US20040186349A1 - Apparatus and methods for achieving endoluminal access - Google Patents

Abstract

The present invention provides methods and apparatus for pleating at least a portion of a patient's body lumen, such as the colon. Pleating is achieved via relative motion between an endoscope and a flexible conduit having an engagement element configured to reversibly engage the body lumen.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This application claims benefit of the filing date of U.S. Provisional Patent Application Serial No. 60/436,518, filed Dec. 24, 2002, which is incorporated herein by reference in its entirety.[0001]
BACKGROUND OF THE INVENTION
• 1. Field of the Invention[0002]
• The present invention relates to methods and apparatus for achieving endoluminal access for instruments, e.g. tubular, fiberoptic instruments, such as colonoscopes, gastroscopes, and the like. More particularly, the present invention relates to methods and apparatus for achieving endoluminal access via anatomical pleating.[0003]
• 2. Description of the Background Art[0004]
• A physician performing a gastrointestinal examination or treatment commonly advances a colonoscope through a patient's anus into the patient's colon. In order to permit full examination of the colon, the colonoscope must be advanced up to the cecum. Advancement may be directed via a steerable distal end portion of the colonoscope. However, at bends in the colon—namely at the sigmoid, and especially at the two colonic flexures—advancement problems regularly occur, including a risk of injury, pain to the patient, cramp-like contractions of the colon, and even an inability to further advance the colonoscope.[0005]
• Such problems stem from the fact that the colon is soft and weakly adhered to the abdomen. After a first deflection of the colonoscope, a principal direction of force by which the colonoscope is advanced no longer points towards the distal end of the colonoscope, but rather points towards the readily yielding wall of the colon. Force application is unpleasant to the patient and precludes access to the cecum in about 10% to 15% of all cases.[0006]
• The concept of pleating or “accordionizing” the colon to facilitate advancement of the colonoscope is described by Eubanks et al. in[0007]Mastery of Endoscopic and Laparascopic Surgery, Eubanks, Swantrom, Soper, pg. 337, 2000, Lippincott Williams & Wilkins.
• “If the colon were a simple noncompliant tube without redundancy or irregularity, colonoscopic intubation would be a rather simple endeavor of advancing the scope while following the tip. Occasionally, especially if there has been a prior sigmoid resection, colonoscopy may be no more demanding than simple scope advancement. However straight advancement usually promotes the development of loops, stretching the colon. When progression of the scope is not impeded by severe tip deflection, the colon can be encouraged to accordionize along the length of the scope. This is most likely to occur if the scope is repeatedly advanced and withdrawn. In some areas, particularly distally, this is most effective if it is performed with small rapid strokes, referred to as dithering the scope. Elsewhere, such as the transverse colon, this maneuver is performed with long, gentle strokes of 30 to 50 cm.”[0008]
• FIGS. 1-3 describe Prior Art methods of accomplishing such accordionization or pleating, as described by Eubanks et al. In FIG. 1, elongation intubation of colon C through anus A is described using[0009]colonoscope10 havingsteerable deflection tip12. In FIG. 1A,scope10 is advanced into proximal sigmoidS. Deflection tip12 then is turned into the distal descending colon DC, as in FIG. 1B. In FIG. 1C, sigmoid S is accordionized ontoscope10 via simultaneous clockwise torqueing, shaft withdrawal and flattening ofdeflection tip12. Further distal advancement ofscope10 then is achievable without causing pain to the patient, etc.
• FIG. 2 describe intubation via looping. In FIG. 2A,[0010]scope10 is inserted into sigmoid S with counterclockwise torqueing during scope advancement. In FIG. 2B, the broad loop in the sigmoid flattens the sigmoid-descending colon junction. Subsequent clockwise rotation ofscope10 with concurrent withdrawal accordionizes sigmoid S onto the scope.
• FIG. 3 describe intubation of ascending colon AC. In FIG. 3A,[0011]scope10 has a view of the ascending colon with sharp angulation in the right colic flexure F. In FIG. 3B, transverse colon TC is elevated into the upper abdomen via clockwise torqueing and withdrawal ofscope10. As seen in FIG. 3C,scope10 is then advanced via clockwise torqueing of the scope, flattening ofdeflection tip12 and evacuation of air from the distended colon C, thereby accordionizing the colon onto the scope. Complete intubation of cecum Ce then is achieved by further advancingscope10, as in FIG. 3D.
• According to Eubanks et al., accordionization most consistently enables examination of the greatest length of colon with the least amount of scope. In contrast to techniques where the scope is advanced up into the colon, accordionization should be viewed as bringing the colon down over the scope.[0012]
• “This technique employs simultaneous application of both dithering and torqueing. While the shaft is being advanced approximately 6 to 10 cm, a small amount of counterclockwise torque of about 45 to 60 degrees is applied. The process is reversed by applying clockwise torque and simultaneous withdrawal of the scope for the same length. This cycle is repeated in a rhythmic manner at a rate of about one cycle per second, but without advancement of the shaft. It is useful to hold the shaft of the scope close to the anus to avoid over-advancing. Although the first few dithering/torquing cycles may appear to accomplish little, by rhythmically continuing this motion, the cumulative effect is to pleat a short segment of sigmoid colon onto the scope. As one acquires experience with this technique, it soon becomes apparent that the cyclic rhythm, amount of torque, degree of tip deflection, and shaft advancement distance are all variables that can by altered to achieve maximum effect. If this technique is successful, the descending colon can be readily intubated as far as the splenic flexure by applying clockwise torque during shaft advancement with minimal deflection of the tip. With this approach, the endoscopist is attempting to straighten the colon as he or she progresses, rather than intentionally creating a loop that has to be removed later. Several principles should be kept in mind when this technique is performed:[0013]
