US20040138529A1 - Endoluminal tool deployment system - Google Patents

Abstract

Systems, devices and methods are provided for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body having a scope therethrough. Some embodiments of the systems include an elongated main body which is rigidizable and/or torque transmitting to improve manipulation through passageways in the body.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This application is a continuation-in-part of, and claims the benefit of priority from co-pending U.S. patent application Ser. No. 10/346,709, filed Jan. 15, 2003, and also claims the benefit of prior Provisional Application No. 60/______, filed on May 19, 2003, the full disclosures of which are hereby incorporated herein by reference.[0001]
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
• NOT APPLICABLE[0002]
REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK.
• NOT APPLICABLE[0003]
BACKGROUND OF THE INVENTION
• The present invention relates generally to medical devices, systems and methods. More particularly, the present invention relates to devices, systems and methods for use in endoscopic or laparoscopic procedures.[0004]
• Endoscopy is a form of minimally invasive procedure wherein the interior of the body is accessed and visualized through an orifice in the body, such as the esophagus or rectum. Such access allows a surgeon or physician to view and/or treat internal portions of the orifice or internal tissues or organs which are accessible through the orifice. These procedures may be for diagnostic purposes, such as visual inspection or the removal of a tissue sample for biopsy, or the procedure may be used for treatment purposes, such as the removal of a polyp or tumor or the restructuring of tissue. While these procedures can be done using regular open surgery, endoscopy usually involves less pain, less risk, less scarring, and faster recovery of the patient.[0005]
• Endoscopy is typically performed with the use of an endoscope, a small circular tube containing optical components. Traditional endoscopes comprise a small diameter “snake-like” insertion tube having a distal end which is inserted into the orifice to the desired internal location. Fiber optics extend through the insertion tube and terminate at the distal end to allow axial viewing from the distal end. Images of the internal location near the distal end of the endoscope are transmitted to a video monitor for the physician to view. A control handle allows the endoscopist to control the direction of the scope and in some cases, permits the actuation of air, water and suction utilities that may be required for the endoscopy procedure.[0006]
• Since endoscopes may be used to perform a treatment at an internal location, some endoscopes are equipped with a lumen through which a surgical instrument or tool may be passed. Generally, the lumen extends through the length of the insertion tube to the distal end so that the end effector of the inserted instrument protrudes from the distal end in the axial direction. Thus, the instrument is directed in parallel to the fiber optics so that the end effector is positioned along the line of view.[0007]
• Such endoscopes have a number of constraints which limit their usefulness in performing diagnostic and surgical procedures. To begin, surgical instruments and tools are inserted axially through a working lumen in the endoscope. And, most of these endoscopes only allow axial and rotational movement of the tool beyond the distal end. This helps to maintain positioning of the tool within the field of view of the endoscope which is also directed axially. However, this limits the variety and complexity of procedures that may be performed. For example, procedures which involve tissue approximation pose great difficulty since only one portion of tissue may be grasped at a time and lateral, rather than axial, movement may be required. Although steering of an axially inserted tool may be possible near the distal end, such steering typically positions the end effector of the tool out of the field of view of the axially directed scope.[0008]
• A similar minimally invasive procedure which overcomes some of these constraints is laparoscopy. In laparoscopy, the interior of the body is accessed and visualized through a small incision. When accessing the abdomen, the incision is usually made in the navel. Laparoscopy was initially used by gynecologists to diagnose and treat conditions relating to the female reproductive organs: uterus, fallopian tubes, and ovaries. It is now used for a wider range of procedures, including operations that in the past required open surgery, such as removal of the appendix (appendectomy) and gallbladder removal (cholecystectomy). Laparoscopy is performed with a device which allows the surgeon or physician to view and/or treat internal tissues or organs which are accessible through the incision. This device is the same or similar to an endoscope, sometimes referred to as a laparoscope. The device comprises a small diameter insertion tube having a distal end which is inserted into the incision to the desired internal location. Fiber optics extend through the insertion tube and terminate at the distal end to allow axial viewing from the distal end. Images of the internal location near the distal end are transmitted to a video monitor for the physician to view. Sometimes, access through an incision creates a shorter, straighter and more direct access path than through an orifice. Therefore, some laparoscopes may have a shorter and stiffer insertion tube than some endoscopes.[0009]
• Although laparoscopes suffer from many of the same limitations as endoscopes, laparoscopy allows additional surgical instruments and tools to be inserted through separate incisions to perform procedures. Proper location of the incisions can allow instruments to be positioned in various directions. Therefore, movement and viewing is not limited to the axis of the laparoscope and simultaneous viewing of the tissues and the instruments may be more readily achieved during the procedure. However, these additional benefits are achieved at the cost of increased invasiveness. Access paths must be created for the instruments with the use of trocars requiring general anesthesia, risk of complications and infection, and increased overall recovery time for the access paths to heal. In addition, access may be difficult or contraindicated in some patients, particularly in the morbidly obese.[0010]
• Thus, it would be desired to provide an improved methods, devices and systems to perform minimally invasive procedures. Particularly, methods, devices and systems which would provide the benefits of endoscopy, such as lower invasiveness and access to deeply internal locations, with the benefits of laparoscopy, such as the use of multiple instruments with movement and viewing along various axes. The devices and systems would be reliable, convenient and easy to use with improved outcomes for patients due to reduction in invasiveness and therefore risk, cost and recovery time. At least some of these objectives will be met by the invention described hereinafter.[0011]
• In addition, it would be desired to provide improved methods, devices and systems which would provide improve passage and manipulation through endovascular passageways. Typical endoscopes have a length in the range of 130 to 190 cm and may be used to traverse a variety of tortuous paths within the body. For example, endoscopes may be used to access the lower gastrointestinal tract from entry through the anus, sometimes reaching as far as the cecum at the distal end of the colon. The upper gastrointestinal tract may be accessed through the esophagus to the stomach and the upper regions of the small intestine. Achieving access to any of these regions, particularly through the colon, involves tedious manipulation of the endoscope. Much of this manipulation involves torqueing of the endoscope. However, once a substantial length of the endoscope has passed into the body, torqueing becomes increasingly difficult. In addition, accessing such regions usually takes place through minimally supported lumens, such as the colon, which do not provide resistive strength or through open cavities, such as the stomach, which do not provide particular pathways for the endoscope. This also limits the use of endoscopic access to desired treatment locations.[0012]
• Thus, it would be desired to provide improved methods, devices and systems to access desired treatment locations. Particularly, methods, devices and systems which would improve the ability to access desired treatment locations minimally invasively, particularly endoscopically or laparoscopically. The devices and systems would be reliable, convenient and easy to use with improved outcomes for patients due to reduction in invasiveness and therefore risk, cost and recovery time. At least some of these objectives will be met by the invention described hereinafter.[0013]
BRIEF SUMMARY OF THE INVENTION
• The present invention provides systems, devices and methods for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Some embodiments of the systems include an elongated main body which is rigidizable and/or torque transmitting to improve manipulation through passageways in the body. And, some embodiments of the systems include an elongated main body having a scope therethrough and at least one steerable tool arm which extends from the distal end of the main body. In these embodiments, the system typically includes two tool arms, each arm steerable to form a curve laterally outward which then bends laterally inward so that the arms form a an angular or boomerang shape. In addition, end effectors extend from the distal ends of each arm for use in manipulation of tissue. The angular shape brings the end effectors together in view of the scope for cooperative movements which are continuously visible by the surgeon through the scope. In addition, the tool arms may be steerable in any additional direction and may be rotateable to allow grasping, pulling, tugging, elevation and more complex manipulation of tissue. Thus, the systems and devices of the present invention provide many of the capabilities of open surgery or laparoscopic surgery with an endoscopic approach. In addition, the systems and devices of the present invention provide improvements in manipulation for accessing desired treatment locations.[0014]
• In a first aspect of the present invention, the tool arm(s) comprise a shaft having a proximal end and a deflectable or steerable distal end. In some embodiments, the steerable distal end will be laterally stabilized so that the distal end may be steered, i.e. bent or manipulated, within a plane but will resist deflection outside of the plane during use. The steering plane will generally be parallel to a central axis of the scope but may be rotated by rotation of the tool arm. In this way, the arm(s) will maintain stable positioning within the field of view of the scope and will resist accidental deflection outside of the field. It may be appreciated that the tool arm may also be translated axially within the stabilized plane while maintaining viewing within the field.[0015]
• A preferred structure for achieving lateral stability comprises a plurality of adjacent links. Usually, the links are pivotally attached by hinged structures. In some embodiments, the hinged structures comprise pivot pins which are disposed parallel to one another and generally transverse to the stabilized plane in which the arm may be steered. In other embodiments, the hinged structures comprise male and female bearing surfaces which define axes, wherein the axes are disposed in parallel to limit deflection of the distal section to within the plane. A variety of other structures are also available to provide lateral stability, such as deployment frames, various shaped linkages connected by reinforcements or pullwires, and slotted tubes, to name a few.[0016]
• Typically, the distal end includes at least two steerable sections, wherein a distal-most steerable section includes a tip section which curves in a first direction and wherein an intermediate steerable section includes a base which curves in the opposite direction, where both curves are in the stabilized plane. In some embodiments, the tip section curve has a radius which is greater than that of the curve of the base. To achieved such curvatures, the adjacent links may be shaped to allow substantially continuous deflection. Or, the adjacent links may be shaped so that the steerable distal end is deflectable to form a predetermined curvature wherein the arm is then restricted from further deflection.[0017]
• Means for selectively deflecting the distal section of the tool arm(s) often comprise at least one pullwire or one pushwire. Such pull or pushwires may be present in any quantity and arrangement. The means for selectively deflecting the distal section can further include at least one spring which is configured to straighten the distal section in opposition to the pullwire or pushwire.[0018]
• In some embodiments, the tool arm includes an end effector disposed at its distal end. A wide variety of end effectors may be used depending on the procedure or tissue manipulations which are desired. For example, end effectors may include but are not limited to knives, needles, sutures, staplers, fasteners, clippers, electrosurgical or hemostatic cutters and coagulators, laser welders, cryosurgery instruments, secondary scopes, forceps, lasers hooks, tongs, graspers, retractors, probes, clamps, scissors, tissue approximation devices and suction applicators. Alternatively, the tool arm may include a tool deployment lumen through which a tool having an end effector may be passed. In these embodiments, the tool arm may include a steering cuff arranged for passage of the tool therethrough so that manipulation of the tool within the steering cuff steers the distal end of the tool arm. Thus, in either case, manipulation of the end effector and the tool arm may be interconnected.[0019]
• In another aspect of the present invention, the elongated main body has a distal end, a proximal end, and an arm guide lumen extending through at least a distal section of the elongated main body. In preferred embodiments, the elongated main body has a viewing or scope lumen extending therethrough and terminating in the distal tip. It may be appreciated that the scope lumen may be used for passage of any viewing element or device or the scope lumen may comprise a viewing element or device fixed or integrated within the main body. Herein, it will be assumed that the term “scope lumen” will be used to refer to either of these embodiments.[0020]
• The arm guide lumens and the viewing scope lumen may be arranged in any suitable fashion within the main body. For example, when the elongated main body has a second arm guide lumen, the distal terminations of the two arm guide lumens and the one viewing scope lumen may be arranged in a generally triangular pattern on the distal tip of the main body. Alternatively, the lumens may be aligned, wherein the viewing scope lumen is disposed between the arm guide lumens.[0021]
• Typically, at least the distal section of the elongated main body is steerable. In some embodiments, the elongated main body comprises a first section and a second section, the first section disposed proximally of the second section, and the first and second sections are independently lockable. Thus, the first section may be lockable while the second section remains steerable. Such steering may be achieved with means for selectively deflecting the second section within at least a single plane. This may include retroflexion wherein the distal end of the main body is directed toward the proximal end. In some embodiments, the distal section of the elongated main body comprises a plurality of adjacent links to allow for such steering.[0022]
• Typically, at least the distal section of the elongated main body has a generally cylindrical exterior wherein the arm guide lumen does not extend out of the cylindrical exterior. And, the arm guide lumen terminates at a distal tip of the elongated main body so that the tool arm advances through the distal tip. Likewise, as mentioned previously, the elongated main body typically has a viewing scope lumen extending therethrough and terminating in the distal tip.[0023]
• In yet another aspect of the present invention, the tool arms may have a distal end which is steerable by a variety of mechanisms. For example, the distal end may be comprised of a flexible tube having at least one pullwire attached thereto so that manipulation of the at least one pullwire deflects the steerable distal end. Or, the tool arm may have a steerable distal end which comprises a flexible tube having shape memory material so that emergence of the steerable distal end from the distal tip of the main body allows deflection of the steerable distal end to a shape memory position. Or, the tool arm may further comprise a deployment frame extending from the distal tip of the main body, the frame comprising at least two supports each attached to one of the at least two tool arms so that manipulation of the deployment frame deflects the attached tool arms.[0024]
• In an additional embodiment of the present invention, the endoluminal tool deployment system may be comprised of an elongated main body having a distal end, a proximal end, and at least two arm guide lumens extending over or through at least a distal section of the elongated main body, wherein said arm guide lumens extend fully to a distal tip of the main body, and at least two tool arms adapted to extend through the arm guide lumens of the elongated main body, said tool arms emerging from the distal tip of the main body.[0025]
• In still another aspect of the present invention, the endoluminal tool deployment system comprises an elongated main body having a distal end, a proximal end, and an arm guide lumen extending through at least a distal section of the elongated main body, wherein at least the distal section comprises a plurality of adjacent links. The system further includes a means for selectively deflecting the distal section within at least a single plane, and at least one tool arm adapted to extend through the arm guide lumen of the elongated main body.[0026]
• In a further aspect of the present invention, a method is provided for deploying one or more tools in an anatomical space. In a preferred embodiment, the method comprises introducing a distal end of a main body to said anatomical space, advancing a tool arm from a tool deployment lumen in said main body into said anatomical space, deflecting and positioning the tool arm to locate a distal tip thereof adjacent to a target location within the anatomical space, wherein a distal section of the arm is curved and laterally stabilized in a single plane, and advancing a tool through a lumen of the tool arm to the target location.[0027]
• In some embodiments, deflecting and positioning comprises tensioning a plurality of adjacent hinged links within the distal section of the tool arm. The adjacent hinged links may be joined by hinge pins which are disposed perpendicularly to the single plane such that the pins stabilize the distal section and inhibit deflection outside of the single plane. The method may further comprise viewing the target location through a viewing scope disposed in the main body, wherein the tool arm extends axially from a distal tip of the main body from a location adjacent to the viewing scope.[0028]
• In some embodiments, an endoluminal system is provided comprising an elongated main body having a proximal end, a distal end sized for passage through a body lumen, and at least one lumen extending between the proximal and distal ends. The system further includes a torque transmitting feature which provides torque transmission between the proximal and distal ends while the main body is unlocked and able to form a desired configuration. In addition, the system includes a locking mechanism which locks the main body in the desired configuration. The at least one lumen may be used for passage of any desired device, including, for example, a viewing scope and optionally one or more tool arms. In addition, the system typically includes a steering mechanism which steers the main body to the desired configuration while the main body is unlocked. In most embodiments, the steering mechanism comprises at least one pullwire extending through the plurality of adjacent links.[0029]
• In preferred embodiments, at least a portion of the elongated main body comprises a plurality of adjacent links. Torque may be transmitted through the adjacent links by a variety of torque transmitting features. For example, in some embodiments, when the plurality of adjacent links comprises at least a first link and an adjacent second link, the torque transmitting feature comprising at least one protrusion or tooth from the first link slidably engageable with at least one groove in the adjacent second link, the torque transmitting feature providing torque transmission through the portion of the main body while the links are rotateable. In some embodiments, the at least one protrusion comprises a pair of protrusions, each protrusion extending outwardly from an outer surface of the first link in a diametrically opposite position from the other protrusion. Correspondingly, the at least one groove may comprise a pair of grooves, each groove configured to accept one or the pair of protrusions passing therein. When the first link comprises a first domed ring having the outer surface and the adjacent second link comprises a second domed ring having an inner surface, the outer surface of the first domed ring is mateable with the inner surface of the second domed ring along a longitudinal axis, and the rings are rotateable away from the longitudinal axis. In some embodiments, each groove comprises a first groove end and a second groove end, the groove ends substantially aligned with the longitudinal axis to allow sliding of the protrusions along the grooves during rotation of the rings away from the longitudinal axis. It may be appreciated that such protrusions may extend inwardly from an inner surface and the grooves may be disposed on the outer surface of an adjacent link to accept such protrusions. Thus, the protrusions and associated grooves may function in a similar manner in an inverse arrangement.[0030]
• In other embodiments, the torque transmitting feature comprises a protrusion or a pin from the first link slidably engageable with a slot in the adjacent second link. This is an example of a torque transmitting feature which provides torque transmission by preventing disengagement of the adjacent links while the main body is unlocked and able to form a desired configuration. In some embodiments, the plurality of adjacent engageable links comprises at least a first link and an adjacent second link and the torque transmitting feature comprising at least one pin from the first link slidably engageable with at least one slot in the adjacent second link. Further, in some embodiments, the at least one pin comprises a pair of pins, each pin extending outwardly from an outer surface of the first link in a diametrically opposite position from the other pin. Similarly, the at least one slot comprises a pair of slots, each slot configured to accept one or the pair of pins passing therethrough.[0031]
• In preferred embodiments, the first link comprises a first domed ring having the outer surface and the adjacent second link comprises a second domed ring having an inner surface, the outer surface of the first domed ring being mateable with the inner surface of the second domed rings along a longitudinal axis, and the rings being rotateable away from the longitudinal axis. Typically, each slot comprises an elongate opening between a first slot end and a second slot end, the slot ends substantially aligned with the longitudinal axis to allow sliding of the pins through the slots during rotation of the rings away from the longitudinal axis. It may be appreciated that such pins may extend inwardly from an inner surface and extend through slots on adjacent links. Thus, the pins and associated slots may function in a similar manner in an inverse arrangement.[0032]
• In yet other embodiments, the torque transmitting feature comprises a torque transmitting covering over the plurality of adjacent engageable links to prevent disengagement of the adjacent links. In some instances, the torque transmitting covering comprises a snuggly fit sheath including reinforcements, such as a braided material. The reinforcements may comprise nylon, polyurethane, polyethylene, Teflon, metal, or polymer, for example. Optionally, the reinforcements may be coated with a polymer or the reinforcements may be covered with a separate polymer component. Alternatively, the torque transmitting covering may comprise a polymer coating over the links themselves.[0033]
• In still further embodiments, an endoluminal device is provided comprising an elongated main body having a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends, at least a portion of the elongated main body comprising at least a first link and an adjacent second link which are rotateable relative to each other when unlocked, one of the at least one lumen extending through the links having at least one partition. An elongated shaft is present passing through one of the at least one lumen in a manner to transmit torque by contacting the least one partition. In addition, a locking mechanism is provided which locks the links upon actuation by preventing rotation of the links relative to each other.[0034]
• In some embodiments, the at least one partition comprises an inward protrusion. And, the at least one lumen extending through the links may have a fluted shape forming the inward protrusions. In other embodiments, the at least one partition comprises a divider spanning across the one of the at least one lumen. The shaft passes through the at least one lumen and is positioned between partitions in each of the links. Torqueing of the plurality of adjacent links is transmitted through the shaft and partitions. For example, by applying torque to a first link, the first link rotates about the longitudinal axis until the shaft contacts a partition. Since the partitions are generally aligned, the shaft will also contact partitions in a second link. Therefore, torque is transmitted from the first link to the second link. This transmission may be repeated through any number of links, transmitting torque through a plurality of adjacent links.[0035]
• In additional embodiments, the torque transmitting feature comprises an oval shape of the plurality of adjacent links. And, in other embodiments, the torque transmitting feature comprises a plurality of wires or rods extending through the adjacent links. In preferred embodiments, the plurality of rods comprises approximately 8 to 64 rods. Torque is transmitted from link to link through these torque transmitting features.[0036]
• Further, a method of accessing is provided comprising providing an elongated main body having a proximal end, a distal end, a visualizing element and a locking mechanism, wherein the main body is capable of forming a desired configuration in an unlocked state and holding the desired configuration in a locked state. The method further includes introducing the main body through a body passageway in the unlocked state forming the desired configuration so that the distal end reaches a target location, actuating the locking mechanism to hold the main body in the desired configuration, and viewing the target location with the use of the visualizing element.[0037]
• Introducing the main body may comprise allowing the main body to assume a shape of the body passageway in the unlocked state forming the desired configuration. Or, introducing the main body may comprise steering the main body through the body passageway in the unlocked state forming the desired configuration. In either situation, in some embodiments, the main body comprises a plurality of adjacent links so that actuating the locking mechanism comprises holding the links in a fixed relation to each other. In particular, the plurality of adjacent links sometimes comprises a plurality of nestable elements so that holding the links comprises wedging the links together to hold them by friction.[0038]
• When the main body includes at least one lumen extending between the proximal and distal ends, the method may further comprise introducing an instrument through the at least one lumen. In some embodiments, the instrument comprises a tool arm. When the elongated main body further includes a visualizing lumen and the visualizing element comprises an endoscope, the method may further comprise positioning the endoscope within the visualizing lumen.[0039]
• Other objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.[0040]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates an embodiment of a system of the present invention.[0041]
• FIG. 2 illustrates the system of FIG. 1 in an assembled arrangement.[0042]
• FIG. 2A depicts the cross-section of the system of FIG. 2, and FIG. 2B depicts an alternative cross-section.[0043]
• FIGS.[0044]3A-3D,4-6 illustrate possible movements of the steerable distal ends of the tool arms.
• FIGS.[0045]7A-7B illustrate the use of an embodiment of the system to perform a mucosectomy.
• FIGS.[0046]8A-8C illustrate an embodiment of the main body in a variety of positions.
• FIG. 9A shows an embodiment of the shaft of the main body comprised of a multiplicity of nestable elements, and FIG. 9B provides an exploded view of these elements.[0047]
• FIGS.[0048]9C-9E provide cross-sectional views of various nestable elements.
• FIG. 10A provides an exploded view of nestable elements having a pullwire extending through their centers and FIG. 10B provides a cross-sectional view one of the nestable elements.[0049]
• FIG. 10C illustrates the nestable elements of FIG. 10A with the inclusion of liners and FIG. 10D provides a cross-sectional view of one of the nestable elements.[0050]
• FIGS.[0051]10E-100 illustrate embodiments of the main body.
• FIG. 11 illustrates an embodiment of a tool arm.[0052]
• FIGS.[0053]12A-12B,13A-13B,14 illustrate embodiments of adjacent links disposed at the distal end of a tool arm.
• FIG. 15 illustrates examples of possible deflections or movements of an embodiment of the tool arm.[0054]
• FIGS.[0055]16A-16B illustrate another embodiment of a tool arm comprising a plurality of adjacent links.
• FIGS.[0056]17,17A-17C illustrate an embodiment of a tool arm which is steerable to a predetermined arrangement.
• FIGS.[0057]18A-18B illustrate the creation of distinct curvatures achieved by separate pullwires.
• FIG. 19 illustrates two tool arms steered to a predetermined arrangement.[0058]
• FIG. 20 illustrates an embodiment including both links which are steerable to a predetermined arrangement and links which are unrestrictedly steerable.[0059]
• FIGS.[0060]21A-21B illustrate an embodiment of a tool arm comprised of a slotted tube.
• FIGS.[0061]21C-21D illustrate an embodiment of a tool arm comprised of a tube wherein a pullwire is positioned on the outside of the tube.
• FIGS.[0062]21E-21F illustrate an embodiment of a tool arm comprised of a polymer wall co-extruded with shape memory material.
• FIGS.[0063]21G-21H illustrate a mechanism for steering the tool arms including a deployment frame.
• FIGS.[0064]22A-22B,23,24 illustrate embodiments of the shaft of the main body.
• FIGS.[0065]25A-25B provide a view of the proximal end of an embodiment of the main body wherein two tool arms are present, each including a steering cuff.
• FIGS.[0066]26,27A-27B,28A-28B illustrate embodiments of a steering cuff.
• FIGS.[0067]29,29A-29D illustrate embodiments of a tool having an end effector in the form of various types of scissors.
• FIG. 30 illustrates an embodiment of the tool having an end effector in the form of gator toothed graspers.[0068]
• FIG. 31 illustrates an embodiment of the tool having an end effector in the form of an articulatable grasper.[0069]
• FIGS.[0070]32-36 illustrate embodiments of the tool having end effectors in the form of various shaped retractors.
• FIGS.[0071]37A-37B illustrate grasping hooks inserted through auxiliary lumens in the main body and FIG. 37C illustrates a fixation device which may be deployed by the tool arms when such grasping hooks are used in a plication procedure.
• FIGS. 38, 39,[0072]40A-40B illustrate alternative tools passed through auxiliary lumens in the main body.
• FIG. 41 illustrates a tool passed through an arm guide lumen for use in conjunction with a tool arm.[0073]
• FIG. 42 illustrates an arm used to cleanse a portion of the main body, particularly the scope lens.[0074]
• FIGS.[0075]43A-43F illustrate a torque transmitting feature utilizing a tooth and groove concept to maintain alignment of the plurality of adjacent links at locations along its length.
• FIGS.[0076]44A-44D illustrate a torque transmitting feature utilizing a pin and slot concept to maintain alignment of the plurality of adjacent links at locations along its length.
• FIGS.[0077]45A-45C illustrate the use of a torque transmitting covering over the plurality of adjacent links providing torque transmission therethrough while the links are rotateable.
• FIGS.[0078]46A-46D illustrate cross-sectional views of a link wherein one of the at least one lumen extending through the links has at least one partition.
• FIGS.[0079]47A-47B illustrate a torque transmitting feature wherein the links have an oval cross-section.
• FIGS.[0080]48A-48C illustrate a torque transmitting feature comprising a plurality of rods extending through the adjacent links.
DETAILED DESCRIPTION OF THE INVENTION
• I. Overview[0081]
• An embodiment of a[0082]system2 of the present invention is illustrated in FIG. 1. Thesystem2 includes an elongatedmain body10 having aproximal end12 and adistal end14 terminating in adistal tip16. Themain body10 is used to access an internal target location within a patient's body. Typically, thedistal end14 is passed through a body orifice and one or more naturally occurring body lumens to the target location, such as in endoscopy, while theproximal end12 remains outside of the body. Therefore, themain body10 has a deflectable and/orsteerable shaft20, either due to choice of material or design of theshaft20 to include links, hinges, coils or other similar structures to allow deflection. Thus, FIG. 1 illustrates themain body10 in a deflected position wherein thebody10 includes curvatures. Such deflection and/or steering may be useful in traversing body lumens to the target location and is achievable by manipulation of ahandle22 near theproximal end12. It may be appreciated, however, that thesystem2 may be used in laparoscopic procedures wherein such deflection and/or steering may be less utilized for placement of themain body10. In either case, rigidization of some or all theshaft20 may be desired, for example to provide a stable visualization platform. Therefore, portions of theshaft20 of themain body10 are lockable to maintain a desired shape and provide rigidity, either due to choice of material or design of theshaft20 to include locking mechanisms, as will be described in later sections.
• The[0083]main body10 also includes at least onearm guide lumen26 which extends over or through at least a distal section of themain body10, typically along the majority of the length of thebody10 as shown. Here in FIG. 1, twoarm guide lumens26 are shown, each extending from a position along theshaft20 near theproximal end12 to thedistal tip16. In addition, themain body10 includes ascope lumen24 which extends through theshaft20 to thedistal tip16.
• The[0084]system2 also includes at least onetool arm30, two are shown in FIG. 1, eacharm30 of which is insertable through a separatearm guide lumen26 as indicated by dashed line. Eachtool arm30 has aproximal end32, adistal end34 and ashaft36 therebetween. Thedistal end34 is steerable, such as by manipulation of adjacent links as schematically indicated. Such steerability may be controlled by asteering cuff35 which is part of theproximal end32. Theshaft36 is typically flexible or deflectable to allow deflection of the surroundingmain body shaft20. Eachtool arm30 additionally includes atool deployment lumen38 therethrough.
• In this embodiment, the[0085]system2 also includes at least onetool40, two are shown in FIG. 1. Eachtool40 includes adistal end42, aproximal end44 and anelongate shaft46 therebetween to allow passage through thetool deployment lumen38 of thearm30. Eachtool40 has anend effector48 disposed at thedistal end42 and optionally ahandle50 at theproximal end44 for manipulation of theend effector48 from outside the body. Thetool40 is advanced so that theend effector48 emerges from thedistal end34 of thearm30.
• FIG. 2 illustrates the[0086]system2 of FIG. 1 in an assembled arrangement. Here, thetool arms30 are shown inserted through thearm guide lumens26 of themain body shaft20. The steerable distal ends34 of thearms30 protrude from thedistal end14 of themain body10 and the proximal ends32 of thearms30 protrude from theproximal end12 of themain body10. As shown, the steering cuffs35 are located at the proximal ends32 of thearms30. In addition, thetools40 are shown inserted through thetool deployment lumens38 so that theend effectors48 extend beyond the steerable distal ends34 of thearms34. Likewise, the proximal ends44 of thetools40 withhandles50 are shown protruding from the steering cuffs35. Movement of thetools40 against the steering cuffs35 will actuate steering of the distal ends34 of thearms30, as will be described in later sections.
• FIG. 2A provides a cross-sectional view of[0087]system2 of FIG. 2. Since theshaft20 of themain body10 has a generally cylindrical exterior in this embodiment, the cross-section of theshaft20 has a circular shape. It may be appreciated that cylindrical shafts may alternatively have an elliptical, oval or oblong cross-section. Theshaft20 has an outer diameter in the range of about 5 to 25 mm, preferably approximately 14 mm. Theshaft20 has awall21 with a thickness in the range of about 0.5 to 5 mm, preferably about 2-3 mm, defining an innercentral lumen23. Within thewall21 lies various pushwires orpullwires96, hereinafter referred to as pullwires, for steering themain body10 which may be present in a variety of quantities and arrangements. Alternatively, thepullwires96 may be present within thecentral lumen23. At least onearm guide lumen26, two are shown, extend through thecentral lumen23. Eacharm guide lumen26 has an inner diameter in the range of about 0.5 to 5 mm, preferably about 4 mm. Positioned within thelumens26 are theshafts36 of thetool arms30. And, likewise, positioned within theshafts36 are thetools40. FIG. 2A also illustrates thescope lumen24 which has an inner diameter in the range of about 2 to 10 mm, preferably about 4 mm. In this embodiment, the twoarm guide lumens26 and thescope lumen24 are arranged in a generally triangular pattern which is maintained to thedistal tip16, however any suitable arrangement may be used which allows viewing of the tool arms, particularly the end effectors, by the scope. For example, FIG. 2B illustrates a cross-section of an embodiment wherein theshaft20 has an oval shape and thearm guide lumens26 and thescope lumen24 are generally aligned. Here, thescope lumen24 is disposed between thearm guide lumens26 to facilitate viewing of thetool arms30. Also illustrated in FIGS. 2A and 2B are additional lumens which may be used for various needs. For example, an irrigation/suction lumen60, aninsufflation lumen56 and anauxiliary lumen58 may be present, each having an inner diameter in the range of about 0.5 to 5 mm, preferably about 2 mm. Theauxiliary lumen58 may be utilized for a variety of uses, such as insertion of additional tools, such as a macerator, a grasping tool, a cutting tool or a light source, to name a few, for use in conjunction with the end effectors present at the distal ends of thearms30 or the distal ends of thetools40 inserted through thearms30.
• FIGS.[0088]3A-3D illustrate a series of movements of the steerable distal ends34 of thetool arms30. This series serves only as an example, as a multitude of movements may be achieved by the distal ends34 independently or together. FIG. 3A illustrates thedistal tip16 of themain body10. Thescope lumen24 is shown along with twoarm guide lumens26 terminating at thedistal tip16 and forming a triangular pattern as illustrated in FIG. 2A. FIG. 3B illustrates the advancement of the distal ends34 of thetool arms30 through thearm guide lumens26 so that thearms30 extend beyond thedistal tip16. FIGS.3C-3D illustrate deflection of thearms30 to a preferred arrangement. FIG. 3C illustrates deflection of thearms30 laterally outward. This is achieved by curvature in the outward direction near thebase64 of the steerabledistal end34. FIG. 3D illustrates deflection of thetip section66 of thedistal end34 laterally inward achieved by curvature in the inward direction so that eacharm30 forms a hook shape. By facing thetip sections66 of thearms30 toward each other as shown, thetip sections66 are positioned directly in the path of thescope lumen24. Therefore, when ascope28 is positioned within thescope lumen24, thetip sections66 of thetool arms30 and anytools40 advanced therethrough, will be visible through thescope28. In FIGS.3C-3D, deflection of thearms30 is achieved with the use ofadjacent links62 in the areas of desired curvature. Embodiments ofsuch links62 and other mechanisms of deflection will be discussed in later sections. Further, the deflection of FIGS.3A-3D are shown to be within a single plane. However, various embodiments include deflection in multiple planes. Likewise, thearms30 are shown to be deflected simultaneously in FIGS.3A-3D, however thearms30 may be deflected selectively or independently.
• FIGS.[0089]4-6 illustrate additional possible movements of thetool arms30. For example, FIG. 4 illustrates axial movement of thetool arms30. Eachtool arm30 can independently move distally or proximally, such as by sliding within thetool deployment lumen38, as indicated by arrows. Such movement maintains thearms30 within the same plane yet allows more diversity of movement and therefore surgical manipulations. FIG. 5 illustrates rotational movement of thetool arms30. Eachtool arm30 can independently rotate, such as by rotation of thearm30 within thetool deployment lumen38, as indicated by circular arrow. Such rotation moves thearm30 through a variety of planes. By combining axial, lateral and rotational movement, thearms30, and therefore thetools40 positioned therethrough, may be manipulated through a wide variety of positions in one or more planes.
• FIG. 6 illustrates further articulation of the[0090]tool arms30. In some embodiments, thearms30 are deflectable to form a predetermined arrangement, such as illustrated in FIG. 3D. Typically, when forming the predetermined arrangement, thearms30 are steerable up until the formation of the predetermined arrangement wherein thearms30 are then restricted from further deflection. In other embodiments, the arms are deflectable to a variety of positions and are not limited by a predetermined arrangement. Such an embodiment is illustrated in FIG. 6 wherein thearms30 articulate so that thetip sections66 curl inwardly toward thedistal tip16 of themain body10. Again, thetip sections66 are positioned in front of thescope lumen24 andscope28 for viewing. Typically, the tip sections66aare positioned on opposite sides of acentral axis31 of thescope28, wherein the field of view (indicated by arrow29) spans up to approximately 140 degrees, approximately 70 degrees on each side of thecentral axis31. In addition, the depth of field is typically in the range of approximately 1-10 cm.
• As mentioned previously, the endoluminal[0091]tool deployment system2 of the present invention may be used to access a various internal tissues or organs to perform a wide variety of surgical procedures. FIGS.7A-7B illustrate the use of an embodiment of thesystem2 to perform a mucosectomy, or removal of a portion of the mucosa and/or submucosa of the stomach. FIG. 7A illustrates advancement of themain body10 through the esophagus E to the stomach S. Themain body10 is then steered to a desired position within the stomach S and the stomach mucosa M is visualized through thescope28 at thedistal tip16. Referring to FIG. 7B, thetool arms30 are then advanced through themain body10 and articulated. As mentioned,tools40 may be advanced through thetool arms30 or anend effector48 may be disposed at the distal end of eacharm30. Here, agrasper80 is disposed at the distal end of onearm30 and a cutter81 is disposed at the distal end of theother arm30. Thegrasper80 is used to grasp a portion of the mucosa M. The grasped portion of mucosa M can then be elevated by rotation or manipulation of thetool arm30. This allows safe resection of the portion of mucosa M by cutting with the use of thecutter82, as shown. Manipulation and resection of the tissue is visualized throughout the procedure through thescope28 which is aligned with thetip sections66, and therefore endeffectors48.
• It may be appreciated that the systems, methods and devices of the present invention are applicable to diagnostic and surgical procedures in any location within a body, particularly any natural or artificially created body cavity. Such locations may be disposed within the gastrointestinal tract, urology tract, peritoneal cavity, cardiovascular system, respiratory system, trachea, sinus cavity, female reproductive system and spinal canal, to name a few. Access to these locations may be achieved through any body lumen or through solid tissue. For example, the stomach may be accessed through an esophageal approach, the heart through a port access approach, the rectum through a rectal approach, the uterus through a vaginal approach, the spinal column through a port access approach and the abdomen through a port access approach.[0092]
• A variety of procedures may be performed with the systems and devices of the present invention. The following procedures are intended to provide suggestions for use and are by no means considered to limit such usage: Laryngoscopy, Rhinoscopy, Pharyngoscopy, Bronchoscopy, Sigmoidoscopy (examination of the sigmoid colon, the sigmoid colon is the portion that connects the descending colon to the rectum; primarily for diagnostic purposes, however a biopsy procedure and trans anal micro surgery may be performed for removing tumors), Colonoscopy (examination of colon; for the removal of polyps and tumors or for biopsy), and Esophagogastroduodenoscopy (EGD) which enables the physician to look inside the esophagus, stomach, and duodenum (first part of the small intestine). The procedure might be used to discover the reason for swallowing difficulties, nausea, vomiting, reflux, bleeding, indigestion, abdominal pain, or chest pain.[0093]
• In addition, endoscopic retrograde cholangiopancreatography (ERCP) may be achieved which enables the surgeon to diagnose disease in the liver, gallbladder, bile ducts, and pancreas. In combination with this process endoscopic sphincterotomy can be done for facilitating ductal stone removal. ERCP may be important for identification of abnormalities in the pancreatic and biliary ductal system. Other treatments include Cholecystectomy (removal of diseased gallbladder), CBD exploration (for common bile duct stones), appendicectomy.(removal of diseased appendix), hernia repair TAP, TEPP and other (all kinds of hernia), fundoplication and HISS procedures (for gastro esophageal reflux disease), repair of duodenal perforation, gastrostomy for palliative management of late stage upper G.I.T. carcinoma), selective vagotomy (for peptic ulcer disease), splenectomy (removal of diseased spleen), gastric restrictive and malabsorbtive procedures (for morbid obesity), upper and lower G.I. endoscopies (diagnostic as well as therapeutic endoscopies), pyloroplastic procedures (for children's congenital deformities), colostomy, colectomy, adrenalectomy (removal of adrenal gland for pheochromocytoma), liver biopsy, gastrojejunostomy, subtotal liver resection, gastrectomy, small intestine partial resections (for infarction or stenosis or obstruction), adhesions removal, treatment of rectum prolaps, Heller's Myotomy, devascularization in portal hypertension, attaching a device to a tissue wall and local drug delivery to name a few.[0094]
• II Main Body[0095]
