Methods and apparatus for obtaining endoluminal access

The present invention provides methods and apparatus for obtaining endoluminal access. An elongate body is configured for insertion within a body lumen, conduit, organ, orifice, passageway or cavity, the elongate body having a working axis and a distal region, and an articulating element disposed near the distal region, the articulating element configured to articulate off-axis from the working axis of the elongate body. The elongate may achieve access in an endoluminal or a laparoscopic fashion. Methods of using the apparatus are also provided.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is related to, but does not claim priority from, U.S. patent application Ser. No. 10/824,936, filed Apr. 14, 2004, which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to methods and apparatus for obtaining endoluminal access. More particularly, the present invention relates to methods and apparatus for obtaining endoluminal access utilizing off-axis articulation.

Medical endoscopy entails the insertion of an elongate body into a body lumen, conduit, organ, orifice, passageway, etc. The elongate body typically has a longitudinal or working axis and a distal region, and a visualization element disposed near the distal region in-line with the working axis. The visualization element may comprise an optical fiber that extends through the elongate body, or a video chip having an imaging sensor, the video chip coupled to or including a signal-processing unit that converts signals obtained by the imaging sensor into an image. The elongate body may also include a working lumen to facilitate passage of diagnostic or therapeutic tools therethrough, or for injection of fluids or to draw suction.

The maximum delivery profile for a medical endoscope may be limited by the cross-sectional profile of the body lumen, conduit, organ, orifice, passageway, etc., in which the endoscope is disposed. At the same time, advances in therapeutic endoscopy have led to an increase in the complexity of operations attempted with endoscopes, as well as the complexity of tools advanced through the working lumens of endoscopes. As tool complexity has increased, a need has arisen in the art for endoscopes having relatively small delivery profiles that allow access through small body lumens, but that have relatively large working lumens that enable passage of complex diagnostic or therapeutic tools. Furthermore, as the complexity of operations attempted with endoscopes has increased, there has arisen a need for enhanced visualization platforms, including three-dimensional or stereoscopic visualization platforms.

As with endoscopy, ever more challenging procedures are being conducted utilizing laparoscopic techniques. Due to, among other factors, the profile of instruments necessary to perform these procedures, as well as a need to provide both visualization and therapeutic instruments, laparascopic procedures commonly require multiple ports to obtain the necessary access. Multiple ports also may be required due to the limited surgical space accessible with current, substantially rigid straight-line laparoscopic instruments.

In view of the foregoing, it would be desirable to provide methods and apparatus for obtaining endoluminal access that facilitate introduction of the apparatus into relatively small body lumens, while providing for introduction of at least one relatively large tool, as compared to standard endoscopes or laparoscopes. It also would be desirable to provide methods and apparatus that facilitate single port laparoscopy.

BRIEF SUMMARY OF THE INVENTION

Endoluminal access that facilitates introduction of the apparatus into relatively small body lumens while providing for introduction of at least one relatively large tool, as compared to a standard endoscope or laparoscope, may be accomplished by providing an elongate body configured for insertion within a body lumen, conduit, organ, orifice, passageway, etc. The elongate body has a working or main longitudinal axis and a distal region, and at least one articulating element disposed near or at the distal region. The articulating element generally is configured to articulate off-axis or out-of-line from the working axis of the elongate body such that the element (or elements) are extendable and retractable in a radial direction relative to the working axis. The element may comprise, for example, the distal region of a working lumen extending through the elongate body; a visualization element, such as a fiber optic or video chip; a diagnostic or therapeutic tool; or an illumination element. Additional alternative articulating elements will be apparent to one of skill in the art.

The articulating elements may alternatively or additionally provide radially extendable platforms from which various tools may be advanced and/or therapies may be conducted. This extendable platform may allow the user to deploy the elements once the apparatus has been desirably situated within the body giving the user a versatile platform from which to access a greater portion of the body lumen while maintaining a device having a relatively small delivery profile.

Advantageously, the articulating element provides the elongate body with a collapsed delivery configuration and a radially expanded deployed configuration. The collapsed delivery profile may facilitate passage of the elongate body within small body lumens, cavities, etc., while the expanded deployed profile may facilitate diagnosis or therapy via the elongate body once the elongate body is disposed within the body lumen. For example, off-axis articulation of the articulating element may expose distal openings of one or more working lumens extending through the elongate body.