• 1. This method should be started early in the process of intubation in the rectosigmoid to minimize the deflection angle.[0014]
• 2. It is not always necessary to see the entire lumen, but one should avoid pushing directly into the colonic wall.[0015]
• 3. The endoscopist should resist the temptation to advance the scope as soon as the lumen is seen, and should continue with this process to maximize the accordionization of the entire sigmoid colon.[0016]
• 4. Excessive gas insufflation is a deterrent to accordionization.[0017]
• 5. If this technique is not successful, one can proceed with intentional looping.”[0018]
• As will be apparent, the accordionization technique described by Eubanks et al. requires significant skill and experience on the part of the endoscopist in order to be successful. Furthermore, many variables must be taken into account in order to properly accordionize the colon, including cyclic rhythm, amount of torque, degree of tip deflection, and shaft advancement distance. It is expected that these limitations will hamper broad acceptance of accordionization techniques.[0019]
• In view of the aforementioned limitations, it would be desirable to provide methods and apparatus for pleating the colon that require less skill and experience on the part of the endoscopist.[0020]
• It also would be desirable to provide methods and apparatus that simplify and expedite pleating.[0021]
BRIEF SUMMARY OF THE INVENTION
• In view of the foregoing, it is an object of the present invention to provide methods and apparatus for pleating the colon that require less skill and experience on the part of the endoscopist.[0022]
• It is another object of the present invention to provide methods and apparatus that simplify and expedite pleating.[0023]
• These and other objects of the present invention are accomplished by providing apparatus that facilitates formation and retention of colonic pleats, thereby allowing physicians to use the scope as a tool for diagnosis and therapy, rather than as an access tool. The apparatus engages a proximal portion of the lumen to be intubated, and withdraws the lumen proximally over a relatively stationary endoscope or other device. This shortens an elongated section of luminal anatomy by compressing it in an accordion-like fashion over the endoscope or other device.[0024]
• In a first embodiment, an endoscope is partially advanced with an external engagement sheath. The sheath then is activated to engage the lumen wall. Once engaged, the lumen is pulled proximally by withdrawing or rotating the sheath. In an alternative embodiment, the scope is extended distally of the external sheath to “hook” tissue with its deflectable tip. The scope then is withdrawn towards the sheath, forming a pleat that is pulled back over the sheath. Once a pleat has been formed, an engagement member is activated on the sheath to retain the pleat.[0025]
• In yet another embodiment, engagement catheters are provided that may be advanced through the scope's working channel. The engagement catheters are extended beyond the scope to engage tissue and withdraw it towards the scope. The engagement catheters optionally may be used in conjunction with an external engagement sheath to initiate, position, and/or capture a pleat. Single anchoring/engagement members may be used, a plurality of engagement members may be used, a continuum of engagement members may be used, multiple sheaths may be used, etc.[0026]
• Pleating apparatus and methods of the present invention may be utilized to gain full access into a human colon. In contrast to known colonoscopic maneuvering techniques to shorten/straighten the colon and aid in intubation, the present invention provides separate pleating apparatus that may be used in conjunction with the endoscope to replace or reduce difficult prior art scope maneuvering techniques.[0027]
• Methods of using the apparatus of the present invention also are provided.[0028]
BRIEF DESCRIPTION OF THE DRAWINGS
• The above and other objects and advantages of the present invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:[0029]
• FIGS. 1A-1C are side views, partially in section, illustrating a prior art method of intubating and accordionizing the colon via elongation;[0030]
• FIGS. 2A-2C are side views, partially in section, illustrating a prior art method of intubating and accordionizing the colon via looping;[0031]
• FIGS. 3A-3D are side views, partially in section, illustrating a prior art method of intubating and accordionizing the ascending colon;[0032]
• FIGS. 4A-4C are side views, partially in section, illustrating a method of intubating and pleating the colon with a first embodiment of balloon apparatus of the present invention;[0033]
• FIG. 5 is a side-sectional view of the apparatus of FIG. 4;[0034]
• FIG. 6 is a side view, partially in section, illustrating the conformable nature of the apparatus of FIG. 4;[0035]
• FIG. 7 is a side view, partially in section, illustrating pleating via an alternative, non-conforming embodiment of the balloon apparatus of FIG. 4;[0036]
• FIGS. 8A and 8B are side-sectional views of another embodiment of apparatus in accordance with the present invention comprising expandable spines, shown, respectively, in a collapsed configuration and in an expanded configuration;[0037]