• As mentioned previously, the[0096]system2 of the present invention includes an elongatedmain body10 having aproximal end12 and adistal end14 terminating in adistal tip16. Themain body10 may have a variety of features which are present in a variety of combinations. Generally, the features include deflectability, steerability, torqueability, lockability, lumens for the passage of visualization elements, tool arms, and/or instruments, and integral visualization elements, tool arms, and/or instruments, to name a few. In addition, the main body may have any of these features throughout any portion of the main body, including the entire length of the main body or individual subportions.
• One embodiment of the[0097]main body10 is illustrated in FIGS.8A-8C,9A-9D. In this embodiment, themain body10 includes deflectability and/or steerability and lumens for the passage of visualization elements, tool arms, and/or instruments, such asscope lumen24. FIG. 8A illustrates the main body in a straight configuration. Since themain body10 is used to access an internal target location within a patient's body, themain body10 has a deflectable and/orsteerable shaft20. Thus, FIG. 8B illustrates themain body10 having various curvatures in its deflected or steered state. In preferred embodiments, themain body10 is steerable so that themain body10 may be advanced through unsupported anatomy and directed to desired locations within hollow body cavities. In some embodiments, themain body10 includes afirst section90 which is proximal to asecond section92, as indicated in FIG. 8B. Although bothsections90,92 are steerable, thefirst section90 may be locked in place while thesecond section92 is further articulated. This is illustrated in FIG. 8C, wherein thefirst section90 is shown in a locked position unchanged from FIG. 8B and thesecond section92 is shown in various retroflexed positions. In retroflexion, thesecond section92 is curved or curled laterally outwardly so that thedistal tip16 is directed toward theproximal end12 of themain body10. Optionally, thesecond section92 may also be locked, either in retroflexion or in any other position.
• Steering and locking may be achieved by any suitable mechanisms. In some embodiments, the[0098]shaft20 comprises a multiplicity ofnestable elements260, as illustrated in FIG. 9A. FIG. 9B provides an exploded view of thenestable elements260 of FIG. 9A. Here it can be seen that theelements260 are disposed so that adistal surface262 of oneelement260 coacts with aproximal surface264 of an adjacent element. Each of thenestable elements260 includes one or morepullwire lumens98 through which pullwires96 pass. Thepullwires96 are used to hold theelements260 in nesting alignment and to provide steering and locking. Thepullwires98 preferably are made from a superelastic material, e.g. nickel titanium alloy, to provide flexibility, kink-resistance and smooth movement of thepullwires96 through thepullwire lumens98. Alternatively, thepullwires96 may be made from braided stainless steel, a single stainless steel wire, poly-para-phenylene terephthalamide (such as Kevlar®), a high tensile strength monofilament thread, combinations thereof or any suitable materials.
• Generally, the[0099]adjacent surfaces262,264 are contoured to mate so that when thepullwires96 are relaxed, surfaces262,264 can rotate relative to one another. This allows theshaft20 to form curvatures throughout its length in any direction. Eachpullwire96 is fixed at its distal end to aspecific element260 along theshaft20 or to thedistal tip16. When tension is applied to aspecific pullwire96, a curvature forms in theshaft20 proximal to the fixation point, thus steering theshaft20. Thepullwires96 may be arranged in various patterns to achieve steering in various directions. For example, FIG. 9C is a cross-sectional view of theshaft20 in thefirst section90 of FIG. 8B. Here, eight pullwires96 (fourpullwires96aand fourpullwires96b) are shown passing through thewall21. Fourpullwires96aterminate at the distal end of thefirst section90 and are used to steer thefirst section90. Since the pullwires96aare equidistantly positioned, applying tension to the pullwires96a, either individually or in combination, steers thefirst section90 in any desired direction. Thefirst section90 may be locked in place by holding the tension in the pullwires96ausing any suitable mechanisms. For example, tension may be applied to thepullwires96 simultaneously until theelements260 are compressed to a state in which they are locked by friction wherein the tension is held.
• FIG. 9D is a cross-sectional view of the[0100]shaft20 in thesecond section92 of FIG. 8B. Here, fourpullwires96bare shown passing through thewall21. Thesepullwires96bextended through thefirst section90, as indicated in FIG. 9C, and terminate near thedistal tip16. Since thepullwires96bare equidistantly positioned, applying tension to thepullwires96b, either individually or in combination, steers thesecond section92 in any desired direction. Since thepullwires96balso pass through thefirst section90, such steering may also effect the curvature in thefirst section90 when the first section is not locked. However, such effects are minimal, may be counteracted or compensated for by steering in thefirst section90, and may be avoided by locking. Thesecond section92 may be also be locked in place by holding the tension in thepullwires96busing any suitable mechanisms.
• In this embodiment, the[0101]wall21 extends continuously from theproximal end12 to thedistal end14 with the first andsecond sections90,92 determined by the termination points of thepullwires96 which extend therethrough. Alternatively, the first andsecond sections90,92 may be comprised of separate shafts which are coaxially positioned adjacent to one another.
• In the embodiment illustrated in FIG. 9B, the[0102]nestable elements260 have acentral lumen23 which passes through the length of themain body10. Instruments or tools may be passed through thislumen23, as indicated in FIGS.9C-9D, or tubes may be present within thelumen23 through which instruments or tools may be passed. In preferred embodiments, thenestable elements260 have holes formed therein so that lumens are formed by alignment of the holes when theelements260 are stacked. For example, FIG. 9E provides a cross-sectional view of anestable element260 illustrating the holes formed therein which serve as lumens. As shown, ascope lumen24,arm guide lumens26, andauxiliary lumens58 extend through the center of theelement260 whilepullwire lumens98 are located around the periphery.
• It may be appreciated that[0103]pullwire lumens98 may also extend through the center of theelement260. For example, FIG. 10A illustrates an embodiment having a pullwire96 which extends through the center of the stackednestable elements260. FIG. 10A provides an exploded view of thenestable elements260 wherein theelements260 are disposed so that adistal surface262 of oneelement260 coacts with aproximal surface264 of an adjacent element. As shown, each of thenestable elements260 includes apullwire lumen98 through its center. FIG. 10B provides a cross-sectional view of anestable element260 of FIG. 10A. As shown, thenestable element260 includes a lockingpullwire lumen98chaving a pullwire96ctherethrough in the center of theelement260 surrounded by various other lumens, such as ascope lumen24,arm guide lumens26,auxiliary lumen58 and variouspullwire lumens98 used for steering. Once theelements260 are positioned in a desired arrangement, theshaft20 may be locked in place by thecentral pullwire96c. Applying tension to thepullwire96ccompresses theelements260 to a state in which they are locked by friction wherein the tension is held.
• In addition,[0104]liners266 may be passed through any of the lumens of the stackednestable elements260.Such liners266 form create a continuous lumen connecting the lumen holes of thenestable elements260. FIG. 1C illustrates thenestable elements260 of FIG. 10A with the inclusion ofliners266 passing through, for example, thearm guide lumens26. Likewise, FIG. 10D provides a cross-sectional view of anestable element260 of FIG. 10C. Here,liners266 are shown positioned through thenestable element260 forminglumens24,26,58 therethrough. It may also be appreciated thatliners266 may extend throughpullwire lumens98 as well. Theliners266 may be coated on their luminal surface with a hydrophilic coating for reducing friction or theliners266 may be comprised of a lubricious polymer such as Teflon®, fluoroethylene polymer (FEP) or the like.
• As mentioned previously, it may be appreciated that the[0105]shaft20 of themain body10 may have a variety of structures to provide features such as deflectability, steerability, torqueability, lockability, visualization and various tools, etc. Exemplary embodiments of structures which provide deflectability, steerability and or lockability are described above and provided in co-pending U.S. patent application Ser. No. 10/281,462 filed Oct. 25, 2002, which is a continuation in part of U.S. patent application Ser. Nos. 10/173,203, 10/173,227, 10/173,238 and 10/173,220, all of which were filed on Jun. 13, 2002 and herein incorporated by reference for all purposes. Also of interest and incorporated by reference for all purposes are co-pending U.S. patent application Ser. Nos. 10/281,461 and 10/281,426 each filed on Oct. 25, 2002. It is understood that lockablility includes locking the main body in a desired configuration to maintain one or more curvatures along its length. Thus, in these instances the main body is shape lockable. Structures which provide torqueability will be described in later sections, however it is understood that these features are applicable to any of the embodiments described herein.
• In addition, it may be appreciated that the[0106]main body10 may be comprised of a traditional endoscope or laparoscope. Exemplary embodiments of traditional endoscopes are provided in U.S. Pat. Nos. 3,948,251; 4,036,218; 4,201,198; 4,224,929; 4,988,171; 5,020,539; 5,035,231; 5,068,719; 5,170,775; 5,172,225; 5,187,572; and 5,196,928, all of which are herein incorporated by reference for all purposes. FIG. 10E illustrates theshaft20 of themain body10 comprising atraditional endoscope650, or other endoscope, which includes a visualizingelement652 and at least onelight source654. In this embodiment, theendoscope650 includes twoarm guide lumens26 for the passage oftool arms30. Thetool arms30 each haveend effectors48, as shown, ortools40 which haveend effectors48 may be advanced through atool deployment lumen38 in eacharm30. FIG. 10F provides a cross-sectional view of theshaft20 of FIG. 10E. FIG. 10G illustrates theshaft20 of themain body10 comprising a plurality of steerable and/or lockablenestable elements260 and atraditional endoscope650, or other endoscope, passing therethrough which includes a visualizingelement652 and at least onelight source654. Theendoscope650 may be advanceable and/or retractable through anendoscope lumen656 in theshaft20 of themain body10 or may be fixed within theshaft20. Theendoscope650 may be positioned so that adistal end658 of theendoscope650 is flush with thedistal tip16 of theshaft20 or is disposed at any position along theshaft20 including extending beyond thedistal tip16, as shown. FIG. 10H provides a cross-sectional view of FIG. 10G. Here, thewall21 of theshaft20 is more clearly visible includingpullwires96 for steering and/or locking. Further, theshaft20 of themain body10 may include one or morearm guide lumens26 for the passage oftool arms30, as shown in FIG. 101. Thetool arms30 each haveend effectors48, as shown, ortools40 which haveend effectors48 may be advanced through atool deployment lumen38 in eacharm30. FIG. 10J provides a cross-sectional view of FIG. 10I.
• FIG. 10K illustrates the[0107]shaft20 of themain body10 having an integral orintegrated visualizing element652 and at least onelight source654. Again, theshaft20 comprising a plurality ofnestable elements260 for steering and/or locking. Optionally, theshaft10 may also include alumen660, illustrated in FIGS.10M-10N, for passage of a variety of tools, instruments or devices therethrough, includingtool arms30. Or, as shown in FIG. 10O, theshaft20 having an integral visualizing element and at least onelight source654 may have individualarm guide lumens26 for the passage oftool arms30. It may also be appreciated that thetool arms30 of FIG. 10O may alternatively be fixed or integral with theshaft20.
• The visualizing[0108]elements652 of any of the embodiments include elements which transmit and/or detect a visual image. For example, such visualizingelements652 may include a coherent fiber optic bundle, an ultrasound device, and/or charge coupled devices (CCD) for operation in the visible spectrum of electromagnetic radiation, the infrared spectrum of electromagnetic radiation, the ultraviolet spectrum of electromagnetic radiation, and/or the x-ray spectrum of electromagnetic radiation.
• III Tool Arms[0109]
• As mentioned previously,[0110]system2 also includes at least onetool arm30, eacharm30 of which is insertable through a separatearm guide lumen26 in themain body10. As shown in FIG. 11, eachtool arm30 has aproximal end32, adistal end34 and ashaft36 therebetween. Thedistal end34 is steerable, such as by manipulation ofadjacent links62 as schematically indicated. Such stecrability may optionally be controlled by asteering cuff35, disposed within theproximal end32. Eachtool arm30 additionally includes atool deployment lumen38 therethrough.
• A. Distal End[0111]
• FIGS.[0112]12A-12B illustrate an embodiment ofadjacent links62 disposed at thedistal end34 to allow steerability of thearm30. Here, links62 are pivotally connected byhinge structures100. As shown in FIG. 12A, thelinks62 are shaped so that connection by thehinge structures100 createsgaps102 between thelinks62 directly opposite to thehinge structures100. Apullwire96 is shown extending through thelinks62 and terminating at afixation point104. Referring now to FIG. 12B, retraction of thepullwire96 draws thelinks62 together, minimizing thegaps102 between thelinks62. Due to the shape and arrangement of thelinks62, this movement creates a curve in thearm30 as shown. Thedistal end34 may be steered to have any curvature between substantially straight and a maximum curvature wherein thegaps102 are completely closed or another limiting feature is established. In some embodiments, up to 360 degree curvature of thedistal end34 is possible. Thedistal end34 may be returned to a straightened position by advancement of thepullwire96 or by the presence of a spring which will straighten thedistal end34 by recoil force.
• FIGS.[0113]13A-13B illustrate a similar embodiment ofadjacent links62 disposed at thedistal end34 to allow steerability of thearm30. Again, links62 are pivotally connected byhinge structures100. However, as shown in FIG. 13A, thelinks62 are shaped so that connection by thehinge structures100 createsgaps102 between thelinks62 on both sides of thehinge structures100. Apullwire96 is shown extending through thelinks62 and terminating at afixation point104. Referring now to FIG. 13B, retraction of thepullwire96 draws thelinks62 together, minimizing thegaps102 between thelinks62 along thepullwire96 and maximizing thegaps102 on the opposite side of thehinge structures100. Due to this shape and arrangement of thelinks62, this movement creates a curve in thearm30 as shown. Thedistal end34 may also be returned to a straightened position by advancement of thepullwire96 or by the presence of a spring which will straighten thedistal end34 by recoil force. However, in this embodiment, thedistal end34 may be deflected or curved in the opposite direction by continued advancement of thepullwire96. Advancement of thepullwire96 minimizes thegaps102 on the opposite side of thehinge structures100 causing a curvature in the opposite direction. Likewise, a spring may be present to straighten thedistal end34 from a curvature in this opposite direction.
• FIG. 14 illustrates an embodiment similar to the embodiment illustrated in FIGS.[0114]13A-13B. Thelinks62 are shown pivotally connected byhinge structures100. Here thehinge structures100 comprise pivot pins106 which are arranged in parallel to limit deflection to a single plane. In some embodiments, the hinge structures comprise male and female bearing surfaces which define axes, wherein the axes are disposed in parallel to limit deflection of the distal section to within the single plane. Thelinks62 are shaped so that connection by the pivot pins106 createsgaps102 between thelinks62. Closure of thegaps102 on one side of the pivot pins106 simultaneously opens gaps on the other side of thepins106. FIG. 14 also illustrates anend effector48 of atool40 which has been advanced through thetool deployment lumen38 of thearm30.