With traditional endoscopes or laparoscopes, a maximum profile of the working lumen is constrained by geometry of the visualization element. Conversely, the apparatus described herein enables one or more visualization elements, working lumens, tools, illumination elements, etc., to be aligned with the working axis of the elongate body in the delivery configuration, and articulated out of alignment in the radially deployed configuration, thereby significantly reducing geometric constraints. As will be apparent, the working lumen(s), tool(s), illumination elements and visualization element(s) optionally may be provided as part of multiple distinct devices. For example, a standard endoscope or laparoscope may be provided as a visualization element, while one or more working lumens may be disposed within an overtube or endoluminal tool deployment system (e.g., as described in Applicant's co-pending U.S. patent application Ser. No. 10/797,485, filed Mar. 9, 2004, which is incorporated herein by reference in its entirety) disposed over the standard endoscope/laparoscope. Apparatus of the present invention additionally or alternatively may be advanced through a trocar or multi-lumen insert, as described, for example, in Applicant's co-pending U.S. patent application Ser. No. 10/843,682, filed May 10, 2004, which is incorporated herein by reference in its entirety.

Optionally, multiple articulating elements may be provided near the distal region of the elongate body. When the multiple articulating elements comprise two or more visualization elements, stereoscopic visualization may be provided. When the multiple elements comprise multiple working lumens or tools, complex therapeutic or diagnostic endoluminal procedures may be performed. Combinations of various articulating elements may be provided.

When used in conjunction with laparoscopic endoluminal access, off-axis articulating element(s) may facilitate achievement of complex diagnostic and/or therapeutic laparoscopic procedures through a single port or opening. Likewise, when utilized for endoscopic endoluminal access, the articulating element(s) may facilitate otherwise unachievable endoscopic procedures. Thus, off-axis articulating element(s) may enable a transition of procedures currently performed in an open surgical fashion or via multiple laparoscopic ports to less invasive endoscopic or laparoscopic techniques. It is expected that the element(s) also may facilitate novel procedures that may not be performed utilizing current methods and apparatus.

It should be understood that, in addition to obtaining endoluminal access, the apparatus and methods described herein also may be utilized to obtain access to non-luminal spaces, regions, or cavities within a patient, for example, to the patient's peritoneum.

DETAILED DESCRIPTION OF THE INVENTION

Endoluminal access may be achieved more effectively by utilizing off-axis articulation with an apparatus advanced within a body lumen, e.g., advanced endoluminally or laparoscopically within the body lumen. As described herein, off-axis articulating elements may act as radially extendable platforms from which various tools may be advanced or therapies may be conducted. This extendable platform may allow the user to deploy the elements once the apparatus has been desirably situated within the body, thereby giving the user a versatile platform from which to access a greater portion of the body lumen while maintaining a device having a relatively small delivery profile.

With reference toFIGS. 1 and 2, a first variation of the apparatus is shown. Apparatus10comprises elongate body12configured for insertion within a body lumen, conduit, organ, orifice or passageway, e.g., via laparoscopic or endoluminal techniques. Body12comprises working axis W and distal region13. The elongate body may, for example, comprise a flexible, steerable, rigidizable and/or multi-segmented body, such as described in Applicant's co-pending U.S. patent application Ser. No. 10/797,485, filed Mar. 9, 2004, which has been incorporated by reference above. Body12alternatively may be substantially rigid and/or straight-line, and may be configured for laparoscopic access to the body lumen, etc. As will be apparent, flexible, steerable and/or rigidizable instruments may be advanced laparoscopically or endoluminally. Laparoscopic surgical techniques are described, for example, in Applicant's co-pending U.S. patent application Ser. No. 10/843,682, filed May 10, 2004, which has been incorporated by reference above.

Apparatus10also comprises at least one articulating element20, shown in this example as two elements20aand20b(collectively referred to as elements20), disposed near or at distal region13of body12. Elongate body12further comprises housing14, which may be slidably disposed over one or more working lumens16, illustratively shown as working lumens16aand16b. Articulating elements20may be pivotally coupled to housing14by linkages21aand21b, which extend between hinges22aand22bof elements20aand20band hinges15aand15b, respectively, of housing14. Push/pull members24aand24balso may be provided to actuate articulating elements20aand20b, respectively, between the collapsed profile and radially extended profile.

Members24aand24bmay extend along elongate body12, for example, between housing14and lumens16, to a proximal region of the elongate body (not shown) for manipulation by a medical practitioner. The members may be coupled to one another for coordinated actuation of articulating elements20, or may be decoupled for independent actuation. Furthermore, the members may comprise cables or coils, as described hereinafter, adapted to convey control elements between the articulating elements and the elongate body.

As seen inFIGS. 1 and 2, articulating elements20are configured to articulate off-axis or out-of-line from working axis W of elongate body12.FIG. 1Ashows articulating elements20in a collapsed delivery configuration having a reduced delivery profile suited for delivery within a body orifice, lumen, cavity, etc.FIG. 1Bshows articulating elements20in a partially articulated configuration.FIGS. 1C and 2show the articulating elements fully articulated to a deployed configuration of expanded profile.

Articulating elements20may be articulated from the reduced profile ofFIGS. 1A and 1Dto the expanded profile ofFIGS. 1C and 1Eby retracting members24relative to housing14. The articulating elements may be articulated back to the collapsed profile, as desired, by advancing members24relative to housing14. As will be apparent, elements20alternatively may be articulated by advancing or retracting housing14relative to members24.