• FIGS. 9A-9C are side views, partially in section, illustrating a method of pleating the colon with the apparatus of FIG. 8;[0038]
• FIGS. 10A and 10B, respectively, are side and isometric views of alternative expandable spine apparatus shown collapsed and expanded;[0039]
• FIGS. 11A-11C are side views, partially in section, illustrating a method of pleating the colon with expandable mesh apparatus in accordance with the present invention;[0040]
• FIGS. 12A and 12B are side views of an alternative embodiment of the apparatus of FIG. 11 comprising a multi-humped expandable mesh, shown collapsed and expanded;[0041]
• FIGS. 13A-13D are isometric and side views of an alternative embodiment of oversheath pleating apparatus of the present invention comprising an expandable helix;[0042]
• FIGS. 14A-14C illustrate a method of pleating the colon with a pleat capture sheath of the present invention used in conjunction with a colonoscope;[0043]
• FIGS. 15A-15C are, respectively, isometric, side-sectional, and cross-sectional views of suction pleating apparatus of the present invention;[0044]
• FIG. 16 is a schematic view of an illustrative vacuum source and shut-off valve for use with the apparatus of FIG. 15;[0045]
• FIGS. 17A-17C are side views, partially in section, illustrating a method of pleating the colon utilizing the apparatus of FIG. 15 as an oversheath pleater;[0046]
• FIG. 18 is a schematic view of alternative suction pleating apparatus comprising a shape-lockable overtube;[0047]
• FIGS. 19A-19D are isometric views of further alternative suction pleating apparatus comprising various extendable anchors;[0048]
• FIG. 20 is a schematic view of pleating apparatus of the present invention configured for delivery through the working channel of a colonoscope;[0049]
• FIGS. 21A-21D are schematic views of various alternative engagement tips for the apparatus of FIG. 20;[0050]
• FIGS. 22A-22D are side views, partially in section, illustrating a method of using the through-scope pleating apparatus of FIG. 20 in conjunction with the pleat capture apparatus of FIG. 14 to form and capture pleats;[0051]
• FIGS. 23A-23C are side views, partially in section, illustrating a method of pleating the colon according to the present invention.[0052]
• FIGS. 24A-24C are side views, partially in section, illustrating a method of pleating the colon with continuous engagement apparatus of the present invention;[0053]
• FIGS. 25A-25C are side views, partially in section, illustrating a method of pleating with alternative continuous engagement apparatus comprising a corrugated tube;[0054]
• FIGS. 26A and 26B are side views, partially in section, illustrating a method of pleating with braided continuous engagement apparatus;[0055]
• FIG. 27 is an isometric view of continuous engagement apparatus comprising a braided mesh and a split sheath;[0056]
• FIGS. 28A and 28B are side views of cable-actuated braided engagement apparatus of the present invention; and[0057]
• FIGS. 29A and 29B are, respectively, a side view, partially in section, and an isometric view of an alternative embodiment of the apparatus of FIG. 28.[0058]
DETAILED DESCRIPTION OF THE INVENTION
• The present invention relates to methods and apparatus for achieving endoluminal access for instruments, e.g. tubular, fiberoptic instruments, such as colonoscopes, gastroscopes, and the like. More particularly, the present invention relates to methods and apparatus for achieving endoluminal access via anatomical pleating.[0059]
• One aspect of the invention comprises a pleating sheath that is advanceable over a colonoscope. The sheath, which preferably is fabricated from an extrusion of plastic material, is placed over the scope prior to use. Rounding off a leading edge or overmolding of the sheath may provide the sheath with a soft tip of foam or elastomer that acts as an atraumatic tip. Preferably, a metal spring coil is embedded in the wall of the sheath to provide flexibility in combination with kink-resistance. Alternatively, the sheath may be fabricated with a braided component embedded in the wall. This too allows good flexibility while maintaining strength.[0060]
• The sheath may be configured to minimize friction between itself and the colonoscope. This may be achieved by a variety of techniques, for example, the sheath may have internal ridges or nubs to reduce surface contact area, roller wheels or ball bearings may be provided in the wall to create rolling friction instead of sliding friction, or preferably a hydrophilic coating may be applied to the sheath's inner surface. The coating is activated by wetting with, e.g., water or saline, and significantly reduces the coefficient of friction between the scope and the sheath's internal surface.[0061]
• In use, the colonoscope preferably is advanced into the colon to a desired or achievable depth. Then, the pleating sheath preferably is back loaded up the scope or is introduced simultaneously with the scope. An anchoring feature preferably is provided at the tip of the sheath to engage the colon wall. The sheath then is withdrawn while the scope is held in place or further advanced. Withdrawal of the activated sheath pulls the colon proximally. The sheath-engaged colon pleats along the scope towards the anus. This shortens the colon by taking its stretched-out natural length and “bunching up” a portion of it.[0062]
• With reference to FIGS. 4-6, a pleating sheath embodiment is described comprising an engagement member having a distensible balloon. In FIG. 4A, pleating[0063]sheath50 is shown advanced overscope10 to a bend within a patient's colon C. In FIG. 4B,distensible balloon60 ofsheath50 is inflated to releasably engage the patient's colon in the vicinity of the bend. With colon C engaged,sheath50 is retracted relative toscope10, thereby pleating the colon over the scope and facilitating further advancement of the scope, as seen in FIG. 4C.Balloon60 then may be deflated to disengagesheath50 from colon C, and the sheath may be further translated relative toscope10.Balloon60 may be re-inflated, as desired, to engage the colon at additional locations, for example, to facilitate additional pleating.
• FIG. 5 illustrates[0064]lumen52 ofsheath50, which is sized for advancement overscope10, as well asinflation lumen54, which facilitates inflation and deflation ofballoon60, e.g., via a standard syringe coupled to a proximal region of the sheath (not shown). The physician inflates the balloon by injecting a prescribed amount of liquid or gas via the syringe. As seen in FIG. 6,distensible balloon60 has the advantage of achieving a minimal collapsed profile to aid in easy insertion, and also complies with the anatomy wherever it is inflated. The surface of said balloon optionally may have a texture to aid in engaging the wall of the colon.
• As seen in FIG. 7, a non-distensible balloon alternatively may be provided.[0065]Non-distensible balloon70 advantageously may be preformed into a desired shape. For example, the balloon may be formed to take on the inflated shape of a cone or “barbed” structure that preferentially engages the colon wall upon withdrawal. It also may have a maximum expansion size that could not be overridden by excessive inflation volume.
• Similar to the balloons described hereinabove, mechanical structures may be used to form the expanding anchor/engagement member. For example, as seen in FIG. 8, concentric sheaths may be provided.[0066]Apparatus100 comprises concentric, thin-walledinner sheath110 andouter sheath120.Inner sheath110 extends slightly distal ofouter sheath120, and comprisesinner lumen112 configured for advancement overscope10.Spines130, which may comprise slits formed inouter sheath120 and/or may, for example, comprise plastic, elastomeric, or metallic spines, connect the tip ofinner sheath110 with the tip ofouter sheath120. Relative translational motion between the two sheaths approximates the connected tips and causes the spines to “elbow out” or expand from the collapsed delivery profile of FIG. 8A to the expanded engagement profile of FIG. 8B.
• This relative motion may be achieved with a handle/slider mechanism, per se known, that the user operates to expand or contract the anchoring spines as desired. Alternatively, the mechanism for forming the “elbowed out” spines may use temperature-activated memory metal or plastic, in which flushing with a particular temperature liquid causes the spines to take on a desired profile. Electrical heating may also be used.[0067]
• With reference to FIG. 9, a method of using[0068]apparatus100 to pleat colon C is described. In FIG. 9A,apparatus100 is advanced overscope10 to a tortuous bend in the colon.Outer sheath120 is then advanced relative toinner sheath110, which causesspines130 to expand outward and reversibly engage colon C, as in FIG. 9B. In FIG. 9C,apparatus100 is withdrawn relative toscope10, thereby pleating the colon over the scope and facilitating further distal advancement of the scope.Outer sheath120 may then be retracted relative toinner sheath110 to disengagespines130 from colon C. This cycle of relative motion betweenscope10,inner sheath110 andouter sheath120 may be repeated as desired at additional distal locations within the colon to further pleat the colon.
• With reference to FIG. 10, a particularly atraumatic expanded spine structure is described.[0069]Apparatus150 comprisesspines160 that not only “elbow out,” they also “loop out” simultaneously to create a smooth edged expanded profile. FIG. 9A illustrates the collapsed configuration, while FIG. 9B illustrates the expanded configuration.
• Referring now to FIG. 1, expandable, tubular-braid like material also may be used.[0070]Braided mesh180 ofapparatus170 is extremely porous and compliant, yet exceptionally strong due to the composition of numerous interlaced fibrous elements.Braid180 is made from individual monofilament elements combined in an opposing helical pattern. The nature of the braided tubular structure allows it to have two diameter states. Axial tension of opposing ends of the braid causes it to elongate and reduce in diameter, as in FIG. 11A. Axial compression causes the braid to reduce in length while simultaneously expanding in diameter, as in FIGS. 11B and 11C. A disk-like anchor is made by forming two ends of a short length of braid intosmall diameter collars182A and182B. This may be accomplished by heat forming the mesh into continuous, diametrically fixed bushings that transition into the braid tube. Alternatively, the braid may be glued, overmolded, soldered, welded onto separate bushings. These bushings are then connected to, e.g.,co-axial sheaths110 and120 described above. Bringing the sheath ends in closer proximity causes braidedspines180 to expand outwardly into the anchoring disk of FIGS. 11B and 11C.
• In FIG. 11A,[0071]apparatus170 is coaxially advanced overscope10 to a bend incolon C. Mesh180 is then expanded to engage the colon, as in FIG. 11B. Next,apparatus170 is retracted relative toscope10, as in FIG. 11C, thereby pleating the colon over the scope and facilitating further distal advancement of the scope.Mesh180 is then collapsed, and the pleating technique may be repeated, as needed.
• With reference to FIG. 12, an alternative embodiment of[0072]apparatus170 is described.Apparatus170′ comprises ‘accordion’mesh180′ that forms multiple humps upon expansion, as seen in FIG. 12B, but that may be reduced for coaxially translation aboutscope10, as in FIG. 12A. It is expected that the multiple humps ofaccordion mesh170′ will facilitate pleating of the colon by contacting the colon over an increased surface area.
• Referring now to FIG. 13, much like the expanding spines and braid meshes described hereinabove,[0073]resilient helix192 ofapparatus190 may be drawn down to a low profile by attaching the ends of the helix to concentrically-disposedinner sheath110 andouter sheath120. Bringing the tube ends together expandshelix192, as in FIG. 13B, while pulling them apart collapses the helix, as in FIG. 13A. As seen FIGS. 13C and 13D, optionalelastomeric jacket194 may be placed overhelix192 in order to spread the contact area over a wider location than just the helix, thereby making the helix less traumatic. The spiral nature of expandinghelix192 also promotes some rotational motion of the tip, like an auger, which may help induce colon engagement or proximal motion of the colon. Alternatively, the helix may be made of temperature-activated memory metal or plastic, in which expansion of the helix is activated by exposure to a liquid of a predetermined temperature or electrical heating.Apparatus190, as well as the other mechanically expanding structures described hereinabove, may be used like the balloon embodiments to engage the colon wall, after which proximal motion of the sheath causes pleating.
• Apparatus of the present invention described with respect to FIGS. 4-13 illustrate use of an activated pleating sheath to actively pull back the colon wall. With reference to FIG. 14,[0074]pleat capture sheath200 is described, wherein colon C is pleated viaengagement anchor210, which is used to capture pleat P formed by a hooking maneuver conducted withdeflection tip12 ofscope10. In FIG. 14A,scope10 is advanced beyond a distal end ofapparatus200,deflection tip12 is steered into a hook shape, engaged to the colon wall, and then drawn back. The colon thereby forms pleat P overapparatus200, as seen in FIG. 14B. As seen in FIG. 14C,engagement anchor210 then may be activated to engage colon C and create a physical stop point so that pleat P cannot spontaneously slide forward on its own. Forming the pleat withscope10 and capturing it withapparatus200 may be repeated multiple times until the desired section of colon is available.Engagement member210 ofapparatus200 may employ any of the engagement structures described and illustrated previously, as well others, per se known. In FIG. 14,engagement member210 illustratively comprises an expandable balloon.
• Referring now to FIG. 15, suction is used commonly in the GI tract to bring an endoscope into contact with mucosa. Accordingly, as seen in FIG. 15A,[0075]apparatus220 may comprisesuction anchor222 having one ormore suction ports224 disposed on a distal region ofsheath226, for example, to pleat the colon or capture pleats formed byscope10.Scope10 may be translated withinlumen227 ofsheath226, as seen in FIG. 15B. Preferably, one ormore evacuation lumens225 run through the sheath and attach externally to a vacuum source (see FIG. 16). FIG. 15C illustrate exemplary alternative cross-sections ofsheath226 along section line A-A of FIG. 15B.Additional evacuation lumens225 may be provided, as needed, to coupleadditional suction ports224 ofsuction anchor222 to the vacuum source. Suction-based engagement may replace any of the expandable anchors shown and described above.
• When[0076]numerous suction ports224 are provided, a system of vacuum shut off valves may be used to block the continuation of suction through ports not in contact with tissue. For example, as shown in FIG. 16, eachport224 may be coupled tovacuum source230 via avacuum line232 having avalve234. Each valve may comprisechamber235 havingaperture236 through whichcork237 may be removably disposed to prevent flow therethrough.Cork237 may be coupled tocompression spring238 that biases the cork from occludingaperture236 when its associatedport224 is in contact with tissue. When associatedsuction port224 is not in contact with tissue,vacuum source230aspirates cork237 against the biasing force ofcompression spring238 to occludeaperture236, therebydecoupling vacuum source230 from thenon-contacting port224. This preventsapparatus220 from spontaneously adhering to different places after an initial acceptable anchoring occurs. Also, this feature prevents a continual evacuation of insufflation gas after anchoring is achieved. Generally, a quantity of gas pressure is desired in the colon to help tent it so that it is more easily accessed and visualized.
• With reference to FIG. 17, a method of using[0077]apparatus220 as a pleating oversheath to pleat the colon is described. As will be apparent,apparatus220 alternatively may be used to capture pleats formed viadeflection tip12 ofscope10. In FIG. 17A,apparatus220 is translationally advanced overscope10. Activation ofvacuum source230 causesdistal vacuum ports224 ofvacuum anchor222 to attach to mucosa along the wall of colon C, as in FIG. 17B. As seen in FIG. 17C, vacuum-anchoredsheath226 then is withdrawn relative toscope10, thereby pleating the colon as described previously.
• Advantageously,[0078]vacuum anchor222 providesapparatus220 with a small profile, even while engaging tissue. A degree of anchoring achievable withapparatus220 may be specified, for example, by controlling the size ofvacuum ports224, the strength of suction applied byvacuum source230, and inclusion of safety vents. An optional release mechanism (not shown) may also be provided, wherebysuction anchor222 releases colon C whensheath226 is retracted with sufficient force.
• [0079]Suction anchor222 may have numerous configurations. For example, suction port(s)224 may be configured as a single point, an elongated window, or multiple windows. Furthermore, port(s)224 may be located at a specific position along the wall ofsheath226, or may be distributed about the diameter or circumference.
• Referring now to FIG. 18, alternative suction anchoring apparatus in accordance with the present invention is described.[0080]Apparatus240 comprises shape-lockable overtube250 havingsuction anchor222 disposed on a distal end of the overtube.Apparatus250 further comprises actuation handle260 disposed at a proximal end ofovertube250 for reversibly transitioning the overtube from a flexible configuration to a substantially rigid configuration while the overtube is disposed in a desired arrangement. Shape-lockable overtubes are described in greater detail in Applicant's co-pending U.S. patent application Ser. No. 10/281,462, filed Oct. 25, 2002, which is incorporated herein by reference in its entirety.Suction activation valve252, as well assuction conduit254 for attaching to vacuumsource230, is also coupled to handle260.