• FIG. 15 illustrates examples of possible deflections or movements of the[0115]tool arms30. Here, twoarms30 are shown emerging from thedistal tip16 of the elongatedmain body10. Thedistal end34 of eacharm30 is steerable and comprised of a plurality ofadjacent links62. Thearm30 on the left is shown steered to a position wherein thetip section66 is curled inwardly forming an almost complete circular shape. In contrast, thearm30 on the right is shown steered to a position wherein thetip section66 is deflected slightly inwardly forming an arc shape. Thus, thearms30 may be independently steerable to varying degrees of curvature. Preferably, thearms30 are steerable inwardly to perform surgical procedures in cooperation and to maintain visibility through the centrally located scope.
• FIGS.[0116]16A-16B illustrate another embodiment of atool arm30 comprising a plurality ofadjacent links62. Here, thelinks62 are comprised ofdisks110 having faces which are angled to formgaps102 between thedisks110 when thedisks110 are stacked. Thedisks110 are connected by one or more wires orribbons112. In this embodiment, illustrated in FIG. 16B, tworibbons112 are present, each at diametrically opposite positions within the wall of each of the stackeddisks110 so that the angled faces are aligned between theribbons112. Theribbons112 may be embedded in the wall, co-molded with the stacked disks or simply advanced through a lumen in the wall. Theribbons112 maintain relative position of thedisks110 and stabilize the steerabledistal end34 to be deflectable in only a single plane. Also shown in FIG. 16B,lumens114 are present between theribbons112 for positioningpullwires96 therethrough. Thepullwires96 pass through the angled portions of thedisks110 so that application of tension to apullwire96 draws the angled faces of thedisks110 together to close thegaps102 therebetween. This in turn widens the diametricallyopposite gaps102 creating curvature in the stack.
• As mentioned previously, in some embodiments, the[0117]arms30 are deflectable to form a predetermined arrangement, such as previously illustrated in FIG. 3D. Typically, when forming the predetermined arrangement, thearms30 are steerable up until the formation of the predetermined arrangement wherein thearms30 are then restricted from further deflection. FIG. 17 illustrates an embodiment of such anarm30 comprising a plurality ofadjacent links62 wherein thearm30 is steerable to a predetermined arrangement. As shown, thedistal end34 comprises a base64 which deflects thedistal end34 outwardly and atip section66 which deflects inwardly. Between thebase64 andtip section66 lies aspacer68 which is rigid. Thespacer68 may be considered a larger elongate link or simply a straight section. Usage ofsuch spacers68 is optional and may be used to create specific predetermined arrangements. FIG. 17A is an enlarged view of thetip section66 which illustrates the shapes of thelinks62 which are pivotally connected byhinge structures100 formed into thelinks62.Gaps102 are present on opposite sides of thestructures100 to allow curvature of thedistal end34. The size of thegaps102 will vary due to varying sizes and shapes of thelinks64 so that closure of thegaps102 forms a specific curvature. This is most easily seen in FIGS.17B-17C. FIG. 17B illustrateslinks62 of the base64 having varying shapes to creategaps102 of varying size. As shown, apullwire96 extends through thelinks62 along thegaps102. Applying tension to thepullwire96 draws thelinks62 together to close thegaps102 and to form a predetermined curve as in FIG. 17C.
• The predetermined arrangement of FIG. 17 includes curvatures in opposite directions, the base[0118]64 curving laterally outwardly and thetip section66 curving laterally inwardly. These distinct curvatures may be achieved byseparate pullwires96. For example, as shown in FIG. 18A, afirst pullwire97amay be positioned along one side of thetool arm30 terminating at afixation point104alocated midway along thedistal end34. Thelinks62 which lie proximally of thisfixation point104aform thebase64. Asecond pullwire97bmay be positioned along the opposite side of thearm30 terminating at afixation point104blocated at the tip of thedistal end34. Generally, thelinks62 which lie between thefixation point104aand thefixation point104bform thetip section66. Referring now to FIG. 18B, by applying tension to thefirst pullwire97a, the base curves laterally outwardly, and by applying tension to thesecond pullwire97b, the tip section curves laterally inwardly.
• FIG. 19 illustrates two[0119]tool arms30 which are steered to a predetermined arrangement. Such steering is achieved with the use ofpullwires96 as illustrated in FIGS.18A-18B. Fixation points104bare visible while fixation points104aare hidden within thearms30. As shown, thelinks62 are varied in size and shape to form this arrangement when tension is applied to thepullwires96. For example, thelinks62 are generally larger thought thebases64 and smaller through thetip sections66. Further, this embodiment includesstabilizers120 which pass through thearms30 for stability.
• In some embodiments, the steerable[0120]distal end34 includes both types of links, links which are steerable to a predetermined arrangement and links which are unrestrictedly steerable. For example, FIG. 20 illustrates an embodiment wherein thebase64 is comprised oflinks62 which are appropriately shaped and sized to deflect laterally outwardly to form a predetermined arrangement. Such deflection is achieved with a pullwire which is hidden from view and terminates midway along thedistal end34. In this embodiment, thetip section66 is comprised oflinks62 which are appropriately sized and shape to deflect laterally inwardly in an unrestricted fashion. Thelinks62 of thetip section66 are hinged together bypivot pins106 to provide support throughout the unrestricted movement. In addition, atool40 having anend effector48 is shown passed through thetool deployment lumen38 in thearm30. Also shown in FIG. 20, thearms30 are rotated to lie in different planes, a feature which has been described in previous sections.
• It may be appreciated that the embodiments which include links may have any number of links. For example, the steerable[0121]distal end34 may have twolinks62 which are hinged together by ahinge structure100. In this example, theshaft36 would direct thefirst link62 in a first direction and thehinge structure100 would turn thedistal tip16 towards a second direction. The addition ofmore linkages62 would create a smoother curve and/or allow multiple curves throughout the steerabledistal end34.
• Although the previous embodiments of the[0122]tool arms30 have been comprised of a plurality of adjacent links, it may be appreciated that thearms30 may be comprised of material in any suitable form. For example, eacharm30 may be comprised of a polymeric tube which has been pre-shaped, such as by heat setting, to form a desired curvature. The polymeric tube is comprised of a material which is sufficiently flexible to allow straightening of the curve for delivery through thearm guide lumen26 and adequately flexible to allow recoiling of thearm30 to form the desired curvature upon emergence from thelumen30.
• In another embodiment, each[0123]arm30 is comprised of a slotted tube, as illustrated in FIGS.21A-21B. Referring to FIG. 21A, atube130 has a series ofslots132 along its length. In this embodiment, theslots132 are present along one side of thetube130 however, it may be appreciated that theslots132 may be present on both sides of the tube or along any portion of the tube which is desired to deflect. Referring back to FIG. 21A, thepullwire96 is positioned within the tube along theslots132 and fixed to thetube130 at afixation point104. By applying tension to thepullwire96, thetube130 is deflected toward thepullwire96 as shown in FIG. 21B. The presence of theslots132 allows thetube130 to be comprised of a relatively rigid or thick material while deflecting and curving with minimal buckling or impedance by thetube130. It may be appreciated that thetube130 of FIGS.21A-21 B may alternatively be a solid-walled tube without slots comprised of a thinner or more flexible material which itself allows deflection and curvature with minimal buckling or impedance. Further, each of the following embodiments illustratingvarious tool arms30 may be comprised of solid-walled or slotted tubes, or any other suitable tube construction.
• FIGS.[0124]21C-21D illustrate an embodiment of thearm30 comprised of atube130 wherein apullwire96 is positioned on the outside of thetube130 and fixed to thetube130 at afixation point104. By applying tension to thepullwire96, thetube130 is deflected toward thepullwire96 as shown in FIG. 21D. Since thepullwire96 is disposed outside of thetube130, thepullwire96 forms a tether to thefixation point104 and does not follow along the surface of thetube130.
• FIGS.[0125]21E-21F illustrate an embodiment of thearm30 comprised of a polymer wall co-extruded with shape memory material, such as nitinol wire. FIG. 21E illustrates thearm30 in a straightened position, wherein thearm30 is passed through thearm guide lumen26, and a curved position, wherein thearm30 recoils to a shape-memory curve. FIG. 21F provides a cross-sectional view of thearm30 of FIG. 21E illustrating shape-memory material280 distributed within the wall of thearm30.
• FIGS.[0126]21G-21H illustrate an alternative mechanism for steering thetool arms30. Referring to FIG. 21G, theshaft20 of themain body10 is illustrated having a pair oftool arms30 extending therefrom. Surrounding thearms30 lies adeployment frame290. Theframe290 is comprised of a semi-rigid or rigid material, such as stainless steel wire, which provides sufficient strength to apply force to thearms30. Theframe290 comprises at least twosupports292, each extending from thedistal tip16 of theshaft20 and connecting at apeak294. Eachsupport292 attaches to atool arm30 at anattachment point296. Theframe290 also includes anactuation support298 extending from thedistal tip16 to thepeak294. Thearms30 and supports292,298 advance from thedistal tip16 of themain body10 to a desired location in the body in a straight configuration as illustrated in FIG. 21G. Referring to FIG. 21H, application of tension to theactuation support298 draws thepeak294 toward thedistal tip16 causing thesupports292 to bow or bend outward drawing the attachedarms30 outward. Likewise, thesupports292 may include hinges wherein thesupports292 would bend at the hinge. Although FIG. 21H illustrates thearms30 bending at the attachment points296, it may be appreciated that thearms30 may bend at any location. Such bending directs thetool deployment lumens38 toward each other to facilitate coordination of tools passed therethrough. Movement of thepeak294 proximally and distally varies the curvature of thearms30 and provides steering. Theframe290 also serves to create a working space, restricting surrounding tissue from encroaching on thearms30 andtools40.
• In most embodiments, the distal ends of the tool arms are lockable to maintain a deflected position. Such locking may be achieved by any suitable mechanisms. When the tool arm is steerable by manipulation of pullwires or pushwires, the wires may be held in place to lock the distal end in a desired position. In embodiments comprising a multiplicity of nestable elements through which pullwires pass, the pullwires are typically used to hold the elements in nesting alignment and to provide steering and locking. By applying tension to the pullwires simultaneously, the elements may be compressed to a state in which they are locked by friction wherein the tension is held. Other locking mechanism may also be used. Further, the tool arms may be locked rotationally and axially within the main body to maintain positioning of the tool arm in relation to the main body.[0127]
• B. Shaft[0128]
• As described previously, the[0129]shaft36 of thetool arm30 passes though themain body10. In embodiments wherein themain body10 is deflectable, theshaft36 is also deflectable. However, although it is desired that theshaft36 be laterally deflectable, it is also desired that theshaft36 maintain axial rigidity. Any suitable construction may be used, including a braid reinforced torqueable tube. Additional embodiments are described below.
• FIGS.[0130]22A-22B illustrate embodiments of theshaft36 comprising acoil140. Here, illustrated in FIG. 22A, the turns of thecoil140 lie adjacent to each other to prevent axial movement and maintain axial rigidity. However, the coil configuration allows deflection of theshaft36 as shown in FIG. 22B.
• In another embodiment, illustrated in FIG. 23, the[0131]shaft36 comprises a plurality ofadjacent linkages150. Here, eachlinkage150 includes a pair of protrudingstructures152 on its face and a pair ofnotches154 on its base. The protrudingstructures152 andnotches154 are both arc shaped so that the protrudingstructures152 of onelinkage150 rotateably interfit with thenotches154 of an adjacentlystacked linkage150. By alternating the position of the pairs of protrudingstructures152 andnotches154 as shown in FIG. 23, theshaft36 is flexible in both lateral bending directions while maintaining stiffness axially and in torsion. Also shown are flaredlumens158 which pass through the protrudingstructures152 and the wall of theshaft36. Flaring allows for a rod or wire passed therethrough to move within thelumen158 as alinkage150 rotates over the protrudingstructure152. Roundpullwire lumens156 pass through thenotches154 and the wall of theshaft36 as shown. The rod or wire holds thelinkages150 in a stacked configuration and optionally may be used to steer theshaft36.
• In another embodiment, illustrated in FIG. 24, the[0132]shaft36 comprises a plurality ofadjacent linkages160 which are also stacked to provide lateral deflection while maintaining axial rigidity. Here, eachlinkage160 includes a pair of protrudingstructures162 on its face and a pair ofnotches164 on its base. The protrudingstructures162 andnotches164 are both arc shaped so that the protrudingstructures162 of onelinkage160 rotateably interfit with thenotches164 of an adjacentlystacked linkage160. By alternating the position of the pairs of protrudingstructures162 andnotches164 as shown in FIG. 24, theshaft36 is flexible in both lateral bending directions while maintaining stiffness axially and in torsion. In this embodiment, thelinkages150 include acentral lumen166 through which a rod or wire is passed. The rod or wire is used to hold thelinkages60 in the stacked configuration.
• C. Proximal End[0133]
• The[0134]proximal end32 of thetool arm30 may simply terminate in an endpiece or connector for passage of atool40 through itstool deployment lumen38. However, theproximal end32 may optionally include asteering cuff35 for steering thetool arm30, particularly for steering itsdistal end34.
• FIG. 25A illustrates an embodiment of the[0135]proximal end12 of themain body10 wherein twotool arms30 are present, each inserted through anarm guide lumen26 in theshaft20 of themain body10. As shown, eachtool arm30 includes asteering cuff35 which remains outside of themain body10 and thetool deployment lumen38 is accessible through thesteering cuff35. FIG. 25B illustrates an alternative embodiment of theproximal end12 wherein twotool arms30 are present, each inserted through anarm guide lumen26 through thehandle22 of themain body10. Again, eachtool arm30 includes asteering cuff35 which remains outside of themain body10 and thetool deployment lumen38 is accessible through thesteering cuff35. This embodiment also includes alocking mechanism170 on eacharm30. Thelocking mechanism170 can be manipulated, such as by turning alever172 shown in FIG. 25B, to lock thedistal end34 or thetool arm30 in a steered or deflected position.
