the use of approximately straight flexures when unarticulated, in some embodiments, the flexures of the present invention may be shape set to be non-straight as well. For example, FIG. 11 illustrates a flexure that has been shape-set to be curved to one side when relaxed, in accordance with an embodiment of the present invention. While flexure 1100 in FIG. 11 is identical in structure to flexure 400 in FIG. 4, flexure 1100 has been shape-set to be curved away from the direction of articulation 1101. This allows the flexure 1100 to reach a range of 180 degrees of motion rather than simply 90 degrees. For example, while flexure 1100 may reach operative regions to the left when the tendon 1102 is relaxed, flexure 1100 may reach operative regions in front of flexure 1100 and operative regions to the right upon tensioning tendon 1102.

[0082] Shape-setting allows the flexure to have additional degrees of freedom and reach. In some embodiments, a shape-set flexure may be used in combination with an outer shaft, such that extension of the flexure from the shaft allows the shape-set flexure to reach farther to one side as well as articulate in the opposite direction.

[0083] Elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein. While the invention is susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. The invention is not limited, however, to the particular forms or methods disclosed, but to the contrary, covers all modifications, equivalents and alternatives thereof. What is claimed is: