Apparatus for advancing a device from one body lumen to another

ES 2 575 245 T3

DESCRIPTION

Apparatus for advancing a device from one body light to another

Background of the invention

Field of the invention. The present invention relates generally to medical apparatus and methods. In particular, the present invention relates to a guidewire type tissue penetrating device having the ability to hold adjacent tissue layers in juxtaposition while tools are being inserted through.

A number of endoscopic intralight and other procedures require access from a body lumen to an adjacent body lumen. For example, a number of procedures can be carried out by entering the gastrointestinal (GI) tract, particularly the esophagus, stomach, duodenum, small or large intestine, and passing tools from the GI tract to adjacent organs, ducts, cavities, and others. structures, such as the bile duct, pancreatic duct, gallbladder, urinary tract, a cyst or pseudocyst, an abscess, and the like. Such an access into the adjacent body lumen will require forming a penetration or other access hole from within the first body lumen, through a wall of the first body lumen, through a wall of the second body lumen, and even into the second body light. Furthermore, depending on the procedure being carried out, it will usually be necessary to place a catheter, a stent, a drainage tube or the like through the penetrations that have been formed in each of the body lumens.

Of particular interest to the present invention, after a penetration from the first body lumen to a second body lumen has been formed, and a guidewire or other tracking device has been placed through such penetrations, is that it can be difficult to advance one intervention tool or another from the first body lumen, over the guidewire, to the second body lumen. It will be appreciated that most body lights have relatively weak or flabby wall structures. Many currently available interventional tools have atraumatic, blunt, or other distal ends that have a tendency to push the walls away from the lumen when engaged by the tool as the tool is advanced over the guidewire. This is particularly true of entry through the wall of the second body lumen into the interior of the second body lumen. Therefore, even a successful placement of a guidewire from a first body lumen to a second body lumen does not guarantee a successful introduction of a therapeutic or other device over the guidewire.

A particular problem may appear with translight penetration from the GI tract into an adjacent duct or an organ that contains a lumen. Such an access is often necessary to place a catheter, stent, or other drainage device. Although ductal structures such as the common bile duct and the lumen-containing organ such as the gallbladder are immediately adjacent to the stomach and small intestine, they are not attached and a lead wire or penetration device within the gallbladder or the bile duct from the stomach or small intestine can displace the target structure, resulting in an effusion within the peritoneal cavity. Therefore, it is desirable that a juxtaposition of the lumen from the gallbladder or bile duct to the stomach or small intestine be achieved as soon as possible after a first penetration and is safely maintained until the implant can be placed. drainage catheter or stent.

For these reasons, it would be desirable to provide guide wires and other tracking devices that can be used to provide access from a first body lumen to a second body lumen in a manner that facilitates entry into the second body lumen. In particular, it would be desirable to provide guidewires and guidewire-like devices that can stabilize adjacent lumen wall structures and prevent or inhibit spillage when one therapeutic or other tool is being inserted over the guidewire. Such tools and methods should be compatible with standard endoscopes and other envelopes that can be used to access a target location in the gastrointestinal tract or other body lumen. At least some of these objectives will be met by the inventions described below.

Description of the state of the art. Guidewires and guidewire-type devices having inflatable occlusion balloons are described in US Patent Nos. 4,790,813; 5,207,229; 5,209,727; 6,251,084; 6,475,185; 6,902,535; 6,942,678; 7,150,723 and 7,169,161. Trocars and trocar-type devices having balloons and other deployable anchors are described in US Patent Nos. 3,039,468; 3,717,151; 4,608,965; 5,183,464; 5,197,971; 5,275,610; 5,290,249; 5,330,497; 5,353,785; 5,443,484; 5,688,247; 5,713,870; 5,817,062; 5,882,340; 5,935,107; 6,632,197 and 7,377,897. Other patents of interest include US Patent Nos. 4,705,040; 5,275,611; 5,304,198; 6,080,174; 6,626,919; 6,635,068 and 7,331,980.

Prior art document US2008 / 0065012 discloses a guidewire comprising a guidewire body having a distal end and a proximal end; an expandable balloon near said distal end of the guidewire body and a blade disposed on the expandable balloon on the guidewires, said blade having a retracted configuration in the guidewire body and a deployed configuration

ES 2 575 245 T3 having a cutting edge that extends outside the guidewire body.

Brief summary of the invention

The present invention provides a guide wire as defined in the appended claims.

Described herein are methods and apparatus for establishing access tracts from a first body lumen to a second body lumen. In particular, the methods described herein provide a juxtaposition of the body lumen walls so that catheters, stents, and other tools can be advanced through the access tract with minimal or no spillage of the contents. of light through the tract that is being formed. The apparatus comprises guidewire or guidewire-like devices having an anchor at or near their distal ends. The anchors may be deployed in the second body lumen or the target so that the guide wire can be pulled or otherwise closely tensioned to draw the wall of the second body lumen against the wall of the first body lumen. By maintaining a tension on the guidewire, the two walls can be kept in close juxtaposition in order to minimize or avoid spillage of the contents of both body lights through the holes that have been formed in the walls of the light. Such juxtaposition and stabilization of tissue also facilitates an introduction of catheters and other tools over the guidewire or guidewire-like device while maintaining tissue position and sealing.

The anchors can take various forms and will often be configured to provide a workspace or cavity on the inner side of the wall of the second body lumen. Such a workspace or cavity allows a catheter, stent, or other working tool to advance over the guidewire through the access tract and into the second body lumen without interference from the anchor. The apparatus may also include one or more deployable blade (s) to enlarge a tissue penetration as the guidewire is advanced. The guide wires may have distal tissue penetrating tips, in which case they can be used to form the initial penetration from the first body lumen to the second body lumen. Alternatively, the guidewires can have conventional "soft" guidewire tips or other non-penetrating structures, in which the guidewires can be introduced through a pre-formed tissue tract formed by needles, trocars, or the like. .

The methods and apparatus described herein can be used to form or pass through a preformed tissue access tract from any first body lumen to any adjacent second body lumen. Most commonly, the first body lumen will be part of the gastrointestinal (GI) tract including the esophagus, stomach, duodenum, small intestine, large intestine, and colon. The second body lumen will normally be a lumen or other cavity or structure that is adjacent to the gastrointestinal tract, including ducts such as the bile duct and pancreatic duct, organs that contain a lumen such as the gallbladder and urinary gallbladder, tissue organs solid, such as the pancreas and liver, as well as diseased structures, such as cysts, pseudocysts, abscesses, and the like. After an access has been established, various therapeutic or diagnostic tools can be introduced, usually by passing them coaxially over the guidewire in a conventional manner. Devices include catheters, stents, electrosurgical tools, drug delivery devices, implantable anchors, implantable pacing devices, and the like.

In a first example, methods are provided for advancing a device from a first body lumen to a second body lumen. The methods comprise advancing a guidewire through the first body lumen to a target location. The guidewire is penetrated distally through a wall of the first body lumen at the target site and into the second body lumen through a wall of the second body lumen. Often the guidewire will have a tissue penetrating tip that allows the guidewire to form the first and second lumen wall penetrations. Alternatively, the lumen wall penetrations may have been previously formed using trocars, needles, or other tissue penetrating devices. An initial guidewire placement will normally be accomplished through an endoscope, wrap, or other tool that allows an identification of the target location and a direction or orientation of the guidewire toward the target location.

After the guidewire has been passed from the first body lumen, through the tissue tract and into the second body lumen, an anchor in the guidewire in the second body lumen will expand. By pulling the guide wire closely, the expanded anchor can engage against the inner wall of the second body lumen to draw said wall against the wall of the first body lumen. Pulling of the guidewire can continue or it can be fixed or immobilized in order to continue to apply tension to the guidewire and keep the first and second lumen walls in juxtaposition. While the juxtaposition is being maintained, a tool can be advanced over the tensioned guidewire from the first body lumen and into the second body lumen. Typically, tension will be applied to the guidewire for the entire time the tool is being advanced. The first body light can be any body light, typically a light that is accessible through a natural body orifice, such as the gastrointestinal tract. The second body lumen will usually be an organ or other structure that is adjacent to the

ES 2 575 245 T3 first body lumen, normally being one of the organs or structures listed above. The methods described herein will find a particular use to access a pancreatic pseudocyst through the stomach or duodenum in order to place a stent or drainage catheter in order to drain the pseudocyst. The methods will also find use in accessing the bile and pancreatic ducts from the duodenum in order to drain the duct. The methods will find even more use in accessing the gallbladder from the duodenum or stomach in order to drain the gallbladder.

In most cases, the guidewire, or at least a portion of it, will be flexible enough that it can be advanced through a wrap in the first body lumen and conform to the shape of the first body lumen. At other times, however, the guidewire may be less flexible (stiffer), sometimes being substantially rigid, so that the first body lumen or other access passage will conform to the shape of the guidewire when it is being used. going forward.