• FIG. 26 illustrates an embodiment of a[0136]steering cuff35 disposed at theproximal end32 of atool arm30 wherein atool40 is passed therethrough. In this embodiment, thetool arm30 includes four pullwires96 (three are visible in FIG. 26) which are equidistantly positioned around the perimeter of theshaft36. Thepullwires96 are used to steer thedistal end34 of thearm30 as previously described. As shown, thetool40 has adistal end42 with anend effector48 which emerges from thedistal end34 of thearm30. Likewise, thetool40 has aproximal end44 which emerges from thesteering cuff35. In this embodiment, thesteering cuff35 has a funnel shape wherein one end is attached to at least thepullwires96 and typically additionally to thearm30 itself. Deflection of theproximal end44 of thetool40, indicated byangular arrow180, presses theproximal end44 against thesteering cuff35 which rotates thesteering cuff35 to a deflected position, indicated by dashed line. Such rotation applies tension to pullwires96 diametrically opposite to the deflected position as indicated byarrows182. Such tension steers thedistal end34 of thearm30. Thus, manipulation of thetool40 within thesteering cuff35 can be used to steer thedistal end34 of thearm30.
• FIGS.[0137]27A-27B and FIGS.28A-28B illustrate another embodiment of asteering cuff35. Here, thesteering cuff35 has a sphere shape and is disposed at theproximal end32 of thetool arm30. Thetool40 is passed through alumen184 in the sphere shapedcuff35 so that thedistal end42 of the tool emerges from thedistal end34 of thearm30 and theproximal end44 remains outside of thecuff35 as shown. In this embodiment, thetool arm30 includes four pullwires96 (three are visible) which are equidistantly positioned around the perimeter of theshaft36. Thepullwires96 are used to steer thedistal end34 of thearm30 as previously described. FIG. 27A illustrates thepullwires96 emerging from theshaft36 of thearm30 and attached to the surface of the sphere shapedcuff35. Likewise, FIG. 27B provides a similar view, however in this case thearm30 is cutaway to reveal thepullwires96 extending through lumens in theshaft36 and thetool40 extending through thetool deployment lumen38. FIG. 28A illustrates the embodiment in the straight position. Deflection of theproximal end44 of thetool40, indicated byangular arrow180, presses theproximal end44 against thesteering cuff35 which rotates thesteering cuff35 to a deflected position, as shown in FIG. 28B. Such rotation applies tension to pullwires96 diametrically opposite to the deflected position as indicated byarrow182. Such tension steers thedistal end34 of thearm30. Thus, manipulation of thetool40 within thesteering cuff35 can be used to steer thedistal end34 of thearm30.
• It may be appreciated that the embodiments of the[0138]steering cuff35 depicted in FIG. 26 and FIGS.27A-27B,28A-28B may include any number ofpullwires96 for any desired level of steerability. For example, in each embodiment, twopullwires96 may be present disposed on opposite sides of thesteering cuff35 for movement of the steerabledistal end34 of anarm30 in a single plane. This would be the case for laterally stabilizedarms30.
• IV. Tool[0139]
• As mentioned previously, the[0140]system2 also includes at least onetool40. In some embodiments, thetool40 may simply comprises anend effector48 positioned at the distal end of thetool arm30 wherein theend effector48 is operated by manipulation of mechanisms which extend through thearm30. In other embodiments, eachtool40 includes adistal end42, aproximal end44 and anelongate shaft46 therebetween to allow passage through thetool deployment lumen38 of thearm30. Theshaft46 is typically desired to be a torque-stable tube comprised of any suitable material, such as a braid or coil-reinforced extrusion. In these embodiments, eachtool40 has anend effector48 disposed at thedistal end42 and optionally ahandle50 at theproximal end44 for manipulation of theend effector48 from outside the body. Thus, thetool40 is advanced so that theend effector48 emerges from thedistal end34 of thearm30.
• A wide variety of[0141]end effectors48 may be used depending on the procedure or tissue manipulations which are desired. For example,end effectors48 may include but are not limited to knives, needles, sutures, staplers, fasteners, clippers, electrosurgical or hemostatic cutters and coagulators, laser welders, cryosurgery instruments, secondary scopes, forceps, lasers hooks, tongs, graspers, retractors, probes, clamps, scissors, tissue approximation devices and suction applicators.
• FIG. 29 illustrates an embodiment of a[0142]tool40 having anend effector48 in the form ofscissors200. Scissors are one of the oldest surgical instruments used by surgeons. Scissors are used to perform many tasks in open surgical procedure but its use in minimal access surgery requires greater skill. As shown, thescissors200 includes twoblades202, afulcrum204 andforce applicators206. The cutting force of thescissors200 works on the law of lever. The force applied on theblade202 can be calculated by length of theforce applicators206 and force applied on theapplicators206. Thescissors200 of thetool40 do not apply the exact law of lever because of the cylinder action of thelong shaft46, but the design ofapplicators206 helps in the amplification of force by lever action. When theblades202 of thescissors200 close, its sharp edges grind against each other and any tissue which comes between the blades of scissors will be cut.
• The[0143]scissors200 of FIG. 29 provide an example of straight scissors wherein the blades are straight. This is a widely used instrument for mechanical dissection in laparoscopic surgery. Other types of scissors includecurved scissors214, illustrated in FIG. 29A, wherein theblade202 of thescissors214 is slightly curved. In some cases curvedscissors214 are preferred because the curvature of theblade202 of this scissors creates additional angles of manipulation and may provide a better view through the scope. Other types of scissors includeserrated scissors216 whereinserrated edges218 prevent the tissue from slipping out of theblades202. This may be useful in cutting a slippery tissue or ligature. Still other types of scissors includehook scissors220 which encircle a tissue structure before cutting. Since the tissue is held between its hooked blades, there is minimal chance of slipping. Thehook scissor220 is especially useful for cutting secured ducts or arteries. Likewise, the cutting of nerve bundles in neurectomy becomes may benefit from the use ofhook scissors220.Hook scissors220 are also helpful in partial cutting of cystic ducts for intra-operative cholangiography. Further, additional types of scissors includemicrotip scissors222. One of the main advantages ofmicrotip scissors222 is to cut ducts partially for facilitating cannulation. Likewise, thisscissor222 may be used for cutting the cystic duct for performing intra-operative cholangiogram. Exploration of small ducts like common bile duct is very helpful withmicrotip scissors222 due to its fine small blades.Fine microtip scissors222 are also available in curved form.
• FIG. 30 illustrates an embodiment of a[0144]tool40 having anend effector48 in the form of gatortoothed graspers230. Thesegraspers230 have reverse angledteeth232 which are capable of providing an aggressive grip on tissue. In addition, thegraspers230 are cupped to allow tissue to herniated when the tissue is compressed. Thus, thegraspers230 may be useful for pelviscopy and handling fibrous ovaries and uterine tissue.
• FIG. 31 illustrates an embodiment of a[0145]tool40 having anend effector48 in the form of anarticulatable grasper236. Thegrasper236 includes anarticulation section238 betweengrasper jaws240 and theshaft46. This allows thegrasper236 to articulate in an additional degree of freedom relative totool arm30.
• Embodiments of the[0146]tool40 having anend effector48 may be in the form of various shaped retractors. Examples of such retractors include anangled retractor242, (FIG. 32), hooked retractors244 (FIGS.33-34), a triangular retractor246 (FIG. 35), and a circular retractor (FIG. 36), to name a few. Each retractor is flexible and allows for manipulation of organs and tissue structures.
• V. Auxiliary Lumens[0147]
• As mentioned previously, lumens in addition to the[0148]scope lumen24 and arm guidelumens26 may be present within themain body10 and may be consideredauxiliary lumens58.Such lumens58 may be used for any purpose, such as irrigation, suction, insufflation, macerating, illuminating, grasping, or cutting to name a few, and are typically used in conjunction with thearms30 and/ortools40 inserted through thearms30 or positioned at the ends of thearms30.
• In one embodiment, illustrated in FIG. 37A, grasping[0149]hooks310 are inserted through a single auxiliary lumen or through separate auxiliary lumens58 (shown) in theshaft20. The grasping hooks310 may be comprised of any suitable material, such as shape-memory wire or shapeable polymer, that allows a hook shape to be formed once thehooks310 have emerged from thedistal tip16. In addition, thehooks310 may have a pointed or sharp tip to assist in grasping or piercing tissue. Referring to FIG. 37B, the graspinghooks310 may be used to grasp a portion of tissue T to create a plication or fold. Thetool arms30 may then be extended on opposite sides of the folded tissue T to deploy afixation device312 which will hold the plication in place. FIG. 37C illustrates such afixation device312 comprising atie314 passing through the tissue T withanchors316 positioned on either side of the plication. Thetie314 may be comprised of a suture, wire or rod, for example, and theanchors316 may be comprised of knots, disks or expandable umbrellas, to name a few. Such plication procedures may be used for treating gastroesophageal reflux disease (GERD).
• Alternatively, other tools may be passed through[0150]auxiliary lumens58 for similar or other purposes. For example, a corkscrew device320 (FIG. 38) or a grasper claw322 (FIG. 39) may be passed through anauxiliary lumen58 for grasping tissue T. Or, tissue T may be grasped with a suction device. FIG. 40A illustrates a suction device324 in an undeployed configuration. The suction device324 comprises adeployment sleeve328 which houses anexpandable funnel326. Withdrawal of thedeployment sleeve328 releases thefunnel326 allowing thefunnel326 to self-expand, as shown in FIG. 40B. The increased surface area of thefunnel326 allows for adequate suction for grasping tissue T and holding the tissue T within thefunnel326.
• It may be appreciated that[0151]tools40 may alternatively be passed through anarm guide lumen26 for use in conjunction with atool arm30 passed through anotherarm guide lumen26. For example, as illustrated in FIG. 41, amacerator336 may be passed through anarm guide lumen26 for maceration of tissue T or a blood clot while atool arm30 is used for irrigation and aspiration. Themacerator336 macerates the tissue T to form small particles which may be more readily aspirated. Further, irrigation through thearm30 may be used to cleanse portions of the device. For example, as illustrated in FIG. 42, thearm30 may be steered to face thescope28 allowing irrigation to cleanse thescope28 thus improving viewing.
• VI Torque Transmission[0152]
• As mentioned previously, the[0153]system2 of the present invention includes an elongatedmain body10 having aproximal end12 and adistal end14 terminating in adistal tip16. An embodiment of themain body10 was illustrated in various configurations in FIGS.8A-8C utilizing steering and/or locking. Steering and locking may be achieved by any suitable mechanisms. In some embodiments, theshaft20 comprises a plurality of adjacent links, such asnestable elements260 illustrated in FIG. 9A. FIG. 9B provided an exploded view of thenestable elements260 of FIG. 9A, illustrating that theelements260 are disposed so that adistal surface262 of oneelement260 coacts with aproximal surface264 of an adjacent element. And, each of thenestable elements260 includes one or morepullwire lumens98 through which pullwires96 pass. Thepullwires96 are used to hold theelements260 in nesting alignment and to provide steering and locking. Generally, theadjacent surfaces262,264 are contoured to mate so that when thepullwires96 are relaxed, surfaces262,264 can rotate relative to one another. This allows theshaft20 to form curvatures throughout its length in any direction.
• In addition to steering with the use of[0154]pullwires96, themain body10 can be manipulated by torqueing. Typically, thedistal end14 of themain body10 is positioned within the body while theproximal end12 remains outside of the body. It is often desired to rotate thedistal end14 within the body by manually rotating theproximal end12. To achieve this effectively, themain body10 should be capable of effectively transmitting torque. To achieve this, particularly through portions of themain body10 which include adjacent links, such asnestable elements260, a torque transmitting feature may be included.
• One such torque transmitting feature is illustrated in FIGS.[0155]43A-43F. FIGS.43A-43F illustrate the use of a tooth and groove concept to maintain alignment of the plurality of adjacent links at locations along its length. By maintaining alignment in particular locations, torque may be more easily transmitted while still allowing freedom of rotation of the links for steering.
• FIG. 43A is a perspective view of one of the plurality of adjacent links, a[0156]first link500. Thefirst link500 has atop edge502, abottom edge504, anouter surface506 and aninner surface508 forming a domed ring-like structure having alumen505 therethrough.Pullwire lumens98 are shown passing through theinner surface508 and out through thetop edge502. It may be appreciated that thepullwire lumens98 may be used for other elements, such as support wires or rigidizing wires, however at least some of thepullwire lumens98 are used for passing pullwires96 for steering. Thefirst link500 also includes a torque transmitting feature comprising at least one protrusion, such as atooth510, which protrudes inward from theinner surface508 in this embodiment. Thetooth510 may have any suitable shape or size and may extend beyond theedges502,504. In this embodiment, thetooth510 has afirst tooth end512 and asecond tooth end514 wherein thefirst tooth end512 is flush with theinner surface508 and thesecond tooth end514 protrudes outwardly toward thebottom edge504 of thelink500 forming a wedge shape. The torque transmitting feature also includes at least onegroove516 in theouter surface506. Thegroove516 is sized, shaped and positioned so that when thefirst link500 is engaged with an adjacent link, thegroove516 in thefirst link500 accepts atooth510 on the adjacent link.
• In some embodiments, a pair of[0157]teeth510,510′ are present wherein onetooth510 is located in a diametrically opposite position from theother tooth510′. Likewise, a pair ofgrooves516,516′ are also present wherein onegroove516 is located in a diametrically opposite position from theother groove516′, or 180 degrees apart. Typically, the pair ofteeth510,510′ and pair ofgrooves516,516′ are located so that each are separated by approximately 90 degrees, as shown in FIG. 43A. FIG. 43B provides a side view and FIG. 43C provides a partial perspective view of the link of FIG. 43A.
• The[0158]first link500 is engageable with a series or plurality of additional links, each having the same or similar features as thefirst link500. Such a plurality of adjacent links is shown in FIG. 43D. Here, thefirst link500 is shown mated with asecond link520, athird link522, afourth link524 and afifth link526. Thelinks500,520,522,524,526 are each individually rotateable by steering, such as with the use ofpullwires96 as described in related earlier sections. FIG. 43E, illustrates four of theselinks500,520,522,524 wherein theouter surface506 of each link is mated with theinner surface508 of an adjacent link along alongitudinal axis530. Thefirst link500 is shown to have a pair ofteeth510,510′, onetooth510 disposed in a position along theinner surface508 which is diametrically opposite to theother tooth510′. The onetooth510 is slidably engageable with agroove516 in theouter surface506 of the adjacentsecond link520 and theother tooth510′ is slidably engageable with agroove516′ in a diametrically opposite position in theouter surface506. In this embodiment,groove516 has afirst groove end518 and asecond groove end519. The groove ends518,519 are substantially aligned with thelongitudinal axis530 to allow sliding of thetooth510 along thegroove516 during rotation of the link away from thelongitudinal axis530. Likewise, groove516′ has afirst groove end518′ and asecond groove end519′ in a similar arrangement.