As seen inFIGS. 1C and 2, articulation of elements20to the expanded deployed configuration advantageously exposes distal openings17aand17bof working lumens16aand16b, respectively. In the delivery configuration ofFIG. 1A, the lumens and articulating elements are aligned with working axis W of elongate body12. Such alignment reduces the delivery profile of apparatus10, but also causes articulating elements20to be disposed in-line with lumens16, thereby blocking distal openings17of the lumens.

Articulating elements20off-axis and out of alignment with working axis W exposes distal openings17of lumens16. Once exposed, lumens16may be used for passage of diagnostic or therapeutic tools from the proximal to the distal region of apparatus10, as well as to draw suction, inject fluids, etc. By providing apparatus10with elements that articulate, lumens16may be provided with larger cross-sectional profiles than otherwise would be possible for a given delivery profile, as compared to apparatus having needed elements that cannot articulate.

Each articulating element20may comprise, for example, the distal region of a working lumen extending through elongate body12. Alternatively, each articulating element may comprise a visualization element, such as a fiber optic or video chip. As yet another alternative, each articulating element may comprise a diagnostic or therapeutic tool, or an illumination element. Additional alternative articulating elements will be apparent.

InFIGS. 1 and 2, articulating elements20illustratively comprise visualization elements30aand30b. Elements30may comprise illumination sources32aand32b, as well as optics34aand34b. Optional illumination sources32may be used to provide light for imaging with elements30, while optics34may, for example, comprise lenses, filters, etc. The optics may be coupled to one or more optical fibers and/or video chips that transmit visual information to a proximal region of apparatus10. Optional flushing elements35also may be provided. Control elements for visualization elements30, such as electrical wires, flushing lumens, etc., may run within or along push/pull members24.

When video chips having imaging sensors are coupled to optics34, the chips may be adapted to receive, as well as to transmit and/or signal process, visual information. Illustrative imaging sensors that may be used as part of visualization elements30include, but are not limited to, charge coupled device (“CCD”) image sensors, complementary metal oxide semiconductor (“CMOS”) image sensors, multi-layer solid state image sensors, direct image sensors, and combinations thereof. The video chips may wirelessly transmit signals to a processing and/or display unit, or one or more wires may extend along the length of the elongate body to carry such signals.

Since apparatus10has two articulating visualization elements30, the apparatus10is adapted to provide stereoscopic or 3-dimensional visualization. Stereoscopic visualization may be displayed to a medical practitioner, for example, via a viewfinder disposed in front of the practitioner's eyes or via a standard monitor. A depth of field, a focal point or depth, and/or a field of view of stereoscopic images produced with visualization elements30may be altered, for example, by changing a degree of articulation of elements30, by varying parameters of optics34, via digital signal processing techniques, etc.

Referring now toFIGS. 3 and 4, an alternative variation of apparatus10is described. Apparatus10′ comprises housing14′ having at least one slot40. Linkages21a′ extend between hinges22aof elements20′ and slot40of housing14′ . In this variation, linkages21a′ are longer than more distal linkages21b, and are slidably disposed within slot40of the housing. Apparatus10′ further comprises proximal push/pull members42aand42bcoupled to the proximal regions of articulating elements20aand20b, respectively, as well as distal push/pull members44aand44bcoupled to the distal regions of elements20.

As seen inFIGS. 3A-3E, actuation of articulating elements20a′ and20b′ may be achieved by coordinated movements of proximal members42aand42b, distal members44aand44band housing14′. InFIGS. 3A and 3D, apparatus10′ is disposed in the collapsed delivery configuration suitable for advancement within a body lumen. InFIG. 3B, members42aand42b, as well as members44aand44b, have been retracted relative to housing14′. This causes long linkages21a′ to articulate about hinges22aof elements20′ and slide proximally within slot40of housing14′, while linkages21barticulate about hinges15band22b. Elements20a′ and20b′ articulate out of alignment and off-axis from working axis W of elongate body12, thereby exposing distal openings17aand17bof lumens16aand16b.

As seen inFIGS. 3C,3E and4, subsequent advancement of proximal members42aand42brelative to housing14′ and distal members44aand44bcauses long linkages21a′ to slide distally within slot40and articulate about hinges22a. Such movement causes the distal regions of elements20′ to articulate inwards relative to the proximal regions of the elements, thereby changing the relative angle between elements20a′ and20b′. As will be apparent, elements20a′ and20b′ may be articulated in either a coordinated fashion or individually.

When elements20a′ and20b′ comprise visualization elements (optionally used in a stereoscopic fashion), relative angulation of the elements may be used to dynamically alter a focal point or depth, a depth of field and/or a field of view provided by the elements. When the elements comprise tools (e.g. grasping tool arms, cutting tools, plicating tools, affixing tools, etc.) or lumens, the tools or lumens may be angled for better positioning of the tools/lumens. When the elements comprise illumination elements, angling or angulation of the elements may better light a region of interest. As will be apparent, any combination of various articulating and/or angulate-able elements20may be provided, including combinations of visualization elements, illumination elements, tools, lumens, etc.