• [0081]Apparatus240 may be used to pleat a patient's colon in a manner similar to that described forapparatus220 in FIG. 17. Handle260 may then be actuated to reversibly rigidize overtube250 and maintain the colon in the pleated configuration.Scope10 may be advanced throughhandle260 andovertube250.
• Referring to FIG. 19, to enhance engagement of suction ports to the colon wall, the suction ports may be configured to extend beyond the sheath. Such deployable ports advantageously facilitate contacting of the colon wall over a larger surface area, thereby enhancing holding force. Various low profile or deployable appendages may be utilized. In FIG. 19A,[0082]apparatus270 comprises a plurality of portedcoils272 that may be extended out ofsheath271 to “find” and engage the colon wall. In FIG. 19B,apparatus270′ comprises thin,elongated suction pad274 that extends fromsheath271. In FIG. 19C,apparatus270″ comprises pre-shaped,ported tube276 that may be advanced out ofsheath271 to form a helical suction pad. In FIG. 19D,apparatus270′″ comprises elastomerically coated mesh hose or braid278 that may be extended fromsheath271 to form a large-surface-area suction funnel. Additional extendable suction anchors will be apparent to those of skill in the art.
• Apparatus and methods of the present invention described thus far comprise apparatus configured for advancement over[0083]scope10 in order to pleat the colon. An alternative method for engaging the colon and creating pleats employs tools disposed through the working channel of the scope. With reference to FIG. 20,catheter300 with expandingtip310 may be advanced through workingchannel14 beyond the distal tip ofscope10, and then activated to engage the colon distal of the scope. Withdrawal of the catheter relative to the scope pulls the colon back towards the scope tip, thereby causing a pleat to form on the scope. Expandingtip310 may comprise any of the expanding structures described previously, including suction.
• FIG. 21 illustrate various embodiments of[0084]catheter300. In FIG. 21A,expandable tip310 ofcatheter300′ comprisesMalcot312. In FIG. 21B,tip310 ofcatheter300″ compriseshelix314.Catheter300′″ of FIG. 21C compriseshook316, whilecatheter300″″ of FIG. 21D comprisespre-shaped suction tube318. Additional engagement tip will be apparent to those of skill in the art.
• [0085]Engagement catheter300 may be used in conjunction with oversheath pleating apparatus and/or pleat engagement/capture sheaths described previously to induce and/or capture colon pleats. In FIG. 22, a balloon engagement tip embodiment ofcatheter300 is used in conjunction withscope10 andpleat capture sheath200 of FIG. 14 to pleat colon C. In FIG. 22A,catheter300 is advanced through workingchannel14 ofscope10, such thatballoon engagement tip310 is disposed distal of the scope.Sheath200 is advanced overscope10 to a position proximal of the distal end of the scope.Balloon engagement tip310 ofcatheter300 then is activated to engage and anchor against the colon, as in FIG. 22B. In FIG. 22C,catheter300 is withdrawn relative toscope10 andsheath200, thereby pleating the colon.Engagement anchor210 ofpleat capture sheath200 then is activated to capture pleat P, as seen in FIG. 22D.Catheter300 then may be de-activated and advanced again to engage a new section of colon C.
• Referring now to FIG. 23, an embodiment of the present invention is described comprising multiple external sheaths and anchors.[0086]Apparatus350 comprises a balloon-tipped, Mother-Daughter sheath assembly havingmother sheath352 withballoon353 anddaughter sheath354 withballoon355.Sheaths352 and354 may be used to “hand over hand” pull the colon proximally, in which each sheath operates similar to the balloon tipped sheath initially described. Providing multiple engagement sheaths facilitates more intricate pleating of the colon.
• The Mother-Daughter sheath assembly of[0087]apparatus350 may be introduced overscope10, as seen in FIG. 23A. In FIG. 23B,balloon353 ofmother sheath352 is activated to anchor colon C to the mother sheath, anddaughter sheath354 is advanced withscope10. Simultaneously,mother sheath352 is withdrawn, thereby pleating a portion of the colon.Balloon355 ofdaughter sheath354 then is activated, as seen in FIG. 23C, and the daughter sheath is withdrawn relative to the scope. Immediately after activation ofdaughter balloon355,mother balloon353 is deflated. Asdaughter sheath354 completes its withdrawal, a new section of colon C is pleated over deflatedmother balloon355. The mother balloon then is re-inflated, capturing the two sections of colon in a pleat.Daughter balloon355 then is deflated, anddaughter sheath354 is advanced again into a new section of the colon. This procedure may be repeated as many times as desired, and the sheaths may be advanced and inflated as far as, and as much as, desired.
• Such stepwise formation of a pleat alternatively may be achieved in a similar mother-daughter manner using any of the other expanding or suction anchors described previously. Furthermore, the sheaths of[0088]apparatus350 optionally may be moved relative to one another, and/or the balloons inflated and deflated, using a mechanical or electromechanical actuator. The actuator may include a handle/slider that is coupled to reciprocating inflation bladders. The arrangement may be actuated by repeatedly engaging a trigger or slide by the user.