• The[0159]second link520 also includes a pair ofteeth510,510′ which are each disposed 90 degrees from thegrooves516,516′. Therefore, only onetooth510 is visible in thesecond link520 since theteeth510,510′ aligned in the view of FIG. 43E, however it may be appreciated that each of the pair ofteeth510,510′ in thesecond link520 are slidably engaged with one of a pair ofgrooves516,516′ in thethird link522. Likewise, thethird link522 is shown to have a pair ofteeth510,510′, onetooth510 disposed in a position along theinner surface508 which is diametrically opposite to theother tooth510′. The onetooth510 is slidably engageable with agroove516 in theouter surface506 of the adjacentfourth link524 and theother tooth510′ is slidably engageable with agroove516′ in a diametrically opposite position in theouter surface506.
• Steering rotates at least some of the links away from the[0160]longitudinal axis530, such as illustrated in FIG. 43F. Here, thefirst link500 is shown rotated along anotheraxis532 which forms an angle with thelongitudinal axis530. Such rotation slides the onetooth510 on thefirst link500 downward along thegroove516 in thesecond link520 while theother tooth510′ slides upward along thegroove516′ in thesecond link520. Thus, thefirst link500 is free to rotate in this plane. It may be appreciated that each link is free to rotate in at least a plane defined by the alignment of teeth and grooves. When the position of such aligned teeth and grooves are varied along the length of the plurality of adjacent links, the links are able to rotate in various directions.
• In addition, torqueing of the plurality of adjacent links is transmitted through the aligned teeth and grooves. For example, by applying torque to the[0161]fourth link524, as indicated byarrow534 in FIG. 43F, thefourth link524 will rotate about thelongitudinal axis530 until one of thegrooves516′ contacts the slidably engagedtooth510′ which transmits the torque to thethird link522. This transmission is repeated through each of the links, transmitting torque to thefirst link500.
• Another embodiment of a torque transmitting feature is illustrated in FIGS.[0162]44A-44D. FIGS.44A-44D illustrate the use of a pin and slot concept to maintain alignment of the plurality of adjacent links at locations along its length. By maintaining alignment in particular locations, torque may be more easily transmitted while still allowing freedom of rotation of the links for steering. In addition, the pin and slot concept prevents disengagement of the adjacent links while the main body is unlocked. This further enhances torque transmission.
• FIG. 44A is a perspective view of one of the plurality of adjacent links, a[0163]first link500. Thefirst link500 has atop edge502, abottom edge504, anouter surface506 and aninner surface508 forming a domed ring-like structure having alumen505 therethrough. Although pullwire lumens are not shown, it may be appreciated that pullwire lumens may be present, for example passing through the inner surface and out through the top edge. It may also be appreciated that the pullwire lumens may be used for other elements, such as support wires or rigidizing wires, however at least some of the pullwire lumens are used for passing pullwires for steering. Thefirst link500 also includes a torque transmitting feature comprising at least one protrusion, such as apin550, which protrudes outward from theouter surface506. The torque transmitting feature also includes at least oneslot552, providing an opening between theinner surface508 and theouter surface506.
• In some embodiments, a pair of[0164]pins550,550′ are present wherein onepin550 is located in a diametrically opposite position from theother pin550′. Likewise, a pair ofslots552,552′ are also present wherein oneslot552 is located in a diametrically opposite position from theother slot552′, or approximately 180 degrees apart. Typically, the pair ofpins550,550′ and pair ofslots552,552′ are located so that each is separated by approximately 90 degrees as illuatrated.
• FIG. 44B provides a side view of the[0165]first link500 of FIG. 44A. Dimensions provided are related to an exemplary embodiment are not intended to be limiting. It may be appreciated that thepin550 may have any suitable shape or size and may be positioned anywhere along theouter surface506. In this embodiment, thepins550,550′ each have a cylindrical shape with a cross-sectional diameter of approximately 0.0325 in. and each is positioned near thetop edge502. Eachslot552 is sized, shaped and positioned so that when thefirst link500 is engaged with an adjacent link, aslot552 in thefirst link500 accepts apin550 on the adjacent link. Typically, eachslot552 is positioned near thebottom edge504, preferably 0.010 in. from thebottom edge504 as illustrated in FIG. 44B. Also illustrated in FIG. 44B, eachslot552 has afirst slot end554 and asecond slot end556, typically approximately 0.090 in. apart. The slot ends554,556 are substantially aligned with thelongitudinal axis530 to allow sliding of thepin550 through the slot during rotation of the link away from thelongitudinal axis530, as will be illustrated in FIGS.44C-44D.
• FIG. 44C illustrates the[0166]first link500 engaged with asecond link520 having the same or similar features as thefirst link500. Thelinks500,520 are each individually rotateable by steering, such as with the use of pullwires96 (not shown) as described in related earlier sections. As shown, theouter surface506 of each link is mated with theinner surface508 of an adjacent link along alongitudinal axis530. Thefirst link500 is shown to have a pair ofslots552,552′, oneslot552 which is visible in this view. Extending through the oneslot552 is apin550 which protrudes from theouter surface506 of the adjacentsecond link520. It may be appreciated that thesecond link520 also has anadditional pin550′ which passes throughslot552′.
• Steering rotates at least some of the links away from the[0167]longitudinal axis530, such as illustrated in FIG. 44D. Here, thefirst link500 is shown rotated along anotheraxis532 which forms an angle with thelongitudinal axis530. Such rotation slides onepin550 on thesecond link520 upward along theslot552 in thefirst link500 while anotherpin510′ slides downward along theslot552′ in thefirst link500. Thus, thesecond link520 is free to rotate in this plane. It may be appreciated that each link is free to rotate in at least a plane defined by the alignment of pins and slots. When the position of such aligned pins and slots are varied along the length of the plurality of adjacent links, the links are able to rotate in various directions.
• In addition, torqueing of the plurality of adjacent links is transmitted through the aligned pins and slots. For example, by applying torque to the[0168]second link520, thesecond link520 will rotate about thelongitudinal axis530 until one of the slots contacts the slidably engaged pin which transmits the torque to thefirst link500. This transmission may be repeated through any number of links, transmitting torque through a plurality of adjacent links.
• Another torque transmitting feature is illustrated in FIGS.[0169]45A-45C. FIGS.45A-45C illustrate the use of a torque transmitting covering over the plurality of adjacent links providing torque transmission therethrough while the links are rotateable. FIG. 45A illustrates an embodiment of the torque transmitting covering. In this embodiment, the covering570 comprises asheath576 havingreinforcements578 throughout.Such reinforcements578 are comprised of nylon, polyurethane, polyethylene, Teflon, metal, polymer or any suitable material and are typically braided or woven, however any arrangement of thereinforcements578 may be used. Thereinforcements578 may be dipped in a polymer dispersion in a suitable solvent to coat thereinforcements578. Such coating holds thereinforcements578 together in a desired arrangement suitable for torque transmission. Alternatively or in addition, thereinforcements578 may be sprayed, painted or otherwise coated with a polymer. Likewise, other methods of forming the covering570 may be used. It may also be appreciated that the covering570 may be formed withoutreinforcements578. The coating may also be an independent component that is draped over thereinforcements578.
• The covering[0170]570 may have any suitable size or shape, but is typically an elongate tube sized to fit snuggly around the plurality of adjacent links which are rotateable relative to each other when unlocked. Typically the covering570 has a wall thickness in the range of approximately 0.005 to 0.015 in., typically in the range of approximately 0.010 to 0.015 in. Snug fit of the covering around the adjacent links prevents the links from disengaging while allowing the links to rotate during steering. Thus, the covering570 may also be formed by dipping the adjacent links in a polymer dispersion to form a coating on the links.
• FIG. 45B illustrates the covering[0171]570 fit over a series or plurality of adjacent links (afirst link500,second link520,third link522,fourth link524 and fifth link526) wherein the outer surface of each link is mated with the inner surface of the adjacent link along alongitudinal axis530. Thelinks500,520,522,524,526 are each individually rotateable by steering, such as with the use ofpullwires96 as described in related earlier sections.
• Torqueing of the plurality of adjacent links is transmitted with the use of the[0172]covering570. For example, by applying torque to thefifth link526 and surrounding covering570, as indicated byarrow572 in FIG. 45C, thefifth link526 will rotate about thelongitudinal axis530 along with the surroundingcovering570. The torqueing force applied to the covering570 will be transmitted along the length of the covering570 from thefifth link526 toward thefirst link500. Since the covering570 is snuggly fit around the links, the links will maintain engagement, assisting in the transmission of torque. Thus, thefirst link500 will then rotate about thelongitudinal axis530, as indicated byarrow574, in response to the rotation of thefifth link526.
• Another torque transmitting feature is illustrated in FIGS.[0173]46A-46E. As mentioned, embodiments of the main body typically include a proximal end, a distal end and at least one lumen extending between the proximal and distal ends, at least a portion of the elongated main body comprising at least a first link and an adjacent second link which are rotateable relative to each other when unlocked. FIGS.46A-46D illustrate cross-sectional views of a link wherein one of the at least one lumen extending through the links has at least one partition. For example, referring to FIG. 46A, afirst link500 is shown havinglumen505 extending therethrough. Thelumen505 has twopartitions590, eachpartition590 having the form of an inward protrusion. Any number ofpartitions590 may be present, such as two, three, four, five, six, seven, eight or more. For example, FIG. 46B illustrates afirst link500 having alumen505 with fivepartitions590. In this example, thepartitions590 provide thelumen505 with a fluted shape. Thepartitions590 may have any shape, for example, blunt, pointed, rounded, or square, and may extend inwardly any distance. For example, FIG. 46C illustrates afirst link500 having alumen505 withpartitions590 which extend further into thelumen505 than in the embodiments of FIGS.46A-46B. Further, as illustrated in FIG. 46D, thepartitions590 may comprise at least onedivider592 spanning across thelumen505 of thelink500 formingsub-lumens594. In addition, also illustrated in FIGS.46A-46D, thelinks500 may also include other lumens, such as steering orpullwire lumens98 for the passage of pullwires used in steering.
• The[0174]partitions590 are used as a torque transmitting feature with the use of anelongated shaft600 passing through thelumen505, as illustrated in FIG. 46E. As shown, thefirst link500 is engageable with a plurality of adjacent links, such as asecond link520 andthird link522, each having the same or similar features as thefirst link500. In addition, thelinks500,520,522 are arranged so that thepartitions590 within each link are generally aligned. Theshaft600 passes through thelumen505 and is positioned betweenpartitions590 in each of the links. Torqueing of the plurality of adjacent links is transmitted through theshaft600 andpartitions590. For example, by applying torque to thefirst link500, thelink500 rotates about thelongitudinal axis530 until theshaft600 contacts apartition590. Since thepartitions590 are generally aligned, theshaft600 will also contactpartitions590 in thesecond link520 andthird link522. Therefore, torque is transmitted from thefirst link500 to thethird link522. This transmission may be repeated through any number of links, transmitting torque through a plurality of adjacent links.
• Another torque transmitting feature is illustrated in FIGS.[0175]47A-47B. As mentioned, embodiments of the main body typically include a proximal end, a distal end and at least one lumen extending between the proximal and distal ends, wherein at least a portion of the elongated main body comprises a plurality of adjacent links. FIG. 47A illustrates a section of adjacent links, including afirst link500, asecond link520 and athird link522, wherein the links have an oval cross-section. As mentioned previously, and illustrated in FIG. 2B, the links may have an oval shape for a variety of purposes, including providing for a desired arrangement of, for example, ascope28 andoptionally tool arms30 passing throughlumen505. The oval shape may also function as a torque transmitting feature. As shown in FIG. 47B, torqueing of thefirst link500 rotates thefirst link500 about thelongitudinal axis530, as indicated byarrows602. Thefirst link500 will contact thesecond link522 due to the oval shape, as shown. This will cause thesecond link522 to rotate, as indicated byarrows604. Thus, torque is transmitted to thesecond link522. This transmission may be repeated through any number of links, transmitting torque through a plurality of adjacent links.
• Another torque transmitting feature is illustrated in FIGS.[0176]48A-48C. As mentioned previously, embodiments of the main body typically include a proximal end, a distal end and at least one lumen extending between the proximal and distal ends, wherein at least a portion of the elongated main body comprises a plurality of adjacent links. A cross-sectional view of one of these adjacent links, such as thefirst link500, is shown in FIGS.48A-48C, wherein each of the links have the same or similar cross-section. The torque transmitting feature comprises a plurality of wires orrods620 extending through the adjacent links. FIG. 48A shows eightrods620, symmetrically arranged aroundlumen505. It may be appreciated, however, that therods620 may be present in any arrangement. When torque is applied to a link which is adjacent to thefirst link500, therods620 passing through thefirst link500 transmit the torque (indicated by arrows622) to thefirst link500 thereby rotating thefirst link500. This transmission may be repeated through any number of links, transmitting torque through a plurality of adjacent links. Similarly, FIG. 48B shows sixteenrods620, symmetrically arrangement aroundlumen505. Again, when torque is applied to a link which is adjacent to thefirst link500, therods620 passing through thefirst link500 transmit the torque (indicated by arrows622) to thefirst link500 thereby rotating thefirst link500. Thus, themore rods620 present the higher the torque transmission. FIG. 48C shows thirty-tworods620, symmetrically arrangement aroundlumen505. Any number ofrods620 may be present, typically ranging from eight to sixty-four. It may also be appreciated that therod620 may be comprised of any suitable material, such as metal, metal wire, polymer, nitinol, filament or fiber, to name a few. Also, some or all of therods620 may be pushwires orpullwires96.
• Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.[0177]