In a preferred example, expanding the anchor will comprise expanding an anchor having a recess on one side adjacent to the wall of the second body lumen. The recess allows a tool to be advanced so that its distal end is received in the recess (i.e., the recess provides a space that can accommodate the distal end of the tool as it advances through tissue wall penetrations) , without disrupting the deployment of the anchor or its ability to continuously apply tension to the lumen wall of the second body cavity. The anchors can take various forms, including balloon anchors, mechanical elements, box structures, or the like. The anchors can be symmetrical so that they engage the second lumen wall around an interface or lip that is generally circular and concentric with the access tract. In other cases, the anchor may be asymmetrical so that it is located only on a single side of the access passage. In the second cases, it may be possible to advance a catheter or other access tool over the guidewire with a distal end of the access tool passing over a portion of the guidewire where there is no anchoring structure.

In some example embodiments, the guidewire may include a deployable blade that can be opened prior to or during advancement of the guidewire through tissue penetration. The drop-down blade will enlarge the penetration that is being formed. Such an enlarged penetration can accommodate a passage of larger diagnostic, therapeutic, or other tools. It will be appreciated, however, that an enlarged tissue penetration may require an improved seal while a treatment tool is being advanced and stabilized at penetration.

In another example, a guidewire comprises a guidewire body having a distal end and a proximal end. An expandable anchor is disposed at or near the distal end of the guidewire body and a blade is also disposed adjacent the expandable anchor. The blade will have a retracted configuration that conforms to the guidewire body and a deployed configuration that has a cutting edge extending out of the guidewire body. Therefore, advancement of the guidewire with the blade extended or unfolded will enlarge penetration by forming incision (s), usually radially aligned on the tissue tract walls in the tissue of the first and second body lumens. The manufacture and use of such cutting blades is described in detail in another provisional pending application 61 / 171,228 (Agent's File No. 026923-001200US).

The guidewire bodies will normally have a length in the range of 100 cm to 500 cm, more usually 150 to 250 cm, and an external diameter, at least at the distal end, in the range of 0.4 mm to 5 mm. , more usually 0.5mm to 2mm. The guidewire body may have a solid core, but will more typically have a hollow center in order to allow for swelling, expansion, or other manipulation of the anchor and optionally the blade (s). The anchor can take any of the forms discussed above, including balloons, boxes, Malecots, self-deploying springs, flanges, cones, or the like. Similarly, a wide variety of different drop down blades can be provided. In their simplest form, the devices can include only a single blade mounted on a center pivot. Two, three or four blades may alternatively be provided on individual pivots and may be deployed in a symmetrical or asymmetrical manner. Both the blades and the anchors may be self-deploying or alternatively they may require separate deployment mechanisms in order to selectively expand and contract the anchors and / or blades. The blade will normally be distally distal to the expandable anchor to allow the tissue tract to enlarge prior to deployment and placement of the anchor. Alternatively, the blade and anchor may be positioned adjacent to each other, typically wherein the blade opens in a first radial orientation while the expandable anchor opens in a second radial orientation.

In another example, the present invention comprises guidewires having a guidewire body with a distal end and a proximal end. An expandable anchor in the guidewire body has a retracted configuration that conforms to an outer surface of the guidewire body and an expanded configuration that has a distal surface and a proximal surface. The proximal surface has a peripheral edge and a concave space or region on the peripheral edge. The concave space or region provides a working space when the peripheral edge of the anchor is drawn proximally against a tissue surface of the target body lumen. In particular, the workspace allows a catheter, stent, or other tool or device to be advanced over the

ES 2 575 245 T3 guidewire while the anchor continues to apply tension to keep the first and second lumen walls in juxtaposition.

The particular dimensions of the catheter body are described above. The expandable anchor will typically have a peripheral diameter in the range of 1mm to 20mm and the cavity provided by the anchor will have a volume in the range of 0.05ml to 1ml. The cavity will usually have a generally conical shape with an apex attached to the catheter shaft and a peripheral base generally disposed concentrically around the catheter shaft at a location proximal to the apex. The guidewire may have either a tissue penetrating tip, such as a sharp tip, an electrosurgical tip, or the like. Alternatively or additionally, the distal tip of the guidewire body may be steerable.

Brief description of the drawings

Fig. 1 illustrates a guidewire having an expandable anchor manufactured in accordance with the principles of the present invention.