• With reference now to FIG. 24, a continuous anchor/pleating engagement sheath is described.[0089]Apparatus400 comprisessheath410 having external thread-like spiral rib420. The spiral rib may comprise, for example, an elongated balloon that is introduced in a low profile deflated state. Once in a desired position,rib420 may be activated by inflation, and then used to rotationally draw the colon into a pleat.
• As seen in FIG. 24A,[0090]sheath410 is slid into place overscope10. In FIG. 24B, a secondary twisting rotation engages colon C alongrib420, which draws the colon down the length ofsheath410 like an auger and pleats the colon, as in FIG. 24C. Colon C alternatively may be pleated by initially screwingapparatus400 into position, with no linear advancement ofsheath410 overscope10. The sheath would be positioned slightly in the rectum and rotated to bring the colon down over it. Preferably, a hybrid motion comprising some linear advancement and some twisting would be used to achieve pleating.
• With reference to FIG. 25, another embodiment of a continuous engagement sheath is described comprising an expandable corrugated tube. In FIG. 25A,[0091]expandable tube452 ofapparatus450 is inserted into colon C in its extended collapsed form.Apparatus450 comprises a thin walled inner sheath (not shown) attached to the distal tip oftube452. Retracting the inner sheath while holding the outer corrugated tube stationary causes the corrugations to expand outward and engage the colon wall, as in FIG. 25B.Tube452 may be used to actively engage the mucosa, or the enhanced frictional surface of the compressed corrugations may engage the length of the colon wall. As corrugations form alongtube452 due to withdrawal of the inner sheath, the sheath tip moves proximally, bringing with it the engaged colon, as in FIG. 25C.Apparatus450 may be further retracted after expansion/corrugation oftube452 to further pleat the engaged colon.
• FIG. 26 illustrate yet another embodiment of apparatus of the present invention that continuously engages the colon wall.[0092]Apparatus470 comprises expanding braid tube orsleeve480 that is disposed overinner sheath490. As the inner sheath is pulled proximal while the braid sleeve is held at anus A, as in FIG. 26A, the distal tip junction ofsleeve480 andsheath490 is withdrawn down the colon. This is accompanied by the textured braid sleeve expanding to engage the colon wall. Continued withdrawal of the inner sheath pulls the tip back further and continues braid expansion, thereby engaging and pleating the colon, as in FIG. 26B.Apparatus470 is similar toapparatus170 of FIG. 11, as well asapparatus170′ of FIG. 12, except thatengagement braid480 is disposed over a substantially greater longitudinal distance along the apparatus.
• With reference to FIG. 27,[0093]apparatus500 comprises braid tube orsleeve510 coupled at its distal end toinner sheath520. The inner sheath comprises optional split orseam522, such that as it is removed from the colon it can be “pealed” away fromscope10.Split522 may comprise a thinning in the wall ofsheath520 to facilitate tearing thereof, or may comprise a zipper or other similar mechanism to permit the sheath to be reformed even after it has been split. The split sheath is beneficial in that it would not occupy space over the scope's shaft outside of the patient; many colonoscopists value the ability to hold the scope shaft directly near the anus to obtain adequate feel of the scope and optimum scope maneuvering.
• Another feature demonstrated by a braid pleating sleeve is its ability to be very flexible in its elongated state. When it is compressed it has a tendency to straighten and feel much firmer. The braid pleating sheath therefore may act as a flexibly placed pleating sheath that transforms into a sturdy, more conventional straightening tube after activation.[0094]
• Referring now to FIG. 28, further alternative pleating braid apparatus is described. When pleating with[0095]apparatus470′,inner sheath490′ is left in position, andpleating braid480′ is withdrawn or extended by activating opposing cables A and B. Distal bushing C of the pleating braid may be coupled to one or more pleat-forming cables B and one or more return cables A, as seen in FIG. 28A. When cable B is tensioned, distal collar C is drawn in the proximal direction towards the proximal bushing, thereby pleating the braid and inducing the colon to pleat. When cable A is tensioned and cable B is released, distal bushing C may be pulled in the distal direction to return the braid to its elongated, non-pleated state. To reciprocate tension between cables A and B, lever arm Ar having pivot P may be coupled to the cables. As illustrated in FIG. 28B, when a user turns the lever arm in the counterclockwise direction, cable B is tensioned, taking up slack within cable A. Similarly, when the lever arm is turned in the clockwise direction, cable A is tensioned, and slack within cable B is taken up.
• With reference to FIG. 29, an alternative cable-controlled pleating sleeve is shown.[0096]Apparatus550 comprises pleat-forming cables C and D, which extend fromdistal slide collar552, through proximal fixed collar554 and out of the patient.Apparatus550 further comprises return cables A and B, which extend fromdistal slide collar552 throughsheath560 and out of the patient. It may be preferential to have this arrangement mirrored to better balance the cable forces. For clarity of the sketch, mirrored cables are not shown in FIG. 29.
• Although preferred illustrative embodiments of the present invention are described above, it will be evident to one skilled in the art that various changes and modifications may be made therein without departing from the invention. For example, although the apparatus has been described as suited for pleating the colon, it should be understood that the apparatus alternatively may be used to pleat any other suitable body lumen, for example, alternative portions of the gastrointestinal lumen, the small bowel, vascular lumens, etc. 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.[0097]