Referring now toFIG. 5, an alternative variation is described comprising articulation biasing. Apparatus50comprises elongate body52having working axis W, distal region53, working lumen54, control lumen56and ramp58. Apparatus50may further comprise articulating element60disposed near or at distal region53of body52. Articulating element60is coupled to elongate body52by proximal linkage62and torsion spring64. Linkage62extends between hinge63of articulating element60and control rod59disposed within control lumen56of body52. Torsion spring64extends between hinge65of the articulating element and hinge55of the elongate body. Torsion spring64provides element60with articulation biasing. In other variations, other biasing elements aside from torsion springs may be utilized.

As seen in dotted profile inFIG. 5, advancement of control rod59relative to elongate body52advances linkage62along ramp58and articulates element60, thereby exposing the distal end of lumen54. Torsion spring64has a natural tendency to push element60off-axis and biases the element to the articulated position. Once element60has ‘sprung-up’ to the articulated position, further advancement of rod59controls the angle Θ of element60relative to elongate body52. Retraction of rod59may overcome the articulation biasing of spring64and return apparatus50to the collapsed delivery configuration. The spring constant of torsion spring64may be specified to control a degree of articulation biasing provided by the spring.

Referring now toFIG. 6, another variation is described wherein the articulating element comprises a steerable shaft. Apparatus70comprises elongate body72having working axis W, distal region73and lumen74. Apparatus70further comprises articulating element80disposed near distal region73of elongate body72. Element80is coupled to the elongate body by previously-described linkages21disposed between hinges15and22.

Articulating element80comprises steerable shaft82. Shaft82may be passively articulate-able or, alternatively, may be actively controllable. Any number of conventional methods may be utilized to articulate the shape and configuration of shaft82. InFIG. 6, shaft82illustratively may, for example, be steerable in any number of directions. In this variation, shaft82may be steerable in at least four directions, e.g., via four control wires routed through or along cable84and elongate body72to a proximal region of apparatus70for manipulation by a medical practitioner. Cable84may also be used to articulate element80. As discussed hereinbelow with respect toFIGS. 11 and 12, proximal of cable84, the control wires for steerable shaft82preferably are routed through or along body72in spaces that would not be usable as working lumens or for tool insertion.

During delivery, articulating element80and steerable shaft82preferably are aligned with working axis W of elongate body72. Advantageously, the ability to articulate element80off-axis post-delivery allows apparatus70to have both a large working lumen74and a small collapsed delivery profile. Furthermore, steerable shaft82gives the apparatus an off-axis platform with added finctionality for performing complex procedures. The steering capability of shaft82may be used to steer therapeutic or diagnostic tools, and/or for illumination, visualization, fluid flushing, suction, etc., into better position for conducting such procedures.

Various methods and apparatus for controlling elements used in conjunction with shaft82may be routed through cable84along with the control wires for shaft82. For example, when a visualization element is coupled to steerable shaft82, electrical wires may run through cable84for sending and/or receiving signals, power, etc., to/from the visualization element. In such a variation, the visualization element would allow direct visualization during insertion within a body lumen, while providing off-axis visualization and steering, as well as facilitating tool introduction, post-articulation. Alternatively or additionally, when a working lumen is disposed through steerable shaft82, cable84may comprise a lumen for connecting the shaft lumen to a lumen extending through elongate body72of apparatus70.

Referring now toFIG. 7, an alternative variation of apparatus70is described comprising multiple articulating elements having steerable shafts. Apparatus70′ comprises first articulating element80aand second articulating element80b. Elements80comprise first steerable shaft82aand second steerable shaft82b, respectively. Lumens74aand74bextend through elongate body72′ and are exposed upon articulation of elements80aand80b, respectively. As will be apparent, a single lumen or more than two lumens alternatively may be provided. Likewise, more than two articulating elements and/or steerable shafts optionally may be provided.

InFIG. 7, first steerable shaft82aillustratively is shown with working lumen86that extends through the shaft, as well as through cable84aand elongate body72′. Exemplary grasper tool90is shown advanced through lumen86. Second steerable shaft82billustratively is shown with visualization element88coupled to an end thereof. Electrical wires, e.g., for powering and transmitting signals to/from the visualization element, are disposed within cable84b. As will be apparent, steerable shafts82may be provided with additional or alternative capabilities.