Claims (54)

What is claimed is:

1. An endoluminal system comprising:

an elongated main body having a proximal end, a distal end sized for passage through a body lumen, and at least one lumen extending between the proximal and distal ends;

a torque transmitting feature which provides torque transmission between the proximal and distal ends while the main body is unlocked and able to form a desired configuration; and

a locking mechanism which locks the main body in the desired configuration.

2. The endoluminal system ofclaim 1, further comprising a visualizing element.

3. The endoluminal system ofclaim 2, wherein the visualizing element is integral with the main body.

4. The endoluminal system ofclaim 2, wherein the at least one lumen comprises a visualizing lumen and the visualizing element is configured for passage through the visualizing lumen.

5. The endoluminal system ofclaim 4, wherein the visualizing element comprises an endoscope.

6. The endoluminal system ofclaim 1, wherein the at least one lumen comprises an arm guide lumen.

7. The endoluminal system ofclaim 6, further comprising at least one tool arm being adapted to extend through the arm guide lumen.

8. The endoluminal system ofclaim 1, further comprising a steering mechanism which steers the main body to the desired configuration while the main body is unlocked.

9. The endoluminal system ofclaim 1, wherein at least a portion of the elongated main body comprises a plurality of adjacent links.

10. The endoluminal system ofclaim 9, wherein the plurality of adjacent links comprises at least a first link and an adjacent second link, the torque transmitting feature comprising a tooth from the first link slidably engageable with a groove in the adjacent second link.

11. The endoluminal system ofclaim 9, wherein the plurality of adjacent links comprises at least a first link and an adjacent second link, the torque transmitting feature comprising a pin from the first link slidably engageable with a slot in the adjacent second link.

12. The endoluminal system ofclaim 9, wherein the torque transmitting feature comprises a fluted shape of the at least one lumen.

13. The endoluminal system ofclaim 9, wherein the torque transmitting feature comprises an oval shape of the plurality of adjacent links.

14. The endoluminal system ofclaim 13, wherein the torque transmitting feature comprises a plurality of rods extending through the adjacent links.

15. The endoluminal system ofclaim 14, wherein the plurality of rods comprises approximately 8 to 64 rods.

16. The endoluminal system ofclaim 9, wherein the steering mechanism comprises at least one pullwire extending through the plurality of adjacent links.

17. The endoluminal system ofclaim 1, wherein the torque transmitting feature comprises a torque transmitting covering over the main body extending between the proximal and distal ends.

18. The endoluminal system ofclaim 17, wherein the torque transmitting covering comprises a sheath having reinforcements.

19. An endoluminal device comprising:

an elongated main body having a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends, at least a portion of the elongated main body comprising a plurality of adjacent engageable links; and

a torque transmitting feature which provides torque transmission by preventing disengagement of the adjacent links while the main body is unlocked and able to form a desired configuration.

20. The endoluminal device ofclaim 19, wherein the plurality of adjacent engageable links comprises at least a first link and an adjacent second link, the torque transmitting feature comprising at least one pin from the first link slidably engageable with at least one slot in the adjacent second link.

21. The endoluminal device ofclaim 20, wherein the at least one pin comprises a pair of pins, each pin extending outwardly from an outer surface of the first link in a diametrically opposite position from the other pin.

22. The endoluminal device ofclaim 21, wherein the at least one slot comprises a pair of slots, each slot configured to accept one or the pair of pins passing therethrough.

23. The endoluminal device ofclaim 22, wherein the first link comprises a first domed ring having the outer surface and the adjacent second link comprises a second domed ring having an inner surface, the outer surface of the first domed ring mateable with the inner surface of the second domed ring along a longitudinal axis, and the rings rotateable away from the longitudinal axis.

24. The endoluminal device ofclaim 22, wherein each slot comprises an elongate opening between a first slot end and a second slot end, the slot ends substantially aligned with the longitudinal axis to allow sliding of the pins through the slots during rotation of the rings away from the longitudinal axis.

25. The endoluminal device ofclaim 19, wherein the torque transmitting feature comprises a torque transmitting covering over the plurality of adjacent engageable links to prevent disengagement of the adjacent links.

26. The endoluminal device ofclaim 19, further comprising a locking mechanism which locks the links in the desired configuration.

27. An endoluminal device comprising:

an elongated main body having a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends, at least a portion of the elongated main body comprising a at least a first link and an adjacent second link which are rotateable relative to each other when unlocked;

a torque transmitting feature comprising at least one protrusion from the first link slidably engageable with at least one groove in the adjacent second link, the torque transmitting feature providing torque transmission through the portion of the main body while the links are rotateable; and

a locking mechanism which locks the links upon actuation by preventing rotation of the links relative to each other.

28. The endoluminal device ofclaim 27, wherein the at least one protrusion comprises a pair of protrusions, each protrusion extending outwardly from an outer surface of the first link in a diametrically opposite position from the other protrusion.

29. The endoluminal device ofclaim 28, wherein the at least one groove comprises a pair of grooves, each groove configured to accept one or the pair of protrusions passing therein.

30. The endoluminal device ofclaim 29, wherein the first link comprises a first domed ring having the outer surface and the adjacent second link comprises a second domed ring having an inner surface, the outer surface of the first domed ring mateable with the inner surface of the second domed ring along a longitudinal axis, and the rings rotateable away from the longitudinal axis.

31. The endoluminal device ofclaim 30, wherein each groove comprises a first groove end and a second groove end, the groove ends substantially aligned with the longitudinal axis to allow sliding of the protrusions along the grooves during rotation of the rings away from the longitudinal axis.

32. An endoluminal device comprising:

an elongated main body having a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends, at least a portion of the elongated main body comprising a plurality of adjacent links which are rotateable relative to each other when unlocked;

a torque transmitting covering over the plurality of adjacent links providing torque transmission therethrough while the links are rotateable; and

a locking mechanism which locks the links upon actuation by preventing rotation of the links relative to each other.

33. The endoluminal device ofclaim 32, wherein the torque transmitting covering comprises a snuggly fit sheath.

34. The endoluminal device ofclaim 33, wherein the sheath includes reinforcements.

35. The endoluminal device ofclaim 34, wherein the reinforcements comprises nylon, polyurethane, polyethylene, Teflon, metal, or polymer.

36. The endoluminal device ofclaim 34, wherein the reinforcements have a braided or woven arrangement.

37. The endoluminal device ofclaim 34, wherein the reinforcements has been coated with a polymer.

38. The endoluminal device ofclaim 32, wherein the torque transmitting covering comprises a polymer coating.

39. An endoluminal device comprising:

an elongated main body having a proximal end, a distal end, and at least one lumen extending between the proximal and distal ends, at least a portion of the elongated main body comprising at least a first link and an adjacent second link which are rotateable relative to each other when unlocked, one of the at least one lumen extending through the links having at least one partition;

an elongated shaft passing through one of the at least one lumen in a manner to transmit torque by contacting the least one partition; and

a locking mechanism which locks the links upon actuation by preventing rotation of the links relative to each other.

40. The endoluminal device ofclaim 39, wherein the at least one partition comprises an inward protrusion.

41. The endoluminal device ofclaim 40, wherein the at least one lumen extending through the links has a fluted shape forming the inward protrusions.

42. The endoluminal device ofclaim 40, wherein the at least one partition comprises at least one divider spanning across the one of the at least one lumen.

43. The endoluminal device ofclaim 39, wherein the at least one lumen includes at least one steering lumen through which a pullwire passes for use in steering the elongated main body.

44. The endoluminal device ofclaim 43, wherein the at least one steering lumen comprises a plurality of steering lumens around the one of the at least one lumens.

45. A method of accessing comprising:

providing an elongated main body having a proximal end, a distal end, a visualizing element and a locking mechanism, wherein the main body is capable of forming a desired configuration in an unlocked state and holding the desired configuration in a locked state;

introducing the main body through a body passageway in the unlocked state forming the desired configuration so that the distal end reaches a target location;

actuating the locking mechanism to hold the main body in the desired configuration; and

viewing the target location with the use of the visualizing element.

46. A method as inclaim 45, wherein introducing the main body comprises allowing the main body to assume a shape of the body passageway in the unlocked state forming the desired configuration.

47. A method as inclaim 46, wherein the main body comprises a plurality of adjacent links and wherein actuating the locking mechanism comprises holding the links in a fixed relation to each other.

48. A method as inclaim 47, wherein the plurality of adjacent links comprises a plurality of nestable elements and wherein holding the links comprises wedging the links together to hold them by friction.

49. A method as inclaim 45, wherein introducing the main body comprises steering the main body through the body passageway in the unlocked state forming the desired configuration.

50. A method as inclaim 49, wherein the main body comprises a plurality of adjacent links and wherein actuating the locking mechanism comprises holding the links in a fixed relation to each other.

51. A method as inclaim 50, wherein the plurality of adjacent links comprises a plurality of nestable elements and wherein holding the links comprises wedging the links together to hold them by friction.

52. A method as inclaim 45, wherein the main body includes at least one lumen extending between the proximal and distal ends, and further comprising introducing an instrument through the at least one lumen.

53. A method as inclaim 52, wherein the instrument comprises a tool arm.

54. A method as inclaim 45, wherein the elongated main body further includes a visualizing lumen and the visualizing element comprises an endoscope, the method further comprising positioning the endoscope within the visualizing lumen.

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