Fig. 2 illustrates a second embodiment of a guidewire having an expandable anchor and a deployable blade manufactured in accordance with the principles of the present invention.

Fig. 3 illustrates an expandable balloon-type anchor having a single inflation lumen with a valve to allow inflation and sealing of the balloon.

Fig. 4 illustrates an expandable balloon-type anchor having a working space or cavity in a proximal surface thereof.

Fig. 5 illustrates a guidewire having a distal cutting blade and an expandable proximal anchor.

Fig. 6 illustrates a guidewire having an asymmetric expandable anchor and a catheter with an asymmetric end that can bypass the anchor when advanced over the guidewire.

Figs. 7A and 7B illustrate a low profile anchor structure in which a tubular guidewire body is divided into three segments and can be deployed by axial foreshortening.

Fig. 8 illustrates a guidewire with an expandable braid anchor.

FIG. 9 illustrates a guidewire having a pair of self-deploying wire anchors and a deployable blade that is radially offset by 90 ° from the anchors.

Fig. 10 illustrates a guidewire having a deployable light anchor and a radially offset deployable blade.

Fig. 11 illustrates a guidewire having a unique structure that provides both a cutting blade and a deployable anchor.

FIGS. 12A and 12B illustrate a guidewire having a segmented self-penetrating tip, in which the tip can be axially advanced and deployed into three flipping anchor elements.

FIGS. 13A-13D illustrate a method in accordance with the present invention in which a pair of adjacent tissue layers are held in juxtaposition while advancing a tool over a guidewire.

Detailed description of the invention

Referring to Fig. 1, a guidewire 10 manufactured in accordance with the principles of the present invention comprises an elongated body 12 having a distal end 14 and a proximal end 16. An expandable anchor is disposed near the distal end 14 of catheter body 12 and can expand from a contracted configuration (shown in solid line) that closely conforms to the exterior of the catheter body to an expanded configuration (shown in broken line). which will have a width or diameter significantly greater than the diameter of the catheter body, normally being at least twice as wide, often being at least four times as wide, being sometimes six times as wide or greater. The expandable anchor 18 can have any one of several structures and geometries. The expandable anchor 18 is shown as an inflatable balloon having a conical geometry with the wide portion or base oriented in a proximal direction. Thus, the base will be able to engage and seal against tissue in the second or target body lumen when the guidewire is drawn in a proximal direction.

An exemplary first guidewire 10 may have the dimensions and properties generally associated with conventional medical guidewires. For example, catheter body 12 may be flexible enough to

ES 2 575 245 T3 adapt to a sinuous path through a body light when moving forward. It may comprise a steerable tip 20 at its distal end to allow the catheter to be advanced and steered through a body lumen. It can be solid or hollow, normally being hollow to allow inflation of the balloon 18 (usually using a valve structure as described in more detail with respect to Fig. 3). Typically, it will be free of any structure at the proximal end which would prevent a coaxial insertion of the catheter, stent, or other tool there. Alternatively, a removable connector or other structure (not shown) could be removably attached to the proximal end, for example, to be attached to a source of inflation to inflate the balloon.

An exemplary second guidewire structure 30 is illustrated in FIG. 2. A guidewire 30 includes a catheter body 32 that may be stiffer, optionally being rigid, in contrast to guidewire body 12 of guidewire 10. For example, guidewire body 32 may be formed by a relatively stiff hypotube over its entire length. A guidewire 30 is also illustrated as having both an anchor mechanism 34 and a blade mechanism 36, with particular deployment mechanisms for both the anchor and the blades illustrated below. Other blade actuation mechanisms are described in detail in another pending application 61 / 171,228 (Agent's File No. 026923-001200US). Guidewire 30 also includes a self-penetrating tip 38, which is illustrated as a faceted tip. Other sharp tips and self-penetrating designs may be employed, including bevel tips, electrosurgical tips, piercing tips, and the like.