Claims (20)

What is claimed is:

1. Apparatus for pleating at least a portion of a patient's body lumen, the apparatus comprising:

a first flexible conduit; and

a second flexible conduit comprising an engagement element,

wherein the second flexible conduit is configured for sliding axial movement relative to the first flexible conduit, and

wherein the engagement element is configured to reversibly engage the patient's body lumen.

2. The apparatus ofclaim 1, wherein the body lumen comprises a lumen chosen from the group consisting of the patient's colon, gastrointestinal lumen, small bowel, vascular lumens, and combinations thereof.

3. The apparatus ofclaim 1, wherein the first flexible conduit comprises an endoscope.

4. The apparatus ofclaim 1, wherein the second flexible conduit comprises a sheath coaxially disposed about the first flexible conduit.

5. The apparatus ofclaim 1, wherein the first flexible conduit comprises a lumen, and wherein the second flexible conduit is configured for sliding axial movement within the lumen.

6. The apparatus ofclaim 1, wherein the first flexible conduit comprises a deflection tip.

7. The apparatus ofclaim 1, wherein the engagement element is chosen from the group consisting of expandable spines, balloons, distensible balloons, non-distensible balloons, expandable meshes, expandable braids, cut tubing, expandable anchors, expandable helices, suction elements, extendable elements, malcots, corrugated tubes, spiral ribs, continuous engagement elements, pleat capture elements, and combinations thereof.

8. The apparatus ofclaim 1, wherein the second flexible conduit is configured to pleat the body lumen.

9. The apparatus ofclaim 1, wherein the first flexible conduit is configured to pleat the body lumen and the second flexible conduit is configured to maintain pleats formed by the first flexible conduit.

10. The apparatus ofclaim 1, wherein the second flexible conduit is adapted to transition between a flexible configuration and a substantially rigid configuration in a desired arrangement.

11. A method for pleating a least a portion of a patient's body lumen, the method comprising:

advancing a first flexible conduit into the body lumen;

advancing a second flexible conduit having an engagement element along the first flexible conduit;

actuating the engagement element to reversibly engage the body lumen; and

retracting the second flexible conduit relative to the first flexible conduit, thereby pleating at least a portion of the body lumen.

12. The method ofclaim 11, wherein advancing a first flexible conduit further comprises advancing an endoscope.

13. The method ofclaim 11, wherein advancing the second flexible conduit along the first flexible conduit further comprises advancing the second flexible conduit over the first flexible conduit.

14. The method ofclaim 11, wherein advancing the second flexible conduit along the first flexible conduit further comprises advancing the second flexible conduit through the first flexible conduit.

15. The method ofclaim 11 further comprising advancing the first flexible conduit further into the body lumen.

16. The method ofclaim 11 further comprising disengaging the engagement element from the body lumen.

17. The method ofclaim 16 further comprising advancing a third conduit over the first and second conduits, and maintaining body lumen pleats with the third conduit.

18. A method for pleating a least a portion of a patient's body lumen, the method comprising:

advancing a first flexible conduit into the body lumen;

advancing a second flexible conduit having an capture element along the first flexible conduit;

engaging the body lumen with the first flexible conduit;

retracting the first flexible conduit relative to the second flexible conduit, thereby pleating at least a portion of the body lumen; and

actuating the capture element of the second flexible conduit to maintain body lumen pleats.

19. The method ofclaim 18 further comprising advancing the first flexible conduit further within the body lumen.

20. The method ofclaim 18 wherein advancing the first flexible conduit further comprises advancing an endoscope into the body lumen.

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