With reference toFIG. 8, illustrative embodiments of atraumatic tips for use with apparatus of the present invention are described. InFIG. 8A, apparatus70ofFIG. 6is shown with atraumatic tip76. Tip76provides a smooth transition between elongate body72and articulating element80with steerable shaft82. Tip76may, for example, comprise an inflatable balloon that may be inflated as shown during insertion and delivery of apparatus70, then deflated prior to articulation of element80and off-axis steering of shaft82, so as not to block or impede articulation or the distal opening of the lumen74post-articulation.

InFIG. 8B, apparatus50ofFIG. 5comprises alternative atraumatic tip78having cap79, which optionally may be fabricated from rubber. As illustrated by the cut-away section inFIG. 8B, the cap may be U-shaped to both provide a smooth transition between elongate body52and articulating element60in the delivery configuration, as well as to ensure that the cap does not block or impede lumen54post-articulation.

With reference now toFIGS. 9, a variation of the apparatus ofFIGS. 1 and 2is described comprising an articulating illumination element and an articulating visualization element. InFIG. 9A, articulating element20aof apparatus10comprises previously described visualization articulating element30, while articulating element20bcomprises illumination articulating element100. Control wires for both element30and element100, illustratively routed through coils or cables84, are proximally coupled to control/power unit110. As seen inFIG. 9B, illumination element100comprises at least one light emitting diode (“LED”)102, as well as optional sensor104. Other variations may utilize other types of lights or illumination methods, e.g., incandescent lights, fluorescent lights or chemicals, etc. Control unit110may coordinate signals from visualization element30and sensor104to appropriately set the white balance of visualization element30, as well as the intensity of light emitted from LEDs102, etc.

With reference toFIG. 10, a combination articulating element is described that provides illumination, visualization and fluid flushing. Articulating element120comprises visualization element130having lens132and video chip134with an image sensor, such as a CCD or CMOS image sensor. The video chip is coupled to power source136, as well as signal processing and/or display unit138.

Element120further comprises illumination element140for illuminating a region of interest to facilitate visualization with element130. Illumination element140comprises optical fibers142, which are illustratively disposed in a ring about lens132. Fibers142are coupled to light source144.

Element120also comprises flushing element150for cleaning lens132of visualization element130, as well as optical fibers142of illumination element140. Flushing element150comprises tube152having lumen154that distally terminates at side port156disposed adjacent to lens132. Tube152may be proximally coupled to fluid injection element158, which may, for example, comprise a syringe filled with saline.

Referring now toFIG. 11, a liner for use with an elongate body is described. Liner160comprises polymeric substrate162having control elements164embedded or disposed therein. Liner160may, for example, be disposed within the working lumen of an elongate body of the present invention, such as working lumen16of elongate body12of apparatus10. Polymeric substrate162may seal the lumen and preclude contact between the elongate body and bodily fluids. Furthermore, control elements164may extend between proximally-disposed control, power, injection, processing, etc., units and a distally-disposed cable that communicates with an articulating element of the present invention. The control elements may comprise, for example, tension wires, electrical wires, optical fibers, fluid transport tubes, etc. The elements may be slidable relative to substrate162, or may be fixed relative to the substrate. When the position of control elements164is fixed relative to the substrate, substrate162and elements164may be coextruded to form liner160. It is expected that routing the control elements within a liner will save room, thereby allowing for a larger working lumen for a given delivery profile.

With reference toFIG. 12, alternative apparatus for routing control elements is described.FIG. 12illustrates exemplary link200for an elongate body. A plurality of such links may be nested within one another to form the elongate body. Steerable and/or shape-lockable elongate bodies formed from a plurality of nested links have been described previously, for example, in Applicant's co-pending U.S. patent application Ser. No. 10/797,485, filed Mar. 9, 2004, which has been incorporated herein by reference. Link200comprises working lumen202and through-holes204. Control elements162may be routed through the through-holes. InFIG. 12, exemplary control element162is illustratively disposed within coil206. Coil206may protect the control element during bending of an elongate body formed from a plurality of links200. Furthermore, coil206may provide superior torqueability and/or pushability to such an elongate body.

One method for obtaining endoluminal access comprises advancing an elongate body or guide, as described above, into a body lumen or other cavity, e.g. advancing the elongate body or guide laparoscopically or endoluminally. The elongate body comprises an articulating element disposed near a distal region thereof, and the exemplary method further comprises articulating the articulating element from a position in-line with a working axis of the elongate body to a position out-of-line or off-axis from the working axis. Articulating the articulating element may expand the articulating element from a reduced delivery configuration to an expanded deployed configuration in a radially extended manner. Furthermore, articulating the element may expose the distal opening of a lumen through which a tool, fluid, suction, etc., may be advanced or withdrawn.

The method may further comprise imaging within the body lumen via an articulated visualization element. Such imaging optionally may be stereoscopic, and the depth of field, field of view, focal point or depth, etc., of such imaging may be altered. Additionally or alternatively, the method may comprise performing diagnostic or therapeutics actions via tools or instruments attached to, or advanced along, an articulated element. The method further may comprise repositioning the articulating element in-line with the working axis of the elongate body and manipulating or removing the elongate body from the body lumen, as well as optionally re-articulating the element. The elongate body may be steered and/or rigidized while obtaining endoluminal access.