Referring now to FIG. 3, a guidewire 40 comprises a guidewire body 42 having an inflatable balloon anchor 44 at a distal end 46 thereof. Inflatable balloon anchor 44 will preferably be formed of polyurethane, silicone, or other elastomeric material such that advancement of a catheter or other tool over guidewire body 42 allows the distal end of the tool to deform a proximal surface 48 of the balloon so that a recess or cavity 50 can be formed to house the tool, as shown with a broken line. Since it is generally desirable to maintain a small diameter in guidewire body 42, guidewire 40 employs a single lumen 52 for balloon inflation. The balloon can be inflated by attaching a syringe or other source of inflation to a proximal end (not shown) of guidewire body 42 and closing balloon inflation port 54 by attracting a valve ball 56 closely using a valve wire. 58 after the ball has been inflated. In this way, the valve can be opened first to allow inflation (as shown in broken line) and then closed to preserve inflation in the balloon (as shown in solid line). Of course, it will be possible to place other valves in the single lumen 52. For example, a valve mechanism similar to a pneumatic type valve can be placed at or near the proximal end of the guidewire body 42. Inflation can be introduced through the valve in a conventional manner (such as for tires) and can be released by pressing the valve stem inward (again as is conventional with a tire inflation mechanism). A wide variety of other single lumen balloon inflation and deflation mechanisms are known and described in the patent literature.

Referring now to FIG. 4, a guidewire 60 includes a guidewire body 62 having an inflatable balloon 64 at a distal end 66 thereof. Balloon 64 is generally cylindrical, but has a preformed wall notch 68 that defines a cavity or working space 70 when the balloon is fully inflated. Such a preformed balloon can be formed of elastomeric materials (eg. g. silicone rubbers), but will more usually be formed of non-stretchable materials such as polyethylene terephthalate, nylon, and the like). The cavity 70 is surrounded by a peripheral base or lip 72 that can engage a tissue wall surrounding a tissue penetration when the guidewire 60 is drawn proximally after it has entered the body lumen and is has inflated the ball 64. The cavity 70 is useful to allow an advancement of a catheter or other work tool through the penetration of tissue or tract while the balloon 64 is being attracted against the tissue structure to apply a tension to maintain a juxtaposition of walls of the tissue. adjacent tissue.

Referring now to Fig. 5, a guidewire 80 includes a guidewire body 82 having an inflatable balloon anchor 84 and a pair of deployable blades 86. Each blade has a leading cutting edge 88 that is at the same time. disposed towards the tissue when the blade is fully deployed, as illustrated in Fig. 5. Inflatable balloon anchor 84 can be inflated by a single internal lumen, as previously described, and blades 86 can be moved between a constricted configuration (where they are fully retracted into catheter body 82) and the deployed configuration that is being deployed. illustrates. A wide variety of specific deployment configurations are illustrated in another pending provisional application 61 / 171.228 (Agent's File No. 026923-001200US). Catheter 80 is shown with a sharp, tissue penetrating tip 90, thus the guidewire can be used to form the penetration, enlarge the penetration with the deployable blades 88, and then seal the resulting enlarged tissue penetration. with the ball 84.

Referring now to Fig. 6, yet another guidewire 100 comprising a guidewire body 102 includes an asymmetric balloon anchor 104. The balloon anchor 104 extends externally from the guidewire body 102 in only a radial direction, leaving other radial portions of the guidewire free of structure. Therefore, a catheter 106 having an angled end 108 can be advanced over the lead wire.

ES 2 575 245 T3 guide 100 and at least partially bypass the deployable balloon anchor 104 by orienting the advancement tip 110 of the catheter so that it passes through a side of the guide wire opposite that of the asymmetric balloon (the side free of anchoring structure ). Guidewire 100 is shown as having a self-penetrating tip 112, but could also be configured to have a blunt, steerable, or other tip.

Referring now to Figs. 7A and 7B, a guidewire 120 can be manufactured to have a particularly small diameter (low profile) by forming an expandable anchor structure 122 integrally in the guidewire body 124. The guidewire 124 comprises a hypotube or other small tubular structure. A distal portion of the tubular structure is divided along three lines to form three independent elements 126 formed of an elastic material, typically an elastic material such as nitinol or stainless spring steel or alternatively an elastic polymer. The elements 126 are formed to be positioned in the radially constrained fabrication of Fig. 7A and can be radially expanded, as shown in Fig. 7B, axially foreshortening the end of guidewire body 124, typically pulling a tension member 128 to attract distal end 130 in a proximal direction. Guidewire 120 is shown as having a steerable tip 132, but could also have a tissue penetrating tip.

Referring now to Fig. 8, a guidewire 140 may have an expandable anchor 142 in the form of a radially expanding braid. The braid will be formed as a tubular structure having a diameter similar to that of guidewire body 144. By drawing onto a central member 146, the distal tip 148 of the guidewire can be foreshortened to radially expand braid 142, as shown. shown in Fig. 8. The manufacture of suitable radially expandable braids is shown in various patents, including US Patent Nos. 6,080,174 and 7,331,980.

Referring now to Fig. 9, a guidewire 160 comprises a guidewire body 162 having self-expanding anchor members 164 and a deployable blade 168. Anchor members 164 are disposed on opposite sides of the body of guidewire and have generally preformed spiral structures. An outer wrap 170 can be axially advanced and retracted to close and deploy anchors 164. A deployable blade structure 168 is pivotally attached to open and close in a slot 172 in guidewire body 162. Ties 174 are provided to open and close the blade. Knife mechanisms of this type are described in more detail in another pending provisional application 61 / 171,228 (Agent's File No. 026923-001200US).

Referring now to FIG. 10, a guidewire 180 having a guidewire body 182 includes self-expanding band anchors 184 that assume the illustrated shape when unconstrained and that can be folded into grooves 186 (only one of which is illustrated) on guidewire body 182 to allow the anchors to lay flat. They can be constricted by pulling proximal ends of the anchors with ties or by using a constriction wrap. A cutting blade 190 is pivotally attached to move in and out of a second slot 192, in which the slots 186 and 192 are orthogonally opposed (positioned at 90 degrees to each other), so that the anchors and blades can be deployed without interference. A guidewire 180 is shown with a self-penetrating tip 196, but could also have non-penetrating tips.

Referring now to FIG. 11, a guidewire 200 includes a guidewire body 202 having a self-penetrating tip 204 at its distal end. A single slot 206 is formed in the body and a single deployable structure 210 is provided that can be rotated in and out of the slot. A rotation can be achieved using ties, springs or the like. Structure 210 serves as both a cutting blade and an anchor. A leading or distal edge 212 of the frame is sharp so that it can cut tissue when the guidewire is advanced. The proximal side of frame 214 is configured to grasp tissue when the guide wire is drawn proximally into tissue.

Referring now to FIGS. 12A and 12B, a guidewire 220 comprises a tubular guidewire body 222 having three axially extensible elements 224 therein. Each of the elements 224 has a tissue penetrating tip 226 in which the tips will be drawn together to form a unitary tissue penetrating tip, as shown in Fig. 12A, to pass through the tissue layers. to form the initial tissue penetration. After guidewire 220 has been advanced to the target body lumen, however, elements 224 may be advanced axially through body 222 so that the tips, which are preformed to flip as shown in Fig. 12B, they will be turned upside down and attached to the tissue as an anchor. Such an anchor can be retracted by drawing elements 224 closely relative to guidewire body 22.

Referring now to Figs. 13A-13D, the methods according to the present invention will be described in more detail. As shown in Fig. 13A, an endoscope E can be advanced into an internal body space, such as the esophagus, to identify a target location D in a first layer of CT1 tissue. For example, the endoscope may include a viewing element 300 (typically a fiber optic or small camera) and an illumination source 302 (typically a fiber optic or LED) to allow such viewing. The endoscope will also typically include a working channel 304 that can be used to advance a guidewire 320 of

ES 2 575 245 T3 according to the principles of the present invention (Fig. 13B). Optionally, although not shown, a tissue penetration may be pre-formed, for example, by a trocar such as that described in another co-pending application 61 / 171,228 (Agent's File No. 026923-001200US). As shown in Fig. 13B, however, guidewire 320 in this example has a self-penetrating tip 322 and a penetrating enlargement deployable blade 324 such that advancement of the guidewire through tissue layers CT1 and CT2 provides elongated incisions. I1 and I2. A penetration of guidewire 320 through incisions I1 and I2 does not by itself draw the tissue layers CT1 and CT2 together as desired. To achieve the desired tissue juxtaposition, blade 324 retracts and a conical anchor 330 deploys, as shown in FIG. 13C. Guidewire 320 is drawn proximally so that deployed anchor 330 engages the second tissue layer CT2 and draws that layer against the first tissue layer CT1 to form a firm juxtaposition, as shown in Fig. 13C. While maintaining juxtaposition, a catheter C can be advanced through the working channel of the endoscope, over the guidewire, and through incisions I1 and I2, as shown in Fig. 13D. The catheter can be used for various purposes, including drainage, stenting, or the like. The conical balloon anchor 330 provides a working space 332 that allows the distal end 334 of catheter C to pass through the I1 and I2 tissue layer incisions and into the working space 332 without disturbing an engagement of the anchor 330 with the fabric, thus allowing a juxtaposition of fabric to be maintained.

While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.