Referring now toFIG. 13, an exemplary endoluminal method and apparatus for obtaining endoluminal access is described. InFIG. 13A, apparatus10ofFIGS. 1 and 2is shown with an exemplary elongate body12formed from a plurality of links200ofFIG. 12. Articulating element(s)20are disposed at the end of elongate steerable and shape-lockable/rigidizable body12. Apparatus10is advanced per-orally and endoluminally through the patient's esophagus E past gastroesophageal junction GE into stomach S with articulating elements20disposed in a low profile delivery configuration. Visualization element30may, for example, be positioned on one or more of the articulating elements20to provide direct visualization during endoluminal positioning of apparatus10, as well as to provide direct visualization of tools advanced through lumen(s)16of elongate body12of the apparatus post-articulation of element(s)20.

As seen inFIG. 13B, body12may be steered, retroflexed, etc., into a desired configuration for diagnosis or treatment. Exemplary endoluminal treatments, such as gastric reduction and treatment of GERD, have been described previously, for example, in Applicant's co-pending U.S. patent application Ser. No. 10/734,562, filed Dec. 12, 2003; and Ser. No. 10/841,233, filed May 7, 2004, both of which are incorporated herein by reference in their entireties. Once properly positioned, element(s)20may be articulated off-axis to expose one or more lumens16through which additional tools or instruments, such as tissue plication assembly210and tissue manipulation assembly220, may be advanced. As will be apparent, other tools also may be utilized, depending upon the desired diagnostic and/or therapeutic procedure to be performed upon the tissue. As seen inFIG. 13C, after completion of a diagnostic or therapeutic procedure; such as formation, approximation and securement of anterior and posterior tissue folds F to partition stomach S; the apparatus may be returned to a low-profile configuration by retracting the tools or instruments back within lumen(s)16and articulating element(s)20back into alignment with the longitudinal axis of elongate body12of apparatus10. Apparatus10then may be removed from the patient to complete the procedure.

With reference toFIGS. 14 and 15, an exemplary laparoscopic method and apparatus for obtaining endoluminal access is described. InFIG. 14, apparatus70ofFIG. 6is shown with an exemplary elongate body72formed from a plurality of links200ofFIG. 12. One or more lumens74extend through body72, and articulating element80, having four-way steerable shaft82and optional visualization element30, is disposed near distal region73of the elongate body. Illustrative control handle230is provided to manipulate apparatus70. Lumen231extends through the handle and communicates with lumen(s)74of elongate body72. Knob232of handle230may facilitate steering of elongate body72, while knob234may control off-axis articulation of element80, and knobs236aand236b(seeFIG. 15B) may control four-way steering of shaft82. Knob236amay, for example, facilitate steering of shaft82along an axis perpendicular to a steering axis controllable via knob236b. Handle230further comprises shape-locking or rigidizing lever238for maintaining a configuration of elongate body72. Steering, off-axis articulation and and/or shape-locking of apparatus70with handle230preferably is achieved via tensioning wires that extend along elongate body72through through-holes204of links200(seeFIG. 12).

Apparatus70may be used in conjunction with trocar assembly250to perform single-port laparoscopic procedures. Trocar assembly250may be any standard or customized trocar assembly and may comprise obturator252having sharpened tip254, as well as trocar260having lumen261with a universal or other fluid seal therein. Lumen261and the fluid seal are configured for passage of obturator252therethrough. The lumen and seal are also configured for passage of apparatus70or other apparatus therethrough.

Trocar260optionally may comprise member264for stabilizing the trocar against tissue, as described hereinafter. Member264optionally may be expandable and/or inflatable, and may be expandable from a low profile configuration, as shown in dotted profile inFIG. 14, to the illustrated expanded configuration. The optional low profile configuration may facilitate placement of member264across the wall of a body lumen or cavity.

Trocar260may comprise a substantially rigid tubular shaft, or may be flexible and passively or actively steerable, as illustrated in dotted profile inFIG. 14. When actively steerable, trocar260may, for example, be fabricated from a plurality of links200and manipulated via optional control handle270. Additional laparoscopic apparatus and methods, which may be utilized as desired in combination with apparatus of the present invention, are described in Applicant's co-pending U.S. patent application Ser. No. 10/843,682, filed May 10, 2004, which has been incorporated herein by reference.

As seen inFIG. 15A, an incision may be formed through a patient's skin, and trocar260, having obturator252disposed therethrough, may be advanced through the incision directly into stomach S, as shown, or into the peritoneal space. Treatment or diagnosis (e.g., obesity treatment, appendectomy, cholecystectomy or gall bladder removal, etc.) may be performed within the peritoneum (seeFIG. 16), or trocar assembly250may be further advanced into a body lumen, such as the stomach. InFIG. 15A, sharpened tip254of obturator252pierces the wall of stomach S, and a distal region of trocar260is advanced within the stomach. Obturator252then may be removed from lumen261of trocar260, and member264optionally may be expanded. If the member is disposed within stomach S, trocar260may be retracted such that a position of the trocar is stabilized against the internal wall of the stomach. Alternatively, if the member is disposed exterior to the patient, as inFIG. 15A, the trocar may be advanced such that the position of the trocar is stabilized against the patient's skin or exterior. InFIG. 15, although trocar260illustratively has been placed through the antrum of the patient's stomach, it should be understood that the trocar alternatively may be positioned at any other location, as desired.

As seen inFIG. 15B, once trocar260has been properly placed, apparatus70may be advanced through the trocar into stomach S with articulating element80disposed in a low profile delivery configuration. Elongate body72then may be steered into a desired configuration for diagnosis or treatment and optionally may be rigidized or shape-locked, e.g., via lever238, to maintain the desired configuration. Optional visualization element30coupled to articulating element80may facilitate steering of elongate body72into a desired configuration or position. Once apparatus70is properly positioned, element80may be articulated off-axis to expose one or more lumen(s)74through which additional tools or instruments, such as tissue plication assembly210and tissue manipulation assembly220, may be advanced.

Plication assembly210illustratively comprises elongate, flexible shaft212coupled to control handle214for operating the plication assembly. Likewise, manipulation assembly220illustratively comprises elongate, flexible shaft222coupled to control handle224for operating the manipulation assembly. As will be apparent, additional or alternative instruments, such as an endoscope or laparoscope may be utilized. Furthermore, the instruments optionally may be configured for passage through steerable shaft82of articulating element80to facilitate off-axis use of the instruments. InFIG. 15, shaft82illustratively comprises visualization element30, and procedures performed with assemblies210and220may be monitored via the visualization element.

After completion of a diagnostic or therapeutic procedure, apparatus70may be returned to a flexible, low-profile configuration by releasing lever238, retracting assemblies210and220within lumen(s)74and articulating element80back into alignment with the longitudinal axis of elongate body72, as inFIG. 14. The apparatus then may be retrieved through trocar260. Trocar260may be removed, and the punctures through the stomach wall and the patient's skin may be sutured closed. In this manner, the apparatus facilitates performance of complex endoluminal or peritoneal procedures through a single laparoscopic access port or trocar. The apparatus preferably comprises both visualization and other diagnostic and/or therapeutic tools. As will be apparent, additional laparoscopic ports optionally may be provided, as desired. Furthermore, instruments advanced through the patient's esophagus optionally may be used in conjunction with laparoscopic endoluminally placed instruments. Furtherstill, apparatus70may be advanced across the patient's skin, e.g., into the patient's peritoneum or stomach, without use of an intervening trocar.

With reference now toFIG. 16, an illustrative method of using the apparatus ofFIG. 15in the peritoneal cavity or space is described. Trocar260may be placed through the patient's skin and across the tissue wall within the patient, as described previously, and apparatus70may be advanced through the trocar into peritoneal cavity P. InFIG. 16, member264of trocar260illustratively also is disposed within the peritoneal cavity, and is expanded to stabilize the trocar against the interior wall of the cavity. Articulating element80then may be articulated off-axis, and instruments, such as tissue plication assembly210and tissue manipulation assembly220, may be advanced through lumen(s)74of apparatus70and/or through shaft82of element80to perform a diagnostic and/or therapeutic procedure within the cavity. Articulating element80optionally may comprise visualization element30for monitoring procedures performed via apparatus70. Diagnostic and/or therapeutic procedures may, for example, be performed on the patient's liver L, gall bladder G, stomach S, intestines I, appendix A, etc.

Appendectomy is an exemplary therapeutic procedure that may be performed within the peritoneal cavity. Such a procedure may, for example, proceed as follows. Access to peritoneal cavity P may be gained via an 18-20 mm dilated incision in the umbilicus, similar to a hassan entry. Apparatus70then may be introduced through a trocar, such as trocar260as inFIG. 16, or may be introduced bluntly through the incision in a rigid state, pre-shaped by the surgeon to allow it to be placed in the direction of the target area. A pneumoperitoneum may be established and maintained to the normal standards for conventional laparoscopy, for example, via an insufflation channel extending through an insufflation lumen74of apparatus70. Visualization element30may be connected to a light source and a video monitor exterior to the patient in order to establish visualization, and a proximal section of apparatus70optionally may be locked to a standard table-mounted clamp.

Next, apparatus70may be steered and re-positioned such that an inspection of the Cecum and appendix A can be completed. Element80is articulated off-axis to provide a “top down” view with visualization element30, wherein the Appendix is centered in the field of view. An operating dissector and scissor are introduced, for example, through first and second lumens74of apparatus70. Utilizing the dissector and scissors as necessary, appendix A is bluntly separated from any adherent omentum or adhesions and mobilized. Depending on positioning of the appendix relative to the cecum, further mobilization may be necessary.

A temporary clamp or suture may be introduced through a third lumen74of apparatus70and is placed across the appendiceal mesentery in the standard fashion. The appendiceal mesentery is then ligated and divided using, for example, cautery or ligating clips and scissors. Temporary clamps or sutures then may be placed at the base of the appendix if desired. Scissors are used to transect the base of appendix A flush with the clamp or suture. An anchor stitch may be placed to close the remnant base, or it may be left open and secured by inversion within the cecum. Further anchors may be placed to affect a purse string suture at the cecum and invert the stump. The area may be inspected for hemostasis and irrigated/suctioned in the standard fashion for laparoscopy.

Next, the dissector may be affixed to the tip of the appendix, element80may be articulated back in-line with the longitudinal axis of elongate body72, and apparatus70may be withdrawn through the umbilicus. Alternatively, an anchor may be placed through the tip of the appendix and the suture end may be grasped via the dissector. Apparatus70then may be removed gently from the peritoneal cavity, and the end of appendix A may be pulled through the incision until it can be grasped using a standard surgical clamp. The appendix is delivered through the incision in the standard fashion, and the incision is closed with sutures. It should be understood that the preceding method of removing a patient's appendix utilizing apparatus70is provided for the purposes of illustration, and variations or modifications to the method within the scope of the present invention will be apparent to those of skill in the art.

Cholecystectomy is another exemplary therapeutic procedure that may be performed within peritoneal cavity P. Access to the peritoneal cavity again may be gained via an 18-20 mm dilated incision in the umbilicus, similar to a hassan entry. Apparatus70may be introduced through a trocar or may be introduced bluntly through the incision in a rigid state, pre-shaped by the surgeon to allow it to be placed in the direction of the target area. A pneumoperitoneum may be established and maintained to the normal standards for conventional laparoscopy, for example, via an insufflation channel extending through an insufflation lumen74of apparatus70. Visualization element30may be connected to a light source and a video monitor exterior to the patient in order to establish visualization, and a proximal section of apparatus70optionally may be locked to a standard table-mounted clamp.

Apparatus70is steered and positioned such that an inspection of the upper right quadrant can be completed via visualization element30of articulating element80. Element80then may be articulated off-axis to provide a “top down” view of the fundus of gallbladder G. If the gallbladder cannot be seen, an operating dissector and scissor or electrosurgical hook may be extended through lumen(s)74of apparatus70, and any adhesions may be removed.

A retracting grasper may be inserted through a lumen74of apparatus70and firmly affixed and locked to the fundus of gallbladder G. The gallbladder then may be exposed via anterior and lateral traction, for example, in the manner of conventional laparoscopy. Utilizing scissors advanced through apparatus70to create an incision in the cystic duct and a self-sealing catheter, an intraoperarative cholangiogram may be performed.

The cystic duct may be isolated using the dissector and an electrosurgical hook, and the cystic artery then may be skeletonized and isolated using a similar technique. The location of the common duct and any unusual arterial branches may be visually verified. The electrosurgical hook may be withdrawn, and ligating ties or clips may be placed on the duct and artery, thereby leaving double closure if desired on each patient side. Scissors may be introduced through apparatus70and used to transect the artery and duct, thereby completely mobilizing the gallbladder infundibulum.

The retraction grasper optionally may be maintained at the fundus or may be repositioned centrally along the gallbladder as desired. Utilizing cautery scissors or hook introduced through apparatus70, as well as the operating dissector for additional traction and dissection, the gallbladder serosa is scored, and the fundus is mobilized in the manner of conventional laparoscopy. The gallbladder bed is inspected and any bleeding areas are cauterized. Irrigation may be used to clean the area and facilitate inspection. Once the gallbladder is completely excised, the grasper may be repositioned for easy removal of the specimen. Element80then may be articulated back in-line with the longitudinal axis of elongate body72, and apparatus70may be slowly straightened and withdrawn, pulling gallbladder G along with the locked grasper. Once the gallbladder is visible through the incision, a clamp replaces the grasper, the gallbladder is removed through the umbilicus and the. incision is closed.

It should be understood that the preceding method for performing cholecystectomy utilizing apparatus70is provided for the purposes of illustration, and variations or modifications to the method within the scope of the present invention will be apparent to those of skill in the art. Furthermore, alternative methods and procedures utilizing apparatus70within peritoneal cavity P, stomach S, or any other region of a patient's body will be apparent to those of skill in the art.

Although various illustrative embodiments are described above, it will be evident to one skilled in the art that various changes and modifications are within the scope of the invention. It is intended in the appended claims to cover all such changes and modifications that fall within the true spirit and scope of the invention.